A Study in Patients With Type 2 Diabetes Mellitus

What Was Tested

The trial (phase 3) is built around Insulin Glargine.

The purpose of this study is: * To compare blood sugar control on LY2605541 with insulin glargine after 52 weeks of treatment. * To compare the rate of night time low blood sugar episodes on LY2605541 with insulin glargine during 52 weeks of treatment. * To compare the number of participants on LY2605541 reaching blood sugar targets without low blood sugar episodes at night to those taking insulin glargine after 52 weeks of treatment. * To compare the rate of low blood sugar episodes on LY2605541 with insulin glargine after 52 weeks of treatment.

It had two arms (groups): LY2605541 (experimental) and Glargine (active comparator).

LY2605541 titrated based on blood glucose readings, administered subcutaneously (SC), once daily in combination with at least 2 pre-study oral antihyperglycemic medications (OAMs) prescribed by the personal physician, for 52 or 78 weeks.

Glargine titrated based on blood glucose readings, administered SC, once daily in combination with at least 2 pre-study OAMs prescribed by the personal physician, for 52 or 78 weeks.

The registry classes the interventions as drug.

Who Took Part

Enrollment: 1538 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 type 2 diabetes mellitus, not treated with insulin, for at least 1 year prior to the study. Have been receiving at least 2 OAMs for at least 3 months before entering the study. Are capable of and willing to inject insulin with a vial and syringe and perform self blood glucose monitoring.

The full record lists 5 inclusion and 13 exclusion criteria; among the exclusions: are currently taking, or have taken within the 3 months preceding screening, medications to promote weight loss; have had any episodes of severe hypoglycemia within 6 months prior to screening; have had 1 or more episodes of ketoacidosis or hyperosmolar state/coma in the 6 months prior to the study.

How the Study Was Run

Design: randomized, parallel-group 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.

The Insulin Glargine group and the comparison group ran side by side rather than switching.

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 2011-11 with completion listed for 2014-01.

It ran at 167 sites in United States (66), Germany (11), Canada (10), Poland (8), Romania (7) and Italy (6).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Change From Baseline to 52 Week Endpoint in Hemoglobin A1c (HbA1c) (time frame: Baseline, 52 weeks).

It also tracked 19 secondary outcomes, for example Rate of Total and Nocturnal Hypoglycemia Events, Fasting Serum Glucose (By Laboratory Measurement), Fasting Blood Glucose (By Participant Self-monitored Blood Glucose Readings), 6 Point Self-monitored Blood Glucose (SMBG), Change From Baseline to 52 Weeks in Body Weight and Hemoglobin A1c.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Insulin Glargine in 1538 people.

With 1538 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 Insulin Glargine compound page, all human trials.