Health Condition 1: E119- Type 2 diabetes mellitus without complications
Conditions
Interventions
Intervention1: FDC of Sitagliptin 100 mg plus Gliclazide XR 60 mg Tablets: Patients will be advised to take one tablet once a day orally, swallowed with water at breakfast time in the morning preferab
Sponsors
Eris Lifesciences Ltd.
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, along with diet and exercise control, additionally on stable total daily dose of Metformin Hydrochloride = 1500 mg for at least 8 weeks prior to screening. 3. Patients having inadequate glycemic control defined as glycosylated hemoglobin (HbA1c) levels of = 8.0% to = 11.0% at screening visit. 4. 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. 5. Patients with no abnormality on 12-lead ECG at screening / baseline visit. 6. Patient with ability to understand and provide written informed consent form, which must have been obtained prior to screening. 7. 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 Fasting Plasma Glucose (FPG) = 270 mg/dL at screening. 4. Patients with the Body Mass Index (BMI) > 45.0 kg/m2 at screening. 5. Patients with Estimated glomerular filtration rate (eGFR) 6. Patients with clinically significant impaired hepatic function (SGOT & SGPT more than 3X the ULN and/or Total bilirubin more than 1.5X the ULN) at screening. 7. Patients with a history of congestive heart failure defined as New York Heart Association (NYHA) class III/IV, unstable or acute congestive heart failure. 8. 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. 9. Patients with history of sustained and clinically relevant ventricular arrhythmia. 10. Patients with history or currently suffering with severe and disabling arthralgia. 11. Patients with history or currently suffering with bullous pemphigoid requiring hospitalization and taking DPP-4 inhibitors. 12. Patients with history of inflammatory bowel disease or intestinal ulcers or chronic enteric diseases related to digestion and absorption. 13. Patients with any condition (e.g., infection, trauma and surgery) which require insulin therapy at the time of screening or during the study period. 14. Patients with uncontrolled hypertension with sitting systolic BP = 160 mmHg and/or diastolic BP = 100 mmHg at screening. 15. 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 patient’s participation in the study. 16. Patients who are accepting treatments of arrhythmias. 17. Patients with a history of anaemia or haemoglobinopathy and/or haemoglobin 18. Patients with intolerance, contraindication or potential allergy/hypersensitivity to DPP4 inhibitors or Sufonylureas. 19. Female patients who are pregnant or breast-feeding or expecting to conceive within the projected duration of the study. 20. 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). 21. Patients with history of any malignancy. 22. Patients with history of infection with hepatitis B, hepatitis C or HIV. 23. Patients with donation or transfusion of blood, plasma, or platelets within the past 3 months prior to screening. 24. Patients with a history of substance abuse or dependence that in the opinion of the Investigator is considered to interfere with the patient’s participation in the study. 25. Patients with concurrent participation in another clinical trial or any investigational therapy within 30 days prior to signing informed consent. 26. Patients currently taking any of the prohibited medications(s) and inability/unwillingness to
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean change in glycosylated haemoglobin (HbA1c) from baseline to end of the study visit (week 16).Timepoint: At Screening/baseline visit, Visit 5 [Week 12/Day 84 (±3)] and Visit 6 [Week 16/Day 112 (±3)]. | — |
Secondary
| Measure | Time frame |
|---|---|
| Mean change in fasting plasma glucose (FPG) from baseline to end of the study visit (week 16).Timepoint: At Screening/baseline visit, Visit 3 [Week 2/Day 14 (±3)], Visit 4 [Week 6/Day 42 (±3)], Visit 5 [Week 12/Day 84 (±3)] and Visit 6 [Week 16/Day 112 (±3)].;Number of patients requiring hypoglycemia management during the study.Timepoint: At Visit 3 [Week 2/Day 14 (±3)], Visit 4 [Week 6/Day 42 (±3)], Visit 5 [Week 12/Day 84 (±3)] and Visit 6 [Week 16/Day 112 (±3)].;Number of patients requiring rescue medications during the study.Timepoint: At Visit 3 [Week 2/Day 14 (±3)], Visit 4 [Week 6/Day 42 (±3)], Visit 5 [Week 12/Day 84 (±3)] and Visit 6 [Week 16/Day 112 (±3)].;Proportion of patients achieving a therapeutic glycemic response, defined as HbA1c 7% at the end of the study visit (week 16).Timepoint: At Visit 6 [Week 16/Day 112 (±3)].;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 16).Timepoint: At Screening/baseline visit and Visit 6 [Week 16/Day 112 (±3)].;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 16).Timepoint: At Screening/baseline visit, Visit 3 [Week 2/Day 14 (±3)], Visit 4 [Week 6/Day 42 (±3)], Visit 5 [Week 12/Day 84 (±3)] and Visit 6 [Week 16/Day 112 (±3)].;Mean change in body weight from baseline to end of the study visit (week 16).Timepoint: At Screening/baseline visit, Visit 3 [Week 2/Day 14 (±3)], Visit 4 [Week 6/Day 42 (±3)], Visit 5 [Week 12/Day 84 (±3)] and Visit 6 [Week 16/Day 112 (±3)]. | — |
Countries
India
Contacts
Public ContactMr Ganesh Boddu
Clinwave Research Pvt. Ltd.
Outcome results
None listed