A clinical trial to study effect of a remogliflozin etabonate in the treatment of diabetes mellitus.

Phase 3

Completed

• Conditions: Health Condition 1: null- Type 2 Diabetes mellitusHealth Condition 2: E119- Type 2 diabetes mellitus without complications

• Registration Number: CTRI/2017/07/009121
• Lead Sponsor: Glenmark Pharmaceuticals Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2019-03-05
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 906

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

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified