Long Term Comparative Effectiveness of Once Weekly Semaglutide Versus Standard of Care in a Real World Adult US Population With Type 2 Diabetes - a Randomized Pragmatic Trial

June 7, 2024 updated by: Novo Nordisk A/S

Long Term Comparative Effectiveness of Once Weekly Semaglutide Versus Standard of Care in a Real World Adult US Population With Type 2 Diabetes - a Randomized Pragmatic Clinical Trial

The main purpose of this study is to compare the effects of semaglutide (Ozempic®) with the effects of other treatments for type 2 diabetes in a normal practice setting. The participant will be assigned by chance (like flipping a coin) to one of the following treatment groups: Group 1: semaglutide (Ozempic®) (by injection into skin) Group 2: standard of care antidiabetic medication (oral or injectable). The participant has an equal chance of being in either of the treatment groups. Neither the participant nor the study doctor or study staff will be able to pick which group the participant is in, but the participant will know which study drug the participant has been assigned to. The study doctor will provide the participant with a prescription for the study diabetes medication based on the treatment group the participant is assigned. The participation will last about 2 years.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1278

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • London, Ontario, Canada, N6G 2M1
        • Western University Medical Center at WU of Health Sciences
  • United States
    • California
      • Buena Park, California, United States, 90620
        • American Clinical Trials
      • Fullerton, California, United States, 92835
        • St. Jos Heritage Hlthcr_Fllrtn
      • Garden Grove, California, United States, 92844
        • SC Clinical Research, Inc.
      • Lancaster, California, United States, 93534
        • Om Research LLC
      • Lancaster, California, United States, 93534
        • New Hope Consulting & Clinical Trials
      • Los Alamitos, California, United States, 90720
        • Pacific Clinical Studies
      • Milpitas, California, United States, 95035
        • Pacific Medical Center
      • Mission Hills, California, United States, 91345
        • FACEY Medical Foundation
      • Monterey, California, United States, 93940
        • Monterey Endocrine & Diabetes Institute, Inc
      • Napa, California, United States, 94558
        • Do-Eun Lee
      • Oxnard, California, United States, 93030
        • FORMAT Medical Research
      • San Jose, California, United States, 95148
        • Joselito C Cabaccan, MD
      • Toluca Lake, California, United States, 91602
        • Premier Medical Center, Inc.
      • Torrance, California, United States, 90505
        • Adnab Research/Prestige Care Physician
      • Tulare, California, United States, 93274
        • Altura Centers For Health
      • Visalia, California, United States, 93291
        • Tariq Javed, MD Inc.
      • Walnut Creek, California, United States, 94598
        • Endocrinology & Diabetes Specialists
    • Colorado
      • Denver, Colorado, United States, 80220
        • University of Colorado Hospital
      • Englewood, Colorado, United States, 80113
        • Denver Endocrinology Diabetes and Thyroid Center
    • Connecticut
      • Bristol, Connecticut, United States, 06010
        • ProHealth Physicians/OptumCare
      • Danbury, Connecticut, United States, 06810
        • Western Connecticut Health Network_Danbury
      • Hamden, Connecticut, United States, 06517
        • Endocrine Associates of Connecticut
      • Milford, Connecticut, United States, 06460
        • Ismail Tarkhan MD
      • Milford, Connecticut, United States, 06460
        • Steven L. Saunders MD LLC
    • Georgia
      • Atlanta, Georgia, United States, 30312
        • Primary Care Research
      • Atlanta, Georgia, United States, 30106
        • The Kaufmann Clinic, Inc.
      • Augusta, Georgia, United States, 04915
        • Southern Family Medical Center
      • Blue Ridge, Georgia, United States, 30513
        • River Birch Research Alliance, LLC
      • Buford, Georgia, United States, 30519
        • Gwinnett Research Insti/Buford Family Pract Urgent Care Ctr
      • Columbus, Georgia, United States, 31904
        • Centricity Research
      • LaGrange, Georgia, United States, 30240
        • Medical Care of LaGrange
      • Lilburn, Georgia, United States, 30047
        • Beaver Ruin Primary Care
      • Locust Grove, Georgia, United States, 30248
        • Privia Medical Group of Georgia LLC
      • Marietta, Georgia, United States, 30067
        • Urban Family Practice Assoc
      • Marietta, Georgia, United States, 30060
        • DC Research Works
      • Roswell, Georgia, United States, 30075
        • Atlanta Center for Clinical Research
      • Sandersville, Georgia, United States, 31082
        • Sandersville Family Practice
      • Savannah, Georgia, United States, 31406
        • Meridian Clin Res, LLC
      • Statesboro, Georgia, United States, 30461
        • Family Health Care Center
      • Stockbridge, Georgia, United States, 30281
        • Eagles Landing Diabetes/Endocrinology
      • Suwanee, Georgia, United States, 30024
        • Herman Clinical Research LLC
      • Suwanee, Georgia, United States, 30024
        • Sugarloaf Medical, PC
      • Swainsboro, Georgia, United States, 30401
        • East Georgia Healthcare Center Inc
      • Waycross, Georgia, United States, 31501
        • Coastal Care Medical Clinic
    • Indiana
      • Anderson, Indiana, United States, 46016
        • St. Vincent Research Institute
      • Avon, Indiana, United States, 46123
        • American Health Network of Indiana, LLC_Avon_0
      • Berne, Indiana, United States, 46711
        • Adams County Family Physicians
      • Evansville, Indiana, United States, 47725
        • Deaconess Clinic, Inc.
      • Fort Wayne, Indiana, United States, 46825
        • Associated Surgeons & Physicians LLC
      • Franklin, Indiana, United States, 46131
        • American Health Network of IN LLC_Franklin
      • Greenfield, Indiana, United States, 46140
        • American Health Network of Indiana, LLC_Greenfield
      • Michigan City, Indiana, United States, 46360
        • La Porte County Institute For Clinical Research
      • Mishawaka, Indiana, United States, 46544
        • Beacon Medical Group Swartz-Weikamp
      • Muncie, Indiana, United States, 47304
        • American Health Network of IN LLC
      • New Albany, Indiana, United States, 47150
        • American Health Network of Indiana, LLC
      • Richmond, Indiana, United States, 47374
        • Reid Endocrinology Center
    • Kentucky
      • Ashland, Kentucky, United States, 41101
        • Regional Endorine and Diabetes Associates
      • Ashland, Kentucky, United States, 41101
        • Tri State Primary Caregrayson Health Park
      • Covington, Kentucky, United States, 41011
        • St Elizabeth Physicians Heart
      • Owensboro, Kentucky, United States, 42303
        • The Endocrine & Diabetes Center
      • Paris, Kentucky, United States, 40361
        • Paris Family Physicians PLLC
      • Richmond, Kentucky, United States, 40475
        • Gaurang B. Shah, MD
    • Maine
      • Belfast, Maine, United States, 04915
        • WCMP Family Medicine
    • Michigan
      • Sterling Heights, Michigan, United States, 48310-3503
        • Tri-County Research, Inc.
    • Missouri
      • Chesterfield, Missouri, United States, 63017
        • Diabetes & Endo Specialists Inc
      • Columbia, Missouri, United States, 65201
        • University of Missouri - Columbia
      • Jefferson City, Missouri, United States, 65109
        • Jefferson City Medical Group, PC
      • Saint Louis, Missouri, United States, 63104
        • Saint Louis University
      • Saint Louis, Missouri, United States, 63128
        • South County Endocrinology and Obesity Medicine, LLC
      • Springfield, Missouri, United States, 65803
        • Trinity Healthcare
    • Nevada
      • Las Vegas, Nevada, United States, 89148
        • Palm Research Center Inc-Vegas
    • New York
      • Albany, New York, United States, 12203
        • Albany Medical College - Endo
      • Brooklyn, New York, United States, 11221
        • Prominis Medical Services PC
      • Great Neck, New York, United States, 11021
        • Northwell Health Div of Endo
      • Great Neck, New York, United States, 11023
        • Advanced Internal Medicine Group
      • New York, New York, United States, 10016
        • NYU Grossman School of Med
      • New York, New York, United States, 10016
        • NYC Research, Inc.
      • Yonkers, New York, United States, 10704
        • EDOC LLP
    • North Carolina
      • Charlotte, North Carolina, United States, 28277
        • OnSite Clinical Solutions, LLC_Charlotte
      • Charlotte, North Carolina, United States, 28210
        • OnSite Clinical Solutions, LLC_Charlotte_0
    • North Dakota
      • Fargo, North Dakota, United States, 58104
        • Valley Weight Loss Clinic
    • Ohio
      • Blanchester, Ohio, United States, 45107
        • Catherine LaRuffa, M.D., Inc.
      • Canton, Ohio, United States, 44718
        • Diab & Endo Assoc of Stark Co
      • Carlisle, Ohio, United States, 45005
        • Medical Frontiers, LLC
      • Cleveland, Ohio, United States, 44106
        • University Hospitals of Cleveland Case Medical Center
      • Columbus, Ohio, United States, 43213
        • Centricity Research
      • Columbus, Ohio, United States, 43213
        • Central Ohio Clinical Research LLC
      • Franklin, Ohio, United States, 45005
        • Prestige Clinical Research
      • Franklin, Ohio, United States, 45005
        • Franklin Family Practice
      • Mason, Ohio, United States, 45040
        • Functional Endocrinology
      • Wadsworth, Ohio, United States, 44281
        • New Venture Medical Research
    • Pennsylvania
      • Harleysville, Pennsylvania, United States, 19438
        • Harleysville Medical Associates
      • McMurray, Pennsylvania, United States, 15317
        • Primary Care Research South, Inc
      • Pittsburgh, Pennsylvania, United States, 15236
        • Preferred Primary Care Physicians_Pittsburgh
    • Tennessee
      • Athens, Tennessee, United States, 37303
        • Athens Medical Group
      • Bristol, Tennessee, United States, 24201
        • Pmg Research of Bristol
      • Humboldt, Tennessee, United States, 38343
        • Murphy Research Center
      • McMinnville, Tennessee, United States, 37110
        • Ascend Research Centers, Inc.
    • Texas
      • New Braunfels, Texas, United States, 78130
        • Christus Trinity Clinic Hill Country Landa
      • Sugar Land, Texas, United States, 77478
        • Simcare Medical Research, LLC
    • Utah
      • Saint George, Utah, United States, 84790
        • Chrysalis Clinical Research
    • Virginia
      • Arlington, Virginia, United States, 22205
        • The Endocrinology Group
      • Chatham, Virginia, United States, 24531
        • Chatham Family Medical Center
      • Colonial Heights, Virginia, United States, 23834
        • Swift Creek Family Care
      • Daleville, Virginia, United States, 23083
        • Lawson Family Medicine & Aesthetics
      • Danville, Virginia, United States, 24541
        • Privia Medical Group LLC
      • Falls Church, Virginia, United States, 22044
        • Seven Corners Medical
      • Hampton, Virginia, United States, 23666
        • Hampton Family Practice
      • Lynchburg, Virginia, United States, 24501
        • Medical Associates of Central Virginia, Inc.
      • Newport News, Virginia, United States, 23606
        • C. Lee Ginsburgh
      • Portsmouth, Virginia, United States, 23701
        • Family Medicine Healthcare
      • Radford, Virginia, United States, 24141
        • Family Health Clinic
      • South Boston, Virginia, United States, 24592
        • Halifax Internal Medicine
      • Suffolk, Virginia, United States, 23435
        • Hampton Roads Center for Clinical Research
      • Virginia Beach, Virginia, United States, 23462
        • Corporation Lane Research Center
      • Virginia Beach, Virginia, United States, 23454
        • Endocrinology Consultants
      • Warrenton, Virginia, United States, 20186
        • Piedmont Family Practice PLC
      • Williamsburg, Virginia, United States, 49820
        • Family Care of Williamsburg
    • Wisconsin
      • Green Bay, Wisconsin, United States, 54303
        • St. Vincent Hosp-Prevea Health
      • Milwaukee, Wisconsin, United States, 53211
        • Ascension Medical Group- Germantown Clinic
      • Milwaukee, Wisconsin, United States, 53226
        • Medical College of Wisconsin & Zablocki VAMC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:-

  • Informed consent obtained before any study-related activities. Study-related activities are any procedures that are carried out as part of the study.
  • Male or female, age 18 years or older at the time of signing informed consent.
  • Type 2 diabetes mellitus diagnosis.
  • Treatment with either 1 or 2 oral antidiabetic medications.
  • Current member of a commercial or Medicare health plan with pharmacy benefits.
  • Recorded HbAlc value within the last 90 days prior to randomization.
  • Further intensification with an additional antidiabetic oral or injectable medication is indicated to achieve glycemic target at the discretion of the study physician according to approved labelling.

Exclusion Criteria:

  • Previous randomization in this study
  • Treatment with more than 2 oral antidiabetic medications, oral semaglutide, or any injectable medication in a period of 30 days before the day of eligibility assessment. Temporary/emergency use of any type of insulin is allowed, as is prior insulin treatment for gestational diabetes.
  • Contraindications to semaglutide according to the Food and Drug Administration approved label.
  • Female who is pregnant, breastfeeding or intends to become pregnant
  • Participation in another clinical trial.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Semaglutide
Participants will receive semaglutide subcutaneously (s.c.) in addition to metformin monotherapy as treatment intensification in the course of routine clinical practice. Participants will be followed for 2 years, regardless of changes in antidiabetic treatment over the course of the study.
Drug: Semaglutide
Participants will be prescribed commercially available semaglutide s.c. and will be instructed to initiate treatment with semaglutide s.c. according to the approved label. The study doctor will determine the intended maintenance dose of semaglutide, as well as changes to the maintenance dose thereafter.
Active Comparator: Standard of care
Participants will receive standard of care in addition to metformin monotherapy as treatment intensification in the course of routine clinical practice. Participants will be followed for 2 years, regardless of changes in antidiabetic treatment over the course of the study.
Drug: Standard of care
Participants will receive standard of care, defined as commercially available oral or injectable antidiabetic medication other than semaglutide. Participants will be prescribed and instructed to initiate commercially available antidiabetic medication according to the approved label and, if relevant for the specific antidiabetic medication, adjusted at the discretion of the study doctor.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number of Participants With Glycosylated Haemoglobin (HbA1c) Less Than 7.0 Percentage (%) (53 Millimoles Per Mole [mmol/Mol]) at Year 1 (Yes/No)
Time Frame: At year 1
Number of participants who achieved HbA1c less than 7.0 % (53 mmol/mol) at year 1 is presented. Yes: number of participants who achieved HbA1c less than 7.0 % at year 1; No: number of participants who did not achieve HbA1c less than 7.0 % at year 1.
At year 1

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in HbA1c (Percentage-point [%-Point]) From Baseline to Year 1
Time Frame: Baseline (less than or equal to 90 days prior to randomization at week 0), year 1
Change in HbA1c from baseline to year 1 is presented in %-point.
Baseline (less than or equal to 90 days prior to randomization at week 0), year 1
Number of Participants With HbA1c Less Than 7.0% (53 mmol/Mol) or At Least 1% Point Improvement in HbA1c Compared to Baseline at Year 1 (Yes/No)
Time Frame: At year 1
Number of participants who achieved HbA1c less than 7.0% (53 mmol/mol) or at least 1% point improvement in HbA1c compared to baseline at year 1 is presented. Yes: number of participants who achieved HbA1c less than 7.0% or at least 1% point improvement in HbA1c compared to baseline at year 1; No: number of participants who did not achieve HbA1c less than 7.0% or at least 1% point improvement in HbA1c compared to baseline at year 1
At year 1
Number of Participants With HbA1c Target Attainment Per Healthcare Effectiveness Data and Information Set (HEDIS) Criteria at Year 1 (Yes/No)
Time Frame: At year 1
Number of participants who achieved HbA1c target attainment per HEDIS criteria (less than 8.0% if age ≥ 65 years or with defined comorbidities, otherwise less than 7.0%) at year 1 is presented. Yes: Number of participants who achieved HbA1c target attainment per HEDIS criteria at year 1; No: Number of participants who did not achieve HbA1c target attainment per HEDIS criteria at year 1
At year 1
Change in Body Weight (in Pounds) From Baseline to Year 1
Time Frame: Baseline (less than or equal to 4 weeks prior to the randomization at week 0), year 1
Change in body weight (in pounds) from baseline to year 1 is presented.
Baseline (less than or equal to 4 weeks prior to the randomization at week 0), year 1
Percentage Change in Body Weight From Baseline to Year 1
Time Frame: Baseline (less than or equal to 4 weeks prior to the randomization at week 0), year 1
Percentage change in body weight from baseline to year 1 is presented.
Baseline (less than or equal to 4 weeks prior to the randomization at week 0), year 1
Change in Systolic Blood Pressure (SBP) From Baseline to Year 1
Time Frame: Baseline (less than or equal to 4 weeks prior to the randomization at week 0), year 1
Change in SBP from baseline to year 1 is presented.
Baseline (less than or equal to 4 weeks prior to the randomization at week 0), year 1
Change in Diastolic Blood Pressure (DBP) From Baseline to Year 1
Time Frame: Baseline (less than or equal to 4 weeks prior to the randomization at week 0), year 1
Change in DBP from baseline to year 1 is presented.
Baseline (less than or equal to 4 weeks prior to the randomization at week 0), year 1
Percentage of Medication Possession Ratio (MPR) for Study Drug Medication Adherence for the First Year of the Study
Time Frame: Week 0 to year 1
Percentage of MPR for study drug medication adherence for the first year of the study is presented. Medication adherence referred to a participant's conformance to the provider's recommendation with respect to timing, dosage, and frequency of medication taken during the prescribed length of time. The MPR was used to assess adherence. MPR was calculated as follows: MPR (%) = Sum of days supply for all prescription fills*100/Total number of days in time period. MPR was capped at 100%. MPR was calculated from pharmacy claims data and irrespective of adherence to randomized treatment or changes to antidiabetic treatment.
Week 0 to year 1
Diabetes Treatment Satisfaction Questionnaire, Change Version (DTSQc), Total Treatment Satisfaction Score Measured at Year 1
Time Frame: At year 1
DTSQc total treatment satisfaction score measured at year 1 is presented. The DTSQc provides a measure of how satisfied participants are with their current diabetes treatment compared with previous treatment. It consists of 8 questions, which are to be answered on a Likert scale from -3 to +3 (-3 = much less satisfied now to +3 = much more satisfied now), with 0 (midpoint), representing no change. Six questions are summed to produce a total treatment satisfaction score. The remaining two questions concern perceived frequency of hyperglycemia and perceived frequency of hypoglycemia, respectively. The DTSQc total treatment satisfaction score ranges from -18 to +18, with higher scores associated with greater treatment satisfaction.
At year 1
Change From Baseline in Work Productivity and Activity Impairment, General Health Questionnaire (WPAI-GH) Absenteeism (Work Time Missed) Score at Year 1
Time Frame: Baseline (less than or equal to 4 weeks prior to the randomization at week 0), year 1
Change from baseline in WPAI-GH Absenteeism (work time missed) score at year 1 is presented. The WPAI-GH yields four types of scores: Absenteeism (work time missed), Presenteesism (impairment at work/reduced on-the-job effectiveness), Work productivity loss (overall work impairment/absenteeism plus presenteeism), and Activity Impairment. WPAI outcomes are expressed as impairment percentages (0-100), with higher numbers indicating greater impairment and less productivity, i.e., worse outcomes (percent work time missed due to health, percent impairment while working due to health, percent overall work impairment due to health, percent activity impairment due to health).
Baseline (less than or equal to 4 weeks prior to the randomization at week 0), year 1
Change From Baseline in WPAI-GH Presenteeism (Impairment at Work/Reduced On-the-job Effectiveness) Score at Year 1
Time Frame: Baseline (less than or equal to 4 weeks prior to the randomization at week 0), year 1
Change from baseline in WPAI-GH Presenteeism (Impairment at Work/Reduced On-the-job Effectiveness) score at year 1 is presented. The WPAI-GH yields four types of scores: Absenteeism (work time missed), Presenteesism (impairment at work / reduced on-the-job effectiveness), Work productivity loss (overall work impairment / absenteeism plus presenteeism), and Activity Impairment. WPAI outcomes are expressed as impairment percentages (0-100), with higher numbers indicating greater impairment and less productivity, i.e., worse outcomes (percent work time missed due to health, percent impairment while working due to health, percent overall work impairment due to health, percent activity impairment due to health).
Baseline (less than or equal to 4 weeks prior to the randomization at week 0), year 1
Change From Baseline in WPAI-GH Work Productivity Loss (Overall Work Impairment/Absenteeism Plus Presenteeism) Score at Year 1
Time Frame: Baseline (less than or equal to 4 weeks prior to the randomization at week 0), year 1
Change from baseline in WPAI-GH work productivity loss (overall work impairment/absenteeism plus presenteeism) score at year 1 is presented. The WPAI-GH yields four types of scores: Absenteeism (work time missed), Presenteesism (impairment at work / reduced on-the-job effectiveness), Work productivity loss (overall work impairment / absenteeism plus presenteeism), and Activity Impairment. WPAI outcomes are expressed as impairment percentages (0-100), with higher numbers indicating greater impairment and less productivity, i.e., worse outcomes (percent work time missed due to health, percent impairment while working due to health, percent overall work impairment due to health, percent activity impairment due to health).
Baseline (less than or equal to 4 weeks prior to the randomization at week 0), year 1
Change From Baseline in WPAI-GH Activity Impairment Score at Year 1
Time Frame: Baseline (less than or equal to 4 weeks prior to the randomization at week 0), year 1
Change from baseline in WPAI-GH activity impairment score at year 1 is presented. The WPAI-GH yields four types of scores: Absenteeism (work time missed), Presenteesism (impairment at work/reduced on-the-job effectiveness), Work productivity loss (overall work impairment/absenteeism plus presenteeism), and Activity Impairment. WPAI outcomes are expressed as impairment percentages (0-100), with higher numbers indicating greater impairment and less productivity, i.e., worse outcomes (percent work time missed due to health, percent impairment while working due to health, percent overall work impairment due to health, percent activity impairment due to health).
Baseline (less than or equal to 4 weeks prior to the randomization at week 0), year 1
Number of Participants With HbA1c Less Than 8.0% (64 mmol/Mol) at Year 1 (Yes/No)
Time Frame: At year 1
Number of participants who achieved HbA1c less than 8.0% (64 mmol/mol) at year 1 is presented. Yes: number of participants who achieved HbA1c less than 8.0% (64 mmol/mol) at year 1; No: number of participants who did not achieve HbA1c less than 8.0% (64 mmol/mol) at year 1.
At year 1
Number of Participants With HbA1c Less Than 7.0% (53 mmol/Mol) and No Further Antidiabetic Medication Intensification After Randomization at Year 1 (Yes/No)
Time Frame: At year 1
Number of participants who achieved HbA1c less than 7.0% (53 mmol/mol) and no further antidiabetic medication intensification after randomization at year 1 is presented. Yes: number of participants who achieved HbA1c less than 7.0% (53 mmol/mol) and no further antidiabetic medication intensification after randomization at year 1; No: number of participants who did not achieve HbA1c less than 7.0% (53 mmol/mol) and no further antidiabetic medication intensification after randomization at year 1.
At year 1
Number of Participants With HbA1c Less Than 7.0% (53 mmol/Mol) at Year 1 in Participants With HbA1c >9.0% at Baseline (Yes/No)
Time Frame: At year 1
Number of participants who achieved HbA1c less than 7.0% (53 mmol/mol) at year 1 in participants with HbA1c >9.0% at baseline is presented. Yes: number of participants who achieved HbA1c less than 7.0% (53 mmol/mol) at year 1 in participants with HbA1c >9.0% at baseline; No: number of participants who did not achieve HbA1c less than 7.0% (53 mmol/mol) at year 1 in participants with HbA1c >9.0% at baseline.
At year 1
Number of Participants With HbA1c Less Than 8.0% (64 mmol/Mol) at Year 1 in Participants With HbA1c >9.0% at Baseline (Yes/No)
Time Frame: At year 1
Number of participants who achieved HbA1c less than 8.0% (64 mmol/mol) at year 1 in participants with HbA1c >9.0% at baseline is presented. Yes: number of participants who achieved HbA1c less than 8.0% (64 mmol/mol) at year 1 in participants with HbA1c >9.0% at baseline; No: number of participants who did not achieve HbA1c less than 8.0% (64 mmol/mol) at year 1 in participants with HbA1c >9.0% at baseline
At year 1
Number of Participants With Reported Hypoglycemia Leading to Inpatient Admission or ER Encounter During Year 1 (Yes/No)
Time Frame: Week 0 to year 1
Number of participants who reported hypoglycemia leading to inpatient admission or ER encounter during year 1 is presented. Yes: number of participants who reported hypoglycemia leading to inpatient admission or ER encounter during year 1; No: number of participants who did not report hypoglycemia leading to inpatient admission or ER encounter during year 1.
Week 0 to year 1
Number of Participants With HbA1c Less Than 7.0% (53 mmol/Mol) Without Experiencing Hypoglycemia Leading to Inpatient Admission or ER Encounter and Body Weight Loss of ≥ 5% Versus Baseline at Year 1 (Yes/No)
Time Frame: At year 1
Number of participants who achieved HbA1c less than 7.0% (53 mmol/mol) without experiencing hypoglycemia leading to inpatient admission or ER encounter and body weight loss of ≥ 5% versus baseline at year 1 is presented. Yes: number of participants who achieved HbA1c less than 7.0% (53 mmol/mol) without experiencing hypoglycemia leading to inpatient admission or ER encounter and body weight loss of ≥ 5% versus baseline at year 1; No: number of participants who did not achieve HbA1c less than 7.0% (53 mmol/mol) without experiencing hypoglycemia leading to inpatient admission or ER encounter and body weight loss of ≥ 5% versus baseline at year 1
At year 1
Number of Participants With Absolute HbA1c Reduction of ≥ 0.5% Without Experiencing Hypoglycemia Leading to Inpatient Admission or ER Encounter and a Body Weight Loss of ≥ 5% Versus Baseline at Year 1 (Yes/No)
Time Frame: At year 1
Number of participants who achieved absolute HbA1c reduction of ≥ 0.5% without experiencing hypoglycemia leading to inpatient admission or ER encounter and a body weight loss of ≥ 5% versus baseline at year 1 is presented. Yes: number of participants who achieved absolute HbA1c reduction of ≥ 0.5% without experiencing hypoglycemia leading to inpatient admission or ER encounter and a body weight loss of ≥ 5% versus baseline at year 1; No: number of participants who did not achieve absolute HbA1c reduction of ≥ 0.5% without experiencing hypoglycemia leading to inpatient admission or ER encounter and a body weight loss of ≥ 5% versus baseline at year 1.
At year 1
Number of Participants With HbA1c Less Than 7.0% (53 mmol/Mol) Without Experiencing Hypoglycemia Leading to Inpatient Admission or ER Encounter and No Body Weight Gain Versus Baseline at Year 1 (Yes/No)
Time Frame: At year 1
Number of participants who achieved HbA1c less than 7.0% (53 mmol/mol) without experiencing hypoglycemia leading to inpatient admission or ER encounter and no body weight gain versus baseline at year 1 is presented. Yes: number of participants who achieved HbA1c less than 7.0% (53 mmol/mol) without experiencing hypoglycemia leading to inpatient admission or ER encounter and no body weight gain versus baseline at year 1; No: number of participants who did not achieve HbA1c less than 7.0% (53 mmol/mol) without experiencing hypoglycemia leading to inpatient admission or ER encounter and no body weight gain versus baseline at year 1.
At year 1
Number of Participants With Glycosylated Haemoglobin (HbA1c) Less Than 7.0% (53 Millimoles Per Mole [mmol/Mol]) at Year 2 (Yes/No)
Time Frame: At year 2
Number of participants who achieved HbA1c less than 7.0 % (53 mmol/mol) at year 2 is presented. Yes: number of participants who achieved HbA1c less than 7.0 % at year 2; No: number of participants who did not achieve HbA1c less than 7.0 % at year 2.
At year 2
Change in HbA1c (Percentage-point [%-Point]) From Baseline to Year 2
Time Frame: Baseline (less than or equal to 90 days prior to randomization at week 0), year 2
Change in HbA1c from baseline to year 2 is presented in percentage-point.
Baseline (less than or equal to 90 days prior to randomization at week 0), year 2
Number of Participants Who Attained Individualized HbA1c Target at Year 1 (Yes/No)
Time Frame: At year 1
Number of participants who attained individualized HbA1c target at year 1 is presented. Study physicians set and documented an individualized HbA1c target for participants prior to randomization based on their clinical judgement and knowledge of the participant. Yes: number of participants who achieved individualized HbA1c target attained at year 1; No: number of participants who did not achieve individualized HbA1c target attained at year 1
At year 1
Time to First Study Drug Discontinuation During 2 Years
Time Frame: Week 0 to year 2
Time to first study drug discontinuation during 2 years is presented. First study drug discontinuation=date of the first time a patient is not taking study drug as defined.
Week 0 to year 2
Time to First Treatment Intensification (Add-on) or Change (Switch) After Randomization During 2 Years
Time Frame: Week 0 to year 2
Time to first treatment intensification (add-on) or change (switch) after randomization during 2 years is presented.
Week 0 to year 2
Number of Hypoglycemic Episodes Leading to an Inpatient Admission or Emergency Room (ER) Encounter From Baseline to Year 2
Time Frame: Baseline (less than or equal to 4 weeks prior to the randomization at week 0) to year 2
Number of hypoglycemic episodes leading to an inpatient admission or emergency room (ER) encounter from baseline to year 2 is presented.
Baseline (less than or equal to 4 weeks prior to the randomization at week 0) to year 2
DTSQc, Total Treatment Satisfaction Score Measured at Year 2
Time Frame: At year 2
DTSQc total treatment satisfaction score measured at year 2 is presented. The DTSQc provides a measure of how satisfied participants are with their current diabetes treatment compared with previous treatment. It consists of 8 questions, which are to be answered on a Likert scale from -3 to +3 (-3 = much less satisfied now to +3 = much more satisfied now), with 0 (midpoint), representing no change. Six questions are summed to produce a total treatment satisfaction score. The remaining two questions concern perceived frequency of hyperglycemia and perceived frequency of hypoglycemia, respectively. The DTSQc total treatment satisfaction score ranges from -18 to +18, with higher scores associated with greater treatment satisfaction.
At year 2
Change From Baseline in Short Form 12-Item Version 2 Survey (SF-12 v2), Physical Component Summary (PCS-12) Score at Year 1
Time Frame: Baseline (less than or equal to 4 weeks prior to the randomization at week 0), year 1
Change from baseline in SF-12 v2, PCS-12 score at year 1 is presented. The SF-12 v2 is a 12-item generic health-related quality of life measure that assesses physical and mental functioning. The items were scored using the scoring software. It contains two summary scores: Physical Component Summary (PCS) Score and Mental Component Summary (MCS) Score. The scores are norm-scored such that the scores range from 0-100 with a mean of 50 and standard deviation of 10. A higher score is associated with better quality of life and a lower score, poorer quality of life.
Baseline (less than or equal to 4 weeks prior to the randomization at week 0), year 1
Change From Baseline in SF-12 v2, PCS-12 Score at Year 2
Time Frame: Baseline (less than or equal to 4 weeks prior to the randomization at week 0), year 2
Change from baseline in SF-12 v2, PCS-12 score at year 2 is presented. The SF-12 v2 is a 12-item generic health-related quality of life measure that assesses physical and mental functioning. The items were scored using the scoring software. It contains two summary scores: Physical Component Summary (PCS) Score and Mental Component Summary (MCS) Score. The scores are norm-scored such that the scores range from 0-100 with a mean of 50 and standard deviation of 10. A higher score is associated with better quality of life and a lower score, poorer quality of life.
Baseline (less than or equal to 4 weeks prior to the randomization at week 0), year 2
Change From Baseline in SF-12 v2, Mental Component Summary (MCS-12) Score at Year 1
Time Frame: Baseline (less than or equal to 4 weeks prior to the randomization at week 0), year 1
Change from baseline in SF-12 v2, MCS-12 score at year 1 is presented. The SF-12 v2 is a 12-item generic health-related quality of life measure that assesses physical and mental functioning. The items were scored using the scoring software. It contains two summary scores: PCS Score and MCS Score. The scores are norm-scored such that the scores range from 0-100 with a mean of 50 and standard deviation of 10. A higher score is associated with better quality of life and a lower score, poorer quality of life.
Baseline (less than or equal to 4 weeks prior to the randomization at week 0), year 1
Change From Baseline in SF-12 v2, MCS-12 Score at Year 2
Time Frame: Baseline (less than or equal to 4 weeks prior to the randomization at week 0), year 2
Change from baseline in SF-12 v2, MCS-12 score at year 2 is presented. The SF-12 v2 is a 12-item generic health-related quality of life measure that assesses physical and mental functioning. The items were scored using the scoring software. It contains two summary scores: PCS Score and MCS Score. The scores are norm-scored such that the scores range from 0-100 with a mean of 50 and standard deviation of 10. A higher score is associated with better quality of life and a lower score, poorer quality of life.
Baseline (less than or equal to 4 weeks prior to the randomization at week 0), year 2
Change From Baseline in WPAI-GH Absenteeism (Work Time Missed) Score at Year 2
Time Frame: Baseline (less than or equal to 4 weeks prior to the randomization at week 0), year 2
Change from baseline in WPAI-GH Absenteeism (work time missed) score at year 2 is presented. The WPAI-GH yields four types of scores: Absenteeism (work time missed), Presenteesism (impairment at work/reduced on-the-job effectiveness), Work productivity loss (overall work impairment/absenteeism plus presenteeism), and Activity Impairment. WPAI outcomes are expressed as impairment percentages (0-100), with higher numbers indicating greater impairment and less productivity, i.e., worse outcomes (percent work time missed due to health, percent impairment while working due to health, percent overall work impairment due to health, percent activity impairment due to health).
Baseline (less than or equal to 4 weeks prior to the randomization at week 0), year 2
Change From Baseline in WPAI-GH Presenteeism (Impairment at Work/Reduced On-the-job Effectiveness) Score at Year 2
Time Frame: Baseline (less than or equal to 4 weeks prior to the randomization at week 0), year 2
Change from baseline in WPAI-GH Presenteeism (Impairment at Work/Reduced On-the-job Effectiveness) score at year 2 is presented. The WPAI-GH yields four types of scores: Absenteeism (work time missed), Presenteesism (impairment at work / reduced on-the-job effectiveness), Work productivity loss (overall work impairment / absenteeism plus presenteeism), and Activity Impairment. WPAI outcomes are expressed as impairment percentages (0-100), with higher numbers indicating greater impairment and less productivity, i.e., worse outcomes (percent work time missed due to health, percent impairment while working due to health, percent overall work impairment due to health, percent activity impairment due to health).
Baseline (less than or equal to 4 weeks prior to the randomization at week 0), year 2
Change From Baseline in WPAI-GH Work Productivity Loss (Overall Work Impairment/Absenteeism Plus Presenteeism) Score at Year 2
Time Frame: Baseline (less than or equal to 4 weeks prior to the randomization at week 0), year 2
Change from baseline in WPAI-GH work productivity loss (overall work impairment/absenteeism plus presenteeism) score at year 2 is presented. The WPAI-GH yields four types of scores: Absenteeism (work time missed), Presenteesism (impairment at work / reduced on-the-job effectiveness), Work productivity loss (overall work impairment / absenteeism plus presenteeism), and Activity Impairment. WPAI outcomes are expressed as impairment percentages (0-100), with higher numbers indicating greater impairment and less productivity, i.e., worse outcomes (percent work time missed due to health, percent impairment while working due to health, percent overall work impairment due to health, percent activity impairment due to health).
Baseline (less than or equal to 4 weeks prior to the randomization at week 0), year 2
Change From Baseline in WPAI-GH Activity Impairment Score at Year 2
Time Frame: Baseline (less than or equal to 4 weeks prior to the randomization at week 0), year 2
Change from baseline in WPAI-GH activity impairment score at year 2 is presented. The WPAI-GH yields four types of scores: Absenteeism (work time missed), Presenteesism (impairment at work/reduced on-the-job effectiveness), Work productivity loss (overall work impairment/absenteeism plus presenteeism), and Activity Impairment. WPAI outcomes are expressed as impairment percentages (0-100), with higher numbers indicating greater impairment and less productivity, i.e., worse outcomes (percent work time missed due to health, percent impairment while working due to health, percent overall work impairment due to health, percent activity impairment due to health).
Baseline (less than or equal to 4 weeks prior to the randomization at week 0), year 2
All Cause Healthcare Resource Utilization (HCRU): Mean Number of Inpatient Admissions Per Participant From Baseline to Year 2
Time Frame: From baseline (less than or equal to 4 weeks prior to the randomization at week 0) to year 2
All cause healthcare resource utilization - mean number of inpatient admissions per participant from baseline to year 2 is presented.
From baseline (less than or equal to 4 weeks prior to the randomization at week 0) to year 2
All Cause HCRU: Mean Cumulative Length of Stay for Inpatient Admissions Per Participant From Baseline to Year 2
Time Frame: From baseline (less than or equal to 4 weeks prior to the randomization at week 0) to year 2
All cause HCRU - mean cumulative length of stay for inpatient admissions per participant from baseline to year 2 is presented. Cumulative inpatient length of stay is the sum of the length of stay of all inpatient admissions a participant experiences from baseline to year 2.
From baseline (less than or equal to 4 weeks prior to the randomization at week 0) to year 2
All Cause HCRU: Mean Number of Emergency Room (ER) Encounters Per Participant From Baseline to Year 2
Time Frame: From baseline (less than or equal to 4 weeks prior to the randomization at week 0) to year 2
All cause HCRU - mean number of emergency room (ER) encounters per participant from baseline to year 2 is presented.
From baseline (less than or equal to 4 weeks prior to the randomization at week 0) to year 2
All Cause HCRU: Mean Number of Outpatient Encounters Per Participant From Baseline to Year 2
Time Frame: From baseline (less than or equal to 4 weeks prior to the randomization at week 0) to year 2
All cause HCRU - mean number of outpatient encounters per participant from baseline to year 2 is presented. Physician outpatient office visit is defined by a medical claim with outpatient place of service and an evaluation and management code.
From baseline (less than or equal to 4 weeks prior to the randomization at week 0) to year 2
All Cause HCRU: Mean Number of Medication Visits Per Participant From Baseline to Year 2
Time Frame: From baseline (less than or equal to 4 weeks prior to the randomization at week 0) to year 2
All cause HCRU - mean number of medication visits per participant from baseline to year 2 is presented.
From baseline (less than or equal to 4 weeks prior to the randomization at week 0) to year 2
All Cause HCRU: Number of Participants With Inpatient Admission (Yes/No) From Baseline to Year 2
Time Frame: From baseline (less than or equal to 4 weeks prior to the randomization at week 0) to year 2
All cause HCRU - number of participants with inpatient admission from baseline to year 2 is presented. Yes: number of participants who experienced inpatient admission; no: number of participants who did not experience inpatient admission.
From baseline (less than or equal to 4 weeks prior to the randomization at week 0) to year 2
All Cause HCRU: Number of Participants With ER Encounter (Yes/No) From Baseline to Year 2
Time Frame: From baseline (less than or equal to 4 weeks prior to the randomization at week 0) to year 2
All cause HCRU - number of participants with ER encounter from baseline to year 2 is presented. Yes: number of participants who experienced ER Encounter; no: number of participants who did not experience ER Encounter.
From baseline (less than or equal to 4 weeks prior to the randomization at week 0) to year 2
All Cause HCRU: Number of Participants With Outpatient Encounter (Yes/No) From Baseline to Year 2
Time Frame: From baseline (less than or equal to 4 weeks prior to the randomization at week 0) to year 2
All cause HCRU - number of participants with outpatient encounter from baseline to year 2 is presented. Physician outpatient office visit is defined by a medical claim with outpatient place of service and an evaluation and management code. Yes: number of participants who experienced outpatient encounter; no: number of participants who did not experience outpatient encounter.
From baseline (less than or equal to 4 weeks prior to the randomization at week 0) to year 2
Diabetes Related HCRU: Mean Number of Diabetes Related Inpatient Admissions Per Participant From Baseline to Year 2
Time Frame: From baseline (less than or equal to 4 weeks prior to the randomization at week 0) to year 2
Diabetes related HCRU - mean number of diabetes related inpatient admissions per participant from baseline to year 2 is presented.
From baseline (less than or equal to 4 weeks prior to the randomization at week 0) to year 2
Diabetes Related HCRU: Mean Cumulative Length of Stay for Diabetes Related Inpatient Admissions Per Participant From Baseline to Year 2
Time Frame: From baseline (less than or equal to 4 weeks prior to the randomization at week 0) to year 2
Diabetes related HCRU - mean cumulative length of stay for diabetes related inpatient admissions per participant from baseline to year 2 is presented. Cumulative inpatient length of stay is the sum of the length of stay of all diabetes related inpatient admissions a participant experiences from baseline to year 2.
From baseline (less than or equal to 4 weeks prior to the randomization at week 0) to year 2
Diabetes Related HCRU: Mean Number of Diabetes Related ER Encounters Per Participant From Baseline to Year 2
Time Frame: From baseline (less than or equal to 4 weeks prior to the randomization at week 0) to year 2
Diabetes related HCRU - mean number of diabetes related ER encounters per participant from baseline to year 2 is presented.
From baseline (less than or equal to 4 weeks prior to the randomization at week 0) to year 2
Diabetes Related HCRU: Mean Number of Diabetes Related Outpatient Encounters Per Participant From Baseline to Year 2
Time Frame: From baseline (less than or equal to 4 weeks prior to the randomization at week 0) to year 2
Diabetes related HCRU - mean number of diabetes related outpatient encounters per participant from baseline to year 2 is presented. Physician outpatient office visit is defined by a medical claim with outpatient place of service and an evaluation and management code.
From baseline (less than or equal to 4 weeks prior to the randomization at week 0) to year 2
Diabetes Related HCRU: Mean Number of Diabetes Related Medication Visits Per Participant From Baseline to Year 2
Time Frame: From baseline (less than or equal to 4 weeks prior to the randomization at week 0) to year 2
Diabetes related HCRU - mean number of diabetes related medication visits per participant from baseline to year 2 is presented.
From baseline (less than or equal to 4 weeks prior to the randomization at week 0) to year 2
Diabetes Related HCRU: Number of Participants With Diabetes Related Inpatient Admission (Yes/No) From Baseline to Year 2
Time Frame: From baseline (less than or equal to 4 weeks prior to the randomization at week 0) to year 2
Diabeted related HCRU - number of participants with diabetes related inpatient admission from baseline to year 2 is presented. Yes: number of participants who experienced diabetes related inpatient admission; no: number of participants who did not experience diabetes related inpatient admission.
From baseline (less than or equal to 4 weeks prior to the randomization at week 0) to year 2
Diabetes Related HCRU: Number of Participants With Diabetes Related ER Encounter (Yes/No) From Baseline to Year 2
Time Frame: From baseline (less than or equal to 4 weeks prior to the randomization at week 0) to year 2
Diabeted related HCRU - number of participants with diabeted related ER encounter from baseline to year 2 is presented. Yes: number of participants who experienced diabeted related ER encounter; no: number of participants who did not experience diabeted related ER encounter.
From baseline (less than or equal to 4 weeks prior to the randomization at week 0) to year 2
Diabetes Related HCRU: Number of Participants With Diabetes Related Outpatient Encounter (Yes/No) From Baseline to Year 2
Time Frame: From baseline (less than or equal to 4 weeks prior to the randomization at week 0) to year 2
Diabeted related HCRU - number of participants with diabeted related outpatient encounter from baseline to year 2 is presented. Physician outpatient office visit is defined by a medical claim with outpatient place of service and an evaluation and management code. Yes: number of participants who experienced diabeted related outpatient encounter; no: number of participants who did not experience diabeted related outpatient encounter.
From baseline (less than or equal to 4 weeks prior to the randomization at week 0) to year 2
Number of Participants Who Attained Individualized HbA1c Target at Year 2 (Yes/No)
Time Frame: At year 2
Number of participants who attained individualized HbA1c target at year 2 is presented. Study physicians set and documented an individualized HbA1c target for participants prior to randomization based on their clinical judgement and knowledge of the participant. Yes: number of participants who achieved individualized HbA1c target attained at year 2; No: number of participants who did not achieve individualized HbA1c target attained at year 2
At year 2
Number of Participants With HbA1c Less Than 7.0% (53 mmol/Mol) or At Least 1% Point Improvement in HbA1c Compared to Baseline at Year 2 (Yes/No)
Time Frame: At year 2
Number of participants who achieved HbA1c less than 7.0% (53 mmol/mol) or at least 1% point improvement in HbA1c compared to baseline at year 2 is presented. Yes: number of participants who achieved HbA1c less than 7.0% or at least 1% point improvement in HbA1c compared to baseline at year 2; No: number of participants who did not achieve HbA1c less than 7.0% or at least 1% point improvement in HbA1c compared to baseline at year 2.
At year 2
Number of Participants With HbA1c Less Than 8.0% (64 mmol/Mol) at Year 2 (Yes/No)
Time Frame: At year 2
Number of participants who achieved HbA1c less than 8.0% (64 mmol/mol) at year 2 is presented. Yes: number of participants who achieved HbA1c less than 8.0% (64 mmol/mol) at year 2; No: number of participants who did not achieve HbA1c less than 8.0% (64 mmol/mol) at year 2.
At year 2
Number of Participants With HbA1c Less Than 7.0% (53 mmol/Mol) and No Further Antidiabetic Medication Intensification After Randomization at Year 2 (Yes/No)
Time Frame: At year 2
Number of participants who achieved HbA1c less than 7.0% (53 mmol/mol) and no further antidiabetic medication intensification after randomization at year 2 is presented. Yes: number of participants who achieved HbA1c less than 7.0% (53 mmol/mol) and no further antidiabetic medication intensification after randomization at year 2; No: number of participants who did not achieve HbA1c less than 7.0% (53 mmol/mol) and no further antidiabetic medication intensification after randomization at year 2.
At year 2
Number of Participants With HbA1c Target Attainment Per Healthcare Effectiveness Data and Information Set (HEDIS) Criteria at Year 2 (Yes/No)
Time Frame: At year 2
Number of participants who achieved HbA1c target attainment per HEDIS criteria (less than 8.0% if age ≥ 65 years or with defined comorbidities, otherwise less than 7.0%) at year 2 is presented. Yes: Number of participants who achieved HbA1c target attainment per HEDIS criteria at year 2; No: Number of participants who did not achieve HbA1c target attainment per HEDIS criteria at year 2.
At year 2
Number of Participants With HbA1c Less Than 7.0% (53 mmol/Mol) at Year 2 in Participants With HbA1c >9.0% at Baseline (Yes/No)
Time Frame: At year 2
Number of participants who achieved HbA1c less than 7.0% (53 mmol/mol) at year 2 in participants with HbA1c >9.0% at baseline is presented. Yes: number of participants who achieved HbA1c less than 7.0% (53 mmol/mol) at year 2 in participants with HbA1c >9.0% at baseline; No: number of participants who did not achieve HbA1c less than 7.0% (53 mmol/mol) at year 2 in participants with HbA1c >9.0% at baseline.
At year 2
Number of Participants With HbA1c Less Than 8.0% (64 mmol/Mol) at Year 2 in Participants With HbA1c >9.0% at Baseline (Yes/No)
Time Frame: At year 2
Number of participants who achieved HbA1c less than 8.0% (64 mmol/mol) at year 2 in participants with HbA1c >9.0% at baseline is presented. Yes: number of participants who achieved HbA1c less than 8.0% (64 mmol/mol) at year 2 in participants with HbA1c >9.0% at baseline; No: number of participants who did not achieve HbA1c less than 8.0% (64 mmol/mol) at year 2 in participants with HbA1c >9.0% at baseline.
At year 2
Percentage Change in Body Weight From Baseline to Year 2
Time Frame: Baseline (less than or equal to 4 weeks prior to the randomization at week 0), year 2
Percentage change in body weight from baseline to year 2 is presented.
Baseline (less than or equal to 4 weeks prior to the randomization at week 0), year 2
Change in Body Weight (in Pounds) From Baseline to Year 2
Time Frame: Baseline (less than or equal to 4 weeks prior to the randomization at week 0), year 2
Change in body weight (in pounds) from baseline to year 2 is presented.
Baseline (less than or equal to 4 weeks prior to the randomization at week 0), year 2
Change in Systolic Blood Pressure (SBP) From Baseline to Year 2
Time Frame: Baseline (less than or equal to 4 weeks prior to the randomization at week 0), year 2
Change in SBP from baseline to year 2 is presented.
Baseline (less than or equal to 4 weeks prior to the randomization at week 0), year 2
Change in Diastolic Blood Pressure (DBP) From Baseline to Year 2
Time Frame: Baseline (less than or equal to 4 weeks prior to the randomization at week 0), year 2
Change in DBP from baseline to year 2 is presented.
Baseline (less than or equal to 4 weeks prior to the randomization at week 0), year 2
Number of Participants With Reported Hypoglycemia Leading to Inpatient Admission or ER Encounter During Year 2 (Yes/No)
Time Frame: Week 0 to year 2
Number of participants who reported hypoglycemia leading to inpatient admission or ER encounter during year 2 is presented. Yes: number of participants who reported hypoglycemia leading to inpatient admission or ER encounter during year 2; No: number of participants who did not report hypoglycemia leading to inpatient admission or ER encounter during year 2.
Week 0 to year 2
Number of Participants With HbA1c Less Than 7.0% (53 mmol/Mol) Without Experiencing Hypoglycemia Leading to Inpatient Admission or ER Encounter and Body Weight Loss of ≥ 5% Versus Baseline at Year 2 (Yes/No)
Time Frame: At year 2
Number of participants who achieved HbA1c less than 7.0% (53 mmol/mol) without experiencing hypoglycemia leading to inpatient admission or ER encounter and body weight loss of ≥ 5% versus baseline at year 2 is presented. Yes: number of participants who achieved HbA1c less than 7.0% (53 mmol/mol) without experiencing hypoglycemia leading to inpatient admission or ER encounter and body weight loss of ≥ 5% versus baseline at year 2; No: number of participants who did not achieve HbA1c less than 7.0% (53 mmol/mol) without experiencing hypoglycemia leading to inpatient admission or ER encounter and body weight loss of ≥ 5% versus baseline at year 2.
At year 2
Number of Participants With Absolute HbA1c Reduction of ≥ 0.5% Without Experiencing Hypoglycemia Leading to Inpatient Admission or ER Encounter and a Body Weight Loss of ≥ 5% Versus Baseline at Year 2 (Yes/No)
Time Frame: At year 2
Number of participants who achieved absolute HbA1c reduction of ≥ 0.5% without experiencing hypoglycemia leading to inpatient admission or ER encounter and a body weight loss of ≥ 5% versus baseline at year 2 is presented. Yes: number of participants who achieved absolute HbA1c reduction of ≥ 0.5% without experiencing hypoglycemia leading to inpatient admission or ER encounter and a body weight loss of ≥ 5% versus baseline at year 2; No: number of participants who did not achieve absolute HbA1c reduction of ≥ 0.5% without experiencing hypoglycemia leading to inpatient admission or ER encounter and a body weight loss of ≥ 5% versus baseline at year 2.
At year 2
Number of Participants With HbA1c Less Than 7.0% (53 mmol/Mol) Without Experiencing Hypoglycemia Leading to Inpatient Admission or ER Encounter and No Body Weight Gain Versus Baseline at Year 2 (Yes/No)
Time Frame: At year 2
Number of participants who achieved HbA1c less than 7.0% (53 mmol/mol) without experiencing hypoglycemia leading to inpatient admission or ER encounter and no body weight gain versus baseline at year 2 is presented. Yes: number of participants who achieved HbA1c less than 7.0% (53 mmol/mol) without experiencing hypoglycemia leading to inpatient admission or ER encounter and no body weight gain versus baseline at year 2; No: number of participants who did not achieve HbA1c less than 7.0% (53 mmol/mol) without experiencing hypoglycemia leading to inpatient admission or ER encounter and no body weight gain versus baseline at year 2.
At year 2
Percentage of Medication Possession Ratio (MPR) for Study Drug Medication Adherence For The Two Years of The Study
Time Frame: Week 0 to year 2
Percentage of MPR for study drug medication adherence for the two years of the study is presented. Medication adherence referred to a participant's conformance to the provider's recommendation with respect to timing, dosage, and frequency of medication taken during the prescribed length of time. The MPR was used to assess adherence. MPR was calculated as follows: MPR (%) = Sum of days supply for all prescription fills*100/Total number of days in time period. MPR was capped at 100%. MPR was calculated from pharmacy claims data and irrespective of adherence to randomized treatment or changes to antidiabetic treatment.
Week 0 to year 2

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Novo Nordisk A/S

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Clinical Reporting Anchor and Disclosure (1452), Novo Nordisk A/S

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 13, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 9, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 9, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 11, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 11, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 23, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 3, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 7, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • NN9535-4416
  • U1111-1207-6474 (Other Identifier: World Health Organization (WHO))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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