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

Overview[ - collapse ][ - ]

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.
ConditionDiabetes Mellitus, Type 2
InterventionDrug: rosiglitazone/metformin
PhasePhase 3
SponsorGlaxoSmithKline
Responsible PartyGlaxoSmithKline
ClinicalTrials.gov IdentifierNCT00067951
First ReceivedSeptember 3, 2003
Last UpdatedJune 6, 2013
Last verifiedMay 2013

Tracking Information[ + expand ][ + ]

First Received DateSeptember 3, 2003
Last Updated DateJune 6, 2013
Start DateOctober 2003
Estimated Primary Completion DateNot Provided
Current Primary Outcome MeasuresHemoglobin A1c (HbA1c) reduction after 24 weeks of treatment.
Current Secondary Outcome MeasuresChange 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.

Descriptive Information[ + expand ][ + ]

Brief TitleA Study To Evaluate The Safety And Efficacy Of An Investigational Diabetes Drug In Poorly Controlled Type II Diabetics
Official TitleAn 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
Brief Summary
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.
Detailed DescriptionNot Provided
Study TypeInterventional
Study PhasePhase 3
Study DesignEndpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
ConditionDiabetes Mellitus, Type 2
InterventionDrug: rosiglitazone/metformin
Other Names:
rosiglitazone/metformin
Study Arm (s)Not Provided

Recruitment Information[ + expand ][ + ]

Recruitment StatusCompleted
Estimated Enrollment190
Estimated Completion DateNot Provided
Estimated Primary Completion DateNot Provided
Eligibility 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
GenderBoth
Ages18 Years
Accepts Healthy VolunteersNo
ContactsNot Provided
Location CountriesUnited States, New Zealand

Administrative Information[ + expand ][ + ]

NCT Number NCT00067951
Other Study ID Numbers712753/004
Has Data Monitoring CommitteeNo
Information Provided ByGlaxoSmithKline
Study SponsorGlaxoSmithKline
CollaboratorsNot Provided
Investigators Study Director: GSK Clinical Trials GlaxoSmithKline
Verification DateMay 2013

Locations[ + expand ][ + ]

GSK Investigational Site
Tucson, Arizona, United States, 85745
GSK Investigational Site
Jacksonville, Florida, United States, 32204
GSK Investigational Site
Newburgh, Indiana, United States, 47630
GSK Investigational Site
Las Vegas, Nevada, United States, 89103
GSK Investigational Site
Charlotte, North Carolina, United States, 28210
GSK Investigational Site
Warminster, Pennsylvania, United States, 18974
GSK Investigational Site
Johnson City, Tennessee, United States, 37601
GSK Investigational Site
Bryan, Texas, United States, 77802
GSK Investigational Site
Dallas, Texas, United States, 75230
GSK Investigational Site
Christchurch, New Zealand, 8001
GSK Investigational Site
Rotorua, New Zealand, 3201
GSK Investigational Site
Wellington, New Zealand, 6035