We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00659165
Recruitment Status : Completed
First Posted : April 16, 2008
Results First Posted : October 5, 2011
Last Update Posted : January 19, 2018
Sponsor:
Information provided by (Responsible Party):

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Other
Condition: Diabetes Mellitus
Interventions: Drug: Insulin Detemir
Drug: Insulin Glargine

  Participant Flow

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

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 
Overall Participants Analyzed 
[Units: Participants]
 5   5   10 
Age [1] 
[Units: Participants]
Count of Participants
     
<=18 years      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      5 100.0%      5 100.0%      10 100.0% 
>=65 years      0   0.0%      0   0.0%      0   0.0% 
[1] Data for all enrolled subjects in this crossover study.
Age [1] 
[Units: Years]
Mean (Standard Deviation)
 37  (14)   33  (8)   35  (11) 
[1] Data for all enrolled subjects.
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      3  60.0%      4  80.0%      7  70.0% 
Male      2  40.0%      1  20.0%      3  30.0% 
Region of Enrollment 
[Units: Participants]
     
United States   5   5   10 


  Outcome Measures

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


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

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
No text entered.


  More Information

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:
Drugdex System:Klasko RK: Detemir. Drugdex System. Thomson Micromedex, Greenwood Village, Colorado (2007).


Responsible Party: University of New Mexico
ClinicalTrials.gov Identifier: NCT00659165     History of Changes
Other Study ID Numbers: UNM HRRC # 08-043
First Submitted: April 14, 2008
First Posted: April 16, 2008
Results First Submitted: January 19, 2011
Results First Posted: October 5, 2011
Last Update Posted: January 19, 2018