A post marketing study to evaluate safety and effectiveness of Remogliflozin and Remogliflozin-Metformin Combination in treatment of Diabetes patients

Phase 4

Conditions: Health Condition 1: E119- Type 2 diabetes mellitus without complications

Registration Number: CTRI/2019/11/022062

Lead Sponsor: Glenmark Pharmaceuticals Ltd

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Open to Recruitment

Sex: Not specified

Target Recruitment: 0

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

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

Study & Design

Study Type: PMS

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Safety outcomes <br/ ><br>o Incidence of adverse events <br/ ><br>o Incidence of adverse events of interest <br/ ><br>o Time distribution, progression, regression and resolution/outcome of Incident adverse events <br/ ><br>o Progression and Regression of incident or existing derangement in cardiac, renal, and hepatic parameters <br/ ><br>o Incidence and details of hospitalizations for any diabetic-related disorder or complicationsTimepoint: 12 months

Secondary Outcome Measures

Name	Time	Method
1. Efficacy outcomes <br/ ><br>- Reduction in mean HbA1c, FPG, PPG, Body weight, Waist circumference, Blood pressure <br/ ><br>- Incidence of lack of efficacy <br/ ><br>- Incidence of / Progression / Regression of DM related microvascular (Nephropathy, Neuropathy, Retinopathy) /macrovascular (Coronary artery disease, Stroke, Peripheral vascular disease) complications (Cardiac, Renal, Hepatic etc.) <br/ ><br>2. Clinical profile of patients <br/ ><br>3. Patterns of usage during observation periodTimepoint: 3, 6, 9 and 12 months