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Efficacy and Safety of Oral Semaglutide Versus Placebo in Subjects With Type 2 Diabetes Mellitus Treated With Diet and Exercise Only
Plain-language guide to NCT02906930: phase 3 randomized trial of Semaglutide, 703 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT02906930
- Phase
- phase 3
- Status
- completed
- Start
- 2016-09-20
- Completion (planned or actual)
- 2017-10-30
- Participants
- 703 (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
The trial (phase 3) is built around Semaglutide.
This trial is conducted globally.
It had four arms (groups): one (experimental), one (experimental), one (experimental) and Placebo (placebo comparator).
The registry classes the interventions as drug.
Who Took Part
The registry lists 703 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 double-blind.
Because people in this Semaglutide study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.
Groups ran in parallel: each of the participants stayed in one arm throughout.
Blinding on both sides kept the participants and researchers unaware of who received Semaglutide.
Those kept unaware of assignments: participant and investigator.
It started in 2016-09-20 with completion listed for 2017-10-30.
It ran at 105 sites in United States (56), Turkey (Türkiye) (10), Russia (9), Japan (6), Czechia (5) and Italy (5).
Its stated primary purpose is treatment.
What Was Measured
Researchers chose this as the main measure: Change in HbA1c (time frame: Week 0, week 26).
It also tracked 47 secondary outcomes, for example Change in Body Weight (kg), Change in Fasting Plasma Glucose, Change in Mean 7-point SMPG Profile, Change in Mean Postprandial Increment Over All Meals in SMPG, Change in Fasting Insulin - Ratio to Baseline and Change in Fasting Pro-insulin - Ratio to Baseline.
What This Means in Plain Language
Put simply, this is a phase 3, randomized trial of Semaglutide in 703 people.
With 703 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.