Health Condition 1: E119- Type 2 diabetes mellitus without complications
Conditions
Interventions
Intervention1: Remogliflozin etabonate: One tablet 100 mg to be consumed twice daily with or without food for 1 year.
Intervention2: Remogliflozin-Metformin: Remogliflozin etabonate + Metformin availa
Sponsors
Glenmark Pharmaceuticals Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Adults (more than 18 years) of either gender diagnosed with Type-2 Diabetes Mellitus and eligible to receive oral anti-diabetic medications 2. Patients who are prescribed Remogliflozin (as mono-therapy or combination therapy) or FDC of Remo-Met as per discretion of treating physician in accordance with prescribing information 3. Patients who understand & willing to comply with study requirements and provide written informed consent for participation
Exclusion criteria
Exclusion criteria: 1. Hypersensitivity to the active substance or any of the excipients 2. Patients with moderate to severe renal impairment (defined as glomerular filtration rate [GFR] less than 60 mL/min) 3. Patients with moderate to severe hepatic impairment 4. Patients with evidence of recurrent Urinary tract infections / Genital tract infections (more than 3 episodes in last 12 months) 5. Female Patients who are on oral contraceptives & not willing to switch over to alternative non-hormonal method of contraception 6. Pregnant and lactating females 7. Patients who have participated in any clinical trial 3 months prior to enrolment and would not be participating in clinical study during the period of study participation. 8. Any other medical disorder /clinical condition that in opinion of investigator would pose additional risk to subject or prelude adequate assessment of efficacy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety outcomes o Incidence of adverse events o Incidence of adverse events of interest o Time distribution, progression, regression and resolution/outcome of Incident adverse events o Progression and Regression of incident or existing derangement in cardiac, renal, and hepatic parameters o Incidence and details of hospitalizations for any diabetic-related disorder or complicationsTimepoint: 12 months | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Efficacy outcomes - Reduction in mean HbA1c, FPG, PPG, Body weight, Waist circumference, Blood pressure - Incidence of lack of efficacy - Incidence of / Progression / Regression of DM related microvascular (Nephropathy, Neuropathy, Retinopathy) /macrovascular (Coronary artery disease, Stroke, Peripheral vascular disease) complications (Cardiac, Renal, Hepatic etc.) 2. Clinical profile of patients 3. Patterns of usage during observation periodTimepoint: 3, 6, 9 and 12 months | — |
Countries
India
Contacts
Public ContactDr Sagar Katare
Glenmark Pharmaceuticals Ltd.
Outcome results
None listed