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Liraglutide Efficacy on Glucocorticoid Induced Hyperglycemia in Patients High Risk for Diabetes
Plain-language guide to NCT02016846: phase 3 randomized trial of Liraglutide, 36 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT02016846
- Phase
- phase 3
- Status
- status unknown
- Start
- 2014-01
- Completion (planned or actual)
- 2015-01
- Participants
- 36 (estimated)
- Design
- randomized, double-blind, prevention
- Conditions studied
- Glucocorticoid Induced Hyperglycemia
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
This registered phase 3 trial tested Liraglutide.
It had two arms (groups): Placebo (placebo comparator) and Intervention (active comparator).
The registry classes the interventions as drug.
Who Took Part
36 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: Age \>18 years. Body mass index \>27 kg/m2 OR 1st degree relative with type 2 diabetes mellitus OR hypertension OR hyperlipidemia OR gestational diabetes in the past OR diagnosis of polycystic ovary syndrome.
The full record lists 3 inclusion and 6 exclusion criteria; among the exclusions: diagnosis of diabetes mellitus or treatment with anti-glycemic drug; pancreatitis (acute or chronic) in the past; active malignancy.
How the Study Was Run
Design: randomized, parallel-group and double-blind.
Random assignment meant chance, not the researchers, decided who got Liraglutide and who got the comparison, which limits bias.
Groups ran in parallel: each of the participants stayed in one arm throughout.
As a double-blind Liraglutide study, the assignments were hidden from both participants and investigators until the end.
Those kept unaware of assignments: participant and investigator.
It started in 2014-01 with completion listed for 2015-01.
It ran at 1 site in Israel.
Its stated primary purpose is prevention.
What Was Measured
Researchers chose this as the main measure: Glucose levels 2 hours after 75 gr OGTT (time frame: 6 weeks).
What This Means in Plain Language
Put simply, this is a phase 3, randomized trial of Liraglutide in 36 people.
Its size is small, so on its own it can only give an early look.
Its status is unknown; 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.