A Research Study to Compare Insulin 287 Once a Week to Insulin Glargine ([amount hidden]) Once a Day in People With Type 2 Diabetes.

What Was Tested

In this phase 2 trial, researchers set out to test Insulin Glargine.

The study compares 2 medicines for people with type 2 diabetes: insulin 287 (a new medicine) and insulin glargine (a medicine doctors can already prescribe).

The study doctors will test insulin 287 to see how well it works compared to insulin glargine.

It had two arms (groups): Insulin 287 (experimental) and Insulin glargine (active comparator).

Participants will receive once weekly insulin 287 and once daily placebo in combination with metformin with or without dipeptidyl peptidase-4 inhibitors (DPP4i) during 26 weeks of treatment period.

Participants will receive once daily insulin glargine and once weekly placebo in combination with metformin with or without DPP4i during 26 weeks of treatment period.

The registry classes the interventions as drug.

Who Took Part

The registry lists 247 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. 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) less than or equal to 40.0 kg/m\^2.

The full record lists 6 inclusion and 6 exclusion criteria; among the exclusions: any episodes of diabetic ketoacidosis within the past 90 days prior to the day of screening and between screening and randomisation; presently classified as being in new york heart association (nyha) class iv.

How the Study Was Run

The set-up was randomized, parallel-group and quadruple-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.

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

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, care provider, investigator and outcomes assessor.

It started in 2018-11-29 with completion listed for 2019-12-16.

It ran at 49 sites in United States (14), Czechia (9), Canada (7), Poland (6), Slovakia (6) and Greece (5).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Change in Glycated Haemoglobin (HbA1c) [Percentage Point (%-Point)] (time frame: From baseline (Visit 2) to week 26 (Visit 28)). Change in HbA1c [Millimoles/Mole (mmol/Mol)] (time frame: From baseline (Visit 2) to week 26 (Visit 28)).

It also tracked 14 secondary outcomes, for example Change in Fasting Plasma Glucose, 9-point Profile (Individual SMPG Values), Change in Mean of the 9-point Profile, Defined as the Area Under the Profile Divided by Measurement Time, Fluctuations of the 9-point Profile (Defined as the Integrated Absolute Distance From the Mean Profile Value Divided by Measurement Time), Fasting C-peptide and Change in Body Weight.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Insulin Glargine in 247 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.