Health Condition 1: E119- Type 2 diabetes mellitus without complications
Conditions
Interventions
Intervention1: FDC of remogliflozin etabonate 100 mg and Teneligliptin 10 mg (or Matching Placebo) tablet, orally twice daily: Dosage Form: Tablet
Dosage Frequency: Twice daily
Dose: Remogliflozin et
Sponsors
Glenmark Pharmaceuticals Ltd
Eligibility
Inclusion criteria
Inclusion criteria: Male and female subjects >=18 and 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 Subjects must be willing and able to provide written informed consent. Willing and able to comply with all aspects of the protocol. Must be willing to use a highly effective form of contraception (with pearl index
Exclusion criteria
Exclusion criteria: History of Type 1 diabetes mellitus or secondary diabetes mellitus or diabetes insipidus History of metabolic acidosis or diabetic ketoacidosis 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. BMI >=45.0 kg/m2 at screening Subjects with elevated thyroid stimulating hormone (TSH) level at screening with or without thyroid hormone replacement therapy Estimated glomerular filtration rate (eGFR) 1.5 mg/dL for male subjects and > 1.4 mg/dL for female subjects, at screening 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 Congestive heart failure defined as New York Heart Association (NYHA) class III/IV, unstable or acute congestive heart failure. 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. Subjects with uncontrolled hypertension with sitting systolic BP >=160 mmHg and/or diastolic BP >= 100 mmHg at screening. Note: Subjects with SBP >= 160mmHg and = 100 mmHg and = 160 mmHg or DBP >= 100 mmHg measured at randomization visit. 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 subjectâ??s participation in the study. For male subjects with mean QTcB >=450 msec or female subjects with mean QTcB >=470 msec, triplicate ECG will be performed. If mean QTcB is >=450 msec in males or mean QTcB is >=470 msec in females on triplicate ECG, subject will be excluded from the study. Patients with history of hereditary QT prolongation syndrome or patients having history of Torsades de pointes. Patients with history of abdominal surgery or intestinal obstruction. Patients with history of acute pancreatitis. History of anaemia or haemoglobinopathy and/or haemoglobin Donation or transfusion of blood, plasma, or platelets within the past 3 months prior to enrolment History of malignancy within the last 5 years prior to enrolment, excluding non-melanoma skin cancer (e.g. basal or squamous cell skin carcinoma) or treated carcinoma-in-situ of cervix Intolerance, contraindication or potential allergy/hypersensitivity to any of the ingredients of study medication or any other SGLT2 inhibitors or DPP4 inhibitors Subjects with symptomatic diarrhoea or any other medical condition which the investigators may judge to be a risk for dehydration and hypovolemia Subjects with symptomatic urinary tract infection or mycotic genital infection at s
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean change from baseline in HbA1c levels at week 16Timepoint: 16 Weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Mean change from baseline in body weightTimepoint: 16 weeks;Mean change from baseline in fasting plasma glucose (FPG) levels at weekTimepoint: 16 weeks;Mean change from baseline in HbA1c levelsTimepoint: 12 weeks;Mean change from baseline in post-prandial plasma glucose (PPG)Timepoint: 16 weeks;Proportion of subjects achieving a therapeutic glycemic response, defined as HbA1c 7%.Timepoint: 16 weeks;Proportion of subjects requiring rescue medication for hyperglycaemiaTimepoint: During study treatment | — |
Countries
India
Contacts
Public ContactAmol Pendse
Glenmark Pharmaceuticals Ltd
Outcome results
None listed