Clinical response
hypoglycemia
HYPOGLYCEMIA, PROGRESSION, TOLERANCE, EVENTS, EVENTS
In the ITT set, clinical response was assessed using the Mixed Meal Tolerance Test (MMTT) and total daily consumption of insulin (both slow- and fast-acting) (Fig. Progression of clinical response measured by AUC C-peptide from MMTT (During the study period, the levels of autoantibodies against GAD65 and ZnT8 decreased in IMCY-0098 dose C arm, and the level of autoantibodies against IA-2 decreased in IMCY-0098 dose A arm; however, the differences between treatment arms and placebo were not statistically significant, with the exception of ZnT8 at Week 24 (Additional file The estimated mean change from baseline to Week 24 in fasting C-peptide were − 0.012 for placebo and − 0.108, − 0.041, and − 0.040 for the IMCY-0098 dose A, B, and C groups, respectively. When comparing each IMCY-0098 dose group against placebo, none of the three doses gave a significant change in fasting C-peptide at the 5% significance level. The estimated mean change from baseline to Week 24 in HbA1c was − 0.528 for placebo and − 0.049, − 0.254, and 0.104 for the IMCY-0098 dose A, B, and C groups, respectively.Although no formal analysis was performed for the patient-reported glycemia data, no significant differences were observed for episodes of hypoglycemia (Fig. Mean total number of events of low glucose. Mean total number of low glucose events over the past 14 days. Data are shown for the intent-to-treat population. Error bars show standard deviation. Dose A: 50 μg at Week 0 followed by 3 × 25 μg; dose B: 150 μg at Week 0 followed by 3 × 75 μg; dose C: 450 μg at Week 0 followed by 3 × 225 μg. Events of low glucose were defined as being within the hypoglycaemic range (< 3.9 mmol/L or < 70 mg/dl or < 0.7 g/L)