Evaluate the Immunogenicity of a Novel Glucagon Formulation
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|ClinicalTrials.gov Identifier: NCT01959334|
Recruitment Status : Completed
First Posted : October 10, 2013
Results First Posted : September 6, 2019
Last Update Posted : September 6, 2019
|Condition or disease||Intervention/treatment||Phase|
|Drug-specific Antibodies Diabetes Mellitus||Drug: Nasal Glucagon (NG) Drug: Glucagon IM||Phase 3|
This study is a single center, randomized, laboratory-blinded, three periods, parallel design study.
The main objective of this study is to evaluate the immunogenicity of repeated single doses of glucagon following nasal and intramuscular (IM) administration in adults with Type 1 or Type 2 diabetes (T1D or T2D). The secondary objective is to evaluate the safety and tolerability of glucagon following NG and IM administration in adults with T1D or T2D.
A single dose of glucagon was administered in the morning after a 10-hour overnight fast, either by intranasal or intramuscular route, on 3 occasions. Each drug administration was separated by at least seven calendar days. Patients were randomized in a 2:1 ratio (NG:IMG) to receive NG or IMG at each of the 3 periods.
Blood samples were collected for measurement of anti-glucagon antibodies at screening visit, prior to dosing at Period 3, and at the post-study visit (approximately 4 weeks after the last glucagon administration).
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||75 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Single Center, Randomized, Parallel Safety Study To Evaluate The Immunogenicity Of A Novel Glucagon Formulation Compared To Commercially Available Glucagon Administered By Intramuscular Injection In Adults With Type 1 OR Type 2 Diabetes|
|Study Start Date :||September 2013|
|Actual Primary Completion Date :||December 2013|
|Actual Study Completion Date :||December 2013|
Active Comparator: Glucagon IM
Glucagon dose of 1 milligram (mg) administered intramuscularly (IM).
Drug: Glucagon IM
Other Name: GlucaGen® HypoKit
Experimental: Nasal Glucagon (NG
Nasal Glucagon (NG) doses of 3 mg administered intra-nasally.
Drug: Nasal Glucagon (NG)
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01959334
|Algorithme Pharma Inc.|
|Laval, Quebec, Canada, H7V 4B3|
|Study Director:||Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)||Eli Lilly and Company|