type 2 diabetes
Conditions
Interventions
Pioglitazone and Metformin:adding the compound preparation of Pioglitazone and Metformin(15mg/500mg)
placebo:adding the placebo
Sponsors
Division of Endocrinology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Eligibility
Sex/Gender
All
Age
28 Years to 69 Years
Inclusion criteria
Inclusion criteria: (1) T2DM (WHO criteria, 1999); (2) aged between 18 and 70 years, either male or female; (3) BMI between 19 and 35; (4) subjects who accept initial treatment of sulfonylureas with good diet control and physical exercises, the duration no less than 3 months, the stable dose no less than 1 month, HbA1c between 7 and 11%; (5) not treated with insulin in the last six months; (6) being absence of serious cardiac, hepatic and renal diseases; (7) taking effective contraception measures for women of child-birth period; (8) willing to sign the informed consent form.
Exclusion criteria
Exclusion criteria: Anyone will be excluded with either one of the following situations: (1) T1DM or other special types diabetes; (2) women being pregnant, prepare to be pregnant, lactation period and those who can't take effective measures of contraception; (3) not take corporation for any reason; (4) liver function abnormal as the level of ALT and/or AST increase two times than the normal range; (5)renal function abnormal as serum Creatinine =133mmol/L for females or =135mmol/L for males; (6) serious chronic gastric and intestinal diseases; (7) edema; (8) serious cardiac disease, such as heart failure(New York Heart Association functional class over level III), acute coronary syndrome, old cardiac infarction; (9) for blood pressure, SBP=180mmHg and/or DBP=110 mmHg; (10) white blood cell counting < 4.0×10^9/L or platelet counting < 90×10^9/L, or identified anemia (Hb<120g/L for males or <110g/L for females), or with other blood disorder; (11) with endocrine diseases such as hyperthyroidism and Cushing's syndrome; (12) being allergic to trial drugs or frequently attack with hypoglycemia; (13) mental illness, drug or other agents such as alcohol abuse; (14) DKA or non-ketotic hyperosmolar diabetic coma with the necessity to treat with insulin; (15) stress cases such as surgery or serious trauma; (16) chronic oxygen deficit such as emphysema and COPD; (17) in combination of glucocorticoids, which may influence the glucometabolism; (18) with tumor, especially with bladder tumors and/or with the family history and/or chronic haematuria.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| HbA1; | — |
Secondary
| Measure | Time frame |
|---|---|
| Fasting Blood Glucose;-2h Blood Glucos; | — |
Countries
China
Contacts
Public ContactYu Xuefeng
the Division of Endocrinology, Tongji Hospital, Wuhan
Outcome results
None listed