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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Change in glycosylated haemoglobin (HbA1c)
Change in glycosylated haemoglobin (HbA1c) from baseline to 16 weeks
Time frame: 16 weeks
Change in fasting plasma glucose
Change in fasting plasma glucose from baseline to 16 weeks
Time frame: 16 weeks
Change in cholesterol
Change in fasting total cholesterol, LDL-cholesterol and HDL-cholesterol from baseline to 16 weeks
Time frame: 16 weeks
Change in triglycerides
Change in fasting triglycerides from baseline to 16 weeks
Time frame: 16 weeks
Change in blood pressure
Change in systolic and diastolic blood pressure from baseline to 16 weeks
Time frame: 16 weeks
Change in weight in kilograms
Change in weight from baseline to 16 weeks
Time frame: 16 weeks
Medication adherence
Medication adherence throughout the trial. Adherence will be assessed by self-report surveys entered directly into the ePRO platform (eCRF).
Time frame: 16 weeks
Medication tolerability
Medication tolerability throughout the trial (based on permanent drug cessation due to side effects and incidence of reported side effects). Tolerability will be assessed by recording of adverse effects into self-report surveys, and adverse events identified by the Investigator during study contacts, entered directly into the ePRO platform (eCRF).
Time frame: 16 weeks
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