Health Condition 1: E119- Type 2 diabetes mellitus without complications
Conditions
Interventions
Intervention1: Fixed dose combination of Dapagliflozin 10 mg plus Linagliptin 5 mg tablets: To be taken orally once daily in the morning after breakfast for 16 week
Control Intervention1: FDC of Dapag
Sponsors
Micro Labs Limited
Micro Labs Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Subjects aged >=18 to 2. Inadequate glycemic control at screening defined as HbA1c levels of >=8.0% to 3. Subjects who have received stable dose of metformin IR /ER > 1500 mg/day ( > 1000mg/day for subjects not tolerating) as monotherapy for at least 8 weeks prior to screening 4. Subjects with BMI less than or equal to 45.0 kg/m2 at screening 5. Female subjects of childbearing potential using adequate contraception 6. Willingness to sign written informed consent document
Exclusion criteria
Exclusion criteria: 1. Women of childbearing potential if pregnant (test positive for pregnancy) at screening visit, breast feeding, or not in agreement to use adequate birth control methods to prevent pregnancy throughout the study 2. 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). 3. Patients with Estimated glomerular filtration rate (eGFR) 4. 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. 5. Subjects with History of metabolic acidosis or diabetic ketoacidosis 6. Patients with a history of congestive heart failure defined as New York Heart Association (NYHA) class III/IV, unstable or acute congestive heart failure. 7. Subjects with symptomatic urinary tract infection or mycotic genital infection at screening or history of a recent symptomatic infection within 4 weeks prior to screening 8. Refusal or inability to comply with the requirements of the protocol for any reason, including scheduled clinic visits and laboratory tests. 9. Subjects with Intolerance, contraindication or potential allergy/hypersensitivity to any of the ingredients of study medication or any other SGLT2 inhibitors orDPP4 inhibitors 10. Any other condition that in opinion of the investigator does not justify patientâ??s participation in study. 11. Participation in another clinical trial within past 30 days
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean change in HbA1c (Glycosylated haemoglobin) from baseline at the end of week 16Timepoint: Mean change in HbA1c (Glycosylated haemoglobin) from baseline at the end of week 16 | — |
Secondary
| Measure | Time frame |
|---|---|
| Mean change in Postprandial Blood Glucose (PPBG) from baseline to Week 16 Mean change in Fasting Blood Glucose (FBG) from baseline to Week 16 Proportion of Participants Achieving HbA1c less than7.0% from baseline to Week 16 Mean change in bodyweight - from baseline to Week 16 Timepoint: from baseline to Week 16 | — |
Countries
India
Contacts
Public ContactDr Krishna Kumar M
Micro Labs Limited
Outcome results
None listed