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Semaglutide GLP1 Agonists With Degludec Basal-bolus Insulin in Early Type 1 Diabetes to Basal-bolus

Plain-language guide to NCT06057077: phase 1, phase 2 randomized trial of Semaglutide, 120 participants. Who took part, design and what was measured.

Key Facts

Registry ID
NCT06057077
Phase
phase 1, phase 2
Status
status unknown
Start
2024-01-01
Completion (planned or actual)
2024-12-31
Participants
120 (estimated)
Design
randomized, single-blind, treatment
Conditions studied
Type 1 Diabetes
Results posted
not yet

What This Study Did, in Plain Language

What Was Tested

The trial (phase 1, phase 2) is built around Semaglutide.

Anti GAD 65 and anti IA2 2.

It had two arms (groups): 60 early type 1 diabetes with semaglutide and degludec basal bolus insulin (active comparator) and 60 early type 1 diabetes with degludec basal bolus insulin with regular standard of care (no intervention).

Degludec administered once daily bolus insulin three times daily and time in range and Semaglutide once weekly.

The registry classes the interventions as drug.

More on the Plan

Albumin-bound insulins are not as easily filtered by the kidney as unbound insulins.

Randomization: Participants will be randomized to one of the two arms using a computer-generated random number table.

Blinding: The study is open-label, meaning that participants and investigators will be aware of which treatment arm they are in.

Follow-up: Participants will be followed for 24 weeks.

Who Took Part

Enrollment: 120 planned participants were the target.

It was open to people of any sex aged from 18 years up to 35 years.

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

How the Study Was Run

Design: randomized, parallel-group and single-blind.

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.

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

In this single-blind Semaglutide study one party knew the assignments and the other did not.

Those kept unaware of assignments: participant.

It started in 2024-01-01 with completion listed for 2024-12-31.

Its stated primary purpose is treatment.

What Was Measured

It also tracked 1 secondary outcome, for example the change in weight after follow up of one year.

What This Means in Plain Language

Put simply, this is a phase 1, phase 2, randomized trial of Semaglutide in 120 people.

Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.

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

Our Notes on the Compound

Semaglutide: The active ingredient in several prescription GLP-1 receptor agonist medicines (Ozempic, Wegovy, oral tablets).

Related Pages

Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.