Naltrexone and Hypoglycemia in Type 1 Diabetes

This study has been completed.
Sponsor:
Collaborators:
American Diabetes Association
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier:
NCT01053078
First received: January 19, 2010
Last updated: September 4, 2014
Last verified: September 2014
Results First Received: September 4, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Conditions: Type 1 Diabetes
Hypoglycemia Unawareness
Intervention: Drug: Naltrexone

  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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Naltrexone

Double blind placebo comparable

Naltrexone: 1 month treatment

Naltrexone: Naltrexone 25 mg once daily with dose escalation to 50 mg BID to day 28

Placebo

Naltrexone: 1 month treatment

Naltrexone: Naltrexone 25 mg once daily with dose escalation to 50 mg BID to day 28


Participant Flow:   Overall Study
    Naltrexone     Placebo  
STARTED     14     15  
COMPLETED     10     12  
NOT COMPLETED     4     3  



  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.
No text entered.

Reporting Groups
  Description
Naltrexone

Double blind placebo comparable

Naltrexone: 1 month treatment

Naltrexone: Naltrexone 25 mg once daily with dose escalation to 50 mg BID to day 28

Placebo

Naltrexone: 1 month treatment

Naltrexone: Naltrexone 25 mg once daily with dose escalation to 50 mg BID to day 28

Total Total of all reporting groups

Baseline Measures
    Naltrexone     Placebo     Total  
Number of Participants  
[units: participants]
  10     12     22  
Age  
[units: years]
Mean ± Standard Deviation
  47  ± 13     39  ± 10     42  ± 14  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     10     12     22  
>=65 years     0     0     0  
Gender  
[units: participants]
     
Female     6     6     12  
Male     4     6     10  
Region of Enrollment  
[units: participants]
     
United States     10     12     22  



  Outcome Measures

1.  Primary:   Cerebral Blood Flow   [ Time Frame: 1 month ]

2.  Secondary:   Rates of Hypoglycemia   [ Time Frame: 1 month ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   Yes


  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: Elizabeth Seaquist
Organization: University of Minnesota
phone: 612 624 9176
e-mail: seaqu001@umn.edu


No publications provided


Responsible Party: University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier: NCT01053078     History of Changes
Other Study ID Numbers: Protocol 10087, R01DK062440, 7-09-DCS-02
Study First Received: January 19, 2010
Results First Received: September 4, 2014
Last Updated: September 4, 2014
Health Authority: United States: Food and Drug Administration