Type 2 Diabetes
Conditions
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.
Interventions
DRUGPrusogliptin, 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.
DRUGPrusogliptin 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
DRUGPrusogliptin, 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
DRUGPrusogliptin 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
DRUGPrusogliptin, 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
Sponsors
CSPC Ouyi Pharmaceutical Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Intervention model description
Multicenter, Randomized, Double-blind, Parallel-controlled
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean change from baseline in HbA1c at Week 24 | From baseline to week 24 |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of participants with HbA1c of ≤6.5% and HbA1c of ≤7% at week 24 | From baseline to week 24 |
| Relative change from baseline in HbA1c at week 12 | From baseline to week 12 |
| Relative change from baseline in FPG at week 12 and week 24 | From baseline to week 12 and week 24 |
| 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 |
Countries
China
Outcome results
None listed