Omarigliptin Add-on to Insulin in Japanese Participants With Type 2 Diabetes Mellitus (T2DM, MK-3102-039)

What Was Tested

The trial (phase 4) is built around Insulin (regular human).

It had two arms (groups): one (experimental) and one (experimental).

The registry classes the interventions as biological and drug.

More on the Plan

After the end of treatment each participant will be followed for 21 days.

Who Took Part

Enrollment: 184 actual participants took part.

It was open to people of any sex aged from 20 years with no upper age limit.

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

Examples of who could join: Meet all of following criteria at Week -2 of pre-randomization. On diet and exercise therapy for 6 weeks or longer, AND. Have not been on any additional anti-hyperglycemic agent (AHAs, except for insulin monotherapy) for 8 weeks or longer, AND. Have a body mass index (BMI) \>18 kg/m\^2 and \<40 kg/m\^2.

The full record lists 9 inclusion and 23 exclusion criteria; among the exclusions: has type 1 diabetes mellitus or has a history of diabetic ketoacidosis; thiazolidinediones within 12 weeks; glucagon-like peptide 1 (glp-1) receptor agonists within 12 weeks.

How the Study Was Run

The set-up was randomized, parallel-group and double-blind.

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

The Insulin (regular human) group and the comparison group ran side by side rather than switching.

Blinding on both sides kept the participants and researchers unaware of who received Insulin (regular human).

Those kept unaware of assignments: participant and investigator.

It started in 2016-10-17 with completion listed for 2018-08-21.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Constrained Longitudinal Data Analysis of Change From Baseline in Hemoglobin A1c (HbA1c) at Week 16 Excluding Data After Glycemic Rescue (Phase A) (time frame: Baseline (Day 1) and Week 16). Percentage of Participants Who Experienced One or More Adverse Events (AE) Excluding Data After Glycemic Rescue (Phase A) (time frame: Up to Week 16). Percentage of Participants Who Experienced One or More AE (Omarigliptin [Phase A+B]; Placebo→Omarigliptin [Phase B Only]) (time frame: Up to Week 52).

It also tracked 8 secondary outcomes, for example Change From Baseline in Hemoglobin A1c (HbA1c) at Week 52 (Phase A+B) and Change From Baseline in Fasting Plasma Glucose (FPG) at Week 52 (Phase A+B).

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Insulin (regular human) in 184 people.

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

More context: the Insulin (regular human) compound page, all human trials.