Health Condition 1: E119- Type 2 diabetes mellitus without complications
Conditions
Interventions
Intervention1: FDC of Remogliflozin - Vildagliptin - Metformin: Twice daily orally for 24 weeks
Control Intervention1: NA: NA
Sponsors
Glenmark Pharmaceuticals Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. 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
Exclusion criteria: 1. H/o hypersensitivity or contraindication to the contents of the IP, (Remogliflozin Etabonate, Vildagliptin and Metformin) 2. Patients of Type 1 diabetes. 3. Patient suffering from any moderate to severe hepatic, cardiac, neurologic or neoplastic disorder 4. Patients with eGFR 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. Recurrent urogenital infections 10. 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. 13. 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of related TEAEs of special interest as assessed by physicianTimepoint: Up to Week 24 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Mean change from baseline in HbA1c levels at Week 24 2. Mean change from baseline in HbA1c levels at Week 12 3. Mean change from baseline in FPG, PPG levels, Body weight, Waist circumference, Blood pressure at Week 12 and 24. 4. Proportion of patients achieving target glycemic control of HbA1c =7% at Week 12 and 24 5. Proportion of patients requiring rescue medications by 12 and 24 weeks of treatment. 6. Mean change from baseline in TG, TC, LDL-C and HDL-C at Week 24 7. Incidence of TEAEs, TESAEs, TEAEs leading to dose modification/discontinuation of treatment [Time frame: up to Week 24] 8. Incidence of solicited and unsolicited adverse events (Clinical signs, symptoms, laboratory parameters) during the study period of 24 weeksTimepoint: Up to Week 24 | — |
Countries
India
Contacts
Public ContactRujuta Gadkari
Glenmark Pharmaceuticals Ltd.
Outcome results
None listed