Efficacy and Safety Study of Rosiglitazone/Metformin Therapy vs Rosiglitazone and Metformin in Type 2 Diabetes Subjects

March 19, 2018 updated by: GlaxoSmithKline

A Randomized, Double-blind Trial to Evaluate the Efficacy and Safety of Fixed Dose Rosiglitazone/Metformin Combination Therapy Compared to Both Rosiglitazone and Metformin Monotherapies in Drug Naive Type 2 Diabetes Mellitus Subjects

The purpose of this 32 week study is to demonstrate that fixed-dose combination treatment with rosiglitazone/metformin will safely and effectively control glycemia as first line oral therapy in subjects type 2 diabetes. The primary objective of the study is to demonstrate superiority of rosiglitazone/metformin compared to its rosiglitazone and metformin.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

453

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
  • Brazil
      • São Paulo, Brazil, 04020-041
        • GSK Investigational Site
    • Pernambuco
      • Recife, Pernambuco, Brazil, 50100-130
        • 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, S4S 0A2
        • GSK Investigational Site
      • Regina, Saskatchewan, Canada, S4S 3R8
        • 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
  • Mexico
      • Durango, Mexico, 3400
        • GSK Investigational Site
      • Mexico, D.F., Mexico, 14050
        • GSK Investigational Site
      • Mexico, D.F., Mexico, 11850
        • GSK Investigational Site
    • Baja California Norte
      • Tijuana, Baja California Norte, Mexico, 22320
        • GSK Investigational Site
    • Jalisco
      • Guadalajara, Jalisco, Mexico, 44340
        • GSK Investigational Site
    • Nuevo León
      • Monterrey, Nuevo León, Mexico, 64570
        • 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
      • 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
      • Bristol, Tennessee, United States, 37620
        • GSK Investigational Site
      • 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
      • 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

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 18 to 70 years of age
  • Clinical diagnosis of type 2 diabetes
  • HbA1c >7.5% to 11%
  • FPG <270mg/dL (15mmol)
  • Current treatment with diet and/or exercise alone, or no more than 15 days of an anti-diabetic medication or insulin within 12 weeks of screening

Exclusion Criteria:

  • Clinically significant renal or hepatic disease
  • Presence of anemia
  • Presence of unstable or severe angina, coronary insufficiency, or any congestive heart failure requiring therapy
  • Systolic blood pressure >170mmHg or diastolic blood pressure >100mmHg, while on anti-hypertensive treatment
  • Chronic disease requiring intermittent or chronic treatment with corticosteroids
  • Any female lactating, pregnant, or planning to become pregnant
  • History of hepatocellular reaction, severe edema or a medically serious fluid related event associated with any thiazolidinedione
  • Presence of acute or chronic metabolic acidosis
  • History of diabetic ketoacidosis

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
Change from baseline in hemoglobin A1c (HbA1c) at week 32.
Time Frame: at 32 week
at 32 week

Secondary Outcome Measures

Outcome Measure
Time Frame
Key Secondary Measures: Change in FPG HbA1c and FPG responders Change in insulin, C-peptide, free fatty acids, lipids, insulin sensitivity and beta cell function Adverse Events Vital Signs Weight 32 weeks
Time Frame: at 32 weeksInvalid value
at 32 weeksInvalid value

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.

General Publications

  • Chou H., et. al.; Rosiglitazone and metformin fixed-dose combination provides superior glycaemic control compared to metformin and rosiglitazone monotherapies, and was well tolerated in drug-naïve patients with T2DM [poster]; European Association for the Study of Diabetes, 10-15 September 2005, Athens, Greece.

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 8, 2003

Primary Completion (Actual)

December 1, 2004

Study Completion (Actual)

December 16, 2004

Study Registration Dates

First Submitted

July 9, 2007

First Submitted That Met QC Criteria

July 9, 2007

First Posted (Estimate)

July 11, 2007

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

  • 712753/007

Plan for Individual participant data (IPD)

Study Data/Documents

  1. Informed Consent Form
    Information identifier: 712753/007
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  2. Individual Participant Data Set
    Information identifier: 712753/007
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  3. Dataset Specification
    Information identifier: 712753/007
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  4. Study Protocol
    Information identifier: 712753/007
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  5. Clinical Study Report
    Information identifier: 712753/007
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  6. Statistical Analysis Plan
    Information identifier: 712753/007
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  7. Annotated Case Report Form
    Information identifier: 712753/007
    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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