Efficacy and Safety of Insulin Lispro Biphasic 25 Compared to Humalog® Mix 25 in Type 2 Diabetes Mellitus Patients

What Was Tested

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

It had two arms (groups): Humalog® Mix 25 (active comparator) and Insulin Lispro Biphasic 25 (experimental).

The registry classes the interventions as drug.

Who Took Part

The registry lists 210 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: Signed written consent. Clinical diagnosis of type 2 diabetes mellitus for at least 6 months prior to screening. Body mass index (BMI) of 18.0 to 35 kg/m2 at screening (both values inclusive).

The full record lists 6 inclusion and 17 exclusion criteria; among the exclusions: acute inflammation disease for 3 weeks prior to screening; deviation of the laboratory results conducted during the screening:; history of hematological disorders that can affect the reliability of hba1c estimation (hemoglobinopathies, hemolytic anemia, etc.).

How the Study Was Run

The set-up was randomized, parallel-group and open-label.

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

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

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

It started in 2018-03-14 with completion listed for 2019-01-15.

It ran at 18 sites in Russia (18).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Antibody Response (time frame: 26 weeks).

It also tracked 7 secondary outcomes, for example Adverse Events frequency and degree, HbA1c, Fasting Plasma Glucose Level, Seven-Point Glucose Testing, Body Mass Index and Treatment Satisfaction.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Insulin Lispro in 210 people.

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

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