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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

A Trial to Compare the Efficacy and Safety of 2 Different Batches of Subcutaneous Dasiglucagon in Patients With T1DM

Phase 3
Completed
Conditions
Diabetes Mellitus, Type 1
Hypoglycemia
Interventions
First Posted Date
2019-03-29
Last Posted Date
2023-02-21
Lead Sponsor
Zealand Pharma
Target Recruit Count
92
Registration Number
NCT03895697
Locations
🇨🇦

LMC Diabetes & Manna Research, Toronto, Ontario, Canada

The Bihormonal iLet Bionic Pancreas Feasibility Study

Phase 2
Completed
Conditions
Type 1 Diabetes Mellitus
Interventions
Device: Bihormonal iLet Bionic Pancreas
Device: Insulin-only Bionic Pancreas
First Posted Date
2019-02-15
Last Posted Date
2019-12-16
Lead Sponsor
Massachusetts General Hospital
Target Recruit Count
12
Registration Number
NCT03840278
Locations
🇺🇸

Massachusetts General Hospital, Boston, Massachusetts, United States

A Two-Period Open-label Trial Evaluating Efficacy and Safety of Dasiglucagon in Children With Congenital Hyperinsulinism

Phase 3
Completed
Conditions
Congenital Hyperinsulinism
Interventions
Other: Standard of Care
First Posted Date
2018-12-17
Last Posted Date
2023-12-13
Lead Sponsor
Zealand Pharma
Target Recruit Count
32
Registration Number
NCT03777176
Locations
🇮🇱

Hadassah Medical Center, Jerusalem, Israel

🇬🇧

Alder Hey Children'sHospital NHS Foundation Trust, Liverpool, United Kingdom

🇺🇸

Children's Hospital of Colorado, Aurora, Colorado, United States

and more 7 locations

Evaluation of the Safety, Tolerability and Bioavailability of Dasiglucagon Following Subcutaneous (SC) Compared to IV Administration

Phase 1
Completed
Conditions
Hypoglycemia
Interventions
Drug: Placebo
First Posted Date
2018-11-08
Last Posted Date
2021-03-23
Lead Sponsor
Zealand Pharma
Target Recruit Count
60
Registration Number
NCT03735225
Locations
🇩🇪

CRS Clinical Research Services Mannheim GmbH, Mannheim, Germany

Trial to Confirm the Clinical Efficacy and Safety of Dasiglucagon in the Treatment of Hypoglycemia in Subjects With T1DM

Phase 3
Completed
Conditions
Hypoglycemia
Diabetes Mellitus, Type 1
Interventions
Drug: Placebo
First Posted Date
2018-09-28
Last Posted Date
2021-05-19
Lead Sponsor
Zealand Pharma
Target Recruit Count
45
Registration Number
NCT03688711
Locations
🇺🇸

Rainier Clinical Research, Inc., Renton, Washington, United States

🇺🇸

AMCR Institute, Escondido, California, United States

🇺🇸

ProSciento, Inc., Chula Vista, California, United States

Trial to Confirm the Efficacy and Safety of Dasiglucagon in the Treatment of Hypoglycemia in T1DM Children

Phase 3
Completed
Conditions
Hypoglycemia
Interventions
First Posted Date
2018-09-12
Last Posted Date
2021-06-30
Lead Sponsor
Zealand Pharma
Target Recruit Count
42
Registration Number
NCT03667053
Locations
🇺🇸

AMCR Institute, Inc, Escondido, California, United States

🇺🇸

Indiana University, Department of Pediatrics, Indianapolis, Indiana, United States

🇩🇪

Auf der Bult - Diabetes Center for Children, Hannover, Germany

and more 2 locations

A Trial to Confirm the Efficacy and Safety of Dasiglucagon in the Treatment of Hypoglycemia in Type 1 Diabetes Subjects

Phase 3
Completed
Conditions
Hypoglycemia
Diabetes Mellitus, Type 1
Interventions
First Posted Date
2017-12-20
Last Posted Date
2021-06-10
Lead Sponsor
Zealand Pharma
Target Recruit Count
170
Registration Number
NCT03378635
Locations
🇦🇹

Clinical Research Center, Medizinische Universität Graz, Graz, Austria

🇩🇪

Profil, Neuss, Germany

🇺🇸

ProSciento, Chula Vista, California, United States

and more 1 locations

A Trial to Evaluate the Immunogenicity of Dasiglucagon and GlucaGen in Patients With Type 1 Diabetes Mellitus

Phase 3
Completed
Conditions
Hypoglycemia
Diabetes Mellitus, Type 1
Interventions
First Posted Date
2017-07-13
Last Posted Date
2021-05-04
Lead Sponsor
Zealand Pharma
Target Recruit Count
112
Registration Number
NCT03216226
Locations
🇨🇦

LMC Calgary, Calgary, Canada

🇦🇹

CRC - Clinical Research Center, Medizinische Universität Graz, Graz, Austria

🇩🇪

Diabeteszentrum Hamburg West, Gemeinschaftspraxis für Innere Medizin, Hamburg, Germany

and more 4 locations

Single Doses of ZP4207 Adm. sc to Hypoglycemic TD1 pt. to Describe the PK and PD of ZP4207 as Comp. to Marketed Glucagon

Phase 2
Completed
Conditions
Hypoglycemia
Interventions
First Posted Date
2016-01-21
Last Posted Date
2016-06-15
Lead Sponsor
Zealand Pharma
Target Recruit Count
81
Registration Number
NCT02660008
Locations
🇩🇪

Profil Institut für Stoffwechselforschung GmbH, Neuss, Germany

Multiple Ascending Doses of ZP4207 Administered to HV to Evaluate the Safety, Tolerability, PKs and PDs of ZP4207

Phase 1
Completed
Conditions
Hypoglycemia
Interventions
Drug: Placebo
First Posted Date
2015-03-17
Last Posted Date
2015-11-11
Lead Sponsor
Zealand Pharma
Target Recruit Count
24
Registration Number
NCT02390141
Locations
🇩🇪

Profil GmbH, Neuss, Germany

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