Trial Outcomes & Findings for Effectiveness and Safety of Adding Compound Preparation of Pioglitazone and Metformin for Type 2 Diabetic Patients (NCT NCT02099838)
NCT ID: NCT02099838
Last Updated: 2014-06-25
Results Overview
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).
COMPLETED
PHASE4
98 participants
Baseline, Week 12
2014-06-25
Participant Flow
98 participants were recruited at 15 hospitals in Wuhan between March 2012 and September 2013.
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.
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
47
|
51
|
|
Overall Study
COMPLETED
|
43
|
49
|
|
Overall Study
NOT COMPLETED
|
4
|
2
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
Death
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
3
|
1
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
Baseline Characteristics
Effectiveness and Safety of Adding Compound Preparation of Pioglitazone and Metformin for Type 2 Diabetic Patients
Baseline characteristics by cohort
| Measure |
Pioglitazone and Metformin
n=46 Participants
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
n=51 Participants
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.
|
Total
n=97 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
54.65 years
STANDARD_DEVIATION 9.91 • n=5 Participants
|
54.51 years
STANDARD_DEVIATION 7.23 • n=7 Participants
|
54.61 years
STANDARD_DEVIATION 8.54 • n=5 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
33 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
58 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Han
|
45 participants
n=5 Participants
|
50 participants
n=7 Participants
|
95 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other ethnicity
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
2 participants
n=5 Participants
|
|
Region of Enrollment
China
|
46 participants
n=5 Participants
|
51 participants
n=7 Participants
|
97 participants
n=5 Participants
|
|
Duration of Type 2 Diabetes
|
4.86 years
STANDARD_DEVIATION 3.67 • n=5 Participants
|
4.39 years
STANDARD_DEVIATION 3.63 • n=7 Participants
|
4.64 years
STANDARD_DEVIATION 3.63 • n=5 Participants
|
|
Systolic Blood Pressure(SBP)
|
125.35 mmHg
STANDARD_DEVIATION 9.46 • n=5 Participants
|
128.46 mmHg
STANDARD_DEVIATION 10.38 • n=7 Participants
|
126.86 mmHg
STANDARD_DEVIATION 9.98 • n=5 Participants
|
|
Diastolic Blood Pressure(DBP)
|
76.24 mmHg
STANDARD_DEVIATION 6.38 • n=5 Participants
|
77.83 mmHg
STANDARD_DEVIATION 8.78 • n=7 Participants
|
76.87 mmHg
STANDARD_DEVIATION 7.86 • n=5 Participants
|
|
Height(Male)
|
169.17 cm
STANDARD_DEVIATION 5.03 • n=5 Participants
|
169.92 cm
STANDARD_DEVIATION 6.44 • n=7 Participants
|
169.49 cm
STANDARD_DEVIATION 5.69 • n=5 Participants
|
|
Height(Female)
|
158.23 cm
STANDARD_DEVIATION 6.00 • n=5 Participants
|
159.88 cm
STANDARD_DEVIATION 5.54 • n=7 Participants
|
159.33 cm
STANDARD_DEVIATION 5.68 • n=5 Participants
|
|
Weight(Male)
|
71.18 Kg
STANDARD_DEVIATION 8.03 • n=5 Participants
|
73.37 Kg
STANDARD_DEVIATION 10.89 • n=7 Participants
|
72.05 Kg
STANDARD_DEVIATION 9.39 • n=5 Participants
|
|
Weight(Female)
|
64.85 Kg
STANDARD_DEVIATION 5.49 • n=5 Participants
|
63.00 Kg
STANDARD_DEVIATION 5.49 • n=7 Participants
|
63.62 Kg
STANDARD_DEVIATION 5.49 • n=5 Participants
|
|
ln(Fasting Plasma Glucose(FPG))
|
2.16 ln(mmol/L)
STANDARD_DEVIATION 0.23 • n=5 Participants
|
2.08 ln(mmol/L)
STANDARD_DEVIATION 0.18 • n=7 Participants
|
2.12 ln(mmol/L)
STANDARD_DEVIATION 0.21 • n=5 Participants
|
|
2-hour Postprandial Glucose(2hPPG)
|
16.47 mmol/L
STANDARD_DEVIATION 3.96 • n=5 Participants
|
15.59 mmol/L
STANDARD_DEVIATION 3.81 • n=7 Participants
|
16.02 mmol/L
STANDARD_DEVIATION 3.86 • n=5 Participants
|
|
ln(HbA1c)
|
2.14 ln(percent)
STANDARD_DEVIATION 0.12 • n=5 Participants
|
2.10 ln(percent)
STANDARD_DEVIATION 0.14 • n=7 Participants
|
2.12 ln(percent)
STANDARD_DEVIATION 0.19 • n=5 Participants
|
|
ln(Fasting Insulin)
|
2.21 ln(mU/L)
STANDARD_DEVIATION 0.62 • n=5 Participants
|
2.17 ln(mU/L)
STANDARD_DEVIATION 0.58 • n=7 Participants
|
2.19 ln(mU/L)
STANDARD_DEVIATION 0.60 • n=5 Participants
|
|
ln(2-hour Postprandial Insulin)
|
3.49 ln(mU/L)
STANDARD_DEVIATION 0.67 • n=5 Participants
|
3.48 ln(mU/L)
STANDARD_DEVIATION 0.65 • n=7 Participants
|
3.49 ln(mU/L)
STANDARD_DEVIATION 0.66 • n=5 Participants
|
|
Total Cholesterol(TC)
|
4.76 mmol/L
STANDARD_DEVIATION 0.79 • n=5 Participants
|
4.76 mmol/L
STANDARD_DEVIATION 1.04 • n=7 Participants
|
4.76 mmol/L
STANDARD_DEVIATION 0.92 • n=5 Participants
|
|
Triglyceride(TG)
|
1.76 mmol/L
STANDARD_DEVIATION 0.93 • n=5 Participants
|
1.71 mmol/L
STANDARD_DEVIATION 0.90 • n=7 Participants
|
1.74 mmol/L
STANDARD_DEVIATION 0.91 • n=5 Participants
|
|
High Density Lipoprotein(HDL)
|
1.22 mmol/L
STANDARD_DEVIATION 0.25 • n=5 Participants
|
1.13 mmol/L
STANDARD_DEVIATION 0.22 • n=7 Participants
|
1.17 mmol/L
STANDARD_DEVIATION 0.24 • n=5 Participants
|
|
ln(Low Density Lipoprotein(LDL))
|
0.90 ln(mmol/L)
STANDARD_DEVIATION 0.32 • n=5 Participants
|
0.87 ln(mmol/L)
STANDARD_DEVIATION 0.45 • n=7 Participants
|
0.88 ln(mmol/L)
STANDARD_DEVIATION 0.39 • n=5 Participants
|
|
Glutamic-pyruvic Transaminase(ALT)
|
21.98 U/L
STANDARD_DEVIATION 8.57 • n=5 Participants
|
25.35 U/L
STANDARD_DEVIATION 12.00 • n=7 Participants
|
23.75 U/L
STANDARD_DEVIATION 10.60 • n=5 Participants
|
|
Glutamic-oxaloacetic Transaminase(AST)
|
20.47 U/L
STANDARD_DEVIATION 6.92 • n=5 Participants
|
22.25 U/L
STANDARD_DEVIATION 7.82 • n=7 Participants
|
21.42 U/L
STANDARD_DEVIATION 7.43 • n=5 Participants
|
|
Total Bilirubin(TBil)
|
15.26 mmol/L
STANDARD_DEVIATION 5.87 • n=5 Participants
|
14.09 mmol/L
STANDARD_DEVIATION 5.00 • n=7 Participants
|
14.64 mmol/L
STANDARD_DEVIATION 5.42 • n=5 Participants
|
|
Direct Bilirubin(DBil)
|
3.91 mmol/L
STANDARD_DEVIATION 1.79 • n=5 Participants
|
3.92 mmol/L
STANDARD_DEVIATION 2.11 • n=7 Participants
|
3.92 mmol/L
STANDARD_DEVIATION 1.96 • n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 12Population: 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.
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).
Outcome measures
| Measure |
Pioglitazone and Metformin
n=46 Participants
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
n=51 Participants
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.
|
|---|---|---|
|
Change of HbA1c From Baseline at Week 12
ln(HbA1c) at Baseline
|
2.14 ln(percent)
Standard Deviation 0.12
|
2.10 ln(percent)
Standard Deviation 0.14
|
|
Change of HbA1c From Baseline at Week 12
ln(HbA1c) at Week 12
|
1.95 ln(percent)
Standard Deviation 0.12
|
2.02 ln(percent)
Standard Deviation 0.17
|
|
Change of HbA1c From Baseline at Week 12
Change from Baseline at Week 12
|
0.19 ln(percent)
Standard Deviation 0.14
|
0.07 ln(percent)
Standard Deviation 0.21
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: Based on the full analysis set: all participants who were eligible or drop-out, but eliminated participants were excluded.
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).
Outcome measures
| Measure |
Pioglitazone and Metformin
n=46 Participants
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
n=51 Participants
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.
|
|---|---|---|
|
Change of FPG From Baseline at Week 12
ln(FPG) at Baseline
|
2.16 ln(mmol/L)
Standard Deviation 0.23
|
2.08 ln(mmol/L)
Standard Deviation 0.18
|
|
Change of FPG From Baseline at Week 12
ln(FPG) at Week 12
|
1.91 ln(mmol/L)
Standard Deviation 0.22
|
2.05 ln(mmol/L)
Standard Deviation 0.29
|
|
Change of FPG From Baseline at Week 12
Change from Baseline at Week 12
|
0.25 ln(mmol/L)
Standard Deviation 0.24
|
0.04 ln(mmol/L)
Standard Deviation 0.28
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: Based on the full analysis set: all participants who were eligible or drop-out, but eliminated participants were excluded.
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).
Outcome measures
| Measure |
Pioglitazone and Metformin
n=46 Participants
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
n=51 Participants
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.
|
|---|---|---|
|
Change of 2hPPG From Baseline at Week 12
2hPPG at Baseline
|
16.47 mmol/L
Standard Deviation 3.96
|
15.59 mmol/L
Standard Deviation 3.81
|
|
Change of 2hPPG From Baseline at Week 12
2hPPG at Week 12
|
12.68 mmol/L
Standard Deviation 3.43
|
15.23 mmol/L
Standard Deviation 3.80
|
|
Change of 2hPPG From Baseline at Week 12
Change from Baseline at Week 12
|
3.65 mmol/L
Standard Deviation 3.73
|
0.45 mmol/L
Standard Deviation 3.94
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: Based on the full analysis set: all participants who were eligible or drop-out, but eliminated participants were excluded.
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).
Outcome measures
| Measure |
Pioglitazone and Metformin
n=46 Participants
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
n=51 Participants
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.
|
|---|---|---|
|
Change of Fasting Insulin From Baseline at Week 12
ln(Fasting Insulin) at Baseline
|
2.21 ln(mU/L)
Standard Deviation 0.62
|
2.17 ln(mU/L)
Standard Deviation 0.58
|
|
Change of Fasting Insulin From Baseline at Week 12
ln(Fasting Insulin) at Week 12
|
1.90 ln(mU/L)
Standard Deviation 0.58
|
2.26 ln(mU/L)
Standard Deviation 0.74
|
|
Change of Fasting Insulin From Baseline at Week 12
Change from Baseline at Week 12
|
0.35 ln(mU/L)
Standard Deviation 0.58
|
-0.08 ln(mU/L)
Standard Deviation 0.79
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: Based on the full analysis set: all participants who were eligible or drop-out, but eliminated participants were excluded.
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).
Outcome measures
| Measure |
Pioglitazone and Metformin
n=46 Participants
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
n=51 Participants
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.
|
|---|---|---|
|
Change of 2-hour Postprandial Insulin From Baseline at Week 12
ln(2-hour Postprandial Insulin) at Baseline
|
3.49 ln(mU/L)
Standard Deviation 0.67
|
3.48 ln(mU/L)
Standard Deviation 0.65
|
|
Change of 2-hour Postprandial Insulin From Baseline at Week 12
ln(2-hour Postprandial Insulin) at Week 12
|
3.33 ln(mU/L)
Standard Deviation 0.75
|
3.64 ln(mU/L)
Standard Deviation 0.74
|
|
Change of 2-hour Postprandial Insulin From Baseline at Week 12
Change from Baseline at Week 12
|
0.19 ln(mU/L)
Standard Deviation 0.83
|
-0.15 ln(mU/L)
Standard Deviation 0.77
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: Based on the full analysis set: all participants who were eligible or drop-out, but eliminated participants were excluded.
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).
Outcome measures
| Measure |
Pioglitazone and Metformin
n=46 Participants
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
n=51 Participants
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.
|
|---|---|---|
|
Change of TC From Baseline at Week 12
Change from Baseline at Week 12
|
0.06 mmol/L
Standard Deviation 0.60
|
0.09 mmol/L
Standard Deviation 0.80
|
|
Change of TC From Baseline at Week 12
TC at Baseline
|
4.76 mmol/L
Standard Deviation 0.79
|
4.76 mmol/L
Standard Deviation 1.04
|
|
Change of TC From Baseline at Week 12
TC at Week 12
|
4.74 mmol/L
Standard Deviation 0.88
|
4.66 mmol/L
Standard Deviation 0.83
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: Based on the full analysis set: all participants who were eligible or drop-out, but eliminated participants were excluded.
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).
Outcome measures
| Measure |
Pioglitazone and Metformin
n=46 Participants
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
n=51 Participants
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.
|
|---|---|---|
|
Change of TG From Baseline at Week 12
TG at Baseline
|
1.76 mmol/L
Standard Deviation 0.93
|
1.71 mmol/L
Standard Deviation 0.90
|
|
Change of TG From Baseline at Week 12
TG at Week 12
|
1.66 mmol/L
Standard Deviation 0.94
|
1.85 mmol/L
Standard Deviation 1.49
|
|
Change of TG From Baseline at Week 12
Change from Baseline at Week 12
|
0.09 mmol/L
Standard Deviation 0.77
|
-0.17 mmol/L
Standard Deviation 1.24
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: Based on the full analysis set: all participants who were eligible or drop-out, but eliminated participants were excluded.
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).
Outcome measures
| Measure |
Pioglitazone and Metformin
n=46 Participants
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
n=51 Participants
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.
|
|---|---|---|
|
Change of HDL From Baseline at Week 12
HDL at Baseline
|
1.22 mmol/L
Standard Deviation 0.25
|
1.13 mmol/L
Standard Deviation 0.22
|
|
Change of HDL From Baseline at Week 12
HDL at Week 12
|
1.33 mmol/L
Standard Deviation 0.29
|
1.15 mmol/L
Standard Deviation 0.26
|
|
Change of HDL From Baseline at Week 12
Change from Baseline at Week 12
|
-0.09 mmol/L
Standard Deviation 0.19
|
0.00 mmol/L
Standard Deviation 0.17
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: Based on the full analysis set: all participants who were eligible or drop-out, but eliminated participants were excluded.
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).
Outcome measures
| Measure |
Pioglitazone and Metformin
n=46 Participants
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
n=51 Participants
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.
|
|---|---|---|
|
Change of LDL From Baseline at Week 12
ln(LDL) at Baseline
|
0.90 ln(mmol/L)
Standard Deviation 0.32
|
0.87 ln(mmol/L)
Standard Deviation 0.45
|
|
Change of LDL From Baseline at Week 12
ln(LDL) at Week 12
|
0.89 ln(mmol/L)
Standard Deviation 0.28
|
0.83 ln(mmol/L)
Standard Deviation 0.34
|
|
Change of LDL From Baseline at Week 12
Change from Baseline at Week 12
|
0.02 ln(mmol/L)
Standard Deviation 0.20
|
0.03 ln(mmol/L)
Standard Deviation 0.42
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, Week 12Population: Based on safety set：all participants who received intervention at least once and had actual data of safety record.
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).
Outcome measures
| Measure |
Pioglitazone and Metformin
n=46 Participants
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
n=51 Participants
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.
|
|---|---|---|
|
Change of ALT From Baseline at Week 12
ALT at Baseline
|
21.98 U/L
Standard Error 8.57
|
25.35 U/L
Standard Error 12.00
|
|
Change of ALT From Baseline at Week 12
ALT at Week 12
|
21.63 U/L
Standard Error 7.17
|
24.80 U/L
Standard Error 10.01
|
|
Change of ALT From Baseline at Week 12
Change from Baseline at Week 12
|
0.40 U/L
Standard Error 9.14
|
0.47 U/L
Standard Error 13.88
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, Week 12Population: Based on safety set：all participants who received intervention at least once and had actual data of safety record.
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).
Outcome measures
| Measure |
Pioglitazone and Metformin
n=46 Participants
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
n=51 Participants
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.
|
|---|---|---|
|
Change of AST From Baseline at Week 12
Change from Baseline at Week 12
|
-0.41 U/L
Standard Deviation 7.35
|
0.41 U/L
Standard Deviation 8.50
|
|
Change of AST From Baseline at Week 12
AST at Baseline
|
20.47 U/L
Standard Deviation 6.92
|
22.25 U/L
Standard Deviation 7.82
|
|
Change of AST From Baseline at Week 12
AST at Week 12
|
21.12 U/L
Standard Deviation 5.58
|
21.87 U/L
Standard Deviation 6.03
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, Week 12Population: Based on safety set：all participants who received intervention at least once and had actual data of safety record.
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).
Outcome measures
| Measure |
Pioglitazone and Metformin
n=46 Participants
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
n=51 Participants
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.
|
|---|---|---|
|
Change of TBil From Baseline at Week 12
TBil at Baseline
|
15.26 mmol/L
Standard Deviation 5.87
|
14.09 mmol/L
Standard Deviation 5.00
|
|
Change of TBil From Baseline at Week 12
TBil at Week 12
|
14.72 mmol/L
Standard Deviation 6.09
|
13.44 mmol/L
Standard Deviation 4.23
|
|
Change of TBil From Baseline at Week 12
Change from Baseline at Week 12
|
0.31 mmol/L
Standard Deviation 6.53
|
0.57 mmol/L
Standard Deviation 4.65
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, Week 12Population: Based on safety set：all participants who received intervention at least once and had actual data of safety record.
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).
Outcome measures
| Measure |
Pioglitazone and Metformin
n=46 Participants
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
n=51 Participants
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.
|
|---|---|---|
|
Change of DBil From Baseline at Week 12
DBil at Baseline
|
3.91 mmol/L
Standard Deviation 1.79
|
3.92 mmol/L
Standard Deviation 2.11
|
|
Change of DBil From Baseline at Week 12
DBil at Week 12
|
3.69 mmol/L
Standard Deviation 2.08
|
3.32 mmol/L
Standard Deviation 1.15
|
|
Change of DBil From Baseline at Week 12
Change from Baseline at Week 12
|
0.12 mmol/L
Standard Deviation 2.08
|
0.55 mmol/L
Standard Deviation 2.04
|
Adverse Events
Pioglitazone and Metformin
Placebo
Serious adverse events
| Measure |
Pioglitazone and Metformin
n=46 participants at risk；n=47 participants at risk
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
n=51 participants at risk
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.
|
|---|---|---|
|
Nervous system disorders
Stroke
|
2.1%
1/47 • Number of events 1 • 12 weeks
Safety set included all participants who received intervention at least once and had the actual data of safety index.
|
0.00%
0/51 • 12 weeks
Safety set included all participants who received intervention at least once and had the actual data of safety index.
|
Other adverse events
| Measure |
Pioglitazone and Metformin
n=46 participants at risk；n=47 participants at risk
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
n=51 participants at risk
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.
|
|---|---|---|
|
Endocrine disorders
Hypoglycemia
|
2.2%
1/46 • Number of events 1 • 12 weeks
Safety set included all participants who received intervention at least once and had the actual data of safety index.
|
3.9%
2/51 • Number of events 2 • 12 weeks
Safety set included all participants who received intervention at least once and had the actual data of safety index.
|
|
Hepatobiliary disorders
Abnormal Liver Function
|
13.0%
6/46 • Number of events 6 • 12 weeks
Safety set included all participants who received intervention at least once and had the actual data of safety index.
|
5.9%
3/51 • Number of events 3 • 12 weeks
Safety set included all participants who received intervention at least once and had the actual data of safety index.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place