Immunogenicity of the novel glucagon analog dasiglucagon: Results of a dedicated immunogenicity trial in type 1 diabetes

Pieber, Thomas R.; Ajala, Olubukola; Steen, Oren; Dahl, Dominik; Hansen, Lone Eske; Tehranchi, Ramin

doi:10.1089/dia.2021.0108

Cited by 3 publications

(18 citation statements)

References 2 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…Participants were required to be receiving daily insulin and weigh at least 20 kg. 11 Inclusion and exclusion criteria as well as outcomes measured were similar to those used in the adult trials and are displayed in Table 1. The median time to plasma glucose recovery in the dasiglucagon group was the same as in the adult trials, 10 minutes, vs 30 minutes for the placebo group ( P < 0.001).…”

Section: Efficacymentioning

confidence: 99%

“…The median time to plasma glucose recovery in the dasiglucagon group was the same as in the adult trials, 10 minutes, vs 30 minutes for the placebo group ( P < 0.001). 11 The group receiving reconstituted glucagon also had a median plasma glucose recovery time of 10 minutes. 11 Percentage of participants with plasma glucose recovery is shown in Table 2.…”

Section: Efficacymentioning

confidence: 99%

“…Mean change in plasma glucose at 30 minutes was 98.2 mg/dL in children and adolescents receiving dasiglucagon, vs only 17.3 mg/dL in the placebo group. 11…”

Section: Efficacymentioning

confidence: 99%

“…Nausea and vomiting were seen to occur within 3 hours of administration for all populations, with nausea typically occurring earlier than vomiting and none of these adverse events lasting longer than 3 hours. 5,10,11…”

Section: Safetymentioning

confidence: 99%

“…No significant difference was seen in these adverse effects when dasiglucagon was compared with reconstituted glucagon. 5,10,11…”

Section: Safetymentioning

confidence: 99%

See 4 more Smart Citations

Dasiglucagon: A Novel Ready-to-Use Treatment for Severe Hypoglycemia

Goodhart

2022

Ann Pharmacother

View full text Add to dashboard Cite

Objective: To review dasiglucagon, a novel glucagon analogue approved by the Food and Drug Administration (FDA) for treatment of severe hypoglycemia in 2021. Data Sources: A literature search using the PubMed database (current to March 2022) and ClinicalTrials.gov was conducted using the search term dasiglucagon. Study Selection and Data Extraction: Relevant clinical data from English-language clinical trials were included. Data Synthesis: Dasiglucagon was studied in 3 clinical trials: 1 in patients aged 6 to 17 years and 2 in adults. In all 3 trials, dasiglucagon was found to provide clinically significant benefit in minutes to plasma glucose recovery compared with placebo (10 vs 40, P < 0.001; 10 vs 30, P < 0.001; 10 vs 35, P < 0.0001). Dasiglucagon was also comparable with reconstituted glucagon in plasma glucose recovery time measured from time of administration. The most common adverse events with dasiglucagon were nausea, vomiting, and headache; no serious safety events were observed. Relevance to Patient Care and Clinical Practice: Dasiglucagon is a novel glucagon analogue that is safe and effective for the treatment of severe hypoglycemia, and it is the first to be stable in aqueous solution. This makes dasiglucagon one of only 3 currently available glucagon treatment options that does not require reconstitution prior to administration. Conclusions: Dasiglucagon offers safe and effective treatment for severe hypoglycemia in patients aged 6 years and older. The stability of dasiglucagon in aqueous solution provides an additional option for emergency glucagon treatment that does not require reconstitution prior to administration.

show abstract

Section: Efficacymentioning

confidence: 99%

Section: Efficacymentioning

confidence: 99%

“…Mean change in plasma glucose at 30 minutes was 98.2 mg/dL in children and adolescents receiving dasiglucagon, vs only 17.3 mg/dL in the placebo group. 11…”

Section: Efficacymentioning

confidence: 99%

Section: Safetymentioning

confidence: 99%

“…No significant difference was seen in these adverse effects when dasiglucagon was compared with reconstituted glucagon. 5,10,11…”

Section: Safetymentioning

confidence: 99%

See 3 more Smart Citations

Dasiglucagon: A Novel Ready-to-Use Treatment for Severe Hypoglycemia

Goodhart

2022

Ann Pharmacother

View full text Add to dashboard Cite

show abstract

Dasiglucagon Effects on QTc in Healthy Volunteers: A Randomized, Placebo-Controlled, Dose-Escalation, Double-Blind Study

Tehranchi

Pettersson

Melgaard

et al. 2022

Current Therapeutic Research

View full text Add to dashboard Cite

Integrated safety and efficacy analysis of dasiglucagon for the treatment of severe hypoglycaemia in individuals with type 1 diabetes

Heller

Battelino

Bailey

et al. 2023

Diabetes Obesity Metabolism

Self Cite

View full text Add to dashboard Cite

Aims:To perform an integrated analysis of the safety and efficacy of dasiglucagon, a glucagon analogue available in a ready-to-use aqueous formulation, to treat severe hypoglycaemia (SH) in type 1 diabetes (T1D).Materials and Methods: An integrated analysis of dasiglucagon safety was conducted on data from two placebo-controlled trials (placebo-controlled pool) and two placebo-controlled and four non-placebo-controlled trials (broad pool) in adults with T1D. An integrated analysis of dasiglucagon efficacy was conducted of pooled data and within demographic subgroups from the two placebo-controlled and two nonplacebo-controlled trials in adults with T1D.Results: Dasiglucagon had a similar safety and tolerability profile to that of reconstituted glucagon. In the placebo-controlled datasets, no serious adverse events (AEs), AEs leading to withdrawal from the trial, or deaths were reported. The most common causally related AEs were nausea (56.5%) and vomiting (24.6%). The broad pool safety analysis showed similar results. Dasiglucagon efficacy in time to plasma glucose recovery from insulin-induced SH was similar to that of reconstituted glucagon (median 10.0 and 12.0 minutes, respectively) and superior to placebo (median 40.0 minutes; P < 0.0001). The median recovery time was consistent across all placebo-controlled trial subgroups.Conclusions: Dasiglucagon was well tolerated and effective as a rapid rescue agent for insulin-induced SH in people with T1D.

show abstract

Immunogenicity of the novel glucagon analog dasiglucagon: Results of a dedicated immunogenicity trial in type 1 diabetes

Cited by 3 publications

References 2 publications

Dasiglucagon: A Novel Ready-to-Use Treatment for Severe Hypoglycemia

Dasiglucagon: A Novel Ready-to-Use Treatment for Severe Hypoglycemia

Dasiglucagon Effects on QTc in Healthy Volunteers: A Randomized, Placebo-Controlled, Dose-Escalation, Double-Blind Study

Integrated safety and efficacy analysis of dasiglucagon for the treatment of severe hypoglycaemia in individuals with type 1 diabetes

Contact Info

Product

Resources

About