This study will compare the effect of a new oral agent for type 2 diabetes, sitagliptin, in comparison to thiazolidinediones as the third-line oral agent, in patients with type 2 diabetes mellitus.
The aim of this protocol is to determine the non-inferiority of the effectiveness of sitagliptin compared to a control group of patients treated with thiazolidinediones as add-on therapy, in low-income ethnic minority type 2 diabetic patients who are failing to maintain adequate control with maximal doses of metformin and a sulfonylurea agent.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
108
Sitagliptin 100 mg by mouth once daily
Charles Drew University of Medicine and Science
Los Angeles, California, United States
Hemoglobin A1c (HbA1c) Change From Baseline
Time frame: Baseline, 4 months
Number of Subjects With Hemoglobin A1c 7.5% or Less at 4 Months
Time frame: 4 months
Number of Subjects Maintaining Hemoglobin A1c 7.5% or Less by 1 Year
Time frame: 1 year
Number of Adverse Events
Time frame: 1 year
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