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Semaglutide dose-response in type 2 diabetes with overweight
NCT05486065Phase 2
Key facts
- Status
- Completed
- Start
- Aug 2022
- Primary completion
- Oct 2023
- Countries
- 5
- Sponsor
- Novo Nordisk
- Modality
- Peptides, Recombinant Proteins and Enzymes
- Drugs
- semaglutide
- Conditions
- type 2 diabetes mellitus (T2DM)
01
Overview
Phase 2, randomised, double-blind trial of semaglutide in type 2 diabetes mellitus (T2DM) (6 arms), sponsored by Novo Nordisk. Primary endpoint: Glycated Haemoglobin at 40 weeks. Started Aug 2022; status: completed.
02
Design
6 arms- Study design
- RandomizedDouble-blind
Semaglutide 2 mg
Once-weekly semaglutide 2 mg s.c. injection
Semaglutide placebo 2 mg
Once-weekly semaglutide placebo 2 mg s.c. injection
Semaglutide 8 mg
Once-weekly semaglutide 8 mg s.c. injection
Semaglutide placebo 8 mg
Once-weekly semaglutide placebo 8 mg s.c. injection
Semaglutide 16 mg
Once-weekly semaglutide 16 mg s.c. injection
Semaglutide placebo 16 mg
Once-weekly semaglutide placebo 16 mg s.c. injection
03
Who it enrols
Adults aged 18-64 years with type 2 diabetes mellitus for ≥180 days, HbA1c 7.0-10.5%, BMI ≥27 kg/m², on stable metformin for ≥90 days, eGFR ≥30 mL/min/1.73m², without uncontrolled diabetic retinopathy or maculopathy
04
Endpoints
Primary
Glycated Haemoglobin
Secondary
Body Weight
Treatment-emergent Adverse Events
Treatment-emergent Severe Hypoglycaemic Episodes
05
Results
Primary endpoints met
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