Pharmacokinetics and Pharmacodynamics of BIOD-961 vs. Marketed Glucagons

Phase 1

Completed

• Conditions: Hypoglycemia
• Interventions: Drug: BIOD-961; Drug: Lilly Glucagon; Drug: Novo Glucagon

• Registration Number: NCT02403648
• Lead Sponsor: Biodel

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).

Study Timeline

• Study Start: 2014-11
• Primary Completion: 2015-03
• Study First Submitted: 2015-03-26
• Study First Submitted QC: 2015-03-30
• Study First Posted: 2015-03-31
• Status Verified: 2016-01
• Last Update Submitted: 2016-01-14
• Last Update Posted: 2016-01-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
BIOD-961, 1 mg IM	BIOD-961	Intramuscular delivery of BIOD-961.
Lilly Glucagon, 1 mg IM	Lilly Glucagon	Intramuscular delivery of Lilly glucagon.
Lilly Glucagon, 1 mg SC	Lilly Glucagon	Subcutaneous delivery of Lilly glucagon.
Novo Glucagon, 1 mg SC	Novo Glucagon	Subcutaneous delivery of Novo glucagon.
Novo Glucagon, 1 mg IM	Novo Glucagon	Intramuscular delivery of Novo glucagon.
BIOD-961, 1 mg SC	BIOD-961	Subcutaneous delivery of BIOD-961,

Primary Outcome Measures

Name	Time	Method
Glucagon maximal concentration and area under curve	240 minutes post dose
Glucose maximal concentration and area under curve	240 minutes after dose

Secondary Outcome Measures

Name	Time	Method
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