Clinical trial NCT07026968: A Study of Prusogliptin Tablets Combined With Dapagliflozin Tablets and Metformin Hydrochloride Extended Release Tablets in Type 2 Diabetes
Official title: 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE3
Conditions: Type 2 Diabetes
Lead sponsor: CSPC Ouyi Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2025-06-18
Enrollment: 815
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Multicenter, Randomized, Double-blind, Parallel-controlled
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Mean change from baseline in HbA1c at Week 24
timeFrame: From baseline to week 24
Secondary outcomes:
measure: Proportion of participants with HbA1c of ≤6.5% and HbA1c of ≤7% at week 24
timeFrame: From baseline to week 24
measure: Relative change from baseline in HbA1c at week 12
timeFrame: From baseline to week 12
measure: Relative change from baseline in FPG at week 12 and week 24
timeFrame: From baseline to week 12 and week 24
measure: Relative change from baseline in 2h-PPG at week 12 and week 24
timeFrame: From baseline to week 12 and week 24
measure: Relative change from baseline in weight at week 12 and week 24
timeFrame: From baseline to week 12 and week 24
measure: Relative change from baseline in blood pressure at week 12 and week 24
timeFrame: From baseline to week 12 and week 24
measure: Relative change from baseline in blood lipid level at week 12 and week 24
timeFrame: From baseline to week 12 and week 24
measure: Relative change from baseline in 7-point blood glucose levels and average post-meal blood glucose increments at week 24
timeFrame: From baseline to week 24
measure: Proportion of participants who received rescue treatment after 24 weeks of treatment
timeFrame: From baseline to week 24
Other outcomes:
Locations:
Study officials:
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