Status:
COMPLETED
A Study of Nasal Glucagon in Participants With Type 1 Diabetes Mellitus
Lead Sponsor:
Eli Lilly and Company
Conditions:
Hypoglycemia
Diabetes Mellitus, Type 1
Eligibility:
All Genders
18-64 years
Phase:
PHASE1
Brief Summary
The purpose of this study is to compare a needle-free treatment of hypoglycemia with nasal glucagon (study drug) to a marketed glucagon administered by the intramuscular (IM) route, in participants wi...
Eligibility Criteria
Inclusion
- Diagnosis of Type 1 Diabetes Mellitus (T1DM) for at least 2 years and receiving daily insulin since the time of diagnosis
Exclusion
- Have a history of hypersensitivity to glucagon or any related products or severe hypersensitivity reactions (such as angioedema) to any drugs
- Have a history of pheochromocytoma (that is, adrenal gland tumor) or insulinoma
- Occurrence of an episode of severe hypoglycemia (defined as requiring the assistance of another person in the 1 month prior to enrolling in the study)
- Have a history of epilepsy or seizure disorder
- Are women who are pregnant or lactating
- Have, except for the current regimen of insulin therapy and concomitant medication, regular use of or intended use of any over-the-counter or prescription medications or nutritional supplements that treat hyperglycemia or insulin resistance or that promote weight loss within 14 days before dosing
- Daily use of systemic beta-blocker, indomethacin, warfarin or anticholinergic drugs
- Require daily insulin treatment greater than (\>)1.5 unit/kilograms (U/kg)/body weight
Key Trial Info
Start Date :
November 10 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 13 2018
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT03339453
Start Date
November 10 2017
End Date
January 13 2018
Last Update
September 23 2019
Active Locations (2)
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1
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST) or speak with your personal physician.
Mainz, Germany, 55116
2
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST) or speak with your personal physician.
Neuss, Germany