Evaluation of the Glucoregulatory Effects of Glucagon-like Peptide-1 Receptor (GLP-1 Receptor) Activation in Participants With Type 2 Diabetes Mellitus (MK-0000-222)

Sponsor
Merck Sharp & Dohme LLC
Study ID
NCT01373450
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
MALE
Age
18 Years - 64 Years
Healthy Volunteers
Not accepted

Interventions

  • Oxyntomodulin — DRUG
    3.0 pmol/kg/min as an intravenous (IV) infusion in the morning of the day of graded glucose infusion (GGI) (Day 1)
  • Liraglutide 0.6 mg — DRUG
    Single subcutaneous dose in the evening of the day before the GGI (Day-1)
  • Liraglutide 1.2 mg — DRUG
    Single subcutaneous dose in the evening of the day before the GGI (Day-1)
  • Placebo for Oxyntomodulin — DRUG
    IV infusion in the morning of the day of GGI (Day 1)
  • Placebo for Liraglutide — DRUG
    Single subcutaneous dose in the evening of the day before the GGI (Day-1)

Study Details

This was a four-period crossover study to assess the glycemic effects of a single dose of oxyntomodulin (OXM) on the glucose levels in participants with Type 2 diabetes mellitus (T2DM). Participants were randomly assigned to 1 of 6 treatment sequences consisting of 4 treatment periods, with a 7-day wash-out between each treatment period. The primary hypothesis was that during graded glucose infusion (GGI) oxyntomodulin (OXM) is neutral or better than placebo (Pbo) at lowering ambient plasma glucose levels, and at significantly enhancing insulin secretion.

Key Dates

Start date
Jun 30, 2011
Status verified
Sep 2015
Primary completion
Jul 31, 2011
Completion
Jul 31, 2011

Study Design

Enrollment
12 participants (actual)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Experimental: OXM → Lg-0.6 → Pbo → Lg-1.2
    Participants received Oxyntomodulin 3.0 pmol/kg/min in the first, Liraglutide 0.6 mg in the second, Placebo in the third, and Liraglutide 1.2 mg in the fourth period
  • Experimental: Lg-0.6 → Pbo → OXM → Pbo
    Participants received Liraglutide 0.6 mg in the first, Placebo in the second, Oxyntomodulin 3.0 pmol/kg/min in the third, and Placebo in the fourth period
  • Experimental: Pbo → OXM → Lg-0.6 → Pbo
    Participants received Placebo in the first, Oxyntomodulin 3.0 pmol/kg/min in the second, Liraglutide 0.6 mg in the third, and Placebo in the fourth period
  • Experimental: Lg-0.6 → OXM → Pbo → Lg-1.2
    Participants received Liraglutide 0.6 mg in the first, Oxyntomodulin 3.0 pmol/kg/min in the second, Placebo in the third and Liraglutide 1.2 mg in the fourth period
  • Experimental: OXM → Pbo → Lg-0.6 → Pbo
    Participants received Oxyntomodulin 3.0 pmol/kg/min in the first; Placebo in the second, Liraglutide 0.6 mg in the third, and Placebo in the fourth period
  • Experimental: Pbo → Lg-0.6 → OXM → Lg-1.2
    Participants received Placebo in the first, Liraglutide 0.6 mg in the second, Oxyntomodulin 3.0 pmol/kg/min in the third, and Liraglutide 1.2 mg in the fourth period

Primary Outcome Measure

Change From Baseline in Time-weighted Average of Glucose Measured by Area Under the Curve (AUC) After a Single Dose of Oxyntomodulin (OXM) [ Time Frame: Baseline and during GGI at time points 0, 20, 40, 60, 80, 100, 120, 140, 160 and 165 minutes ]

Related Studies