Type 2 Diabetes Clinical Trial
Official title:
Efficacy of Adding Sitagliptin or Pioglitazone to Patients With Type 2 Diabetes Insufficiently Controlled With Metformin and Sulfonylurea
This 24-weeks study will to compare the glycemic efficacy and safety of sitagliptin with pioglitazone in patients with type 2 diabetes who had inadequate glycemic control despite dual therapy with metformin and a sulfonylurea.
This is a prospective, open-label, randomized, parallel, 24-week study. Inclusion criteria:
type 2 diabetes patients who were treated with stable doses of sulfonylurea and metformin to
their half maximally dose (sulfonylureas > half maximal dose, and metformin > 1500 mg/d) for
> 10 weeks. > 20 years old; A1C:> 7.0 % and < 11% Exclusion criteria: insulin use within 12
weeks of the screening visit, any contraindications for use of sitagliptin or pioglitazone,
impaired renal function (serum creatinine > 1.4 mg/dl), alanine aminotransferase (ALT) or
aspartate aminotransferase levels (AST) > 2.5 times the upper limit of normal (ULN), current
or prepare to pregnancy and lactation.
Primary Purpose:
compare the change in hemoglobin A1c and the proportion of patients achieving A1C < 7%
between the 2 groups
Secondary Purposes:
1. Changes in fasting plasma glucose, high sensitive C-reactive protein (hsCRP)
2. Homeostasis model assessment-β cell function(HOMA-β) will be calculated to assess
changes in β-cell function and HOMA-insulin resistance(HOMA-IR)to assess changes in
insulin resistance
3. Body weight change, proportion of side effects
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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