Insulin Detemir Compared to Insulin Glargine: Appetite and Calories Consumed in Type 1 Diabetes

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of New Mexico
ClinicalTrials.gov Identifier:
NCT00659165
First received: April 14, 2008
Last updated: September 6, 2011
Last verified: January 2011
Results First Received: January 19, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Crossover Assignment;   Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Condition: Diabetes Mellitus
Interventions: Drug: Insulin Detemir
Drug: Insulin Glargine

  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
Sporadic Newspaper advertisement, Albuquerque Journal, July 2008-July 2010.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Three weeks of treatment with each insulin (glargine, detemir) in random order, double blind assignment. Doses of glargine and detemir were equivalent and were based upon existing long acting insulin doses. Doses were titrated up to achieve target fasting glucose < 150 mg/dl. Both long acting insulins were given once daily before breakfast.

Reporting Groups
  Description
Insulin Detemir These people receive insulin detemir first, then insulin glargine. All subjects received three weeks of therapy with their assigned insulin prior to overnight admission for study.
Insulin Glargine These people receive insulin glargine first, then insulin detemir. All subjects received three weeks of therapy with their assigned insulin prior to overnight admission for study.

Participant Flow:   Overall Study
    Insulin Detemir     Insulin Glargine  
STARTED     5     5  
COMPLETED     5     5  
NOT COMPLETED     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.
No text entered.

Reporting Groups
  Description
Insulin Detemir These people receive insulin detemir first, then insulin glargine. All subjects received three weeks of therapy with their assigned insulin prior to overnight admission for study.
Insulin Glargine These people receive insulin glargine first, then insulin detemir. All subjects received three weeks of therapy with their assigned insulin prior to overnight admission for study.
Total Total of all reporting groups

Baseline Measures
    Insulin Detemir     Insulin Glargine     Total  
Number of Participants  
[units: participants]
  5     5     10  
Age [1]
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     5     5     10  
>=65 years     0     0     0  
Age [2]
[units: years]
Mean ± Standard Deviation
  37  ± 14     33  ± 8     35  ± 11  
Gender  
[units: participants]
     
Female     3     4     7  
Male     2     1     3  
Region of Enrollment  
[units: participants]
     
United States     5     5     10  
[1] Data for all enrolled subjects in this crossover study.
[2] Data for all enrolled subjects.



  Outcome Measures

1.  Primary:   Calories Consumed During Test Meal After a 24 Hour Fast.   [ Time Frame: Measured after a 24 hour fast, after treatment with study insulin for at least 3 weeks ]

2.  Secondary:   % Body Fat by Bioelectrical Impedance   [ Time Frame: Once during each hospital admission ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

3.  Secondary:   Satiety Scales   [ Time Frame: performed at 3 points in time during each hospital admission: immediately upon hospital admission, and then again at 12 hours and 24 hours. ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

4.  Secondary:   24-hour Dietary Recall   [ Time Frame: performed once during each hospital admission ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

5.  Secondary:   Food Diary   [ Time Frame: performed daily for each meal during the last week of treatment with each study insulin ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

6.  Secondary:   Resting Energy Expenditure   [ Time Frame: performed once during each hospital admission ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

7.  Secondary:   Serum Satiety Factors   [ Time Frame: measured at 3 points in time during each hospital admission: at admission, 10 minutes prior to study meal and 60 minutes following study meal ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No


  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:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Mark Burge
Organization: Univ NM
phone: 505-272-4658
e-mail: mburge@salud.unm.edu


Publications:


Responsible Party: University of New Mexico
ClinicalTrials.gov Identifier: NCT00659165     History of Changes
Other Study ID Numbers: UNM HRRC # 08-043
Study First Received: April 14, 2008
Results First Received: January 19, 2011
Last Updated: September 6, 2011
Health Authority: United States: Institutional Review Board