A Study to Compare a New Long-Acting Insulin (LY2605541) and Human Insulin NPH in Participants With Type 2 Diabetes

What Was Tested

The trial (phase 3) is built around NPH Insulin (isophane).

The purpose of this study is to compare LY2605541 and human insulin isophane suspension (NPH) using the following measures for participants treated for up to 26 weeks: * Change in participants' overall blood sugar control * The rate of night time low blood sugar episodes * The number of participants that reach blood sugar targets without low night time blood sugar episodes * The total number of low blood sugar episodes reported.

It had two arms (groups): LY2605541 (experimental) and Human Insulin NPH (active comparator).

The registry classes the interventions as drug.

Who Took Part

The registry lists 641 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: Have had type 2 diabetes mellitus for at least 1 year, not treated with insulin. Have been receiving 2 or more OAMs for at least 3 months prior to the study. Have a body mass index (BMI) less than or equal to 45.0 kilograms per square meter (kg/m\^2).

The full record lists 5 inclusion and 14 exclusion criteria; among the exclusions: have used insulin therapy in the past 2 years (except for use during pregnancy or for short term use for acute conditions); have been treated with glucagon-like peptide-1 (glp-1) receptor agonist, rosiglitazone, pramlintide, or weight-loss medication within 3 months before screening; for participants on oams: have any restrictions for cardiac, renal, and hepatic diseases in the local product regulations.

How the Study Was Run

Design: randomized, parallel-group and open-label.

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

Groups ran in parallel: each of the participants stayed in one arm throughout.

Nothing was hidden in this open-label NPH Insulin (isophane) study: the participants and staff both knew the treatment.

It started in 2013-03 with completion listed for 2014-05.

It ran at 63 sites in United States (20), Germany (6), Canada (5), Poland (5), South Korea (5) and Spain (5).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Change From Baseline to 26 Weeks in Hemoglobin A1c (HbA1c) (time frame: Baseline, 26 Weeks).

It also tracked 22 secondary outcomes, for example 30-Day Adjusted Rate of Total and Nocturnal Hypoglycemic Events, Fasting Serum Glucose (FSG) (by Laboratory), Fasting Blood Glucose (FBG) (by Self Monitoring), 6-Point Self-Monitored Blood Glucose (SMBG), Change From Baseline to 26 Weeks in Body Weight and HbA1c.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of NPH Insulin (isophane) in 641 people.

With 641 participants it is a large trial for this field.

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

More context: the NPH Insulin (isophane) compound page, all human trials.