Research Study to Compare Semaglutide Tablets With Empagliflozin or Metformin Tablets in People With Type 2 Diabetes

Part of paid clinical trials in Waco, Texas.

Sponsor
Novo Nordisk A/S
Study ID
NCT06083675
Phase
PHASE3
Status
Withdrawn

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 60 Years
Healthy Volunteers
Not accepted

Interventions

  • Semaglutide — DRUG
    Administered as oral tablets.
  • Empagliflozin — DRUG
    Administered as oral tablets.
  • Metformin — DRUG
    Administered as oral tablets.

Study Details

This study compares the medicines semaglutide with empagliflozin or metformin in people with newly diagnosed type 2 diabetes. This study will look mainly at how well participant's blood sugar and body weight are controlled when they are taking the study medicines. Participants will either get semaglutide tablets, empagliflozin tablets or metformin tablets. Which treatment participants will get is decided by chance. Currently, doses of 3 milligram (mg), 7 mg and 14 mg semaglutide tablets (Rybelsus) can be prescribed in some countries. 25 mg and 50 mg semaglutide tablets are new doses. 10 mg and 25 mg empagliflozin tablets (Jardiance) can be prescribed in some countries. 500 mg metformin tablets (STADA) can be prescribed in some countries. Participants will get 1 to 4 tablets per day for 104 weeks. The study will last for about 2 years and 7 weeks (111 weeks). Participants should not have been treated for weight management 90 days before screening or never been treated with any medicine for type 2 diabetes (except diabetes during pregnancy) before screening. Women cannot take part if pregnant, breast-feeding or plan to get pregnant during the study period.

Key Dates

Start date
Jan 26, 2024
Status verified
Feb 2024
Primary completion
Jan 24, 2025
Completion
May 28, 2027

Study Design

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

Arms

  • Experimental: Semaglutide 25 mg
    Participants will receive 25 mg oral semaglutide once daily in maintenance period after dose escalation period.
  • Experimental: Semaglutide 50 mg
    Participants will receive 50 mg oral semaglutide once daily in maintenance period after dose escalation period.
  • Experimental: Empagliflozin 25 mg
    Participants will 25 mg empagliflozin oral once daily in maintenance period after dose escalation period.
  • Experimental: Metformin 2000 mg
    Participants will receive metformin 1000 mg orally twice daily (total 2000 mg) in maintenance period after dose escalation period.

Primary Outcome Measure

Change in glycated haemoglobin (HbA1c) [ Time Frame: From randomisation (week 0) to week 52 ]

Locations (1)

FacilityCityStateZIPSite coordinators
Hillcrest Family Health CenterWacoTexas76708-

Find similar trials in Waco, TX

By condition
Type 2 diabetes
By specialty
EndocrinologyMetabolic healthWeight loss
By research site
Hillcrest Family Health Center· Waco, TX

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