Study of Two Titration Algorithms With Insulin Glargine [amount hidden] in Type 2 Diabetes Mellitus Patients

What Was Tested

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

It had two arms (groups): Cohort 1 (INSIGHT titration algorithm) (experimental) and Cohort 2 (EDITION titration algorithm) (experimental).

The registry classes the interventions as drug.

More on the Plan

The total study duration is approximately 14 weeks (2 weeks screening and 12 weeks treatment) with a 2-day safety follow-up and a study extension of 12 weeks for eligible patients.

Who Took Part

The registry lists 253 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: Patients with type 2 diabetes mellitus. Patients who are ≥18 years of age. Treated for diabetes for at least 6 months. Signed informed consent form.

The full record lists 7 inclusion and 12 exclusion criteria; among the exclusions: patients with type 1 diabetes mellitus (t1dm); nightshift worker; female patients who are pregnant or lactating.

How the Study Was Run

The set-up was randomized, parallel-group and open-label.

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

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 2015-03 with completion listed for 2016-02.

It ran at 25 sites in Canada (25).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Percentage of patients reaching fasting SMPG ≤[amount hidden]/L without nocturnal (midnight to 6:00 am) hypoglycemia (confirmed or symptomatic or severe).

It also tracked 1 secondary outcome, for example Percentage of patients with adverse events.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Insulin Glargine in 253 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Insulin Glargine compound page, all human trials.