To assess safety and efficacy of Remogliflozin-Metformin-Vildagliptin combination in treatment of patients with Diabetes in India

Phase 4

Completed

• Conditions: Type 2 diabetes mellitus without complications,

• Registration Number: CTRI/2022/05/042581
• Lead Sponsor: Glenmark Pharmaceuticals Ltd

Brief Summary

This study is being conducted to assess safety and efficacy of Remogliflozin+Metformin+Vildagliptin FDC on patients with T2DM. This study is a Prospective, single arm, baseline controlled, multi-centric study. It will be conducted on 215 patients across approx. 9 centres in India. All enrolled patients will be followed up for a period of 24 weeks. AEs, TEAEs will be evaluated during the entire study duration.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-05-20
• Study Completion: 2023-01-28
• Last Update Posted: 2023-09-18

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 215

Inclusion Criteria

• Adult Indian (Age ≥18 years, ≤ 65 years) of either gender, diagnosed with T2DM for more than 6 months 2.
• On ongoing dual drug regimen of stable dose of Metformin+DPP4i or Metformin+SGLT2i since last 12 weeks before screening 3.
• With Daily Metformin Dose on 1000mg or 2000mg 4.
• Uncontrolled glycaemia with HbA1c ≥ 8% at time of screening 5.
• Patient willing to provide signed and dated, written informed consent prior to any study specific procedures.

Exclusion Criteria

• H/o hypersensitivity or contraindication to the contents of the IP, (Remogliflozin Etabonate, Vildagliptin and Metformin) 2.
• Patients of Type 1 diabetes.
• Patient suffering from any moderate to severe hepatic, cardiac, neurologic or neoplastic disorder 4.
• Patients with eGFR <60 mL/min/1.73 m2 at time of initiation of Remogliflozin Etabonate (RE) therapy (eGFR of <45 L/min/1.73m2 in patients on Metformin+RE) 5.
• History of pancreatitis or pancreatic surgery 6.
• Patients with a history of any malignancy 7.
• History of diabetic ketoacidosis 8.
• Any acute/chronic systemic infections 9.
• Patients at risk for volume depletion as judged by the investigator 11.
• Active participation in another clinical study with IP and/or investigational device 12.
• For women only – currently pregnant (confirmed with positive pregnancy test) or breast-feeding.
• Any condition which, in the judgment of the Investigator, may render the patient unable to complete the study or which may pose a significant risk to the patient or patient suspected or with confirmed poor protocol or medication compliance.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of related TEAEs of special interest as assessed by physician	Up to Week 24

Secondary Outcome Measures

Name	Time	Method
1. Mean change from baseline in HbA1c levels at Week 24	2. Mean change from baseline in HbA1c levels at Week 12

Trial Locations

Locations (9)

All India Institute of Medical Sciences; 🇮🇳 Patna, BIHAR, India

Government General Hospital; 🇮🇳 Srikakulam, ANDHRA PRADESH, India

Grant Govt Medical College; 🇮🇳 Mumbai, MAHARASHTRA, India

Jeevan Rekha Hospital; 🇮🇳 Belgaum, KARNATAKA, India

Maulana Azad Medical College; 🇮🇳 Delhi, DELHI, India

PCMCs PGI YCM Hospital; 🇮🇳 Pune, MAHARASHTRA, India

Prakhar Hospital Pvt Ltd; 🇮🇳 Nagar, UTTAR PRADESH, India

S.N. Medical College; 🇮🇳 Agra, UTTAR PRADESH, India

Sterling Multispeciality Hospital; 🇮🇳 Pune, MAHARASHTRA, India

All India Institute of Medical Sciences

🇮🇳Patna, BIHAR, India

Dr Divendu Bhushan

Principal investigator

9661216010

drdivendubhushan@aiimspatna.org