dapagliflozin/metformin/sitagliptin (GMRx4) / George Medicines - LARVOL DELTA

Efficacy and Safety of Triple Fixed Dose Combination of Dapagliflozin + Sitagliptin + Metformin IR in Indian Patients with Type 2 Diabetes Mellitus: A Randomized, Phase 3 Study in Comparison with Dual FDC Sitagliptin + Metformin IR. (PubMed, Adv Ther) - "Triple FDC of DAPA + SITA + MET IR demonstrated superior efficacy in achieving glycaemic control in patients with T2DM compared to dual FDC. There were no major safety concerns."

Journal • P3 data • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

Efficacy of Dapagliflozin + Sitagliptin + Metformin Versus Sitagliptin + Metformin in T2DM Inadequately Controlled on Metformin Monotherapy: A Multicentric Randomized Trial. (PubMed, Adv Ther) - "Among patients with T2DM who have poor glycemic control with metformin monotherapy, triple FDC (Dapa + Sita + Met) effectively helped achieve better glycemic response compared to dual FDC (Sita + Met), with a comparable safety and tolerability profile."

Journal • Monotherapy • Diabetes • Metabolic Disorders • Severe Hypoglycemia • Type 2 Diabetes Mellitus

PiVOT: Polypill Versus Metformin in New Onset Type 2 Diabetes (clinicaltrials.gov) - P2 | N=0 | Withdrawn | Sponsor: George Medicines PTY Limited | N=334 ➔ 0 | Not yet recruiting ➔ Withdrawn

Enrollment change • Trial withdrawal • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

PiVOT: Polypill Versus Metformin in New Onset Type 2 Diabetes (clinicaltrials.gov) - P2 | N=334 | Not yet recruiting | Sponsor: George Medicines PTY Limited | Trial completion date: Nov 2024 ➔ Sep 2025 | Trial primary completion date: Nov 2024 ➔ Sep 2025

Trial completion date • Trial primary completion date • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

PiVOT: Polypill Versus Metformin in New Onset Type 2 Diabetes (clinicaltrials.gov) - P2 | N=334 | Not yet recruiting | Sponsor: George Medicines PTY Limited | Trial completion date: Jun 2024 ➔ Nov 2024 | Initiation date: Aug 2023 ➔ Jan 2024 | Trial primary completion date: Jun 2024 ➔ Nov 2024

Trial completion date • Trial initiation date • Trial primary completion date • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

PiVOT: Polypill Versus Metformin in New Onset Type 2 Diabetes (clinicaltrials.gov) - P2 | N=334 | Not yet recruiting | Sponsor: George Medicines PTY Limited

New P2 trial • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus