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

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00499707

Enrollment

453

Registered

2007-07-11

Start date

2003-10-08

Completion date

2004-12-16

Last updated

2018-03-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus, Type 2

Keywords

HbA1c, Drug-naive, type 2 diabetes

Brief summary

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.

Interventions

DRUGrosiglitazone maleate/metformin hydrochloride

rosiglitazone maleate/metformin hydrochloride

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

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	at 32 weeksInvalid value

Countries

Australia, Brazil, Canada, Mexico, New Zealand, South Korea, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 9, 2026