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Sponsors and Collaborators: |
University of Pennsylvania Pennsylvania Department of Health University of Pennsylvania Clinical and Translational Research Center |
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Information provided by: | University of Pennsylvania |
ClinicalTrials.gov Identifier: | NCT00775684 |
This study evaluates Exenatide, sitagliptin, and glimepiride for the treatment of high blood sugar in patients with impaired fasting glucose or early type 2 diabetes. The purpose of this study is to determine if exenatide and sitagliptin increase the amount of insulin made by the pancreas compared to glimepiride. It is hypothesized that exenatide or sitagliptin will sustain or increase the amount of insulin made by the pancreas in comparison to glimepiride.
Condition | Intervention |
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Pre-Diabetes Type 2 Diabetes |
Drug: Exenatide Drug: Sitagliptin Drug: Glimepiride |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Parallel Assignment, Pharmacodynamics Study |
Official Title: | A Randomized, Controlled Trial Comparing the Effect of Exenatide, Sitagliptin or Glimepiride on Functional ß -Cell Mass in Patients With Impaired Fasting Glucose or Early Type 2 Diabetes |
Estimated Enrollment: | 75 |
Study Start Date: | October 2008 |
Estimated Study Completion Date: | May 2012 |
Estimated Primary Completion Date: | May 2012 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Exenatide: Experimental
Exenatide (Byetta®)—5 µg injected subcutaneously twice daily and increased after 1 month to 10 µg twice daily as tolerated by gastrointestinal effects
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Drug: Exenatide
Exenatide (Byetta®)—5 µg injected subcutaneously twice daily and increased after 1 month to 10 µg twice daily as tolerated by gastrointestinal effects
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Sitagliptin: Experimental
Sitagliptin (Januvia®)—100 mg by mouth every morning
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Drug: Sitagliptin
Sitagliptin (Januvia®)100 mg by mouth every morning
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Glimepiride: Active Comparator
Glimepiride (Amaryl®)—0.5 mg by mouth every morning and then increased by 0.5 - 1.0 mg at each monthly visit to achieve an average fasting glucose < 110mg/dl
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Drug: Glimepiride
Glimepiride (Amaryl®)—0.5 mg by mouth every morning and then increased by 0.5 - 1.0 mg at each monthly visit to achieve an average fasting glucose < 110mg/dl
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The incidence of type 2 diabetes T2D has reached epidemic proportions throughout the world. In the United States more than 1.5 million new cases of diabetes were diagnosed in 2005, and the estimated prevalence of the disease was over 20 million. Another 54 million Americans are believed to have impaired fasting glucose, which represents a "pre-diabetic" state at increased risk for progression to overt diabetes. T2D ultimately results from an inadequate mass of functional beta-cells, where insufficient beta-cell compensation for insulin resistance leads to the development of impaired glucose tolerance and eventually diabetes. Autopsy studies have demonstrated a decreased beta-cell mass occurring with fasting glucose > 110 mg/dl, consistent with functional studies that demonstrate decreased beta-cell (insulin) secretory capacity beginning in the range of impaired fasting glucose. Strategies that might preserve or expand functional beta-cell mass in vivo would be expected to reverse the progressive deterioration in blood glucose control seen with diabetes. One such strategy involves the incretin hormone glucagon-like peptide-1 (GLP-1), which is trophic for islet beta-cells, having both pro-proliferative and anti-apoptotic effects. However, it is not known whether increasing GLP-1 effects can preserve or enhance functional beta-cell mass in humans. This proposal will determine the effect of increasing GLP-1 levels on functional beta-cell mass in human subjects with impaired fasting glucose (fasting glucose 110 - 126 mg/dl) or early T2D (fasting glucose 127 - 149 mg/dl) where a critical window exists for reversing further beta-cell deterioration. GLP-1 effects will be promoted by administration of either the GLP-1 analog, exenatide, or by increasing endogenous GLP-1 levels through administration of the oral DPP4 inhibitor sitagliptin for a 6-month period. To control for the effect of exenatide and sitagliptin on normalization of blood glucose, subjects will be randomized to receive exenatide, sitagliptin or the sulfonylurea glimepiride, the latter being a first-line anti-diabetogenic agent that will serve as an active comparator.
Ages Eligible for Study: | 18 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Jariss Stevens | 215-746-2081 | jariss.stevens@uphs.upenn.edu |
Contact: Cornelia Bakes | 215-746-2085 | cornelia.dalton-bakes@uphs.upenn.edu |
United States, Pennsylvania | |
Rodebaugh Diabetes Center, Hospital of the University of Pennsylvania | Recruiting |
Philadelphia, Pennsylvania, United States, 19104 | |
Contact: Jariss Stevens 215-746-2081 jariss.stevens@uphs.upenn.edu | |
Contact: Cornelia Bakes 215-746-2085 cornelia.dalton-bakes@uphs.upenn.edu | |
Principal Investigator: Michael R. Rickels, M.D., M.S. | |
Sub-Investigator: Mark H. Schutta, M.D. | |
Clinical and Translational Research Center, Hospital of University of Pennsylvania | Recruiting |
Philadelphia, Pennsylvania, United States, 19104 | |
Contact: Jariss Stevens 215-746-2081 jariss.stevens@uphs.upenn.edu | |
Contact: Cornelia Bakes 215-746-2085 cornelia.dalton-bakes@uphs.upenn.edu | |
Principal Investigator: Michael R Rickels, M.D., M.S. | |
Pennsylvania Hospital | Recruiting |
Philadelphia, Pennsylvania, United States, 19107 | |
Contact: Jariss Stevens 215-746-2081 jariss.stevens@uphs.upenn.edu | |
Contact: Cornelia Bakes 215-746-2085 cornelia.dalton-bakes@uphs.upenn.edu | |
Sub-Investigator: Stephen G. Rosen, M.D. |
Principal Investigator: | Michael Rickels, M.D., M.S. | University of Pennsylvania, Division of Endocrinology, Diabetes & Metabolism |
Responsible Party: | UPenn ( Michael R. Rickels M.D., M.S ) |
Study ID Numbers: | 808425 |
Study First Received: | October 17, 2008 |
Last Updated: | October 17, 2008 |
ClinicalTrials.gov Identifier: | NCT00775684 |
Health Authority: | United States: Institutional Review Board |
Exenatide Sitagliptin Glimepiride Glucagon-Like Peptide-1 Impaired Fasting Glucose |
Type 2 Diabetes Beta-cell Function Beta-cell Secretory Capacity Glucose-potentiated arginine |
Metabolic Diseases Exenatide Glucagon Glucose Intolerance Diabetes Mellitus Prediabetic State Endocrine System Diseases Glucagon-Like Peptide 1 |
Sitagliptin Glimepiride Hyperglycemia Diabetes Mellitus, Type 2 Endocrinopathy Glucose Metabolism Disorders Metabolic disorder |
Dipeptidyl-Peptidase IV Inhibitors Hypoglycemic Agents Molecular Mechanisms of Pharmacological Action Immunologic Factors Therapeutic Uses Physiological Effects of Drugs |
Enzyme Inhibitors Cardiovascular Agents Anti-Arrhythmia Agents Immunosuppressive Agents Pharmacologic Actions Protease Inhibitors |