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Dasiglucagon

Generic Name
Dasiglucagon
Brand Names
Zegalogue
Drug Type
Biotech
CAS Number
1544300-84-6
Unique Ingredient Identifier
AD4J2O47FQ
Background

Dasiglucagon is a glucagon analog that acts to increase blood sugar levels. It consists of 29 amino acids similar to endogenous glucagon; however, it contains seven substituted amino acids for improved physical and chemical stability in its drug formulation. In March 2021, the FDA approved dasiglucagon to treat severe hypoglycemia in patients six years and older with diabetes. It is available as a subcutaneous injection marketed as ZEGALOGUE.

Severe hypoglycemia is an acute, life-threatening medical condition resulting from a profound drop in blood glucose levels. It is characterized by neurological impairment, with manifestations like loss of consciousness and seizure. Hypoglycemia is a common side effect of antidiabetic treatments, most notably insulin and sulfonylureas. Although it tends to be more common in type 1 diabetes mellitus, occurring in about 22% to 46% of patients annually, about 7% to 25% of patients with type 2 diabetes mellitus treated with insulin experience severe hypoglycemia a year. Even with close monitoring of blood glucose levels, it is not always possible to prevent severe hypoglycemic events in patients with diabetes, and children are particularly at risk for experiencing severe hypoglycemia. Treatments for severe hypoglycemia have mostly been limited to intravenous dextrose and different glucagon formulations. The approval of dasiglucagon marks the first glucagon analog approved for severe hypoglycemia treatment that does not require administration by a healthcare professional.

Indication

Dasiglucagon is an antihypoglycemic agent indicated for the treatment of severe hypoglycemia in pediatric and adult patients with diabetes aged 6 years and above.

Associated Conditions
Severe Hypoglycemia

Research Study in Japan to Compare Dasiglucagon With Glucagon in Treating Very Low Levels of Blood Sugar in Asian Adults With Type 1 Diabetes and Testing of Dasiglucagon for the Same Condition in Japanese Adolescents

Phase 1
Recruiting
Conditions
Diabetes Mellitus, Type 1
Interventions
First Posted Date
2024-09-19
Last Posted Date
2024-12-16
Lead Sponsor
Novo Nordisk A/S
Target Recruit Count
38
Registration Number
NCT06588504
Locations
🇯🇵

Hakata Clinic, Fukuoka, Japan

A Stable Glucagon Analog Administered by a Bihormonal Closed Loop System

Phase 2
Withdrawn
Conditions
Diabetes Mellitus, Type 1
Interventions
First Posted Date
2022-07-12
Last Posted Date
2024-01-03
Lead Sponsor
Inreda Diabetic B.V.
Registration Number
NCT05454709
Locations
🇳🇱

ZGT hospital, Almelo, Overijssel, Netherlands

A Study to Inv. Safety, Efficacy & PD of Dasiglucagon as Hypoglycemia Rescue Therapy in Children <6 Years With T1D

Phase 3
Recruiting
Conditions
Type 1 Diabetes
Hypoglycemia
Interventions
First Posted Date
2022-05-18
Last Posted Date
2024-08-29
Lead Sponsor
Zealand Pharma
Target Recruit Count
8
Registration Number
NCT05378672
Locations
🇺🇸

Children's Healthcare of Atlanta, Atlanta, Georgia, United States

🇺🇸

Indiana University School of Medicine, Indianapolis, Indiana, United States

🇺🇸

Cook Childrens Health Care System, Fort Worth, Texas, United States

and more 1 locations

Treatment of Post-bariatric Hypoglycaemia

Phase 2
Completed
Conditions
Postprandial Hypoglycemia
Hyperinsulinemic Hypoglycemia
Interventions
Device: HyoPen
Drug: Placebo
First Posted Date
2021-04-08
Last Posted Date
2023-02-02
Lead Sponsor
Filip Krag Knop
Target Recruit Count
24
Registration Number
NCT04836273
Locations
🇩🇰

Center for Clinical Metabolic Research, Herlev-Gentofte Hospital, Hellerup, Denmark

Efficacy and Safety of Dasiglucagon for Treatment of Post-bariatric Hypoglycemia in Roux-en-Y Gastric Bypass (RYGB) Operated Adults

Phase 2
Withdrawn
Conditions
Hypoglycemia
Glucose Metabolism Disorders
Interventions
Drug: Placebo
First Posted Date
2021-04-01
Last Posted Date
2023-02-21
Lead Sponsor
Zealand Pharma
Registration Number
NCT04824872

Pen-Administered Low-Dose Dasiglucagon for Prevention and Treatment of Hypoglycemia in People With Type 1 Diabetes

Phase 2
Completed
Conditions
Type 1 Diabetes
Hypoglycemia
Interventions
First Posted Date
2021-02-21
Last Posted Date
2022-09-07
Lead Sponsor
Steno Diabetes Center Copenhagen
Target Recruit Count
24
Registration Number
NCT04764968
Locations
🇩🇰

Steno Diabetes Center Copenhagen, Gentofte, Denmark

Low-dose Dasiglucagon for Prevention of Insulin-Induced Hypoglycemia in People With Type 1 Diabetes

Phase 2
Completed
Conditions
Type 1 Diabetes
Hypoglycemia
Interventions
Other: Carbohydrate (dextrose tablets)
First Posted Date
2020-06-29
Last Posted Date
2021-02-09
Lead Sponsor
Steno Diabetes Center Copenhagen
Target Recruit Count
20
Registration Number
NCT04449692
Locations
🇩🇰

Steno Diabetes Center Copenhagen, Gentofte, Denmark

Trial Evaluating Efficacy and Safety of Dasiglucagon in Children With Congenital Hyperinsulinism

Phase 2
Completed
Conditions
Congenital Hyperinsulinism
Interventions
Drug: Placebo
First Posted Date
2019-11-21
Last Posted Date
2025-03-14
Lead Sponsor
Zealand Pharma
Target Recruit Count
12
Registration Number
NCT04172441
Locations
🇩🇪

University Children's Hospital, Düsseldorf, Germany

🇺🇸

Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, United States

🇺🇸

Cook Children's Medical Center, Fort Worth, Texas, United States

and more 3 locations

Dasiglucagon in the Treatment of Postprandial Hypoglycaemia After Roux-en-Y Gastric Bypass

Phase 2
Completed
Conditions
Postprandial Hypoglycemia
Hyperinsulinemic Hypoglycemia
Interventions
Other: Placebo (saline)
First Posted Date
2019-06-13
Last Posted Date
2020-03-31
Lead Sponsor
University Hospital, Gentofte, Copenhagen
Target Recruit Count
10
Registration Number
NCT03984370
Locations
🇩🇰

Center for Clinical Metabolic Research, Herlev-Gentofte Hospital, Hellerup, Denmark

Extension Trial Evaluating the Long-term Safety and Efficacy of Dasiglucagon in Children With Congenital Hyperinsulinism

Phase 3
Active, not recruiting
Conditions
Congenital Hyperinsulinism
Interventions
First Posted Date
2019-05-07
Last Posted Date
2024-04-08
Lead Sponsor
Zealand Pharma
Target Recruit Count
44
Registration Number
NCT03941236
Locations
🇩🇪

University Hospital Düsseldorf, Department of Pediatrics, Düsseldorf, Germany

🇺🇸

Cook Children's Medical Center, Fort Worth, Texas, United States

🇮🇱

Hadassah Medical Center, Jerusalem, Israel

and more 7 locations
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