Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Eli Lilly and Company
With
Locemia Solutions ULC
Age
18–70
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Males or females with a history of Type 1 or Type 2 insulin-using diabetes of at least 1 year duration (basal only, basal bolus, meal-time only, or twice a day pre-mixed insulin)
A female participant must meet one of the following criteria:
* Participant is of childbearing potential and agrees to use one of the accepted contraceptive regimens from at least 28 days prior to the first administration of the study drug, during the study and for at least 30 days after the last dose of the study drug.
* 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)
Participants with a body mass index (BMI) greater than or equal to 18.50 kilograms per square meter (kg/m²) and below 35.00 kg/m²
Light-, non- or ex-smokers
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
You may not be if
Females who are pregnant, actively attempting to get pregnant, or are lactating
History of significant hypersensitivity to glucagon or any related products as well as severe hypersensitivity reactions (such as angioedema) to any drugs
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
Suicidal tendency, history of or disposition to seizures, state of confusion, clinically relevant psychiatric diseases
Known presence of rare hereditary problems of galactose and /or lactose intolerance
Known presence or history of pheochromocytoma (i.e. adrenal gland tumor) or insulinoma (i.e. insulin secreting pancreas tumor) Presence of clinically significant findings on nasal examination or bilateral anterior rhinoscopy, such as structural abnormalities, nasal polyps, marked septal deviation, nasal tumors
Nasal surgery in the previous 28 days before Day 1 of this study
Daily use of a systemic beta-blocker drug, indomethacin, warfarin or anticholinergic drugs in the previous 28 days before Day 1 of this study
Any other concomitant maintenance therapy that would influence the outcome of the trial or compromise the safety of the participant, at the discretion of the Investigator and the Sponsor, in the previous 28 days before Day 1 of this study
Significant history of drug dependency or alcohol abuse
Any clinically significant illness in the previous 28 days before Day 1 of this study
Any history of tuberculosis and/or prophylaxis for tuberculosis
Positive urine screening of alcohol and/or drugs of abuse
Concurrent participation or intention of participating in another clinical trial during this study
Participants who took an Investigational Product (in another clinical trial) in the previous 28 days before Day 1 of this study or who have already participated in this clinical study
Participants who donated 50 milliliters (mL) or more of blood in the previous 28 days before Day 1 of this study
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
Clareo Health | A Study of Single and Repeated Doses of Glucagon Administered to Participants With Diabetes
