Dose-response, Safety and Efficacy of Oral Semaglutide Versus Placebo and Versus Liraglutide, All as Monotherapy in Japanese Subjects With Type 2 Diabetes

Sponsor
Novo Nordisk A/S
Study ID
NCT03018028
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Semaglutide — DRUG
    Oral administration once daily
  • Placebo — DRUG
    Oral administration once daily
  • Liraglutide — DRUG
    Subcutaneous (s.c., under the skin) injection once daily

Study Details

This trial is conducted in Asia. The aim of this trial is to investigate the dose-response relationship of once-daily dosing of three dose levels (3, 7 and 14 mg) of oral semaglutide versus placebo as monotherapy on glycaemic control in Japanese subjects with type 2 diabetes mellitus

Key Dates

Start date
Jan 10, 2017
Status verified
Jan 2021
Primary completion
Jan 9, 2018
Completion
Aug 15, 2018

Study Design

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

Arms

  • Experimental: Oral semaglutide 3 mg
  • Experimental: Oral semaglutide 7 mg
  • Experimental: Oral semaglutide 14 mg
  • Placebo Comparator: Oral placebo
  • Active Comparator: Liraglutide 0.9 mg

Primary Outcome Measure

Change in HbA1c (Week 26) [ Time Frame: Week 0, week 26 ]

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