Pharmacokinetics and Pharmacodynamics of BIOD-961 vs. Marketed Glucagons

Biodel

Status and phase: Completed; Phase 1

Conditions: Hypoglycemia

Treatments: Drug: Novo Glucagon; Drug: Lilly Glucagon; Drug: BIOD-961

Study type: Interventional

Funder types: Industry

Identifiers

NCT02403648

6-101

Details and patient eligibility

About

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.

Full 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).

Enrollment: 15 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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15 participants in 6 patient groups

BIOD-961, 1 mg IM

Experimental group

Description:

Intramuscular delivery of BIOD-961.

Treatment:

Drug: BIOD-961

Lilly Glucagon, 1 mg IM

Active Comparator group

Description:

Intramuscular delivery of Lilly glucagon.

Treatment:

Drug: Lilly Glucagon

Novo Glucagon, 1 mg IM

Active Comparator group

Description:

Intramuscular delivery of Novo glucagon.

Treatment:

Drug: Novo Glucagon

BIOD-961, 1 mg SC

Experimental group

Description:

Subcutaneous delivery of BIOD-961,

Treatment:

Drug: BIOD-961

Lilly Glucagon, 1 mg SC

Active Comparator group

Description:

Subcutaneous delivery of Lilly glucagon.

Treatment:

Drug: Lilly Glucagon

Novo Glucagon, 1 mg SC

Active Comparator group

Description:

Subcutaneous delivery of Novo glucagon.

Treatment:

Drug: Novo Glucagon