NCT05833958

Polypill Versus Metformin in New Onset Type 2 Diabetes

Polypill Versus Metformin in New Onset Type 2 Diabetes: a Low Dose Triple Therapy Polypill Versus Metformin for Glycaemic Control in Newly Diagnosed Type 2 Diabetes

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: George Medicines PTY Limited · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to learn about the effect of the GMRx-4 IR polypill compared to metformin monotherapy on glycosylated haemoglobin (HbA1c) when used as first line therapy in adults with recently diagnosed Type 2 Diabetes. The main question it aims to answer is: That the GMRx-4 IR polypill, compared to metformin, will improve glucose lowering in those with recently diagnosed Type 2 Diabetes. Participants will be required to take either: One capsule of the GMRx-4 IR polypill each morning and one 175mg metformin capsule each evening for 16 weeks. Or One metformin 500mg capsule each morning and each evening for 16 weeks. Participants will not know which of the two treatment regimens they will be taking. Participants will be provided with the necessary guidance information, equipment, online support and telephone/video calls from trained members of the study team to complete the study procedures at home although some support from a Healthcare Professional either at home or at a clinic will be offered if needed. The study will involve participants completing the following information and procedures and reporting electronically: Medical History (conditions and treatments) Gender Age Ethnicity/Race Weight Height Blood Pressure Heart Rate Blood collection for measurement of HbA1c (average blood glucose levels over a period of time), fasting glucose, creatinine and estimated glomerular filtration rate (eGFR) for kidney function, cholesterol, pregnancy (if not measured in a urine sample) Urine pregnancy test in women of child-bearing potential Concomitant Medications taken Safety outcomes Tolerability to the study treatment Adherence with taking the study treatment The number of any unused study treatment capsules

Conditions

• Type 2 Diabetes

Interventions

Type	Name	Description
DRUG	GMRx-4 IR polypill - sitagliptin, dapagliflozin, metformin	As described previously
DRUG	Metformin	As described previously - Experimental Arm, 175mg at night
DRUG	Metformin	As described previously - Active Comparator Arm, 500mg in the morning and 500mg at night

Timeline

• Start date: 2024-09-01
• Primary completion: 2025-09-01
• Completion: 2025-09-01
• First posted: 2023-04-27
• Last updated: 2024-09-19