2. Patients and methods
STM, T2D, diabetes
DIABETES
This prospective, interventional randomized study, approved by Ethics Board of Zvezdara University Medical Center (Decision dated 29.01.2019), included 80 newly diagnosed T2D patients with initial HbA1c above 9.0%. They were recruited from the outpatient diabetes clinic of the Zvezdara University Medical Center in Belgrade, during the period of February 2019 to March 2020. Upon signing the informed consent form, they had 3 daily visits at the Center. On the first day, an STM was performed. Thereafter, patients were randomly assigned to receive either: metformin 2000 mg daily (or maximal tolerable dose) and glimepiride, or metformin with a 1-month course of daily basal or twice daily biphasic human insulin. Both patients and investigators were blinded for individual baseline C-peptide values. Randomization of patients was done on consecutive basis. The subjects were educated for insulin application by pens, proper diet, and physical activity. They were provided with meters for blood glucose (BG) self-monitoring, before each main meal, at bedtime and upon awakening. On the second and third days, after discussion of monitored BG levels, doses of insulin and glimepiride were adjusted. Subjects on insulin treatment were advised to continue monitoring BG levels and to report values below 4 mmol/L or above 10 mmol/L, for dose adjustment.The exclusion criteria for the investigated patients encompassed: pregnancy or lactation, decreased renal function below eGFR of 60 mL/min/1.73 mAll patients were tested by a standardized test meal (STM) before treatment and at 3- and 12-month visits. STM consisted of a white-flour bread-roll (24 g of carbohydrates) and 200 mL 2.8% milk-fat yoghurt (12 g of carbohydrates). Upon an overnight fast, serum glucose and C-Pep were analyzed before and 2 hours after STM, which was consumed over 5 min [