drugset / Trial / NCT01334229

Sitagliptin and Kinetics of Triglyceride-rich Lipoproteins Apolipoprotein B48 and B100 in Patients With Type 2 Diabetes

NCT01334229

Phase 3 Completed 22 enrolled Laval University Merck Sharp & Dohme LLC · collab
RandomizedCrossoverQuadruple-blindTreatment

Summary

Sitagliptin is a potent and selective inhibitor of dipeptidyl peptidase IV (DPP-IV), 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 \[13\]. Although clinical studies to date indicate that fasting lipid levels are minimally affected by DPP-IV inhibitor treatment \[14-16\], animal studies suggested that DPP-IV inhibition reduce intestinal triglycerides (TG) absorption and apolipoprotein (apo) production \[17\] and increased chylomicron catabolism \[18\]. Interestingly, a recent study supporting this hypothesis showed that vildagliptin therapy was able to reduce postprandial intestinal triglyceride-rich lipoproteins (TRL) particles in patients with type 2 diabetes \[19\]. Recently, our group has reported that sitagliptin treatment significantly reduced plasma apo B-48 and TG concentrations in the postprandial state. Moreover, animal studies showed that sitagliptin decreased intestinal secretion of intestinal apo B-48, mainly by increasing level of glucagon-like peptide (GLP)-1 \[20\]. Therefore, the present study was designed to examine the effects of sitagliptin on the kinetics of TRL apo B-48 and in patients with type 2 diabetes. A possible reduction in postprandial atherogenic TRL apo B-48-containing lipoprotein 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.

Timeline

Start
2011-04
Primary completion
2013-03
Completion
2013-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Sitagliptin Small molecule 100 mg