A Study on Comparison of Glargine Plus Glulisine With Premixed Insulin in Type 2 Diabetes Patients

What Was Tested

This registered phase 4 trial tested Insulin Glargine.

The primary outcome measures will be to compare the change in HbA1c from baseline to week 24 between Glargine OD + Glulisine in comparison with Premixed insulin initiation in insulin naïve patients with T2DM.

It had two arms (groups): Glargine + Glulisine (experimental) and Premixed Analogue Insulin (70/30) (active comparator).

The registry classes the interventions as drug.

More on the Plan

The subjects will be invited to the study centre from the local population who are willing to participate in the trial.

Each subject will be informed both orally and in writing about the study prior to inclusion in the study and only the subjects who give written informed consent will be included.

The selection of the subjects is based on the inclusion and exclusion criteria defined in the protocol.

The selected subjects will be given a screening number and subjected to screening procedure to find out eligible candidates for enrollment.

Who Took Part

The registry lists 200 actual participants took part.

It was open to people of any sex aged from 18 years up to 65 years.

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

Examples of who could join: Both men and women of age ≥ 18 and ≤ 65 years. Body mass index (BMI) ≤ 40 kg/m2. Have given written informed consent to participate in this study in accordance with local regulations. Subject must have access to telephone for calling into the clinical center as part of test product compliance.

The full record lists 6 inclusion and 6 exclusion criteria; among the exclusions: BMI \> 40 kg/m2; subject is being treated for severe active infection of any type; have had more than one episode of severe hypoglycemia within 6 months prior to entry into the study.

How the Study Was Run

Design: randomized, parallel-group and open-label.

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.

Everyone knew when Insulin Glargine was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

It started in 2016-12-29 with completion listed for 2018-09.

It ran at 8 sites in India (8).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Changes in HbA1c (time frame: Baseline and 24 weeks).

It also tracked 11 secondary outcomes, for example Changes in Fasting Blood Glucose, Changes in postprandial blood glucose, Changes in 7 point self monitored blood glucose profile, Number of events of symptomatic hypoglycemia, Number of events of severe hypoglycemia and Changes in weight.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Insulin Glargine in 200 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

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