Antidiabetic Effects of Adding a DPP-4 Inhibitor to Pre-Existing Treatment With an Incretin Mimetic in Patients With T2D

What this study is testing ClinicalTrials.gov NCT01937598 ↗

Description as written by the study sponsor.

Objectives: To quantify differences in control of glycemia (primary objective) and the secretion of endogenous incretin hormones (secondary objective) comparing sitagliptin or placebo added to pre-existing therapy with liraglutide and metformin

Treatments tested

• Placebo Drug

  Patients administered a single dose of placebo during a mixed meal challenge.

• Mixed meal test Other

  Subjects will be instructed to consume the mixed meal test within 20 minutes. The exact start and stop time of the mixed meal test consumption will be recorded in the CRF. The mixed meal test procedures will be identical for all subjects randomised in the study. To detect the plasma glucose excursion after mixed meal test, plasma glucose will be closely monitored

• Liraglutide also known as Victoza Drug

  Patients on metformin monotherapy will, after screening and randomization, enter a run-in period of 2 weeks with the additional treatment of liraglutide (0.6 mg/d for 1 week followed by 1.2 mg/d for another week) that will be continued for the entire duration of the study.

• Sitagliptin Drug

  Patients administered a single dose of Sitagliptin during a mixed meal challenge.