A Study to Compare the Effect of a Double Dose of Two Long-acting Insulin Therapies in Participants With Type 2 Diabetes

What Was Tested

This registered phase 3 trial tested Insulin Glargine.

Participants will be treated with study insulin daily, in two 4-week study periods.

Each participant will receive insulin peglispro during one treatment period and insulin glargine during the other treatment period.

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

The registry classes the interventions as drug.

Who Took Part

Enrollment: 68 actual participants took part.

It was open to people of any sex aged from 18 years up to 70 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Have type 2 diabetes mellitus (T2DM), based on the World Health Organization (WHO) classification, for ≥1 year. Use any type of basal insulin (except degludec), including once-or twice-daily human insulin neutral protamine Hagedom (NPH), insulin detemir, or insulin glargine. Have body mass index (BMI) ≤40.0 kilograms/square meter (kg/m\^2).

The full record lists 8 inclusion and 13 exclusion criteria; among the exclusions: are using insulin pump therapy; if being treated with sulfonylureas (sus) before screening, then must have sus washed out between screening and randomization; have had any episode of severe hypoglycemia (defined by requiring assistance due to neurologically disabling hypoglycemia) within 6 months before entry into the study.

How the Study Was Run

It was run as a randomized, crossover and double-blind study.

Random assignment meant chance, not the researchers, decided who got Insulin Glargine and who got the comparison, which limits bias.

Each person switched between Insulin Glargine and the comparison at some point, usually with a gap in between.

As a double-blind Insulin Glargine study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant and investigator.

It started in 2014-05 with completion listed for 2015-07.

It ran at 3 sites in Germany (2) and United States (1).

Its stated primary purpose is treatment.

What Was Measured

It also tracked 9 secondary outcomes, for example Percentage of Participants With Hypoglycemia, Nadir Glucose, Time to the Nadir Glucose, Fasting Blood Glucose and Beta Cell Function.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Insulin Glargine in 68 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.