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Effect of Liraglutide on Subclinical Atherosclerosis in Patients With Type 1 Diabetes Mellitus
Plain-language guide to NCT05467514: phase 3 interventional trial of Liraglutide, 35 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT05467514
- Phase
- phase 3
- Status
- completed
- Start
- 2022-07-01
- Completion (planned or actual)
- 2023-02-28
- Participants
- 35 (actual)
- Design
- na, open label (everyone knows who gets what), treatment
- Conditions studied
- Diabetes Mellitus, Type 1
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
The trial (phase 3) is built around Liraglutide.
It had 1 arm (groups): Liraglutide (experimental).
The registry classes the interventions as drug.
Who Took Part
Enrollment: 35 actual participants took part.
It was open to people of any sex aged from 15 years up to 60 years.
Healthy volunteers were not accepted; participants needed the condition being studied.
Examples of who could join: Age from 15 to 60 years. Patients diagnosed with Type 1 Diabetes Mellitus. Diabetes duration more than 1 year.
The full record lists 5 inclusion and 10 exclusion criteria; among the exclusions: pregnant patients or desire to become pregnant in the next 6 months; family history of medullary thyroid cancer or multiple endocrine neoplasia 2; history of pancreatitis.
How the Study Was Run
The set-up was single-group and open-label.
Everyone knew when Liraglutide was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.
Everyone received the same intervention, so there was no separate comparison group inside the trial.
It started in 2022-07-01 with completion listed for 2023-02-28.
It ran at 1 site in Mexico.
Its stated primary purpose is treatment.
What Was Measured
The main thing measured (primary outcome): To assess the effect of liraglutide on carotid intima media thickness in patients with type 1 diabetes mellitus (time frame: Baseline and 6 months).
It also tracked 6 secondary outcomes, for example To assess the effect of liraglutide on cardiovascular risk factors, cardiometabolic markers (BMI, weight and abdominal circumference), To assess the effect of liraglutide on cardiovascular risk factors, cardiometabolic markers Laboratory studies (HbA1c) and To assess the effect of liraglutide on cardiovascular risk factors, cardiometabolic markers. eGDR (Estimated glucose disposal rate).
What This Means in Plain Language
Put simply, this is a phase 3 trial of Liraglutide in 35 people.
Its size is small, so on its own it can only give an early look.
The trial is marked completed; 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.