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Efficacy and Safety of Semaglutide Versus Canagliflozin as add-on to Metformin in Subjects With Type 2 Diabetes
Plain-language guide to NCT03136484: phase 3 randomized trial of Semaglutide, 788 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT03136484
- Phase
- phase 3
- Status
- completed
- Start
- 2017-03-15
- Completion (planned or actual)
- 2018-10-16
- Participants
- 788 (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 Semaglutide.
This trial is conducted in Africa, Asia, Europe, North and South America.
It had two arms (groups): Semaglutide + canagliflozin placebo (experimental) and Canagliflozin + semaglutide placebo (active comparator).
The registry classes the interventions as drug.
Who Took Part
The registry lists 788 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
Design: randomized, parallel-group and double-blind.
Random assignment meant chance, not the researchers, decided who got Semaglutide and who got the comparison, which limits bias.
The Semaglutide group and the comparison group ran side by side rather than switching.
Neither the participants nor the staff measuring them knew who was on Semaglutide, so expectations could not easily colour the readings.
Those kept unaware of assignments: participant and investigator.
It started in 2017-03-15 with completion listed for 2018-10-16.
It ran at 119 sites in United States (57), India (11), United Kingdom (11), Canada (8), Malaysia (6) and Argentina (5).
Its stated primary purpose is treatment.
What Was Measured
Primary outcome: Change in HbA1c (time frame: Week 0, week 52).
It also tracked 60 secondary outcomes, for example Change in Body Weight (kg), Change in Total Fat Mass (kg), Change in FPG (Fasting Plasma Glucose), Change in SMPG (Self-measured Plasma Glucose)- Mean 7-point Profile, Change in SMPG- Mean Postprandial Increment Over All Meals and Change in Fasting Total Cholesterol.
What This Means in Plain Language
Put simply, this is a phase 3, randomized trial of Semaglutide in 788 people.
With 788 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 Semaglutide compound page, all human trials.
Our Notes on the Compound
Semaglutide: The active ingredient in several prescription GLP-1 receptor agonist medicines (Ozempic, Wegovy, oral tablets).
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.