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Efficacy in Controlling Glycaemia With Victoza® (Liraglutide) as add-on to Metformin vs. OADs as add-on to Metformin After up to 104 Weeks of Treatment in Subjects With Type 2 Diabetes
Plain-language guide to NCT02730377: phase 4 randomized trial of Liraglutide, 1991 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT02730377
- Phase
- phase 4
- Status
- completed
- Start
- 2016-03-28
- Completion (planned or actual)
- 2019-08-05
- Participants
- 1991 (actual)
- Design
- randomized, open label (everyone knows who gets what), treatment
- Conditions studied
- Diabetes; Diabetes Mellitus, Type 2
- Results posted
- yes
What This Study Did, in Plain Language
What Was Tested
This registered phase 4 trial tested Liraglutide.
This trial is conducted globally.
OADs as add-on to metformin background treatment for 104 weeks of treatment in subjects with type 2 diabetes.
It had two arms (groups): one (experimental) and OAD (active comparator).
Add-on to metformin.
Add-on to metformin. Treatment with one OAD selected at the discretion of the investigator. Subjects randomised to the OAD arm must remain on the same OAD throughout the trial.
The registry classes the interventions as drug.
Who Took Part
The registry lists 1991 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
The set-up was randomized, parallel-group and open-label.
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.
Nothing was hidden in this open-label Liraglutide study: the participants and staff both knew the treatment.
It started in 2016-03-28 with completion listed for 2019-08-05.
It ran at 232 sites in United States (179), India (16), Canada (12), Russia (5), Lebanon (4) and Serbia (4).
Its stated primary purpose is treatment.
What Was Measured
Primary outcome: Time to Inadequate Glycaemic Control (time frame: Weeks 26-104).
It also tracked 22 secondary outcomes, for example Time to Premature Treatment Discontinuation (for Any Reason Including Inadequate Glycaemic Control), Change in HbA1c, Change in Fasting Plasma Glucose (FPG), Change in Body Weight, Change in Body Mass Index (BMI) and Change in Blood Pressure (Systolic and Diastolic Blood Pressure).
What This Means in Plain Language
Put simply, this is a phase 4, randomized trial of Liraglutide in 1991 people.
With 1991 participants it is a large trial for this field.
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.