Evaluation of safety, tolerability and superiority of RK-01, a valsartan plus celecoxib dual add-on to metformin-HCL XR over metformin in newly diagnosed and obese adult type 2 diabetes patients with high blood pressure, arthritis and inadequate glycemic control with metformin monotherapy, diet and exercise over 26 weeks of treatment. Objective: To assess effect of RK-01 on HbA1c levels, beta cell function and insulin resistance with co-administration of valsartan, celecoxib and metformin-HCl XR relative to metformin monotherapy. Hypothesis: After 26 weeks of treatment with valsartan, celecoxib and metformin-HCl XR provides greater improvements in glycemic, inflammatory and atherogenic parameters compared to metformin monotherapy.
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Change in glycosylated Hemoglobin (HbA1c) for metformin background patients
Timeframe: Baseline and 26 weeks
Change in glycosylated Hemoglobin (HbA1c) for treatment naive patients
Timeframe: Baseline and 26 weeks
Change from baseline in acute insulin response to glucose (AIRg) for metformin background patients
Timeframe: Baseline and 26 weeks
Change from baseline in acute insulin response to glucose (AIRg) for treatment naive patients
Timeframe: Baseline and 26 weeks