Phase 3
N=36
Effects of Sitagliptin on Postprandial Lipemia in Men With Type 2 Diabetes
Diabetes Mellitus · Postprandial Lipemia
Bottom Line
View on ClinicalTrials.gov: NCT00660075 ↗Enrolled (actual)
36
Serious AEs
0.0%
Results posted
Dec 2012
Primary outcome: Primary: Measurement of the Area Under the Curve of Plasma Triglycerides (TG) Levels During Postprandial Period (Time 0,2,4,6,8 Hours) — 30.0; 27.1 mmol*h/L
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Sitagliptin (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Male
- Sponsor
- Laval University
- Primary completion
- Jan 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Measurement of the Area Under the Curve of Plasma Triglycerides (TG) Levels During Postprandial Period (Time 0,2,4,6,8 Hours) |
30.0; 27.1 | — |
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.
Eligibility Criteria
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 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.
Data sourced from ClinicalTrials.gov (NCT00660075). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.