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

Diabetes Mellitus, Type 2 Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02099838
• Other study ID #: Tongji201202
• Status: Completed
• Phase: Phase 4
• First received: March 24, 2014
• Last updated: June 11, 2014
• Start date: January 2012
• Est. completion date: December 2013

Study information

• Verified date: June 2014
• Source: Huazhong University of Science and Technology
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 98
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Drug:
• Pioglitazone and Metformin
taking 1 tablet twice a day (before breakfast and before dinner) orally for 12 weeks
• Placebo
taking 1 tablet twice a day (before breakfast and before dinner) orally for 12 weeks

Locations

Country	Name	City	State
China	Tongji Hospital	Wuhan	Hubei

Sponsors (4)

Lead Sponsor	Collaborator
Huazhong University of Science and Technology	Hubei Xinhua Hospital, Wuhan Iron and Steel Workers' Hospital, Wuhan Pu-Ai Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change of ALT From Baseline at Week 12	Measuring venous level of ALT at the start of the trail and at week 12 in all subjects, then analyzing the change in ALT from baseline at week 12 and comparing that between experiment group and control group. Change = (Baseline Level - Week 12 Level).	Baseline, Week 12	Yes
Other	Change of AST From Baseline at Week 12	Measuring venous level of AST at the start of the trail and at week 12 in all subjects, then analyzing the change in AST from baseline at week 12 and comparing that between experiment group and control group. Change = (Baseline Level - Week 12 Level).	Baseline, Week 12	Yes
Other	Change of TBil From Baseline at Week 12	Measuring venous level of TBil(total bilirubin) at the start of the trail and at week 12 in all subjects, then analyzing the change in TBil from baseline at week 12 and comparing that between experiment group and control group. Change = (Baseline Level - Week 12 Level).	Baseline, Week 12	Yes
Other	Change of DBil From Baseline at Week 12	Measuring venous level of DBil(direct bilirubin) at the start of the trail and at week 12 in all subjects, then analyzing the change in DBil from baseline at week 12 and comparing that between experiment group and control group. Change = (Baseline Level - Week 12 Level).	Baseline, Week 12	Yes
Primary	Change of HbA1c From Baseline at Week 12	Measuring venous level of HbA1c at the start of the trail and at week 12 in all subjects, then using the natural logarithm of HbA1c to analyze the change in HbA1c from baseline at week 12 and compare that between experiment group and control group, since the HbA1c wasn't normal distribution and was logarithmic normal distribution. Change = ln(Baseline Level) - ln(Week 12 Level).	Baseline, Week 12	No
Secondary	Change of FPG From Baseline at Week 12	Measuring venous level of FPG(fasting plasma glucose) at the start of the trail and at week 12 in all subjects, then using the natural logarithm of FPG to analyze the change in FPG from baseline at week 12 and compare that between experiment group and control group, since the FPG wasn't normal distribution and was logarithmic normal distribution. Change = ln(Baseline Level) - ln(Week 12 Level).	Baseline, Week 12	No
Secondary	Change of 2hPPG From Baseline at Week 12	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 and comparing that between experiment group and control group. Change = (Baseline Level - Week 12 Level).	Baseline, Week 12	No
Secondary	Change of Fasting Insulin From Baseline at Week 12	Measuring venous level of fasting insulin at the start of the trail and at week 12 in all subjects, then using the natural logarithm of fasting insulin to analyze the change in fasting insulin from baseline at week 12 and compare that between experiment group and control group, since the fasting insulin wasn't normal distribution and was logarithmic normal distribution. Change = ln(Baseline Level) - ln(Week 12 Level).	Baseline, Week 12	No
Secondary	Change of 2-hour Postprandial Insulin From Baseline at Week 12	Measuring venous level of 2-hour postprandial insulin at the start of the trail and at week 12 in all subjects, then using the natural logarithm of 2-hour postprandial insulin to analyze the change in 2-hour postprandial insulin from baseline at week 12 and compare that between experiment group and control group, since the 2-hour postprandial insulin wasn't normal distribution and was logarithmic normal distribution. Change = ln(Baseline Level) - ln(Week 12 Level).	Baseline, Week 12	No
Secondary	Change of TC From Baseline at Week 12	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 and comparing that between experiment group and control group. Change = (Baseline Level - Week 12 Level).	Baseline, Week 12	No
Secondary	Change of TG From Baseline at Week 12	Measuring venous level of TG(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 and comparing that between experiment group and control group. Change = (Baseline Level - Week 12 Level).	Baseline, Week 12	No
Secondary	Change of HDL From Baseline at Week 12	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 and comparing that between experiment group and control group. Change = (Baseline Level - Week 12 Level).	Baseline, Week 12	No
Secondary	Change of LDL From Baseline at Week 12	Measuring venous level of LDL(Low-Density Lipoprotein) at the start of the trail and at week 12 in all subjects, then using the natural logarithm of LDL to analyze the change in LDL from baseline at week 12 and compare that between experiment group and control group, since the LDL wasn't normal distribution and was logarithmic normal distribution. Change = ln(Baseline Level) - ln(Week 12 Level).	Baseline, Week 12	No