Clinical trial NCT01556594: Safety and Efficacy of a Novel Glucagon Formulation in Type 1 Diabetic Patients Following Insulin-induced Hypoglycemia
Official title: Phase II Study to Investigate the Safety and Efficacy of 2 Dose Levels of a Novel Glucagon Formulation Compared to Commercially Available Glucagon in Type 1 Diabetic Patients Following Insulin-induced Hypoglycemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hypoglycemia
Keywords: Hypoglycemia
Diabetes mellitus
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
Collaborators: name: Locemia Solutions ULC
First posted: 2012-03-16
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: In this study, participants with Type 1 diabetes received insulin through an infusion into a vein to reduce their blood glucose, and then received nasal glucagon (NG) or glucagon for injection under the skin, and their blood glucose was measured for 3 hours.

The main objective of this study was to evaluate the safety and efficacy of intranasal and subcutaneous glucagon (SC) in reversing insulin-induced hypoglycemia in participants with type 1 diabetes.

Detailed description: In the study, up to four (4) treatments were administered as a single dose either intranasally or subcutaneously to eighteen (18) male or female participants under fasting conditions and following the use of insulin to lower blood glucose. The participants were assigned at random to a group that received one treatment for each of the 3 study periods. The glucagon administrations were separated by approximately 7 calendar days. For 2 participants, a single dose of 3 mg NG was administered at the 4th period that was separated by at least 21 calendar days from the 3rd period.

Eligibility criteria: Inclusion Criteria:

* History of type 1 diabetes between 2 and 30 years
* Receiving daily insulin injections or insulin pump therapy for at least 2 years
* If patient is taking Lantus, Levemir or equivalent once-daily in the evening as basal insulin, must be willing to transition to once-daily in the morning at least 48 hours prior to 1st dosing, and to follow this dosing regimen for the entire duration of the study
* Body mass index (BMI) greater than or equal to 20.00 and below or equal to 33.00 kg/m2
* Female patients must not be pregnant, and must be using effective contraception.
* Light-, non- or ex-smokers. A light smoker is defined as someone smoking 10 cigarettes or less per day for at least 3 months before day 1 of this study. An ex smoker is defined as someone who completely stopped smoking for at least 6 months before day 1 of this study

Exclusion Criteria:

* History of an episode of severe hypoglycemia (as defined by an episode that required third party assistance for treatment) in the previous 6 months before day 1 of this study
* Score ≥4 on the Clarke Hypoglycemia Awareness survey at screening
* Presence or history of pheochromocytoma (i.e. adrenal gland tumor)
* Presence or history of significant upper respiratory or allergic (i.e., seasonal rhinitis) disease
* Presence of clinically significant findings on nasal examination and bilateral anterior rhinoscopy
* Known presence of hereditary problems of galactose and /or lactose intolerance
* History of significant hypersensitivity to glucagon or any related products as well as severe hypersensitivity reactions (like angioedema) to any drugs

Primary outcomes:
measure: Percentage of Responders
timeFrame: Pre-dose; 30 minutes following glucagon administration
measure: Number of Participants With at Least One Adverse Event
timeFrame: Within 3 hours post glucagon administration
Secondary outcomes:
measure: Maximum Concentration (Cmax) of Baseline-Adjusted Glucose
timeFrame: Pre-dose; 0.08, 0.17, 0.25, 0.33, 0.5, 0.67, 1.0, 1.5, 2.0, 2.5 and 3.0 hours after glucagon administration
measure: Time to Maximum Concentration (Tmax) of Baseline-Adjusted Glucose
timeFrame: Pre-dose; 0.08, 0.17, 0.25, 0.33, 0.5, 0.67, 1.0, 1.5, 2.0, 2.5 and 3.0 hours after glucagon administration
measure: Maximum Change From Baseline Concentration (Cmax) of Glucagon
timeFrame: Pre-dose; 0.08, 0.17, 0.25, 0.33, 0.5, 0.67, 1.0, 1.5, 2.0, 2.5 and 3.0 hours after glucagon administration
measure: Time to Maximum Concentration (Tmax) of Baseline Adjusted Glucagon
timeFrame: Pre-dose; 0.08, 0.17, 0.25, 0.33, 0.5, 0.67, 1.0, 1.5, 2.0, 2.5 and 3.0 hours after glucagon administration
measure: Area Under the Curve (AUC0-last) of Baseline Adjusted Glucagon
timeFrame: Pre-dose; 0.08, 0.17, 0.25, 0.33, 0.5, 0.67, 1.0, 1.5, 2.0, 2.5 and 3.0 hours after glucagon administration
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: Algorithme Pharma
state: Quebec
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: