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

Hypoglycemia Clinical Trial

— AMG102  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01556594
• Other study ID #: 16416
• Secondary ID: I8R-MC-IGBAAMG10
• Status: Completed
• Phase: Phase 2
• Start date: March 2012
• Est. completion date: July 2012

Study information

• Verified date: September 2019
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: July 2012
• Est. primary completion date: July 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Hypoglycemia

Intervention

Drug:
• Nasal Glucagon 1 mg

• Nasal Glucagon 2 mg

• SC Glucagon

• Nasal Glucagon 3 mg

Locations

Country	Name	City	State
Canada	Algorithme Pharma	Montreal	Quebec

Sponsors (2)

Lead Sponsor	Collaborator
Eli Lilly and Company	Locemia Solutions ULC

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Responders	Participants with a blood glucose increment of =1.5 millimole per liter [mmol/L) within 15 of nadir (5 minutes post dose) and for at least 10 minutes following nadir.	Pre-dose; 30 minutes following glucagon administration
Primary	Number of Participants With at Least One Adverse Event	Safety and tolerability evaluated through the assessment of adverse events. An AE was defined as any untoward medical occurrence in a clinical investigation subject administered the investigational product and which did not necessarily have a causal relationship with this treatment. A summary of other nonserious AEs, and all SAE's, regardless of causality, is located in the Reported Adverse Events section.	Within 3 hours post glucagon administration
Secondary	Maximum Concentration (Cmax) of Baseline-Adjusted Glucose		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
Secondary	Time to Maximum Concentration (Tmax) of Baseline-Adjusted Glucose		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
Secondary	Maximum Change From Baseline Concentration (Cmax) of Glucagon		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
Secondary	Time to Maximum Concentration (Tmax) of Baseline Adjusted Glucagon		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
Secondary	Area Under the Curve (AUC0-last) of Baseline Adjusted Glucagon		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