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)

What this study is testing ClinicalTrials.gov NCT01373450 ↗

Description as written by the study sponsor.

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.

Treatments tested

• 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 also known as Victoza® Drug

  Single subcutaneous dose in the evening of the day before the GGI (Day-1)

• Liraglutide 1.2 mg also known as Victoza® 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)