Comparative Wockhardt's Glucose Clamp Study-Human Isophane Susp [amount hidden] With Novolin70/30, in Healthy Subjects

What Was Tested

In this phase 1 trial, researchers set out to test NPH Insulin (isophane).

It had two arms (groups): Wosulin 70/30 (experimental) and Novolin 70/30 (active comparator).

The registry classes the interventions as biological.

Who Took Part

Enrollment: 53 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. 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; any positive test for drugs of abuse and /or alcohol at screening.

How the Study Was Run

Design: randomized, crossover and quadruple-blind.

Because people in this NPH Insulin (isophane) 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 NPH Insulin (isophane) 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 NPH Insulin (isophane).

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

It started in 2011-01 with completion listed for 2011-05.

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 53 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.