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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00067951
First received: September 3, 2003
Last updated: June 6, 2013
Last verified: May 2013
  Purpose

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.


Condition Intervention Phase
Diabetes Mellitus, Type 2
Drug: rosiglitazone/metformin
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Hemoglobin A1c (HbA1c) reduction after 24 weeks of treatment.

Secondary Outcome Measures:
  • 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.

Estimated Enrollment: 190
Study Start Date: October 2003
Intervention Details:
    Drug: rosiglitazone/metformin
    Other Name: rosiglitazone/metformin
  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00067951

Locations
United States, Arizona
GSK Investigational Site
Tucson, Arizona, United States, 85745
United States, Florida
GSK Investigational Site
Jacksonville, Florida, United States, 32204
United States, Indiana
GSK Investigational Site
Newburgh, Indiana, United States, 47630
United States, Nevada
GSK Investigational Site
Las Vegas, Nevada, United States, 89103
United States, North Carolina
GSK Investigational Site
Charlotte, North Carolina, United States, 28210
United States, Pennsylvania
GSK Investigational Site
Warminster, Pennsylvania, United States, 18974
United States, Tennessee
GSK Investigational Site
Johnson City, Tennessee, United States, 37601
United States, Texas
GSK Investigational Site
Bryan, Texas, United States, 77802
GSK Investigational Site
Dallas, Texas, United States, 75230
New Zealand
GSK Investigational Site
Christchurch, New Zealand, 8001
GSK Investigational Site
Rotorua, New Zealand, 3201
GSK Investigational Site
Wellington, New Zealand, 6035
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00067951     History of Changes
Other Study ID Numbers: 712753/004
Study First Received: September 3, 2003
Last Updated: June 6, 2013
Health Authority: Canada: Health Canada
United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
Hyperglycemia
Type 2 diabetes mellitus
Hemoglobin A1c
HbA1c

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Metformin
Rosiglitazone
Hypoglycemic Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 22, 2014