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Insulin Glargine Versus Twice-Daily NPH

This study has been completed.
Sponsor:
Collaborator:
National Center for Research Resources (NCRR)
Information provided by (Responsible Party):
Charles Drew University of Medicine and Science
ClinicalTrials.gov Identifier:
NCT00687453
First received: May 27, 2008
Last updated: March 25, 2013
Last verified: March 2013
History of Changes
Results First Received: September 15, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Type 2 Diabetes Mellitus
Interventions: Drug: Insulin glargine at bedtime instead of NPH
Drug: NPH twice-daily

  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
Recruitment from Sep 2002 to Dec 2008. Subjects recruited from a diabetes specialty referral clinic, as well as from primary care clinics and through advertising in the South Los Angeles area.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment

Baseline run-in period to document baseline control and reinforce dietary/lifestyle principles.

3 subjects not randomized due to protocol violations.

Reporting Groups
  Description
Insulin Glargine at Bedtime Bedtime insulin glargine titrated to morning fasting glucose readings
NPH Twice-daily Morning and bedtime NPH insulin titrated to pre-supper and fasting glucose readings, respectively

Participant Flow:   Overall Study
    Insulin Glargine at Bedtime     NPH Twice-daily  
STARTED     11     13  
COMPLETED     8     7  
NOT COMPLETED     3     6  



  Baseline Characteristics
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  Outcome Measures

1.  Primary:   Hemoglobin A1c Change From Baseline   [ Time Frame: Baseline to 6 months ]
  Show Outcome Measure 1

2.  Secondary:   Frequency of Pre-supper Glucose Readings 120 mg/dL or Less   [ Time Frame: 6 months ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

3.  Secondary:   Frequency of Total Hypoglycemic Reactions   [ Time Frame: 6 months ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   Yes

4.  Secondary:   Frequency of Severe Hypoglycemic Reactions   [ Time Frame: 6 months ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   Yes

5.  Secondary:   Body Mass Index Change From Baseline   [ Time Frame: 6 months ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

6.  Secondary:   Total Daily Insulin Dose   [ Time Frame: 6 months ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

7.  Secondary:   Any Adverse Event Other Than Hypoglycemia   [ Time Frame: 6 months ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   Yes


  Serious Adverse Events
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  Other Adverse Events
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


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
Early termination leading to smaller than anticipated enrollment.  


Results Point of Contact:  
Name/Title: Stanley H. Hsia, MD
Organization: Charles R. Drew University of Medicine and Science
phone: 323-357-3633
e-mail: stanleyhsia@cdrewu.edu


No publications provided


Responsible Party: Charles Drew University of Medicine and Science
ClinicalTrials.gov Identifier: NCT00687453     History of Changes
Other Study ID Numbers: 03-02-519, U54RR014616
Study First Received: May 27, 2008
Results First Received: September 15, 2010
Last Updated: March 25, 2013
Health Authority: United States: Institutional Review Board