Low-Dose Dasiglucagon Versus Oral Glucose for Prevention of Insulin-Induced Hypoglycemia in People With Type 1 Diabetes: A Phase 2, Randomized, Three-Arm Crossover Study
Research Design and Methods: Twenty adults with type 1 diabetes using either multiple daily injection or insulin pump therapy completed a phase 2, randomized, 3-arm cross-over study. On each study visit, an individualized subcutaneous insulin bolus was administered aiming for a plasma glucose concentration (PG) of 3.0 mmol/L (54 mg/dL). When a PG of 4.5 mmol/L (81 mg/dL) was reached, either 15 g oral glucose from dextrose tablets (CHO), 80 µg dasiglucagon (D80) or 120 µg dasiglucagon (D120) was administered. PG was measured frequently for the following 180 minutes.
Results: Hypoglycemia (<3.9 mmol/L (70 mg/dL)) occurred in 10 participants after CHO, in 5 after D80 and in 4 after D120 (CHO vs D80, p=0.096; CHO vs D120, p=0.034). Time spent in hypoglycemia (<3.9 mmol/L (70 mg/dL)) was 14%, 7% and 6% for CHO, D80, and D120, respectively (p=0.273). The median time (95%CI) from intervention to first increase in PG of 1.1 mmol/L (20 mg/dL) was 30 (25-50), 15 (15-20) and 15 (15-20) minutes for CHO, D80 and D120 (CHO vs D80, p=0.006; CHO vs D120, p=0.003). Episodes of nausea were numerically, but not significantly, higher after dasiglucagon administration. No significant differences in visual analog scale-assessed adverse effects were observed between interventions.
Conclusions: Low-dose dasiglucagon safely and effectively prevented insulin-induced hypoglycemia with a faster glucose-elevating profile than oral glucose.