A Study of MK-0893 on Glucagon-Induced Glycemic Excursion in Healthy Male Participants Following Intravenous Administration of Glucagon, Sandostatine® and Insulin (MK-0893-002)

What Was Tested

This registered phase 1 trial tested Insulin (regular human) and Glucagon.

It had seven arms (groups): one (experimental), one (experimental), one (experimental), one (experimental) and one (experimental).

The registry classes the interventions as biological and drug.

Who Took Part

18 actual participants took part.

It was open to men only aged from 18 years up to 50 years.

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

Examples of who could join: Non-smoker for at least 6 months. Willing to avoid strenuous physical activity. Willing to avoid alcohol, caffeine, and grapefruit juice consumption.

The full record lists 5 inclusion and 9 exclusion criteria; among the exclusions: history of renal, neurologic, gastrointestinal or respiratory disease or any gastrointestinal surgery; history of multiple and/or severe allergies to a prescription, nonprescription or investigational drug or food; history of any cardiovascular/cardiac disease.

How the Study Was Run

Design: randomized, crossover and double-blind.

The participants were allocated by chance, so the Insulin (regular human) group and the comparison group should start out alike.

In the crossover set-up each of the participants took both Insulin (regular human) and the comparison in turn, acting as their own control.

Neither the participants nor the staff measuring them knew who was on Insulin (regular human), so expectations could not easily colour the readings.

Those kept unaware of assignments: participant and investigator.

It started in 2005-07 with completion listed for 2005-12.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Post-infusion Incremental Glucose Area Under the Plasma Concentration Versus Time Curve [AUC0-240 min] Study Part 1 (time frame: Up to 76 hours postdose). Post-infusion Incremental Glucose Area Under the Plasma Concentration Versus Time Curve [AUC0-240 min] Study Part 2 (time frame: Up to 124 hours postdose).

It also tracked 2 secondary outcomes, for example Number of Participants With An Adverse Event (AE) and Number of Participants Who Discontinued Study Treatment Due To AEs.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Insulin (regular human) and Glucagon in 18 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 Insulin (regular human) compound page and the Glucagon compound page, all human trials.