*The efficacy of ZEGALOGUE was demonstrated in 3 randomized, double-blind, placebo-controlled, multicenter clinical trials (Trials A, B, and C) in patients with type 1 diabetes. Trial A (N=170) and Trial B (N=45) were conducted in adult patients. Trial C (N=42) was conducted in patients aged 6-17 years. In all 3 trials, patients were randomized to receive subcutaneous doses of either ZEGALOGUE 0.6 mg, placebo, or (in Trials A and C) glucagon for injection 1.0 mg following controlled insulin-induced hypoglycemia. The primary endpoint for all 3 trials was time to plasma glucose recovery (treatment success), defined as an increase in blood glucose of ≥20 mg/dL from time of administration of study drug, without additional intervention within 45 minutes. Secondary endpoints included assessments of plasma glucose recovery at multiple time points following ZEGALOGUE injection. The primary hypothesis test was superiority of ZEGALOGUE versus placebo.1
Rapid, reliable recovery when every minute counts1
In clinical trials, adult and pediatric patients with type 1 diabetes demonstrated recovery of plasma glucose levels with a single dose of ZEGALOGUE versus placebo1
Three randomized, double-blind, placebo-controlled, multicenter clinical trials in patients with type 1 diabetes: Trial A (N=170) and Trial B (N=45) were conducted in adults; Trial C (N=42) was conducted in patients aged 6-17. Primary endpoint: time to plasma glucose recovery (treatment success), defined as an increase in blood glucose of ≥20 mg/dL from time of administration of study drug, without additional intervention within 45 minutes. Please see full study design below.1*
Available in an autoinjector or a prefilled syringe1
ZEGALOGUE® is prefilled with no reconstitution required.1
First and only glucagon analog for the treatment of severe hypoglycemia1
ZEGALOGUE® offers product stability in an aqueous solution.1,2
Indication and Usage for ZEGALOGUE® (dasiglucagon) injection 0.6 mg/0.6 mL
ZEGALOGUE® (dasiglucagon) injection is indicated for the treatment of severe hypoglycemia in pediatric and adult patients with diabetes aged 6 years and above.
Important Safety Information
Contraindications
ZEGALOGUE® is contraindicated in patients with pheochromocytoma because of the risk of substantial increase in blood pressure and in patients with insulinoma because of the risk of hypoglycemia.
Warnings and Precautions
- ZEGALOGUE® is contraindicated in patients with pheochromocytoma because glucagon products may stimulate the release of catecholamines from the tumor. If the patient develops a substantial increase in blood pressure and a previously undiagnosed pheochromocytoma is suspected, 5 to 10 mg of phentolamine mesylate, administered intravenously, has been shown to be effective in lowering blood pressure.
- In patients with insulinoma, administration of glucagon products may produce an initial increase in blood glucose; however, ZEGALOGUE® administration may directly or indirectly (through an initial rise in blood glucose) stimulate exaggerated insulin release from an insulinoma and cause hypoglycemia. ZEGALOGUE® is contraindicated in patients with insulinoma. If a patient develops symptoms of hypoglycemia after a dose of ZEGALOGUE®, give glucose orally or intravenously.
- Allergic reactions have been reported with glucagon products; these include generalized rash, and in some cases anaphylactic shock with breathing difficulties and hypotension. Advise patients to seek immediate medical attention if they experience any symptoms of serious hypersensitivity reactions.
- ZEGALOGUE® is effective in treating hypoglycemia only if sufficient hepatic glycogen is present. Patients in states of starvation, with adrenal insufficiency or chronic hypoglycemia may not have adequate levels of hepatic glycogen for ZEGALOGUE® administration to be effective. Patients with these conditions should be treated with glucose.
Adverse Reactions
- The most common adverse reactions (≥2%) associated with ZEGALOGUE® in adults were nausea, vomiting, headache, diarrhea and injection site pain; in pediatrics: nausea, vomiting, headache and injection site pain.
Drug Interactions
- Patients taking beta-blockers may have a transient increase in pulse and blood pressure when given ZEGALOGUE®. In patients taking indomethacin, ZEGALOGUE® may lose its ability to raise blood glucose or may produce hypoglycemia. ZEGALOGUE® may increase the anticoagulant effect of warfarin.
Please see Zegalogue® Full Prescribing Information.
References: 1. Zegalogue (dasiglucagon). Prescribing information. Zealand Pharma A/S; April 2021. 2. Hövelmann U, Bysted BV, Mouritzen U, et al. Pharmacokinetic and pharmacodynamic characteristics of dasiglucagon, a novel soluble and stable glucagon analog. Diabetes Care. 2018;41(3):531-537. doi:10.2337/dc17-1402