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Prusogliptin, Dapagliflozin and Metformin in Type 2 Diabetes
NCT07026968Phase 3
Key facts
- Status
- Active, not recruiting
- Start
- Jun 2025
- Primary completion
- Oct 2026
- Countries
- 1
- Sponsor
- CSPC Ouyi Pharmaceutical
- Modality
- Small Molecules
- Drugs
- prusogliptin
- Conditions
- type 2 diabetes mellitus (T2DM)
01
Overview
Phase 3, randomised, double-blind trial of prusogliptin in type 2 diabetes mellitus (T2DM) (5 arms), sponsored by CSPC Ouyi Pharmaceutical. Primary endpoint: Mean change from baseline in Glycated Hemoglobin (HbA1c) at 24 weeks. Started Jun 2025; status: active, not recruiting.
02
Design
5 arms- Study design
- RandomizedDouble-blind
Prusogliptin + Dapa(high) + Met XR
Prusogliptin, Dapagliflozin(high dose), Dapagliflozin (low dose) placebo, plus metformin XR
Dapa(high) + Met XR
Prusogliptin placebo, Dapagliflozin(high dose), Dapagliflozin (low dose) placebo, plus metformin XR
Prusogliptin + Dapa(low) + Met XR
Prusogliptin, Dapagliflozin(high dose) placebo, Dapagliflozin (low dose), plus metformin XR
Dapa(low) + Met XR
Prusogliptin placebo, Dapagliflozin (high dose) placebo, Dapagliflozin (low dose), plus metformin XR
Prusogliptin + Met XR
Prusogliptin, Dapagliflozin (high dose) placebo, Dapagliflozin(low dose) placebo, plus metformin XR
03
Who it enrols
Adults aged 18-75 with type 2 diabetes inadequately controlled on stable metformin therapy (>= 1500 mg/day) for at least 10 weeks, with BMI 18.5-40 kg/m^2 and HbA1c 7.0-10.5% before randomization.
04
Endpoints
Primary
Mean change from baseline in Glycated Hemoglobin (HbA1c)
Secondary
Proportion of participants with HbA1c of <=6.5% and HbA1c of <=7%
Relative change from baseline in HbA1c
Relative change from baseline in Fasting Plasma Glucose (FPG)
Relative change from baseline in 2-hour Postprandial Glucose (2h-PPG)
Relative change from baseline in weight
Relative change from baseline in blood pressure
Relative change from baseline in blood lipid level
Relative change from baseline in 7-point blood glucose levels and average post-meal blood glucose increments
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