Research Study to Compare Semaglutide Tablets With Empagliflozin Tablets Taken Once Daily in People With Type 2 Diabetes and Obesity

Sponsor
Novo Nordisk A/S
Study ID
NCT05444153
Phase
PHASE3
Status
Withdrawn

Conditions

Eligibility Criteria

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

Interventions

  • Semaglutide — DRUG
    Participants will receive 1 tablet of oral semaglutide once daily.
  • Empagliflozin — DRUG
    Participants will receive 1 tablet of empagliflozin once daily.

Study Details

This study compares the medicines semaglutide and empagliflozin in people with newly diagnosed type 2 diabetes and obesity. The study will look mainly at how well the blood sugar and body weight are controlled when participants are taking the study medicine. Participants will either get semaglutide tablets or empagliflozin tablets. Which treatment participants get is decided by chance. Participants will get one tablet per day for 2 years. The study will last for about 2 years and 8 weeks.

Key Dates

Start date
Oct 6, 2022
Status verified
Nov 2022
Primary completion
Oct 2, 2024
Completion
Aug 29, 2025

Study Design

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

Arms

  • Experimental: Oral semaglutide
    Participants will receive once daily oral semaglutide tablet for 104 weeks in a dose escalation fashion of 3milligrams (mg), 7mg, 14 mg and 25 mg once every four weeks during the first 16 weeks and a maintenance dose of 55 mg for the rest 88 weeks.
  • Active Comparator: Empagliflozin
    Participants will receive once daily empagliflozin tablet for up to 104 weeks, starting with a dose of 10 mg for the first 8 weeks and the maintenance dose of 25 mg for the rest 96 weeks.

Primary Outcome Measure

Participants acheiving glycated haemoglobin (HbA1c) less than (<) 7 percentage (%) (Yes/No) [ Time Frame: At week 104 ]

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