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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):
Locemia Solutions ULC
ClinicalTrials.gov Identifier:
NCT01556594
First received: March 15, 2012
Last updated: August 9, 2014
Last verified: August 2014
Results First Received: March 18, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Crossover Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Hypoglycemia
Interventions: Drug: glucagon
Drug: Low dose novel formulation
Drug: high dose novel formulation
Drug: Medium dose novel formulation

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Participants were recruited from the clinical site's database and from patients who responded to advertising in local media.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No significant events occurred with respect to any of the subjects following enrolment. All participants recruited to participate in the study completed all arms of the study.

Reporting Groups
  Description
Gp 1: Low Dose IN, Med Dose IN, SC Low dose IN followed by med dose IN followed by SC injection of glucagon
Gp 2: Low Dose IN, Med Dose IN, SC, High Dose IN Low dose IN followed by medium dose IN followed by SC followed by high dose IN glucagon
Gp 3: Med Dose IN, SC, High Dose IN Med dose IN followed by SC followed by high dose IN glucagon

Participant Flow:   Overall Study
    Gp 1: Low Dose IN, Med Dose IN, SC     Gp 2: Low Dose IN, Med Dose IN, SC, High Dose IN     Gp 3: Med Dose IN, SC, High Dose IN  
STARTED     10     2     6  
COMPLETED     10     2     6  
NOT COMPLETED     0     0     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Healthy volunteers

Reporting Groups
  Description
Group 1 Low dose IN followed by med dose IN followed by SC injection of glucagon
Group 2 Low dose IN followed by med dose IN followed by SC injection followed by high dose IN of glucagon
Group 3 Med dose IN followed by SC injection followed by high dose IN of glucagon
Total Total of all reporting groups

Baseline Measures
    Group 1     Group 2     Group 3     Total  
Number of Participants  
[units: participants]
  10     2     6     18  
Age  
[units: participants]
       
<=18 years     0     0     0     0  
Between 18 and 65 years     10     2     6     18  
>=65 years     0     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation
  34  ± 14     42  ± 2     25  ± 6     32  ± 12  
Gender  
[units: participants]
       
Female     4     0     1     5  
Male     6     2     5     13  
Region of Enrollment  
[units: participants]
       
Canada     10     2     6     18  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Percentage of Responders   [ Time Frame: Within 30 minutes of treatment with test article ]

2.  Primary:   Participants With at Least One Adverse Event   [ Time Frame: Safety evaluations were recorded from dosing up until 3 hours after dosing with test medication ]

3.  Secondary:   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 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Dr. Claude Piche
Organization: AMG Medical
phone: 5144580175
e-mail: claude.piche@amgmedical.com


No publications provided


Responsible Party: Locemia Solutions ULC
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