The Vascular Effects of Exenatide Versus Metformin in Patients With Pre-Diabetes
Overview[ - collapse ][ - ]
Purpose | The purpose of this study is to compare the effects of exenatide versus metformin on vascular health with chronic (3-month) therapy and during a 2-hour period following a meal in patients with pre-diabetes. It is predicted that exenatide will improve vascular health to a greater degree compared to metformin. |
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Condition | Impaired Glucose Tolerance |
Intervention | Drug: Exenatide Drug: Metformin |
Phase | Phase 4 |
Sponsor | St. Paul Heart Clinic |
Responsible Party | St. Paul Heart Clinic |
ClinicalTrials.gov Identifier | NCT00546728 |
First Received | October 17, 2007 |
Last Updated | September 5, 2013 |
Last verified | September 2013 |
Tracking Information[ + expand ][ + ]
First Received Date | October 17, 2007 |
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Last Updated Date | September 5, 2013 |
Start Date | October 2007 |
Estimated Primary Completion Date | July 2011 |
Current Primary Outcome Measures | Change in Reactive Hyperemic Index Over the 3-month Treatment Period [Time Frame: Change from baseline to 3 months] [Designated as safety issue: No]Change in reactive hyperemic index over the 3-month treatment period, which is a measure of endothelial (inner lining of blood vessels) function. This is measured as a ratio of post-occlusion blood flow volume versus baseline blood flow volume in fingertips. Higher ratio values are considered indicative of better arterial health. |
Current Secondary Outcome Measures | Not Provided |
Descriptive Information[ + expand ][ + ]
Brief Title | The Vascular Effects of Exenatide Versus Metformin in Patients With Pre-Diabetes |
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Official Title | The Chronic and Acute Postprandial Vascular Effects of Exenatide vs. Metformin in Abdominally Obese Patients With Impaired Glucose Tolerance |
Brief Summary | The purpose of this study is to compare the effects of exenatide versus metformin on vascular health with chronic (3-month) therapy and during a 2-hour period following a meal in patients with pre-diabetes. It is predicted that exenatide will improve vascular health to a greater degree compared to metformin. |
Detailed Description | Not Provided |
Study Type | Interventional |
Study Phase | Phase 4 |
Study Design | Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment |
Condition | Impaired Glucose Tolerance |
Intervention | Drug: Exenatide exenatide 10 mcg twice daily Drug: Metformin metformin 500 twice daily |
Study Arm (s) |
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Recruitment Information[ + expand ][ + ]
Recruitment Status | Completed |
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Estimated Enrollment | 50 |
Estimated Completion Date | July 2011 |
Estimated Primary Completion Date | July 2011 |
Eligibility Criteria | Inclusion Criteria: - Greater than or equal to 18 years old - Impaired glucose tolerance: 2-hr oral glucose tolerance test (OGTT) plasma glucose >140 mg/dL OR impaired fasting glucose: fasting glucose > or = 100 mg/dL OR elevated glycosylated hemoglobin: Hemoglobin A1c > or = 5.7% - Abdominal obesity: waist circumference >102 cm (men) and >88 cm (women) - Stable cardiovascular medication regimen (or other medications known to affect endothelial function) at least 1 month prior to enrollment and throughout the study Exclusion Criteria: - Type 2 diabetes - Current use of glycemic control medications within one month of randomization - Fasting glucose >126 mg/dL - Current use of weight loss medication - Previous weight loss surgery - History of severe gastrointestinal disease - Standard clinical contraindications to exenatide or metformin therapy - Unstable angina - Heart failure - Stroke or coronary artery bypass graft within 3 months of screening - Women who are currently pregnant or planning to become pregnant - Breastfeeding women - Clinically significant liver disease - Creatinine > 1.5 mg/dL - Hepatic function greater than 3 times upper limit of normal - Patients who are mentally incompetent and cannot sign a Patient Informed Consent |
Gender | Both |
Ages | 18 Years |
Accepts Healthy Volunteers | No |
Contacts | Not Provided |
Location Countries | United States |
Administrative Information[ + expand ][ + ]
NCT Number | NCT00546728 |
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Other Study ID Numbers | SPHC 2007-02 |
Has Data Monitoring Committee | No |
Information Provided By | St. Paul Heart Clinic |
Study Sponsor | St. Paul Heart Clinic |
Collaborators | Amylin Pharmaceuticals, LLC. Eli Lilly and Company International Diabetes Center at Park Nicollet |
Investigators | Principal Investigator: Aaron S. Kelly, Ph.D. University of Minnesota - Clinical and Translational Science Institute |
Verification Date | September 2013 |
Locations[ + expand ][ + ]
International Diabetes Center at Park Nicollet | St. Louis Park, Minnesota, United States, 55416 |
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St. Paul Heart Clinic | St. Paul, Minnesota, United States, 55102 |