Comparative Glucose Clamp Study of Wockhardt's Recombinant Insulin Analog Glargine(Glaritus) With Lantus in T1DM

What Was Tested

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

It had two arms (groups): Glaritus arm (experimental) and Lantus arm (active comparator).

The registry classes the interventions as biological.

Who Took Part

The registry lists 111 actual participants took part.

It was open to people of any sex aged from 18 years up to 60 years.

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

Examples of who could join: Male or female subjects with type 1 diabetes ≥12 months. Age ≥18 and ≤60 years. Considered generally healthy upon completion of medical history, physical examination and biochemical investigations as judged by the Investigator. Signed and dated informed consent obtained before any trial-related activities. (Trial-related activities are any procedure that would not have been performed during normal management of the subject).

The full record lists 5 inclusion and 13 exclusion criteria; among the exclusions: previous participation in this trial, or participation in other clinical trials within the last 30 days; history of alcohol or drug abuse in the past five years; any positive reaction of drug abuse.

How the Study Was Run

It was run as a randomized, crossover and quadruple-blind study.

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

Each person switched between Insulin Glargine and the comparison at some point, usually with a gap in between.

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

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

It started in 2011-06 with completion listed for 2012-05.

It ran at 1 site in United States.

Its stated primary purpose is health services research.

What Was Measured

It also tracked 5 secondary outcomes, for example Safety parameters.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Insulin Glargine in 111 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

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