Full results & analysis
Available in the Gosset platform where reported.
Trial intelligence / Profile preview
Efficacy and Safety of Oral Semaglutide Versus Sitagliptin in T2D Patients on Metformin
NCT04017832Phase 3
Key facts
- Status
- Completed
- Start
- Jul 2019
- Primary completion
- Oct 2021
- Countries
- 9
- Sponsor
- Novo Nordisk
- Modality
- Peptides, Recombinant Proteins and Enzymes
- Drugs
- semaglutide
- Conditions
- type 2 diabetes mellitus (T2DM)
01
Overview
Phase 3, randomised, double-blind trial of semaglutide in type 2 diabetes mellitus (T2DM) (4 arms), sponsored by Novo Nordisk. Primary endpoint: Change From Baseline to Week 26 in Glycated Haemoglobin (HbA1c). Started Jul 2019; status: completed.
02
Design
4 arms- Study design
- RandomizedDouble-blind
Oral Semaglutide 3 mg
Oral semaglutide 3 mg daily + Metformin
Oral Semaglutide 7 mg
Oral semaglutide 7 mg daily (escalated) + Metformin
Oral Semaglutide 14 mg
Oral semaglutide 14 mg daily (escalated) + Metformin
Sitagliptin 100 mg
Sitagliptin 100 mg daily + Metformin
03
Who it enrols
Adults with Type 2 Diabetes Mellitus diagnosed >= 60 days, HbA1c 7.0-10.5%, on stable metformin dose. Excludes renal impairment (eGFR < 60), pancreatitis history, recent CV events, and unstable retinopathy.
04
Endpoints
Primary
Change From Baseline to Week 26 in Glycated Haemoglobin (HbA1c)
Secondary
Change From Baseline to Week 26 in Fasting Plasma Glucose (FPG)
Change From Baseline to Week 26 in Self-measured Plasma Glucose (SMPG) Profile
Number of Participants Who Achieved HbA1c <7.0 %
Change From Baseline to Week 26 in Body Weight
Change From Baseline to Week 26 in Short Form-36 Version 2 Health Survey
Number of Treatment-emergent Adverse Events
05
Results
Primary endpoints met
Beyond the preview
Go deeper on NCT04017832.
Full results, competitive context and analysis are in the Gosset platform.
Competitive context
Available in the Gosset platform where reported.
Bring the full picture into focus.
See how Gosset can support your research on NCT04017832.