A clinical trial to study the efficacy and safety of fixed dose combination of remogliflozin etabonate and vildagliptin in the treatment of type 2 diabetes mellitus.
- Conditions
- Health Condition 1: E119- Type 2 diabetes mellitus without complications
- Registration Number
- CTRI/2020/01/022846
- Lead Sponsor
- Glenmark Pharmaceuticals Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 400
1.Male and female subjects � 18 and � 65 years of age, diagnosed with T2DM.
2.Subjects who have received stable dose of metformin � 1500 mg/day as monotherapy for at least 10 weeks prior to screening and having inadequate glycemic control at screening defined as HbA1c levels of � 8% to � 11%.
1.History of Type 1 diabetes mellitus or secondary diabetes mellitus or diabetes insipidus
2.History of metabolic acidosis or diabetic ketoacidosis
3.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, subject will be excluded from the study.
4.Estimated glomerular filtration rate (eGFR) <60 mL/min/1.73m2 using the Modification of Diet in Renal Disease (MDRD) equation or serum creatinine level of > 1.5 mg/dL for male subjects and > 1.4 mg/dL for female subjects, at screening.
5.Severe hepatic insufficiency and/or significant abnormal liver function defined as aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) > 3X ULN or total serum bilirubin >2.0 mg/dL at screening
6.Congestive heart failure defined as New York Heart Association (NYHA) class III/IV, unstable or acute congestive heart failure.
7.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.
8.Intolerance, contraindication or potential allergy/hypersensitivity to any of the ingredients of study medication or any other SGLT2 inhibitors or DPP4 inhibitors
9.Subjects with symptomatic diarrhoea or any other medical condition which the investigators may judge to be a risk for dehydration and hypovolemia
10.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
11.Subject with a positive result for hepatitis B surface antigen or hepatitis C antibody at screening.
12.Subject is known to be seropositive for human immunodeficiency virus (HIV).
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Mean change in HbA1c levels from baseline to end of treatmentTimepoint: 16 Weeks
- Secondary Outcome Measures
Name Time Method Mean change from baseline in body weight at end of treatmentTimepoint: 16 Weeks;Mean change from baseline in fasting plasma glucose (FPG) levels at end of treatmentTimepoint: 16 weeks;Mean change from baseline in HbA1c levels at week 12Timepoint: 12 Weeks;Mean change from baseline in post-prandial plasma glucose (PPG) at end of treatmentTimepoint: 16 Weeks;Proportion of subjects achieving a therapeutic glycaemic response, defined as HbA1c 7%, end of treatmentTimepoint: 16 Weeks