18 completed, 3 withdrawn. 10 Phase 2, 10 Phase 3, 2 Phase 1, 1 Early Phase 1.
| Phase | Trials | Status |
|---|---|---|
| Phase 2 | 10 | Completed 8, Withdrawn 2 |
| Phase 3 | 10 | Completed 10 |
| Phase 1 | 2 | Completed 2 |
| Early Phase 1 | 1 | Withdrawn 1 |
Follow dasiglucagon: new trials by email Literature Review of dasiglucagon trials Research Report on dasiglucagon
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| 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 Dasiglucagon, Glucagon - Diabetes Mellitus, Type 1 | Phase 1 | Completed | Novo Nordisk A/S | 38 | 2024-09-10 | 2025-12-05 |
| A Stable Glucagon Analog Administered by a Bihormonal Closed Loop System Dasiglucagon, GlucaGen - Diabetes Mellitus, Type 1 | Phase 2 | Withdrawn | Inreda Diabetic B.V. | 2023-12-29 | 2024-01-03 | |
| A Study to Inv. Safety, Efficacy & PD of Dasiglucagon as Hypoglycemia Rescue Therapy in Children <6 Years With T1D Dasiglucagon - Hypoglycemia, Type 1 Diabetes | Phase 3 | Completed | Zealand Pharma | 8 | 2023-05-09 | 2025-07-20 |
| Micro Glucagon During Exercise in Type 1 Diabetes Micro-glucagon, Mini-glucagon - Type 1 Diabetes, Hypoglycemia | Early Phase 1 | Withdrawn | Insel Gruppe AG, University Hospital Bern | 2023-04-01 | 2023-09-01 | |
| Efficacy and Safety of Dasiglucagon for Treatment of Post-bariatric Hypoglycemia in Roux-en-Y Gastric Bypass (RYGB) Operated Adults Dasiglucagon, Placebo - Hypoglycemia, Glucose Metabolism Disorders | Phase 2 | Withdrawn | Zealand Pharma | 2023-02-01 | 2023-02-21 | |
| Treatment of Post-bariatric Hypoglycaemia Dasiglucagon, HyoPen, Placebo - Hyperinsulinemic Hypoglycemia, Postprandial Hypoglycemia | Phase 2 | Completed | Filip Krag Knop | 24 | 2021-08-20 | 2023-02-02 |
| Pen-Administered Low-Dose Dasiglucagon for Prevention and Treatment of Hypoglycemia in People With Type 1 Diabetes Dasiglucagon - Type 1 Diabetes, Hypoglycemia | Phase 2 | Completed | Steno Diabetes Center Copenhagen | 24 | 2021-04-27 | 2022-09-07 |
| Low-dose Dasiglucagon for Prevention of Insulin-Induced Hypoglycemia in People With Type 1 Diabetes Dasiglucagon, Carbohydrate (dextrose tablets) - Type 1 Diabetes, Hypoglycemia | Phase 2 | Completed | Steno Diabetes Center Copenhagen | 20 | 2020-07-02 | 2021-02-09 |
| Trial Evaluating Efficacy and Safety of Dasiglucagon in Children With Congenital Hyperinsulinism dasiglucagon, Placebo - Congenital Hyperinsulinism | Phase 2 / Phase 3 | Completed | Zealand Pharma | 12 | 2020-06-19 | 2025-03-14 |
| Dasiglucagon in the Treatment of Postprandial Hypoglycaemia After Roux-en-Y Gastric Bypass ZP4207, Placebo (saline) - Hyperinsulinemic Hypoglycemia, Postprandial Hypoglycemia | Phase 2 | Completed | University Hospital, Gentofte, Copenhagen | 10 | 2019-09-18 | 2020-03-31 |
| The Bihormonal iLet Bionic Pancreas Feasibility Study Bihormonal iLet Bionic Pancreas, Insulin-only Bionic Pancreas, Dasiglucagon - Type 1 Diabetes Mellitus | Phase 2 / Phase 3 | Completed | Massachusetts General Hospital | 12 | 2019-05-15 | 2019-12-16 |
| Extension Trial Evaluating the Long-term Safety and Efficacy of Dasiglucagon in Children With Congenital Hyperinsulinism dasiglucagon - Congenital Hyperinsulinism | Phase 3 | Completed | Zealand Pharma | 42 | 2019-05-02 | 2026-08-03 |
| A Trial to Compare the Efficacy and Safety of 2 Different Batches of Subcutaneous Dasiglucagon in Patients With T1DM dasiglucagon - Hypoglycemia, Diabetes Mellitus, Type 1 | Phase 3 | Completed | Zealand Pharma | 92 | 2019-03-26 | 2023-02-21 |
| A Two-Period Open-label Trial Evaluating Efficacy and Safety of Dasiglucagon in Children With Congenital Hyperinsulinism Dasiglucagon, Standard of Care - Congenital Hyperinsulinism | Phase 3 | Completed | Zealand Pharma | 32 | 2019-02-07 | 2023-12-13 |
| Evaluation of the Safety, Tolerability and Bioavailability of Dasiglucagon Following Subcutaneous (SC) Compared to IV Administration Dasiglucagon, Placebo - Hypoglycemia | Phase 1 | Completed | Zealand Pharma | 60 | 2018-11-07 | 2021-03-23 |
| Trial to Confirm the Clinical Efficacy and Safety of Dasiglucagon in the Treatment of Hypoglycemia in Subjects With T1DM Dasiglucagon, Placebo - Hypoglycemia, Diabetes Mellitus, Type 1 | Phase 3 | Completed | Zealand Pharma | 45 | 2018-11-01 | 2021-05-19 |
| Trial to Confirm the Efficacy and Safety of Dasiglucagon in the Treatment of Hypoglycemia in T1DM Children dasiglucagon, placebo, GlucaGen HypoKit - Hypoglycemia | Phase 3 | Completed | Zealand Pharma | 42 | 2018-09-28 | 2021-06-30 |
| A Trial to Confirm the Efficacy and Safety of Dasiglucagon in the Treatment of Hypoglycemia in Type 1 Diabetes Subjects Dasiglucagon, GlucaGen, Placebo - Hypoglycemia, Diabetes Mellitus, Type 1 | Phase 3 | Completed | Zealand Pharma | 170 | 2017-12-07 | 2021-06-10 |
| A Trial to Evaluate the Immunogenicity of Dasiglucagon and GlucaGen in Patients With Type 1 Diabetes Mellitus dasiglucagon, GlucaGen - Hypoglycemia, Diabetes Mellitus, Type 1 | Phase 3 | Completed | Zealand Pharma | 112 | 2017-06-28 | 2021-05-04 |
| ZP4207(Dasiglucagon) Administered to T1D Patients to Assess the PK and PD Compared to Marketed Glucagon ZP4207(dasiglucagon) glucagon analogue, Glucagon (Native glucagon) - Diabetes Mellitus Type 1 | Phase 2 | Completed | Zealand Pharma | 38 | 2016-12-01 | 2017-04-21 |
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Diabetes Mellitus, Type 1 (13) · Hypoglycemia (13) · Congenital Hyperinsulinism (5) · Diabetes Mellitus (2) · Glucose Metabolism Disorders (1) · Insulin Resistance (1) · Motor Activity (1)
Zealand Pharma (13) · Steno Diabetes Center Copenhagen (2) · Filip Krag Knop (1) · Inreda Diabetic B.V. (1) · Insel Gruppe AG, University Hospital Bern (1) · Massachusetts General Hospital (1) · Novo Nordisk A/S (1) · University Hospital, Gentofte, Copenhagen (1)
United States (10) · Germany (8) · Denmark (4) · Canada (3) · Israel (3) · United Kingdom (3) · Austria (2) · Japan (1) · Netherlands (1) · Slovenia (1)
Christina M Sylvest, MSc Pharm (3) · Christian Laugesen, MD (2) · Christina Sylvest, MSc Pharm (2) · Charlotte Teglman Schioeler (1) · Christoph Stettler, MD (1) · Filip K Knop, MD, PhD (1) · Filip M. Knop, Prof., MD (1) · G Laverman, MD (1) · Jelena Ivkovic, MD (1) · Steven J Russell, MD (1) · Steven J Russell, MD, PhD (1)
PMID 33906916, PMID 35239971, PMID 35320361, PMID 35464292, PMID 35475907, PMID 37037948
2017 (1), 2019 (1)