Comparative Glucose Clamp Study of Wockhardt's Insulin Human Regular for Injection and Actrapid, in Type 1 Diabetics

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 Actrapid (active comparator).

The registry classes the interventions as biological.

Who Took Part

Enrollment: 28 actual participants took part.

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

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Male or female subjects with type 1 diabetes mellitus. Age between 18 and 45 years (both inclusive). Insulin treatment for at least 12 months before the screening visit. Body Mass Index (BMI) between 18.0 and 35.0 kg/m2. Non-smoker, no nicotine consumption for at least one year.

The full record lists 10 inclusion and 19 exclusion criteria; among the exclusions: uncontrolled hypertension; severe neuropathy (in particular autonomic neuropathy), retinopathy or maculopathy; recurrent major hypoglycemia or hypoglycemic unawareness as judged by the investigator or hospitalization for diabetic ketoacidosis during the 6 months preceding the screening visit.

How the Study Was Run

Design: randomized, crossover and quadruple-blind.

Random assignment meant chance, not the researchers, decided who got Insulin (regular human) and who got the comparison, which limits bias.

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, care provider, investigator and outcomes assessor.

It started in 2008-08 with completion listed for 2009-03.

It ran at 1 site in United States.

Its stated primary purpose is health services research.

What Was Measured

Primary outcome: Mean AUCins.0-12h and Cins.max (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 28 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.