Preferred Treatment of Type 1.5 Diabetes
The purpose of this research was to test whether one treatment was superior over another in the management of type 1.5 diabetes. Specifically we tested recently diagnosed antibody positive type 2 diabetic patients to determine whether treatment with rosiglitazone results in greater preservation of beta cell function compared to treatment with glyburide.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Rosiglitazone Intervention Study in Patients With Type 1.5 Diabetes|
- Changes in Beta Cell Function Assessed by Fasting and Stimulated C-peptide Measured at 36 Months. [ Time Frame: 36 months ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]Number of participants positive for T cell reactivity to islet proteins at 36 months.
|Study Start Date:||February 2000|
|Study Completion Date:||December 2008|
|Primary Completion Date:||September 2008 (Final data collection date for primary outcome measure)|
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.
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Please refer to this study by its ClinicalTrials.gov identifier: 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|