Pharmacokinetics and Pharmacodynamics of BIOD-961 vs. Marketed Glucagons

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-11-30

Brief Summary

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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.

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Detailed Description

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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).

Conditions

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Hypoglycemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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BIOD-961, 1 mg IM

Intramuscular delivery of BIOD-961.

Group Type EXPERIMENTAL

BIOD-961

Intervention Type DRUG

BIOD-961 is a lyophilized glucagon formulation.

Lilly Glucagon, 1 mg IM

Intramuscular delivery of Lilly glucagon.

Group Type ACTIVE_COMPARATOR

Lilly Glucagon

Intervention Type DRUG

Novo Glucagon, 1 mg IM

Intramuscular delivery of Novo glucagon.

Group Type ACTIVE_COMPARATOR

Novo Glucagon

Intervention Type DRUG

BIOD-961, 1 mg SC

Subcutaneous delivery of BIOD-961,

Group Type EXPERIMENTAL

BIOD-961

Intervention Type DRUG

BIOD-961 is a lyophilized glucagon formulation.

Lilly Glucagon, 1 mg SC

Subcutaneous delivery of Lilly glucagon.

Group Type ACTIVE_COMPARATOR

Lilly Glucagon

Intervention Type DRUG

Novo Glucagon, 1 mg SC

Subcutaneous delivery of Novo glucagon.

Group Type ACTIVE_COMPARATOR

Novo Glucagon

Intervention Type DRUG

Interventions

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BIOD-961

BIOD-961 is a lyophilized glucagon formulation.

Intervention Type DRUG

Lilly Glucagon

Intervention Type DRUG

Novo Glucagon

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes