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COMPLETEDPhase 3NCT00499707

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

Lead sponsor: GlaxoSmithKline•48 U.S. locations•View source on ClinicalTrials.gov

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Sponsors

Lead Sponsor

GlaxoSmithKline

Age

18 - 70 years

Sex

ALL

Healthy Volunteers

No

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

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Data from ClinicalTrials.govLast updated on ClinicalTrials.gov: March 21, 2018Terms

Trial snapshot

StatusCOMPLETED

PhasePHASE3

Enrollment453

Start dateOct 2003

Last updatedMar 21, 2018

Condition

Diabetes Mellitus, Type 2

Locations shown

GSK Investigational Site

Anniston, Alabama

GSK Investigational Site

Chandler, Arizona

GSK Investigational Site

Phoenix, Arizona

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 21, 2018Data synced to Clareo: May 10, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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