Effect of Liraglutide on Blood Glucose Control in Subjects With Type 2 Diabetes (LEAD-4)

January 24, 2017 updated by: Novo Nordisk A/S

Effect on Glycemic Control of Liraglutide in Combination With Rosiglitazone Plus Metformin Versus Rosiglitazone Plus Metformin in Subjects With Type 2 Diabetes

This trial is conducted in the United States of America (USA) and Canada. This trial is designed to show the effect of treatment with liraglutide when added to existing rosiglitazone and metformin combination therapy and to compare it with the effects of therapy with rosiglitazone and metformin alone.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

576

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

  • Canada
      • Gatineau, Canada, J8T 8M1
        • Novo Nordisk Investigational Site
      • Mississauga, Canada, L5M 2V8
        • Novo Nordisk Investigational Site
      • Montreal, Canada, H3A 1A1
        • Novo Nordisk Investigational Site
      • Montreal, Canada, H2W 1R7
        • Novo Nordisk Investigational Site
      • Quebec, Canada, G1V 4G2
        • Novo Nordisk Investigational Site
      • Red Deer, Canada, T4N 6V7
        • Novo Nordisk Investigational Site
      • St John's, Canada, A1B 3V6
        • Novo Nordisk Investigational Site
      • Toronto, Canada, M5G 1X5
        • Novo Nordisk Investigational Site
      • Vancouver, Canada, V5Z 1C6
        • Novo Nordisk Investigational Site
      • Windsor, Canada, N8W 3K2
        • Novo Nordisk Investigational Site
    • Alberta
      • Calgary, Alberta, Canada, T2H 2G4
        • Novo Nordisk Investigational Site
      • Edmonton, Alberta, Canada, T5J 3N4
        • Novo Nordisk Investigational Site
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3E 3P4
        • Novo Nordisk Investigational Site
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H 1V7
        • Novo Nordisk Investigational Site
    • Ontario
      • London, Ontario, Canada, N6A 4V2
        • Novo Nordisk Investigational Site
      • Ottawa, Ontario, Canada, K1N 6N5
        • Novo Nordisk Investigational Site
      • Toronto, Ontario, Canada, M5C 2T2
        • Novo Nordisk Investigational Site
    • Quebec
      • Laval, Quebec, Canada, H7T 2P5
        • Novo Nordisk Investigational Site
  • United States
    • Arizona
      • Goodyear, Arizona, United States, 85395
        • Novo Nordisk Investigational Site
    • California
      • Colton, California, United States, 92324
        • Novo Nordisk Investigational Site
      • Concord, California, United States, 94520
        • Novo Nordisk Investigational Site
      • Escondido, California, United States, 92025
        • Novo Nordisk Investigational Site
      • La Jolla, California, United States, 92037
        • Novo Nordisk Investigational Site
      • Long Beach, California, United States, 90822
        • Novo Nordisk Investigational Site
      • Los Angeles, California, United States, 90057
        • Novo Nordisk Investigational Site
      • Los Angeles, California, United States, 90024
        • Novo Nordisk Investigational Site
      • Mission Viejo, California, United States, 92691
        • Novo Nordisk Investigational Site
      • Orange, California, United States, 92869
        • Novo Nordisk Investigational Site
      • Santa Ana, California, United States, 92705
        • Novo Nordisk Investigational Site
      • Santa Barbara, California, United States, 93105
        • Novo Nordisk Investigational Site
      • Spring Valley, California, United States, 91978
        • Novo Nordisk Investigational Site
    • Connecticut
      • New Britain, Connecticut, United States, 06050
        • Novo Nordisk Investigational Site
    • District of Columbia
      • Washington, District of Columbia, United States, 20010
        • Novo Nordisk Investigational Site
    • Florida
      • Fort Myers, Florida, United States, 33907
        • Novo Nordisk Investigational Site
      • Jacksonville, Florida, United States, 32204
        • Novo Nordisk Investigational Site
      • Lake Mary, Florida, United States, 32746
        • Novo Nordisk Investigational Site
      • Plantation, Florida, United States, 33324
        • Novo Nordisk Investigational Site
    • Georgia
      • Athens, Georgia, United States, 30606
        • Novo Nordisk Investigational Site
      • Atlanta, Georgia, United States, 30318
        • Novo Nordisk Investigational Site
      • Atlanta, Georgia, United States, 30032
        • Novo Nordisk Investigational Site
      • Atlanta, Georgia, United States, 30034
        • Novo Nordisk Investigational Site
      • Powder Springs, Georgia, United States, 30127
        • Novo Nordisk Investigational Site
    • Idaho
      • Idaho Falls, Idaho, United States, 83404-7596
        • Novo Nordisk Investigational Site
    • Illinois
      • Peoria, Illinois, United States, 61615
        • Novo Nordisk Investigational Site
    • Indiana
      • New Albany, Indiana, United States, 47150
        • Novo Nordisk Investigational Site
    • Iowa
      • Des Moines, Iowa, United States, 50314
        • Novo Nordisk Investigational Site
    • Kansas
      • Topeka, Kansas, United States, 66606
        • Novo Nordisk Investigational Site
    • Kentucky
      • Lexington, Kentucky, United States, 40503
        • Novo Nordisk Investigational Site
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70808
        • Novo Nordisk Investigational Site
      • New Orleans, Louisiana, United States, 70121
        • Novo Nordisk Investigational Site
    • Maryland
      • Hyattsville, Maryland, United States, 20782
        • Novo Nordisk Investigational Site
    • Mississippi
      • Tupelo, Mississippi, United States, 38801
        • Novo Nordisk Investigational Site
    • Missouri
      • St. Louis, Missouri, United States, 63110
        • Novo Nordisk Investigational Site
    • Nevada
      • Reno, Nevada, United States, 89502
        • Novo Nordisk Investigational Site
    • New Jersey
      • Berlin, New Jersey, United States, 08009
        • Novo Nordisk Investigational Site
      • Plainsboro, New Jersey, United States, 08536
        • Novo Nordisk Investigational Site
    • New York
      • Albany, New York, United States, 12206
        • Novo Nordisk Investigational Site
      • Brooklyn, New York, United States, 11203
        • Novo Nordisk Investigational Site
      • Northport, New York, United States, 11768
        • Novo Nordisk Investigational Site
      • Rochester, New York, United States, 14621
        • Novo Nordisk Investigational Site
    • North Carolina
      • Asheville, North Carolina, United States, 28803
        • Novo Nordisk Investigational Site
      • Chapel Hill, North Carolina, United States, 27599-7172
        • Novo Nordisk Investigational Site
      • Durham, North Carolina, United States, 27710
        • Novo Nordisk Investigational Site
      • Greenville, North Carolina, United States, 27834
        • Novo Nordisk Investigational Site
    • Ohio
      • Cincinnati, Ohio, United States, 45245
        • Novo Nordisk Investigational Site
      • Cleveland, Ohio, United States, 44195
        • Novo Nordisk Investigational Site
      • Columbus, Ohio, United States, 43203
        • Novo Nordisk Investigational Site
      • Columbus, Ohio, United States, 43212
        • Novo Nordisk Investigational Site
      • Dayton, Ohio, United States, 45406
        • Novo Nordisk Investigational Site
      • Kettering, Ohio, United States, 45429
        • Novo Nordisk Investigational Site
      • Mentor, Ohio, United States, 44060
        • Novo Nordisk Investigational Site
    • South Carolina
      • Duncan, South Carolina, United States, 29334
        • Novo Nordisk Investigational Site
    • Tennessee
      • Chattanooga, Tennessee, United States, 37404
        • Novo Nordisk Investigational Site
    • Texas
      • Arlington, Texas, United States, 76014
        • Novo Nordisk Investigational Site
      • Dallas, Texas, United States, 75230
        • Novo Nordisk Investigational Site
      • Dallas, Texas, United States, 75231
        • Novo Nordisk Investigational Site
      • Dallas, Texas, United States, 75390-8858
        • Novo Nordisk Investigational Site
      • Dallas, Texas, United States, 75246
        • Novo Nordisk Investigational Site
      • Houston, Texas, United States, 77030
        • Novo Nordisk Investigational Site
      • Houston, Texas, United States, 77025
        • Novo Nordisk Investigational Site
      • Lubbock, Texas, United States, 79430-8183
        • Novo Nordisk Investigational Site
      • Midland, Texas, United States, 79707
        • Novo Nordisk Investigational Site
      • San Antonio, Texas, United States, 78229
        • Novo Nordisk Investigational Site
      • San Antonio, Texas, United States, 78209
        • Novo Nordisk Investigational Site
    • Utah
      • Salt Lake City, Utah, United States, 84102
        • Novo Nordisk Investigational Site
    • Virginia
      • Newport News, Virginia, United States, 23606
        • Novo Nordisk Investigational Site
      • Richmond, Virginia, United States, 23294
        • Novo Nordisk Investigational Site
    • Washington
      • Spokane, Washington, United States, 99218
        • 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 to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Type 2 diabetes
  • Treated with oral anti-diabetic (OAD) drugs for at least 3 months
  • Treated with one or more OAD and in moderate to poor glycemic control
  • Body Mass Index (BMI) less than or equal to 45.0 kg/m2

Exclusion Criteria:

  • Treatment with insulin within the last three months prior to the trial except due to intercurrent illness, at the discretion of the Investigator
  • Any serious medical condition
  • Treatment with any drug that could interfere with glucose level

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: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
HbA1c
Time Frame: after 26 weeks of treatment
after 26 weeks of treatment

Secondary Outcome Measures

Outcome Measure
Safety and tolerability
body weight
Glycaemic control

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

May 1, 2006

Primary Completion (Actual)

August 1, 2007

Study Completion (Actual)

August 1, 2007

Study Registration Dates

First Submitted

June 1, 2006

First Submitted That Met QC Criteria

June 1, 2006

First Posted (Estimate)

June 2, 2006

Study Record Updates

Last Update Posted (Estimate)

January 25, 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

  • NN2211-1574

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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