Effectiveness and Safety of Adding Compound Preparation of Pioglitazone and Metformin for Type 2 Diabetic Patients
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Pioglitazone and Metformin; Placebo
Intervention description: taking 1 tablet twice a day (before breakfast and before dinner) orally for 12 weeks; taking 1 tablet twice a day (before breakfast and before dinner) orally for 12 weeks
Intervention MeSH terms: Metformin; Pioglitazone
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 98.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Pioglitazone; Metformin; Type 2 Diabetes Mellitus

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.
    

Eligibility 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