Clinical trials: Hypoglycaemia
Type 1 Diabetes Mellitus
Feasibility Study Assessing The Ability Of An Insulin Pump-Controlling Algorithm To Minimize Hypoglycemia And Hyperglycemia In Patients With Type 1 Diabetes In A Clinical Research Setting
The purpose of this study is to evaluate the performance of an insulin pump controlling algorithm while the subject is under close medical supervision in the Clinical Research Center (CRC) setting.
- Trial name
- NCT01401751
- Testing
- Hypoglycemia-Hyperglycemia Minimizer System
- Where
- United States
- Volunteers
- 13 people, healthy volunteers welcome
- Sponsor
- Animas Corporation
Postbariatric Hypoglycemia
Effect of Mizagliflozin on Postprandial Glucose and Insulin in Post-Bariatric Hypoglycemia Subjects
This clinical study will examine the safety and tolerability, as well as the effects of orally administered mizagliflozin on post prandial glucose and insulin levels in subjects diagnosed with post-bariatric hypoglycemia (PBH).
- Trial name
- NCT05541939
- Testing
- Mizagliflozin
- Where
- 2 sites in United States
- Volunteers
- 9 people
- Sponsor
- Vogenx, Inc.
Type 2 Diabetes Mellitus
Effect of Exenatide Plus Metformin vs. Insulin Aspart Plus Metformin on Glycemic Control and Hypoglycemia in Patients With Type 2 Diabetes
This study in Germany is designed to compare the effects of twice-daily exenatide plus metformin and twice-daily premixed human insulin aspart plus metformin with respect to glycemic control, as measured by HbA1c, combined with…
- Trial name
- NCT00434954
- Testing
- exenatide twice daily (BID), premixed insulin aspart twice daily (BID)
- Where
- 39 sites in Germany
- Volunteers
- 494 people
- Sponsor
- AstraZeneca
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
Diabetes, Diabetes Mellitus, Type 1
A Trial Investigating the Effect of Acute Hypoglycaemia on Cognitive Function and Brain Activation Patterns in Subjects With Type 1 Diabetes
This trial is conducted in Europe. The aim of the trial is to compare cognitive function and associated brain activation patterns during an acute hypoglycaemic episode and during euglycaemia (normal blood glucose concentration).
- Trial name
- NCT01789593
- Testing
- glucose clamp
- Where
- Denmark
- Volunteers
- 29 people
- Sponsor
- Novo Nordisk A/S
Type 2 Diabetes Mellitus, Elderly
Phase 4 Study in the Elderly Patients With T2DM
The study will assess the incidence of Hypoglycemia: Percent of patients presenting no hypoglycemia (confirmed events with SMBG and severe episodes) over 6 months follow up in T2DM patients treated with a DPP-4 inhibitor or…
- Trial name
- GLYCEMIA (NCT01238978)
- Testing
- Vildagliptin, "Usual Care"
- Where
- 15 sites in France
- Volunteers
- 46 people
- Sponsor
- Novartis
Type 1 Diabetes Mellitus With Hypoglycemia
A Trial to Investigate Hyperglycemic and Hypoglycemic Excursions in Subjects With Type 1 Diabetes
This is a single center, double-blind, randomized trial in subjects with type 1 diabetes mellitus applying an adaptive design approach.
- Trial name
- NCT04712266
- Testing
- Glucagon, Insulin
- Where
- United States
- Volunteers
- 15 people
- Sponsor
- Abvance Therapeutics
Type 1 Diabetes Mellitus, Type 1 Diabetes Mellitus with Hypoglycemia
A Pilot Study to Assess the Feasibility of a Novel Non-invasive Technology to Measure Changing Blood Glucose Levels in Adults with Type-1 Diabetes Mellitus
The primary aim of this study is to assess the feasibility of the Lab demo 1.0 and associated computational models to detect and track glucose changes noninvasively and transcutaneously in defined and dynamic states of glycemia.
- Conditions
- Type 1 Diabetes Mellitus, Type 1 Diabetes Mellitus with Hypoglycemia, Type 1 Diabetes Mellitus with Hyperglycemia
- Trial name
- NCT06097689
- Testing
- Lab Demo 1.0
- Where
- Switzerland
- Volunteers
- 21 people, healthy volunteers welcome
- Sponsor
- Liom Health AG
Hypoglycemia, Diabetes Mellitus, Type 1
A Trial to Evaluate the Immunogenicity of Dasiglucagon and GlucaGen in Patients With Type 1 Diabetes Mellitus
The trial's objective is to evaluate the immunogenicity of repeated single doses of dasiglucagon* and GlucaGen following subcutaneous (SC) administration in patients with type 1 diabetes mellitus (T1DM) and further to evaluate…
- Trial name
- NCT03216226
- Testing
- dasiglucagon, GlucaGen
- Where
- 7 sites in United States, Austria and 2 more
- Volunteers
- 112 people
- Sponsor
- Zealand Pharma
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
Diabetes, Diabetes Mellitus, Type 2
A Trial to Investigate the Impact of Nocturnal Hypoglycaemia on Sleep in Subjects With Type 2 Diabetes
This trial is conducted in Europe. The aim of this trial is to investigate the impact of low blood sugar during the night on sleep in subjects with type 2 diabetes.
- Trial name
- NCT01780272
- Testing
- glucose clamp
- Where
- Denmark
- Volunteers
- 26 people
- Sponsor
- Novo Nordisk A/S
Hypoglycemia, Diabetes Mellitus, Type 1
A Trial to Confirm the Efficacy and Safety of Dasiglucagon in the Treatment of Hypoglycemia in Type 1 Diabetes Subjects
The objective of the trial is to demonstrate superiority of dasiglucagon compared to placebo following a single subcutaneous dose administered to subjects with type 1 diabetes mellitus (T1DM) with insulin-induced hypoglycemia.
- Trial name
- NCT03378635
- Testing
- Dasiglucagon, GlucaGen
- Where
- 5 sites in United States, Austria and 2 more
- Volunteers
- 170 people
- Sponsor
- Zealand Pharma
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
Pharmacological Action
Sitagliptin and the Risk for Hypoglycaemia in Type 2 Diabetes Patients
Sitagliptin, through its effects on sensitizing alpha-cell sensitivity to glucose, can initiate counter-regulatory glucagon responses at higher glycemic thresholds, thus reducing the number of clinically apparent hypoglycemic…
- Trial name
- NCT03359590
- Testing
- Sitagliptin 100 mg
- Where
- Germany
- Volunteers
- 20 people
- Sponsor
- Profil Institut für Stoffwechselforschung GmbH
Hypoglycemia, Diabetes Mellitus
Clinical Usability of Nasal Glucagon in Treatment of Hypoglycemia in Children and Adolescents
Up to fifty (50) children and adolescents with type 1 diabetes (T1D) aged 4 to ˂18 years at time of enrolment will be selected for inclusion in the study.
- Trial name
- NCT02402933
- Testing
- Nasal Glucagon
- Where
- 3 sites in United States
- Volunteers
- 26 people
- Sponsor
- Eli Lilly and Company
Congenital Hyperinsulinism
CSI-Glucagon for Prevention of Hypoglycemia in Children With Congenital Hyperinsulinism
This is a Phase 2, multi-center, randomized, placebo-controlled, double-blind trial with open-label follow-up designed to assess the efficacy of Xeris Glucagon delivered as a continuous subcutaneous infusion to prevent…
- Trial name
- NCT02937558
- Testing
- Glucagon
- Where
- 5 sites in United States
- Volunteers
- 5 people
- Sponsor
- Xeris Pharmaceuticals
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
Hypoglycemia
Single Ascending Doses of ZP4207 Administered in HV and in T1D to Evaluate Safety, Tolerability PKs and PDs of ZP4207 Compared to a Comparator
The trial is a randomized, double-blind First in Human trial to evaluate the safety and tolerability of ZP4207 in healthy volunteers (HV) and in insulin-induced hypoglycemic T1D (type 1 diabetes) subjects as compared to native…
- Trial name
- NCT02367053
- Testing
- ZP4207, Glucagon
- Where
- Germany
- Volunteers
- 111 people, healthy volunteers welcome
- Sponsor
- Zealand Pharma
Hyperinsulinemic Hypoglycemia
Glucagon Ready to Use (RTU) in Subjects With Hyperinsulinemic Hypoglycemia After Bariatric Surgery
This is a double-blind, placebo-controlled Phase 2 study to assess the efficacy, safety and tolerability of Glucagon RTU when administered to subjects with a history of bariatric surgery during episodes of post-postprandial…
- Trial name
- NCT03770637
- Testing
- Glucagon RTU
- Where
- 5 sites in United States
- Volunteers
- 14 people
- Sponsor
- Xeris Pharmaceuticals
Healthy
Evaluation of Hypo-Safe Hypoglycaemia Alarm Device - the Pilot 2 Study - Healthy Subjects
The objective of this pilot trial is to demonstrate the safety and the performance of the Hyposafe hypoglycaemia alarm device before conducting clinical trials in type 1 diabetes patients.
- Trial name
- NCT02402153
- Testing
- Hyposafe device
- Where
- Denmark
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- UNEEG Medical A/S