- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02099838
Effectiveness and Safety of Adding Compound Preparation of Pioglitazone and Metformin for Type 2 Diabetic Patients
June 11, 2014 updated by: Xuefeng Yu, Huazhong University of Science and Technology
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
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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
Enrollment (Actual)
98
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Hubei
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Wuhan, Hubei, China, 430030
- Tongji Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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.
All participants added 1 tablet of pioglitazone and metformin twice a day (before breakfast and before dinner) orally for 12 weeks.
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taking 1 tablet twice a day (before breakfast and before dinner) orally for 12 weeks
Other Names:
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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.
All participants added 1 tablet of placebo twice a day (before breakfast and before dinner) orally for 12 weeks.
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taking 1 tablet twice a day (before breakfast and before dinner) orally for 12 weeks
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change of HbA1c From Baseline at Week 12
Time Frame: Baseline, Week 12
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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).
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Baseline, Week 12
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change of FPG From Baseline at Week 12
Time Frame: Baseline, 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).
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Baseline, Week 12
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Change of 2hPPG From Baseline at Week 12
Time Frame: Baseline, Week 12
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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).
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Baseline, Week 12
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Change of Fasting Insulin From Baseline at Week 12
Time Frame: Baseline, Week 12
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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).
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Baseline, Week 12
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Change of 2-hour Postprandial Insulin From Baseline at Week 12
Time Frame: Baseline, Week 12
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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
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Change of TC From Baseline at Week 12
Time Frame: Baseline, Week 12
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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).
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Baseline, Week 12
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Change of TG From Baseline at Week 12
Time Frame: Baseline, Week 12
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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).
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Baseline, Week 12
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Change of HDL From Baseline at Week 12
Time Frame: Baseline, Week 12
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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).
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Baseline, Week 12
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Change of LDL From Baseline at Week 12
Time Frame: Baseline, Week 12
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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).
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Baseline, Week 12
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change of ALT From Baseline at Week 12
Time Frame: Baseline, Week 12
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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).
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Baseline, Week 12
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Change of AST From Baseline at Week 12
Time Frame: Baseline, Week 12
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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).
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Baseline, Week 12
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Change of TBil From Baseline at Week 12
Time Frame: Baseline, Week 12
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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).
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Baseline, Week 12
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Change of DBil From Baseline at Week 12
Time Frame: Baseline, Week 12
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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
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Xuefeng Yu, MD, PhD, Division of Endocrinology, Tongji Hospital, Huazhong University of Science & Technology
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2012
Primary Completion (Actual)
December 1, 2013
Study Completion (Actual)
December 1, 2013
Study Registration Dates
First Submitted
March 24, 2014
First Submitted That Met QC Criteria
March 26, 2014
First Posted (Estimate)
March 31, 2014
Study Record Updates
Last Update Posted (Estimate)
June 25, 2014
Last Update Submitted That Met QC Criteria
June 11, 2014
Last Verified
June 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Tongji201202
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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