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

Phase 3

Not yet recruiting

• Conditions: Type 2 Diabetes
• Interventions: Drug: Prusogliptin, Dapagliflozin(high dose), Dapagliflozin (low dose) placebo, plus metformin XR; Drug: Prusogliptin placebo, Dapagliflozin(high dose), Dapagliflozin (low dose) placebo, plus metformin XR; Drug: Prusogliptin, Dapagliflozin(high dose) placebo, Dapagliflozin (low dose), plus metformin XR; Drug: Prusogliptin, Dapagliflozin (high dose) placebo, Dapagliflozin(low dose) placebo, plus metformin XR; Drug: Prusogliptin placebo, Dapagliflozin (high dose) placebo, Dapagliflozin (low dose), plus metformin XR

• Registration Number: NCT07026968
• Lead Sponsor: CSPC Ouyi Pharmaceutical Co., Ltd.

Brief 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.

Study Timeline

• Status Verified: 2025-06
• Study First Submitted: 2025-06-10
• Study First Submitted QC: 2025-06-10
• Last Update Submitted: 2025-06-10
• Study Start: 2025-06-17
• Study First Posted: 2025-06-18
• Last Update Posted: 2025-06-18
• Primary Completion: 2026-10-30
• Study Completion: 2026-11-13

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 815

Inclusion Criteria

• Subjects with type 2 diabetes was confirmed at least 10 weeks prior to the screening;
• Male or female, 18 years ≤ age ≤ 75 years;
• Body Mass Index (BMI) ≥ 18.5 kg/m^2, and ≤40 kg/m^2;
• Stable metformin therapy for at least 10 weeks prior to screening at a dose ≥ 1500 mg per day;
• The glycated hemoglobin must meet the following standards:During screening: 7.5% ≤ HbA1c ≤ 11.0% (local laboratory);Before random sampling: 7.0% ≤ HbA1c ≤ 10.5% (central laboratory);
• Be able to understand and follow the test procedures, voluntarily participate in the test and sign the ICF.

Exclusion Criteria

• Type 1 diabetes or other special types of diabetes;
• ≥2 episodes of Grade 3 hypoglycemia within 6 months prior to screening, or any Grade 3 hypoglycemia occurring from screening to randomization;
• ≥1 episode of acute diabetic complications (e.g., diabetic ketoacidosis, hyperglycemic hyperosmolar state) within 6 months prior to screening or prior to randomization;
• Severe chronic diabetic complications (e.g., proliferative diabetic retinopathy, severe diabetic neuropathy, diabetic foot) within 6 months prior to screening;
• History of acute or chronic pancreatitis at screening or prior to randomization;
• Inflammatory bowel disease, partial intestinal obstruction, or chronic intestinal diseases associated with malabsorption within 6 months prior to screening or prior to randomization;
• Previous gastrointestinal surgeries that may cause malabsorption (excluding polypectomy and appendectomy), or chronic use of medications directly affecting gastrointestinal motility at screening or prior to randomization;
• Any cardiovascular event within 6 months prior to screening or prior to randomization, including: decompensated heart failure (NYHA Class III or IV); unstable angina, myocardial infarction, coronary artery bypass grafting, or coronary stent implantation; long QT syndrome or prolonged QTcF interval (male >450 ms, female >470 ms); clinically significant arrhythmia requiring treatment and deemed unsuitable for trial participation by the investigator;
• Hemorrhagic stroke or acute ischemic stroke within 6 months prior to screening or prior to randomization;
• Acute gallbladder disease within 6 months prior to screening, or active gallbladder disease requiring treatment at screening/prior to randomization;
• History of severe psychiatric disorders (e.g., depression, anxiety disorders), severe osteoporosis, or other medical conditions that may endanger participant safety as judged by the investigator;
• Malignancy (except clinically cured basal cell carcinoma or carcinoma in situ) diagnosed or treated within 5 years prior to screening or prior to randomization;
• Severe infection or trauma within 4 weeks prior to screening/prior to randomization; recurrent urinary tract infections or genital infections within 6 months prior to screening; or symptomatic urinary/genital infections at screening/prior to randomization;
• Clinically significant hematologic diseases (e.g., aplastic anemia, myelodysplastic syndrome) or conditions causing hemolysis or erythrocyte instability (e.g., malaria) at screening/prior to randomization;
• Pregnant or lactating women;
• Other conditions deemed unsuitable for trial participation by the investigator.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Prusogliptin, Dapagliflozin(high dose), plus metformin XR	Prusogliptin, Dapagliflozin(high dose), Dapagliflozin (low dose) placebo, plus metformin XR	-
Dapagliflozin(high dose), plus metformin XR	Prusogliptin placebo, Dapagliflozin(high dose), Dapagliflozin (low dose) placebo, plus metformin XR	-
Prusogliptin, Dapagliflozin(low dose), plus metformin XR	Prusogliptin, Dapagliflozin(high dose) placebo, Dapagliflozin (low dose), plus metformin XR	-
Prusogliptin, plus metformin XR	Prusogliptin, Dapagliflozin (high dose) placebo, Dapagliflozin(low dose) placebo, plus metformin XR	-
Dapagliflozin(low dose), plus metformin XR	Prusogliptin placebo, Dapagliflozin (high dose) placebo, Dapagliflozin (low dose), plus metformin XR	-

Primary Outcome Measures

Name	Time	Method
Mean change from baseline in HbA1c at Week 24	From baseline to week 24

Secondary Outcome Measures

Name	Time	Method
Relative change from baseline in HbA1c at week 12	From baseline to week 12
Relative change from baseline in 2h-PPG at week 12 and week 24	From baseline to week 12 and week 24
Relative change from baseline in weight at week 12 and week 24	From baseline to week 12 and week 24
Relative change from baseline in blood pressure at week 12 and week 24	From baseline to week 12 and week 24
Relative change from baseline in blood lipid level at week 12 and week 24	From baseline to week 12 and week 24
Relative change from baseline in 7-point blood glucose levels and average post-meal blood glucose increments at week 24	From baseline to week 24
Proportion of participants who received rescue treatment after 24 weeks of treatment	From baseline to week 24
Relative change from baseline in FPG at week 12 and week 24	From baseline to week 12 and week 24
Proportion of participants with HbA1c of ≤6.5% and HbA1c of ≤7% at week 24	From baseline to week 24