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
NCT06588504 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 38
Last updated 2025-12-05
Summary
This study will be looking to confirm the effect of dasiglucagon when compared with glucagon for treating very low sugar levels in Asian adults with T1D and the effect of dasiglucagon in Japanese adolescents with T1D. This study wants to demonstrate that dasiglucagon can raise low blood sugar levels just as well as glucagon. Participants will get dasiglucagon and glucagon. In which treatment order participants get study medicines (dasiglucagon and glucagon) is decided by chance. Dasiglucagon is a new medicine, but doctors can prescribe it in the US as it is approved there. Doctors can prescribe glucagon in multiple countries including Japan as an approved medicine. The study will last for about 17 weeks. Participant cannot be in the study if the study doctor thinks that there are risks for participants health. Women cannot take part if pregnant, breast-feeding, plan to get pregnant, during the study period, or not using adequate contraceptive methods. For man: if participant have sex, participant and his partner must use an adequate birth control method during the study.
Conditions
- Diabetes Mellitus, Type 1
Interventions
- DRUG
-
Dasiglucagon
Participants will receive s.c. injection of dasiglucagon.
- DRUG
-
Glucagon
Participants will receive i.m. injection of glucagon.
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
Clinical Transparency (dept. 2834) · Novo Nordisk A/S
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- CROSSOVER
Eligibility
- Min Age
- 12 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-09-10
- Primary Completion
- 2025-07-20
- Completion
- 2025-07-20
- FDA Drug
- Yes
Countries
- Japan
Study Locations
More Related Trials
-
Safety Study of Repeated Doses of Glucagon on Animal Starch in the Liver
NCT01986231 ·Status: COMPLETED ·Phase: NA
-
Postprandial Gut Hormone Responses in Patients With Type 1 Diabetes Mellitus
NCT04430946 ·Status: UNKNOWN ·Phase: NA
-
Effects of Nateglinide on Postprandial Glucose Excursion by Restoring Early Phase Insulin Secretion
NCT01030952 ·Status: COMPLETED ·Phase: PHASE4
-
Glucose-dependent Insulinotropic Polypeptide as a Safeguard Against Hypoglycemia in Patients With Type 1 Diabetes
NCT03556098 ·Status: COMPLETED ·Phase: NA
-
A Pilot Study to Evaluate the Glucagon-Like Peptide 1 Response to the Challenge of Mixed Meals in Chinese Subjects
NCT00884091 ·Status: COMPLETED
-
Glucagon Responses During Oral- and iv Glucose in Patients With Type 1 Diabetes
NCT00704795 ·Status: UNKNOWN
-
The Role of Endogenous Glucagon-like Peptide 1 (GLP-1) in Type 2 Diabetes Mellitus (T2DM)
NCT01449019 ·Status: COMPLETED ·Phase: PHASE1
-
Role of Glucagon-like Peptide-1 Receptor Agonists in Menstrual Irregularities in Adolescent Females With Type 1 Diabetes Mellitus
NCT07319286 ·Status: ENROLLING_BY_INVITATION ·Phase: PHASE1/PHASE2
-
Effects of GRA in Patients With Type 1
NCT04779645 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE2
-
Liraglutide in Type 1 Diabetes
NCT01612468 ·Status: COMPLETED ·Phase: PHASE4
-
The Impact of Subcutaneous Glucagon Before, During and After Exercise a Study in Patients With Type 1 Diabetes Mellitus
NCT02882737 ·Status: COMPLETED ·Phase: NA
-
Glucagon Efficiency After High and Low Carbohydrate Diet
NCT02578498 ·Status: COMPLETED ·Phase: PHASE4
-
Postprandial Blood Glucose Control and Gastric Emptying in Type 1 Diabetes: Pathogenetic Factors and Therapeutic Options
NCT02365740 ·Status: UNKNOWN ·Phase: NA
-
Glucagon Enhanced Insulin Absorption in Diabetes Mellitus Type 1
NCT05960565 ·Status: TERMINATED ·Phase: PHASE2
-
Safety, Tolerability, Pharmacodynamics and Pharmacokinetics of JY09
NCT04354090 ·Status: COMPLETED ·Phase: PHASE1
-
Relationship Between Improvement in Insulin Secretion and Decrease in HbA1c in GLP-1 RA Therapy in T2DM Patients
NCT04135287 ·Status: UNKNOWN ·Phase: PHASE4
-
Effect of Liraglutide on Glucagon Secretion in Subjects With Type 2 Diabetes
NCT01509742 ·Status: COMPLETED ·Phase: PHASE1
-
Study on Lixisenatide and Counterregulation to Hypoglycemia
NCT02020629 ·Status: COMPLETED ·Phase: PHASE4
-
A Comparison of Postprandial Glucose After a MMTT, and the Metabolic Effects of Insulin Withdrawal in a Crossover Study in Subjects With Type 1 Diabetes
NCT04956263 ·Status: COMPLETED ·Phase: PHASE2
-
The Effect of LY2409021 on Blood Sugar Levels When Glucagon Levels Are Increased in Healthy Male Participants
NCT01606423 ·Status: COMPLETED ·Phase: PHASE1
-
Efficacy of Glucagon-like Peptide-1 Receptor Agonists According to Type 2 Diabetes Subtypes
NCT06120556 ·Status: COMPLETED
-
Glucagon-like Peptide 2 - a Glucose Dependent Glucagonotropic Hormone?
NCT03954873 ·Status: COMPLETED ·Phase: NA
-
The Effect of GLP-1 on the Inhibition of Glucagon Secretion
NCT01507597 ·Status: COMPLETED ·Phase: NA
-
The Effect of GLP-1 on Glucose Uptake in the Brain and Heart in Healthy Men During Hypoglycemia
NCT00418288 ·Status: COMPLETED ·Phase: NA
-
Neuronostatin - a Glucagonotropic Agent in Humans?
NCT06143267 ·Status: COMPLETED ·Phase: NA