A Study to Compare LY2963016 to Lantus After a Single Dose to Participants With Type 1 Diabetes Mellitus

What Was Tested

The trial (phase 1) is built around Insulin Glargine.

The study involves a single injection of LY2963016 and a single injection of Lantus, on 2 separate occasions in participants with type I diabetes.

There will be at least 7 days between the two periods, during which time there will be no study treatment, but participants will resume their regular therapy.

It had two arms (groups): LY2963016 (experimental) and Lantus (active comparator).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 20 actual participants took part.

It was open to people of any sex aged from 18 years up to 60 years.

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

Examples of who could join: Have type 1 diabetes mellitus (T1DM) based on the disease diagnostic criteria. Have had a duration of diabetes ≥1 year. Have fasting C-peptide ≤0.3 nanomoles per liter (nmol/L). Have a body mass index ≤29 kilograms per square meter (kg/m²). Have venous access sufficient to allow blood sampling and cannulation for clamp procedures.

The full record lists 6 inclusion and 23 exclusion criteria; among the exclusions: have a history of proliferative retinopathy; have known allergies to insulin glargine, insulin lispro, heparin, or related compounds; have an electrocardiogram (ecg) reading considered outside the normal limits.

How the Study Was Run

Design: randomized, crossover and double-blind.

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.

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

Blinding on both sides kept the participants and researchers unaware of who received Insulin Glargine.

Those kept unaware of assignments: participant and investigator.

It started in 2012-05 with completion listed for 2012-07.

It ran at 1 site in Germany.

Its stated primary purpose is treatment.

What Was Measured

It also tracked 5 secondary outcomes, for example Maximum Glucose Infusion Rate (Rmax), Total Glucose Infused (Gtot) and Time of Maximum Glucose Infusion Rate (tRmax).

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Insulin Glargine in 20 people.

Its size is small, so on its own it can only give an early look.

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

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