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. |
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Condition | Diabetes Mellitus, Type 2 |
Intervention | Drug: rosiglitazone/metformin |
Phase | Phase 3 |
Sponsor | GlaxoSmithKline |
Responsible Party | GlaxoSmithKline |
ClinicalTrials.gov Identifier | NCT00067951 |
First Received | September 3, 2003 |
Last Updated | June 6, 2013 |
Last verified | May 2013 |
Tracking Information[ + expand ][ + ]
First Received Date | September 3, 2003 |
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Last Updated Date | June 6, 2013 |
Start Date | October 2003 |
Estimated Primary Completion Date | Not Provided |
Current Primary Outcome Measures | Hemoglobin A1c (HbA1c) reduction after 24 weeks of treatment. |
Current 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. |
Descriptive Information[ + expand ][ + ]
Brief Title | A Study To Evaluate The Safety And Efficacy Of An Investigational Diabetes Drug In Poorly Controlled Type II Diabetics |
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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 |
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 Description | Not Provided |
Study Type | Interventional |
Study Phase | Phase 3 |
Study Design | Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment |
Condition | Diabetes Mellitus, Type 2 |
Intervention | Drug: rosiglitazone/metformin Other Names: rosiglitazone/metformin |
Study Arm (s) | Not Provided |
Recruitment Information[ + expand ][ + ]
Recruitment Status | Completed |
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Estimated Enrollment | 190 |
Estimated Completion Date | Not Provided |
Estimated Primary Completion Date | Not 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 |
Gender | Both |
Ages | 18 Years |
Accepts Healthy Volunteers | No |
Contacts | Not Provided |
Location Countries | United States, New Zealand |
Administrative Information[ + expand ][ + ]
NCT Number | NCT00067951 |
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Other Study ID Numbers | 712753/004 |
Has Data Monitoring Committee | No |
Information Provided By | GlaxoSmithKline |
Study Sponsor | GlaxoSmithKline |
Collaborators | Not Provided |
Investigators | Study Director: GSK Clinical Trials GlaxoSmithKline |
Verification Date | May 2013 |
Locations[ + expand ][ + ]
GSK Investigational Site | Tucson, Arizona, United States, 85745 |
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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 |