Trial ID: | L3456 |
Source ID: | NCT01959334
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Associated Drug: |
Nasal Glucagon (Ng)
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Title: |
Evaluate the Immunogenicity of a Novel Glucagon Formulation
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Acronym: |
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Status: |
COMPLETED
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Study Results: |
YES
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Results: |
https://ClinicalTrials.gov/show/NCT01959334/results
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Conditions: |
Drug-specific Antibodies|Diabetes Mellitus
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Interventions: |
DRUG: Nasal Glucagon (NG)|DRUG: Glucagon IM
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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) |
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Sponsor/Collaborators: |
Sponsor: Eli Lilly and Company | Collaborators: Locemia Solutions ULC
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Gender: |
ALL
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Age: |
ADULT, OLDER_ADULT
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Phases: |
PHASE3
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Enrollment: |
75
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Study Type: |
INTERVENTIONAL
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Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: OTHER
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Start Date: |
2013-09
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Completion Date: |
2013-12
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Results First Posted: |
2019-09-06
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Last Update Posted: |
2019-09-06
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Locations: |
Algorithme Pharma Inc., Laval, Quebec, H7V 4B3, Canada
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URL: |
https://clinicaltrials.gov/show/NCT01959334
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