A Study to Compare Pharmacokinetics and Pharmacodynamics of RinGlar® to Lantus® in Type 1 Diabetes Mellitus Patients

What Was Tested

The trial (not phased) is built around Insulin Glargine.

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

The registry classes the interventions as drug.

Who Took Part

42 actual participants took part.

It was open to men only 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 informed consent. Caucasian males having confirmed diabetes mellitus type 1 (WHO criteria) for at least 12 months prior to screening. Age of 18-65 (both incl.). At least 6 months of Lantus use. C-peptide ≤ 0,3 nM/L (or 0,5 ng/mL).

The full record lists 10 inclusion and 22 exclusion criteria; among the exclusions: acute inflammatory diseases within 3 weeks before the screening period; history or presence of uncontrolled diabetes mellitus for 6 months prior to screening; deep vein thrombosis of lower extremities in a history of life or in a family history.

How the Study Was Run

It was run as a randomized, crossover and quadruple-blind study.

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.

Each person switched between Insulin Glargine and the comparison at some point, usually with a gap in between.

Neither the participants nor the staff measuring them knew who was on Insulin Glargine, so expectations could not easily colour the readings.

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2017-10-16 with completion listed for 2018-02-16.

It ran at 2 sites in Russia (2).

Its stated primary purpose is basic science.

What Was Measured

Researchers chose this as the main measure: AUC GIR(0-t). AUC(0-t).

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Insulin Glargine in 42 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.