Percentage of Participants With Treatment-emergent Anti-Drug Antibody (ADA)
| Group | Value (percentage of participants) |
|---|---|
| Glucagon IM | 0 |
| Nasal Glucagon (NG) | 2.0 |
Trial · Interventional
CompletedPhase 3Results postedRegistry dataCanada
1 trial · 1 completed · 1 with posted results
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
This study provides information on immunogenicity of Nasal Glucagon (AMG504-1) with regards to the potential development of treatment-emergent anti-glucagon antibodies.
Active comparator
Glucagon IM
Glucagon dose of 1 milligram (mg) administered intramuscularly (IM).
Experimental
Nasal Glucagon (NG
Nasal Glucagon (NG) doses of 3 mg administered intra-nasally.
Outcomes the sponsor listed as primary.
Percentage of Participants With Treatment-emergent Anti-Drug Antibody (ADA)
Time frame · Baseline through study completion (up to 10 weeks)
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.
Percentage of Participants With Neutralizing Antibodies
Time frame · Baseline through study completion (up to 10 weeks)
Number of Participants With At Least One Adverse Event
Time frame · First dose of study drug through the post-study completion (up to 10 weeks)
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.
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
| Group | Value (percentage of participants) |
|---|---|
| Glucagon IM | 0 |
| Nasal Glucagon (NG) | 2.0 |
| Group | Value (percentage of participants) |
|---|---|
| Glucagon IM | 0 |
| Nasal Glucagon (NG) | 0 |
| Group | Value (Participants) |
|---|---|
| Glucagon IM | 21 |
| Nasal Glucagon (NG) | 49 |
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| Glucagon IMGlucagon dose of 1 mg administered intramuscularly as 3 doses separated by at least 7 days. | – | 0 / 26 | 21 / 26 |
| Nasal Glucagon (NG)NG administered at 3 mg as 3 doses, separated by at least 7 days. | – | 0 / 49 | 49 / 49 |
Each cell reads participants affected / participants at risk, as the registry posted them.
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