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Naltrexone and Hypoglycemia in Type 1 Diabetes (Naltrexone)

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ClinicalTrials.gov Identifier: NCT01053078
Recruitment Status : Completed
First Posted : January 21, 2010
Results First Posted : September 12, 2014
Last Update Posted : January 24, 2018
Sponsor:
Collaborators:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
American Diabetes Association
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Single Group Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Conditions Type 1 Diabetes
Hypoglycemia Unawareness
Intervention Drug: Naltrexone
Enrollment 29
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Naltrexone Placebo
Hide Arm/Group Description

Double blind placebo comparable

Naltrexone: 1 month treatment

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

Naltrexone: 1 month treatment

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

Period Title: Overall Study
Started 14 15
Completed 10 12
Not Completed 4 3
Arm/Group Title Naltrexone Placebo Total
Hide Arm/Group Description

Double blind placebo comparable

Naltrexone: 1 month treatment

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

Naltrexone: 1 month treatment

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

Total of all reporting groups
Overall Number of Baseline Participants 10 12 22
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 10 participants 12 participants 22 participants
47  (13) 39  (10) 42  (14)
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 12 participants 22 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
10
 100.0%
12
 100.0%
22
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 12 participants 22 participants
Female
6
  60.0%
6
  50.0%
12
  54.5%
Male
4
  40.0%
6
  50.0%
10
  45.5%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 10 participants 12 participants 22 participants
10 12 22
1.Primary Outcome
Title Cerebral Blood Flow
Hide Description [Not Specified]
Time Frame 1 month
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Naltrexone Placebo
Hide Arm/Group Description:

Double blind placebo comparable

Naltrexone: 1 month treatment

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

Naltrexone: 1 month treatment

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

Overall Number of Participants Analyzed 10 12
Mean (Standard Deviation)
Unit of Measure: percentage of signal intensity change
1.7  (1.9) 1.3  (3.3)
2.Secondary Outcome
Title Rates of Hypoglycemia
Hide Description [Not Specified]
Time Frame 1 month
Outcome Measure Data Not Reported
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Naltrexone Placebo
Hide Arm/Group Description

Double blind placebo comparable

Naltrexone: 1 month treatment

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

Naltrexone: 1 month treatment

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

All-Cause Mortality
Naltrexone Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Naltrexone Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/10 (0.00%)   0/12 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Naltrexone Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   3/10 (30.00%)   0/10 (0.00%) 
Gastrointestinal disorders     
diarrhea *  3/10 (30.00%)  0/10 (0.00%) 
Nervous system disorders     
headache *  3/10 (30.00%)  0/10 (0.00%) 
*
Indicates events were collected by non-systematic assessment
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
Layout table for Results Point of Contact information
Name/Title: Elizabeth Seaquist
Organization: University of Minnesota
Phone: 612 624 9176
EMail: seaqu001@umn.edu
Layout table for additonal information
Responsible Party: University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier: NCT01053078     History of Changes
Other Study ID Numbers: Protocol 10087
R01DK062440 ( U.S. NIH Grant/Contract )
7-09-DCS-02 ( Other Grant/Funding Number: American Diabetes Association )
First Submitted: January 19, 2010
First Posted: January 21, 2010
Results First Submitted: September 4, 2014
Results First Posted: September 12, 2014
Last Update Posted: January 24, 2018