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Conversion of Hyperglycemic Patients Being Treated With Intravenous Insulin Infusions to Lantus Insulin

This study has been completed.
Sponsor:
Collaborator:
Sanofi
Information provided by:
Northwestern University
ClinicalTrials.gov Identifier:
NCT00338104
First received: June 15, 2006
Last updated: April 3, 2009
Last verified: March 2009
History of Changes
Results First Received: December 1, 2008  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Hyperglycemia
Diabetes
Intervention: Drug: insulin glargine

  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
75 patients with hyperglycemia were recruited from the inpatient service at Northwestern Memorial Hospital between August, 2004 and May, 2005.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Patients had to be on a continuous insulin infusion to treat hyperglycemia prior to randomization

Reporting Groups
  Description
40% Group Glargine at 40% of insulin drip rate
60% Group Glargine at 60% of insulin drip rate
80% Group Glargine at 80% of insulin drip rate

Participant Flow:   Overall Study
    40% Group     60% Group     80% Group  
STARTED     25     25     25  
COMPLETED     23     24     22  
NOT COMPLETED     2     1     3  
Protocol Violation                 2                 1                 3  



  Baseline Characteristics
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Reporting Groups
  Description
40% Group Glargine at 40% of insulin drip rate
60% Group Glargine at 60% of insulin drip rate
80% Group Glargine at 80% of insulin drip rate
Total Total of all reporting groups

Baseline Measures
    40% Group     60% Group     80% Group     Total  
Number of Participants  
[units: participants]
 		  25     25     25     75  
Age  
[units: years]
Mean ± Standard Deviation 		  61.4  ± 13.7     60.7  ± 10.8     58.6  ± 10.2     60.2  ± 11.7  
Gender  
[units: participants]
 		       
Female     5     7     7     19  
Male     20     18     18     56  
Body Mass Index  
[units: kg/m2]
Mean ± Standard Deviation 		  28.9  ± 5.0     30.6  ± 6.4     29.9  ± 8.0     29.8  ± 6.6  



  Outcome Measures
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1.  Primary:   Percentage of Blood Glucose Values Between 80 - 140   [ Time Frame: First 24 hours after conversion ]
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2.  Secondary:   Percentage of Glucose Values < 50 mg/dL   [ Time Frame: First 24 hours after conversion ]
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3.  Secondary:   Percentage of Glucose Levels > 180 mg/dL   [ Time Frame: First 24 hours after conversion ]
  Show Outcome Measure 3


  Serious Adverse Events
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  Other Adverse Events
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  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
not all patients were analyzed in each group because insulin not given appropriately to those patients  


Results Point of Contact:  
Name/Title: Mark E. Molitch, M.D.
Organization: Northwestern University
phone: 312 503-4130
e-mail: molitch@northwestern.edu


Publications of Results:


Responsible Party: Mark E. Molitch, M.D., Northwestern University Feinberg School of Medicine
ClinicalTrials.gov Identifier: NCT00338104     History of Changes
Other Study ID Numbers: 0361-028
Study First Received: June 15, 2006
Results First Received: December 1, 2008
Last Updated: April 3, 2009
Health Authority: United States: Institutional Review Board