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Efficacy and Safety of Liraglutide in Combination With Metformin Compared to Metformin Alone, in Children and Adolescents With Type 2 Diabetes
Plain-language guide to NCT01541215: phase 3 randomized trial of Liraglutide, 135 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT01541215
- Phase
- phase 3
- Status
- completed
- Start
- 2012-11-13
- Completion (planned or actual)
- 2017-11-15
- Participants
- 135 (actual)
- Design
- randomized, double-blind, treatment
- Conditions studied
- Diabetes; Diabetes Mellitus, Type 2
- Results posted
- yes
What This Study Did, in Plain Language
What Was Tested
In this phase 3 trial, researchers set out to test Liraglutide.
This trial is conducted globally.
It had two arms (groups): Lira + Met (experimental) and Placebo + Met (placebo comparator).
The registry classes the interventions as drug.
Who Took Part
The registry lists 135 actual participants took part.
It was open to people of any sex aged from 10 years up to 17 years.
Healthy volunteers were not accepted; participants needed the condition being studied.
The full record lists 0 inclusion and 1 exclusion criteria.
How the Study Was Run
The set-up was randomized, parallel-group and double-blind.
The participants were allocated by chance, so the Liraglutide group and the comparison group should start out alike.
The Liraglutide group and the comparison group ran side by side rather than switching.
Blinding on both sides kept the participants and researchers unaware of who received Liraglutide.
Those kept unaware of assignments: participant and investigator.
It started in 2012-11-13 with completion listed for 2017-11-15.
It ran at 185 sites in United States (71), India (17), Russia (10), Hungary (5), Israel (5) and Spain (5).
Its stated primary purpose is treatment.
What Was Measured
The main thing measured (primary outcome): Change in HbA1c (Glycosylated Haemoglobin) (time frame: Week 0, week 26).
It also tracked 79 secondary outcomes, for example Change From Baseline in Fasting Plasma Glucose (FPG), Change From Baseline in Body Mass Index (BMI) Standard Deviation Score (SDS), Change in HbA1c, Change in FPG, Change in Mean 7-point Self-measured Plasma Glucose and Change From Baseline in 7-point Self-measured Plasma Glucose.
What This Means in Plain Language
Put simply, this is a phase 3, randomized trial of Liraglutide in 135 people.
The trial is marked completed; results are posted on the registry, and this page does not restate them.
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.