Effectiveness and Safety of Adding Compound Preparation of Pioglitazone and Metformin for Type 2 Diabetic Patients

• Status: Completed
• Trial end date: 2013-12-01
• Target enrollment: 0
• Participant gender: All

Summary

Secondary failure of sulfonylureas (SUs) can occur in about 30%-40% of type 2 diabetic patients after treatment with SUs for 5 years, although SUs are widely used in type 2 diabetic patients. This study was designed to evaluate the effectiveness and safety of adding compound preparation of pioglitazone and metformin for type 2 diabetic patients who have bad glycemic control with the initial treatment of SUs.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Huazhong University of Science and Technology
• Collaborators: Hubei Xinhua Hospital; Wuhan Iron and Steel Workers' Hospital; Wuhan Pu-Ai Hospital
• Treatments: Metformin; Pioglitazone

Criteria

Inclusion Criteria:

• Type 2 diabetic patients (WHO criterion, 1999)

• 19kg/m2 ≤ BMI ≤ 35kg/m2

• Subject with the initial treatment of SUs on the basis of controlling diet and sport; treatment lasting for no less than 3 months and stable dose for at least 1 month; HbA1c 7-11%

• No insulin therapy during 6 months before being selected

• Not involved in any drug test during 3 months before being selected

• No serious heart, liver or kidney diseases

• Must have effective contraception methods for women of child-bearing age

• Willing to being informed consent

Exclusion Criteria:

• Type 1 diabetes or other specific types of diabetes

• Pregnancy, preparation for pregnancy, lactation and women of child-bearing age incapable of effective contraception methods

• Uncooperative subject because of various reasons

• Abnormal liver function, glutamic-pyruvic transaminase (ALT) and glutamic-oxaloacetic transaminase (AST) > twice the upper limits of normal

• Impairment of renal function, serum creatinine: ≥ 133mmol/L for female，≥ 135mmol/L for male

• Serious chronic gastrointestinal diseases

• Edema

• Serious heart diseases, such as cardiac insufficiency (level III or more according to NYHA), acute coronary syndrome and old myocardial infraction

• Blood pressure: Systolic blood pressure (SBP) ≥ 180mmHg and/or diastolic blood pressure (DBP) ≥ 110mmHg

• White blood count (WBC) < 4.0×109/L or platelet count (PLT) < 90×109/L，or definite anemia (Hb：< 120g/L for male, < 110g/L for female), or other hematological diseases

• Endocrine system diseases, such as hyperthyroidism and hypercortisolism

• Experimental drug allergy or frequent hypoglycemia

• Psychiatric disorders, drug or other substance abuse

• Diabetic ketoacidosis and hyperosmolar nonketotic coma requiring insulin therapy

• Stressful situations such as surgery, serious trauma and so on

• Chronic hypoxic diseases such as pulmonary emphysema and pulmonary heart disease

• Combined use of drugs effecting glucose metabolism such as glucocorticoid

• Tumor, especially bladder tumor and/or family history of bladder tumor and/or long-term hematuria