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A Trial Comparing the Safety and Efficacy of Semaglutide Once Weekly Versus Sitagliptin Once Daily in Japanese Subjects With Type 2 Diabetes
Plain-language guide to NCT02254291: phase 3 randomized trial of Semaglutide, 308 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT02254291
- Phase
- phase 3
- Status
- completed
- Start
- 2014-10-02
- Completion (planned or actual)
- 2015-11-11
- Participants
- 308 (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
The trial (phase 3) is built around Semaglutide.
This trial is conducted in Japan.
It had three arms (groups): one (experimental), one (experimental) and one (active comparator).
The registry classes the interventions as drug.
Who Took Part
The registry lists 308 actual participants took part.
It was open to people of any sex aged from 20 years with no upper age limit.
Healthy volunteers were not accepted; participants needed the condition being studied.
Examples of who could join: Male or female, age 20 years or older at the time of signing informed consent.
The full record lists 3 inclusion and 10 exclusion criteria; among the exclusions: treatment with once-weekly glucagon-like peptide-1 (glp-1) receptor agonists within 90 days prior to screening; any disorder which, in the opinion of the investigator, might jeopardise subject's safety or compliance with the protocol; history of chronic or idiopathic acute pancreatitis.
How the Study Was Run
The set-up was randomized, parallel-group and open-label.
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.
Being open-label, the Semaglutide study did not mask who received what.
It started in 2014-10-02 with completion listed for 2015-11-11.
It ran at 25 sites in Japan (25).
Its stated primary purpose is treatment.
What Was Measured
The main thing measured (primary outcome): Number of Treatment Emergent Adverse Events (TEAEs) (time frame: Weeks 0-30).
It also tracked 2 secondary outcomes, for example Number of Severe or Blood Glucose (BG) Confirmed Symptomatic Hypoglycaemic Episodes and Change in Glycosylated Haemoglobin A1c (HbA1c).
What This Means in Plain Language
Put simply, this is a phase 3, randomized trial of Semaglutide in 308 people.
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.