A Research Study in People With Type 2 Diabetes to Compare Two Types of Insulin: Insulin 287 and Insulin Glargine

What Was Tested

The trial (phase 2) is built around 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.

Different ways of switching from the insulin which the participants are already on to insulin 287 are also compared.

This is done to find the best way to switch to insulin 287.

It had three arms (groups): one (experimental), one (experimental) and Insulin glargine U100 (active comparator).

Participants will receive insulin glargine U100 once daily (OD).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 154 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. Body mass index (BMI) less than or equal to 40.0 kg/m\^2.

The full record lists 8 inclusion and 8 exclusion criteria; among the exclusions: known or suspected hypersensitivity to trial product(s) or related products; female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using an adequate contraceptive method; participation in any clinical trial of an approved or non-approved investigational medicinal product within 90 days before screening.

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.

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

It started in 2019-05-09 with completion listed for 2019-12-19.

It ran at 38 sites in United States (13), Canada (10), Germany (6), Italy (5) and Czechia (4).

Its stated primary purpose is treatment.

What Was Measured

It also tracked 8 secondary outcomes, for example Change in Glycosylated Haemoglobin (HbA1c), 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 154 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.