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

NCT07026968 | Enrolling By Invitation Phase 3

• 1 other identifier: HA1118-015
• Study Type: interventional
• Target: 815
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 2 Diabetes

Outcome Measures

Primary Outcomes (1)

• Mean change from baseline in HbA1c at Week 24

  From baseline to week 24

Secondary Outcomes (9)

• 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

Study Arms (5)

Prusogliptin, Dapagliflozin(high dose), plus metformin XR

EXPERIMENTAL

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

Dapagliflozin(high dose), plus metformin XR

ACTIVE COMPARATOR

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

Prusogliptin, Dapagliflozin(low dose), plus metformin XR

EXPERIMENTAL

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

Dapagliflozin(low dose), plus metformin XR

ACTIVE COMPARATOR

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

Prusogliptin, plus metformin XR

ACTIVE COMPARATOR

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

Interventions

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

Prusogliptin, Dapagliflozin(high dose), plus metformin XR

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

Dapagliflozin(high dose), plus metformin XR

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

Prusogliptin, Dapagliflozin(low dose), plus metformin XR

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

Dapagliflozin(low dose), plus metformin XR

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

Prusogliptin, plus metformin XR

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• CSPC Ouyi Pharmaceutical Co., Ltd.: lead

Study Sites (1)

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

Shijiazhuang, Hebei, 050035, China

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

dapagliflozin

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Multicenter, Randomized, Double-blind, Parallel-controlled

Study Record Dates

• First Submitted: June 10, 2025
• First Posted: June 18, 2025
• Study Start: June 20, 2025
• Primary Completion (Estimated): October 30, 2026
• Study Completion (Estimated): November 13, 2026
• Last Updated: September 29, 2025

Record last verified: 2025-06

Locations

CN (1)