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

Sponsor
Michael A. Nauck
Study ID
NCT01937598
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
25 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • 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 — 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.

Study Details

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

Key Dates

Start date
Aug 31, 2013
Status verified
Dec 2016
Primary completion
Apr 30, 2014
Completion
Jun 30, 2015

Study Design

Enrollment
16 participants (actual)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Sitagliptin, then Placebo
  • Experimental: Placebo, then Sitagliptin

Primary Outcome Measure

Incremental Area Under the Plasma Glucose (BG) Concentration-time Profile (AUC) [ Time Frame: 0 to 300 min post mixed meal test ]

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