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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AMG Medical Inc.
ClinicalTrials.gov Identifier:
NCT01556594
First received: March 15, 2012
Last updated: August 9, 2014
Last verified: August 2014
  Purpose

Hypoglycemia is common in people with type 1 diabetes. Mild and moderate hypoglycaemia is normally treated by consuming oral carbohydrates. During an episode of severe hypoglycaemia however, the person with diabetes is unable to consume carbohydrates and requires help from another person. The current standard treatment for severe hypoglycemia is intravenous glucose or an injection of glucagon, which causes an increase of blood glucose, which allows the person with diabetes to recover sufficiently to consume carbohydrate.

AMG Medical is investigating a novel formulation of glucagon which may be easier to administer than the currently available glucagon formulations.

In this study, patients with Type 1 diabetes will receive injected insulin to reduce their blood glucose, and will then receive one of three doses of the new glucagon formulation or a dose of glucagon for injection, and their blood glucose will be measured for 3 hours.

The study hypothesis is that the new glucagon formulation will be as effective as the current injected formulation at raising blood glucose levels within 15 minutes.


Condition Intervention Phase
Hypoglycemia
Drug: glucagon
Drug: Low dose novel formulation
Drug: high dose novel formulation
Drug: Medium dose novel formulation
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by AMG Medical Inc.:

Primary Outcome Measures:
  • Percentage of Responders [ Time Frame: Within 30 minutes of treatment with test article ] [ Designated as safety issue: No ]
    A responder will be defined as a subject who achieved normal blood glucose ( ≥3.8 mmol/L) within 30 minutes after treatment.

  • Participants With at Least One Adverse Event [ Time Frame: Safety evaluations were recorded from dosing up until 3 hours after dosing with test medication ] [ Designated as safety issue: Yes ]
    Safety and tolerability will be evaluated through the assessment of adverse events, physical examination, laboratory tests, vital signs and ECG.


Secondary Outcome Measures:
  • Mean Peak Plasma Concentration (Cmax) of Glucose [ Time Frame: Samples were obtained at 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 ] [ Designated as safety issue: No ]
    mean plasma glucose level after treatment with test article


Enrollment: 18
Study Start Date: March 2012
Study Completion Date: July 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: SC glucagon injection 1 mg
SC injection
Drug: glucagon
glucagon solution for injection containing 1 mg of glucagon Single subcutaneous injection
Other Names:
  • Glucagon
  • Glucagon for injection (rDNA origin)
Experimental: Low dose novel formulation
Low dose novel formulation
Drug: Low dose novel formulation
Low dose novel formulation
Other Name: Low dose novel formulation
Experimental: High dose novel formulation
High dose novel formulation
Drug: high dose novel formulation
high dose novel formulation
Other Name: high dose novel formulation
Experimental: Medium dose novel formulation
Medium dose novel formulation
Drug: Medium dose novel formulation
Medium dose novel formulation
Other Name: Medium dose novel formulation

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01556594

Locations
Canada, Quebec
Algorithme Pharma
Montreal, Quebec, Canada, H3P 3P1
Sponsors and Collaborators
AMG Medical Inc.
Investigators
Principal Investigator: Eric Sicard, MD Algorithme Pharma Inc
  More Information

No publications provided

Responsible Party: AMG Medical Inc.
ClinicalTrials.gov Identifier: NCT01556594     History of Changes
Other Study ID Numbers: AMG102
Study First Received: March 15, 2012
Results First Received: March 18, 2013
Last Updated: August 9, 2014
Health Authority: Canada: Health Canada
United States: Food and Drug Administration

Keywords provided by AMG Medical Inc.:
Hypoglycemia
Diabetes mellitus

Additional relevant MeSH terms:
Hypoglycemia
Glucose Metabolism Disorders
Metabolic Diseases
Glucagon
Glucagon-Like Peptide 1
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Incretins

ClinicalTrials.gov processed this record on August 26, 2014