Journal
DIABETES CARE
Volume 41, Issue 3, Pages 531-537Publisher
AMER DIABETES ASSOC
DOI: 10.2337/dc17-1402
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Funding
- Zealand Pharma A/S, Denmark
- Adocia
- Biocon
- Dance Pharmaceuticals
- Eli Lilly
- Johnson Johnson
- Julphar
- Medimmune
- Mylan
- Nordic Bioscience
- Novo Nordisk
- Poxel
- Roche Diagnostics
- Saniona
- Sanofi
- Senseonics
- SkyePharma
- Zealand Pharma
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OBJECTIVE Treatment of severe hypoglycemia outside of the hospital setting is limited to glucagon formulations requiring reconstitution before use, which may lead to erroneous or delayed glucagon administration. We compared the pharmacokinetic (PK) and pharmacodynamic (PD) characteristics and safety and tolerability of different doses of dasiglucagon, a novel soluble glucagon analog, with approved pediatric and full doses of GlucaGen in insulin-induced hypoglycemia in patients with type 1 diabetes. RESEARCH DESIGN AND METHODS In this single-center, randomized, double-blind trial, 58 patients with type 1 diabetes received single subcutaneous injections of 0.1, 0.3, 0.6, or 1.0 mg dasiglucagon or 0.5 or 1.0 mg GlucaGen in a state of hypoglycemia (blood glucose target 55 mg/dL) induced by an intravenous insulin infusion. RESULTS Dasiglucagon demonstrated a dose-dependent and rapid increase in plasma concentrations, reaching a maximum at similar to 35 min with a half-life of similar to 0.5 h. Dasiglucagon rapidly increased plasma glucose (PG) by >= 20 mg/dL (9-14 min) to PG >= 70 mg/dL (within 6-10 min), similar to GlucaGen, but with a longer-lasting and greater effect on PG. All patients on both treatments reached these end points within 30 min (pre-defined success criteria). Both treatments were well tolerated. Nausea was the most frequent adverse event, occurring at a similar rate (44-56%). CONCLUSIONS Dasiglucagon was well tolerated and showed an early PD response similar to that of GlucaGen at corresponding doses, suggesting comparable clinical effects of the two glucagon formulations. Dasiglucagon has the potential to become an effective and reliable rescue treatment for severe hypoglycemia in a ready-to-use pen.
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