Comparative Glucose Clamp Study of Wockhardt's Human Isophane Insulin With Novolin N,in Healthy Subjects

What Was Tested

The trial (phase 1) is built around NPH Insulin (isophane).

It had two arms (groups): Wosulin N (experimental) and Novolin N (active comparator).

The registry classes the interventions as biological.

Who Took Part

The registry lists 56 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 more than 18 and less than 45 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 15 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 and/or any positive test for drugs of abuse at screening; any positive reaction of drugs of abuse.

How the Study Was Run

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

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

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

As a double-blind NPH Insulin (isophane) 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 2010-09 with completion listed for 2011-03.

It ran at 1 site in United States.

Its stated primary purpose is health services research.

What Was Measured

Primary outcome: Mean AUC0-24h and Cmax (time frame: Visit 2 and 3).

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of NPH Insulin (isophane) in 56 people.

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

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