NCT07026968

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

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 815 (estimated)
• Sponsor: CSPC Ouyi Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

Avoid duplicating information that will be entered elsewhere, such as Eligibility Criteria or Outcome Measures.

Conditions

• Type 2 Diabetes

Interventions

Type	Name	Description
DRUG	Prusogliptin, Dapagliflozin(high dose), Dapagliflozin (low dose) placebo, plus metformin XR	Prusogliptin, Dapagliflozin(high dose) and Dapagliflozin (low dose) placebo, once a day, 1 tablet per dose; Metformin XR, Once a day, the dosage remains the same as the pre-screening dose.
DRUG	Prusogliptin placebo, Dapagliflozin(high dose), Dapagliflozin (low dose) placebo, plus metformin XR	Prusogliptin placebo, Dapagliflozin (high dose), Dapagliflozin (low dose) placebo, once a day, 1 tablet per dose; Metformin XR, Once a day, the dosage remains the same as the pre-screening dose
DRUG	Prusogliptin, Dapagliflozin(high dose) placebo, Dapagliflozin (low dose), plus metformin XR	Prusogliptin, Dapagliflozin (high dose) placebo, Dapagliflozin (low dose), once a day, 1 tablet per dose; Metformin XR, Once a day, the dosage remains the same as the pre-screening dose
DRUG	Prusogliptin placebo, Dapagliflozin (high dose) placebo, Dapagliflozin (low dose), plus metformin XR	Prusogliptin placebo, Dapagliflozin (high dose) placebo, Dapagliflozin (low dose), once a day, 1 tablet per dose; Metformin XR, Once a day, the dosage remains the same as the pre-screening dose
DRUG	Prusogliptin, Dapagliflozin (high dose) placebo, Dapagliflozin(low dose) placebo, plus metformin XR	Prusogliptin, Dapagliflozin (high dose) placebo, Dapagliflozin (low dose) placebo, once a day, 1 tablet per dose; Metformin XR, Once a day, the dosage remains the same as the pre-screening dose

Timeline

• Start date: 2025-06-20
• Primary completion: 2026-10-30
• Completion: 2026-11-13
• First posted: 2025-06-18
• Last updated: 2026-04-06

Locations

1 site across 1 country: China