70 completed. 70 Phase 2, 13 Phase 1, 6 Phase 3.
| Phase | Trials | Status |
|---|---|---|
| Phase 2 | 70 | Completed 70 |
| Phase 1 | 13 | Completed 13 |
| Phase 3 | 6 | Completed 6 |
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 |
|---|---|---|---|---|---|---|
| Oral Glibenclamide in Preterm Infants With Hyperglycaemia (GALOP) Glibenclamide, Pharmacokinetics study, C-peptide proinsulin ratio - Transient; Hypoglycemia, Neonatal, Preterm | Phase 2 | Completed | Assistance Publique - Hôpitaux de Paris | 35 | 2023-05-20 | 2026-10-02 |
| Insulin and Abatacept in Recently-diagnosed Type 1 Diabetes Abatacept (CTLA4-Ig) and nasal insulin (Humulin R®), Abatacept (CTLA4-Ig) and nasal placebo (0.9% sodium chloride) - Type 1 Diabetes, Diabetes Mellitus, Type 1 | Phase 2 | Completed | Melbourne Health | 68 | 2023-02-13 | 2025-12-24 |
| 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 |
| An Open-Label Multiple Dose Study of RZ358 in Patients With Congenital Hyperinsulinism RZ358 Sequential Group Cohort 1, RZ358 Sequential Group Cohort 2, RZ358 Sequential Group Cohort 3 - Congenital Hyperinsulinism | Phase 2 | Completed | Rezolute | 23 | 2020-02-24 | 2025-05-28 |
| 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 |
| Glucagon Ready-to-Use (RTU) for Prevention of Exercise-Induced Hypoglycemia During Aerobic Exercise in Adults With T1D Glucagon RTU Injection With Insulin Pump Reduction, Vehicle for Glucagon RTU Injection With Insulin Pump Reduction, Glugaon RTU Injection Without Insulin Pump Reduction - Hypoglycemia | Phase 2 | Completed | Xeris Pharmaceuticals | 48 | 2019-08-22 | 2025-08-22 |
| Glucagon Ready to Use (RTU) in Subjects With Hyperinsulinemic Hypoglycemia After Bariatric Surgery Glucagon RTU, Placebo - Hyperinsulinemic Hypoglycemia | Phase 2 | Completed | Xeris Pharmaceuticals | 14 | 2019-05-10 | 2020-05-21 |
| Closed-loop Control of Glucose Levels (Artificial Pancreas) for 12 Days in Adults With Type 1 Diabetes 12-day intervention with sensor-augmented pump therapy, 12-day intervention with single-hormone closed-loop strategy, Insulin pump - Type 1 Diabetes | Phase 2 | Completed | Institut de Recherches Cliniques de Montreal | 36 | 2019-01-24 | 2020-06-11 |
| Effect of Dapagliflozin on IAH in T1DM Dapagliflozin, Placebo oral capsule - Diabetes Mellitus, Type 1, Hypoglycemia | Phase 2 | Completed | Radboud University Medical Center | 15 | 2018-11-23 | 2020-03-23 |
| Pilot Study of OMEGA-3 and Vitamin D in High-Dose in Type I Diabetic Patients Cholecalciferol, Omega 3 fatty acid - Diabetes Mellitus, Type 1, Hypoglycemia | Phase 1 / Phase 2 | Completed | Rodolfo Alejandro | 27 | 2018-07-23 | 2025-09-17 |
| 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 |
| Exenatide and Impaired Hypoglycaemic Awareness in Type 1 Diabetes Exenatide, Placebo - Diabetes Mellitus, Type 1, Hypoglycemia | Phase 2 / Phase 3 | Completed | Radboud University Medical Center | 10 | 2017-02-21 | 2018-04-12 |
| CSI-Glucagon for Prevention of Hypoglycemia in Children With Congenital Hyperinsulinism Glucagon, Placebo - Congenital Hyperinsulinism | Phase 2 | Completed | Xeris Pharmaceuticals | 5 | 2016-10-01 | 2019-12-10 |
| Closed-loop Control of Glucose Levels (Artificial Pancreas) During Postprandial Exercise in Adults With Type 1 Diabetes 60-minute exercise, Insulin pump, Dexcom G4 Platinum glucose sensor - Type 1 Diabetes | Phase 2 | Completed | Institut de Recherches Cliniques de Montreal | 37 | 2016-09-01 | 2019-02-11 |
| Dextrose Gel Does Not Prevent Neonatal Hypoglycemia 40% Dextrose gel - Hypoglycemia, Infant, Small for Gestational Age | Phase 2 / Phase 3 | Completed | Baylor College of Medicine | 236 | 2016-07-01 | 2025-01-08 |
| Safety of Overestimation of a Meal Insulin Bolus in the Context of Dual-hormone Closed-loop Operation - Part 2 Dual-hormone closed-loop, Insulin, Glucagon - Type 1 Diabetes | Phase 2 | Completed | Institut de Recherches Cliniques de Montreal | 11 | 2016-06-01 | 2017-04-26 |
| An Open-Label Study of XOMA 358 in Patients With Hypoglycemia After Gastric Bypass Surgery XOMA 358 single dose level A, XOMA 358 single dose level B, XOMA 358 single dose level C - Hypoglycemia | Phase 2 | Completed | XOMA (US) LLC | 20 | 2016-04-01 | 2021-05-21 |
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Diabetes Mellitus, Type 1 (39) · Insulin Resistance (17) · Congenital Hyperinsulinism (12) · Diabetes Mellitus (7) · Hyperinsulinism (5) · Hyperglycemia (4) · Diabetes Mellitus, Type 2 (3) · Motor Activity (3) · Glucose Metabolism Disorders (2) · Metabolic Diseases (2) · Premature Birth (2) · Diabetes, Gestational (1) · Digestive System Diseases (1) · Dumping Syndrome (1)
Nutritional and Metabolic Diseases (70) · Glucose Metabolism Disorders (68) · Metabolic Diseases (68) · Endocrine System Diseases (47) · Immune System Diseases (40) · Autoimmune Diseases (39) · Diabetes Mellitus (39) · Hyperinsulinism (24) · Congenital, Hereditary, and Neonatal Diseases and Abnormalities (14) · Digestive System Diseases (12) · Infant, Newborn, Diseases (12) · Pancreatic Diseases (11) · Pathological Conditions, Signs and Symptoms (4) · Behavior (3)
Glucagon (13) · Insulin (8) · Methods (5) · dasiglucagon (5) · Exenatide (3) · Exercise (3) · Glyburide (3) · Saline Solution (3) · Sodium Chloride (3) · Tacrolimus (3) · fluorodopa F 18 (3) · Abatacept (2) · Antilymphocyte Serum (2) · Basiliximab (2) · Daclizumab (2)
Institut de Recherches Cliniques de Montreal (13) · Xeris Pharmaceuticals (8) · University of Minnesota (6) · Jaeb Center for Health Research (4) · Assistance Publique - Hôpitaux de Paris (2) · Children's Hospital of Philadelphia (2) · Diva De Leon (2) · National Institute of Allergy and Infectious Diseases (NIAID) (2) · Radboud University Medical Center (2) · Rodolfo Alejandro (2) · Steno Diabetes Center Copenhagen (2) · XOMA (US) LLC (2) · Zealand Pharma (2) · Baylor College of Medicine (1) · Eli Lilly and Company (1)
United States (37) · Canada (20) · Denmark (6) · France (4) · United Kingdom (4) · Germany (3) · Israel (3) · Netherlands (2) · Switzerland (2) · Australia (1) · Belgium (1) · Bulgaria (1) · Georgia (1) · Russia (1) · Spain (1)
Bernhard J. Hering, M.D. (4) · John Lum, MS (3) · Allan Gordon, MD, PhD (2) · Bruce A Buckingham, MD (2) · Christian Laugesen, MD (2) · Lisa J States, MD (2) · Remi Rabasa-Lhoret (2) · Roy W Beck, MD, PhD (2) · A.M. James Shapiro, MD, PhD (1) · Alfred Penfornis, MD, PhD (1) · Andrew Posselt, MD, PhD (1) · Benjamin A. Kohl, MD (1) · Bernhard Hering, MD (1)
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