Efficacy of FDC Regimen of Dapagliflozin/Metformin Compared to Co-administered Dual Therapy on Glycemic Control, Satisfaction and Adherence in Chinese Patients With T2DM: A 24-Week, Multicentre, Randomized, Parallel, Interventional, Non-inferiority, Open-label Study

D1690L00149

Study D1690L00149 is a 24-week, multicentre, randomized, parallel, interventional, non-inferiority, open-label study designed to compare the FDC Regimen of Dapagliflozin/Metformin XR with the Dapagliflozin co-administered with Metformin XR in glycemic lowering control, satisfaction and adherence in Chinese patients with T2DM.

2024-03-27

2025-04-30

2025-04-30

Recruiting

Early phase I

632

Inclusion Criteria: Age and Informed Consent 1. Patient must be 18 to 80 (years of age inclusive), at the time of signing the ICF(s). Type of Patient and Disease Characteristics 2. Newly diagnosed T2DM (WHO diagnostic criteria 1999) ≤ 1 year with medicine treatment naïve. 3. HbA1c 7.5%-10% at screening by local lab and HbA1c 7.5-10% at pre-randomization visit (by central laboratory). 4. BMI ≥19 and ≤40 kg/m2 at screening. Other Inclusion Criteria 5. Capable of giving signed informed consent as described in Appendix A which includes compliance with the requirements and restrictions listed in the ICF and in this protocol. Exclusion Criteria: Medical Conditions 1. Congestive heart failure NYHA classes III or IV or major cardiovascular events within 6 months before screening. (Significant cardiovascular history within the past 6 months prior to screening defined as: myocardial infarction, coronary angioplasty or bypass graft(s), valvular disease or repair, unstable angina pectoris, transient ischemic attack, or cerebrovascular accident.) 2. Patients with clinically apparent hepatobiliary disease, including but not limited to chronic active hepatitis and/or severe hepatic insufficiency. ALT or AST \> 3x ULN, or serum TB \>34.2 μmol/L (\>2 mg/dL). 3. Patients with eGFR\< 45 mL/min per 1.73 m². 4. Diagnosis or history of acute metabolic diabetic complications such as ketoacidosis or hyperglycemic hyperosmolar state, or diabetes insipidus within the past 6 months. 5. For women only - currently pregnant (confirmed with positive pregnancy test) or breastfeeding. 6. Participation in any other study that included drug treatment during the past 3 months before enrolment. Diagnostic Assessments 7. Patients with a known hypersensitivity to Dapa/Met or any of the excipients of the product. 8. Diagnosis or history of: 1. Chronic pancreatitis within past 6 months or idiopathic acute pancreatitis within past 4 weeks. 2. Gastrointestinal disease including gastroenterostomy, enterectomy, roemheld syndrome, severe hernia, intestinal obstruction, intestinal ulcer within past 6 months. 3. Genetic galactose intolerance, lapp lactase deficiency and glucose-galactose malabsorption. 4. Medullary thyroid carcinoma within past 5 years. 5. Organ transplant or AIDS within the past 6 months. 6. Alcohol abuse or illegal drug abuse within the past 12 months. 7. Laser treatment for proliferative retinopathy within 6 months. 8. Stress condition, such as surgery, serious trauma, etc., within past 6 months, or plan to undergo a surgery during study period. 9. Chronic oxygen deficiency diseases, such as pulmonary emphysema, pulmonary heart disease within past 6 months. 10. T1DM, diabetes resulting from pancreatic injury or secondary forms of diabetes, eg, acromegaly or Cushing's syndrome. Other Exclusions 9. Subject is, in the judgment of the Investigator, unlikely to comply with the protocol or has any severe concurrent medical or psychological condition that may affect the interpretation of study results. 10. Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site).

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 632, 'type': 'ESTIMATED'}}

2024-04-15