A prospective active post marketing surveillance study to assess safety and effectiveness of Remogliflozin and Remogliflozin-Metformin Fixed Dose Combination in management of Type 2 Diabetes Mellitus patients in Real world setting - REMOLUTIO

Glenmark Pharmaceuticals Ltd0 个研究点目标入组 0 人开始时间: 待定最近更新: 2021年11月24日

试验速览

暂无简介。

•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

•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

发起方

Glenmark Pharmaceuticals Ltd