Effect of Weekly GLP1 Agonist Treatment in "Double Diabetes"

What Was Tested

This registered phase 3 trial tested Semaglutide.

They constitute a group of patients with "double diabetes" since they have both true type 1 diabetes and inherited insulin resistance, typical of type 2 diabetes.

It had two arms (groups): Semaglutide (experimental) and Control (active comparator).

The registry classes the interventions as biological and drug.

Who Took Part

The registry lists 76 planned participants were the target.

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: Person who has given written consent. Patient over 18 years of age. Patient with type 1 diabetes confirmed by a C-peptide below laboratory standards. Age at diagnosis \< 35 years. BMI (weight/height2) ≥ 27 Kg/m².

The full record lists 14 inclusion and 13 exclusion criteria; among the exclusions: person not affiliated to national health insurance; pregnant, parturient or breastfeeding woman; uncontrolled and potentially unstable diabetic retinopathy or maculopathy, confirmed by a fundus examination performed in the 6 months preceding the selection.

How the Study Was Run

Design: randomized, parallel-group and open-label.

Because people in this Semaglutide 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 Semaglutide was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

It started in 2022-07-12 with completion listed for 2028-08.

It ran at 1 site in France.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Percentage of time spent within glycemic target range ([amount hidden]/l).

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Semaglutide in 76 people.

It is still recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Semaglutide compound page, all human trials.