Clinical trial NCT03339453: A Study of Nasal Glucagon in Participants With Type 1 Diabetes Mellitus
Official title: Comparison of Glucagon Administered by Either the Nasal (LY900018) or Intra-muscular (GlucaGen®) Routes in Adult Patients With Type 1 Diabetes Mellitus During Controlled Insulin-Induced Hypoglycemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Hypoglycemia
Diabetes Mellitus, Type 1
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2017-11-13
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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 with type 1 diabetes mellitus (T1DM).


Eligibility criteria: Inclusion Criteria:

* Diagnosis of Type 1 Diabetes Mellitus (T1DM) for at least 2 years and receiving daily insulin since the time of diagnosis

Exclusion Criteria:

* 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

Primary outcomes:
measure: Percentage of Participants Achieving Treatment Success During Controlled Insulin-Induced Hypoglycemia
timeFrame: Pre-dose up to 30 minutes post each glucagon administration
Secondary outcomes:
measure: Pharmacodynamics (PD): Change From Baseline in Maximal Blood Glucose (BGmax)
timeFrame: Pre-dose; 5, 10, 15, 20, 25, 30, 40, 50, 60, and 90 minutes after glucagon administration
measure: PD: Time to Maximum Concentration (Tmax) of Baseline-Adjusted Glucose
timeFrame: Pre-dose; 5, 10, 15, 20, 25, 30, 40, 50, 60, and 90 minutes after glucagon administration
measure: Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to Tlast (AUC[0-tlast]) of Baseline Adjusted Glucagon
timeFrame: Pre-dose; 5, 10, 15, 20, 25, 30, 40, 50, 60, 90, 120, and 240 minutes after glucagon administration
measure: PK: Maximum Change From Baseline Concentration (Cmax) of Glucagon
timeFrame: Pre-dose; 5, 10, 15, 20, 25, 30, 40, 50, 60, 90, 120, and 240 minutes after glucagon administration
measure: PK: Time to Maximum Concentration (Tmax) of Baseline Adjusted Glucagon
timeFrame: Pre-dose; 5, 10, 15, 20, 25, 30, 40, 50, 60, 90, 120, and 240 minutes after glucagon administration
Other outcomes:
Locations:
city: Mainz
country: Germany
facility: 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.
city: Neuss
country: Germany
facility: 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.
Study officials:
affiliation: Eli Lilly and Company
name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
role: STUDY_DIRECTOR
References:
citation: Suico JG, Hovelmann U, Zhang S, Shen T, Bergman B, Sherr J, Zijlstra E, Frier BM, Plum-Morschel L. Glucagon Administration by Nasal and Intramuscular Routes in Adults With Type 1 Diabetes During Insulin-Induced Hypoglycaemia: A Randomised, Open-Label, Crossover Study. Diabetes Ther. 2020 Jul;11(7):1591-1603. doi: 10.1007/s13300-020-00845-7. Epub 2020 Jun 8.