Completed
PHASE3
INTERVENTIONAL
NCT02254291
A Trial Comparing the Safety and Efficacy of Semaglutide Once Weekly Versus Sitagliptin Once Daily in Japanese Subjects With Type 2 Diabetes
View on ClinicalTrials.gov
Updated Dec 15, 2025
Brief Summary
This trial is conducted in Japan. The purpose is to compare the safety of once-weekly dosing of semaglutide (0.5 and 1.0 mg) versus sitagliptin (100 mg) once daily, both as monotherapy during 30 weeks of treatment in Japanese subjects with type 2 diabetes.
Interventions
Name:
semaglutide
Type:
DRUG
Description:
Once weekly doses of 0.5 mg semaglutide after an initial dose escalation step of 0.25 mg (4 weeks). Total duration of treatment is 30 weeks. Administered subcutaneously (s.c. under the skin).
Name:
semaglutide
Type:
DRUG
Description:
Once weekly doses of 1.0 mg semaglutide after an initial dose escalation step of 0.25 mg (4 weeks) followed by 0.5 mg for 4 weeks. Total duration of treatment is 30 weeks. Administered subcutaneously (s.c. under the skin).
Name:
sitagliptin
Type:
DRUG
Description:
Daily doses of 100 mg sitagliptin. Total duration of treatment is 30 weeks. Administered as oral tablets.
Primary Outcomes
Measure:
Number of Treatment Emergent Adverse Events (TEAEs)
TimeFrame:
Weeks 0-30
Description:
An adverse events (AEs) was defined as any unfavourable and unintended sign (including an abnormal laboratory finding), symptom or disease temporally associated with the use of a product, whether or not considered related to the product. All AEs mentioned here are treatment emergent adverse events (TEAE) defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment (week 0-30 treatment period) and no later than the follow-up visit during the on-treatment observation period (date of last dose + 42 days).
Trial Information
NCT ID
NCT02254291
Status
Completed
Study Type
INTERVENTIONAL
Phases
PHASE3
Sponsor
Novo Nordisk A/S
Last Updated
December 15, 2025