A Study for Patients With Type 2 Diabetes

What Was Tested

This registered phase 2 trial tested Insulin Glargine.

Comparison of fasting blood glucose levels in patients with Type 2 diabetes after 12 weeks of treatment with a new basal insulin analog or with insulin glargine.

It had three arms (groups): one (experimental), one (experimental) and Insulin glargine (active comparator).

Participants took both LY2605541 and their pre-study insulin for first several days.

The registry classes the interventions as drug.

More on the Plan

Prestudy therapy also includes once daily insulin glargine or neutral protamine Hagedorn (NPH) insulin.

The 12-week active treatment phase will be followed by a 4-week follow-up period, during which patients will return to the basal insulin recommended by the investigator.

Who Took Part

289 actual participants took part.

It was open to people of any sex aged from 18 years with no upper age limit.

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

Examples of who could join: Type 2 diabetes mellitus (T2DM) for at least 1 year. At least 18 years of age. Body Mass Index (BMI) 19 to 45 kilogram/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 visit.

The full record lists 7 inclusion and 19 exclusion criteria; among the exclusions: long-term use of short- or rapid-acting or premixed insulin within the 6 months before the study. short-term insulin therapy or occasional use are permitted; use of any glucose-lowering medications not allowed by the inclusion criteria in the 3 months before entry into the study; use of prescription or over-the-counter medications to promote weight loss within 3 months before entry into the study.

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 Glargine 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 Glargine study did not mask who received what.

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

It ran at 25 sites in Australia (4), Russia (4), United States (3), Hungary (3), Puerto Rico (3) and Romania (3).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Fasting Blood Glucose (FBG) Level at Week 12 Endpoint as Measured by the 8-Point Self-Monitored Blood Glucose (SMBG) Profiles (time frame: Week 12).

It also tracked 20 secondary outcomes, for example Change From Baseline in Fasting Blood Glucose (FBG) at Week 12 Endpoint, Change From Baseline in Hemoglobin A1c (HbA1c) at Week 12 Endpoint, 8-Point Self-Monitored Blood Glucose (SMBG) Measures at Week 12 Endpoint, Percentage of Participants With Hypoglycemia From Baseline Through Week 12, Rate of Hypoglycemia Per 30 Days From Baseline Through Week 12 and Percentage of Participants With Antibody Status Change From Baseline to Week 12 and Week 16.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Insulin Glargine in 289 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.