Diabetes Mellitus Clinical Trial
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
This study provides information on immunogenicity of Nasal Glucagon (AMG504-1) with regards to the potential development of treatment-emergent anti-glucagon antibodies.
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).
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