A Trial Comparing the Efficacy, Patient-reported Outcomes and Safety of Insulin Degludec 200 U/mL vs Insulin Glargine in Subjects With Type 2 Diabetes Mellitus Requiring High-dose Insulin

January 24, 2017 updated by: Novo Nordisk A/S
This trial is conducted in the United States of America (USA). The aim of the trial is to confirm the efficacy of IDeg (insulin degludec) versus IGlar (insulin glargine) in controlling glycaemia. Subjects are to continue their pre-trial metformin treatment.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

145

Phase

  • Phase 3

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

  • Puerto Rico
      • Manati, Puerto Rico, 00674
        • Novo Nordisk Investigational Site
  • United States
    • Arizona
      • Mesa, Arizona, United States, 85206
        • Novo Nordisk Investigational Site
    • California
      • Fresno, California, United States, 93720
        • Novo Nordisk Investigational Site
      • Greenbrae, California, United States, 94904
        • Novo Nordisk Investigational Site
      • San Ramon, California, United States, 94583
        • Novo Nordisk Investigational Site
    • Florida
      • Bradenton, Florida, United States, 34201
        • Novo Nordisk Investigational Site
      • Hialeah, Florida, United States, 33012
        • Novo Nordisk Investigational Site
      • Homestead, Florida, United States, 33030
        • Novo Nordisk Investigational Site
      • Jacksonville, Florida, United States, 32207
        • Novo Nordisk Investigational Site
      • Kissimmee, Florida, United States, 34741
        • Novo Nordisk Investigational Site
      • Miami, Florida, United States, 33156
        • Novo Nordisk Investigational Site
      • Miami, Florida, United States, 33155
        • Novo Nordisk Investigational Site
      • Miami Lakes, Florida, United States, 33016
        • Novo Nordisk Investigational Site
      • St. Petersburg, Florida, United States, 33709
        • Novo Nordisk Investigational Site
    • Georgia
      • Roswell, Georgia, United States, 30076
        • Novo Nordisk Investigational Site
    • Illinois
      • Avon, Illinois, United States, 46123
        • Novo Nordisk Investigational Site
      • Chicago, Illinois, United States, 60611
        • Novo Nordisk Investigational Site
    • Kentucky
      • Lexington, Kentucky, United States, 40502
        • Novo Nordisk Investigational Site
      • Madisonville, Kentucky, United States, 42431
        • Novo Nordisk Investigational Site
    • Louisiana
      • Metairie, Louisiana, United States, 70002
        • Novo Nordisk Investigational Site
      • Slidell, Louisiana, United States, 70461-4231
        • Novo Nordisk Investigational Site
    • Maryland
      • Rockville, Maryland, United States, 20852
        • Novo Nordisk Investigational Site
    • Massachusetts
      • Worcester, Massachusetts, United States, 01655
        • Novo Nordisk Investigational Site
    • Michigan
      • Southfield, Michigan, United States, 48034-7661
        • Novo Nordisk Investigational Site
    • Missouri
      • Jefferson City, Missouri, United States, 65109
        • Novo Nordisk Investigational Site
    • Nevada
      • Las Vegas, Nevada, United States, 89106
        • Novo Nordisk Investigational Site
    • New Jersey
      • Lawrenceville, New Jersey, United States, 08648
        • Novo Nordisk Investigational Site
    • New York
      • Albany, New York, United States, 12206
        • Novo Nordisk Investigational Site
      • Northport, New York, United States, 11768
        • Novo Nordisk Investigational Site
      • Staten Island, New York, United States, 10301
        • Novo Nordisk Investigational Site
    • North Carolina
      • Greenville, North Carolina, United States, 27834
        • Novo Nordisk Investigational Site
    • Ohio
      • Franklin, Ohio, United States, 45005
        • Novo Nordisk Investigational Site
      • Kettering, Ohio, United States, 45429
        • Novo Nordisk Investigational Site
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Novo Nordisk Investigational Site
    • Tennessee
      • Chattanooga, Tennessee, United States, 37411
        • Novo Nordisk Investigational Site
      • Kingsport, Tennessee, United States, 37660
        • Novo Nordisk Investigational Site
      • Nashville, Tennessee, United States, 37212
        • Novo Nordisk Investigational Site
    • Texas
      • Dallas, Texas, United States, 75230
        • Novo Nordisk Investigational Site
      • Dallas, Texas, United States, 75246
        • Novo Nordisk Investigational Site
      • Dallas, Texas, United States, 75218
        • Novo Nordisk Investigational Site
      • Kingsville, Texas, United States, 78363-6322
        • Novo Nordisk Investigational Site
      • San Antonio, Texas, United States, 78207
        • Novo Nordisk Investigational Site
      • Schertz, Texas, United States, 78154
        • Novo Nordisk Investigational Site
      • Sugar Land, Texas, United States, 77478
        • Novo Nordisk Investigational Site
    • Washington
      • Tacoma, Washington, United States, 98405
        • Novo Nordisk Investigational Site
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53209
        • 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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Type 2 diabetes
  • Current treatment with once daily insulin glargine in vials with a daily dose equal to or above 65 U and equal to or below 100 U
  • Current treatment with a stable dose of metformin plus/minus one additional oral antidiabetic drug (OAD) for at least 12 weeks
  • Glycosylated haemoglobin (HbA1c) equal to or above 7.5%

Exclusion Criteria:

  • Current treatment with insulin other than insulin glargine in vials
  • Treatment with thiazolidinediones or glucagon-like peptide-1 (GLP-1) receptor agonists within 12 weeks
  • Stroke; heart failure; myocardial infarction; unstable angina pectoris; coronary arterial bypass graft or angioplasty
  • Suffer from cancer (except basal cell skin cancer and squamous-cell cancer)

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: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: IDeg followed by IGlar
Drug: insulin degludec
Cross-over trial, part 1: Individually adjusted IDeg administered subcutaneously (s.c., under the skin) once daily for 16 weeks in each treatment period.
Drug: insulin glargine
Cross-over trial, part 2: Individually adjusted IGlar administered subcutaneously (s.c., under the skin) once daily for the 16 week run-in period followed by 16 weeks in each treatment period.
Experimental: IGlar followed by IDeg
Drug: insulin degludec
Cross-over trial, part 1: Individually adjusted IDeg administered subcutaneously (s.c., under the skin) once daily for 16 weeks in each treatment period.
Drug: insulin glargine
Cross-over trial, part 2: Individually adjusted IGlar administered subcutaneously (s.c., under the skin) once daily for the 16 week run-in period followed by 16 weeks in each treatment period.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline (Visit 18) in Glycosylated Haemoglobin (HbA1c) at the End of Each 16 Week Treatment Period
Time Frame: Week 0, week 16 of each treatment period.
Values for change in HbA1c after each 16 weeks of treatment periods A and B.
Week 0, week 16 of each treatment period.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Patient Reported Outcome (PRO) Scores From Baseline to the End of Each 16 Week Treatment Period
Time Frame: Week 0, week 16 of each treatment period.
Changes in subjects quality of life and insulin device satisfaction were evaluated using the following PROs: the Short-Form 36 Health Survey version 2 (SF-36) and the Treatment Related Impact Measure-Diabetes Device (TRIM-DD). PRO total scores were measured from baseline to the end of each 16-week treatment period. Responses were measured on a scale of 0 to 100, where higher scores indicated a better quality of life and higher insulin device satisfaction on the SF-36 and TRIM-DD questionnaires, respectively.
Week 0, week 16 of each treatment period.
Change in PRO Scores From the End of Treatment Period A Until After 4 Weeks of Treatment in Treatment Period B
Time Frame: Week 16, week 20
SF-36 and TRIM-DD total scores were measured at the end of treatment A (week 16) and 4 weeks into treatment B (week 20). Responses were measured on a scale of 0 to 100, where higher scores indicated a better quality of life and higher insulin device satisfaction on the SF-36 and TRIM-DD questionnaires, respectively.
Week 16, week 20
Change From Baseline in Central Laboratory Measured Fasting Plasma Glucose (FPG) at the End of Each 16 Week Treatment Period
Time Frame: Week 0, week 16, week 32
Values of FPG in mmol/L from baseline to each 16 weeks of treatment periods.
Week 0, week 16, week 32
Change in FPG From the End of Treatment Period A Until After 4 Weeks of Treatment in Treatment Period B
Time Frame: Week 16, week 20
Values of FPG in mmol/L from the end of treatment period A until after 4 weeks of treatment in treatment period B.
Week 16, week 20
Number of Adverse Events (AEs)
Time Frame: From baseline to the end of each 16 week treatment period.
Number of treatment emergent adverse events (TEAEs) from week 0 to week 16 of the randomised treatment periods. A TEAE was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomised treatment. TEAEs were attributed to the treatment given in the period in which the event occurred.
From baseline to the end of each 16 week treatment period.

Collaborators and Investigators

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

Sponsor

Novo Nordisk A/S

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

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

April 1, 2012

Primary Completion (Actual)

January 1, 2014

Study Completion (Actual)

January 1, 2014

Study Registration Dates

First Submitted

April 2, 2012

First Submitted That Met QC Criteria

April 2, 2012

First Posted (Estimate)

April 4, 2012

Study Record Updates

Last Update Posted (Actual)

March 7, 2017

Last Update Submitted That Met QC Criteria

January 24, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NN1250-3943
  • U1111-1123-4774 (Other Identifier: WHO)

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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