Adding Sitagliptin or Pioglitazone to Type 2 Diabetes Mellitus Insufficiently Controlled With Metformin and Sulfonylurea
Adding Sitagliptin or Pioglitazone to Type 2 Diabetes Mellitus 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
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 or aspartate aminotransferase
 levels > 2.5 times the upper limit of normal

 -  Current or prepare to pregnancy and lactation