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Trial record 4 of 34 for:    "Diabetic Ketoacidosis"

Basal Insulin in the Management of Patients With Diabetic Ketoacidosis (DKA)

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ClinicalTrials.gov Identifier: NCT00590044
Recruitment Status : Completed
First Posted : January 10, 2008
Results First Posted : April 30, 2009
Last Update Posted : December 5, 2013
Sponsor:
Collaborator:
Sanofi
Information provided by (Responsible Party):
Guillermo Umpierrez, Emory University

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Diabetic Ketoacidosis
Interventions: Drug: insulin glargine+ glulisine
Drug: NPH + Regular insulin

  Participant Flow

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
Glargine (Lantus) + Glulisine Daily insulin glargine (Lantus) + glulisine (Apidra) before meals
NPH + Regular Split-mixed NPH + Regular insulin twice daily

Participant Flow:   Overall Study
    Glargine (Lantus) + Glulisine   NPH + Regular
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

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
Glargine (Lantus) + Glulisine Daily insulin glargine (Lantus) + glulisine (Apidra) before meals
NPH + Regular Split-mixed NPH + Regular insulin twice daily
Total Total of all reporting groups

Baseline Measures
   Glargine (Lantus) + Glulisine   NPH + Regular   Total 
Overall Participants Analyzed 
[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   [ Time Frame: 1 year ]

2.  Secondary:   Mean Daily Blood Glucose Concentration While on the Insulin Drip   [ Time Frame: blood glucose (BG) before meals and at bedtime ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

3.  Secondary:   Frequency of Hypoglycemia   [ Time Frame: blood glucose (BG) before meals, at bedtime and as needed ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

4.  Secondary:   Frequency of Hyperglycemia   [ Time Frame: blood glucose (BG) before meals, at bedtime and as needed ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  


  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:  
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: Guillermo Umpierrez
Organization: Emory University SOM
phone: 4047781663
e-mail: geumpie@emory.edu



Responsible Party: Guillermo Umpierrez, Emory University
ClinicalTrials.gov Identifier: NCT00590044     History of Changes
Other Study ID Numbers: IRB00005062a
First Submitted: December 28, 2007
First Posted: January 10, 2008
Results First Submitted: January 30, 2009
Results First Posted: April 30, 2009
Last Update Posted: December 5, 2013