Prandial Insulin Dosing in Hospitalized Patients (ICHO)

This study has been completed.
Sponsor:
Collaborator:
Novo Nordisk A/S
Information provided by (Responsible Party):
Kathleen Dungan, The Ohio State University
ClinicalTrials.gov Identifier:
NCT01101867
First received: April 8, 2010
Last updated: July 2, 2013
Last verified: July 2013
Results First Received: April 9, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Diabetes
Admitting Hospital
Non-critically Ill
Intervention: Drug: Aspart

  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
Flexible Dose Insulin Aspart dose is determined based upon carbohydrate intake and is administered immediately post-meal. Prandial insulin was based upon the formula: CIR=400/TDD where CIR refers to the carbohydrate-to-insulin ratio and TDD refers to the total daily calculated dose of insulin (based upon total daily insulin dose or upon weight, depending upon whether a patient is insulin naive or not, respectively).
Fixed Dose Fixed meal dose of Insulin Aspart (based upon total daily insulin dose or upon weight, depending upon whether a patient is insulin naive or not, respectively). Half of the TDD was divided into three equal fixed doses given immediately after each meal.

Participant Flow:   Overall Study
    Flexible Dose     Fixed Dose  
STARTED     63     63  
COMPLETED     62     59  
NOT COMPLETED     1     4  



  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
Flexible Dose aspart dose determined based upon carbohydrate intake.
Fixed Dose fixed meal dose of aspart (based upon weight or total daily insulin dose)
Total Total of all reporting groups

Baseline Measures
    Flexible Dose     Fixed Dose     Total  
Number of Participants  
[units: participants]
  63     63     126  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     48     49     97  
>=65 years     15     14     29  
Age  
[units: years]
Mean ± Standard Deviation
  57  ± 10     56  ± 12     57  ± 11  
Gender  
[units: participants]
     
Female     25     29     54  
Male     38     34     72  
Region of Enrollment  
[units: participants]
     
United States     63     63     126  



  Outcome Measures
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1.  Primary:   Mean Glucose   [ Time Frame: day 3 ]

2.  Secondary:   Postprandial Glucose   [ Time Frame: day 3 ]

3.  Secondary:   Hypoglycemia   [ Time Frame: 72 hour ]

4.  Secondary:   Rate of Change in Glucose   [ Time Frame: 72 hour ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

5.  Secondary:   Treatment Satisfaction   [ Time Frame: day 3 ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

6.  Secondary:   1,5-anhydroglucitol Change   [ Time Frame: day 1 to day 3 ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No


  Serious Adverse Events


  Other Adverse Events


  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.


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.  


Results Point of Contact:  
Name/Title: Dr. Kathleen Dungan
Organization: The Ohio State University
phone: 614-685-3333
e-mail: kathleen.dungan@osumc.edu


No publications provided


Responsible Party: Kathleen Dungan, The Ohio State University
ClinicalTrials.gov Identifier: NCT01101867     History of Changes
Other Study ID Numbers: Novo Nordisk xxxx
Study First Received: April 8, 2010
Results First Received: April 9, 2013
Last Updated: July 2, 2013
Health Authority: United States: Food and Drug Administration