Comparison of MyStar DoseCoach to Routine Titration in Adult Patients With Type 2 Diabetes Mellitus Using Toujeo

What Was Tested

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

It had two arms (groups): MyStar DoseCoach (experimental) and Routine Titration (active comparator).

MyStar DoseCoach - Device-supported treat-to-target regimen. Insulin glargine is administered subcutaneously on top of potential background therapy using oral anti-diabetic drug(s) or GLP1 RA injectable antihyperglycemic drug(s).

Routine Titration - Routine titration defined by the Investigator. Insulin glargine is administered subcutaneously on top of potential background therapy using oral anti-diabetic drug(s) or GLP1 RA injectable antihyperglycemic drug(s).

The registry classes the interventions as device and drug.

More on the Plan

The maximum study duration will be 21 weeks per patient that will consist of a 4-week screening period, a 16-week treatment period, and 1-week follow-up period.

Who Took Part

The registry lists 151 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 diagnosed at least one year before the screening visit. Patients who are insulin naïve (and considered by the investigator to be appropriate candidates for basal insulin therapy), or treated with basal insulin as their only insulin. Signed informed consent.

The full record lists 5 inclusion and 20 exclusion criteria; among the exclusions: aged \<18 years; diabetes other than type 2 diabetes mellitus; mystar dosecoach device is not appropriate for the patient or use of device is otherwise contraindicated (in the opinion of the investigator).

How the Study Was Run

The set-up was 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.

The Insulin Glargine group and the comparison group ran side by side rather than switching.

Nothing was hidden in this open-label Insulin Glargine study: the participants and staff both knew the treatment.

It started in 2015-12 with completion listed for 2016-11.

It ran at 19 sites in United Kingdom (10) and Germany (9).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Percentage of patients reaching fasting SMPG target range [amount hidden]/dL ([amount hidden]/L) at Week 16 (mean of the last 5 readings recorded over the last 2 weeks) without a severe hypoglycemic episode during the 16-week on-treatment period.

It also tracked 17 secondary outcomes, for example Mean FSMPG glucose change from baseline (mean of the last 5 readings recorded over the last 2 weeks), Mean FPG glucose change from baseline, Mean HbA1c change from baseline, Percentage of patients with hypoglycemic events, Number of hypoglycemic events and 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 151 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.