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

GlaxoSmithKline190 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

190

Conditions

Diabetes Mellitus, Type 2

Interventions

rosiglitazone/metforminDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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

Locations (94)

Outcomes

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.

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

GSK Investigational Site

Anniston, Alabama, United States

GSK Investigational Site

Chandler, Arizona, United States

GSK Investigational Site

Phoenix, Arizona, United States

GSK Investigational Site

Phoenix, Arizona, United States

GSK Investigational Site

Tucson, Arizona, United States

GSK Investigational Site

Encinitas, California, United States

GSK Investigational Site

Fullerton, California, United States

GSK Investigational Site

Los Banos, California, United States

GSK Investigational Site

Mission Viejo, California, United States

GSK Investigational Site

Jacksonville, Florida, United States

...and 84 more locations