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Basal Insulin in the Management of Patients With Diabetic Ketoacidosis (DKA)
This study has been completed.
Study NCT00590044   Information provided by Emory University
First Received: December 28, 2007   Last Updated: May 18, 2009   History of Changes
Study Type: Interventional
Study Design: Randomized, Open Label, Parallel Assignment
Condition: Diabetic Ketoacidosis
Interventions: Drug: insulin glargine+ glulisine
Drug: NPH + Regular insulin

  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
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
1 Daily insulin glargine (Lantus) + glulisine (Apidra) before meals
2 Split-mixed NPH + Regular insulin twice daily

Participant Flow:   Overall Study
  1 2
STARTED   38     36  
COMPLETED   34     34  
NOT COMPLETED   4     2  
      Withdrawal by Subject               2                 2  
      wrong insulin arm assigned               1                 0  
      Protocol Violation               1                 0  



  Baseline Characteristics
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Reporting Groups
  Description
1 Daily insulin glargine (Lantus) + glulisine (Apidra) before meals
2 Split-mixed NPH + Regular insulin twice daily

Baseline Measures
  1 2 Total
Number of Participants  
[units: participants]
38 36 74
Age  
[units: participants]
     
<=18 years 0 0 0
Between 18 and 65 years 38 36 74
>=65 years 0 0 0
Age  
[units: years]
Mean ± Standard Deviation
39 ± 12 38 ± 12 38.5 ± 12
Gender  
[units: participants]
     
Female 14 12 26
Male 24 24 48
Region of Enrollment  
[units: participants]
     
United States 38 36 74



  Outcome Measures

1.  Primary:   Mean Daily Blood Glucose Concentration After the Resolution of DKA   [ 1 year ]


  Serious Adverse Events
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  Other Adverse Events
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