Logo 1 Logo 2

Clinical Trial Details

Trial ID: L2480
Source ID: NCT02806960
Associated Drug: Nasal Glucagon
Title: A Study of Single and Repeated Doses of Glucagon Administered to Participants With Diabetes
Acronym:
Status: TERMINATED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT02806960/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, Day 1: -0.5, -0.25, 0, 0.08, 0.17, 0.33, 0.5, 0.75, 1.0, 1.25, 1.5, 1.75, 2, 2.5, and 3 hours post dose for each treatment|PK: Area Under the Curve Extrapolated to Infinity (AUC[0-inf]) of Baseline Adjusted Glucagon, Day 1: -0.5, -0.25, 0, 0.08, 0.17, 0.33, 0.5, 0.75, 1.0, 1.25, 1.5, 1.75, 2, 2.5, and 3 hours post dose for each treatment|PK: Time to Maximum Concentration (Tmax) of Baseline Adjusted Glucagon, Day 1: -0.5, -0.25, 0, 0.08, 0.17, 0.33, 0.5, 0.75, 1.0, 1.25, 1.5, 1.75, 2, 2.5, and 3 hours post dose for each treatment|PK: Maximum Change From Baseline Concentration (Cmax) of Glucagon, Day 1: -0.5, -0.25, 0, 0.08, 0.17, 0.33, 0.5, 0.75, 1.0, 1.25, 1.5, 1.75, 2, 2.5, and 3 hours post dose for each treatment|Pharmacodynamics (PD): Area Under the Effect Concentration Time Curve (AUEC₀-₁.₅) of Blood Glucose (BG), Day 1: -0.5, -0.25, 0, 0.08, 0.17, 0.33, 0.5, 0.75, 1.0, 1.25, and 1.5 hours post dose for each treatment|PD: Time to Maximum Concentration (Tmax) of Baseline-Adjusted Glucose, Day 1: -0.5, -0.25, 0, 0.08, 0.17, 0.33, 0.5, 0.75, 1.0, 1.25, 1.5, 1.75, 2, 2.5, and 3 hours post dose for each treatment|PD: Baseline-Adjusted Glucose Maximum Concentration (BGmax), Day 1: -0.5, -0.25, 0, 0.08, 0.17, 0.33, 0.5, 0.75, 1.0, 1.25, 1.5, 1.75, 2, 2.5, and 3 hours post dose for each treatment |
Sponsor/Collaborators: Sponsor: Eli Lilly and Company | Collaborators: Locemia Solutions ULC
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE1
Enrollment: 12
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: BASIC_SCIENCE
Start Date: 2014-06
Completion Date: 2014-08
Results First Posted: 2019-12-13
Last Update Posted: 2019-12-13
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/NCT02806960