Drug updated on 9/4/2024
Dosage Form | Injection (subcutaneous; 0.6 mg/0.6 mL single-dose autoinjector, 0.6 mg/0.6 mL single-dose prefilled syringe) |
Drug Class | Antihypoglycemic agents |
Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- Indicated for the treatment of severe hypoglycemia in pediatric and adult patients with diabetes aged 6 years and above.
Latest News
Summary
- Zegalogue (dasiglucagon) is indicated for the treatment of severe hypoglycemia in pediatric and adult patients with diabetes aged 6 years and above.
- This summary is based on the review of two systematic review(s)/meta-analysis(es). [1-2]
- Dasiglucagon significantly reduced recovery time of blood glucose by increasing levels by 20.0 mg/dL from baseline, showing superior effectiveness compared to placebo (PMD: -23.30%, 95% CI: 23.97 to 22.63, p < 0.00001) and oral glucose (MD: -15.00 minutes; 95% CI: -20.33 to -9.67; p < 0.00001), but no statistically significant difference compared to glucagon (MD: -0.76 minutes; 95% CI: -2.19 to 0.66; p = 0.29).
- In studies focusing on patients with Type 1 Diabetes Mellitus (T1DM), dasiglucagon demonstrated statistically significant improvement in glucose recovery time compared to glucagon in one study (PMD: 1.08%, 95% CI: 1.96 to 0.21, p = 0.02), but another study found no significant difference in time to recovery (MD: -0.76 minutes; 95% CI: -2.19 to 0.66; p = 0.29).
- The effectiveness of dasiglucagon was consistently superior to placebo and oral glucose in reducing time to recovery, with no significant safety concerns noted in the studies focused on T1DM patients, and the safety profile was comparable to glucagon.
- The safety outcomes of dasiglucagon were comparable to native glucagon, with no significant safety concerns or adverse effects explicitly noted in patients with Type 1 Diabetes Mellitus (T1DM).
- No specific safety comparisons with placebo or oral glucose were highlighted, and no significant adverse effects were reported in the studies.
- There is no population types or subgroups information available in the reviewed studies.
Product Monograph / Prescribing Information
Document Title | Year | Source |
---|---|---|
Zegalogue (dasiglucagon) Prescribing Information. | 2023 | Rechon Life Science AB Malmö, Sweden |
Systematic Reviews / Meta-Analyses
Document Title | Year | Source |
---|---|---|
Clinical efficacy and safety of dasiglucagon in severe hypoglycemia associated with patients of type 1 diabetes mellitus: a systematic review and meta-analysis. | 2023 | Expert Review of Clinical Pharmacology |
Dasiglucagon for the treatment of insulin-induced hypoglycemia in patients with type 1 diabetes mellitus: a meta-analysis. | 2023 | Balkan Medical Journal |