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Prandial Insulin Dosing in Hospitalized Patients (ICHO)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01101867
First Posted: April 12, 2010
Last Update Posted: October 23, 2017
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.
Collaborator:
Novo Nordisk A/S
Information provided by (Responsible Party):
Kathleen Dungan, The Ohio State University
Results First Submitted: April 9, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Diabetes
Admitting Hospital
Non-critically Ill
Interventions: Drug: Aspart fixed dose
Drug: Aspart flexible dose

  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 
Overall Participants Analyzed 
[Units: Participants]
 63   63   126 
Age 
[Units: Participants]
Count of Participants
     
<=18 years      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      48  76.2%      49  77.8%      97  77.0% 
>=65 years      15  23.8%      14  22.2%      29  23.0% 
Age 
[Units: Years]
Mean (Standard Deviation)
 57  (10)   56  (12)   57  (11) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      25  39.7%      29  46.0%      54  42.9% 
Male      38  60.3%      34  54.0%      72  57.1% 
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 reported.   Anticipated Reporting Date:   No text entered.  

5.  Secondary:   Treatment Satisfaction   [ Time Frame: day 3 ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

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


  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
Miscalculation of meal doses, mistimed doses, lack of complete documentation of carbohydrate intake, and dosing conducted by an experienced clinician may have contributed to the findings.


  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: Dr. Kathleen Dungan
Organization: The Ohio State University
phone: 614-685-3333
e-mail: kathleen.dungan@osumc.edu



Responsible Party: Kathleen Dungan, The Ohio State University
ClinicalTrials.gov Identifier: NCT01101867     History of Changes
Other Study ID Numbers: Novo Nordisk xxxx
First Submitted: April 8, 2010
First Posted: April 12, 2010
Results First Submitted: April 9, 2013
Results First Posted: July 2, 2013
Last Update Posted: October 23, 2017