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Sponsored by: |
The University of Texas Health Science Center at San Antonio |
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Information provided by: | The University of Texas Health Science Center at San Antonio |
ClinicalTrials.gov Identifier: | NCT00820573 |
In patients with type 2 diabetes with inadequate glycemic control on diet and exercise after 6 weeks of treatment:
Objective: To assess the effects of co-administration of sitagliptin and metformin compared to placebo on hepatic glucose production (HGP).
Hypothesis: After 6 weeks of treatment, the co-administration of sitagliptin and metformin provides greater reduction in hepatic glucose production (HGP) compared to placebo.
Condition | Intervention | Phase |
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Diabetes |
Drug: Sitagliptin Drug: Metformin Drug: Sitagliptin and Metformin Drug: Placebo |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Crossover Assignment, Safety/Efficacy Study |
Official Title: | Mechanisms of Glucose Lowering Effects of Sitagliptin and Metformin Alone and in Combination in Patients With Type 2 Diabetes Mellitus |
Estimated Enrollment: | 64 |
Study Start Date: | March 2009 |
Estimated Study Completion Date: | September 2010 |
Estimated Primary Completion Date: | September 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Placebo Comparator
Placebo
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Drug: Placebo
Placebo 6 weeks
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2: Experimental
Sitagliptin
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Drug: Sitagliptin
tablet, 100 mg/day, 6 weeks
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3: Experimental
Metformin
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Drug: Metformin
tablet, 1000 mg/ bid, 6 weeks
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4: Experimental
Sitagliptin + Metformin
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Drug: Sitagliptin and Metformin
tablet, Sitagliptin (100mg/day) + tablet, Metformin (1000 mg/bid), 6 weeks
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Ages Eligible for Study: | 18 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Patients must have the following laboratory values:
Exclusion Criteria:
Patients are excluded from participation in the study if they meet any of the following criteria:
Contact: Eugenio Cersosimo, MD | 210-358-7200 | cersosimo@uthscsa.edu |
Contact: Curtis Triplitt, PharmD | 210-358-7200 | triplitt@uthscsa.edu |
United States, Texas | |
Texas Diabetes Institute | |
San Antonio, Texas, United States, 78207 |
Principal Investigator: | Ralph A DeFronzo, MD | University of TX Health Science Center |
Responsible Party: | University of TX Health Scoence Center at San Antonio ( Ralph A. DeFronzo, M.D. ) |
Study ID Numbers: | 35464 |
Study First Received: | January 8, 2009 |
Last Updated: | January 9, 2009 |
ClinicalTrials.gov Identifier: | NCT00820573 |
Health Authority: | United States: Institutional Review Board |
Diabetes |
Metabolic Diseases Metformin Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases |
Endocrinopathy Metabolic disorder Glucose Metabolism Disorders Sitagliptin |
Dipeptidyl-Peptidase IV Inhibitors Hypoglycemic Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs |
Enzyme Inhibitors Pharmacologic Actions Protease Inhibitors |