The Safety and Efficacy of MK-1293 Versus Lantus™ in Participants With Type 2 Diabetes Mellitus (MK-1293-006)

What Was Tested

In this phase 3 trial, researchers set out to test Insulin Glargine.

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

MK-1293 administered subcutaneously once daily in the evening.

Lantus™ administered subcutaneously once daily in the evening.

The registry classes the interventions as drug.

Who Took Part

The registry lists 531 actual participants took part.

It was open to people of any sex aged from 18 years with no upper age limit.

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

Examples of who could join: Diagnosis of Type 2 Diabetes Mellitus (T2DM) as defined by the American Diabetes Association (ADA) or the European Association for the Study of Diabetes (EASD). Body mass index (BMI) \<45 kg/m\^2.

The full record lists 3 inclusion and 30 exclusion criteria; among the exclusions: on a weight loss program within the last 8 weeks; received injectable incretin-based therapy (e.g., victoza™, byetta™) within the prior 8 weeks; bariatric surgery within 12 months prior to signing the informed consent.

How the Study Was Run

The set-up was randomized, parallel-group and open-label.

The participants were allocated by chance, so the Insulin Glargine group and the comparison group should start out alike.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Nothing was hidden in this open-label Insulin Glargine study: the participants and staff both knew the treatment.

It started in 2014-02-11 with completion listed for 2015-03-11.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Change From Baseline in Participant Hemoglobin A1C Level at Week 24 (time frame: Baseline and Week 24). Percentage of Participants With Confirmed Anti-Insulin Antibodies (AIA) up to Week 24 (time frame: Up to 24 weeks).

It also tracked 9 secondary outcomes, for example Change From Baseline in Participant Body Weight at Week 24, Percentage of Participants Experiencing an Adverse Event (AE) of Hypoglycemia Up to Week 24, Percentage of Participants Experiencing an AE Over the 24-week Treatment Period, Change From Baseline in Participant Fasting Plasma Glucose (FPG) at Week 24 and Change From Baseline in Participant 7-Point Average of Self-Monitored Blood Glucose (SMBG) at Week 24.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Insulin Glargine in 531 people.

With 531 participants it is a large trial for this field.

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, all human trials.