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

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.
ClinicalTrials.gov Identifier: NCT00338104
Recruitment Status : Completed
First Posted : June 20, 2006
Results First Posted : April 6, 2009
Last Update Posted : April 6, 2009
Information provided by:
Northwestern University

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Hyperglycemia
Intervention: Drug: insulin glargine

  Participant Flow

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
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

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
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 
Overall Participants Analyzed 
[Units: Participants]
 25   25   25   75 
[Units: Years]
Mean (Standard Deviation)
 61.4  (13.7)   60.7  (10.8)   58.6  (10.2)   60.2  (11.7) 
[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

1.  Primary:   Percentage of Blood Glucose Values Between 80 - 140   [ Time Frame: First 24 hours after conversion ]

2.  Secondary:   Percentage of Glucose Values < 50 mg/dL   [ Time Frame: First 24 hours after conversion ]

3.  Secondary:   Percentage of Glucose Levels > 180 mg/dL   [ Time Frame: First 24 hours after conversion ]

  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
not all patients were analyzed in each group because insulin not given appropriately to those patients

  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: 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
First Submitted: June 15, 2006
First Posted: June 20, 2006
Results First Submitted: December 1, 2008
Results First Posted: April 6, 2009
Last Update Posted: April 6, 2009