Clinical trials: Hypoglycemia
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
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 2
Efficacy and Safety of Alogliptin Plus Metformin in Patients With Type 2 Diabetes
The purpose of this study is to evaluate the safety and effectiveness of alogliptin combined with metformin, once daily (QD) or twice daily (BID), in participants with Type 2 Diabetes.
- Trial name
- AM7D (NCT01023581)
- Testing
- Alogliptin, Metformin
- Where
- 201 sites in United States, Czechia and 11 more
- Volunteers
- 784 people
- Sponsor
- Takeda
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
Type 2 Diabetes Mellitus (T2DM)
Study of Sitagliptin Treatment in Patients With Type 2 Diabetes During Ramadan (0431-263)
This study will examine whether the incidence of hypoglycemia in patients fasting for Ramadan is lower when treated with sitagliptin as compared to sulfonylurea treatment.
- Trial name
- NCT01131182
- Testing
- Sitagliptin phosphate, Comparator: Sulfonylurea, Metformin
- Volunteers
- 1,147 people
- Sponsor
- Merck Sharp & Dohme LLC
Hypoglycemia, Complications of Bariatric Procedures
Delivery of G-Pump™ (Glucagon Infusion) From an OmniPod® to Prevent Hypoglycemia in Post-Bariatric Surgery Patients
The primary objective of this study is to test an optimized control system for sensor-guided (physician administered) delivery of glucagon, and test Proof-of-Concept (POC) in a clinical setting in patients with severe…
- Trial name
- NCT02733588
- Testing
- G-Pump™ (glucagon infusion)
- Where
- United States
- Volunteers
- 8 people
- Sponsor
- Xeris Pharmaceuticals
Diabetes Mellitus, Type 1, Hypoglycemia
T1 Diabetes Hypoglycemia Prevention Pilot
A single center pilot study assessing the Vigilant Diabetes Management System for the prevention of recurrent mild to moderate hypoglycemia in type I diabetes patients.
- Trial name
- NCT02682940
- Testing
- Vigilant Diabetes Management Application
- Where
- United States
- Volunteers
- 4 people, healthy volunteers welcome
- Sponsor
- InSpark Technologies, Inc.
Type 1 Diabetes Mellitus
A Study to Evaluate Safety, Pharmacokinetics, and Pharmacodynamics of a Single Dose of SAR438544 in Comparison to Glucagon in Type 1 Diabetes Mellitus Patients Under Induced Hypoglycemia
Primary Objective: To assess the pharmacodynamic response (PD) of a single subcutaneous (SC) dose of SAR438544 versus recombinant glucagon in type 1 diabetes mellitus (T1DM) patients under induced hypoglycemia.
- Trial name
- NCT02635243
- Testing
- SAR438544, r-glucagon, insulin
- Sponsor
- Sanofi
Hypoglycemia
G-Pen™ for Hypoglycemia Rescue in T1D Patients
This is an open-label, exploratory pilot study in patients with T1D. The study will involve two daytime clinical research center visits 7-14 days apart.
- Trial name
- NCT02423980
- Testing
- Glucagon
- Where
- United States
- Volunteers
- 7 people
- Sponsor
- Xeris Pharmaceuticals
Type 2 Diabetes Mellitus, Hypoglycemia
Hypoglycemia: Physician and Patient Perspectives
The purpose of this study is to assess the burden of hypoglycemia and identify unmet need related to the management of hypoglycemia among Type 2Diabetes Mellitus (T2DM) patients on OADs and/or insulin.
- Trial name
- NCT01176656
- Volunteers
- 800 people
- Sponsor
- AstraZeneca
Type 1 Diabetes Mellitus
A Safety, Tolerability and Efficacy Study of Sernova's Cell Pouch™ for Clinical Islet Transplantation
The Cell Pouch™ is a novel implantable device, that is transplanted with therapeutic cells such as insulin producing islets. This combination product is designed for the treatment of Type 1 Diabetes Mellitus (T1D) with…
- Trial name
- NCT03513939
- Testing
- Sernova Cell Pouch
- Where
- United States
- Volunteers
- 17 people
- Sponsor
- Sernova Biotherapeutics Inc.
Diabetes Mellitus, Type 1
Insulin Glargine in Type I Diabetes Mellitus> Main Study "AT.LANTUS": A Trial Comparing Lantus Algorithms to Achieve Normal Blood Glucose Targets in Subjects With Uncontrolled Blood Sugar. Sub-study: "HALT"(Hypoglycaemia Avoidance With Lantus Trial)
Primary objective: AT.LANTUS main study* To determine the optimal treatment algorithm for insulin glargine based on the incidence of severe hypoglycaemia.(*Target Number of patients for the main study:2346) HALT Sub-study** To…
- Trial name
- AT-LANTUS (NCT00390728)
- Testing
- Insulin Glargine
- Volunteers
- 2,346 people
- Sponsor
- Sanofi
Post-Bariatric Hypoglycemia
Pasireotide s.c. in Patients With Post-Bariatric Hypoglycaemia
The Total duration of trial participation for each participant with post-bariatric hypoglycemia will be a maximum of 59 weeks, with the following duration of trial periods 19 weeks for the Core Phase.
- Trial name
- PASIPHY (NCT05928390)
- Testing
- Pasireotide Diaspartate
- Where
- 29 sites in United States, Belgium and 4 more
- Volunteers
- 93 people
- Sponsor
- RECORDATI GROUP
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.
Hypoglycemia
Glucagon Ready-to-Use (RTU) for Prevention of Exercise-Induced Hypoglycemia During Aerobic Exercise in Adults With T1D
This study is a randomized, placebo-controlled, double-blind, 2-treatment, 2-period, crossover comparison in a clinical research center (CRC) setting, followed by a randomized, placebo-controlled, double-blinded, 2-arm parallel…
- Trial name
- NCT03841526
- Testing
- Glucagon RTU Injection With Insulin Pump Reduction, Vehicle for Glucagon RTU Injection With Insulin Pump Reduction, Glugaon RTU Injection Without Insulin Pump Reduction
- Where
- Canada
- Volunteers
- 48 people
- Sponsor
- Xeris Pharmaceuticals
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, Type 2 Diabetes
Closed Loop Glucose Control in a Simulated ICU Setting
This is a proof of concept safety study of a rule-based closed loop glucose control system designed for use in the intensive care unit setting.
- Conditions
- Type 1 Diabetes, Type 2 Diabetes, Stress Induced Hyperglycemia
- Trial name
- NCT07646067
- Testing
- FUSION closed loop glucose control system
- Volunteers
- 6 people
- Sponsor
- Ideal Medical Technologies
Diabetes Mellitus, Type 1
A Study of LY3532226 in Participants With Type 1 Diabetes Mellitus
The main purpose of this study is to evaluate the response of glucagon to insulin-induced low blood sugar after administration of the study drug LY3532226 in participants with type 1 diabetes mellitus (T1DM).
- Trial name
- NCT05887999
- Testing
- LY3532226
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- Eli Lilly and Company
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
A Study to Determine the Absorption of Peroral Insulin in Dextran Matrix (ORA3)
A pharmacokinetic study on the absorption of perorally delivered insulin in dextran matrix after single dose administration.
- Trial name
- ORA3 (NCT01114750)
- Where
- Sweden
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- Bows Pharmaceuticals AG