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Clinical Trial Details

Trial ID: L3460
Source ID: NCT01640834
Associated Drug: Ly2409021
Title: Study of LY2409021 in Participants With Type 1 Diabetes
Acronym:
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT01640834/results
Conditions: Diabetes Mellitus, Type 1
Interventions: DRUG: LY2409021|DRUG: Placebo|DRUG: Glucagon
Outcome Measures: Primary: Pharmacodynamics: Change From Baseline to Day 2 in 24-hour Insulin Dose, The mean absolute change in total insulin dose over 24 hours (Day 2, 24-hour insulin dose - Day 1, 24-hour insulin dose) is reported., Baseline (Day 1), Day 2 | Secondary: Pharmacodynamics: Percentage Change From Baseline to Day 2 in 24-hour Insulin, The percentage change in total insulin dose over 24 hours (Day 2, 24-hour insulin dose - Day 1, 24-hour insulin dose) is reported., Baseline (Day 1), Day 2|Pharmacokinetics: Maximum Concentration (Cmax) of LY2409021, Predose (Day 2) through 120 hours postdose (Day 7)|Pharmacokinetics: Area Under the Concentration Curve (AUC) of LY2409021, Exposure in terms of AUC of LY2409021 from time 0 extrapolated to infinity (AUCinf) is reported., Predose (Day 2) through 120 hours postdose (Day 7)|Pharmacodynamics: Change From Baseline in 24 Hour Insulin Dose During Drug Washout Period, Data were not captured, and, therefore, this outcome measure was not analyzed. Zero participants were included in the analysis., Baseline (Day 1), Day 3 up to Day 6|Pharmacodynamics: Change From Baseline in 24 Hour Insulin Dose Needed to Maintain Euglycemia, Data were not captured, and, therefore, this outcome measure was not analyzed. Zero participants were included in the analysis., Baseline (Day 1), Day 3 up to Day 6|Pharmacodynamics: Maximum Concentration (Cmax) of Glucose Concentration After 1 Milligram (mg) Glucagon Injection on Day 3, The Cmax of glucose following a single dose of glucagon (1 mg) administered via an intramuscular injection is reported., Day 3|Pharmacodynamics: Area Under the Glucose Concentration Curve After a Single Dose of Glucagon on Day 3, Area under the glucose concentration curve from time 0 through 2 hours after a single dose of glucagon (1 milligram) administered via an intramuscular injection is reported., Day 3
Sponsor/Collaborators: Sponsor: Eli Lilly and Company
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE1
Enrollment: 20
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2012-07
Completion Date: 2012-09
Results First Posted: 2018-10-29
Last Update Posted: 2018-10-29
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., Neuss, 41460, Germany
URL: https://clinicaltrials.gov/show/NCT01640834

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress