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

NCT ID: NCT02099838

Last Updated: 2014-06-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 98 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-01-31
• Study Completion Date: 2013-12-31

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.

Conditions

Diabetes Mellitus, Type 2

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Pioglitazone and Metformin

Type 2 diabetic patients only took SUs previously. During a week for washout before the trial, they received diet and sport instructions, kept the SUs unchanged and didn't use any drugs affecting blood glucose. All participants added 1 tablet of pioglitazone and metformin twice a day (before breakfast and before dinner) orally for 12 weeks.

Group Type: EXPERIMENTAL

Pioglitazone and Metformin

Intervention Type: DRUG

taking 1 tablet twice a day (before breakfast and before dinner) orally for 12 weeks

Placebo

Type 2 diabetic patients only took SUs previously. During a week for washout before the trial, they received diet and sport instructions, kept the SUs unchanged and didn't use any drugs affecting blood glucose. All participants added 1 tablet of placebo twice a day (before breakfast and before dinner) orally for 12 weeks.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

taking 1 tablet twice a day (before breakfast and before dinner) orally for 12 weeks

Interventions

Pioglitazone and Metformin

taking 1 tablet twice a day (before breakfast and before dinner) orally for 12 weeks

Intervention Type: DRUG

Placebo

taking 1 tablet twice a day (before breakfast and before dinner) orally for 12 weeks

Intervention Type: DRUG

Other Intervention Names

Compound Preparation of Pioglitazone and Metformin; Kashuangping; H20100180

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Wuhan Iron and Steel Workers' Hospital

OTHER

Sponsor Role: collaborator

Wuhan Pu-Ai Hospital

OTHER

Sponsor Role: collaborator

Hubei Xinhua Hospital

OTHER

Sponsor Role: collaborator

Huazhong University of Science and Technology

OTHER

Sponsor Role: lead

Responsible Party

Xuefeng Yu

Director of Department of Endocrinology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Xuefeng Yu, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Division of Endocrinology, Tongji Hospital, Huazhong University of Science & Technology

Locations

Tongji Hospital

Wuhan, Hubei, China

Countries

China

Other Identifiers

Tongji201202

Identifier Type: -

Identifier Source: org_study_id