Comparative Bioequivalence Study of Wockhardt's Insulin Analogue Lispro (Listro™) With Humalog® in Healthy Subjects

What Was Tested

The trial (phase 1) is built around Insulin Lispro.

It had two arms (groups): Listro™ Arm (experimental) and Humalog® Arm (active comparator).

The registry classes the interventions as biological.

Who Took Part

It was open to people of any sex aged from 18 years up to 50 years.

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

Examples of who could join: Healthy male or female subjects. Age ≥18 and ≤50 years. Considered generally healthy upon completion of medical history, physical examination and biochemical investigations as judged by the Investigator. Body Mass Index (BMI) between 18.0 and 27.0 kg/m2, inclusive. Non-smoker, defined as no nicotine consumption for at least one year.

The full record lists 6 inclusion and 22 exclusion criteria; among the exclusions: previous participation in this trial or other clinical trials within the last 30 days; history of alcohol or drug abuse in the past five years; any positive screen for drugs of abuse.

How the Study Was Run

The set-up was randomized, crossover and quadruple-blind.

Because people in this Insulin Lispro study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

In the crossover set-up each of the participants took both Insulin Lispro and the comparison in turn, acting as their own control.

As a double-blind Insulin Lispro study, the assignments were hidden from both participants and investigators until the end.

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

It started in 2011-11 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 6 secondary outcomes, for example Safety endpoints.

What This Means in Plain Language

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

It was withdrawn before enrolling anyone; no results are posted to the registry yet, so nothing here describes outcomes.

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