A Research Study Comparing a New Medicine Oral Semaglutide to Placebo in People With Type 2 Diabetes

Sponsor
Novo Nordisk A/S
Study ID
NCT04109547
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Oral semaglutide — DRUG
    Tablets to be taken once-daily for 26 weeks
  • Placebo — DRUG
    Tablets to be taken once-daily for 26 weeks

Study Details

The study compares 2 medicines for type 2 diabetes: oral semaglutide (a new medicine) and placebo (a dummy medicine). Researchers will test semaglutide to see how well it works compared to placebo. The study will also test if semaglutide is safe. Participants will either get semaglutide or placebo - which treatment is decided by chance. Participants will get 1 tablet a day to take with up to half a glass of water. Participants must take the tablet first thing in the morning on an empty stomach. After taking the tablet, participants must not eat or drink anything for at least 30 minutes. After the 30 minutes, participants can have their first meal of the day and take any other medicines they may need. The study will last for about 8 months (36 weeks). Participants will have 9 clinic visits and 2 phone calls with the study doctor. At all 9 of the clinic visits, participants will have blood samples taken. At 5 of the clinic visits, participants must arrive fasting. This means they cannot eat for 8 hours before the visit. It is fine to drink water up to 2 hours before the visit. This is for some of the blood samples that will be taken at the visit. Women cannot take part if pregnant, breastfeeding or planning to become pregnant during the study period.

Key Dates

Start date
Oct 1, 2019
Status verified
Sep 2024
Primary completion
Sep 23, 2021
Completion
Oct 27, 2021

Study Design

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

Arms

  • Experimental: Oral semaglutide 3mg
    Subjects will remain on 3 mg for the entire treatment period (26 weeks)
  • Experimental: Oral semaglutide 7mg
    Subjects will receive 3 mg for for the first 4 weeks, 7 mg for the remainder of the treatment period
  • Experimental: Oral semaglutide 14mg
    Subjects will receive 3 mg for the first 4 weeks, 7 mg for the next 4 weeks and 14 mg for the remainder of the treatment period
  • Placebo Comparator: Placebo (oral semaglutide)
    Subjects will receive placebo tablets for the entire treatment period

Primary Outcome Measure

Change From Baseline in Glycosylated Haemoglobin (HbA1c) [ Time Frame: Baseline (Week 0), Week 26 ]

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