Extension Study to Assess Safety and Efficacy of Mylan's Insulin Glargine and Lantus® in Type 1 Diabetes Mellitus (T1DM) Patients

What Was Tested

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

It had two arms (groups): one (experimental) and Lantus® (active comparator).

The registry classes the interventions as drug.

Who Took Part

The registry lists 127 actual participants took part.

It was open to people of any sex aged from 18 years up to 66 years.

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

Examples of who could join: Patients who have completed the 52-week treatment period (irrespective of their age at the completion of MYL-GAI-3001 trial) of the MYL-GAI-3001 trial and were assigned to Lantus® in that study. Patients or their legal representatives must give written and signed informed consent before starting any protocol-specific procedures. Female patients complying with the following:. Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception. Postmenopausal females must have had no menstrual bleeding for at least 1 year prior to inclusion in MYL-GAI-3001 study.

The full record lists 10 inclusion and 5 exclusion criteria; among the exclusions: history or presence of a medical condition or disease that in the investigator's opinion would place the patient at an unacceptable risk from trial participation; patients scheduled to receive another investigational drug during the extension study period; any major elective surgery requiring hospitalization planned during the extension study period.

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.

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 2015-12 with completion listed for 2017-03.

It ran at 81 sites in United States (39), Slovakia (11), Czechia (6), Hungary (6), Latvia (6) and Canada (5).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Change in Hemoglobin A1c (HbA1c) From Baseline (time frame: Baseline to 36 weeks).

It also tracked 10 secondary outcomes, for example Change From Baseline in Fasting Plasma Glucose, Overall Average of Self-monitoring Blood Glucose (SMBG) Change From Baseline, Local and Systemic Allergic Reactions, Hypoglycemic Rate, Hypoglycemic Incidence and Change From Baseline in Total Insulin Antibodies - Lantus Assay.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Insulin Glargine in 127 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, all human trials.