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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

Page last updated: August 20, 2015

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