257-OR: Pen-Administered Low-Dose Dasiglucagon vs. Usual Care for Prevention and Treatment of Nonsevere Hypoglycemia in People with Type 1 Diabetes during Free-Living Conditions: A Phase 2, Randomized, Two-Period, Crossover Outpatient Study

Abstract

Objective: To evaluate the efficacy, safety and feasibility of pen-administered low-dose dasiglucagon for prevention and treatment of non-severe hypoglycemia in people with type 1 diabetes during free-living conditions. Methods: Twenty-four adults with insulin pump-treated type 1 diabetes completed a phase 2, randomized, open-label, 2-period cross-over study with 2-week periods. During the usual care (UC) and dasiglucagon (DASI) period, participants managed impending and manifest episodes of hypoglycemia with regular carbohydrate consumption or pen-administered low-dose (80 µg) s.c. dasiglucagon, respectively. Glycemic control was evaluated using continuous glucose monitoring (Dexcom G6) and event-registration of prevention and treatment episodes. Patient-reported outcomes (PRO) were collected following study completion. Results: Participants administered dasiglucagon (IQR: 7-15) times during the 2-week period. Compared with UC, the mean difference (±SEM) in time in range (70-180 mg/dL) was 2.4%-point (±1.5%) (UC: 61.5%, DASI: 63.9%, p=0.129) , difference in time below range (<70 mg/dL) was 0.5%-point (±0.4%) (UC: 3.1%, DASI: 2.6%, p=0.170) , while total daily carbohydrate intake was significantly reduced (UC: 192 g, DASI: 172 g, p=0.007) . Dasiglucagon use was safe and well tolerated with nausea being the most frequent adverse effect (no. of participants: UC: 4, DASI: 8, p=0.206) . PRO demonstrated that 96% (p<0.001) of participants were likely to include dasiglucagon as part of their future routine management of hypoglycemia. Conclusion: Utilization of pen-administered, low-dose dasiglucagon for prevention and treatment of non-severe hypoglycemia during free-living conditions was safe and efficacious while significantly reducing the total daily carbohydrate intake and yielding high treatment satisfaction. Disclosure C.Laugesen: None. A.G.Ranjan: None. S.Schmidt: None. K.Nørgaard: Advisory Panel; Medtronic, Novo Nordisk A/S, Consultant; Novo Nordisk A/S, Research Support; Dexcom, Inc., Medtronic, Novo Nordisk A/S, Zealand Pharma A/S, Speaker's Bureau; Medtronic, Stock/Shareholder; Novo Nordisk A/S. Funding SteDiabetes Center Copenhagen is the sponsor of this investigator-initiated trial. Zealand Pharma provided financial support to the conduct of the study and supplied the study medication.