Polypill Versus Metformin in New Onset Type 2 Diabetes
Status:
Not yet recruiting
Trial end date:
2024-06-01
Target enrollment:
Participant gender:
Summary
The goal of this clinical trial is to learn about the effect of the GMRx4 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 GMRx4 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 GMRx4 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