A Trial Comparing the Safety and Efficacy of Semaglutide Once Weekly Versus Sitagliptin Once Daily in Japanese Subjects With Type 2 Diabetes

Sponsor
Novo Nordisk A/S
Study ID
NCT02254291
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
20 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • semaglutide — DRUG
    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).
  • semaglutide — DRUG
    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).
  • sitagliptin — DRUG
    Daily doses of 100 mg sitagliptin. Total duration of treatment is 30 weeks. Administered as oral tablets.

Study Details

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.

Key Dates

Start date
Oct 2, 2014
Status verified
Dec 2017
Primary completion
Nov 11, 2015
Completion
Nov 11, 2015

Study Design

Enrollment
308 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Semaglutide 0.5 mg
  • Experimental: Semaglutide 1.0 mg
  • Active Comparator: Sitagliptin 100 mg

Primary Outcome Measure

Number of Treatment Emergent Adverse Events (TEAEs) [ Time Frame: Weeks 0-30 ]

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