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

What Was Tested

In this phase 1 trial, researchers set out to test Insulin (regular human).

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

Regular insulin for injection (recombinant human insulin).

The registry classes the interventions as biological.

More on the Plan

It is a crossover study.

Who Took Part

Enrollment: 25 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 ≥ 18 and ≤ 45 years. 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. 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 15 exclusion criteria; among the exclusions: previous participation in this trial or other clinical trials within the last 3 months; history of alcohol or drug abuse; any positive reaction of drugs of abuse.

How the Study Was Run

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

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

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

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

Those kept unaware of assignments: participant and investigator.

It started in 2008-01 with completion listed for 2008-02.

It ran at 2 sites in United States (2).

Its stated primary purpose is treatment.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Insulin (regular human) in 25 people.

Its size is small, so on its own it can only give an early look.

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.