A Study of Prusogliptin Tablets Combined With Dapagliflozin Tablets and Metformin Hydrochloride Extended Release Tablets in Type 2 Diabetes

Conditions

• Type 2 Diabetes

Eligibility Criteria

Sex

ALL

Age

18 Years - 75 Years

Healthy Volunteers

Not accepted

Interventions

• Prusogliptin, Dapagliflozin(high dose), Dapagliflozin (low dose) placebo, plus metformin XR — DRUG
  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.
• Prusogliptin placebo, Dapagliflozin(high dose), Dapagliflozin (low dose) placebo, plus metformin XR — DRUG
  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
• Prusogliptin, Dapagliflozin(high dose) placebo, Dapagliflozin (low dose), plus metformin XR — DRUG
  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
• Prusogliptin placebo, Dapagliflozin (high dose) placebo, Dapagliflozin (low dose), plus metformin XR — DRUG
  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
• Prusogliptin, Dapagliflozin (high dose) placebo, Dapagliflozin(low dose) placebo, plus metformin XR — DRUG
  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

Study Details

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.

Key Dates

Start date

Jun 20, 2025

Status verified

Jun 2025

Primary completion

Oct 30, 2026

Completion

Nov 13, 2026

Study Design

Enrollment

815 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Prusogliptin, Dapagliflozin(high dose), plus metformin XR
• Active Comparator: Dapagliflozin(high dose), plus metformin XR
• Experimental: Prusogliptin, Dapagliflozin(low dose), plus metformin XR
• Active Comparator: Dapagliflozin(low dose), plus metformin XR
• Active Comparator: Prusogliptin, plus metformin XR

Primary Outcome Measure

Mean change from baseline in HbA1c at Week 24 [ Time Frame: From baseline to week 24 ]

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