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Pharmacokinetics and Pharmacodynamics of BIOD-961 vs. Marketed Glucagons

Information source: Biodel
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hypoglycemia

Intervention: BIOD-961 (Drug); Lilly Glucagon (Drug); Novo Glucagon (Drug)

Phase: Phase 1

Status: Active, not recruiting

Sponsored by: Biodel

Official(s) and/or principal investigator(s):
Linda Morrow, MD, Principal Investigator, Affiliation: Profil Institute for Clinical Research, Inc.
Alan Krasner, MD, Study Director, Affiliation: Biodel


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.

Clinical Details

Official title: Pharmacokinetics and Pharmacodynamics of BIOD-961 vs. Glucagon for Injection (Eli Lilly) and GlucaGen® (Novo Nordisk) Administered by Subcutaneous and Intramuscular Injection in Normal, Healthy Volunteers

Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome:

Glucagon maximal concentration and area under curve

Glucose maximal concentration and area under curve

Secondary outcome:

Time to maximal glucagon concentration

Time to maximal glucose concentration

Maximal glucose excursion

Area under the glucose time curve from 0 to return to baseline after blood glucose peaked

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).


Minimum age: 18 Years. Maximum age: 60 Years. Gender(s): Both.


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


Locations and Contacts

Additional Information

Starting date: November 2014
Last updated: March 30, 2015

Page last updated: August 23, 2015

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