Health Condition 1: E119- Type 2 diabetes mellitus without complications
Conditions
Interventions
Intervention1: FDC of Dapagliflozin 5 mg plus Vildagliptin SR 100 mg Tablets: Patients will be advised to take one tablet once daily orally, swallowed as a whole with water in the morning after breakf
Sponsors
Exemed Pharmaceuticals
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male or Female Patients aged between 18 to 65 years (both inclusive) with diagnosis of Type 2 diabetes mellitus. 2. Patients who have received stable dose of Metformin >= 1500 mg/day as monotherapy for at least 3 months prior to screening and having inadequate glycemic control at screening defined as HbA1c levels of >= 8.0% to 3. Women of childbearing potential (WOCBP) must be using an acceptable method of contraception to avoid pregnancy throughout the study. WOCBP must have a negative urine pregnancy test at screening / baseline visit. 4. Patient with ability to understand and provide written informed consent form, which must have been obtained prior to screening. 5. Patients willing to comply with the protocol requirements.
Exclusion criteria
Exclusion criteria: 1. Patients with a history of Type 1 diabetes mellitus or secondary diabetes mellitus or diabetes insipidus. 2. Patients with a history of metabolic acidosis or diabetic ketoacidosis. 3. Patients with a history of bariatric surgery or lap-band procedure within 12 months prior to screening. 4. Patients with Fasting Plasma Glucose (FPG) > 270 mg/dL at screening (If FPG is > 270 mg/dL at screening, FPG will be repeated within 1 week. If repeat FPG is > 270 mg/dL, patient will be excluded from the study). 5. Patients with the Body Mass Index (BMI) >= 45.0 kg/m2 at screening. 6. Patients with Estimated glomerular filtration rate (eGFR) 7. Patients with clinically significant impaired hepatic function (SGOT & SGPT more than 3X the UNL and/or Total bilirubin more than 2X the UNL) at screening. 8. Patients with a history of congestive heart failure defined as New York Heart Association (NYHA) class III/IV, unstable or acute congestive heart failure. 9. Patients with significant cardiovascular history defined as: myocardial infarction, unstable angina pectoris, transient ischemic attack, unstable or previously undiagnosed arrhythmia, cardiac surgery or revascularization (coronary angioplasty or bypass grafts), or cerebrovascular accident. 10. Patients with uncontrolled hypertension with sitting systolic BP >= 160 mmHg and/or diastolic BP >= 100 mmHg at screening. 11. Any abnormality on 12-lead ECG at screening that in the opinion of the investigator is clinically significant and is judged as potential risk for patientâ??s participation in the study. 12. Patients with history of hereditary QT prolongation syndrome or patients having history of Torsades de pointes. 13. Patients who are accepting treatments of arrhythmias. 14. Patients with a history of anaemia or haemoglobinopathy and/or haemoglobin 15. Patients with known history of acute pancreatitis. 16. Patients with intolerance, contraindication or potential allergy/hypersensitivity to any of the ingredients of study medication or any other DPP4 inhibitors or SGLT-2 inhibitors. 17. Patients with a history of severe hepatobiliary disease or hepatotoxicity with any medication. 18. Patients with known case of congenital renal glucosuria, history of unstable or rapidly progressing renal disease. 19. Patients with a history of urinary tract infections including urosepsis and pyelonephritis. 20. Patients with a history of genital mycotic infections. 21. Patients with known immunocompromised status. 22. Patients receiving treatment with systemic corticosteroids. 23. Pregnant or breast-feeding, or expecting to conceive within the projected duration of the study. 24. Female patients who are of childbearing potential and who are neither surgically sterilized nor willing to use reliable contraceptive methods (like hormonal, barrier methods or intrauterine device). 25. Patients with history of any malignancy. 26. Patients with known case of infection with hepatitis B, hepatitis C or HIV. 27. Patients with donation or transfusion of blood, plasma, or platelets within the past 3 months prior to screening. 28. Patients with a history of substance abuse
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean change in glycosylated haemoglobin (HbA1c) from baseline to end of the study visit (week 24).Timepoint: At Screening/baseline visit, Visit 5 [Week 12 / Day 84 (±2)] and Visit 7 [Week 24 / Day 168 (±2)]. | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse events / serious adverse events reported during the study.Timepoint: Throughout the study.;Changes in clinical laboratory parameters from baseline to end of the study visit (week 24).Timepoint: At Screening/baseline visit, Visit 5 [Week 12 / Day 84 (±2)] and Visit 7 [Week 24 / Day 168 (±2)].;Hypoglycemic episodes during the study.Timepoint: Throughout the study.;Mean change in 2-hr post prandial plasma glucose (2-hr PPG) from baseline to end of the study visit (week 24).Timepoint: At Screening/baseline visit, Visit 3 [Week 2 / Day 14 (±2)], Visit 4 [Week 6 / Day 42 (±2)], Visit 5 [Week 12 / Day 84 (±2)], Visit 6 [Week 18 / Day 126 (±2)] and Visit 7 [Week 24 / Day 168 (±2)].;Mean change in body weight from baseline to end of the study visit (week 24).Timepoint: At Screening/baseline visit, Visit 3 [Week 2 / Day 14 (±2)], Visit 4 [Week 6 / Day 42 (±2)], Visit 5 [Week 12 / Day 84 (±2)], Visit 6 [Week 18 / Day 126 (±2)] and Visit 7 [Week 24 / Day 168 (±2)].;Mean change in fasting plasma glucose (FPG) from baseline to end of the study visit (week 24).Timepoint: At Screening/baseline visit, Visit 3 [Week 2 / Day 14 (±2)], Visit 4 [Week 6 / Day 42 (±2)], Visit 5 [Week 12 / Day 84 (±2)], Visit 6 [Week 18 / Day 126 (±2)] and Visit 7 [Week 24 / Day 168 (±2)].;Proportion of patients achieving a therapeutic glycemic response, defined as HbA1c 7% at the end of the study visit (week 24).Timepoint: At Visit 7 [Week 24 / Day 168 (±2)]. | — |
Countries
India
Contacts
Public ContactMr Mihir Upadhyay
Exemed Pharmaceuticals
Outcome results
None listed