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| Sponsor: | Laval University |
|---|---|
| Collaborator: |
Merck |
| Information provided by: | Laval University |
| ClinicalTrials.gov Identifier: | NCT00660075 |
Purpose
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 |
|---|---|---|
|
Diabetes Mellitus Postprandial Lipemia |
Drug: Sitagliptin Drug: Placebo |
Phase III |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| 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 |
|---|---|
|
Experimental: 1
Sitagliptin 100 mg/d for 6 weeks
|
Drug: Sitagliptin
Sitagliptin 100 mg/d for 6 weeks
|
|
Placebo Comparator: 2
Placebo for 6 weeks
|
Drug: Placebo
Placebo for 6 weeks
|
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| 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 |
More Information
| Responsible Party: | Patrick Couture/Associate professor of medicine/Laval University, Laval University |
| ClinicalTrials.gov Identifier: | NCT00660075 History of Changes |
| Other Study ID Numbers: | SITA001 |
| Study First Received: | April 14, 2008 |
| Last Updated: | April 16, 2008 |
| Health Authority: | Canada: Health Canada |
|
Diabetes mellitus Postprandial Hyperlipidemia Atherosclerosis |
|
Diabetes Mellitus Diabetes Mellitus, Type 2 Hyperlipidemias Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Dyslipidemias Lipid Metabolism Disorders |
Sitagliptin Dipeptidyl-Peptidase IV Inhibitors Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Hypoglycemic Agents Physiological Effects of Drugs |