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 Was Tested

In this phase 1 trial, researchers set out to test Liraglutide and Oxyntomodulin.

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.

It had six arms (groups): OXM → Lg-0.6 → Pbo → Lg-1.2 (experimental), Lg-0.6 → Pbo → OXM → Pbo (experimental), Pbo → OXM → Lg-0.6 → Pbo (experimental), Lg-0.6 → OXM → Pbo → Lg-1.2 (experimental) and OXM → Pbo → Lg-0.6 → Pbo (experimental).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 12 actual participants took part.

It was open to men only aged from 18 years up to 64 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Have a body mass index (BMI) of ≤38.0 kg/m\^2. Have a clinical diagnosis of Type 2 diabetes mellitus. Judged to be in good health.

The full record lists 4 inclusion and 11 exclusion criteria; among the exclusions: have untreated hypertension with blood pressure of \>160/95 mmhg; have a history of neoplastic disease within the past 5 years; have a history of hypersensitivity to oxm, liraglutide, insulin or haemaccel®.

How the Study Was Run

Design: randomized, crossover and triple-blind.

Because people in this Liraglutide study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

In the crossover set-up each of the participants took both Liraglutide and the comparison in turn, acting as their own control.

Blinding on both sides kept the participants and researchers unaware of who received Liraglutide.

Those kept unaware of assignments: participant, care provider and investigator.

It started in 2011-06 with completion listed for 2011-07.

Its stated primary purpose is treatment.

What Was Measured

It also tracked 3 secondary outcomes, for example Change From Baseline in Insulinotrophic Effect (ISR/G) at the Highest Glucose Infusion Rate After Two Periods of Placebo Treatment.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Liraglutide and Oxyntomodulin in 12 people.

Its size is small, so on its own it can only give an early look.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

More context: the Liraglutide compound page and the Oxyntomodulin compound page, all human trials.