Phase 3Active, not recruiting
A Study of Prusogliptin Tablets Combined With Dapagliflozin Tablets and Metformin Hydrochloride Extended Release Tablets in Type 2 Diabetes
A Multicenter, Randomized, Double-blind, Parallel-controlled, Phase III Clinical Trial to Evaluate the Efficacy and Safety of the Triple Combination Therapy of Prusogliptin , Dapagliflozin and Metformin in Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control on Metformin Alone
- Sponsor
- CSPC Ouyi Pharmaceutical Co., Ltd. (Industry)
- Enrolment
- 815 planned
- Conditions
- Type 2 Diabetes
- Interventions
- Prusogliptin, Dapagliflozin(high dose), Dapagliflozin (low dose) placebo, plus metformin XR; Prusogliptin placebo, Dapagliflozin(high dose), Dapagliflozin (low dose) placebo, plus metformin XR; Prusogliptin, Dapagliflozin(high dose) placebo, Dapagliflozin (low dose), plus metformin XR; Prusogliptin placebo, Dapagliflozin (high dose) placebo, Dapagliflozin (low dose), plus metformin XR; Prusogliptin, Dapagliflozin (high dose) placebo, Dapagliflozin(low dose) placebo, plus metformin XR
- Ages
- adults, older adults
- Registry
- NCT07026968
Full record on ClinicalTrials.gov
From the registry
This study is a multicenter, randomized, double-blind, parallel-controlled, phase III clinical trial to evaluate efficacy and safety of the triple combination therapy of prusogliptin, dapagliflozin and metformin in subjects with type 2 diabetes who have inadequate glycemic control on metformin alone.
Primary outcomes
- Mean change from baseline in HbA1c at Week 24
History
Study completion expected
Primary completion expected
Last registry update
Started
Registered