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Clinical Trial Details

Trial ID: L6599
Source ID: NCT02232971
Associated Drug: Glucagon
Title: Treatment of Low Blood Sugar With Glucagon Among Patients With Type 1 Diabetes
Acronym: GluST1
Status: UNKNOWN
Study Results: NO
Results:
Conditions: Diabetes Mellitus, Type 1
Interventions: DRUG: Glucagon|OTHER: Isotonic saline solution
Outcome Measures: Primary: Maximum plasma glucose response, Plasma glucose measured every five minutes after administration | Secondary: Duration of hyperglycemic effect of glucagon, Plasma glucose is measured every five minutes. Time period is two -three hours after glucagon administration | Other: Plasma Catecholamine, Measured at 0, 5, 10, 15, 30, 45, 60, 90, 120,180, 240 minutes after glucagon administration|Plasma free fatty acids, Measured at 0, 5, 10, 15, 30, 45, 60, 90, 120,180, 240 minutes after glucagon administration|Plasma Beta-Hydroxybutyric acid, Measured at 0, 5, 10, 15, 30, 45, 60, 90, 120,180, 240 minutes after glucagon administration|Plasma Glucagon, Measured at 0, 5, 10, 15, 30, 45, 60, 90, 120,180, 240 minutes after glucagon administration|Serum Growth hormone, Measured at 0, 5, 10, 15, 30, 45, 60, 90, 120,180, 240 minutes after glucagon administration|Serum Cortisol, Measured at 0, 5, 10, 15, 30, 45, 60, 90, 120,180, 240 minutes after glucagon administration|Serum Insulin (Novorapid), Measured at 0, 5, 10, 15, 30, 45, 60, 90, 120,180, 240 minutes after glucagon administration|Adverse reaction: Stomach pain, Visual analog scale, One time before and after insulin administration. One time before glucagon administration. After glucagon administration at T=15 min., T=60 min., T=120 min., T=240 min.|Adverse reaction: Headache, Visual Analog scale, One time before and after insulin administration. One time before glucagon administration. After glucagon administration at T=15 min., T=60 min., T=120 min., T=240 min.|Adverse Reaction: Vertigo, Visual analog scale, One time before and after insulin administration. One time before glucagon administration. After glucagon administration at T=15 min., T=60 min., T=120 min., T=240 min.|Adverse reaction: Nausea, Visual analog scale, One time before and after insulin administration. One time before glucagon administration. After glucagon administration at T=15 min., T=60 min., T=120 min., T=240 min.|Adverse reaction: Hunger, Visual analog scale, One time before and after insulin administration. One time before glucagon administration. After glucagon administration at T=15 min., T=60 min., T=120 min., T=240 min.|Plasma triglycerides, Measured at 0, 5, 10, 15, 30, 45, 60, 90, 120,180, 240 minutes after glucagon administration
Sponsor/Collaborators: Sponsor: Hvidovre University Hospital | Collaborators: The Novo Nordic Foundation|University of Copenhagen
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE4
Enrollment: 8
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: SINGLE (PARTICIPANT)|Primary Purpose: BASIC_SCIENCE
Start Date: 2014-09
Completion Date: 2015-07
Results First Posted:
Last Update Posted: 2015-03-25
Locations: Hvidovre University Hospital, Hvidovre, 2650, Denmark
URL: https://clinicaltrials.gov/show/NCT02232971