drugset / Trial / NCT06083675

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

NCT06083675

Phase 3 Withdrawn Novo Nordisk A/S
RandomizedParallel-groupOpen-labelTreatment

Summary

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.

Timeline

Start
2024-01-26
Primary completion
2025-01-24
Completion
2027-05-28

Drugs

EvaluationDrugModalityDoseRoute
Subject Empagliflozin Small molecule 25 mg Oral
Subject Metformin Small molecule 1000 mg Oral
Subject Semaglutide Peptide 25 mg Oral
Subject Semaglutide Peptide 50 mg Oral