A Study Comparing Insulin Peglispro With Insulin Glargine as Basal Insulin Treatment

What Was Tested

This registered phase 3 trial tested Insulin Glargine.

The purpose of this study is to compare insulin peglispro (LY2605541) to insulin glargine in Asian insulin naïve participants who have been treated with oral anti hyperglycemia medications.

Participants will receive 26 weeks of treatment.

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

Insulin Peglispro administered subcutaneously (SC) once daily for 26 weeks in combination with Oral Antihyperglycemic Medications (OAMs).

Insulin Glargine administered SC once daily for 26 weeks in combination with OAMs.

The registry classes the interventions as drug.

Who Took Part

388 actual participants took part.

It was open to people of any sex aged from 20 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 (T2DM) for at least 1 year not treated with insulin. Have been receiving at least two oral antihyperglycemic medications (OAMs) for at least 3 months prior to screening. Body mass index (BMI) ≤35.0 kilogram per square meter (kg/m\^2). Inject insulin with a pre-filled insulin pen and perform Self-Monitored Blood Glucose (SMBG). Record keeping as required by this protocol.

The full record lists 7 inclusion and 17 exclusion criteria; among the exclusions: have used insulin therapy (outside of pregnancy) anytime in the past 2 years, except for short term treatment of acute conditions; have been treated with rosiglitazone, pramlintide, glucagon-like peptide-1 (glp-1) receptor agonist within 3 months prior to screening; local oam restrictions: 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.

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

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

Nothing was hidden in this open-label Insulin Glargine study: the participants and staff both knew the treatment.

It started in 2013-07 with completion listed for 2015-04.

It ran at 31 sites in Japan (18), Taiwan (7) and South Korea (6).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Change From Baseline to Week 26 in Hemoglobin A1c (HbA1c) (time frame: Baseline, Week 26).

It also tracked 17 secondary outcomes, for example 30-Day Adjusted Rate of Total and Nocturnal Hypoglycemic Events, Fasting Serum Glucose (FSG), Fasting Blood Glucose (FBG), Change From Baseline to Week 26 in Body Weight, 9-Point Self-Monitored Blood Glucose (SMBG) and Percentage of Participants With Detectable Anti-Insulin Peglispro Antibodies at Week 26.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Insulin Glargine in 388 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.