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

Primary Purpose

Diabetes Mellitus, Type 2

Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Pioglitazone and Metformin
Placebo
Sponsored by
Huazhong University of Science and Technology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Mellitus, Type 2 focused on measuring Pioglitazone, Metformin, Type 2 Diabetes Mellitus

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Tongji Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Pioglitazone and Metformin

Placebo

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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).
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).
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).
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).
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).
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).
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).
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).

Full Information

First Posted
March 24, 2014
Last Updated
June 11, 2014
Sponsor
Huazhong University of Science and Technology
Collaborators
Wuhan Iron and Steel Workers' Hospital, Wuhan Pu-Ai Hospital, Hubei Xinhua Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02099838
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2014
Overall Recruitment Status
Completed
Study Start Date
January 2012 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
December 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Huazhong University of Science and Technology
Collaborators
Wuhan Iron and Steel Workers' Hospital, Wuhan Pu-Ai Hospital, Hubei Xinhua Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2
Keywords
Pioglitazone, Metformin, Type 2 Diabetes Mellitus

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
98 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pioglitazone and Metformin
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Pioglitazone and Metformin
Other Intervention Name(s)
Compound Preparation of Pioglitazone and Metformin, Kashuangping, H20100180
Intervention Description
taking 1 tablet twice a day (before breakfast and before dinner) orally for 12 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
taking 1 tablet twice a day (before breakfast and before dinner) orally for 12 weeks
Primary Outcome Measure Information:
Title
Change of HbA1c From Baseline at Week 12
Description
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).
Time Frame
Baseline, Week 12
Secondary Outcome Measure Information:
Title
Change of FPG From Baseline at Week 12
Description
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).
Time Frame
Baseline, Week 12
Title
Change of 2hPPG From Baseline at Week 12
Description
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).
Time Frame
Baseline, Week 12
Title
Change of Fasting Insulin From Baseline at Week 12
Description
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).
Time Frame
Baseline, Week 12
Title
Change of 2-hour Postprandial Insulin From Baseline at Week 12
Description
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).
Time Frame
Baseline, Week 12
Title
Change of TC From Baseline at Week 12
Description
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).
Time Frame
Baseline, Week 12
Title
Change of TG From Baseline at Week 12
Description
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).
Time Frame
Baseline, Week 12
Title
Change of HDL From Baseline at Week 12
Description
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).
Time Frame
Baseline, Week 12
Title
Change of LDL From Baseline at Week 12
Description
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).
Time Frame
Baseline, Week 12
Other Pre-specified Outcome Measures:
Title
Change of ALT From Baseline at Week 12
Description
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).
Time Frame
Baseline, Week 12
Title
Change of AST From Baseline at Week 12
Description
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).
Time Frame
Baseline, Week 12
Title
Change of TBil From Baseline at Week 12
Description
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).
Time Frame
Baseline, Week 12
Title
Change of DBil From Baseline at Week 12
Description
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).
Time Frame
Baseline, Week 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xuefeng Yu, MD, PhD
Organizational Affiliation
Division of Endocrinology, Tongji Hospital, Huazhong University of Science & Technology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tongji Hospital
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430030
Country
China

12. IPD Sharing Statement

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

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