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Clinical Trial Details

Trial ID: L3443
Source ID: NCT02806973
Associated Drug: Nasal Glucagon
Title: A Study of Single or Repeated Doses of Glucagon in Participants With Diabetes
Acronym:
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT02806973/results
Conditions: Diabetes Mellitus, Type 1|Diabetes Mellitus, Type 2
Interventions: DRUG: Nasal Glucagon
Outcome Measures: Primary: Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to T(AUC[0-tlast]) of Baseline-Adjusted Glucagon, -0.5, -0.25, 0.00, 0.08, 0.17, 0.33, 0.50, 0.75, 1.00, 1.25, 1.50, 1.75, 2.00, 2.50, 3.00 hours after glucagon administration|PK: Time to Maximum Concentration (Tmax) of Baseline Adjusted Glucagon, -0.5, -0.25, 0.00, 0.08, 0.17, 0.33, 0.50, 0.75, 1.00, 1.25, 1.50, 1.75, 2.00, 2.50, 3.00 hours after glucagon administration|PK: Maximum Change From Baseline Concentration (Cmax) of Glucagon, -0.5, -0.25, 0.00, 0.08, 0.17, 0.33, 0.50, 0.75, 1.00, 1.25, 1.50, 1.75, 2.00, 2.50, 3.00 hours after glucagon administration|Pharmacodynamics (PD): Area Under the Effect Concentration Time Curve (AUEC0-3) of Baseline-Adjusted Glucose From Time Zero up to 3 Hours, -0.5, -0.25, 0.00, 0.08, 0.17, 0.33, 0.50, 0.75, 1.00, 1.25, 1.50, 1.75, 2.00, 2.50, 3.00 hours after glucagon administration|PD: Time to Maximum Concentration (Tmax) of Baseline-Adjusted Glucose, -0.5, -0.25, 0.00, 0.08, 0.17, 0.33, 0.50, 0.75, 1.00, 1.25, 1.50, 1.75, 2.00, 2.50, 3.00 hours after glucagon administration|PD: Baseline-Adjusted Glucose Maximum Concentration (BGmax), -0.5, -0.25, 0.00, 0.08, 0.17, 0.33, 0.50, 0.75, 1.00, 1.25, 1.50, 1.75, 2.00, 2.50, 3.00 hours after glucagon administration | Other: PK: Area Under the Curve Extrapolated to Infinity (AUC[0-inf]) of Glucagon, -0.5, -0.25, 0.00, 0.08, 0.17, 0.33, 0.50, 0.75, 1.00, 1.25, 1.50, 1.75, 2.00, 2.50, 3.00 hours after glucagon administration
Sponsor/Collaborators: Sponsor: Eli Lilly and Company | Collaborators: Locemia Solutions ULC
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE1
Enrollment: 32
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: BASIC_SCIENCE
Start Date: 2015-01
Completion Date: 2015-04
Results First Posted: 2019-10-14
Last Update Posted: 2019-10-14
Locations: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Mount-Royal, Quebec, H3P 3P1, Canada
URL: https://clinicaltrials.gov/show/NCT02806973

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress