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

NCT ID: NCT01556594

Last Updated: 2019-09-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-03-31
• Study Completion Date: 2012-07-31

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.

Conditions

Hypoglycemia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Nasal Glucagon 1 mg

Nasal glucagon (NG) administered as single dose of 1 milligram (mg).

Group Type: EXPERIMENTAL

Nasal Glucagon 1 mg

Intervention Type: DRUG

Nasal Glucagon 2 mg

NG administered as single dose of 2 mg.

Group Type: EXPERIMENTAL

Nasal Glucagon 2 mg

Intervention Type: DRUG

SC Glucagon

Glucagon solution dose of 1 mg administered as a single subcutaneous (SC) injection.

Group Type: ACTIVE_COMPARATOR

SC Glucagon

Intervention Type: DRUG

Nasal Glucagon 3 mg

NG administered as single dose of 3 mg (composed of one dose of 1 mg NG immediately followed by one dose of 2mg NG).

Group Type: EXPERIMENTAL

Nasal Glucagon 3 mg

Intervention Type: DRUG

Interventions

Nasal Glucagon 1 mg

Intervention Type: DRUG

Nasal Glucagon 2 mg

Intervention Type: DRUG

SC Glucagon

Intervention Type: DRUG

Nasal Glucagon 3 mg

Intervention Type: DRUG

Other Intervention Names

Dry Powder Nasal Glucagon; AMG504-1; LY900018; Dry Powder Nasal Glucagon; AMG504-1; LY900018; Glucagon; Glucagon for injection (rDNA origin); Dry Powder Nasal Glucagon; AMG504-1; LY900018

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Locemia Solutions ULC

INDUSTRY

Sponsor Role: collaborator

Eli Lilly and Company

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

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

Eli Lilly and Company

Locations

Algorithme Pharma

Montreal, Quebec, Canada

Countries

Canada

Other Identifiers

I8R-MC-IGBA

Identifier Type: OTHER

Identifier Source: secondary_id

AMG102

Identifier Type: OTHER

Identifier Source: secondary_id

16416

Identifier Type: -

Identifier Source: org_study_id