A Prospective, Multicenter, Phase -IV Study to Assess the Safety of Fixed Dose Combination of Dapagliflozin and Saxagliptin in Indian Type 2 Diabetes Mellitus (T2D) Patients

D1683C00013

A prospective, multicenter, phase -IV study to assess the safety of fixed dose combination of dapagliflozin and saxagliptin in Indian Type 2 Diabetes Mellitus (T2D) patients.

2021-04-07

2023-03-14

2023-03-14

Completed

Early phase I

200

Inclusion criteria: For inclusion in the study subjects should fulfil the following criteria: 1. Provision of signed and dated, written informed consent prior to any study specific procedures according to local Indian procedure. 2. Male and female patients aged \> 18 and above 3. Documented history of type 2 diabetes mellitus with HbA1c level \>7.0% and ≤ 10% at screening visit 4. Patients who are on a stable dose of antidiabetic drugs (including on Metformin dose between 1000-2000mg) in the past 3 months 5. Female subjects must be 1 year post-menopausal, surgically sterile, or using an acceptable method of contraception (an acceptable method of contraception is defined as a barrier method in conjunction with a spermicide) for the duration of the study (from the time they sign consent) to prevent pregnancy. In addition, oral contraceptives, approved contraceptive implant, long-term injectable contraception, intrauterine device, or tubal ligation are allowed. Oral contraception alone is not acceptable; additional barrier methods in conjunction with spermicide must be used. Exclusion criteria: 1. Known allergies or contraindication to the contents of the IP, dapagliflozin or saxagliptin tablets. 2. Active participation in another clinical study with IP and/or investigational device 3. For women only - currently pregnant (confirmed with positive pregnancy test) or breast-feeding. 4. Type 1 diabetes mellitus. 5. Treatment with a SGLT2 inhibitor, GLP-1 agonist or DPP4 inhibitors at Visit 1 or 2 6. Patients with moderate to severe renal impairment (eGFR persistently \<45 mL/min/1.73 m2 by CKD-EPI (Chronic Kidney Disease Epidemiology Collaboration) formula or end-stage renal disease (ESRD) or 'Unstable or rapidly progressing renal disease 7. Patients with severe hepatic impairment (Child-Pugh class C) 8. History of pancreatitis or pancreatic surgery 9. Patients with a history of any malignancy 10. Patients with any of the following CV/Vascular Diseases within 3 months prior to signing the consent at enrolment, as assessed by the investigator: * Myocardial infarction. * Cardiac surgery or revascularization (CABG/PTCA). * Unstable angina. * Transient ischemic attack (TIA) or significant cerebrovascular disease. * Unstable or previously undiagnosed arrhythmia. 11. History of heart failure 12. Severe uncontrolled hypertension defined as systolic blood pressure ≥180 mm Hg and/or diastolic blood pressure ≥110 mm Hg at any visit up to randomisation 13. History of diabetic ketoacidosis 14. Any acute/chronic systemic infections 15. Recurrent urogenital infections 16. Patients at risk for volume depletion as judged by the investigator 17. Any condition which, in the judgment of the Investigator, may render the patient unable to complete the study or which may pose a significant risk to the patient or patient suspected or with confirmed poor protocol or medication compliance

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 200, 'type': 'ACTUAL'}}

2023-05-06