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
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
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
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
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
Diabetes Pump With Predictive Low Glucose Suspend Pivotal Trial
A 6-week crossover study will compare PLGS to SAP outcomes in adults and youth > 6 years old with type 1 diabetes (T1D).
- Trial name
- NCT03195140
- Testing
- Predictive Low Glucose Suspend
- Where
- 4 sites in United States
- Volunteers
- 103 people
- Sponsor
- Tandem Diabetes Care, Inc.
Hypoglycemia, Diabetes Mellitus
Clinical Usability of Intranasal Glucagon in Treatment of Hypoglycemia
Up to two hundred (200) adult participants with type 1 diabetes (T1D) aged 18 to 75 years will be selected for inclusion in the study.
- Conditions
- Hypoglycemia, Diabetes Mellitus, Drug-Specific Antibodies
- Trial name
- NCT02171130
- Testing
- Nasal Glucagon
- Where
- 9 sites in United States, Canada
- Volunteers
- 129 people
- Sponsor
- Eli Lilly and Company
Diabetes Mellitus, Type 2, Hypoglycemia
A Study of Tirzepatide in Participants With Type 2 Diabetes Mellitus
The main purpose of this study is to learn more about how tirzepatide affects the body's response to low blood sugar (hypoglycemia). The study is open to participants with type 2 diabetes.
- Trial name
- NCT04050553
- Testing
- Tirzepatide
- Where
- Austria
- Volunteers
- 42 people
- Sponsor
- Eli Lilly and Company
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
Congenital Hyperinsulinism
A Two-Period Open-label Trial Evaluating Efficacy and Safety of Dasiglucagon in Children With Congenital Hyperinsulinism
The objective of the trial is to evaluate the efficacy and safety of dasiglucagon administered as a subcutaneous (SC) infusion in reducing hypoglycemia in children with CHI.
- Trial name
- NCT03777176
- Testing
- Dasiglucagon, Standard of Care
- Where
- 10 sites in United States, Germany and 2 more
- Volunteers
- 32 people
- Sponsor
- Zealand Pharma
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
Congenital Hyperinsulinism
Trial Evaluating Efficacy and Safety of Dasiglucagon in Children With Congenital Hyperinsulinism
The objective of the trial is to evaluate the efficacy of dasiglucagon in reducing glucose requirements in children with persistent congenital hyperinsulinism (CHI) requiring continuous intravenous (IV) glucose administration to…
- Trial name
- NCT04172441
- Testing
- dasiglucagon
- Where
- 6 sites in United States, Germany and 2 more
- Volunteers
- 12 people
- Sponsor
- Zealand Pharma
Diabetes Mellitus, Type 1
A Study of LY2605541 and Glargine in Participants With Type 1 Diabetes
This study has 2 parts. Each participant will receive a daily injection of LY2605541 during one treatment period and a daily injection of insulin glargine during one treatment period.
- Trial name
- NCT01769404
- Testing
- LY2605541, Insulin Glargine
- Where
- Germany
- Volunteers
- 25 people
- Sponsor
- Eli Lilly and Company
Type 1 Diabetes Mellitus
An Evaluation of Novel Glucose Sensing Technology on Hypoglycaemia in Type 1 Diabetes (IMPACT)
The purpose of this study is to evaluate the impact of the Abbott Sensor Based Glucose Monitoring System on hypoglycaemia compared to Self Monitoring Blood Glucose (SMBG) testing using a randomised controlled study design in…
- Trial name
- IMPACT (NCT02232698)
- Testing
- Sensor Based Glucose Monitoring System, Standard Blood Glucose Monitoring
- Where
- 23 sites in Austria, Germany and 3 more
- Volunteers
- 328 people
- Sponsor
- Abbott Diabetes Care
Postbariatric Hypoglycemia
Safety and Efficacy of Exendin 9-39 in Patients With Postbariatric Hypoglycemia
This clinical study will evaluate whether taking an investigational drug called exendin 9-39 is safe, well-tolerated, and helps to prevent low blood sugar in people who have had bariatric surgery and later develop a rare…
- Trial name
- PREVENT (NCT03373435)
- Testing
- exendin 9-39
- Where
- 5 sites in United States
- Volunteers
- 18 people
- Sponsor
- Eiger BioPharmaceuticals
Type 2 Diabetes Mellitus
Study to Compare Sitagliptin Versus Sulfonylurea Treatment During Ramadan Fasting in Patients With Type 2 Diabetes (MK-0431-262)
This is a study comparing the incidence of hypoglycemia while using sitagliptin treatment versus sulfonylurea (SU) treatment in participants with type 2 diabetes mellitus (T2DM) who regularly take an SU drug, and choose to fast…
- Trial name
- NCT01340768
- Testing
- Sitagliptin, Sulfonylurea, Metformin
- Volunteers
- 870 people
- Sponsor
- Merck Sharp & Dohme LLC
Hypoglycemia, Diabetes Mellitus, Type 1
Safety and Efficacy of G-Pen Compared to Lilly Glucagon for Hypoglycemia Rescue in Adult Type 1 Diabetics
This is a blinded, randomized crossover study to compare the safety and efficacy of G-Pen (glucagon injection) to Lilly Glucagon (glucagon for injection [rDNA origin]) for hypoglycemia rescue of adult patients with type 1…
- Trial name
- NCT02656069
- Testing
- G-Pen (glucagon injection), Lilly Glucagon (glucagon injection [rDNA origin])
- Where
- 7 sites in United States, Canada
- Volunteers
- 80 people
- Sponsor
- Xeris Pharmaceuticals