Immunogenicity Safety Study of Wockhardt's Recombinant Insulin Analogue in Type 1 Diabetic Patients

What Was Tested

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

It had two arms (groups): one (experimental) and Lantus® (active comparator).

Basal bolus Insulin analog glargine (Lantus®) to be injected subcutaneously.

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 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 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 4 inclusion and 5 exclusion criteria; among the exclusions: A Patient who is pregnant or is currently breast-feeding; A Patient with history of severe hypoglycemia within the past year; patients who are hepatitis b or c positive on testing or have positive medical history of hiv at screening.

How the Study Was Run

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

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

Groups ran in parallel: each of the participants stayed in one arm throughout.

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

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Change in HbAlc from baseline till the end of treatment period (time frame: 12 months).

It also tracked 1 secondary outcome, for example Percentage change in immunogenic response.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Insulin Glargine 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It was withdrawn before enrolling anyone; no results are posted to the registry yet, so nothing here describes outcomes.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 Glargine compound page, all human trials.