At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Evaluation of the Glucoregulatory Effects of GLP-1 Receptor Activation in Patients With Type 2 Diabetes Mellitus
In Brief
A Phase 1 clinical trial evaluating Oxyntomodulin, Liraglutide 0.6 mg, and 3 other interventions for Type 2 Diabetes Mellitus. Completed, enrolled 12 participants.
Detailed Summary
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.
Study Details
Timeline
Interventions
3.0 pmol/kg/min as an intravenous (IV) infusion in the morning of the day of graded glucose infusion (GGI) (Day 1)
Single subcutaneous dose in the evening of the day before the GGI (Day-1)
Single subcutaneous dose in the evening of the day before the GGI (Day-1)
IV infusion in the morning of the day of GGI (Day 1)
Single subcutaneous dose in the evening of the day before the GGI (Day-1)