Comparison of Glargine to Degludec Insulin Transition With or Without a Bridging Glargine Dose

What Was Tested

The trial (phase 4) is built around Insulin Glargine.

It had two arms (groups): Insulin Glargine and Insulin Degludec (experimental) and Insulin Degludec and placebo (placebo comparator).

The registry classes the interventions as drug.

More on the Plan

There is no guidance on what to do in those 48-72 hours.

Who Took Part

The registry lists 59 actual participants took part.

It was open to people of any sex aged from 18 years up to 75 years.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: Patients must meet ALL inclusion criteria to be included in the study. Patient age is 18-75 years. Diagnosis of T1D of at least 1-year duration. Has the ability to provide informed consent before any trial-related activities. Treated with insulin glargine as their basal insulin in the 3 months preceding screening visit.

The full record lists 14 inclusion and 15 exclusion criteria; among the exclusions: patient must not have any of the exclusion criteria to be included in the study; patients with egfr \<30 on at least 2 measurements within 1-year of the screening visit; history of myocardial infarction within 6 months preceding the screening visit.

How the Study Was Run

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

The participants were allocated by chance, so the Insulin Glargine group and the comparison group should start out alike.

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

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 2020-02-14 with completion listed for 2022-09-07.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Mean Change in Percent Time in Range.

It also tracked 7 secondary outcomes, for example Coefficient of Variation (CV) of Percent-time-in-range, Time Above Range-2 (TAR-2), Time Below Range-1 (TBR-1), Time Below Range-2 (TBR-2) and Correction Boluses.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Insulin Glargine in 59 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.