Clinical Usability of Intranasal Glucagon in Treatment of Hypoglycemia

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

129 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-05-31

Study Completion Date

2015-08-31

Brief Summary

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Up to two hundred (200) adult participants with type 1 diabetes (T1D) aged 18 to 75 years will be selected for inclusion in the study. The target is to obtain treatment response and user-experience data following use of nasal glucagon (AMG504-1) in treating episodes of hypoglycemia. The population will be enriched to include participants who suffer from impaired hypoglycemia awareness.

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Detailed Description

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This study is designed to evaluate the effectiveness of nasal glucagon (NG) administered under clinical use conditions in treating episodes of hypoglycemia in persons with T1D.

This study also aims to assess the ease with which caregivers can administer the experimental medication in treatment of hypoglycemic events.

The study will also generate data on the participants' assessment of local tolerability and provide information on immunogenicity of nasal glucagon with regards to the potential development of anti-glucagon antibodies.

Conditions

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Hypoglycemia Diabetes Mellitus Drug-Specific Antibodies

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Nasal glucagon

3 mg nasal glucagon powder delivered using a nasal powder dosing device.

Group Type EXPERIMENTAL

Nasal Glucagon

Intervention Type DRUG

3 mg nasal glucagon powder

Interventions

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Nasal Glucagon

3 mg nasal glucagon powder

Intervention Type DRUG

Other Intervention Names

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Dry-Mist Nasal Glucagon AMG504-1 LY900018

Eligibility Criteria

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Inclusion Criteria

* Male or Female Person with diabetes (PWD) lives with or is in frequent contact with one or more caregivers who are available to administer the glucagon in case of an episode of severe or moderate hypoglycemia
* With a history of type 1 diabetes \>1 year
* At least 18 years of age but not older than 75 years
* Body mass index (BMI) greater than or equal to 18.50 and below 35.00 kg/m2.
* PWD will be otherwise healthy according to medical history, general physical examination (including vital signs), nasal examination, and laboratory tests (biochemistry, hematology, and urinalysis).
* For female subjects, a urine pregnancy test must be negative.

Exclusion Criteria

* Presence or history of pheochromocytoma (i.e. adrenal gland tumor) or insulinoma.
* Use of a daily systemic beta-blockers, indomethacin, warfarin or anticholinergic drugs.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No