Comparative Glucose Clamp Study of Wockhardt's Insulin Human Regular for Injection and Actrapid, in Healthy Subjects.

What Was Tested

The trial (phase 1) is built around Insulin (regular human).

It had two arms (groups): Wosulin R (experimental) and Actrapid (active comparator).

The registry classes the interventions as biological.

Who Took Part

The registry lists 42 actual participants took part.

It was open to people of any sex aged from 18 years up to 45 years.

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

Examples of who could join: Healthy male or female subject. Age between 18 and 45 years (both inclusive). 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 35.0 kg/m2 (both inclusive). Non-smoker, defined as no nicotine consumption for at least one year.

The full record lists 6 inclusion and 14 exclusion criteria; among the exclusions: previous participation in this trial or other clinical trials within the last 3 months; pregnant, breast-feeding or intention of becoming pregnant or not using adequate contraceptive measures; history of alcohol or drug abuse within the past 5 years and/or any positive test for drugs of abuse at screening.

How the Study Was Run

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

The participants were allocated by chance, so the Insulin (regular human) group and the comparison group should start out alike.

Each person switched between Insulin (regular human) and the comparison at some point, usually with a gap in between.

Neither the participants nor the staff measuring them knew who was on Insulin (regular human), so expectations could not easily colour the readings.

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

It started in 2008-07 with completion listed for 2008-09.

It ran at 1 site in United States.

Its stated primary purpose is health services research.

What Was Measured

Primary outcome: The area under the GIR-time curve at steady state from 240 to 300 minutes (AUCGIR-SS) (time frame: Visit 2 and 3).

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Insulin (regular human) in 42 people.

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

More context: the Insulin (regular human) compound page, all human trials.