A clinical trial to study the efficacy and safety of fixed dose combination of remogliflozin etabonate and vildagliptin in the treatment of type 2 diabetes mellitus.

Phase 3

Completed

• Conditions: Type 2 diabetes mellitus without complications,

• Registration Number: CTRI/2020/01/022846
• Lead Sponsor: Glenmark Pharmaceuticals Ltd

Brief Summary

This study is a randomized, double blind, double dummy, active controlled, parallel group, multi-centre trial comparing the safety and efficacy of FDC of remogliflozin etabonate (100 mg) and vildagliptin (50 mg) given twice daily with that of FDC of empagliflozin (25 mg) and linagliptin (5 mg) once daily in 400 patients who have inadequately controlled type 2 diabetes mellitus on stable dose of metformin for at least 10 weeks. The subject’s will continue to receive metformin at stable doses of ≥ 1500 mg per day, throughout the study period in an open label manner. The study consist of screening period of up to 3 weeks and includes a 2 week run in period, 16 weeks study treatment and a safety follow��’up period of 2 weeks post last dose of the study drug. The primary outcome measures will be mean change from baseline in HbA1c at the end of treatment. Any adverse event (AE), either clinical/laboratory, will be recorded and assessed for severity, seriousness and causality.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-01-31
• Study Completion: 2021-07-23
• Last Update Posted: 2021-11-19

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

• 1.Male and female subjects ≥ 18 and ≤ 65 years of age, diagnosed with T2DM.
• 2.Subjects who have received stable dose of metformin ≥ 1500 mg/day as monotherapy for at least 10 weeks prior to screening and having inadequate glycemic control at screening defined as HbA1c levels of ≥ 8% to ≤ 11%.

Exclusion Criteria

• 1.History of Type 1 diabetes mellitus or secondary diabetes mellitus or diabetes insipidus 2.History of metabolic acidosis or diabetic ketoacidosis 3.FPG >270 mg/dL at screening.
• If FPG is >270 mg/dL at screening, FPG will be repeated within 1 week.
• If repeat FPG is >270 mg/dL, subject will be excluded from the study.
• 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.Severe hepatic insufficiency and/or significant abnormal liver function defined as aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) > 3X ULN or total serum bilirubin >2.0 mg/dL at screening 6.Congestive heart failure defined as New York Heart Association (NYHA) class III/IV, unstable or acute congestive heart failure.
• 7.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.
• 8.Intolerance, contraindication or potential allergy/hypersensitivity to any of the ingredients of study medication or any other SGLT2 inhibitors or DPP4 inhibitors 9.Subjects with symptomatic diarrhoea or any other medical condition which the investigators may judge to be a risk for dehydration and hypovolemia 10.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 11.Subject with a positive result for hepatitis B surface antigen or hepatitis C antibody at screening.
• 12.Subject is known to be seropositive for human immunodeficiency virus (HIV).

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Mean change in HbA1c levels from baseline to end of treatment	16 Weeks

Secondary Outcome Measures

Name	Time	Method
Mean change from baseline in HbA1c levels at week 12	12 Weeks
Mean change from baseline in fasting plasma glucose (FPG) levels at end of treatment	16 weeks
Mean change from baseline in post-prandial plasma glucose (PPG) at end of treatment	16 Weeks
Mean change from baseline in body weight at end of treatment	16 Weeks
Proportion of subjects achieving a therapeutic glycaemic response, defined as HbA1c 7%, end of treatment	16 Weeks

Trial Locations

Locations (28)

Apex Hospital Pvt.Ltd; 🇮🇳 Jaipur, RAJASTHAN, India

Arthur Asirvatham Hospital; 🇮🇳 Madurai, TAMIL NADU, India

Bangalore Diabetes Centre; 🇮🇳 Bangalore, KARNATAKA, India

Bhatia Hospital; 🇮🇳 Mumbai, MAHARASHTRA, India

Brij Medical Centre Pvt. Ltd.; 🇮🇳 Nagar, UTTAR PRADESH, India

BSES Municipal General Hospital; 🇮🇳 Mumbai, MAHARASHTRA, India

Dayanand Medical College & Hospital; 🇮🇳 Ludhiana, PUNJAB, India

Diabetes Thyroid & Endocrine Centre; 🇮🇳 Jaipur, RAJASTHAN, India

Diacon Hospital; 🇮🇳 Bangalore, KARNATAKA, India

Eternal Hospital, Unit of Eternal Heart Care Centre and Research; 🇮🇳 Jaipur, RAJASTHAN, India

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Apex Hospital Pvt.Ltd

🇮🇳Jaipur, RAJASTHAN, India

Dr Vipul Khandelwal

Principal investigator

9829193517

dr.vipul@yahoo.co.in