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| Name | Class |
|---|---|
| Wuhan Iron and Steel Workers' Hospital | OTHER |
| Wuhan Pu-Ai Hospital | OTHER |
| Hubei Xinhua Hospital | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pioglitazone and Metformin | Experimental | 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. |
|
| Placebo | Placebo Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pioglitazone and Metformin | Drug | taking 1 tablet twice a day (before breakfast and before dinner) orally for 12 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Change of AST From Baseline at Week 12 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Xuefeng Yu, MD, PhD | Division of Endocrinology, Tongji Hospital, Huazhong University of Science & Technology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tongji Hospital | Wuhan | Hubei | 430030 | China |
All participants were randomized to the two groups.They had a week for washout before the trial, during which they received diet and sport instructions, kept the sulfonylureas (SUs) unchanged and didn't use any drugs affecting blood glucose.
98 participants were recruited at 15 hospitals in Wuhan between March 2012 and September 2013.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Based on the full analysis set: all participants who were eligible or drop-out, but eliminated participants were excluded.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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). | Based on the full analysis set: all participants who were eligible or drop-out, but eliminated participants were excluded. Intention to treat analysis and last observational carried forward(LOCF) imputation method. | Posted | Mean | Standard Deviation | ln(percent) | Baseline, Week 12 |
|
12 weeks
Safety set included all participants who received intervention at least once and had the actual data of safety index.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Stroke | Nervous system disorders | Systematic Assessment | The only death caused by sudden stroke had no clinical association with the drug and wasn't included in safety set. So the total number of participants at risk for serious adverse events in experiment group was 47 rather than 46. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypoglycemia | Endocrine disorders | Systematic Assessment | The total number of participants at risk for other adverse events in experiment group was 46 based on safety set. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Yu | Huazhong University of Science and Technology | 027-83662883 | xfyu188@163.com |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D000077205 | Pioglitazone |
| D008687 | Metformin |
| ID | Term |
|---|---|
| D045162 | Thiazolidinediones |
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
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| Placebo | Drug | taking 1 tablet twice a day (before breakfast and before dinner) orally for 12 weeks |
|
| Baseline, Week 12 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
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 |
| 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 |
| 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 |
| Withdrawal by Subject |
|
| BG001 |
| 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
| Region of Enrollment | Number | participants |
|
| Duration of Type 2 Diabetes | Mean | Standard Deviation | years |
|
| Systolic Blood Pressure(SBP) | Mean | Standard Deviation | mmHg |
|
| Diastolic Blood Pressure(DBP) | Mean | Standard Deviation | mmHg |
|
| Height(Male) | Mean | Standard Deviation | cm |
|
| Height(Female) | Mean | Standard Deviation | cm |
|
| Weight(Male) | Mean | Standard Deviation | Kg |
|
| Weight(Female) | Mean | Standard Deviation | Kg |
|
| ln(Fasting Plasma Glucose(FPG)) | Mean | Standard Deviation | ln(mmol/L) |
|
| 2-hour Postprandial Glucose(2hPPG) | Mean | Standard Deviation | mmol/L |
|
| ln(HbA1c) | Mean | Standard Deviation | ln(percent) |
|
| ln(Fasting Insulin) | Mean | Standard Deviation | ln(mU/L) |
|
| ln(2-hour Postprandial Insulin) | Mean | Standard Deviation | ln(mU/L) |
|
| Total Cholesterol(TC) | Mean | Standard Deviation | mmol/L |
|
| Triglyceride(TG) | Mean | Standard Deviation | mmol/L |
|
| High Density Lipoprotein(HDL) | Mean | Standard Deviation | mmol/L |
|
| ln(Low Density Lipoprotein(LDL)) | Mean | Standard Deviation | ln(mmol/L) |
|
| Glutamic-pyruvic Transaminase(ALT) | Mean | Standard Deviation | U/L |
|
| Glutamic-oxaloacetic Transaminase(AST) | Mean | Standard Deviation | U/L |
|
| Total Bilirubin(TBil) | Mean | Standard Deviation | mmol/L |
|
| Direct Bilirubin(DBil) | Mean | Standard Deviation | mmol/L |
|
| OG001 | 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. |
|
|
|
| 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). | Based on the full analysis set: all participants who were eligible or drop-out, but eliminated participants were excluded. | Posted | Mean | Standard Deviation | ln(mmol/L) | Baseline, Week 12 |
|
|
|
|
| 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). | Based on the full analysis set: all participants who were eligible or drop-out, but eliminated participants were excluded. | Posted | Mean | Standard Deviation | mmol/L | Baseline, Week 12 |
|
|
|
|
| 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). | Based on the full analysis set: all participants who were eligible or drop-out, but eliminated participants were excluded. | Posted | Mean | Standard Deviation | ln(mU/L) | Baseline, Week 12 |
|
|
|
|
| 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). | Based on the full analysis set: all participants who were eligible or drop-out, but eliminated participants were excluded. | Posted | Mean | Standard Deviation | ln(mU/L) | Baseline, Week 12 |
|
|
|
|
| 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). | Based on the full analysis set: all participants who were eligible or drop-out, but eliminated participants were excluded. | Posted | Mean | Standard Deviation | mmol/L | Baseline, Week 12 |
|
|
|
|
| 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). | Based on the full analysis set: all participants who were eligible or drop-out, but eliminated participants were excluded. | Posted | Mean | Standard Deviation | mmol/L | Baseline, Week 12 |
|
|
|
|
| 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). | Based on the full analysis set: all participants who were eligible or drop-out, but eliminated participants were excluded. | Posted | Mean | Standard Deviation | mmol/L | Baseline, Week 12 |
|
|
|
|
| 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). | Based on the full analysis set: all participants who were eligible or drop-out, but eliminated participants were excluded. | Posted | Mean | Standard Deviation | ln(mmol/L) | Baseline, Week 12 |
|
|
|
|
| Other Pre-specified | 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). | Based on safety set：all participants who received intervention at least once and had actual data of safety record. | Posted | Mean | Standard Error | U/L | Baseline, Week 12 |
|
|
|
|
| Other Pre-specified | 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). | Based on safety set：all participants who received intervention at least once and had actual data of safety record. | Posted | Mean | Standard Deviation | U/L | Baseline, Week 12 |
|
|
|
|
| Other Pre-specified | 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). | Based on safety set：all participants who received intervention at least once and had actual data of safety record. | Posted | Mean | Standard Deviation | mmol/L | Baseline, Week 12 |
|
|
|
|
| Other Pre-specified | 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). | Based on safety set：all participants who received intervention at least once and had actual data of safety record. | Posted | Mean | Standard Deviation | mmol/L | Baseline, Week 12 |
|
|
|
|
| 1 |
| 47 |
| 7 |
| 46 |
| EG001 | 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. | 0 | 51 | 5 | 51 |
|
|
| Abnormal Liver Function | Hepatobiliary disorders | Systematic Assessment | 6 participants in experiment group and 3 participants in control group had mildly abnormal liver functions at week 12, but these abnormities had no clinical significance. |
|
Not provided
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| D004700 | Endocrine System Diseases |
| D001393 |
| Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| Change from Baseline at Week 12 |
|
Null hypothesis is that there was no difference in change of FPG between before and after treatment in Placebo group. The test was performed with a significance level of 0.05. |
| Wilcoxon (Mann-Whitney) |
| 0.0849 |
The a priori threshold for statistical significance is 0.05; the change was statistical significant with P-value less than 0.05. |
| No |
| Superiority or Other |
| Null hypothesis is that there was no difference in change of FPG between Pioglitazone and Metformin group and Placebo group. The test was performed with a significance level of 0.05. | Wilcoxon (Mann-Whitney) | 0.0005 | The a priori threshold for statistical significance is 0.05; the change was statistical significant with P-value less than 0.05. | No | Superiority or Other |
| Change from Baseline at Week 12 |
|
Null hypothesis is that there was no difference in change of 2hPPG between before and after treatment in Placebo group. The test was performed with a significance level of 0.05. |
| Wilcoxon (Mann-Whitney) |
| 0.2428 |
The a priori threshold for statistical significance is 0.05; the change was statistical significant with P-value less than 0.05. |
| No |
| Superiority or Other |
| Null hypothesis is that there was no difference in change of 2hPPG between Pioglitazone and Metformin group and Placebo group. The test was performed with a significance level of 0.05. | Wilcoxon (Mann-Whitney) | 0.0003 | The a priori threshold for statistical significance is 0.05; the change was statistical significant with P-value less than 0.05. | No | Superiority or Other |
| Change from Baseline at Week 12 |
|
Null hypothesis is that there was no difference in change of fasting insulin between before and after treatment in Placebo group.. The test was performed with a significance level of 0.05. |
| Wilcoxon (Mann-Whitney) |
| 0.7353 |
The a priori threshold for statistical significance is 0.05; the change was statistical significant with P-value less than 0.05. |
| No |
| Superiority or Other |
| Null hypothesis is that there was no difference in change of fasting insulin between Pioglitazone and Metformin group and Placebo group. The test was performed with a significance level of 0.05. | Wilcoxon (Mann-Whitney) | 0.0013 | The a priori threshold for statistical significance is 0.05; the change was statistical significant with P-value less than 0.05. | No | Superiority or Other |
| Change from Baseline at Week 12 |
|
Null hypothesis is that there was no difference in change of 2-hour postprandial insulin between before and after treatment in Placebo group. The test was performed with a significance level of 0.05. |
| Wilcoxon (Mann-Whitney) |
| 0.4006 |
The a priori threshold for statistical significance is 0.05; the change was statistical significant with P-value less than 0.05. |
| No |
| Superiority or Other |
| Null hypothesis is that there was no difference in change of 2-hour postprandial insulin between Pioglitazone and Metformin group and Placebo group. The test was performed with a significance level of 0.05. | Wilcoxon (Mann-Whitney) | 0.0614 | The a priori threshold for statistical significance is 0.05; the change was statistical significant with P-value less than 0.05. | No | Superiority or Other |
| Change from Baseline at Week 12 |
|
Null hypothesis is that there was no difference in change of TC between before and after treatment in Placebo group. The test was performed with a significance level of 0.05. |
| Wilcoxon (Mann-Whitney) |
| 0.4236 |
The a priori threshold for statistical significance is 0.05; the change was statistical significant with P-value less than 0.05. |
| No |
| Superiority or Other |
| Null hypothesis is that there was no difference in change of TC between Pioglitazone and Metformin group and Placebo group. The test was performed with a significance level of 0.05. | Wilcoxon (Mann-Whitney) | 1.0000 | The a priori threshold for statistical significance is 0.05; the change was statistical significant with P-value less than 0.05. | No | Superiority or Other |
| Change from Baseline at Week 12 |
|
Null hypothesis is that there was no difference in change of TG between before and after treatment in Placebo group. The test was performed with a significance level of 0.05. |
| Wilcoxon (Mann-Whitney) |
| 0.6963 |
The a priori threshold for statistical significance is 0.05; the change was statistical significant with P-value less than 0.05. |
| No |
| Superiority or Other |
| Null hypothesis is that there was no difference in change of TG between Pioglitazone and Metformin group and Placebo group. The test was performed with a significance level of 0.05. | Wilcoxon (Mann-Whitney) | 0.3204 | The a priori threshold for statistical significance is 0.05; the change was statistical significant with P-value less than 0.05. | No | Superiority or Other |
| Change from Baseline at Week 12 |
|
Null hypothesis is that there was no difference in change of HDL between before and after treatment in Placebo group. The test was performed with a significance level of 0.05. |
| Wilcoxon (Mann-Whitney) |
| 0.3812 |
The a priori threshold for statistical significance is 0.05; the change was statistical significant with P-value less than 0.05. |
| No |
| Superiority or Other |
| Null hypothesis is that there was no difference in change of HDL between Pioglitazone and Metformin group and Placebo group. The test was performed with a significance level of 0.05. | Wilcoxon (Mann-Whitney) | 0.0108 | The a priori threshold for statistical significance is 0.05; the change was statistical significant with P-value less than 0.05. | No | Superiority or Other |
| Change from Baseline at Week 12 |
|
Null hypothesis is that there was no difference in change of LDL between before and after treatment in Placebo group. The test was performed with a significance level of 0.05. |
| Wilcoxon (Mann-Whitney) |
| 0.1248 |
The a priori threshold for statistical significance is 0.05; the change was statistical significant with P-value less than 0.05. |
| No |
| Superiority or Other |
| Null hypothesis is that there was no difference in change of LDL between Pioglitazone and Metformin group and Placebo group. The test was performed with a significance level of 0.05. | Wilcoxon (Mann-Whitney) | 0.3620 | The a priori threshold for statistical significance is 0.05; the change was statistical significant with P-value less than 0.05. | No | Superiority or Other |
| Change from Baseline at Week 12 |
|
Null hypothesis is that there was no difference in change of ALT between before and after treatment in Placebo group. The test was performed with a significance level of 0.05. |
| Wilcoxon (Mann-Whitney) |
| 0.3681 |
The a priori threshold for statistical significance is 0.05; the change was statistical significant with P-value less than 0.05. |
| No |
| Superiority or Other |
| Null hypothesis is that there was no difference in change of ALT between Pioglitazone and Metformin group and Placebo group. The test was performed with a significance level of 0.05. | Wilcoxon (Mann-Whitney) | 0.2589 | The a priori threshold for statistical significance is 0.05; the change was statistical significant with P-value less than 0.05. | No | Superiority or Other |
| Change from Baseline at Week 12 |
|
Null hypothesis is that there was no difference in change of AST between before and after treatment in Placebo group. The test was performed with a significance level of 0.05. |
| Wilcoxon (Mann-Whitney) |
| 0.7801 |
The a priori threshold for statistical significance is 0.05; the change was statistical significant with P-value less than 0.05. |
| No |
| Superiority or Other |
| Null hypothesis is that there was no difference in change of AST between Pioglitazone and Metformin group and Placebo group. The test was performed with a significance level of 0.05. | Wilcoxon (Mann-Whitney) | 0.8744 | The a priori threshold for statistical significance is 0.05; the change was statistical significant with P-value less than 0.05. | No | Superiority or Other |
| Change from Baseline at Week 12 |
|
Null hypothesis is that there was no difference in change of TBil between before and after treatment in Placebo group. The test was performed with a significance level of 0.05. |
| Wilcoxon (Mann-Whitney) |
| 0.7675 |
The a priori threshold for statistical significance is 0.05; the change was statistical significant with P-value less than 0.05. |
| No |
| Superiority or Other |
| Null hypothesis is that there was no difference in change of TBil between Pioglitazone and Metformin group and Placebo group. The test was performed with a significance level of 0.05. | Wilcoxon (Mann-Whitney) | 0.6918 | The a priori threshold for statistical significance is 0.05; the change was statistical significant with P-value less than 0.05. | No | Superiority or Other |
| Change from Baseline at Week 12 |
|
Null hypothesis is that there was no difference in change of DBil between before and after treatment in Placebo group. The test was performed with a significance level of 0.05. |
| Wilcoxon (Mann-Whitney) |
| 0.0997 |
The a priori threshold for statistical significance is 0.05; the change was statistical significant with P-value less than 0.05. |
| No |
| Superiority or Other |
| Null hypothesis is that there was no difference in change of DBil between Pioglitazone and Metformin group and Placebo group. The test was performed with a significance level of 0.05. | Wilcoxon (Mann-Whitney) | 0.5015 | The a priori threshold for statistical significance is 0.05; the change was statistical significant with P-value less than 0.05. | No | Superiority or Other |