Preferred Treatment of Type 1.5 Diabetes

This study has been completed.
Sponsor:
Collaborators:
Seattle Institute for Biomedical and Clinical Research
GlaxoSmithKline
Information provided by:
University of Washington
ClinicalTrials.gov Identifier:
NCT00194896
First received: September 14, 2005
Last updated: August 16, 2011
Last verified: August 2011
Results First Received: February 22, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Type 2 Diabetes Mellitus
Interventions: Drug: rosiglitazone
Drug: glyburide

  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
Recruited through endocrinology physicians.

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
Rosiglitazone Autoantibody Positive Rosiglitazone is an oral antidiabetic agent which acts primarily by increasing insulin sensitivity. The rosiglitazone treatment group commenced therapy with 4 milligram (mg) once per day and increase to twice per day if adequate glycemic control was not achieved. Autoantibody positive for one or multiple islet autoantibodies. These autoantibodies include insulin autoantibodies(IAA), islet cell autoantibodies (ICA), glutamic acid decarboxylase (GAD),and/or islet cell autoantibodies 512 (IA2).
Rosiglitazone Autoantibody Negative Rosiglitazone is an oral antidiabetic agent which acts primarily by increasing insulin sensitivity. The rosiglitazone treatment group commenced therapy with 4 mg once per day and increase to twice per day if adequate glycemic control was not achieved. Autoantibody negative for insulin autoantibodies (IAA), islet cell autoantibodies (ICA), glutamic acid decarboxylase (GAD), and islet cell autoantibodies 512 (IA2).
Glyburide Autoantibody Positive Glyburide is a sulfonylurea. Glyburide therapy was initiated with 2.5 mg in the morning or the patient was maintained on the dose they had been receiving prior to starting the study. This starting dose was raised by 2.5 in the evening and further up to a maximum of 10 mg twice a day if necessary to achieve desired glycemic control. Autoantibody positive for one or multiple islet autoantibodies. These autoantibodies include insulin autoantibodies(IAA), islet cell autoantibodies (ICA), glutamic acid decarboxylase (GAD), islet cell autoantibodies 512 (IA2).
Glyburide Autoantibody Negative Glyburide is a sulfonylurea. Glyburide therapy was initiated with 2.5 mg in the morning or the patient was maintained on the dose they had been receiving prior to starting the study. This starting dose was raised by 2.5 in the evening and further up to a maximum of 10 mg twice a day if necessary to achieve desired glycemic control. Autoantibody negative for insulin autoantibodies (IAA), islet cell autoantibodies (ICA), glutamic acid decarboxylase (GAD), and islet cell autoantibodies 512 (IA2).

Participant Flow:   Overall Study
    Rosiglitazone Autoantibody Positive     Rosiglitazone Autoantibody Negative     Glyburide Autoantibody Positive     Glyburide Autoantibody Negative  
STARTED     15     15     13     21  
COMPLETED     4     10     7     9  
NOT COMPLETED     11     5     6     12  



  Baseline Characteristics
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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
Rosiglitazone Autoantibody Positive Rosiglitazone is an oral antidiabetic agent which acts primarily by increasing insulin sensitivity. The rosiglitazone treatment group commenced therapy with 4 milligram (mg) once per day and increase to twice per day if adequate glycemic control was not achieved. Autoantibody positive for one or multiple islet autoantibodies. These autoantibodies include insulin autoantibodies(IAA), islet cell autoantibodies (ICA), glutamic acid decarboxylase (GAD),and/or islet cell autoantibodies 512 (IA2).
Rosiglitazone Autoantibody Negative Rosiglitazone is an oral antidiabetic agent which acts primarily by increasing insulin sensitivity. The rosiglitazone treatment group commenced therapy with 4 mg once per day and increase to twice per day if adequate glycemic control was not achieved. Autoantibody negative for insulin autoantibodies (IAA), islet cell autoantibodies (ICA), glutamic acid decarboxylase (GAD), and islet cell autoantibodies 512 (IA2).
Glyburide Autoantibody Positive Glyburide is a sulfonylurea. Glyburide therapy was initiated with 2.5 mg in the morning or the patient was maintained on the dose they had been receiving prior to starting the study. This starting dose was raised by 2.5 in the evening and further up to a maximum of 10 mg twice a day if necessary to achieve desired glycemic control. Autoantibody positive for one or multiple islet autoantibodies. These autoantibodies include insulin autoantibodies(IAA), islet cell autoantibodies (ICA), glutamic acid decarboxylase (GAD), islet cell autoantibodies 512 (IA2).
Glyburide Autoantibody Negative Glyburide is a sulfonylurea. Glyburide therapy was initiated with 2.5 mg in the morning or the patient was maintained on the dose they had been receiving prior to starting the study. This starting dose was raised by 2.5 in the evening and further up to a maximum of 10 mg twice a day if necessary to achieve desired glycemic control. Autoantibody negative for insulin autoantibodies (IAA), islet cell autoantibodies (ICA), glutamic acid decarboxylase (GAD), and islet cell autoantibodies 512 (IA2).
Total Total of all reporting groups

Baseline Measures
    Rosiglitazone Autoantibody Positive     Rosiglitazone Autoantibody Negative     Glyburide Autoantibody Positive     Glyburide Autoantibody Negative     Total  
Number of Participants  
[units: participants]
  15     15     13     21     64  
Age  
[units: participants]
         
<=18 years     0     0     0     0     0  
Between 18 and 65 years     14     13     12     18     57  
>=65 years     1     2     1     3     7  
Age  
[units: years]
Mean ± Standard Deviation
  55.4  ± 8.8     56.4  ± 8.7     53.7  ± 9     57.5  ± 6.9     55.8  ± 1.6  
Gender  
[units: participants]
         
Female     4     4     2     8     18  
Male     11     11     11     13     46  
Region of Enrollment  
[units: participants]
         
United States     15     15     13     21     64  



  Outcome Measures
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1.  Primary:   Changes in Beta Cell Function Assessed by Fasting and Stimulated C-peptide Measured at 36 Months.   [ Time Frame: 36 months ]

2.  Secondary:   Patients Positive for T Cell Responses to Islet Proteins at 36 Months.   [ Time Frame: 36 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
Small numbers based on high drop out of participants.


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


Results Point of Contact:  
Name/Title: Jerry P. Palmer, MD
Organization: University of Washington
phone: 206-764-2495
e-mail: jpp@u.washington.edu


Publications:

Publications automatically indexed to this study:

Responsible Party: Jerry P. Palmer, MD, Professor, Principal Investigator, University of Washington, Seattle Institute for Biomedical & Clinical Research
ClinicalTrials.gov Identifier: NCT00194896     History of Changes
Other Study ID Numbers: 16707-D, 496539-188;, 16707D
Study First Received: September 14, 2005
Results First Received: February 22, 2011
Last Updated: August 16, 2011
Health Authority: United States: Institutional Review Board