Comparison of Insulin Tregopil (IN-105) With Insulin Aspart in Type 2 Diabetes Mellitus Patients

What Was Tested

In this phase 2, phase 3 trial, researchers set out to test Insulin Aspart.

The study will be conducted in 2 parts, Part I and Part II.

The study duration will be approximately 37 weeks for Part I and for Part II of the study respectively.

It had three arms (groups): one (experimental), one (experimental) and Insulin Aspart (active comparator).

The registry classes the interventions as drug.

More on the Plan

For Part I and Part II, the study duration will be approximately 37 weeks (3 weeks Screening, 8 weeks Run-in, 24 weeks Treatment, 2 weeks Safety follow-up).

An Independent Data and Safety Monitoring Board (DSMB) will evaluate the data from Part I of the study.

Part II of the study will be initiated after approval from the office of Drugs Controller General of India (DCGI) and Data Safety Monitoring Board (DSMB) recommendation based on review of data from Part I of the study.

The eligible patients will go through a Run-in period of 8 weeks.

Who Took Part

The registry lists 143 actual participants took part.

It was open to people of any sex aged from 18 years up to 70 years.

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

Examples of who could join: Eligible for initiation of or already receiving insulin glargine. Body mass index of 18.5 to 35.0 kg/m2.

The full record lists 6 inclusion and 8 exclusion criteria; among the exclusions: patients with t1dm; treatment with glucagon-like peptide 1 agonists within 12 weeks prior to screening; ongoing treatment with oads (eg, thiazolidinediones) contraindicated or unapproved for combination treatment with insulin.

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 Aspart and who got the comparison, which limits bias.

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

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

It started in 2017-12-26 with completion listed for 2019-02-06.

It ran at 1 site in India.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Change From Baseline in HbA1c at 24 Weeks (Part 1) (time frame: Week 0, Week 24).

It also tracked 9 secondary outcomes, for example Change From Baseline in HbA1c at Week 12 (Part 1), Percentage of Participants With Hypoglycemia Events During 24-week Treatment Period (Part 1), Weight (Kgs) (Part 1), Lipid Profile (Part 1), Post-prandial Glucose (PPG) Excursion (Part 1) and Number of Participants With Treatment-Emergent Adverse Events (Part 1).

What This Means in Plain Language

Put simply, this is a phase 2, phase 3, randomized trial of Insulin Aspart in 143 people.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

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