Clinical trial NCT02099838: Effectiveness and Safety of Adding Compound Preparation of Pioglitazone and Metformin for Type 2 Diabetic Patients
Official title: The Randomized Multiple Center Trial for 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 Sulfonylureas
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Diabetes Mellitus, Type 2
Keywords: Pioglitazone
Metformin
Type 2 Diabetes Mellitus
Lead sponsor: Huazhong University of Science and Technology
Sponsor class: OTHER
Collaborators: name: Wuhan Iron and Steel Workers' Hospital
name: Wuhan Pu-Ai Hospital
name: Hubei Xinhua Hospital
First posted: 2014-03-31
Enrollment: 98
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: Design of this clinical trial was multicenter, randomized, double-blind and placebo parallel controlled. Type 2 diabetic patients having bad glycemic control with the initial treatment of SUs were included. They were randomly divided into experiment group and control group, respectively taking compound preparation of pioglitazone and metformin (2mg/500mg) and placebo with identical shape immediately before a meal twice a day. Course of the treatment was 12 weeks.

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

Primary outcomes:
measure: Change of HbA1c From Baseline at Week 12
timeFrame: Baseline, Week 12
Secondary outcomes:
measure: Change of FPG From Baseline at Week 12
timeFrame: Baseline, Week 12
measure: Change of 2hPPG From Baseline at Week 12
timeFrame: Baseline, Week 12
measure: Change of Fasting Insulin From Baseline at Week 12
timeFrame: Baseline, Week 12
measure: Change of 2-hour Postprandial Insulin From Baseline at Week 12
timeFrame: Baseline, Week 12
measure: Change of TC From Baseline at Week 12
timeFrame: Baseline, Week 12
measure: Change of TG From Baseline at Week 12
timeFrame: Baseline, Week 12
measure: Change of HDL From Baseline at Week 12
timeFrame: Baseline, Week 12
measure: Change of LDL From Baseline at Week 12
timeFrame: Baseline, Week 12
Other outcomes:
measure: Change of ALT From Baseline at Week 12
timeFrame: Baseline, Week 12
measure: Change of AST From Baseline at Week 12
timeFrame: Baseline, Week 12
measure: Change of TBil From Baseline at Week 12
timeFrame: Baseline, Week 12
measure: Change of DBil From Baseline at Week 12
timeFrame: Baseline, Week 12
Locations:
city: Wuhan
country: China
facility: Tongji Hospital
state: Hubei
Study officials:
affiliation: Division of Endocrinology, Tongji Hospital, Huazhong University of Science & Technology
name: Xuefeng Yu, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: