Clinical trials: Severe Hypoglycemia
Diabetes Mellitus, Type 1, Impaired Hypoglycemic Awareness
A Safety, Tolerability, and Efficacy Study of VX-880 and VX-017 in Participants With Type 1 Diabetes
This study will evaluate the safety, tolerability and efficacy of VX-880 infusion and VX-017 infusion in participants with type 1 diabetes (T1D) and impaired awareness of hypoglycemia (IAH) and severe hypoglycemia.
- Conditions
- Diabetes Mellitus, Type 1, Impaired Hypoglycemic Awareness, Severe Hypoglycemia
- Trial name
- NCT04786262
- Testing
- VX-880, VX-017
- Where
- 29 sites in United States, Canada and 8 more
- Volunteers
- 57 people
- Sponsor
- Vertex Pharmaceuticals Incorporated
Diabetes Mellitus Type 1
A Study of the Safety and Efficacy of Pancreatic Endocrine Cell Clusters Implanted Into the Omentum of Type 1 Diabetes Patients With Severe Hypoglycemia
This study will evaluate the safety, efficacy and durability of SR-02 administered to the omentum of patients of Type 1 diabetes with severe recurrent hypoglycemia. The study will also help establish the optimal treatment dose.
- Trial name
- SUGR (NCT06651515)
- Testing
- Allogeneic Pancreatic Endocrine Cell Clusters
- Where
- 2 sites in United States
- Sponsor
- Seraxis
Type 1 Diabetes
Prevention of Severe Hypoglycaemia With Hypo-Safe Hypoglycaemia Alarm Device
Hypoglycaemia is the most common acute complication in insulin-treated diabetes. The fear of hypoglycaemia discourages diabetic subjects from the attempt to maintain tight glycemic control, which in turn leads to increased…
- Trial name
- NCT01178476
- Testing
- Hyposafe Hypoglycaemia alarm device
- Where
- Denmark
- Sponsor
- UNEEG Medical A/S
Hypoglycemia
Safety, Tolerability, Pharmacokinetic (PK) and Pharmacodynamic (PD) Study of G-Pen(TM) (Glucagon Injection) to Treat Severe Hypoglycemia
The purpose of this study is to demonstrate that G-Pen(TM) glucagon is comparable to Lilly Glucagon(TM) in terms of safety and efficacy, as a treatment for severe hypoglycemia, a complication of diabetes.
- Trial name
- NCT01972152
- Testing
- G-Pen(TM) 1 mg, Lilly Glucagon(TM) 1 mg, G-Pen(TM) 0.5 mg
- Where
- United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Xeris Pharmaceuticals
Hypoglycemia, Type 1 Diabetes
A Study to Inv. Safety, Efficacy & PD of Dasiglucagon as Hypoglycemia Rescue Therapy in Children <6 Years With T1D
This research study will investigate whether dasiglucagon as a rescue therapy for participants under 6 years of age works and is safe to use.
- Trial name
- NCT05378672
- Testing
- Dasiglucagon
- Where
- 2 sites in United States
- Volunteers
- 8 people
- Sponsor
- Zealand Pharma
Diabetes Mellitus, Type 1
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
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.
- Trial name
- NCT06588504
- Testing
- Dasiglucagon, Glucagon
- Where
- Japan
- Volunteers
- 38 people
- Sponsor
- Novo Nordisk A/S
Diabete Mellitus, Diabete Type 1
Study of the Safety and Efficacy of Pancreatic Endocrine Cells in Adult Patients With Type 1 Diabetes
This study will evaluate the safety, efficacy and durability of SR-02 administered to the omentum of patients of Type 1 diabetes with severe recurrent hypoglycemia. The study will also help establish the optimal treatment dose.
- Trial name
- NCT07581197
- Testing
- Allogeneic pancreatic endocrine cell clusters
- Volunteers
- 9 people
- Sponsor
- Seraxis
Insulin Hypoglycemia, Type 1 Diabetes Mellitus
G-Pen Compared to Glucagen Hypokit for Severe Hypoglycemia Rescue in Adults With Type 1 Diabetes
This is a multi-center, randomized, controlled, single-blind, two-way crossover efficacy and safety study in subjects with Type 1 diabetes mellitus.
- Conditions
- Insulin Hypoglycemia, Type 1 Diabetes Mellitus, Severe Hypoglycemia
- Trial name
- NCT03738865
- Testing
- G-Pen, Novo Glucagon
- Where
- 7 sites in United States, Austria and 1 more
- Volunteers
- 132 people
- Sponsor
- Xeris Pharmaceuticals
Type 1 Diabetes, Type 1 Diabetes Mellitus With Hypoglycemia
Pilot Study Evaluating Safety of ExOlin® in Patients With Poorly Controlled Type 1 Diabetes
First in Human, pilot investigation An Open Label, Monocentric, Pilot Study Evaluating Safety of ExOlin® in Patients with Poorly Controlled Type 1 Diabetes with High Glucose Fluctuations, Prone to Severe Hypoglycemia
- Trial name
- Pilot'Ex (NCT05221359)
- Testing
- ExOlin®, Insulin aspart
- Where
- France
- Volunteers
- 8 people
- Sponsor
- Defymed
Hypoglycemia Unawareness, Diabetes Mellitus, Type 1
Glucagon Infusion in T1D Patients With Recurrent Severe Hypoglycemia: Effects on Counter-Regulatory Responses
This is a prospective, randomized, controlled, double-blind, parallel 4-group trial with the primary analysis after 4 weeks of treatment with continuous subcutaneous glucagon infusion (CSGI) or placebo.
- Trial name
- NCT03490942
- Testing
- Glucagon
- Where
- 5 sites in United States
- Volunteers
- 49 people
- Sponsor
- Xeris Pharmaceuticals
Hypoglycemia
Trial to Confirm the Efficacy and Safety of Dasiglucagon in the Treatment of Hypoglycemia in T1DM Children
A phase 3, randomized, double-blind, placebo- and active-controlled, parallel-arm trial to assess the efficacy, safety, and pharmacokinetics of dasiglucagon relative to placebo and GlucaGen® when administered as a rescue therapy…
- Trial name
- NCT03667053
- Testing
- dasiglucagon, GlucaGen HypoKit
- Where
- 5 sites in United States, Germany and 1 more
- Volunteers
- 42 people
- Sponsor
- Zealand Pharma
Type 1 Diabetes
A Study of Nasal Glucagon (LY900018) in Pediatric Participants With Type 1 Diabetes
The main purpose of this study is to evaluate the safety and tolerability of a study drug called nasal glucagon (Baqsimi) in pediatric participants with type 1 diabetes (T1D) aged 1 to less than 4 years.
- Trial name
- RescuiNGkids (NCT04992312)
- Testing
- Glucagon Nasal Powder [Baqsimi]
- Where
- 8 sites in United States
- Volunteers
- 7 people
- Sponsor
- Eli Lilly and Company
T1DM - Type 1 Diabetes Mellitus, Pancreatogenic Diabetes Mellitus
An Exploratory Clinical Study Evaluating Allogeneic iPSC-derived Pancreatic Islet Cells (CRG-002) for the Treatment of Diabetic Patients With Hypoglycemia Unawareness or Severe Hypoglycemic Events
This study is an open-label, single-arm, non-randomized trial designed to evaluate the safety and preliminary efficacy of CRG-002 administered via portal vein infusion or transplantation beneath the anterior rectus sheath in…
- Trial name
- NCT07503028
- Testing
- CRG002
- Where
- China
- Volunteers
- 10 people
- Sponsor
- Celregen Therapeutics
Hypoglycemia, Type 1 Diabetes
EEG-Changes During Insulininduced Hypoglycemia in Type 1 Diabetes
The aim of this study is based on recent pilot studies carried out at Odense University Hospital showing that the acute changes in electroencephalographic (EEG) signals (i.e.
- Trial name
- NCT00810420
- Where
- Denmark
- Sponsor
- UNEEG Medical A/S
Diabetes Mellitus, Type 1
The Real-World Control-IQ Glycemic Control and Quality of Life Study in Type 1 Diabetes in France
This post-market surveillance study is primarily designed to demonstrate the ongoing safety of the Control-IQ system, the ongoing performance of glycemic control and quality of life with Control-IQ system use, and the rate of use…
- Trial name
- RECORD-IQ (NCT07211126)
- Testing
- t:slim X2 insulin pump with Control-IQ technology (Control-IQ System)
- Where
- 25 sites in France
- Volunteers
- 350 people
- Sponsor
- Tandem Diabetes Care, Inc.
Type 1 Diabetes
Study Comparing Effectiveness of Intraperitoneal Insulin Administration to Subcutaneous Insulin Administration
The purpose of this study is to evaluate the effectiveness of insulin delivered in the peritoneum (abdomen)by an implantable pump in Type 1 diabetics.
- Trial name
- MIP310 (NCT00211536)
- Testing
- Medtronic MiniMed Implantable Pump Human Recombinant Insulin, Medtronic MiniMed Implantable Pump System, Aventis HOE21PH U400
- Where
- 5 sites in United States
- Volunteers
- 107 people
- Sponsor
- Medtronic MiniMed, Inc.
Diabetes Mellitus, Type 1, Hypoglycemia
A Study to Investigate Safety and Effectiveness of Porcine Pancreatic Cells (OPF-310) in Patients With Type 1 Diabetes Mellitus
This study is First In Human study for Encapsulated Porcine Islet Cells for Xenotransplantation (OPF-310). The purpose of this study to assess the safety, tolerability, and efficacy of OPF-310 transplantation and to define the…
- Conditions
- Diabetes Mellitus, Type 1, Hypoglycemia, Islet Cell Transplantation, Type 1 Diabetes
- Trial name
- NCT06575426
- Testing
- OPF-310
- Where
- United States
- Volunteers
- 13 people
- Sponsor
- Otsuka Pharmaceutical Factory, Inc.
Insulin Hypoglycemia, Type 1 Diabetes Mellitus
G-Pen™ Compared to Lilly Glucagon for Hypoglycemia Rescue in Adults With Type 1 Diabetes
This is a non-inferiority, multi-center, randomized, controlled, single-blind, two-way crossover efficacy and safety study in subjects with Type 1 diabetes mellitus.
- Conditions
- Insulin Hypoglycemia, Type 1 Diabetes Mellitus, Severe Hypoglycemia
- Trial name
- NCT03439072
- Testing
- G-Pen, Lilly Glucagon
- Where
- 6 sites in United States, Canada
- Volunteers
- 81 people
- Sponsor
- Xeris Pharmaceuticals