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Effect and Safety of Liraglutide [amount hidden] in Subjects With Overweight or Obesity and Type 2 Diabetes Mellitus Treated With Basal Insulin
Plain-language guide to NCT02963922: phase 3 randomized trial of Liraglutide, 396 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT02963922
- Phase
- phase 3
- Status
- completed
- Start
- 2017-02-06
- Completion (planned or actual)
- 2018-09-10
- Participants
- 396 (actual)
- Design
- randomized, double-blind, treatment
- Conditions studied
- Metabolism and Nutrition Disorder; Obesity
- 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): one (experimental) and Placebo (placebo comparator).
The registry classes the interventions as drug.
Who Took Part
The registry lists 396 actual participants took part.
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.
The full record lists 0 inclusion and 1 exclusion criteria.
How the Study Was Run
It was run as a randomized, parallel-group and double-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.
Neither the participants nor the staff measuring them knew who was on Liraglutide, so expectations could not easily colour the readings.
Those kept unaware of assignments: participant and investigator.
It started in 2017-02-06 with completion listed for 2018-09-10.
It ran at 54 sites in United States (19), Canada (8), Germany (8), Turkey (Türkiye) (7), Israel (6) and Italy (4).
Its stated primary purpose is treatment.
What Was Measured
The main thing measured (primary outcome): Change in Body Weight (%) (time frame: Week 0, week 56).
It also tracked 44 secondary outcomes, for example Change in Waist Circumference, Change in HbA1c, Change in FPG, Change in Short Form-36 (SF-36) v2.0 Acute, Physical Functioning Score, Change in Impact of Weight on Quality of Life-Lite for Clinical Trial Version (IWQoL-Lite for CT), Physical Function Domain (5-items) Score and Change in 7-point SMPG Profile Mean Daytime Glucose Value.
What This Means in Plain Language
Put simply, this is a phase 3, randomized trial of Liraglutide in 396 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.