4 completed, 4 recruiting. 3 Not applicable, 3 Phase 3, 2 Phase 1, 2 Phase 2.
| Phase | Trials | Status |
|---|---|---|
| Not applicable | 3 | Completed 2, Recruiting 1 |
| Phase 3 | 3 | Completed 2, Recruiting 1 |
| Phase 1 | 2 | Recruiting 2 |
| Phase 2 | 2 | Recruiting 2 |
Follow Severe Hypoglycemia: new trials by email Literature Review of Severe Hypoglycemia trials Research Report on Severe 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 |
|---|---|---|---|---|---|---|
| A Safety, Tolerability, and Efficacy Study of E-islet 01 in Participants With Type 1 Diabetes Allogeneic Human E-islet (E-islet 01) - Diabetes Mellitus, Type 1, Impaired Hypoglycemic Awareness | Phase 1 / Phase 2 | Recruiting | EndoCell Therapeutics, Inc. | 21 | 2025-08-11 | 2025-08-22 |
| A Study to Investigate Safety and Effectiveness of Porcine Pancreatic Cells (OPF-310) in Patients With Type 1 Diabetes Mellitus OPF-310 - Diabetes Mellitus, Type 1, Hypoglycemia | Phase 1 / Phase 2 | Recruiting | Otsuka Pharmaceutical Factory, Inc. | 13 | 2025-06-10 | 2026-08-21 |
| Longitudinal Study of the GLUcagon REsponse to Hypoglycemia in Children and Adolescents With New-onset Type 1 DIAbetes Insulin-induced hypoglycemia test, Glucagon profile, Biological sample once - Severe Hypoglycemia, Type1diabetes | Not applicable | Recruiting | Cliniques universitaires Saint-Luc- Université Catholique de Louvain | 1000 | 2022-05-25 | 2025-01-13 |
| Comparing the Effectiveness of Two Approaches to Preventing Severe Hypoglycemia in Patients With Type 2 Diabetes (PHT2) Proactive Care Management, MyHC-T2D education program - Severe Hypoglycemia | Not applicable | Completed | Kaiser Permanente | 259 | 2022-01-26 | 2025-05-06 |
| 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 |
| 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 |
| 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 |
| Patient Safety Learning Laboratory: Making Acute Care More Patient-Centered Patient Safety health information technology - Central Line-Associated Bloodstream Infection (CLABSI), Venous Thromboembolism | Not applicable | Completed | Brigham and Women's Hospital | 21000 | 2015-04-01 | 2019-07-10 |
Hypoglycemia (8) · Diabetes Mellitus, Type 1 (5) · Diabetes Mellitus (2) · Autoimmune Diseases (1) · Catheter-Related Infections (1) · Diabetes Mellitus, Type 2 (1) · Drug-Related Side Effects and Adverse Reactions (1) · Glucose Metabolism Disorders (1) · Immune System Diseases (1) · Metabolic Diseases (1) · Venous Thromboembolism (1)
Nutritional and Metabolic Diseases (8) · Endocrine System Diseases (7) · Glucose Metabolism Disorders (7) · Metabolic Diseases (7) · Diabetes Mellitus (5) · Autoimmune Diseases (4) · Immune System Diseases (4) · Cardiovascular Diseases (1) · Chemically-Induced Disorders (1) · Embolism and Thrombosis (1) · Infections (1) · Thromboembolism (1) · Vascular Diseases (1)
Glucagon (2)
Xeris Pharmaceuticals (2) · Brigham and Women's Hospital (1) · Cliniques universitaires Saint-Luc- Université Catholique de Louvain (1) · EndoCell Therapeutics, Inc. (1) · Kaiser Permanente (1) · Otsuka Pharmaceutical Factory, Inc. (1) · Vertex Pharmaceuticals Incorporated (1)
United States (6) · Canada (3) · Austria (1) · Belgium (1) · China (1) · France (1) · Germany (1) · Italy (1) · Netherlands (1) · Norway (1) · Saudi Arabia (1) · Switzerland (1) · United Kingdom (1)
David W Bates, MD MSc (1) · James Ralston, MD, MPH (1) · Philippe Lysy, Pr (1)
PMID 33201236, PMID 34620618, PMID 35322535, PMID 38253252, PMID 40544428, PMID 41202120, PMID 42118187, PMID 42648789