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

Sponsor
Novo Nordisk A/S
Study ID
NCT04017832
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Oral semaglutide — DRUG
    Oral semaglutide to be taken every morning in a fasting state, to be followed by sitagliptin placebo after 30 minutes. Only then participants can have their first meal of the day and their pre-study metformin tablets
  • Sitagliptin — DRUG
    Sitagliptin to be taken every morning, 30 minutes after taking the oral semaglutide placebo tablet. Then participants can have their first meal of the day and their pre-study metformin tablets
  • Placebo (oral semaglutide) — DRUG
    Placebo tablet to be taken first thing in the morning
  • Placebo (sitagliptin) — DRUG
    Placebo tablet to be taken 30 minutes after oral semaglutide

Study Details

This study compares 2 medicines for type 2 diabetes: oral semaglutide (a new medicine) and sitagliptin (a medicine doctors can already prescribe). Participants will either get oral semaglutide or sitagliptin - which treatment is decided by chance. Participants will get 2 tablets a day to take first thing in the morning on an empty stomach. Only 1 tablet has study medicine in it. The other tablet is a dummy medicine (placebo). After taking the semaglutide tablet, participants may not eat or drink anything for at least 30 minutes. After the 30 minutes, participants must take the sitagliptin tablet. Then participants can have their first meal of the day and take any other medicines they may need, including their metformin. The study will last for about 7 months (33 weeks). Participants will have 8 clinic visits and 1 phone call with the study doctor. At all 8 of the clinic visits, participants will have blood samples taken.

Key Dates

Start date
Jul 29, 2019
Status verified
Sep 2024
Primary completion
Oct 27, 2021
Completion
Oct 27, 2021

Study Design

Enrollment
1,441 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Oral semaglutide 3 mg and placebo (sitagliptin)
    Oral semaglutide tablets 3 mg and sitagliptin placebo tablets for 26 weeks
  • Experimental: Oral semaglutide 7 mg and placebo (sitagliptin)
    Oral semaglutide tablets and sitagliptin placebo tablets. The dose of oral semaglutide will be escalated over 4 weeks, after which the target dose of 7 mg is taken for 22 weeks
  • Experimental: Oral semaglutide 14 mg and placebo (sitagliptin)
    Oral semaglutide tablets and sitagliptin placebo tablets. The dose of oral semaglutide will be escalated over 8 weeks, after which the target dose of 14 mg is taken for 18 weeks
  • Experimental: Sitagliptin 100 mg and placebo (oral semaglutide)
    Sitagliptin tablets and oral semaglutide placebo tablets for 26 weeks

Primary Outcome Measure

Change From Baseline to Week 26 in Glycated Haemoglobin (HbA1c) (%) [ Time Frame: From baseline to week 26 ]

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