Preferred Treatment of Type 1.5 Diabetes
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|ClinicalTrials.gov Identifier: NCT00194896|
Recruitment Status : Completed
First Posted : September 19, 2005
Results First Posted : August 10, 2011
Last Update Posted : March 29, 2018
|Condition or disease||Intervention/treatment||Phase|
|Type 2 Diabetes Mellitus||Drug: rosiglitazone Drug: glyburide||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||64 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Rosiglitazone Intervention Study in Patients With Type 1.5 Diabetes|
|Study Start Date :||February 2000|
|Actual Primary Completion Date :||September 2008|
|Actual Study Completion Date :||December 2008|
Active Comparator: rosiglitazone
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.
Tablet taken orally at a dosage of 4 mg once per day and increase to twice per day if adequate glycemic control was not achieved. Study drug was taken up to 3 years.
Other Name: Avandia
Active Comparator: glyburide
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.
Tablet taken orally, initially 2.5 mg in the morning or dose subject received prior to starting the study. Dosage was increased by 2.5 mg in the evening up to a maximum of 10 mg twice a day if necessary to achieve desired glycemic control. Study drug was taken up to 3 years.
- Changes in Beta Cell Function Assessed by Fasting and Stimulated C-peptide Measured at 36 Months. [ Time Frame: 36 months ]Changes in beta cell function assessed by fasting and stimulated C-peptide measured at 36 months.
- Patients Positive for T Cell Responses to Islet Proteins at 36 Months. [ Time Frame: 36 months ]Number of participants positive for T cell reactivity to islet proteins at 36 months.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00194896
|United States, Washington|
|DVA Puget Sound Health Care System|
|Seattle, Washington, United States, 98108|
|Principal Investigator:||Jerry P Palmer, MD||Seattle Institute for Biomedical & Clinical Research, University of Washington, DVA Puget Sound Health Care System|