A Study in Adults With Type 2 Diabetes

What Was Tested

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

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

LY2963016 titrated based on blood glucose readings, administered subcutaneously, once daily in combination with at least 2 oral antihyperglycemic medications (OAMs) \[alpha glucosidase inhibitors (AGI), dipeptidyl peptidases intravenous (DPP-IV), meglitinide (MEG), metformin (MET), sulfonylurea (SU), and thiazolidinedione (TZD)\] administered per standard of care for 24 weeks.

Lantus titrated based on blood glucose readings, administered subcutaneously, once daily in combination with at least 2 OAMs (AGI, DPP-IV, MEG, MET, SU, and TZD) administered per standard of care for 24 weeks.

The registry classes the interventions as drug.

Who Took Part

The registry lists 759 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 based on the disease diagnostic criteria World Health Organization (WHO) classification. Have been taking at least 2 types of oral diabetes medications for at least 12 weeks prior to entering the study. Have a body mass index of less than or equal to 45 kilogram per meter squared (kg/m\^2).

The full record lists 4 inclusion and 6 exclusion criteria; among the exclusions: have active cancer or have had cancer within the past 5 years (with the exception of basal cell carcinoma or carcinoma in situ); have an excessive resistance to insulin or hypersensitivity to lantus; have taken any other insulin other than lantus within the past 30 days.

How the Study Was Run

Design: randomized, parallel-group and triple-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.

Neither the participants nor the staff measuring them knew who was on Insulin Glargine, so expectations could not easily colour the readings.

Those kept unaware of assignments: participant, care provider and investigator.

It started in 2011-09 with completion listed for 2012-09.

It ran at 62 sites in United States (28), Germany (7), Mexico (4), Poland (4), Puerto Rico (4) and Spain (3).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Change From Baseline up to 24 Weeks in Hemoglobin A1c (HbA1c) (time frame: Baseline, Endpoint (up to 24 weeks)).

It also tracked 12 secondary outcomes, for example Change From Baseline in Insulin Antibody Levels, Change From Baseline in Hemoglobin A1c (HbA1c), 7-Point Self-Monitored Blood Glucose (SMBG) Profiles, Glycemic Variability of Fasting Blood Glucose, Change From Baseline in Body Weight and Adult Low Blood Sugar Survey (ALBSS).

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Insulin Glargine in 759 people.

With 759 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.