Immunogenicity Study of Wockhardt's Insulin Lispro/Lispro Mix Basal Bolus Regimen in Type 1 Diabetics

What Was Tested

In this phase 3 trial, researchers set out to test Insulin Lispro.

It had two arms (groups): Lispro arm (experimental) and Humalog® arm (active comparator).

Lispro and Lispro Mix 75/25 /Lispro Mix 50/50.

Humalog® and Humalog® Mix75/25 / Humalog® Mix50/50.

The registry classes the interventions as biological.

Who Took Part

It was open to people of any sex aged from 18 years up to 55 years.

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

Examples of who could join: Patients who understand the nature of the study and are willing to provide written informed consent. Patients who have been pre-diagnosed as cases of type-1 diabetes for a period not less than 1 year. Male or Female Patients ≥ 18 and \< 55 years of age. Patients with body mass index (BMI) of 18.0 to 30.0 kg/m2. Patients who are cooperative, reliable, and agree to have regular injections of insulin and are willing to comply with protocol procedures.

The full record lists 6 inclusion and 8 exclusion criteria; among the exclusions: females who are pregnant or lactating, or not practicing adequate contraception; A Patient with compromised hepatic or renal function; A Patient with history or evidence of allergy to insulin preparations.

How the Study Was Run

It was run as a randomized, parallel-group and open-label study.

Random assignment meant chance, not the researchers, decided who got Insulin Lispro and who got the comparison, which limits bias.

The Insulin Lispro group and the comparison group ran side by side rather than switching.

Being open-label, the Insulin Lispro study did not mask who received what.

It started in 2012-02 with completion listed for 2013-03.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Change in HbA1c (time frame: 6 months).

It also tracked 2 secondary outcomes, for example Percentage change in the immunogenic response and Correlation of the immunogenicity with hypoglycemia.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Insulin Lispro in people.

It was withdrawn before enrolling anyone; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Insulin Lispro compound page, all human trials.