Overview

Evaluate the Immunogenicity of a Novel Glucagon Formulation

Status:
Completed
Trial end date:
2013-12-01
Target enrollment:
0
Participant gender:
All
Summary
This study provides information on immunogenicity of Nasal Glucagon (AMG504-1) with regards to the potential development of treatment-emergent anti-glucagon antibodies.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Eli Lilly and Company
Collaborator:
Locemia Solutions ULC
Treatments:
Glucagon
Glucagon-Like Peptide 1
Criteria
Inclusion Criteria:

1. Availability for the entire study period

2. Motivated volunteer and absence of intellectual problems likely to limit the validity
of consent to participate in the study or the compliance with protocol requirements;
ability to cooperate adequately; ability to understand and observe the instructions of
the physician or designee

3. Male or female patient with a history of Type 1 or Type 2 diabetes of at least 2 years
duration

4. A female volunteer must meet one of the following criteria:

1. Participant is of childbearing potential and agrees to use one of the accepted
contraceptive regimens throughout the entire duration of the study (from the
screening visit until study completion). Additionally, if the participant is
using systemic contraceptives, she must use an additional form of acceptable
contraception. An acceptable method of contraception includes one of the
following:

- Abstinence from heterosexual intercourse

- Systemic contraceptives (birth control pills, injectable/implant /insertable
hormonal birth control products, transdermal patch)

- Intrauterine device (with and without hormones)

- Condom with spermicide

or

2. Participant is of non-childbearing potential, defined as surgically sterile (i.e.
has undergone complete hysterectomy, bilateral oophorectomy, or tubal ligation)
or in a menopausal state (at least 1 year without menses)

5. Volunteer aged of at least 18 years but not older than 70 years

6. Volunteer with a BMI greater than or equal to 18.50 and below 35.00 kg/m2

7. Light-, non- or ex-smokers. A light smoker is defined as someone smoking 10 cigarettes
or less per day for at least 3 months before day 1 of this study. An ex- smoker is
defined as someone who completely stopped smoking for at least 6 months before day 1
of this study

8. In good general health with no conditions that could influence the outcome of the
trial, and in the judgment of the Investigator is a good candidate for the study based
on review of available medical history, physical examination and clinical laboratory
evaluations

9. Willingness to adhere to the protocol requirements as evidenced by the informed
consent form (ICF) duly read, signed and dated by the volunteer

The informed consent form must be signed by all volunteers, prior to their participation in
the study.

Exclusion Criteria:

1. Females who are pregnant, actively attempting to get pregnant, or are lactating

2. History of significant hypersensitivity to glucagon or any related products as well as
severe hypersensitivity reactions (such as angioedema) to any drugs

3. Presence of significant gastrointestinal, liver or kidney disease, or any other
conditions which in the judgment of the Investigator could interfere with the
absorption, distribution, metabolism or excretion of drugs, or could potentiate or
predispose to undesired effects

4. Suicidal tendency, history of or disposition to seizures, state of confusion,
clinically relevant psychiatric diseases

5. Known presence of rare hereditary problems of galactose and /or lactose intolerance

6. Known presence or history of pheochromocytoma (i.e. adrenal gland tumor) or insulinoma
(i.e. insulin secreting pancreas tumor)

7. Presence of clinically significant findings on nasal examination or bilateral anterior
rhinoscopy, such as structural abnormalities, nasal polyps, marked septal deviation,
nasal tumors

8. Nasal surgery in the previous 28 days before Day 1 of this study

9. Use of a systemic beta-blocker drug, indomethacin, warfarin or anticholinergic drugs
in the previous 28 days before Day 1 of this study

10. Use of an immunomodulator medication (including steroids, glucocorticoids, tacrolimus,
etc.) in the 28 days before day 1 of this study

11. Any other concomitant maintenance therapy that would influence the outcome of the
trial or compromise the safety of the patient, at the discretion of the Investigator
and the Sponsor, in the previous 28 days before day 1 of this study

12. Significant history of drug dependency or alcohol abuse (> 3 units of alcohol per day,
intake of excessive alcohol, acute or chronic)

13. Any clinically significant illness in the previous 28 days before day 1 of this study

14. Any history of tuberculosis and/or prophylaxis for tuberculosis

15. Positive urine screening of alcohol and/or drugs of abuse

16. Females who are pregnant according to a positive pregnancy test

17. Concurrent participation or intention of participating in another clinical trial
during this study

18. Volunteers who took an Investigational Product (in another clinical trial) or donated
50 mL or more of blood in the previous 28 days before day 1 of this study

19. Donation of 500 mL or more of blood (Canadian Blood Services, Hema-Quebec, clinical
studies, etc.) in the previous 56 days before day 1 of this study

No participants will be allowed to enroll in this study more than once (i.e. if the study
is conducted with more than 1 group).