Efficacy and Safety Study of Rosiglitazone/Metformin Therapy vs Rosiglitazone and Metformin in Type 2 Diabetes Subjects
Information source: GlaxoSmithKline
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Diabetes Mellitus, Type 2
Intervention: rosiglitazone maleate/metformin hydrochloride (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: GlaxoSmithKline Official(s) and/or principal investigator(s): GSK Clinical Trials, Study Director, Affiliation: GlaxoSmithKline
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.
Clinical Details
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
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Primary outcome: Change from baseline in hemoglobin A1c (HbA1c) at week 32.
Secondary outcome: 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
Eligibility
Minimum age: 18 Years.
Maximum age: 70 Years.
Gender(s): Both.
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
Locations and Contacts
GSK Investigational Site, São Paulo 04020-041, Brazil
GSK Investigational Site, Pusan 602-739, Korea, Republic of
GSK Investigational Site, Seoul 139-872, Korea, Republic of
GSK Investigational Site, Uijeongbu, 480-821, Korea, Republic of
GSK Investigational Site, Mexico, D.F. 14050, Mexico
GSK Investigational Site, Auckland 1311, New Zealand
GSK Investigational Site, Auckland 1701, New Zealand
GSK Investigational Site, Christchurch 8001, New Zealand
GSK Investigational Site, Rotorua 3201, New Zealand
GSK Investigational Site, Wellington 6035, New Zealand
GSK Investigational Site, Charlotte, North Carolina 28210, United States
GSK Investigational Site, Monterrey, Nuevo León 64570, Mexico
GSK Investigational Site, Warminster, Pennsylvania 18974, United States
GSK Investigational Site, Recife, Pernambuco 50100-130, Brazil
GSK Investigational Site, Arlington, Texas 76017, United States
Additional Information
http://ctr.gsk.co.uk/Summary/Rosiglitazone/III_712753_007.pdf
Starting date: October 2003
Last updated: April 14, 2015
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