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

CSPC Pharmaceutical Group

Status and phase: Invitation-only; Phase 3

Conditions: Type 2 Diabetes

Treatments: Drug: Prusogliptin placebo, Dapagliflozin(high dose), Dapagliflozin (low dose) placebo, plus metformin XR; Drug: Prusogliptin placebo, Dapagliflozin (high dose) placebo, Dapagliflozin (low dose), plus metformin XR; Drug: Prusogliptin, Dapagliflozin(high dose), Dapagliflozin (low dose) placebo, plus metformin XR; Drug: Prusogliptin, Dapagliflozin (high dose) placebo, Dapagliflozin(low dose) placebo, plus metformin XR; Drug: Prusogliptin, Dapagliflozin(high dose) placebo, Dapagliflozin (low dose), plus metformin XR

Study type: Interventional

Funder types: Industry

Identifiers

NCT07026968

HA1118-015

Details and patient eligibility

About

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.

Full description

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

Enrollment: 815 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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815 participants in 5 patient groups

Prusogliptin, Dapagliflozin(high dose), plus metformin XR

Experimental group

Treatment:

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

Dapagliflozin(high dose), plus metformin XR

Active Comparator group

Treatment:

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

Prusogliptin, Dapagliflozin(low dose), plus metformin XR

Experimental group

Treatment:

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

Dapagliflozin(low dose), plus metformin XR

Active Comparator group

Treatment:

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

Prusogliptin, plus metformin XR

Active Comparator group

Treatment:

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