Safety and Efficacy of Oral Semaglutide Versus Dulaglutide Both in Combination With One OAD (Oral Antidiabetic Drug) in Japanese Subjects With Type 2 Diabetes

Sponsor
Novo Nordisk A/S
Study ID
NCT03015220
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, as add-on to pre-trial oral antidiabetic drug (OAD).
  • Dulaglutide — DRUG
    Subcutaneously administration (s.c., under the skin) once-weekly, as add-on to pre-trial oral antidiabetic drug (OAD).

Study Details

This trial is conducted in Asia. The aim of this trial is to investigate Safety and efficacy of oral semaglutide versus dulaglutide both in combination with one OAD (oral antidiabetic drug) in Japanese subjects with type 2 diabetes.

Key Dates

Start date
Jan 10, 2017
Status verified
Feb 2021
Primary completion
Jul 12, 2018
Completion
Jul 12, 2018

Study Design

Enrollment
458 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
  • Active Comparator: Dulaglutide 0.75 mg

Primary Outcome Measure

Number of Treatment-emergent Adverse Events (TEAEs) [ Time Frame: Weeks 0-57 ]

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