Last updated: 11/04/2018 04:07:26

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

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GSK study ID
712753/007
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Clinicaltrials.gov ID
NCT00499707
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: 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
Trial description: 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.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Allocation:
Randomized
Primary outcomes:

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

Timeframe: at 32 week

Secondary outcomes:

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

Timeframe: at 32 weeksInvalid value

Interventions:
  • Drug: rosiglitazone maleate/metformin hydrochloride
    • Enrollment:
    453
    Primary completion date:
    Not applicable
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical 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.
    Medical condition
    Diabetes Mellitus, Type 2
    Product
    metformin, rosiglitazone, rosiglitazone/metformin
    Collaborators
    Not applicable
    Study date(s)
    October 2003 to December 2004
    Type
    Interventional
    Phase
    3

    Participation criteria

    Sex
    Female & Male
    Age
    18 - 70 years
    Accepts healthy volunteers
    No
    • 18 to 70 years of age
    • Clinical diagnosis of type 2 diabetes
    • Clinically significant renal or hepatic disease
    • Presence of anemia
    Inclusion and exclusion criteria
    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

    Trial location(s)

    Location
    Status
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    Location
    GSK Investigational Site
    Jackson, Mississippi, United States, 39202
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Midland, Texas, United States, 79705
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Jacksonville, Florida, United States, 32204
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Charlotte, North Carolina, United States, 28210
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Regina, Saskatchewan, Canada, S4S 3R8
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Kingston, New York, United States, 12401
    Status
    Study Complete
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    Showing 1 - 6 of 101 Results

    Study documents

    Clinical study report
    Available language(s): English
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    Scientific result summary
    Available language(s): English
    Download document(s)

    If you wish to request for full study report, please contact - [email protected]

    Results overview

    Refer to study documents

    Recruitment status
    Study complete
    Actual primary completion date
    Not applicable
    Actual study completion date
    2004-16-12

    Plain language summaries

    Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

    Additional information about the trial

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    Additional information
    http://ctr.gsk.co.uk/Summary/Rosiglitazone/III_712753_007.pdf
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