Trial reportPediatric diabetes2021
Dasiglucagon, a next-generation ready-to-use glucagon analog, for treatment of severe hypoglycemia in children and adolescents with type 1 diabetes: Results of a phase 3, randomized controlled trial.
Trial report in Pediatric diabetes, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 18 papers, 1 of them a synthesis that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
18 citing papers in PubMed, 1 synthesis or guideline pooled it, 35 citations in OpenAlex.
- Dasiglucagon for the Treatment of Insulin-induced Hypoglycemia in Patients with Type 1 Diabetes Mellitus: A Meta-analysisBalkan medical journal · 2023Pooled it
- Dasiglucagon, a next-generation ready-to-use glucagon analog, for treatment of severe hypoglycemia in children and adolescents with type 1 diabetes: Results of a phase 3, randomized controlled trial.Pediatric diabetes · 2021Trial
- The 'Designer' Artificial Pancreas: How Does Current Technology Mimic Pancreatic Physiology?Cureus · 2025Review
- Response to Letter to the Editor From He et al: "Dasiglucagon in Children With Congenital Hyperinsulinism up to 1 Year of Age: Results From a Randomized Clinical Trial".The Journal of clinical endocrinology and metabolism · 2025Article
- Uniform trehalose nanogels for glucagon stabilization.RSC applied polymers · 2024Article
- Out of Sight, Out of Mind: A Call to Action for the Treatment of Hypoglycemia.Clinical diabetes : a publication of the American Diabetes Association · 2024Article
- Systematic Literature Review and Indirect Treatment Comparison of Three Ready-to-Use Glucagon Treatments for Severe Hypoglycemia.Diabetes therapy : research, treatment and education of diabetes and related disorders · 2023Review
- Managing Severe Hypoglycaemia in Patients with Diabetes: Current Challenges and Emerging Therapies.Diabetes, metabolic syndrome and obesity : targets and therapy · 2023Review
- ISPAD Clinical Practice Consensus Guidelines 2022: Assessment and management of hypoglycemia in children and adolescents with diabetes.Pediatric diabetes · 2022Article
- The past, present, and future physiology and pharmacology of glucagon.Cell metabolism · 2022Review
- Closed-loop insulin delivery: update on the state of the field and emerging technologies.Expert review of medical devices · 2022Review
- Closed-Loop Artificial Pancreas Therapy for Type 1 Diabetes.Current cardiology reports · 2022Review
- A year in pharmacology: new drugs approved by the US Food and Drug Administration in 2021.Naunyn-Schmiedeberg's archives of pharmacology · 2022Review
- Review
- Dasiglucagon demonstrates reduced costs in the treatment of severe hypoglycemia in a budget impact model.Journal of managed care & specialty pharmacy · 2022Article
- Investigating Polyphenol Nanoformulations for Therapeutic Targets against Diabetes Mellitus.Evidence-based complementary and alternative medicine : eCAM · 2022Review
- Diabetes: how to manage patients experiencing hypoglycaemia.Drugs in context · 2022Review
- Dasiglucagon: an effective medicine for severe hypoglycemia.European journal of clinical pharmacology · 2021Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
10 authors at 5 institutions in 4 countries.
Funding
Abstract
backgroundDasiglucagon, a next-generation, ready-to-use aqueous glucagon analog formulation, has been developed to treat severe hypoglycemia in individuals with diabetes.
objectiveThe aim of this trial was to evaluate the safety and efficacy of dasiglucagon in pediatric individuals with type 1 diabetes (T1DM). Participants were children and adolescents (6-17 years) with T1DM.
methodsIn this randomized double-blind trial, 42 participants were randomly allocated (2:1:1) to a single subcutaneous (SC) injection of dasiglucagon (0.6 mg), placebo, or reconstituted glucagon (GlucaGen; dosed per label) during insulin-induced hypoglycemia. The primary endpoint was time to plasma glucose (PG) recovery (first PG increase ≥20 mg/dL after treatment initiation without rescue intravenous glucose). The primary comparison was dasiglucagon vs. placebo; glucagon acted as a reference.
resultsThe median time (95% confidence interval) to PG recovery following SC injection was 10 min (8-12) for dasiglucagon vs. 30 min (20 to -) for placebo (P < .001); the median time for glucagon was 10 min (8-12), which did not include the time taken to reconstitute the lyophilized powder. PG recovery was achieved in all participants in the dasiglucagon and glucagon groups within 20 min of dosing compared to 2 out of 11 patients (18%) with placebo. The most frequent adverse events were nausea and vomiting, as expected with glucagon treatment.
conclusionsConsistent with adult phase 3 trials, dasiglucagon rapidly and effectively restored PG levels following insulin-induced hypoglycemia in children and adolescents with T1DM, with an overall safety profile similar to glucagon.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.