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

October 31, 2023 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

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1278

Phase

  • 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

  • United States
    • California
      • Buena Park, California, United States, 90620
        • Novo Nordisk Investigational Site
      • Fullerton, California, United States, 92835
        • Novo Nordisk Investigational Site
      • Garden Grove, California, United States, 92844
        • Novo Nordisk Investigational Site
      • Lancaster, California, United States, 93534
        • Novo Nordisk Investigational Site
      • Los Alamitos, California, United States, 90720
        • Novo Nordisk Investigational Site
      • Milpitas, California, United States, 95035
        • Novo Nordisk Investigational Site
      • Mission Hills, California, United States, 91345
        • Novo Nordisk Investigational Site
      • Monterey, California, United States, 93940
        • Novo Nordisk Investigational Site
      • Napa, California, United States, 94558
        • Novo Nordisk Investigational Site
      • Oxnard, California, United States, 93030
        • Novo Nordisk Investigational Site
      • Pomona, California, United States, 91766-2007
        • Novo Nordisk Investigational Site
      • San Jose, California, United States, 95148
        • Novo Nordisk Investigational Site
      • Toluca Lake, California, United States, 91602
        • Novo Nordisk Investigational Site
      • Torrance, California, United States, 90505
        • Novo Nordisk Investigational Site
      • Tulare, California, United States, 93274
        • Novo Nordisk Investigational Site
      • Visalia, California, United States, 93291
        • Novo Nordisk Investigational Site
      • Walnut Creek, California, United States, 94598
        • Novo Nordisk Investigational Site
    • Colorado
      • Denver, Colorado, United States, 80220
        • Novo Nordisk Investigational Site
      • Englewood, Colorado, United States, 80113
        • Novo Nordisk Investigational Site
    • Connecticut
      • Bristol, Connecticut, United States, 06010
        • Novo Nordisk Investigational Site
      • Danbury, Connecticut, United States, 06810
        • Novo Nordisk Investigational Site
      • Hamden, Connecticut, United States, 06517
        • Novo Nordisk Investigational Site
      • Milford, Connecticut, United States, 06460
        • Novo Nordisk Investigational Site
    • Georgia
      • Atlanta, Georgia, United States, 30106
        • Novo Nordisk Investigational Site
      • Atlanta, Georgia, United States, 30312
        • Novo Nordisk Investigational Site
      • Augusta, Georgia, United States, 04915
        • Novo Nordisk Investigational Site
      • Blue Ridge, Georgia, United States, 30513
        • Novo Nordisk Investigational Site
      • Buford, Georgia, United States, 30519
        • Novo Nordisk Investigational Site
      • Columbus, Georgia, United States, 31904
        • Novo Nordisk Investigational Site
      • LaGrange, Georgia, United States, 30240
        • Novo Nordisk Investigational Site
      • Lilburn, Georgia, United States, 30047
        • Novo Nordisk Investigational Site
      • Locust Grove, Georgia, United States, 30248
        • Novo Nordisk Investigational Site
      • Marietta, Georgia, United States, 30060
        • Novo Nordisk Investigational Site
      • Marietta, Georgia, United States, 30067
        • Novo Nordisk Investigational Site
      • Roswell, Georgia, United States, 30075
        • Novo Nordisk Investigational Site
      • Sandersville, Georgia, United States, 31082
        • Novo Nordisk Investigational Site
      • Savannah, Georgia, United States, 31406
        • Novo Nordisk Investigational Site
      • Statesboro, Georgia, United States, 30461
        • Novo Nordisk Investigational Site
      • Stockbridge, Georgia, United States, 30281
        • Novo Nordisk Investigational Site
      • Suwanee, Georgia, United States, 30024
        • Novo Nordisk Investigational Site
      • Swainsboro, Georgia, United States, 30401
        • Novo Nordisk Investigational Site
      • Waycross, Georgia, United States, 31501
        • Novo Nordisk Investigational Site
    • Indiana
      • Anderson, Indiana, United States, 46016
        • Novo Nordisk Investigational Site
      • Avon, Indiana, United States, 46123
        • Novo Nordisk Investigational Site
      • Berne, Indiana, United States, 46711
        • Novo Nordisk Investigational Site
      • Evansville, Indiana, United States, 47725
        • Novo Nordisk Investigational Site
      • Fort Wayne, Indiana, United States, 46825
        • Novo Nordisk Investigational Site
      • Franklin, Indiana, United States, 46131
        • Novo Nordisk Investigational Site
      • Greenfield, Indiana, United States, 46140
        • Novo Nordisk Investigational Site
      • Michigan City, Indiana, United States, 46360
        • Novo Nordisk Investigational Site
      • Mishawaka, Indiana, United States, 46544
        • Novo Nordisk Investigational Site
      • Muncie, Indiana, United States, 47304
        • Novo Nordisk Investigational Site
      • New Albany, Indiana, United States, 47150
        • Novo Nordisk Investigational Site
      • Richmond, Indiana, United States, 47374
        • Novo Nordisk Investigational Site
    • Kentucky
      • Ashland, Kentucky, United States, 41101
        • Novo Nordisk Investigational Site
      • Covington, Kentucky, United States, 41011
        • Novo Nordisk Investigational Site
      • Owensboro, Kentucky, United States, 42303
        • Novo Nordisk Investigational Site
      • Paris, Kentucky, United States, 40361
        • Novo Nordisk Investigational Site
      • Richmond, Kentucky, United States, 40475
        • Novo Nordisk Investigational Site
    • Maine
      • Belfast, Maine, United States, 04915
        • Novo Nordisk Investigational Site
    • Michigan
      • Sterling Heights, Michigan, United States, 48310-3503
        • Novo Nordisk Investigational Site
    • Missouri
      • Chesterfield, Missouri, United States, 63017
        • Novo Nordisk Investigational Site
      • Columbia, Missouri, United States, 65201
        • Novo Nordisk Investigational Site
      • Jefferson City, Missouri, United States, 65109
        • Novo Nordisk Investigational Site
      • Saint Louis, Missouri, United States, 63104
        • Novo Nordisk Investigational Site
      • Saint Louis, Missouri, United States, 63128
        • Novo Nordisk Investigational Site
      • Springfield, Missouri, United States, 65803
        • Novo Nordisk Investigational Site
    • Nevada
      • Las Vegas, Nevada, United States, 89148
        • Novo Nordisk Investigational Site
    • New York
      • Albany, New York, United States, 12203
        • Novo Nordisk Investigational Site
      • Brooklyn, New York, United States, 11221
        • Novo Nordisk Investigational Site
      • Great Neck, New York, United States, 11021
        • Novo Nordisk Investigational Site
      • Great Neck, New York, United States, 11023
        • Novo Nordisk Investigational Site
      • New York, New York, United States, 10016
        • Novo Nordisk Investigational Site
      • Yonkers, New York, United States, 10704
        • Novo Nordisk Investigational Site
    • North Carolina
      • Charlotte, North Carolina, United States, 28277
        • Novo Nordisk Investigational Site
      • Charlotte, North Carolina, United States, 28210
        • Novo Nordisk Investigational Site
    • North Dakota
      • Fargo, North Dakota, United States, 58104
        • Novo Nordisk Investigational Site
    • Ohio
      • Blanchester, Ohio, United States, 45107
        • Novo Nordisk Investigational Site
      • Canton, Ohio, United States, 44718
        • Novo Nordisk Investigational Site
      • Carlisle, Ohio, United States, 45005
        • Novo Nordisk Investigational Site
      • Cleveland, Ohio, United States, 44106
        • Novo Nordisk Investigational Site
      • Columbus, Ohio, United States, 43213
        • Novo Nordisk Investigational Site
      • Franklin, Ohio, United States, 45005
        • Novo Nordisk Investigational Site
      • Mason, Ohio, United States, 45040
        • Novo Nordisk Investigational Site
      • Wadsworth, Ohio, United States, 44281
        • Novo Nordisk Investigational Site
    • Pennsylvania
      • Harleysville, Pennsylvania, United States, 19438
        • Novo Nordisk Investigational Site
      • Lansdale, Pennsylvania, United States, 19446-1002
        • Novo Nordisk Investigational Site
      • McMurray, Pennsylvania, United States, 15317
        • Novo Nordisk Investigational Site
      • Pittsburgh, Pennsylvania, United States, 15236
        • Novo Nordisk Investigational Site
    • Tennessee
      • Athens, Tennessee, United States, 37303
        • Novo Nordisk Investigational Site
      • Bristol, Tennessee, United States, 24201
        • Novo Nordisk Investigational Site
      • Humboldt, Tennessee, United States, 38343
        • Novo Nordisk Investigational Site
      • McMinnville, Tennessee, United States, 37110
        • Novo Nordisk Investigational Site
    • Texas
      • New Braunfels, Texas, United States, 78130
        • Novo Nordisk Investigational Site
      • Sugar Land, Texas, United States, 77478
        • Novo Nordisk Investigational Site
    • Utah
      • Saint George, Utah, United States, 84790
        • Novo Nordisk Investigational Site
    • Virginia
      • Arlington, Virginia, United States, 22205
        • Novo Nordisk Investigational Site
      • Chatham, Virginia, United States, 24531
        • Novo Nordisk Investigational Site
      • Colonial Heights, Virginia, United States, 23834
        • Novo Nordisk Investigational Site
      • Daleville, Virginia, United States, 23083
        • Novo Nordisk Investigational Site
      • Danville, Virginia, United States, 24541
        • Novo Nordisk Investigational Site
      • Falls Church, Virginia, United States, 22044
        • Novo Nordisk Investigational Site
      • Hampton, Virginia, United States, 23666
        • Novo Nordisk Investigational Site
      • Lynchburg, Virginia, United States, 24501
        • Novo Nordisk Investigational Site
      • Newport News, Virginia, United States, 23606
        • Novo Nordisk Investigational Site
      • Portsmouth, Virginia, United States, 23701
        • Novo Nordisk Investigational Site
      • Radford, Virginia, United States, 24141
        • Novo Nordisk Investigational Site
      • South Boston, Virginia, United States, 24592
        • Novo Nordisk Investigational Site
      • Suffolk, Virginia, United States, 23435
        • Novo Nordisk Investigational Site
      • Virginia Beach, Virginia, United States, 23462
        • Novo Nordisk Investigational Site
      • Virginia Beach, Virginia, United States, 23454
        • Novo Nordisk Investigational Site
      • Warrenton, Virginia, United States, 20186
        • Novo Nordisk Investigational Site
      • Williamsburg, Virginia, United States, 49820
        • Novo Nordisk Investigational Site
    • Wisconsin
      • Green Bay, Wisconsin, United States, 54303
        • Novo Nordisk Investigational Site
      • Milwaukee, Wisconsin, United States, 53226
        • Novo Nordisk Investigational Site
      • Milwaukee, Wisconsin, United States, 53211
        • Novo Nordisk Investigational Site

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

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
Intervention / Treatment
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

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

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) at Year 2 (Yes/No)
Time Frame: At year 2
At year 2
Change in HbA1c (%-Point) From Baseline to Year 2
Time Frame: Baseline (less than or equal to 90 days prior to randomization at week 0), year 2
Baseline (less than or equal to 90 days prior to randomization at week 0), year 2
Number of Participants With Individualized HbA1c Target Attained at Year 1 (Yes/No)
Time Frame: At year 1
Number of participants who achieved individualized HbA1c target attained 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
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
Time to First Study Drug Discontinuation During 2 Years
Time Frame: Week 0 to year 2
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
Week 0 to year 2
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
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
Baseline (less than or equal to 4 weeks prior to the randomization at week 0) to year 2
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
DTSQc, Total Treatment Satisfaction Score Measured at Year 2
Time Frame: At year 2
At year 2
Change From Baseline in Short Form 12-Item Version 2 Survey (SF-12 v2), Physical Summary Component (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 summary component (PCS) Score and Mental summary component (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
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 Summary Component (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
Baseline (less than or equal to 4 weeks prior to the randomization at week 0), year 2
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 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
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 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 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
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 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 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
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 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
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
Baseline (less than or equal to 4 weeks prior to the randomization at week 0), year 2
All Cause Healthcare Resource Utilization (HCRU): Number of Inpatient Admissions 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
From baseline (less than or equal to 4 weeks prior to the randomization at week 0) to year 2
All Cause HCRU: Cumulative Length of Stay for Inpatient Admissions 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
From baseline (less than or equal to 4 weeks prior to the randomization at week 0) to year 2
All Cause HCRU: Number of Emergency Room (ER) Encounters 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
From baseline (less than or equal to 4 weeks prior to the randomization at week 0) to year 2
All Cause HCRU: Number of Outpatient Encounters 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
From baseline (less than or equal to 4 weeks prior to the randomization at week 0) to year 2
All Cause HCRU: Number of Medications 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
From baseline (less than or equal to 4 weeks prior to the randomization at week 0) to year 2
All Cause HCRU: Occurrence of 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
From baseline (less than or equal to 4 weeks prior to the randomization at week 0) to year 2
All Cause HCRU: Occurrence of 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
From baseline (less than or equal to 4 weeks prior to the randomization at week 0) to year 2
All Cause HCRU: Occurrence of 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
From baseline (less than or equal to 4 weeks prior to the randomization at week 0) to year 2
Diabetes Related HCRU: Number of Diabetes Related Inpatient Admissions 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
From baseline (less than or equal to 4 weeks prior to the randomization at week 0) to year 2
Diabetes Related HCRU: Cumulative Length of Stay for Diabetes Related Inpatient Admissions 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
From baseline (less than or equal to 4 weeks prior to the randomization at week 0) to year 2
Diabetes Related HCRU: Number of Diabetes Related ER Encounters 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
From baseline (less than or equal to 4 weeks prior to the randomization at week 0) to year 2
Diabetes Related HCRU: Number of Diabetes Related Outpatient Encounters 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
From baseline (less than or equal to 4 weeks prior to the randomization at week 0) to year 2
Diabetes Related HCRU: Number of Diabetes Related Medications 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
From baseline (less than or equal to 4 weeks prior to the randomization at week 0) to year 2
Diabetes Related HCRU: Occurrence of 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
From baseline (less than or equal to 4 weeks prior to the randomization at week 0) to year 2
Diabetes Related HCRU: Occurrence of 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
From baseline (less than or equal to 4 weeks prior to the randomization at week 0) to year 2
Diabetes Related HCRU: Occurrence of 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
From baseline (less than or equal to 4 weeks prior to the randomization at week 0) to year 2
Number of Participants With Individualized HbA1c Target Attained at Year 2 (Yes/No)
Time Frame: 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
At year 2
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 8.0% (64 mmol/Mol) at Year 2 (Yes/No)
Time Frame: 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 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) and No Further Antidiabetic Medication Intensification After Randomization at Year 2 (Yes/No)
Time Frame: 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
At year 2
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 7.0% (53 mmol/Mol) at Year 2 in Participants With HbA1c >9.0% at Baseline (Yes/No)
Time Frame: At year 2
At year 2
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 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
At year 2
Change in Body Weight (in Percentage) From Baseline to Year 2
Time Frame: Baseline (less than or equal to 4 weeks prior to the randomization at week 0), year 2
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
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
Time Frame: Baseline (less than or equal to 4 weeks prior to the randomization at week 0), year 2
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
Time Frame: Baseline (less than or equal to 4 weeks prior to the randomization at week 0), year 2
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 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 Reported Hypoglycemia Leading to Inpatient Admission or ER Encounter During Year 2 (Yes/No)
Time Frame: Week 0 to 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 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 Body Weight Loss of ≥ 5% Versus Baseline at Year 2 (Yes/No)
Time Frame: 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
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 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 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
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
Week 0 to year 2

Collaborators and Investigators

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

Sponsor

Novo Nordisk A/S

Investigators

  • 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)

July 13, 2018

Primary Completion (Actual)

June 9, 2022

Study Completion (Actual)

June 9, 2023

Study Registration Dates

First Submitted

July 11, 2018

First Submitted That Met QC Criteria

July 11, 2018

First Posted (Actual)

July 23, 2018

Study Record Updates

Last Update Posted (Estimated)

November 3, 2023

Last Update Submitted That Met QC Criteria

October 31, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID 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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