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Safety and Efficacy of a Novel Glucagon Formulation in Type 1 Diabetic Patients Following Insulin-induced Hypoglycemia (AMG102)

Primary Purpose

Hypoglycemia

Status
Completed
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
Nasal Glucagon 1 mg
Nasal Glucagon 2 mg
SC Glucagon
Nasal Glucagon 3 mg
Sponsored by
Eli Lilly and Company
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypoglycemia focused on measuring Hypoglycemia, Diabetes mellitus

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Algorithme Pharma

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Active Comparator

Experimental

Arm Label

Nasal Glucagon 1 mg

Nasal Glucagon 2 mg

SC Glucagon

Nasal Glucagon 3 mg

Arm Description

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

NG administered as single dose of 2 mg.

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

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

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Maximum Concentration (Cmax) of Baseline-Adjusted Glucose
Time to Maximum Concentration (Tmax) of Baseline-Adjusted Glucose
Maximum Change From Baseline Concentration (Cmax) of Glucagon
Time to Maximum Concentration (Tmax) of Baseline Adjusted Glucagon
Area Under the Curve (AUC0-last) of Baseline Adjusted Glucagon

Full Information

First Posted
March 15, 2012
Last Updated
September 5, 2019
Sponsor
Eli Lilly and Company
Collaborators
Locemia Solutions ULC
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1. Study Identification

Unique Protocol Identification Number
NCT01556594
Brief Title
Safety and Efficacy of a Novel Glucagon Formulation in Type 1 Diabetic Patients Following Insulin-induced Hypoglycemia
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
March 2012 (undefined)
Primary Completion Date
July 2012 (Actual)
Study Completion Date
July 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Eli Lilly and Company
Collaborators
Locemia Solutions ULC

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypoglycemia
Keywords
Hypoglycemia, Diabetes mellitus

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
18 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Nasal Glucagon 1 mg
Arm Type
Experimental
Arm Description
Nasal glucagon (NG) administered as single dose of 1 milligram (mg).
Arm Title
Nasal Glucagon 2 mg
Arm Type
Experimental
Arm Description
NG administered as single dose of 2 mg.
Arm Title
SC Glucagon
Arm Type
Active Comparator
Arm Description
Glucagon solution dose of 1 mg administered as a single subcutaneous (SC) injection.
Arm Title
Nasal Glucagon 3 mg
Arm Type
Experimental
Arm Description
NG administered as single dose of 3 mg (composed of one dose of 1 mg NG immediately followed by one dose of 2mg NG).
Intervention Type
Drug
Intervention Name(s)
Nasal Glucagon 1 mg
Other Intervention Name(s)
Dry Powder Nasal Glucagon, AMG504-1, LY900018
Intervention Type
Drug
Intervention Name(s)
Nasal Glucagon 2 mg
Other Intervention Name(s)
Dry Powder Nasal Glucagon, AMG504-1, LY900018
Intervention Type
Drug
Intervention Name(s)
SC Glucagon
Other Intervention Name(s)
Glucagon, Glucagon for injection (rDNA origin)
Intervention Type
Drug
Intervention Name(s)
Nasal Glucagon 3 mg
Other Intervention Name(s)
Dry Powder Nasal Glucagon, AMG504-1, LY900018
Primary Outcome Measure Information:
Title
Percentage of Responders
Description
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.
Time Frame
Pre-dose; 30 minutes following glucagon administration
Title
Number of Participants With at Least One Adverse Event
Description
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.
Time Frame
Within 3 hours post glucagon administration
Secondary Outcome Measure Information:
Title
Maximum Concentration (Cmax) of Baseline-Adjusted Glucose
Time Frame
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
Title
Time to Maximum Concentration (Tmax) of Baseline-Adjusted Glucose
Time Frame
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
Title
Maximum Change From Baseline Concentration (Cmax) of Glucagon
Time Frame
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
Title
Time to Maximum Concentration (Tmax) of Baseline Adjusted Glucagon
Time Frame
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
Title
Area Under the Curve (AUC0-last) of Baseline Adjusted Glucagon
Time Frame
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
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)
Organizational Affiliation
Eli Lilly and Company
Official's Role
Study Director
Facility Information:
Facility Name
Algorithme Pharma
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3P 3P1
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
IPD Sharing Time Frame
Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
IPD Sharing Access Criteria
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
IPD Sharing URL
https://vivli.org/

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

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