Health Condition 1: null- Type 2 Diabetes mellitus Health Condition 2: E119- Type 2 diabetes mellitus without complications
Conditions
Interventions
Intervention1: Remogliflozin etabonate: Remogliflozin etabonate 100 mg (or Matching Placebo) tablet orally twice daily for 24 weeks
Intervention2: Remogliflozin etabonate: Remogliflozin etabonate 250
Sponsors
Glenmark Pharmaceuticals Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male and female aged between 18 to65 years of age, diagnosed with type 2 diabetes mellitus (T2DM) at the time of informed consent. 2. Subjects who have received stable dose of metformin > 1500 mg/day ( > 1000 mg/day for subjects not tolerating) as monotherapy for at least 8 weeks prior to screening and having inadequate glycemic control at screening (visit 1) defined as HbA1c levels of >7% to <=10%.
Exclusion criteria
Exclusion criteria: 1. Diagnosis of Type 1 diabetes mellitus or secondary diabetes mellitus 2. History of metabolic acidosis or diabetic ketoacidosis 3. FPG 240 mg/dL at screening or randomization 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. 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. 6. History of anaemia or haemoglobinopathy and/or serum haemoglobin 10 g/dL (100 g/L) for men; haemoglobin 9 g/dL (90 g/L) for women at screening 7. Intolerance, contraindication or potential allergy/hypersensitivity to any of the ingredients of study medication or any other SGLT2 inhibitors 8. 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 9. Positive serology for Human Immunodeficiency Virus (HIV), Hepatitis B virus (HBV) and Hepatitis C virus (HCV) at screening.26. 10. Pregnant or breastfeeding.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean change in HbA1c levels from baselineTimepoint: 24 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Mean change from baseline in fasting lipids (total cholesterol [TC], low-density lipoprotein cholesterol [LDL-C], high-density lipoprotein cholesterol [HDL-C] and triglycerides [TG])Timepoint: 12 and 24 weeks;Mean change from baseline in fasting plasma glucose (FPG) levelsTimepoint: 1, 12 and 24 weeks;Mean change from baseline in post-prandial plasma glucose (PPG) levelsTimepoint: 1, 12 and 24 weeks;Mean change from baseline in total body weightTimepoint: 12 and 24 weeks;Mean change in HbA1c levels from baselineTimepoint: 12 weeks;Mean change in HbA1c levels with remogliflozin etabonate 100 mg and 250 mg BID, stratified for baseline HbA1cTimepoint: 24 weeks;Pharmacokinetics parameter assessment of GSK189075, GSK189074 and GSK279782 (Cmax, Tmax, AUC0-t and AUC0-tau)Timepoint: PK Sampling: Day 1 and day 8;Proportion of subjects achieving a therapeutic glycemic response (HbA1c 7%)Timepoint: 24 weeks;Proportion of subjects meeting criteria for rescue medication based on protocol defined criteria for hyperglycaemiaTimepoint: 24 weeks | — |
Countries
India
Contacts
Public ContactAmol Pendse
Glenmark Pharmaceuticals Limited
Outcome results
None listed