Trials / Completed
CompletedNCT01959334
Evaluate the Immunogenicity of a Novel Glucagon Formulation
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
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 75 (actual)
- Sponsor
- Eli Lilly and Company · Industry
- Sex
- All
- Age
- 18 Years – 70 Years
- Healthy volunteers
- Not accepted
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).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Nasal Glucagon (NG) | |
| DRUG | Glucagon IM |
Timeline
- Start date
- 2013-09-01
- Primary completion
- 2013-12-01
- Completion
- 2013-12-01
- First posted
- 2013-10-10
- Last updated
- 2019-09-06
- Results posted
- 2019-09-06
Locations
1 site across 1 country: Canada
Source: ClinicalTrials.gov record NCT01959334. Inclusion in this directory is not an endorsement.