Conditions: Drug-specific Antibodies Diabetes Mellitus
Keywords: Diabetes Mellitus Hypoglycemia Glucagon Anti-glucagon Antibody Immunogenicity
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 75
Healthy volunteers: no

Brief summary:
This study provides information on immunogenicity of Nasal Glucagon (AMG504-1) with regards to the potential development of treatment-emergent anti-glucagon antibodies.

Detailed description:
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).

Arms:
arm 1: Glucagon dose of 1 milligram (mg) administered intramuscularly (IM). arm 2: Nasal Glucagon (NG) doses of 3 mg administered intra-nasally.

Interventions: intervention 1: Nasal Glucagon (NG) intervention 2: Glucagon IM
Intervention descriptions: intervention 1: None intervention 2: None

Protocol document: