A Study of LY2963016 Compared to Lantus® in Adult Chinese Participants With Type 2 Diabetes Mellitus

What Was Tested

In this phase 3 trial, researchers set out to test Insulin Glargine.

The purpose of this study is to compare long-acting basal insulin analog LY2963016 to Lantus® in insulin naïve adult Chinese participants with Type 2 Diabetes Mellitus (T2DM) on 2 or more oral antihyperglycemic medications (OAMs).

Participants will continue their OAMs throughout the study.

It had two arms (groups): LY2963016 (experimental) and Lantus® (active comparator).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 536 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 T2DM based on the disease diagnostic criteria World Health Organization (WHO) classification. Body mass index (BMI) ≤35 kilograms per meter squared.

The full record lists 4 inclusion and 14 exclusion criteria; among the exclusions: have used any glucagon like peptide (glp-1) receptor agonists within the previous 90 days; are currently taking traditional medicine (herbal medicine or patent medicine) with known/specified content of anti-hyperglycemic effects within 3 months before screening; have had more than one episode of severe hypoglycemia within 6 months prior to entry into the study.

How the Study Was Run

The set-up was randomized, parallel-group and open-label.

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.

Everyone knew when Insulin Glargine was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

It started in 2018-03-22 with completion listed for 2020-03-18.

It ran at 32 sites in China (32).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Change From Baseline in Hemoglobin A1c (HbA1c) (LY2963016 to Lantus®) (time frame: Baseline, Week 24).

It also tracked 11 secondary outcomes, for example Change From Baseline in HbA1c (Lantus® to LY2963016), Change From Baseline in 7-Point Self-Monitored Blood Glucose (SMBG) Values, Change From Baseline in Glycemic Variability of Fasting Blood Glucose, Change From Baseline in Body Weight, Insulin Treatment Satisfaction Questionnaire (ITSQ) and Number of Participants With Detectable Anti-Glargine Antibodies.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Insulin Glargine in 536 people.

With 536 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.