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

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

Overview[ - collapse ][ - ]

Purpose	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.
Condition	Diabetes Mellitus, Type 2
Intervention	Drug: Pioglitazone and Metformin Drug: Placebo
Phase	Phase 4
Sponsor	Huazhong University of Science and Technology
Responsible Party	Huazhong University of Science and Technology
ClinicalTrials.gov Identifier	NCT02099838
First Received	March 24, 2014
Last Updated	March 26, 2014
Last verified	March 2014

Tracking Information[ + expand ][ + ]

First Received Date	March 24, 2014
Last Updated Date	March 26, 2014
Start Date	January 2012
Estimated Primary Completion Date	December 2013
Current Primary Outcome Measures	HbA1c [Time Frame: Baseline, Week 12] [Designated as safety issue: No]Measuring venous level of HbA1c at the start of the trail and at week 12 in all subjects, then analyzing the change in HbA1c from baseline at week 12 of experimental group and comparing that between experiment group and control group.
Current Secondary Outcome Measures	FPG [Time Frame: Baseline, Week 12] [Designated as safety issue: No]Measuring venous level of FPG(fasting plasma glucose) at the start of the trail and at week 12 in all subjects, then analyzing the change in FPG from baseline at week 12 of experimental group and comparing that between experiment group and control group. 2hPPG [Time Frame: Baseline, Week 12] [Designated as safety issue: No]Measuring venous level of 2hPPG(2-hour postprandial glucose) at the start of the trail and at week 12 in all subjects, then analyzing the change in 2hPPG from baseline at week 12 of experimental group and comparing that between experiment group and control group. Fasting Insulin [Time Frame: Baseline, Week 12] [Designated as safety issue: No]Measuring venous level of fasting insulin at the start of the trail and at week 12 in all subjects, then analyzing the change in fasting insulin from baseline at week 12 of experimental group and comparing that between experiment group and control group. 2-hour Postprandial Insulin [Time Frame: Baseline, Week 12] [Designated as safety issue: No]Measuring venous level of 2-hour postprandial insulin at the start of the trail and at week 12 in all subjects, then analyzing the change in 2-hour postprandial insulin from baseline at week 12 of experimental group and comparing that between experiment group and control group. Total Cholesterol [Time Frame: Baseline, Week 12] [Designated as safety issue: No]Measuring venous level of TC(Total Cholesterol) at the start of the trail and at week 12 in all subjects, then analyzing the change in TC from baseline at week 12 of experimental group and comparing that between experiment group and control group. Total Triglyceride [Time Frame: Baseline, Week 12] [Designated as safety issue: No]Measuring venous level of TG(Total Triglyceride) at the start of the trail and at week 12 in all subjects, then analyzing the change in TG from baseline at week 12 of experimental group and comparing that between experiment group and control group. HDL [Time Frame: Baseline, Week 12] [Designated as safety issue: No]Measuring venous level of HDL(High-Density Lipoprotein) at the start of the trail and at week 12 in all subjects, then analyzing the change in HDL from baseline at week 12 of experimental group and comparing that between experiment group and control group. LDL [Time Frame: Baseline, Week 12] [Designated as safety issue: No]Measuring venous level of LDL(Low-Density Lipoprotein) at the start of the trail and at week 12 in all subjects, then analyzing the change in LDL from baseline at week 12 of experimental group and comparing that between experiment group and control group. Adverse Event Rate [Time Frame: Up to 12 weeks] [Designated as safety issue: Yes]Calculating the number of subjects having adverse event such as hypoglycemia and the rates of adverse rate in experiment group and control group.

Descriptive Information[ + expand ][ + ]

Brief Title	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
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.
Study Type	Interventional
Study Phase	Phase 4
Study Design	Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Condition	Diabetes Mellitus, Type 2
Intervention	Drug: Pioglitazone and Metformin taking 1 tablet twice a day (before breakfast and before dinner) orally for 12 weeks Other Names: Compound Preparation of Pioglitazone and Metformin Kashuangping H20100180 Drug: Placebo taking 1 tablet twice a day (before breakfast and before dinner) orally for 12 weeks Other Names: Placebo
Study Arm (s)	Experimental: 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. They all participants added 1 tablet of pioglitazone and metformin twice a day (before breakfast and before dinner) orally for 12 weeks. Placebo Comparator: 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. They all participants added 1 tablet of placebo twice a day (before breakfast and before dinner) orally for 12 weeks.

Recruitment Information[ + expand ][ + ]

Recruitment Status	Completed
Estimated Enrollment	98
Estimated Completion Date	December 2013
Estimated Primary Completion Date	December 2013
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, ALT and 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: SBP ≥ 180mmHg and/or DBP ≥ 110mmHg - WBC ＜ 4.0×109/L or 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
Gender	Both
Ages	18 Years
Accepts Healthy Volunteers	No
Contacts	Not Provided
Location Countries	China

Administrative Information[ + expand ][ + ]

NCT Number	NCT02099838
Other Study ID Numbers	Tongji201202
Has Data Monitoring Committee	Yes
Information Provided By	Huazhong University of Science and Technology
Study Sponsor	Huazhong University of Science and Technology
Collaborators	Wuhan Iron and Steel Workers' Hospital Wuhan Pu-Ai Hospital Hubei Xinhua Hospital
Investigators	Principal Investigator: Xuefeng Yu, MD, PhD Division of Endocrinology, Tongji Hospital, Huazhong University of Science & Technology
Verification Date	March 2014

Locations[ + expand ][ + ]