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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
120
add sitagliptin100mg/d to pre-study OADs
add pioglitazone 30mg/d to pre-study OADs
Division of Endocrinology and Metabolism, Department of Internal Medicine, Mackay Memorial Hospital
Taipei, Taipei, Taiwan
Mean Change in Glycosylated Hemoglobin (A1C)
A1C change from baseline to 24 weeks
Time frame: 24 weeks
Baseline A1C
baseline A1C
Time frame: Baseline
The Percentages of Patient Achieving an A1C <7%
The percentages of patient achieving an A1C \<7% at endpoint
Time frame: 24 weeks
Changes in Fasting Plasma Glucose
fasting serum sugar change from baseline to 24 weeks
Time frame: 24 weeks
Changes in High Sensitive C-reactive Protein
fasting high sensitive serum C-reactive protein change from baseline to 24 weeks
Time frame: 24 weeks
Changes in Homoeostasis Model Assessment of Insulin Resistance (HOMA-IR)
HOMA-IR change from baseline to 24 weeks
Time frame: 24 weeks
Body Weight Change
body weight change from baseline to 24 weeks
Time frame: 24 weeks
Percentages of Patients With Total Adverse Events (AE)
percentages of total adverse events
Time frame: 24 weeks
Change in Fasting Total-cholesterol
Total-cholesterol change from baseline to 24 weeks
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Time frame: 24 weeks
Change in Fasting Low-density Lipoprotein Cholesterol (LDL-C)
LDL-C change from baseline to 24 weeks
Time frame: 24 weeks
Change in Fasting Triglycerides(TG)
TG change from baseline to 24 weeks
Time frame: 24 weeks
Change in Fasting High-density Lipoprotein Cholesterol(HDL-C)
HDL-C change from baseline to 24 weeks
Time frame: 24 weeks
Change in Fasting Plasma Alanine-aminotransferase (ALT)
ALT change from baseline to 24 weeks
Time frame: 24 weeks
Percentages of Patients With Mild to Moderate Hypoglycemia
Incidence of mild to moderate hypoglycemia after treatment
Time frame: 24 weeks
Percentages of Patients With Edema
proportion of edema after treatment
Time frame: 24 weeks
Percentages of Patients With Gastrointestinal Adverse Events
Proportion of Gastrointestinal adverse events after treatment
Time frame: 24 weeks
Percentages of Patients With Nasopharyngitis
Proportion of Nasopharyngitis after treatment
Time frame: 24 weeks
Percentages of Patients With Severe Hypoglycemia
Proportion of severe hypoglycemia after treatment
Time frame: 24 weeks
Baseline Fasting Plasma Glucose
Baseline fasting plasma glucose
Time frame: baseline
Baseline High Sensitive C-reactive Protein
Baseline high sensitive C-reactive Protein
Time frame: baseline
Baseline Homoeostasis Model Assessment of Insulin Resistance (HOMA-IR)
Baseline HOMA-IR
Time frame: Baseline HOMA-IR
Baseline Alanine-aminotransferase (ALT)
Baseline alanine-aminotransferase
Time frame: Baseline
Baseline Body Weight
Baseline body weight
Time frame: Baseline
Baseline Total Cholesterol
Baseline Total cholesterol
Time frame: Baseline
Baseline Triglyceride (TG)
Baseline TG
Time frame: Baseline
Baseline Low-density Lipoprotein Cholesterol (LDL-C)
Baseline LDL-C
Time frame: Baseline
Baseline High-density Lipoprotein Cholesterol (HDL-C)
Baseline HDL-C
Time frame: Baseline