A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of MK-1293 Compared With a Basal Insulin in Participants With Type 1 Diabetes (MK-1293-005)

What Was Tested

In this phase 1 trial, researchers set out to test Insulin Glargine and Insulin Aspart.

It had two arms (groups): MK-1293 / EU-Lantus™ / MK-1293 / EU-Lantus™ (experimental) and EU-Lantus™ / MK-1293 / EU-Lantus™ / MK-1293 (experimental).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 76 actual participants took part.

It was open to people of any sex aged from 18 years up to 65 years.

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

Examples of who could join: Has type 1 diabetes mellitus diagnosed at least 12 months before screening. Has a body mass index \>18.0 and \<=30.0 kg/m\^2. Has a weight \>=50 kg. Postmenopausal female participant is without menses for \>=1 year. Surgically sterile female participant status is post hysterectomy, oophorectomy, or tubal ligation.

The full record lists 10 inclusion and 16 exclusion criteria; among the exclusions: has a history of diabetic ketoacidosis within the past 6 months; is positive for hepatitis b surface antigen, hepatitis c, or human immunodeficiency virus; vaccination within 12 weeks of start of study participation.

How the Study Was Run

Design: randomized, crossover and triple-blind.

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

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

Those kept unaware of assignments: participant, investigator and outcomes assessor.

It started in 2014-02-10 with completion listed for 2015-03-30.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: PD: Maximum Glucose Infusion Rate (GIRmax) (time frame: Up to 30 hours postdose). M1 Glargine Metabolite PK: Maximum Plasma Concentration (Cmax) (time frame: Up to 24 hours postdose).

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Insulin Glargine and Insulin Aspart in 76 people.

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

More context: the Insulin Glargine compound page and the Insulin Aspart compound page, all human trials.