Effects of Sitagliptin on Postprandial Lipemia in Men With Type 2 Diabetes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00660075
Recruitment Status : Completed
First Posted : April 17, 2008
Results First Posted : December 11, 2012
Last Update Posted : December 11, 2012
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Patrick Couture, Laval University

Brief Summary:
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 triglyceride (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 triglyceride-rich lipoproteins (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 or disease Intervention/treatment Phase
Diabetes Mellitus Postprandial Lipemia Drug: Sitagliptin Drug: Placebo Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : February 2008
Primary Completion Date : January 2009
Study Completion Date : April 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Measurement of the Area Under the Curve of Plasma Triglycerides (TG) Levels During Postprandial Period (Time 0,2,4,6,8 Hours) [ Time Frame: At the end of the two 6-week interventions ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Type 2 diabetes as defined by the American Diabetes Association;
  • Non-smoker;
  • Body mass index between 25.0 and 40.0 kg/m2;
  • Baseline HbA1c between 6.5 and 8.5%;
  • Baseline fasting plasma glucose < 15.0 mmol/L;
  • Plasma triglyceride levels between 1.5 and 8.0 mmol/L (135 and 710 mg/dl) at week and -4;
  • Patients having received stable doses of metformin for at least 3 months before randomization;
  • Subjects must be willing to give written informed consent and able to adhere to dosing schedule, visit schedule and phone follow-up assessment;
  • Patients should be otherwise generally healthy, without elevations in hepatic transaminases or abnormal renal function or coagulation;
  • Patients having normal TSH at screening.

Exclusion Criteria:

  • Patients with extreme dyslipidemias, such as familial hypercholesterolemia will be excluded;
  • Patients with type 1 diabetes, secondary form of diabetes or acute metabolic diabetic complications will be excluded;
  • Patients having received or being treated with insulin or a thiazolidinedione within the past 6 months will be excluded;
  • Subjects will be excluded if they have cardiovascular disease (CVD) (coronary heart disease, cerebrovascular disease or peripheral arterial disease) or if they are taking other medications known to affect lipoprotein metabolism (e.g. steroids, beta blockers, thiazide diuretics, lipid lowering agents, significant alcohol intake etc.);
  • Subjects who are in a situation or have any condition that, in the opinion of the investigator, may interfere with optimal participation in the study;
  • Individuals with a history of mental instability, drug or alcohol abuse or individuals who have been treated or are being treated for severe psychiatric illness that, in the opinion of the investigator, may interfere with optimal participation in the study;
  • History of alcohol or drug abuse within the past 2 years. Patients must not take alcohol during the study;
  • Disorders of the hematologic, digestive, or central nervous systems, including cerebrovascular disease and degenerative disease, that would limit study evaluation or participation;
  • Known impairment of renal function (serum creatinine levels > 1.7 mg/dL for men), dysproteinemia, nephrotic syndrome, or other renal disease (24-hour urinary protein ≥3 ± 1 g);
  • Active or chronic hepatobiliary or hepatic disease. In addition, patients with AST or ALT >2 x upper limit of the laboratory reference range will be excluded;
  • Subjects with coagulopathy (prothrombin time [PT] or partial thromboplastin time [PTT] at Visit 1 >1.5 times control;
  • Patients who are known to have tested positive for human immunodeficiency virus (HIV);
  • Patients who are currently enrolled in another clinical study;
  • Patients who have used any investigational drug within 30 days of the first clinic visit;
  • Congestive heart failure NYHA Class III or IV. Uncontrolled cardiac arrhythmias within 3 months of study entry;
  • Uncontrolled diabetes mellitus (HbA1c>8.5%) or other endocrine or metabolic disease known to influence serum lipids or lipoproteins. Clinically euthyroid subjects on replacement doses of thyroid hormone are eligible for enrollment.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00660075

Canada, Quebec
Laval University Medical Center
Quebec City, Quebec, Canada, G1V 4G2
Sponsors and Collaborators
Laval University
Merck Sharp & Dohme Corp.
Principal Investigator: Patrick Couture, MD, PhD Laval University

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Patrick Couture, Médecin, Laval University Identifier: NCT00660075     History of Changes
Other Study ID Numbers: SITA001
First Posted: April 17, 2008    Key Record Dates
Results First Posted: December 11, 2012
Last Update Posted: December 11, 2012
Last Verified: November 2012

Keywords provided by Patrick Couture, Laval University:
Diabetes mellitus

Additional relevant MeSH terms:
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Lipid Metabolism Disorders
Sitagliptin Phosphate
Hypoglycemic Agents
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action