Safety and Efficacy of a Novel Glucagon Formulation in Type 1 Diabetic Patients Following Insulin-induced Hypoglycemia

• Status: Completed
• Trial end date: 2012-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eli Lilly and Company
• Collaborator: Locemia Solutions ULC
• Treatments: Glucagon; Glucagon-Like Peptide 1

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