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Clinical Trial Details

Trial ID: L3456
Source ID: NCT01959334
Associated Drug: Nasal Glucagon (Ng)
Title: Evaluate the Immunogenicity of a Novel Glucagon Formulation
Acronym:
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT01959334/results
Conditions: Drug-specific Antibodies|Diabetes Mellitus
Interventions: DRUG: Nasal Glucagon (NG)|DRUG: Glucagon IM
Outcome Measures: Primary: Percentage of Participants With Treatment-emergent Anti-Drug Antibody (ADA), Glucagon anti-drug antibodies (ADA) were assessed at baseline through study completion. Percentage of participants (Pts) with ADA=(number of Pts with treatment-emergent ADA/number of Pts assessed)\*100. Treatment-Emergent ADA includes treatment-induced ADA and treatment boosted ADA. Treatment-induced is defined as participants with 'Not Detected' ADA at baseline (drug-naive) and at least one post-baseline ADA 'Detected' sample with a corresponding titer that is one 2-fold dilution higher than the MRD (minimal required dilution) of the assay. For the nasal glucagon Tier 1-3 ADA screening assay, the MRD is 1:20. Treatment-boosted is defined as Patient with ADA 'Detected' at baseline (drug-naive) and at least one post-baseline ADA 'Detected' sample with a corresponding titer that is at least (\>or=) 4-fold higher than the baseline titer., Baseline through study completion (up to 10 weeks)|Percentage of Participants With Neutralizing Antibodies, Baseline through study completion (up to 10 weeks)|Number of Participants With At Least One Adverse Event, Safety parameters assessed included the occurrence of adverse events, the measurement of clinical laboratory parameters; vital signs, ECGs, physical examination, blood glucose, and examination of the injection site (following the IM administration). An AE was defined as any untoward medical occurrence in a clinical investigation subject administered the investigational product and which did not necessarily have a causal relationship with this treatment A summary of other nonserious AEs, and all SAE's, regardless of causality, is located in the Reported Adverse Events section., First dose of study drug through the post-study completion (up to 10 weeks) |
Sponsor/Collaborators: Sponsor: Eli Lilly and Company | Collaborators: Locemia Solutions ULC
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 75
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: OTHER
Start Date: 2013-09
Completion Date: 2013-12
Results First Posted: 2019-09-06
Last Update Posted: 2019-09-06
Locations: Algorithme Pharma Inc., Laval, Quebec, H7V 4B3, Canada
URL: https://clinicaltrials.gov/show/NCT01959334