A Study of the Safety and Efficacy of MK-1293 Compared to Lantus™ in Participants With Type 1 Diabetes Mellitus (T1DM) (MK-1293-003)

What Was Tested

The trial (phase 3) is built around Insulin Glargine.

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

The registry classes the interventions as drug.

Who Took Part

Enrollment: 508 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: T1DM For at least 1 year.

The full record lists 3 inclusion and 25 exclusion criteria; among the exclusions: history of ketoacidosis in the last 6 months; history of intolerance or hypersensitivity to lantus™ or contraindication to lantus™ or one of its excipients; used a formulation of insulin glargine other than lantus™.

How the Study Was Run

Design: randomized, parallel-group and open-label.

Random assignment meant chance, not the researchers, decided who got Insulin Glargine and who got the comparison, which limits bias.

The Insulin Glargine group and the comparison group ran side by side rather than switching.

Everyone knew when Insulin Glargine was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

It started in 2013-10-17 with completion listed for 2015-05-04.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Primary: Change From Baseline in Hemoglobin A1c (A1C) at Week 24 (time frame: Baseline and Week 24). Percentage of Participants With Any Confirmed Positive Anti-insulin Antibody (AIA) at Any Time Up Through Week 24 (time frame: Up to Week 24). Percentage of Participants With Negative AIA at Baseline Who Develop Confirmed Positive AIA at Any Time Up Through Week 24 (time frame: Up to Week 24).

It also tracked 23 secondary outcomes, for example Change From Baseline in A1C at Week 52, Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24, Percentage of Participants With Confirmed Positive AIA Up Through Week 52, Percentage of Participants With Negative AIA at Baseline Who Develop Confirmed Positive AIA at Any Time Up Through Week 52, Change From Baseline in AIA Titer After 52 Weeks of Treatment and Change From Baseline in FPG at Week 52.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Insulin Glargine in 508 people.

With 508 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.