A Study That Will Evaluate Ketogenesis and Glucose-Dependent Insulin Secretion Methodologies in Healthy Male Subjects (MK-0000-159)(COMPLETED)

What Was Tested

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

It had six arms (groups): Treatment sequence 1 (experimental), Treatment sequence 2 (experimental), Treatment sequence 3 (experimental), Treatment sequence 4 (experimental) and Treatment sequence 5 (experimental).

The registry classes the interventions as drug.

Who Took Part

The registry lists 12 actual participants took part.

It was open to men only aged from 18 years up to 45 years.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: Subject is judged to be in good health based on medical history, physical examination, and laboratory safety tests. Subject has a Body Mass Index of ≥27 kg/m\^2 and ≤35 kg/m\^2 and weighs ≥70 kg at the prestudy (screening) visit. Subject has been a nonsmoker and/or has not used nicotine or nicotine-containing products for at least approximately 6 months. Subject is willing to avoid strenuous physical activity (weight lifting, running, bicycling, etc.) for the duration of the study.

The full record lists 4 inclusion and 8 exclusion criteria; among the exclusions: subject has a history of stroke, chronic seizures, or major neurological disorder; subject has irritable bowel disease, or recurrent occurrences of nausea, vomiting, diarrhea, or abdominal pain; subject has a history of hypertension requiring treatment.

How the Study Was Run

It was run as a randomized, crossover and double-blind study.

Because people in this Oxyntomodulin 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 Oxyntomodulin and the comparison in turn, acting as their own control.

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

Those kept unaware of assignments: participant and investigator.

It started in 2010-04 with completion listed for 2010-05.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Ambient plasma glucose concentration during the GGI (time frame: Last 160 minutes of OXM/placebo infusion). plasma βOHB + AcAc concentrations (time frame: First 300 minutes of OXM/placebo infusion).

What This Means in Plain Language

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

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

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

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