36 completed, 7 terminated, 5 recruiting, 4 unknown. 57 Phase 3, 14 Phase 2.
| Phase | Trials | Status |
|---|---|---|
| Phase 3 | 57 | Completed 36, Terminated 7, Recruiting 5, Unknown 4, Withdrawn 3, Active not recruiting 2 |
| Phase 2 | 14 | Completed 6, Terminated 5, Withdrawn 2, Unknown 1 |
Follow Hypoglycemia: new trials by email Literature Review of Hypoglycemia trials Research Report on Hypoglycemia
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 |
|---|---|---|---|---|---|---|
| Avexitide for Treatment of Post-Bariatric Hypoglycemia Avexitide, Placebo - Post Bariatric Hypoglycemia | Phase 3 | Active not recruiting | Amylyx Pharmaceuticals Inc. | 75 | 2025-04-29 | 2026-08-24 |
| A Phase 3 Study of Ersodetug in Patients With Tumor Hyperinsulinism Ersodetug - Tumor Hyperinsulinism (Tumor HI) | Phase 3 | Recruiting | Rezolute | 16 | 2025-04-16 | 2026-09-28 |
| RCT Glargine vs NPH for Treatment of DM in Pregnancy Insulin glargine, insulin NPH - Diabetes Mellitus in Pregnancy, Type 2 Diabetes Mellitus (T2DM) | Phase 3 | Recruiting | Loyola University | 160 | 2024-04-01 | 2024-10-01 |
| RZ358 Treatment for Congenital Hyperinsulinism RZ358 (5 mg/kg) + SOC (Standard-of-Care) or Placebo + SOC, RZ358 (10 mg/kg) or Placebo + SOC, RZ358 (5-10 mg/kg) + SOC - Congenital Hyperinsulinism | Phase 3 | Active not recruiting | Rezolute | 56 | 2024-01-11 | 2026-01-08 |
| 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 |
| Canakinumab for the Treatment of Postprandial Hypoglycemia Canakinumab, Placebo (0.9% NaCl) - Postprandial Hypoglycemia | Phase 3 | Recruiting | University Hospital, Basel, Switzerland | 56 | 2023-04-17 | 2025-01-29 |
| Empagliflozin for the Treatment of Postprandial Hypoglycemia Empagliflozin (Jardiance®;, Placebo Control Intervention - Postprandial Hypoglycemia | Phase 3 | Terminated | University Hospital, Basel, Switzerland | 40 | 2022-03-11 | 2024-08-16 |
| A Safety, Tolerability, and Efficacy Study of VX-880 and VX-017 in Participants With Type 1 Diabetes VX-880, VX-017 - Diabetes Mellitus, Type 1, Impaired Hypoglycemic Awareness | Phase 3 | Recruiting | Vertex Pharmaceuticals Incorporated | 57 | 2021-03-29 | 2026-09-01 |
| 18F-DOPA II - PET Imaging Optimization 18F-DOPA, Furosemide Injection - Congenital Hyperinsulinism, Neuroblastoma | Phase 3 | Recruiting | University of Alberta | 800 | 2021-01-20 | 2026-02-09 |
| Novolog vs. Fiasp Insulin in Non-critically Ill Hospitalized Patients With Type 2 Diabetes Mellitus Insulin glargine, NovoLog, Insulin Fiasp - Type 2 Diabetes Treated With Insulin | Phase 3 | Completed | Boston Medical Center | 137 | 2020-12-07 | 2024-03-19 |
| 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 |
| Prevention of Hypoglycemia Among Diabetes Patients Admitted to Internal Medicine Departments With Nutritional Care Glucerna - Hypoglycemia, Malnutrition; Diabetes | Phase 3 | Unknown | Eyal Leibovitz | 500 | 2019-07-01 | 2021-04-23 |
| 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 |
| 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 |
| G-Pen Compared to Glucagen Hypokit for Severe Hypoglycemia Rescue in Adults With Type 1 Diabetes G-Pen, Novo Glucagon - Insulin Hypoglycemia, Type 1 Diabetes Mellitus | Phase 3 | Completed | Xeris Pharmaceuticals | 132 | 2018-09-27 | 2020-05-22 |
| Safety and Feasibility Evaluation of the APS APP Artificial Pancreas App - Type 1 Diabetes Mellitus | Phase 2 / Phase 3 | Completed | Sansum Diabetes Research Institute | 6 | 2018-02-28 | 2018-09-05 |
| G-Pen™ Compared to Lilly Glucagon for Hypoglycemia Rescue in Adults With Type 1 Diabetes G-Pen, Lilly Glucagon - Insulin Hypoglycemia, Type 1 Diabetes Mellitus | Phase 3 | Completed | Xeris Pharmaceuticals | 81 | 2018-01-23 | 2020-02-17 |
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Diabetes Mellitus, Type 1 (22) · Diabetes Mellitus (15) · Hyperglycemia (10) · Diabetes Complications (8) · Congenital Hyperinsulinism (6) · Diabetes Mellitus, Type 2 (4) · Insulin Resistance (3) · Metabolic Diseases (3) · Neuroendocrine Tumors (3) · Diabetic Neuropathies (2) · Glucose Metabolism Disorders (2) · Hyperinsulinism (2) · Neuroblastoma (2) · Parkinson Disease (2)
Nutritional and Metabolic Diseases (57) · Glucose Metabolism Disorders (55) · Metabolic Diseases (54) · Endocrine System Diseases (42) · Diabetes Mellitus (26) · Immune System Diseases (22) · Autoimmune Diseases (21) · Congenital, Hereditary, and Neonatal Diseases and Abnormalities (8) · Hyperinsulinism (8) · Digestive System Diseases (6) · Infant, Newborn, Diseases (6) · Pancreatic Diseases (6) · Nervous System Diseases (4) · Female Urogenital Diseases and Pregnancy Complications (3)
Insulin Aspart (9) · dasiglucagon (9) · Insulin, Regular, Human (7) · Glucagon (4) · Islets of Langerhans Transplantation (3) · Antilymphocyte Serum (2) · Basiliximab (2) · Continuous Glucose Monitoring (2) · Etanercept (2) · Glucagon-Like Peptide 1 (2) · Insulin (2) · Insulin Glargine (2) · Liraglutide (2) · Metformin (2) · Standard of Care (2)
Zealand Pharma (9) · Florida Atlantic University (8) · Baylor College of Medicine (3) · Eli Lilly and Company (3) · University Hospital, Basel, Switzerland (3) · University of Alberta (3) · Xeris Pharmaceuticals (3) · Hvidovre University Hospital (2) · National Institute of Allergy and Infectious Diseases (NIAID) (2) · Rezolute (2) · Sansum Diabetes Research Institute (2) · Albert Einstein Healthcare Network (1) · Amylyx Pharmaceuticals Inc. (1) · Boston Medical Center (1) · Centre Hospitalier of Chartres (1)
United States (38) · Canada (15) · Germany (9) · United Kingdom (7) · Switzerland (6) · France (5) · Israel (5) · Austria (3) · Denmark (3) · Netherlands (3) · Bulgaria (1) · Czechia (1) · Georgia (1) · Greece (1) · Hungary (1)
Betty Tuller, PhD (4) · Betty Tuller, Ph.D (3) · Christina M Sylvest, MSc Pharm (2) · Christina Sylvest, MSc Pharm (2) · Eyal Dassau, PhD (2) · Rubina Heptulla, MD (2) · Alan Sinclair (1) · Ali Naji, PhD (1) · Ananda Basu, MD (1) · Andrew Posselt, MD, PhD (1) · Bernhard Hering, MD (1) · Betty Tuller, Ph.D. (1) · Boris Kovatchev, PhD (1)
PMID 34620618, PMID 15793249, PMID 17717285, PMID 19174497, PMID 19821755, PMID 23438305, PMID 23630300, PMID 24023652, PMID 24400655, PMID 24420499, PMID 25629445, PMID 25888011, PMID 26486191, PMID 27208344, PMID 27465220, PMID 29030383, PMID 29563196, PMID 29605395, PMID 35239971, PMID 35322535, PMID 40067436, PMID 40544428, PMID 41202120
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