Study of How Single Rising Doses of SAR161271 Are Absorbed and Act in Patients With Type 1 Diabetes Mellitus (T1DM)

What Was Tested

This registered phase 1, phase 2 trial tested Insulin Glargine.

Secondary Objective: \- To establish relative potency of SAR161271 compared with insulin glargine in patients with T1DM.

It had three arms (groups): one (experimental), one (experimental) and one (experimental).

The registry classes the interventions as drug.

More on the Plan

The total per patient is between 31 and 67 days; including post-study visit between 108 and 172 days.

Who Took Part

The registry lists 46 actual participants took part.

It was open to men only aged from 18 years up to 60 years.

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

Examples of who could join: Stable insulin regimen for at least 2 months before the study. Body weight between 50-110 kg inclusive; body mass index between 18-30 kg/m2, inclusive. Certified as healthy for T1DM by a comprehensive clinical assessment.

The full record lists 6 inclusion and 5 exclusion criteria; among the exclusions: blood donation, any volume, within 1 month before inclusion; presence or history of drug hypersensitivity, or allergic disease diagnosed and treated by a physician.

How the Study Was Run

Design: randomized, crossover and double-blind.

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

In the crossover set-up each of the participants took both Insulin Glargine and the comparison in turn, acting as their own control.

As a double-blind Insulin Glargine study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant and investigator.

It started in 2010-02 with completion listed for 2010-05.

It ran at 1 site in Germany.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: - Safety in terms of adverse and serious adverse events, vital signs, ECG, safety laboratory for each cohort.

It also tracked 2 secondary outcomes, for example - anti-insulin antibody production.

What This Means in Plain Language

Put simply, this is a phase 1, phase 2, randomized trial of Insulin Glargine in 46 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.