Polypill Versus Metformin in New Onset Type 2 Diabetes

Sponsor
George Medicines PTY Limited
Study ID
NCT05833958
Phase
PHASE2
Status
Withdrawn

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

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

Key Dates

Start date
Sep 30, 2024
Status verified
Aug 2024
Primary completion
Sep 30, 2025
Completion
Sep 30, 2025

Study Design

Enrollment
0 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: GMRx-4 IR polypill in the morning and metformin Immediate Release (IR)175mg at night
    One GMRx-4 IR polypill capsule (metformin IR 175mg + dapagliflozin 2.5mg + sitagliptin 17.5mg) in the morning and one metformin IR 175mg capsule at night. Capsules are taken with, or just after, food, and swallowed whole with water. Capsules will be taken at, or as close as possible to, the same time of morning (GMRx-4 IR) and the same time of evening (metformin 175mg) each day for 16 weeks.
  • Active Comparator: Metformin IR 500mg in the morning and at night
    One metformin IR 500mg capsule in the morning and at night. Capsules are taken with, or just after, food, and swallowed whole with water. Capsules will be taken at, or as close as possible to, the same time of morning and the same time of evening each day for 16 weeks.

Primary Outcome Measure

Change in glycosylated haemoglobin (HbA1c) [ Time Frame: 16 weeks ]

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