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Incretin Effect on the Immunological Phenotype
Plain-language guide to NCT01782261: phase 2 randomized trial of Liraglutide, 15 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT01782261
- Phase
- phase 2
- Status
- completed
- Start
- 2012-02
- Completion (planned or actual)
- 2015-02
- Participants
- 15 (actual)
- Design
- randomized, open label (everyone knows who gets what), treatment
- Conditions studied
- Type 1 Diabetes
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
This registered phase 2 trial tested Liraglutide.
Assessment of the effect of incretin based therapies (Liraglutide and Saxagliptin) on immune cells in healthy subjects and patients with type 1 diabetes.
It had two arms (groups): Liraglutide (experimental) and Saxagliptin (active comparator).
The registry classes the interventions as drug.
More on the Plan
Assessment of immunological effects of Saxagliptin and Liraglutide on immune cells of the peripheral blood.
Who Took Part
15 actual participants took part.
It was open to people of any sex aged from 18 years up to 50 years.
Healthy volunteers could join, not only people with the condition.
Examples of who could join: Healthy subjects or patients with type 1 diabetes.
The full record lists 1 inclusion and 4 exclusion criteria; among the exclusions: treatment with glp-1-analoga (liraglutide, exenatide); treatment with dpp4-inhibitor (sitagliptin, vildagliptin, saxagliptin); chronic disease including a long-term medication over 4 weeks per year (except type 1 diabetes).
How the Study Was Run
The set-up was randomized, parallel-group and open-label.
Because people in this Liraglutide study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.
The Liraglutide group and the comparison group ran side by side rather than switching.
Nothing was hidden in this open-label Liraglutide study: the participants and staff both knew the treatment.
It started in 2012-02 with completion listed for 2015-02.
It ran at 1 site in Austria.
Its stated primary purpose is treatment.
What Was Measured
It also tracked 1 secondary outcome, for example Immunophenotyping.
What This Means in Plain Language
Put simply, this is a phase 2, randomized trial of Liraglutide in 15 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.