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Sponsors and Collaborators: |
Laval University Merck |
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Information provided by: | Laval University |
ClinicalTrials.gov Identifier: | NCT00660075 |
Sitagliptin is a potent and selective inhibitor of dipeptidyl peptidase IV (DPP-4), and has been shown to reduce fasting and postprandial glucose levels in patients with type 2 diabetes mainly through incretin hormone-mediated improvements in islet function. Although clinical studies to date indicate that fasting lipid levels are minimally affected by DPP-4 inhibitor treatment, animal studies suggested that DPP-4 inhibition reduce intestinal TG absorption and apolipoprotein production and increased chylomicron catabolism. Therefore, the present study was designed to examine the effects of sitagliptin on postprandial lipemia in patients with type 2 diabetes. A possible reduction in postprandial atherogenic TRL levels by sitagliptin would add to therapeutic utility of this DPP-4 inhibitor and suggest the potential to reduce cardiovascular risk in patients with type 2 diabetes.
Condition | Intervention | Phase |
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Diabetes Mellitus Postprandial Lipemia |
Drug: Sitagliptin Drug: Placebo |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Crossover Assignment, Efficacy Study |
Official Title: | A Randomized, Double-Blind, Placebo-Controlled, Crossover Study To Evaluate The Effects of Sitagliptin on Postprandial Plasma Lipoprotein Concentrations in Men With Type 2 Diabetes |
Estimated Enrollment: | 30 |
Study Start Date: | February 2008 |
Estimated Study Completion Date: | February 2009 |
Estimated Primary Completion Date: | January 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Sitagliptin 100 mg/d for 6 weeks
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Drug: Sitagliptin
Sitagliptin 100 mg/d for 6 weeks
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2: Placebo Comparator
Placebo for 6 weeks
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Drug: Placebo
Placebo for 6 weeks
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Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
steroids, beta blockers, thiazide diuretics, lipid lowering agents, significant alcohol intake etc.).
Contact: Patrick Couture, MD, PhD | 418-654-2106 | patrick.couture@crchul.ulaval.ca |
Contact: André J Tremblay, PhD | 418-654-2106 | andre.tremblay@crchul.ulaval.ca |
Canada, Quebec | |
Laval University Medical Center | Recruiting |
Quebec City, Quebec, Canada, G1V 4G2 | |
Principal Investigator: Patrick Couture, MD, PHD |
Principal Investigator: | Patrick Couture, MD, PhD | Laval University |
Responsible Party: | Laval University ( Patrick Couture/Associate professor of medicine/Laval University ) |
Study ID Numbers: | SITA001 |
Study First Received: | April 14, 2008 |
Last Updated: | April 16, 2008 |
ClinicalTrials.gov Identifier: | NCT00660075 History of Changes |
Health Authority: | Canada: Health Canada |
Diabetes mellitus Postprandial Hyperlipidemia Atherosclerosis |
Atherosclerosis Dipeptidyl-Peptidase IV Inhibitors Metabolic Diseases Hyperlipidemias Diabetes Mellitus, Type 2 Diabetes Mellitus |
Endocrine System Diseases Endocrinopathy Glucose Metabolism Disorders Metabolic Disorder Protease Inhibitors Sitagliptin |
Dipeptidyl-Peptidase IV Inhibitors Metabolic Diseases Molecular Mechanisms of Pharmacological Action Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases |
Enzyme Inhibitors Glucose Metabolism Disorders Pharmacologic Actions Protease Inhibitors Sitagliptin |