Efficacy and Safety of Insulin RinGlar® Compared to Lantus® SoloStar® in Type 1 Diabetes Mellitus Patients

What Was Tested

The trial (phase 3) is built around Insulin Glargine.

It had two arms (groups): Lantus® SoloStar® (active comparator) and Insulin RinGlar® (experimental).

The registry classes the interventions as drug.

Who Took Part

The registry lists 180 actual participants took part.

It was open to people of any sex aged from 18 years up to 65 years.

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

Examples of who could join: Signed written consent. Diabetes mellitus type 1 for at least 12 months prior to screening. Body mass index (BMI) of 18.0 to 35 kg/m2 at screening (both values inclusive). Subject is able and willing to comply with the requirements of the study protocol.

The full record lists 6 inclusion and 28 exclusion criteria; among the exclusions: contraindication to the use of insulin glargine; history of treatment any biosimilar insulin; history of treatment any experimental drugs or medical devices for 3 months prior to screening.

How the Study Was Run

Design: 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.

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

Everyone knew when Insulin Glargine was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

It started in 2018-07-04 with completion listed for 2019-02-25.

It ran at 14 sites in Russia (14).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Antibody Response (time frame: 26 weeks).

It also tracked 10 secondary outcomes, for example Adverse Events frequency and degree, Glycated hemoglobin, Fasting Plasma Glucose Level, Seven-Point Glucose Testing, Body Mass Index and Treatment Satisfaction.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Insulin Glargine in 180 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.