A Study for Patients With Type 1 Diabetes

What Was Tested

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

Comparison of blood glucose levels in patients with Type 1 diabetes when they take a new basal insulin analog and when they take insulin glargine.

It had two arms (groups): LY2605541 First, Then Insulin Glargine (experimental) and Insulin Glargine First, Then LY2605541 (active comparator).

Participants received LY2605541 for 8 weeks, followed by insulin glargine for 8 weeks.

Participants received insulin glargine for 8 weeks, followed by LY2605541 for 8 weeks.

The registry classes the interventions as drug.

More on the Plan

Prestudy treatment for patients who enter this study will be once daily insulin glargine along with mealtime insulins.

Patients will continue to use their mealtime insulins throughout the study.

The study will consist of 16 weeks of treatment and 4 weeks of follow-up.

The 16 weeks of treatment will consist of two 8-week periods (Periods 1 and 2) during which patients will receive insulin glargine for 8 weeks and LY2605541 for 8 weeks in a random sequence.

Who Took Part

The registry lists 138 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: Body mass index (BMI) 19 to 45 kilogram per square meter (kg/m²). Women of childbearing potential must test negative for pregnancy before receiving treatment and agree to use reliable birth control until completing the follow-up.

The full record lists 5 inclusion and 20 exclusion criteria; among the exclusions: twice daily use of insulin glargine within 30 days prior to the study; use of any oral or injectable medication intended for the treatment of diabetes mellitus other than insulins in the 3 months prior to the study; use of an insulin pump.

How the Study Was Run

The set-up was randomized, crossover and open-label.

The participants were allocated by chance, so the Insulin Glargine group and the comparison group should start out alike.

Each person switched between Insulin Glargine and the comparison at some point, usually with a gap in between.

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

It started in 2010-01 with completion listed for 2010-12.

It ran at 13 sites in United States (10) and Israel (3).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Daily Average Blood Glucose (Avg. BG) at Week 8 Endpoint as Measured by the 8-Point Self-Monitored Blood Glucose (SMBG) Profiles (time frame: Week 8 of each treatment period).

It also tracked 11 secondary outcomes, for example Change From Baseline in Hemoglobin (HbA1c) at Week 8 Endpoint of Period I, 8-Point Self-Monitored Blood Glucose (SMBG) Measures at Week 8 Endpoint, Percentage of Participants With Antibody Status Change From Baseline to Week 8, Week 16 and Week 20, Percentage of Participants With Hypoglycemia Baseline Through Week 8, Rate of Hypoglycemia Per 30 Days Baseline Through Week 8 and Glycemic Variability in Fasting Blood Glucose (FBG) at Week 8 Endpoint.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Insulin Glargine in 138 people.

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.