Hypoglycemia
Conditions
Brief summary
BIOD-961 is a dry powder formulation of glucagon intended for use in a device that mixes (reconstitutes) the powder with liquid to make it easier for users to treat patients with severe hypoglycemia. The purpose of this study is to evaluate how much BIOD-961 absorbs into the bloodstream, how much it raises glucose concentrations (the intended effect) and compare to two glucagon products already on the market.
Detailed description
Subjects receive on separate days, in random order one of the following: 1 mg BIOD-961 intramuscularly (IM), 1 mg Lilly (IM), 1 mg Novo (IM), 1 mg BIOD-961 subcutaneously (SC), 1 mg Lilly (SC), and 1 mg Novo (SC).
Interventions
Sponsors
Biodel
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
* Body Mass Index: 18.5-25.0 kg/m2 inclusive. * Subject has provided informed consent and has signed and dated an informed consent form before any trial-related activities.
Exclusion criteria
* Type 1 or type 2 diabetes mellitus. * History of pheochromocytoma, insulinoma, glucagonoma, or glycogen storage disease. * History of regular alcohol consumption as defined by alcohol intake exceeding 7 drinks per week for females or 14 drinks per week for males, where 1 drink = 5 ounces of wine or 12 ounces of beer or 1.5 ounces of hard liquor. * Significant cardiovascular (to include New York Heart Association (NYHA) Class III or- IV functional capacity or uncontrolled hypertension), respiratory, gastrointestinal, hepatic, renal, neurological, psychiatric and/or hematological disease. * Any significant cardiovascular event history, including angina, myocardial infarction, therapeutic coronary procedure (e.g, percutaneous transluminal coronary angioplasty, coronary bypass surgery), stroke, or transient ischemic attack. * Females who are breast feeding, pregnant, or intending to become pregnant during the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Glucagon maximal concentration and area under curve | 240 minutes post dose |
| Glucose maximal concentration and area under curve | 240 minutes after dose |
Secondary
| Measure | Time frame |
|---|---|
| Time to maximal glucagon concentration | 240 minutes after dose |
| Time to maximal glucose concentration | 240 minutes after dose |
| Maximal glucose excursion | 240 minutes after dose |
| Area under the glucose time curve from 0 to return to baseline after blood glucose peaked | 240 minutes after dose |
Outcome results
None listed