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

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ClinicalTrials.gov Identifier: NCT01556594
Recruitment Status : Completed
First Posted : March 16, 2012
Results First Posted : August 13, 2014
Last Update Posted : September 23, 2019
Sponsor:
Collaborator:
Locemia Solutions ULC
Information provided by (Responsible Party):
Eli Lilly and Company

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.


Condition or disease Intervention/treatment Phase
Hypoglycemia Drug: Nasal Glucagon 1 mg Drug: Nasal Glucagon 2 mg Drug: SC Glucagon Drug: Nasal Glucagon 3 mg Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : March 2012
Actual Primary Completion Date : July 2012
Actual Study Completion Date : July 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hypoglycemia
Drug Information available for: Glucagon

Arm Intervention/treatment
Experimental: Nasal Glucagon 1 mg
Nasal glucagon (NG) administered as single dose of 1 milligram (mg).
Drug: Nasal Glucagon 1 mg
Other Names:
  • Dry Powder Nasal Glucagon
  • AMG504-1
  • LY900018

Experimental: Nasal Glucagon 2 mg
NG administered as single dose of 2 mg.
Drug: Nasal Glucagon 2 mg
Other Names:
  • Dry Powder Nasal Glucagon
  • AMG504-1
  • LY900018

Active Comparator: SC Glucagon
Glucagon solution dose of 1 mg administered as a single subcutaneous (SC) injection.
Drug: SC Glucagon
Other Names:
  • Glucagon
  • Glucagon for injection (rDNA origin)

Experimental: 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).
Drug: Nasal Glucagon 3 mg
Other Names:
  • Dry Powder Nasal Glucagon
  • AMG504-1
  • LY900018




Primary Outcome Measures :
  1. Percentage of Responders [ Time Frame: Pre-dose; 30 minutes following glucagon administration ]
    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.

  2. Number of Participants With at Least One Adverse Event [ Time Frame: Within 3 hours post glucagon administration ]
    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 :
  1. 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 ]
  2. 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 ]
  3. 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 ]
  4. 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 ]
  5. 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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01556594


Locations
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Canada, Quebec
Algorithme Pharma
Montreal, Quebec, Canada, H3P 3P1
Sponsors and Collaborators
Eli Lilly and Company
Locemia Solutions ULC
Investigators
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Study Director: 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) Eli Lilly and Company
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Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT01556594    
Other Study ID Numbers: 16416
I8R-MC-IGBA ( Other Identifier: Eli Lilly and Company )
AMG102 ( Other Identifier: Locemia Solutions ULC )
First Posted: March 16, 2012    Key Record Dates
Results First Posted: August 13, 2014
Last Update Posted: September 23, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
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.
Access Criteria: A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
URL: https://vivli.org/
Keywords provided by Eli Lilly and Company:
Hypoglycemia
Diabetes mellitus
Additional relevant MeSH terms:
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Hypoglycemia
Glucose Metabolism Disorders
Metabolic Diseases
Glucagon
Glucagon-Like Peptide 1
Gastrointestinal Agents
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Incretins