A Study To Evaluate The Safety And Efficacy Of An Investigational Diabetes Drug In Poorly Controlled Type II Diabetics

The purpose of this research study is to determine if a new investigational diabetes drug is safe and effective in treating people who have Type II diabetes mellitus with very high HbA1c or FPG (fasting plasma glucose) levels. The HbA1c test, also called the hemoglobin A1c test or glycated hemoglobin test, is a measurement of the average amount of sugar in the blood over the last 2 to 3 months. FPG is a test that measures the amount of sugar in the blood after an 8 hour fast.

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Key information

Conditions

Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Hyperglycemia Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

GSK Investigational Site, Camperdown, New South Wales, Australia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Laboratory result for HbA1c >11% or FPG >270mg/dL
Clinical diagnosis of Type II diabetes
Prior treatment with diet and/or exercise alone, or less than 15 days of prior treatment with an oral anti-diabetic medication or insulin.

Exclusion criteria

Women who are pregnant

Treatment and study plan

rosiglitazone/metformin

Drug

Primary outcomes

Hemoglobin A1c (HbA1c) reduction after 24 weeks of treatment.

Secondary outcomes

Change in FPG, insulin,C-peptide, insulin sensitivity,beta cell function, free fatty acids, lipids. Change in weight, vital signs, clinical laboratory tests, and adverse experiences.

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study title

An Open-label Trial to Evaluate the Safety and Efficacy of Fixed Dose Rosiglitazone/Metformin Combination Therapy in Poorly-controlled Subjects With Type 2 Diabetes Mellitus

Important dates

Study start: 2003
Primary completion: 2004
Study completion: 2004
First posted: Sep 5, 2003
Registry last updated: Mar 21, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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