Health Condition 1: E119- Type 2 diabetes mellitus without complications
Conditions
Interventions
Intervention1: FDC of Dapagliflozin 10 mg plus Sitagliptin 100 mg plus Metformin Hydrochloride ER 1000 mg Tablets: FDC of Dapagliflozin 10 mg plus Sitagliptin 100 mg plus Metformin Hydrochloride ER 10
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 are on stable dose of Metformin �1500 mg/day as monotherapy for at least 6 weeks prior to screening and having inadequate glycemic control at screening defined as HbA1c levels of � 8.0% to � 10.0%. 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. Patients with no abnormality on 12-lead ECG at screening / baseline visit. 5. Patient with ability to understand and provide written informed consent form, which must have been obtained prior to screening. 6. 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. 5. Patients with the Body Mass Index (BMI) ââ?°Â¥ 40.0 kg/m2 at screening. 6. Patients with Estimated glomerular filtration rate (eGFR) 7. Patients with clinically significant impaired hepatic function (SGOT & SGPT more than 2.5X the ULN and/or Total bilirubin more than 1.5X the ULN) at screening. 8. Patients taking loop diuretics within one week prior to screening or planning to take during the study. 9. Patients with a history of congestive heart failure defined as New York Heart Association (NYHA) class III/IV, unstable or acute congestive heart failure. 10. 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. 11. Patients with uncontrolled hypertension with sitting systolic BP ââ?°Â¥ 160 mmHg and/or diastolic BP ââ?°Â¥ 100 mmHg at screening. 12. 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 patientââ?¬•s participation in the study. 13. Patients who are accepting treatments of arrhythmias. 14. Patients with a history of anaemia or haemoglobinopathy and/or haemoglobin 15. Patients with a history of hypothyroidism or hyperthyroidism. 16. Patients with known history of acute pancreatitis and/or serum amylase and/or lipase > 3 X ULN. 17. Patients with a history of COVID-19 infection within 8 weeks prior to study drug administration or patients with suspected signs and symptoms of COVID-19 / Confirmed novel coronavirus infection (COVID-19). 18. 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. 19. Patients with known case of congenital renal glucosuria, history of unstable or rapidly progressing renal disease. 20. Patients with a history of urinary tract infections including urosepsis and pyelonephritis. 21. Patients with a history of acute conditions with the potential to alter renal function such as dehydration, severe infection, shock or intravascular administration of iodinated contrast agents. 22. Patients with a history of genital mycotic infections. 23. Patients with known immunocompromised status. 24. Patients with a history or currently suffering with bullous pemphigoid requiring hospitalization. 25. Patients receiving treatment with systemic corticosteroids. 26. Female patients who are pregnant or breast-feeding or expecting to conceive within the projected duration of the study. 27. Female patients who are of childbearing potential and who
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean change in glycosylated haemoglobin (HbA1c) from baseline to end of the study visit (week 16).Timepoint: Screening visit (Visit 1), Baseline or Randomization Visit (Visit 3/Day 1), Visit 6 [Week 12/Day 84 (Ã?±2)] and Visit 7 [Week 16/Day 112 (Ã?±2)]. | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse events / serious adverse events reported during the study.Timepoint: Screening visit (Visit 1), Run-in Period (Visit 2), Baseline or Randomization Visit (Visit 3/Day 1), Visit 4 [Week 4/Day 28 (Ã?±2)], Visit 5 [Week 8/Day 56 (Ã?±2)], Visit 6 [Week 12/Day 84 (Ã?±2)] and Visit 7 [Week 16/Day 112 (Ã?±2)].;Changes in clinical laboratory parameters from baseline to end of the study visit (week 16).Timepoint: Screening visit (Visit 1) and Visit 7 [Week 16/Day 112 (Ã?±2)].;Hypoglycemic episodes during the study.Timepoint: Visit 4 [Week 4/Day 28 (Ã?±2)], Visit 5 [Week 8/Day 56 (Ã?±2)], Visit 6 [Week 12/Day 84 (Ã?±2)] and Visit 7 [Week 16/Day 112 (Ã?±2)].;Mean change in 2-hr post prandial plasma glucose (2-hr PPG) from baseline to end of the study visit (week 16).Timepoint: Screening visit (Visit 1), Baseline or Randomization Visit (Visit 3/Day 1), Visit 6 [Week 12/Day 84 (Ã?±2)] and Visit 7 [Week 16/Day 112 (Ã?±2)].;Mean change in body weight from baseline to end of the study visit (week 16).Timepoint: Screening visit (Visit 1), Baseline or Randomization Visit (Visit 3/Day 1), Visit 4 [Week 4/Day 28 (Ã?±2)], Visit 5 [Week 8/Day 56 (Ã?±2)], Visit 6 [Week 12/Day 84 (Ã?±2)] and Visit 7 [Week 16/Day 112 (Ã?±2)].;Mean change in fasting plasma glucose (FPG) from baseline to end of the study visit (week 16).Timepoint: Screening visit (Visit 1), Baseline or Randomization Visit (Visit 3/Day 1), Visit 4 [Week 4/Day 28 (Ã?±2)], Visit 5 [Week 8/Day 56 (Ã?±2)], Visit 6 [Week 12/Day 84 (Ã?±2)] and Visit 7 [Week 16/Day 112 (Ã?±2)].;Proportion of patients achieving a therapeutic glycemic response, defined as HbA1c 7% at the end of the study visit (week 16).Timepoint: Visit 7 [Week 16/Day 112 (Ã?±2)]. | — |
Countries
India
Contacts
Public ContactMr Mihir Upadhyay
Clinwave Research Pvt. Ltd.
Outcome results
None listed