A Study To Evaluate The Safety And Efficacy Of An Investigational Diabetes Drug In Poorly Controlled Type II Diabetics

March 19, 2018 updated by: GlaxoSmithKline

An Open-label Trial to Evaluate the Safety and Efficacy of Fixed Dose Rosiglitazone/Metformin Combination Therapy in Poorly-controlled Subjects With Type 2 Diabetes Mellitus

The purpose of this research study is to determine if a new investigational diabetes drug is safe and effective in treating people who have Type II diabetes mellitus with very high HbA1c or FPG (fasting plasma glucose) levels. The HbA1c test, also called the hemoglobin A1c test or glycated hemoglobin test, is a measurement of the average amount of sugar in the blood over the last 2 to 3 months. FPG is a test that measures the amount of sugar in the blood after an 8 hour fast.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

190

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

  • Australia
    • New South Wales
      • Camperdown, New South Wales, Australia, 2050
        • GSK Investigational Site
      • St Leonards, New South Wales, Australia, 2065
        • GSK Investigational Site
      • Wollongong, New South Wales, Australia, 2500
        • GSK Investigational Site
    • Queensland
      • Kippa Ring, Queensland, Australia, 4021
        • GSK Investigational Site
      • Woolloongabba, Queensland, Australia, 4102
        • GSK Investigational Site
    • South Australia
      • North Adelaide, South Australia, Australia, 5006
        • GSK Investigational Site
    • Victoria
      • Caulfield, Victoria, Australia, 3162
        • GSK Investigational Site
    • Western Australia
      • Fremantle, Western Australia, Australia, 6959
        • GSK Investigational Site
      • Perth, Western Australia, Australia, 6000
        • GSK Investigational Site
  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T3E 0C5
        • GSK Investigational Site
    • British Columbia
      • Coquitlam, British Columbia, Canada, V3K 3V9
        • GSK Investigational Site
      • Langley, British Columbia, Canada, V3A 4H9
        • GSK Investigational Site
    • New Brunswick
      • Moncton, New Brunswick, Canada, E1G 1A7
        • GSK Investigational Site
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3K 5R3
        • GSK Investigational Site
    • Ontario
      • Brampton, Ontario, Canada, L6T 3T1
        • GSK Investigational Site
      • Burlington, Ontario, Canada, L7M 4Y1
        • GSK Investigational Site
      • Courtice, Ontario, Canada, L1E 3C3
        • GSK Investigational Site
      • Kitchener, Ontario, Canada, N2C 2N9
        • GSK Investigational Site
      • North Bay, Ontario, Canada, P1B 2H3
        • GSK Investigational Site
      • Oshawa, Ontario, Canada, L1H 1C2
        • GSK Investigational Site
      • Peterborough, Ontario, Canada, K9J 7B3
        • GSK Investigational Site
      • Peterborough, Ontario, Canada, K9H 5G1
        • GSK Investigational Site
      • Renfrew, Ontario, Canada, K7V 1P6
        • GSK Investigational Site
      • Stoney Creek, Ontario, Canada, L8G 2V6
        • GSK Investigational Site
      • Toronto, Ontario, Canada, M3J 1N2
        • GSK Investigational Site
    • Quebec
      • Laval, Quebec, Canada, H7T 2P5
        • GSK Investigational Site
      • Montreal, Quebec, Canada, H3S 2W1
        • GSK Investigational Site
      • Montreal, Quebec, Canada, H4N 2W2
        • GSK Investigational Site
      • Montreal, Quebec, Canada, H1V 1X4
        • GSK Investigational Site
      • Plessisville, Quebec, Canada, G6L 3J1
        • GSK Investigational Site
      • Pointe-Claire, Quebec, Canada, H9R 4S3
        • GSK Investigational Site
      • Saint Insidore De Dorchester, Quebec, Canada, G0S 2S0
        • GSK Investigational Site
      • Saint Marc Des Carrieres, Quebec, Canada, G0A 4B0
        • GSK Investigational Site
      • Sainte Jerome, Quebec, Canada, J7Z 5T3
        • GSK Investigational Site
      • Sherbrooke, Quebec, Canada, J1H 1Z1
        • GSK Investigational Site
    • Saskatchewan
      • Regina, Saskatchewan, Canada, S4P 3X1
        • GSK Investigational Site
      • Saskatoon, Saskatchewan, Canada, S7K 0M5
        • GSK Investigational Site
  • Korea, Republic of
      • Pusan, Korea, Republic of, 602-739
        • GSK Investigational Site
      • Seoul, Korea, Republic of, 139-872
        • GSK Investigational Site
      • Uijeongbu,, Korea, Republic of, 480-821
        • GSK Investigational Site
  • New Zealand
      • Auckland, New Zealand, 1701
        • GSK Investigational Site
      • Auckland, New Zealand, 1311
        • GSK Investigational Site
      • Christchurch, New Zealand, 8001
        • GSK Investigational Site
      • Rotorua, New Zealand, 3201
        • GSK Investigational Site
      • Wellington, New Zealand, 6035
        • GSK Investigational Site
  • United States
    • Alabama
      • Anniston, Alabama, United States, 36207
        • GSK Investigational Site
    • Arizona
      • Chandler, Arizona, United States, 85224
        • GSK Investigational Site
      • Phoenix, Arizona, United States, 85050
        • GSK Investigational Site
      • Phoenix, Arizona, United States, 85014
        • GSK Investigational Site
      • Tucson, Arizona, United States, 85745
        • GSK Investigational Site
    • California
      • Encinitas, California, United States, 92024
        • GSK Investigational Site
      • Fullerton, California, United States, 92835
        • GSK Investigational Site
      • Los Banos, California, United States, 93635
        • GSK Investigational Site
      • Mission Viejo, California, United States, 92691
        • GSK Investigational Site
    • Florida
      • Jacksonville, Florida, United States, 32204
        • GSK Investigational Site
      • Melbourne, Florida, United States, 32901
        • GSK Investigational Site
      • Miami, Florida, United States, 33156
        • GSK Investigational Site
      • Orlando, Florida, United States, 32806
        • GSK Investigational Site
      • Saint Cloud, Florida, United States, 34769
        • GSK Investigational Site
    • Georgia
      • Atlanta, Georgia, United States, 30342
        • GSK Investigational Site
      • Atlanta, Georgia, United States, 30308
        • GSK Investigational Site
      • Fayetteville, Georgia, United States, 30214
        • GSK Investigational Site
      • Woodstock, Georgia, United States, 30189
        • GSK Investigational Site
    • Illinois
      • Chicago, Illinois, United States, 60607
        • GSK Investigational Site
    • Indiana
      • Evansville, Indiana, United States, 47713
        • GSK Investigational Site
      • Newburgh, Indiana, United States, 47630
        • GSK Investigational Site
    • Louisiana
      • Slidell, Louisiana, United States, 70461
        • GSK Investigational Site
    • Mississippi
      • Jackson, Mississippi, United States, 39202
        • GSK Investigational Site
    • Missouri
      • Chesterfield, Missouri, United States, 63017
        • GSK Investigational Site
      • Kansas City, Missouri, United States, 64111
        • GSK Investigational Site
      • Saint Louis, Missouri, United States, 63376
        • GSK Investigational Site
    • Nevada
      • Las Vegas, Nevada, United States, 89103
        • GSK Investigational Site
    • New York
      • Kingston, New York, United States, 12401
        • GSK Investigational Site
      • New York, New York, United States, 10032
        • GSK Investigational Site
      • New York, New York, United States, 10024
        • GSK Investigational Site
      • New York, New York, United States, 10029
        • GSK Investigational Site
      • Rochester, New York, United States, 14609
        • GSK Investigational Site
    • North Carolina
      • Charlotte, North Carolina, United States, 28210
        • GSK Investigational Site
    • Ohio
      • Mogadore, Ohio, United States, 44260
        • GSK Investigational Site
    • Pennsylvania
      • Downingtown, Pennsylvania, United States, 19335
        • GSK Investigational Site
      • Warminster, Pennsylvania, United States, 18974
        • GSK Investigational Site
      • West Chester, Pennsylvania, United States, 19382
        • GSK Investigational Site
    • Tennessee
      • Johnson City, Tennessee, United States, 37601
        • GSK Investigational Site
    • Texas
      • Arlington, Texas, United States, 76017
        • GSK Investigational Site
      • Beaumont, Texas, United States, 77701
        • GSK Investigational Site
      • Bryan, Texas, United States, 77802
        • GSK Investigational Site
      • Corpus Christi, Texas, United States, 78411
        • GSK Investigational Site
      • Dallas, Texas, United States, 75230
        • GSK Investigational Site
      • Midland, Texas, United States, 79705
        • GSK Investigational Site
      • San Antonio, Texas, United States, 78221
        • GSK Investigational Site
      • San Antonio, Texas, United States, 78237
        • GSK Investigational Site
    • Washington
      • Seattle, Washington, United States, 98108
        • GSK Investigational Site
      • Spokane, Washington, United States, 99207
        • GSK Investigational Site
      • Wenatchee, Washington, United States, 98801
        • GSK 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

16 years to 68 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Laboratory result for HbA1c >11% or FPG >270mg/dL
  • Clinical diagnosis of Type II diabetes
  • Prior treatment with diet and/or exercise alone, or less than 15 days of prior treatment with an oral anti-diabetic medication or insulin.

Exclusion Criteria:

  • Women who are pregnant

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Hemoglobin A1c (HbA1c) reduction after 24 weeks of treatment.

Secondary Outcome Measures

Outcome Measure
Change in FPG, insulin,C-peptide, insulin sensitivity,beta cell function, free fatty acids, lipids. Change in weight, vital signs, clinical laboratory tests, and adverse experiences.

Collaborators and Investigators

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

Sponsor

GlaxoSmithKline

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.

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

October 17, 2003

Primary Completion (Actual)

November 1, 2004

Study Completion (Actual)

November 30, 2004

Study Registration Dates

First Submitted

September 3, 2003

First Submitted That Met QC Criteria

September 4, 2003

First Posted (Estimate)

September 5, 2003

Study Record Updates

Last Update Posted (Actual)

March 21, 2018

Last Update Submitted That Met QC Criteria

March 19, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 712753/004

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Study Data/Documents

  1. Statistical Analysis Plan
    Information identifier: 712753/004
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  2. Informed Consent Form
    Information identifier: 712753/004
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  3. Clinical Study Report
    Information identifier: 712753/004
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  4. Study Protocol
    Information identifier: 712753/004
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  5. Individual Participant Data Set
    Information identifier: 712753/004
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  6. Dataset Specification
    Information identifier: 712753/004
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  7. Annotated Case Report Form
    Information identifier: 712753/004
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register

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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