NCT02403648

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for phase_1

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2014

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

March 26, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 31, 2015

Completed
Last Updated

January 15, 2016

Status Verified

January 1, 2016

Enrollment Period

4 months

First QC Date

March 26, 2015

Last Update Submit

January 14, 2016

Conditions

Hypoglycemia

Outcome Measures

Primary Outcomes (2)

  • Glucagon maximal concentration and area under curve

    240 minutes post dose

  • Glucose maximal concentration and area under curve

    240 minutes after dose

Secondary Outcomes (4)

  • 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

Study Arms (6)

BIOD-961, 1 mg IM

EXPERIMENTAL

Intramuscular delivery of BIOD-961.

Drug: BIOD-961

Lilly Glucagon, 1 mg IM

ACTIVE COMPARATOR

Intramuscular delivery of Lilly glucagon.

Drug: Lilly Glucagon

Novo Glucagon, 1 mg IM

ACTIVE COMPARATOR

Intramuscular delivery of Novo glucagon.

Drug: Novo Glucagon

BIOD-961, 1 mg SC

EXPERIMENTAL

Subcutaneous delivery of BIOD-961,

Drug: BIOD-961

Lilly Glucagon, 1 mg SC

ACTIVE COMPARATOR

Subcutaneous delivery of Lilly glucagon.

Drug: Lilly Glucagon

Novo Glucagon, 1 mg SC

ACTIVE COMPARATOR

Subcutaneous delivery of Novo glucagon.

Drug: Novo Glucagon

Interventions

BIOD-961DRUG

BIOD-961 is a lyophilized glucagon formulation.

BIOD-961, 1 mg IMBIOD-961, 1 mg SC
Lilly GlucagonDRUG
Lilly Glucagon, 1 mg IMLilly Glucagon, 1 mg SC
Novo GlucagonDRUG
Novo Glucagon, 1 mg IMNovo Glucagon, 1 mg SC

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Hypoglycemia

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Linda Morrow, MD

    Profil Institute for Clinical Research, Inc.

    PRINCIPAL INVESTIGATOR

  • Alan Krasner, MD

    Biodel

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 26, 2015

First Posted

March 31, 2015

Study Start

November 1, 2014

Primary Completion

March 1, 2015

Last Updated

January 15, 2016

Record last verified: 2016-01