Nutritional, Metabolic, Endocrine
Conditions
Interventions
Metformin Slow Release Arm
Glimepiride Arm
Sitagliptin Arm
Sponsors
National Institute for Health and Care Research
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Men or women aged =18 years with a diagnosis of type 2 diabetes within the previous six months and not receiving glucose-lowering medication or, if metformin-treated, have received treatment for <7 days at the recruitment visit, and a BMI <25 kg/m2. 2. Glycated haemoglobin (HbA1c) =7.5% to =10.5% (58-91 mmol/mol) 3. Capacity to provide informed consent.
Exclusion criteria
Exclusion criteria: 1. Patients with secondary diabetes (diabetes either due to specific medications, endocrinopathies like Cushing’s syndrome, hyperthyroidism, or pancreatic disorders like chronic pancreatitis, pancreatic cancer, and pancreatectomy). 2. History of intolerance or allergy to any of the three study drugs. 3. Estimated glomerular filtration rate (e-GFR) of 3 times the upper limit of normal (>60 IU/L for females and >90 U/L for males) at baseline. 5. Current pregnancy or planned pregnancy in the next 12 months 6. Current long-term use of oral or injected glucocorticoids. 7. Participation in another interventional clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean change in glycated haemoglobin (HbA1c) from baseline to 12 months. | — |
Secondary
| Measure | Time frame |
|---|---|
| Continuous Glucose Monitoring (CGM) Sub-Study Outcomes. Assessed only in a subgroup of 40 participants per arm. (CGM worn for 2 weeks beginning at this visit) Metrics include mean glucose, TIR (4–10 mmol/L), time below range, number/duration of hypoglycaemic episodes.;Mean change in fasting blood glucose (FBG) from baseline to 12 months.;Need for additional glucose-lowering medication — measured as the proportion of participants who meet the rescue criteria and require add-on therapy before 12 months. Determined by HbA1c results at follow-up visits.;Proportion achieving HbA1c <53 mmol/mol (7%) without rescue therapy;Mean weight change (baseline to 12 months);Discontinuation of therapy before 12 months;Hospitalisation due to hypoglycaemia. Assessed through participant reports and review;Quality of Life and Treatment Satisfaction. Instruments: WHOQOL-BREF and DTSQ | — |
Countries
Cameroon, Uganda
Contacts
Public ContactIvan;Sylvain Namakoola Meya;Zemsi Tenkeu
Clinical Trialist;Clinical Trial Manager
Outcome results
None listed