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Liraglutide in the Prevention of Type 2 Diabetes After Gestational Diabetes
Plain-language guide to NCT04324229: not phased randomized trial of Liraglutide, 80 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT04324229
- Phase
- not phased
- Status
- active, not recruiting
- Start
- 2020-02-07
- Completion (planned or actual)
- 2024-09-30
- Participants
- 80 (estimated)
- Design
- randomized, single-blind, prevention
- Conditions studied
- Gestational Diabetes
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
The trial (not phased) is built around Liraglutide.
Obese women with history of gestational diabetes are in great danger to develop type 2 diabetes (T2D) within 5-10 years after delivery.
It had two arms (groups): liraglutide (active comparator) and placebo (placebo comparator).
The registry classes the interventions as drug.
More on the Plan
Gestational diabetes is the major risk factor for T2D in women and more than every tenth will develop gestational diabetes during pregnancy.
BMI should be ≥30 kg/m2.
Both treatments are given by similar device s.c. once daily during 365 days.
Before starting the treatment, clinical examination and laboratory test are done.
Who Took Part
80 planned participants were the target.
It was open to women only.
Healthy volunteers could join, not only people with the condition.
Examples of who could join: History of gestational diabetes with treatment with metformin and/or insulin. Delivery 6 to 18 months before screening. BMI ≥30 kg/m2. Use of contraceptives (IU-device or oral contraceptive).
The full record lists 4 inclusion and 7 exclusion criteria; among the exclusions: type 1 or type 2 diabetes; use of antidepressives, statins or anti-hyperglycemic therapies; severe hepatic insufficiency.
How the Study Was Run
It was run as a randomized, parallel-group and single-blind study.
The participants were allocated by chance, so the Liraglutide group and the comparison group should start out alike.
Groups ran in parallel: each of the participants stayed in one arm throughout.
Only one side, usually the participants, was kept unaware of whether Liraglutide was given.
Those kept unaware of assignments: investigator.
It started in 2020-02-07 with completion listed for 2024-09-30.
It ran at 1 site in Finland.
Its stated primary purpose is prevention.
What Was Measured
The main thing measured (primary outcome): Incidence of type 2 diabetes (time frame: from year 1 to 5).
What This Means in Plain Language
Put simply, this is a not phased, randomized trial of Liraglutide in 80 people.
Its status is active not recruiting; no results are posted to the registry yet, so nothing here describes outcomes.
More context: the Liraglutide compound page, all human trials.
Our Notes on the Compound
Liraglutide: A once-daily GLP-1 receptor agonist peptide; sold as Victoza for type 2 diabetes and Saxenda for weight management.
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.