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Clinical Trial Details

Trial ID: L4831
Source ID: NCT02081014
Associated Drug: G-Pen Mini™ (Glucagon Injection)
Title: Safety and Efficacy Study of Mini-Dose Glucagon (G-Pen Mini) in Patients With Type 1 Diabetes
Acronym:
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT02081014/results
Conditions: Hypoglycemia
Interventions: DRUG: G-Pen Mini™ (glucagon injection)
Outcome Measures: Primary: Serious Adverse Events, Number of serious adverse events (SAEs) per treatment, From first dose until follow-up call, up to 7 weeks per subject | Secondary: Glucagon Cmax (Fasting), Pharmacokinetic parameter: Maximum concentration of glucagon, Approximately 15 and 0 minutes before each injection and at 5, 10, 15, 20, 30, 45, 60, 120 and 180 minutes post-injection|Glucagon Cmax (Post-insulin), Pharmacokinetic parameter: Maximum concentration of glucagon, Approximately 15 and 0 minutes before each injection and at 5, 10, 15, 20, 30, 45, 60, and 120 minutes post-injection|Glucagon Area Under the Curve (AUC) (Fasting), Pharmacokinetic parameter: Area under the glucagon concentration curve from 0 to 120 minutes, Approximately 15 and 0 minutes before each injection and at 5, 10, 15, 20, 30, 45, 60, and 120 minutes post-injection|Glucagon AUC (Post-insulin), Pharmacokinetic parameter: Area under the glucagon concentration curve from 0 to 120 minutes, Approximately 15 and 0 minutes before each injection and at 5, 10, 15, 20, 30, 45, 60, and 120 minutes post-injection|Glucagon Tmax (Fasting), Pharmacokinetic parameter: Time to reach maximum concentration of glucagon, Approximately 15 and 0 minutes before each injection and at 5, 10, 15, 20, 30, 45, 60, 120 and 180 minutes post-injection|Glucagon Tmax (Post-insulin), Pharmacokinetic parameter: Time to reach maximum concentration of glucagon, Approximately 15 and 0 minutes before each injection and at 5, 10, 15, 20, 30, 45, 60, and 120 minutes post-injection|Glucose Cmax (Fasting), Pharmacodynamic parameter: Maximum concentration of glucose, Approximately 15 and 0 minutes before each injection and at 5, 10, 15, 20, 30, 45, 60, 120 and 180 minutes post-injection|Glucose Cmax (Post-insulin), Pharmacodynamic parameter: Maximum concentration of glucose, Approximately 15 and 0 minutes before each injection and at 5, 10, 15, 20, 30, 45, 60, and 120 minutes post-injection|Glucose AUC (Fasting), Pharmacodynamic parameter: baseline adjusted area under the glucagon concentration curve from 0 to 120 minutes, Approximately 15 and 0 minutes before each injection and at 5, 10, 15, 20, 30, 45, 60, and 120 minutes post-injection|Glucose AUC (Post-insulin), Pharmacodynamic parameter: baseline adjusted area under the glucose concentration curve from 0-120 minutes, Approximately 15 and 0 minutes before each injection and at 5, 10, 15, 20, 30, 45, 60, and 120 minutes post-injection|Glucose Tmax (Fasting), Pharmacodynamic parameter: Time to reach maximum concentration of glucose, Approximately 15 and 0 minutes before each injection and at 5, 10, 15, 20, 30, 45, 60, 120 and 180 minutes post-injection|Glucose Tmax (Post-insulin), Pharmacodynamic parameter: Time to reach maximum concentration of glucose, Approximately 15 and 0 minutes before each injection and at 5, 10, 15, 20, 30, 45, 60, and 120 minutes post-injection
Sponsor/Collaborators: Sponsor: Xeris Pharmaceuticals | Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)|Emissary International LLC
Gender: ALL
Age: ADULT
Phases: PHASE2
Enrollment: 13
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: SINGLE (PARTICIPANT)|Primary Purpose: TREATMENT
Start Date: 2014-03
Completion Date: 2014-11
Results First Posted: 2016-05-16
Last Update Posted: 2018-04-05
Locations: Baylor College of Medicine, Children's Nutritional Research Center, Texas Children's Hospital, Houston, Texas, 77030, United States
URL: https://clinicaltrials.gov/show/NCT02081014