Outcomes
hypercalcemia, Hypoglycaemia, Hypercalcemia, hypoglycaemia
RENAL, ADVERSE EVENTS, HYPERCALCEMIA, HYPERCALCEMIA, SECONDARY, HYPOGLYCAEMIA, HYPOGLYCAEMIA
The primary endpoint was β-cell function measured via the absolute change from baseline to month 24 in fasting C-peptide levels. Prespecified secondary endpoints were the change from baseline to month 6, 12, 18 in fasting C-peptide levels, the change from baseline to month 24 in the area under the concentration-time curve for MMTT-stimulated C-peptide levels over 2 h (2-h C-peptide AUC) and the proportion of participants who had a ΔC-peptide response at month 24 (defined as either having an increase in ΔC-peptide levels versus baseline or not decreasing >40%). Other prespecified endpoints were HbASafety measures included adverse events, hypoglycaemia and hypercalcemia reported by patients or noted by the investigator. Vital signs, physical examination and clinical laboratory tests were assessed at each clinic visits. Renal ultrasound was conducted at baseline and month 1, 3, 6, 12, 18, 24. Hypoglycaemia was defined as a confirmed blood glucose <3.9 mmol/L irrespective of clinical symptoms or have symptoms consistent with hypoglycaemia and prompt recovery after oral carbohydrate, intravenous administration of glucose or glucagon with or without glucose measurement. Hypercalcemia was defined as two consecutive measurements of an uncorrected serum calcium level higher than the upper limit of the normal range for the clinical laboratory at each trial site.