Research Study Comparing a New Medicine Semaglutide to Liraglutide in People With Type 2 Diabetes

Sponsor
Novo Nordisk A/S
Study ID
NCT03191396
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Semaglutide — DRUG
    Dose gradually increased to 1.0 mg, given s.c. (under the skin), once-weekly for 30 weeks. Participants will remain on their pre-study anti-diabetic drugs (tablets), if any
  • Liraglutide — DRUG
    Dose gradually increased to 1.2 mg, given s.c. once-daily for 30 weeks. Participants will remain on their pre-study anti-diabetic drugs, if any

Study Details

This study is conducted in Europe. The aim of the study is to compare the effect of semaglutide subcutaneous (s.c., under the skin) 1.0 mg once-weekly to liraglutide s.c.1.2 mg once-daily on blood sugar levels after 30 weeks of treatment in people with type 2 diabetes. The study will last approximately 9 months (37 weeks). Each participant will have 7 visits at the clinic and 3 phone calls with the study doctor. At the visits, participants will have a number of tests, for example: general health checks, blood samples, heart and eye checks etc. Participants will also fill in some forms about their health and satisfaction with their diabetes treatment.

Key Dates

Start date
Jun 27, 2017
Status verified
Oct 2019
Primary completion
Jul 9, 2018
Completion
Aug 13, 2018

Study Design

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

Arms

  • Experimental: Semaglutide
    Half the study participants are randomised to receive semaglutide
  • Active Comparator: Liraglutide
    Half the study participants are randomised to receive liraglutide

Primary Outcome Measure

Change in HbA1c [ Time Frame: Week 0, week 30 ]

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