A Trial to Assess the Efficacy and Safety of M1 Pram P037 Prandial Insulin in Subjects With Type 1 Diabetes (T1DM)

What Was Tested

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

It had two arms (groups): M1 Pram P037 (experimental) and Insulin lispro (active comparator).

Multi daily administration of M1 Pram P037 by subcutaneous injection.

Multi daily administration of insulin lispro (Humalog®) by subcutaneous injection.

The registry classes the interventions as drug.

More on the Plan

After a run in period in case of basal insulin switch or Continuous Glucose Monitoring (CGM) initiation, eligible subjects will enter a 3 weeks baseline recording period.

Subjects will then be randomized to either M1 Pram P037 treatment or active comparator treatment (insulin lispro).

Both investigator and enrolled subjects will be unblinded to treatment.

Study participants will use CGM until follow-up visit.

Who Took Part

The registry lists 80 actual participants took part.

It was open to people of any sex aged from 18 years up to 64 years.

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

Examples of who could join: Signed and dated informed consent obtained before any trial-related activities. Trial-related activities are any procedures that would not have been done during normal management of the subject. Subjects with type 1 diabetes mellitus. Body Mass Index (BMI) between 25.0 and 35.0 kg/m\^2, both inclusive. Diabetes duration of at least 12 months. Using any CGM or Flash Glucose Monitoring (FGM) for at least 1 month or willing to use CGM during the trial.

The full record lists 7 inclusion and 22 exclusion criteria; among the exclusions: known or suspected hypersensitivity to imps or any of the excipients or to any component of the imp formulation; type 2 diabetes mellitus; history of multiple and/or severe allergies to drugs or foods or a history of severe anaphylactic reaction.

How the Study Was Run

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

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

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

Nothing was hidden in this open-label Insulin Lispro study: the participants and staff both knew the treatment.

It started in 2021-03-23 with completion listed for 2022-02-24.

It ran at 2 sites in Germany (2).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Body weight change from baseline to week 16 of treatment (time frame: From week 0 to week 16).

It also tracked 15 secondary outcomes, for example TIR [70-180] mg/dL, %TIR [70-180] mg/dL, TIR [70-140] mg/dL, %TIR [70-140] mg/dL, MeanG_24h and CVG_24h.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Insulin Lispro in 80 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.