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Clinical Trial Details

Trial ID: L3194
Source ID: NCT03738865
Associated Drug: G-Pen
Title: G-Pen Compared to Glucagen Hypokit for Severe Hypoglycemia Rescue in Adults With Type 1 Diabetes
Acronym:
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT03738865/results
Conditions: Insulin Hypoglycemia|Type 1 Diabetes Mellitus|Severe Hypoglycemia
Interventions: DRUG: G-Pen|DRUG: Novo Glucagon
Outcome Measures: Primary: Severe Hypoglycemia Rescue, Number of subjects with an increase in plasma glucose concentration from below 54 mg/dL (3 mmol/L) to greater than 70 mg/dL (3.89 mmol/L) or an increase in plasma glucose concentration \> 20 mg/dL (\> 1.11 mmol/L) within 30 minutes after administration of glucagon, At 30 minutes following administration of study drug | Secondary: Plasma Glucose Response 1, Number of subjects with an increase in plasma glucose concentration from below 54 mg/dL (3 mmol/L) to greater than 70 mg/dL (3.89 mmol/L) within 30 minutes of a decision to dose, At 30 minutes following a decision to administer study drug|Plasma Glucose Response 2, Number of subjects with an increase in plasma glucose concentration \> 20 mg/dL (\> 1.11 mmol/L) after administration of glucagon., At 0-30 minutes following a decision to administer study drug|Administration Time, Mean time (minutes) to administer study drug from a decision to dose, At 0-10 minutes from a decision to administer study drug|Hypoglycemia Resolution, Mean time (minutes) to complete resolution of the overall sensation of hypoglycemia from a decision to dose, At 0-90 minutes following administration of study drug
Sponsor/Collaborators: Sponsor: Xeris Pharmaceuticals | Collaborators: Empiristat, Inc.
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 132
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: SINGLE (PARTICIPANT)|Primary Purpose: TREATMENT
Start Date: 2018-09-27
Completion Date: 2019-04-02
Results First Posted: 2020-05-13
Last Update Posted: 2020-05-22
Locations: Diablo Clinical Research, Walnut Creek, California, 94598, United States|Atlanta Diabetes Associates, Atlanta, Georgia, 30318, United States|PPD-Las Vegas Clinical Research Unit, Las Vegas, Nevada, 89113, United States|Rainier Research Center, Renton, Washington, 98057, United States|Medizinische Universität Graz-Center for Medical Research, Graz, 8010, Austria|LMC Diabetes & Endocrinology, Toronto, Ontario, M4G 3E8, Canada|AltaSciences, Montréal, Quebec, H3P 3P1, Canada
URL: https://clinicaltrials.gov/show/NCT03738865