A Research Study to Compare Two Types of Insulin: Insulin 287 and Insulin Glargine in People With Type 2 Diabetes Who Have Not Used Insulin Before

What Was Tested

This registered phase 2 trial tested Insulin Glargine.

This study compares insulin 287 (a possible new medicine) to insulin glargine (a medicine doctors can already prescribe) in people with type 2 diabetes.

It had four arms (groups): Insulin 287 algorithm A (experimental), Insulin 287 algorithm B (experimental), Insulin 287 algorithm C (experimental) and Insulin Glargine algorithm D (active comparator).

Controlled on metformin with or without DPP4i (dipeptidyl peptidase-4 inhibitors) and with or without SGLT2i (sodium-glucose cotransporter 2 inhibitors).

Controlled on metformin with or without DPP4i and with or without SGLT2i.

Controlled on metformin with or without DPP4i and with or without SGLT2i.

The registry classes the interventions as drug.

Who Took Part

The registry lists 205 actual participants took part.

It was open to people of any sex aged from 18 years up to 75 years.

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

Examples of who could join: Male or female, aged 18-75 years (both inclusive) at the time of signing informed consent. Diagnosed with type 2 diabetes mellitus greater than or equal to 180 days prior to the day of screening. Free or fixed combination therapy: Metformin as outlined above plus/minus DPP4i with or without SGLT2i is allowed:. Insulin-naïve. However, short term insulin treatment for a maximum of 14 days prior to the day of screening is allowed, as is prior insulin treatment for gestational diabetes. Body mass index (BMI) below or equal to 40.0 kg/m\^2.

The full record lists 8 inclusion and 0 exclusion criteria.

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.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Being open-label, the Insulin Glargine study did not mask who received what.

It started in 2019-05-09 with completion listed for 2019-12-12.

It ran at 43 sites in United States (12), Germany (9), Slovakia (6), Poland (5), Croatia (4) and Spain (4).

Its stated primary purpose is treatment.

What Was Measured

It also tracked 8 secondary outcomes, for example Change in HbA1c (Glycated Haemoglobin), Change in Fasting Plasma Glucose (FPG), Change in Body Weight, Number of Treatment Emergent Adverse Events (TEAEs) and Number of Severe Hypoglycaemic Episodes (Level 3).

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Insulin Glargine in 205 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.