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

NCT ID: NCT07026968

Last Updated: 2025-09-29

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: PHASE3
• Total Enrollment: 815 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-06-20
• Study Completion Date: 2026-11-13

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.

Conditions

Type 2 Diabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Prusogliptin, Dapagliflozin(high dose), plus metformin XR

Group Type: EXPERIMENTAL

Prusogliptin, Dapagliflozin(high dose), Dapagliflozin (low dose) placebo, plus metformin XR

Intervention Type: 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.

Dapagliflozin(high dose), plus metformin XR

Group Type: ACTIVE_COMPARATOR

Prusogliptin placebo, Dapagliflozin(high dose), Dapagliflozin (low dose) placebo, plus metformin XR

Intervention Type: 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(low dose), plus metformin XR

Group Type: EXPERIMENTAL

Prusogliptin, Dapagliflozin(high dose) placebo, Dapagliflozin (low dose), plus metformin XR

Intervention Type: 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

Dapagliflozin(low dose), plus metformin XR

Group Type: ACTIVE_COMPARATOR

Prusogliptin placebo, Dapagliflozin (high dose) placebo, Dapagliflozin (low dose), plus metformin XR

Intervention Type: 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, plus metformin XR

Group Type: ACTIVE_COMPARATOR

Prusogliptin, Dapagliflozin (high dose) placebo, Dapagliflozin(low dose) placebo, plus metformin XR

Intervention Type: 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

Interventions

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.

Intervention Type: 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

Intervention Type: 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

Intervention Type: 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

Intervention Type: 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

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

CSPC Ouyi Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

No. 896, Zhongshan East Road, High-tech Industrial Development Zone

Shijiazhuang, Hebei, China

Countries

China

Other Identifiers

HA1118-015

Identifier Type: -

Identifier Source: org_study_id