Trial Outcomes & Findings for Efficacy and Safety of Pioglitazone and Metformin Combination Therapy in Treating Type 2 Diabetes Mellitus. (NCT NCT00727857)
NCT ID: NCT00727857
Last Updated: 2011-07-29
Results Overview
The change between the value of Glycosylated Hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at final visit or week 24 and Glycosylated Hemoglobin collected at baseline.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
600 participants
Primary outcome timeframe
Baseline and Week 24
Results posted on
2011-07-29
Participant Flow
Participants were enrolled at 134 investigative sites in the United States (including Puerto Rico), Argentina, Chile, Guatemala, Mexico and Peru from 13 June 2007 to 29 August 2008.
Participants who had not received treatment with antidiabetic medication 12 weeks prior to Screening were enrolled in one of three, twice-daily (BID) treatment groups.
Participant milestones
| Measure |
Pioglitazone 15 mg/Metformin 850 mg BID
Pioglitazone 15 mg /metformin 850 mg combination tablets, orally, twice daily for up to 24 weeks
|
Pioglitazone 15 mg BID
Pioglitazone 15 mg, tablets, orally, twice daily for up to 24 weeks
|
Metformin 850 mg BID
Metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.
|
|---|---|---|---|
|
Overall Study
STARTED
|
201
|
189
|
210
|
|
Overall Study
COMPLETED
|
157
|
125
|
142
|
|
Overall Study
NOT COMPLETED
|
44
|
64
|
68
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Efficacy and Safety of Pioglitazone and Metformin Combination Therapy in Treating Type 2 Diabetes Mellitus.
Baseline characteristics by cohort
| Measure |
Pioglitazone 15 mg/Metformin 850 mg BID
n=201 Participants
Pioglitazone 15 mg /metformin 850 mg combination tablets, orally, twice daily for up to 24 weeks
|
Pioglitazone 15 mg BID
n=189 Participants
Pioglitazone 15 mg, tablets, orally, twice daily for up to 24 weeks
|
Metformin 850 mg BID
n=210 Participants
Metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.
|
Total
n=600 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
2 participants
n=5 Participants
|
6 participants
n=7 Participants
|
6 participants
n=5 Participants
|
14 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Asian
|
3 participants
n=5 Participants
|
5 participants
n=7 Participants
|
5 participants
n=5 Participants
|
13 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
12 participants
n=5 Participants
|
13 participants
n=7 Participants
|
14 participants
n=5 Participants
|
39 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
White
|
123 participants
n=5 Participants
|
109 participants
n=7 Participants
|
124 participants
n=5 Participants
|
356 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Multiracial
|
61 participants
n=5 Participants
|
56 participants
n=7 Participants
|
61 participants
n=5 Participants
|
178 participants
n=4 Participants
|
|
Body Mass Index
|
30.84 kg/m²
STANDARD_DEVIATION 5.74 • n=5 Participants
|
31.18 kg/m²
STANDARD_DEVIATION 5.50 • n=7 Participants
|
30.83 kg/m²
STANDARD_DEVIATION 5.66 • n=5 Participants
|
30.94 kg/m²
STANDARD_DEVIATION 5.63 • n=4 Participants
|
|
Age Continuous
|
54.7 years
STANDARD_DEVIATION 12.23 • n=5 Participants
|
54.0 years
STANDARD_DEVIATION 12.08 • n=7 Participants
|
53.7 years
STANDARD_DEVIATION 12.00 • n=5 Participants
|
54.1 years
STANDARD_DEVIATION 12.09 • n=4 Participants
|
|
Sex: Female, Male
Female
|
111 Participants
n=5 Participants
|
123 Participants
n=7 Participants
|
112 Participants
n=5 Participants
|
346 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
90 Participants
n=5 Participants
|
66 Participants
n=7 Participants
|
98 Participants
n=5 Participants
|
254 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline and Week 24Population: Participant must have baseline and at least one post-baseline value. Last Observation Carried Forward (LOCF) for missing final/week 24 visit
The change between the value of Glycosylated Hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at final visit or week 24 and Glycosylated Hemoglobin collected at baseline.
Outcome measures
| Measure |
Pioglitazone 15 mg/Metformin 850 mg BID
n=188 Participants
Pioglitazone 15 mg /metformin 850 mg combination tablets, orally, twice daily for up to 24 weeks
|
Pioglitazone 15 mg BID
n=162 Participants
Pioglitazone 15 mg, tablets, orally, twice daily for up to 24 weeks
|
Metformin 850 mg BID
n=193 Participants
Metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.
|
|---|---|---|---|
|
Percent Change From Baseline in Glycosylated Hemoglobin
|
-1.83 percentage of Glycosylated Hemoglobin
Standard Error 0.122
|
-0.96 percentage of Glycosylated Hemoglobin
Standard Error 0.131
|
-0.99 percentage of Glycosylated Hemoglobin
Standard Error 0.120
|
SECONDARY outcome
Timeframe: Baseline and Week 24Population: Participant must have baseline and at least one post-baseline value. LOCF for missing final/week 24 visit
The change between the value of Fasting Plasma Glucose collected at final visit or week 24 and Fasting Plasma Glucose collected at baseline.
Outcome measures
| Measure |
Pioglitazone 15 mg/Metformin 850 mg BID
n=196 Participants
Pioglitazone 15 mg /metformin 850 mg combination tablets, orally, twice daily for up to 24 weeks
|
Pioglitazone 15 mg BID
n=176 Participants
Pioglitazone 15 mg, tablets, orally, twice daily for up to 24 weeks
|
Metformin 850 mg BID
n=202 Participants
Metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.
|
|---|---|---|---|
|
Change From Baseline in Fasting Plasma Glucose
|
-39.9 mg/dL
Standard Error 3.48
|
-22.2 mg/dL
Standard Error 3.67
|
-24.8 mg/dL
Standard Error 3.42
|
SECONDARY outcome
Timeframe: Baseline and Week 24Population: Participant must have baseline and at least one post-baseline value. LOCF for missing final/week 24 visit
The change between the Fasting Insulin value collected at final visit or week 24 and Fasting Insulin collected at baseline.
Outcome measures
| Measure |
Pioglitazone 15 mg/Metformin 850 mg BID
n=178 Participants
Pioglitazone 15 mg /metformin 850 mg combination tablets, orally, twice daily for up to 24 weeks
|
Pioglitazone 15 mg BID
n=146 Participants
Pioglitazone 15 mg, tablets, orally, twice daily for up to 24 weeks
|
Metformin 850 mg BID
n=185 Participants
Metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.
|
|---|---|---|---|
|
Change From Baseline in Fasting Insulin
|
-3.91 μIU/mL
Standard Error 0.736
|
-3.18 μIU/mL
Standard Error 0.812
|
-0.98 μIU/mL
Standard Error 0.722
|
SECONDARY outcome
Timeframe: Baseline and Week 24Population: Participant must have baseline and at least one post-baseline value. LOCF for missing final/week 24 visit
The change between Homeostasis Model Assessment of Insulin Resistance collected at final visit or week 24 and Homeostasis Model Assessment of Insulin Resistance collected at baseline. Homeostasis Model Assessment measures insulin resistance, calculated by insulin times glucose, divided by a constant (22.5).
Outcome measures
| Measure |
Pioglitazone 15 mg/Metformin 850 mg BID
n=160 Participants
Pioglitazone 15 mg /metformin 850 mg combination tablets, orally, twice daily for up to 24 weeks
|
Pioglitazone 15 mg BID
n=139 Participants
Pioglitazone 15 mg, tablets, orally, twice daily for up to 24 weeks
|
Metformin 850 mg BID
n=172 Participants
Metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.
|
|---|---|---|---|
|
Change From Baseline in Homeostasis Model Assessment - Insulin Resistance
|
-2.704 percent of insulin resistance
Standard Error 0.4274
|
-2.075 percent of insulin resistance
Standard Error 0.4586
|
-1.085 percent of insulin resistance
Standard Error 0.4123
|
SECONDARY outcome
Timeframe: Baseline and Week 24Measurement for High Sensitivity C-reactive Protein was collected at final visit or week 24 and at baseline. Percent change from baseline is calculated as: \[(Week 24 - baseline levels)/baseline\]\*100
Outcome measures
| Measure |
Pioglitazone 15 mg/Metformin 850 mg BID
n=190 Participants
Pioglitazone 15 mg /metformin 850 mg combination tablets, orally, twice daily for up to 24 weeks
|
Pioglitazone 15 mg BID
n=168 Participants
Pioglitazone 15 mg, tablets, orally, twice daily for up to 24 weeks
|
Metformin 850 mg BID
n=196 Participants
Metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.
|
|---|---|---|---|
|
Median Percent Change From Baseline in High Sensitivity C-reactive Protein
|
-36.7 percent
Full Range 4.6719 • Interval -97.7 to 2060.0
|
-34.0 percent
Full Range 8.1275 • Interval -98.9 to 2314.6
|
-26.2 percent
Full Range 12.5526 • Interval -99.5 to 1636.3
|
SECONDARY outcome
Timeframe: Baseline and Week 24Population: Participant must have baseline and at least one post-baseline value. LOCF for missing final/week 24 visit
The change between Adiponectin collected at final visit or week 24 and Adiponectin collected at baseline.
Outcome measures
| Measure |
Pioglitazone 15 mg/Metformin 850 mg BID
n=179 Participants
Pioglitazone 15 mg /metformin 850 mg combination tablets, orally, twice daily for up to 24 weeks
|
Pioglitazone 15 mg BID
n=148 Participants
Pioglitazone 15 mg, tablets, orally, twice daily for up to 24 weeks
|
Metformin 850 mg BID
n=183 Participants
Metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.
|
|---|---|---|---|
|
Change From Baseline in Adiponectin
|
7.8 mcg/ml
Standard Error 0.55
|
9.2 mcg/ml
Standard Error 0.61
|
-0.3 mcg/ml
Standard Error 0.55
|
SECONDARY outcome
Timeframe: Baseline and Week 24Population: Participant must have baseline and at least one post-baseline value. LOCF for missing final/week 24 visit
The change between Total Cholesterol collected at final visit or week 24 and Total Cholesterol collected at baseline.
Outcome measures
| Measure |
Pioglitazone 15 mg/Metformin 850 mg BID
n=178 Participants
Pioglitazone 15 mg /metformin 850 mg combination tablets, orally, twice daily for up to 24 weeks
|
Pioglitazone 15 mg BID
n=154 Participants
Pioglitazone 15 mg, tablets, orally, twice daily for up to 24 weeks
|
Metformin 850 mg BID
n=182 Participants
Metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.
|
|---|---|---|---|
|
Change From Baseline in Total Cholesterol
|
1.06 mg/dL
Standard Error 1.183
|
4.79 mg/dL
Standard Error 1.271
|
-2.72 mg/dL
Standard Error 1.169
|
SECONDARY outcome
Timeframe: Baseline and Week 24Population: Participant must have baseline and at least one post-baseline value. LOCF for missing final/week 24 visit
The change between Low-Density Lipoprotein Cholesterol collected at final visit or week 24 and Low-Density Lipoprotein Cholesterol collected at baseline.
Outcome measures
| Measure |
Pioglitazone 15 mg/Metformin 850 mg BID
n=177 Participants
Pioglitazone 15 mg /metformin 850 mg combination tablets, orally, twice daily for up to 24 weeks
|
Pioglitazone 15 mg BID
n=152 Participants
Pioglitazone 15 mg, tablets, orally, twice daily for up to 24 weeks
|
Metformin 850 mg BID
n=180 Participants
Metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.
|
|---|---|---|---|
|
Change From Baseline in Low-Density Lipoprotein Cholesterol
|
1.19 mg/dL
Standard Error 2.015
|
6.08 mg/dL
Standard Error 2.175
|
-1.37 mg/dL
Standard Error 1.998
|
SECONDARY outcome
Timeframe: Baseline and Week 24Population: Participant must have baseline and at least one post-baseline value. LOCF for missing final/week 24 visit
The change between High-Density Lipoprotein Cholesterol collected at final visit or week 24 and High-Density Lipoprotein Cholesterol collected at baseline.
Outcome measures
| Measure |
Pioglitazone 15 mg/Metformin 850 mg BID
n=177 Participants
Pioglitazone 15 mg /metformin 850 mg combination tablets, orally, twice daily for up to 24 weeks
|
Pioglitazone 15 mg BID
n=152 Participants
Pioglitazone 15 mg, tablets, orally, twice daily for up to 24 weeks
|
Metformin 850 mg BID
n=180 Participants
Metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.
|
|---|---|---|---|
|
Change From Baseline in High-Density Lipoprotein Cholesterol
|
14.20 mg/dL
Standard Error 1.440
|
9.88 mg/dL
Standard Error 1.552
|
6.09 mg/dL
Standard Error 1.426
|
SECONDARY outcome
Timeframe: Baseline and Week 24Population: Participant must have baseline and at least one post-baseline value. LOCF for missing final/week 24 visit
The change between Triglycerides collected at final visit or week 24 and Triglycerides collected at baseline.
Outcome measures
| Measure |
Pioglitazone 15 mg/Metformin 850 mg BID
n=180 Participants
Pioglitazone 15 mg /metformin 850 mg combination tablets, orally, twice daily for up to 24 weeks
|
Pioglitazone 15 mg BID
n=157 Participants
Pioglitazone 15 mg, tablets, orally, twice daily for up to 24 weeks
|
Metformin 850 mg BID
n=184 Participants
Metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.
|
|---|---|---|---|
|
Change From Baseline in Triglycerides
|
-5.95 mg/dL
Standard Error 2.901
|
-5.54 mg/dL
Standard Error 3.107
|
-1.78 mg/dL
Standard Error 2.871
|
SECONDARY outcome
Timeframe: Baseline and Week 24Population: Participant must have baseline and at least one post-baseline value. LOCF for missing final/week 24 visit
The change between Low Density Lipoprotein particle concentration collected at final visit or week 24 and Low Density Lipoprotein particle concentration collected at baseline.
Outcome measures
| Measure |
Pioglitazone 15 mg/Metformin 850 mg BID
n=174 Participants
Pioglitazone 15 mg /metformin 850 mg combination tablets, orally, twice daily for up to 24 weeks
|
Pioglitazone 15 mg BID
n=149 Participants
Pioglitazone 15 mg, tablets, orally, twice daily for up to 24 weeks
|
Metformin 850 mg BID
n=176 Participants
Metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.
|
|---|---|---|---|
|
Change From Baseline in Mean Low Density Lipoprotein Particle Concentration
|
-240.6 nmol/L
Standard Error 23.50
|
-217.2 nmol/L
Standard Error 25.40
|
-176.4 nmol/L
Standard Error 23.36
|
SECONDARY outcome
Timeframe: Baseline and Week 24The change between Low Density Lipoprotein collected at final visit or week 24 and Low Density Lipoprotein collected at baseline.
Outcome measures
| Measure |
Pioglitazone 15 mg/Metformin 850 mg BID
n=174 Participants
Pioglitazone 15 mg /metformin 850 mg combination tablets, orally, twice daily for up to 24 weeks
|
Pioglitazone 15 mg BID
n=149 Participants
Pioglitazone 15 mg, tablets, orally, twice daily for up to 24 weeks
|
Metformin 850 mg BID
n=176 Participants
Metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.
|
|---|---|---|---|
|
Change From Baseline in Mean Low Density Lipoprotein Particle Size
|
0.55 nm
Standard Deviation 0.049
|
0.6 nm
Standard Deviation 0.053
|
0.2 nm
Standard Deviation 0.049
|
SECONDARY outcome
Timeframe: Baseline and Week 24The change between Large Low Density Lipoprotein collected at final visit or week 24 and Large Low Density Lipoprotein collected at baseline.
Outcome measures
| Measure |
Pioglitazone 15 mg/Metformin 850 mg BID
n=174 Participants
Pioglitazone 15 mg /metformin 850 mg combination tablets, orally, twice daily for up to 24 weeks
|
Pioglitazone 15 mg BID
n=149 Participants
Pioglitazone 15 mg, tablets, orally, twice daily for up to 24 weeks
|
Metformin 850 mg BID
n=176 Participants
Metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.
|
|---|---|---|---|
|
Change From Baseline in Large Low Density Lipoprotein (L3) Concentration
|
96.0 nmol/L
Standard Error 12.53
|
115.7 nmol/L
Standard Error 13.52
|
18.4 nmol/L
Standard Error 12.46
|
SECONDARY outcome
Timeframe: Baseline and Week 24The change between Intermediate-Density Low Density Lipoprotein collected at final visit or week 24 and Intermediate-Density Low Density Lipoprotein collected at baseline
Outcome measures
| Measure |
Pioglitazone 15 mg/Metformin 850 mg BID
n=174 Participants
Pioglitazone 15 mg /metformin 850 mg combination tablets, orally, twice daily for up to 24 weeks
|
Pioglitazone 15 mg BID
n=149 Participants
Pioglitazone 15 mg, tablets, orally, twice daily for up to 24 weeks
|
Metformin 850 mg BID
n=176 Participants
Metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.
|
|---|---|---|---|
|
Change From Baseline in Intermediate-Density Low Density Lipoprotein Concentration
|
-16.3 nmol/L
Standard Error 3.39
|
-11.0 nmol/L
Standard Error 3.66
|
-17.3 nmol/L
Standard Error 3.37
|
SECONDARY outcome
Timeframe: Baseline and Week 24The change between Medium-Small Low Density Lipoprotein collected at final visit or week 24 and Medium-Small Low Density Lipoprotein collected at baseline
Outcome measures
| Measure |
Pioglitazone 15 mg/Metformin 850 mg BID
n=174 Participants
Pioglitazone 15 mg /metformin 850 mg combination tablets, orally, twice daily for up to 24 weeks
|
Pioglitazone 15 mg BID
n=149 Participants
Pioglitazone 15 mg, tablets, orally, twice daily for up to 24 weeks
|
Metformin 850 mg BID
n=176 Participants
Metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.
|
|---|---|---|---|
|
Change From Baseline in Medium-Small Low Density Lipoprotein Concentration
|
-63.8 nmol/L
Standard Error 5.95
|
-66.0 nmol/L
Standard Error 6.43
|
-35.3 nmol/L
Standard Error 5.92
|
SECONDARY outcome
Timeframe: Baseline and Week 24The change between Small Low Density Lipoprotein collected at final visit or week 24 and Small Low Density Lipoprotein collected at baseline
Outcome measures
| Measure |
Pioglitazone 15 mg/Metformin 850 mg BID
n=174 Participants
Pioglitazone 15 mg /metformin 850 mg combination tablets, orally, twice daily for up to 24 weeks
|
Pioglitazone 15 mg BID
n=149 Participants
Pioglitazone 15 mg, tablets, orally, twice daily for up to 24 weeks
|
Metformin 850 mg BID
n=176 Participants
Metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.
|
|---|---|---|---|
|
Change From Baseline in Small Low Density Lipoprotein Concentration
|
-319.3 nmol/L
Standard Error 28.06
|
-321.3 nmol/L
Standard Error 30.34
|
-179.0 nmol/L
Standard Error 27.91
|
SECONDARY outcome
Timeframe: Baseline and Week 24The change between Very Small Low Density Lipoprotein collected at final visit or week 24 and Very Small Low Density Lipoprotein collected at baseline
Outcome measures
| Measure |
Pioglitazone 15 mg/Metformin 850 mg BID
n=174 Participants
Pioglitazone 15 mg /metformin 850 mg combination tablets, orally, twice daily for up to 24 weeks
|
Pioglitazone 15 mg BID
n=149 Participants
Pioglitazone 15 mg, tablets, orally, twice daily for up to 24 weeks
|
Metformin 850 mg BID
n=176 Participants
Metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.
|
|---|---|---|---|
|
Change From Baseline in Very Small Low Density Lipoprotein Concentration
|
-255.5 nmol/L
Standard Error 22.37
|
-255.2 nmol/L
Standard Error 24.18
|
-143.8 nmol/L
Standard Error 22.25
|
SECONDARY outcome
Timeframe: Baseline and Week 24The change between High Density Lipoprotein collected at final visit or week 24 and High Density Lipoprotein collected at baseline.
Outcome measures
| Measure |
Pioglitazone 15 mg/Metformin 850 mg BID
n=174 Participants
Pioglitazone 15 mg /metformin 850 mg combination tablets, orally, twice daily for up to 24 weeks
|
Pioglitazone 15 mg BID
n=149 Participants
Pioglitazone 15 mg, tablets, orally, twice daily for up to 24 weeks
|
Metformin 850 mg BID
n=176 Participants
Metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.
|
|---|---|---|---|
|
Change From Baseline in Mean High Density Lipoprotein Particle Concentration
|
0.28 μmol/L
Standard Error 0.271
|
-0.80 μmol/L
Standard Error 0.293
|
0.62 μmol/L
Standard Error 0.269
|
SECONDARY outcome
Timeframe: Baseline and Week 24The change between High Density Lipoprotein collected at final visit or week 24 and High Density Lipoprotein collected at baseline.
Outcome measures
| Measure |
Pioglitazone 15 mg/Metformin 850 mg BID
n=174 Participants
Pioglitazone 15 mg /metformin 850 mg combination tablets, orally, twice daily for up to 24 weeks
|
Pioglitazone 15 mg BID
n=149 Participants
Pioglitazone 15 mg, tablets, orally, twice daily for up to 24 weeks
|
Metformin 850 mg BID
n=176 Participants
Metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.
|
|---|---|---|---|
|
Change From Baseline in Mean High Density Lipoprotein Particle Size
|
0.15 nm
Standard Error 0.021
|
0.19 nm
Standard Error 0.022
|
0.11 nm
Standard Error 0.021
|
SECONDARY outcome
Timeframe: Baseline and Week 24The change between Large High Density Lipoprotein collected at final visit or week 24 and Large High Density Lipoprotein collected at baseline
Outcome measures
| Measure |
Pioglitazone 15 mg/Metformin 850 mg BID
n=174 Participants
Pioglitazone 15 mg /metformin 850 mg combination tablets, orally, twice daily for up to 24 weeks
|
Pioglitazone 15 mg BID
n=149 Participants
Pioglitazone 15 mg, tablets, orally, twice daily for up to 24 weeks
|
Metformin 850 mg BID
n=176 Participants
Metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.
|
|---|---|---|---|
|
Change From Baseline in Large High Density Lipoprotein (H4+H5) Concentration
|
0.70 μmol/L
Standard Error 1.80
|
1.02 μmol/L
Standard Error 0.194
|
0.52 μmol/L
Standard Error 0.179
|
SECONDARY outcome
Timeframe: Baseline and Week 24The change between Intermediate-Medium High Density Lipoprotein collected at final visit or week 24 and Intermediate-Medium High Density Lipoprotein collected at baseline
Outcome measures
| Measure |
Pioglitazone 15 mg/Metformin 850 mg BID
n=174 Participants
Pioglitazone 15 mg /metformin 850 mg combination tablets, orally, twice daily for up to 24 weeks
|
Pioglitazone 15 mg BID
n=149 Participants
Pioglitazone 15 mg, tablets, orally, twice daily for up to 24 weeks
|
Metformin 850 mg BID
n=176 Participants
Metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.
|
|---|---|---|---|
|
Change From Baseline in Intermediate-Medium High Density Lipoprotein (H3) Concentration
|
1.34 μmol/L
Standard Error 0.285
|
1.62 μmol/L
Standard Error 0.308
|
-0.09 μmol/L
Standard Error 0.283
|
SECONDARY outcome
Timeframe: Baseline and Week 24The change between Small High Density Lipoprotein collected at final visit or week 24 and Small High Density Lipoprotein collected at baseline
Outcome measures
| Measure |
Pioglitazone 15 mg/Metformin 850 mg BID
n=174 Participants
Pioglitazone 15 mg /metformin 850 mg combination tablets, orally, twice daily for up to 24 weeks
|
Pioglitazone 15 mg BID
n=149 Participants
Pioglitazone 15 mg, tablets, orally, twice daily for up to 24 weeks
|
Metformin 850 mg BID
n=176 Participants
Metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.
|
|---|---|---|---|
|
Change From Baseline in Small High Density Lipoprotein (H1+H2) Concentration
|
-1.78 μmol/L
Standard Error 0.349
|
-3.41 μmol/L
Standard Error 0.377
|
0.19 μmol/L
Standard Error 0.347
|
SECONDARY outcome
Timeframe: Baseline and Week 24The change between Very Low Density Lipoprotein collected at final visit or week 24 and Very Low Density Lipoprotein collected at baseline.
Outcome measures
| Measure |
Pioglitazone 15 mg/Metformin 850 mg BID
n=174 Participants
Pioglitazone 15 mg /metformin 850 mg combination tablets, orally, twice daily for up to 24 weeks
|
Pioglitazone 15 mg BID
n=149 Participants
Pioglitazone 15 mg, tablets, orally, twice daily for up to 24 weeks
|
Metformin 850 mg BID
n=176 Participants
Metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.
|
|---|---|---|---|
|
Change From Baseline in Mean Very Low Density Lipoprotein Particle Concentration
|
-2.78 nmol/L
Standard Error 2.204
|
0.98 nmol/L
Standard Error 2.381
|
-11.30 nmol/L
Standard Error 2.191
|
SECONDARY outcome
Timeframe: Baseline and Week 24The change between Very Low Density Lipoprotein collected at final visit or week 24 and Very Low Density Lipoprotein collected at baseline.
Outcome measures
| Measure |
Pioglitazone 15 mg/Metformin 850 mg BID
n=174 Participants
Pioglitazone 15 mg /metformin 850 mg combination tablets, orally, twice daily for up to 24 weeks
|
Pioglitazone 15 mg BID
n=149 Participants
Pioglitazone 15 mg, tablets, orally, twice daily for up to 24 weeks
|
Metformin 850 mg BID
n=176 Participants
Metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.
|
|---|---|---|---|
|
Change From Baseline in Mean Very Low Density Lipoprotein Particle Size
|
-2.64 nm
Standard Error 0.616
|
-3.79 nm
Standard Error 0.666
|
-0.20 nm
Standard Error 0.612
|
SECONDARY outcome
Timeframe: Baseline and Week 24The change between Large-Chylomicrons Very Low Density Lipoprotein collected at final visit or week 24 and Large-Chylomicrons Very Low Density Lipoprotein collected at baseline
Outcome measures
| Measure |
Pioglitazone 15 mg/Metformin 850 mg BID
n=174 Participants
Pioglitazone 15 mg /metformin 850 mg combination tablets, orally, twice daily for up to 24 weeks
|
Pioglitazone 15 mg BID
n=149 Participants
Pioglitazone 15 mg, tablets, orally, twice daily for up to 24 weeks
|
Metformin 850 mg BID
n=176 Participants
Metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.
|
|---|---|---|---|
|
Change From Baseline in Large-Chylomicrons Very Low Density Lipoprotein Concentration
|
-1.71 nmol/L
Standard Error 0.351
|
-1.97 nmol/L
Standard Error 0.379
|
-1.96 nmol/L
Standard Error 0.349
|
SECONDARY outcome
Timeframe: Baseline and Week 24The change between Medium-Intermediate Very Low Density Lipoprotein collected at final visit or week 24 and Medium-Intermediate Very Low Density Lipoprotein collected at baseline
Outcome measures
| Measure |
Pioglitazone 15 mg/Metformin 850 mg BID
n=174 Participants
Pioglitazone 15 mg /metformin 850 mg combination tablets, orally, twice daily for up to 24 weeks
|
Pioglitazone 15 mg BID
n=149 Participants
Pioglitazone 15 mg, tablets, orally, twice daily for up to 24 weeks
|
Metformin 850 mg BID
n=176 Participants
Metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.
|
|---|---|---|---|
|
Change From Baseline in Medium-Intermediate Very Low Density Lipoprotein (V3+V4) Concentration
|
-4.07 nmol/L
Standard Error 1.434
|
-3.01 nmol/L
Standard Error 1.550
|
-6.48 nmol/L
Standard Error 1.426
|
SECONDARY outcome
Timeframe: Baseline and Week 24Population: Participant must have baseline and at least one post-baseline value. LOCF for missing final/week 24 visit
The change between Small Very Low Density Lipoprotein collected at final visit or week 24 and Small Very Low Density Lipoprotein collected at baseline
Outcome measures
| Measure |
Pioglitazone 15 mg/Metformin 850 mg BID
n=174 Participants
Pioglitazone 15 mg /metformin 850 mg combination tablets, orally, twice daily for up to 24 weeks
|
Pioglitazone 15 mg BID
n=149 Participants
Pioglitazone 15 mg, tablets, orally, twice daily for up to 24 weeks
|
Metformin 850 mg BID
n=176 Participants
Metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.
|
|---|---|---|---|
|
Change From Baseline in Small Very Low Density Lipoprotein (V1+V2) Concentration
|
3.05 nmol/L
Standard Error 1.249
|
5.9 nmol/L
Standard Error 1.350
|
-2.86 nmol/L
Standard Error 1.239
|
Adverse Events
Pioglitazone 15 mg/Metformin 850 mg BID
Serious events: 2 serious events
Other events: 84 other events
Deaths: 0 deaths
Pioglitazone 15 mg BID
Serious events: 3 serious events
Other events: 61 other events
Deaths: 0 deaths
Metformin 850 mg BID
Serious events: 5 serious events
Other events: 95 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Pioglitazone 15 mg/Metformin 850 mg BID
n=201 participants at risk
Pioglitazone 15 mg /metformin 850 mg combination tablets, orally, twice daily for up to 24 weeks
|
Pioglitazone 15 mg BID
n=190 participants at risk
Pioglitazone 15 mg, tablets, orally, twice daily for up to 24 weeks
|
Metformin 850 mg BID
n=209 participants at risk
Metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/201 • Adverse events were summarized by onset date occurring on or after the first dose of double-blind study medication and on or prior to 14 days after the permanent discontinuation of the double-blind study medication.
One participant was randomized to Metformin 850 mg but inadvertently received Pioglitazone 15 mg. Analyses performed on Efficacy Variables were based on Randomized Treatment; analyses on Safety Variables were based on Actual Treatment Received.
|
0.00%
0/190 • Adverse events were summarized by onset date occurring on or after the first dose of double-blind study medication and on or prior to 14 days after the permanent discontinuation of the double-blind study medication.
One participant was randomized to Metformin 850 mg but inadvertently received Pioglitazone 15 mg. Analyses performed on Efficacy Variables were based on Randomized Treatment; analyses on Safety Variables were based on Actual Treatment Received.
|
0.48%
1/209 • Adverse events were summarized by onset date occurring on or after the first dose of double-blind study medication and on or prior to 14 days after the permanent discontinuation of the double-blind study medication.
One participant was randomized to Metformin 850 mg but inadvertently received Pioglitazone 15 mg. Analyses performed on Efficacy Variables were based on Randomized Treatment; analyses on Safety Variables were based on Actual Treatment Received.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/201 • Adverse events were summarized by onset date occurring on or after the first dose of double-blind study medication and on or prior to 14 days after the permanent discontinuation of the double-blind study medication.
One participant was randomized to Metformin 850 mg but inadvertently received Pioglitazone 15 mg. Analyses performed on Efficacy Variables were based on Randomized Treatment; analyses on Safety Variables were based on Actual Treatment Received.
|
0.53%
1/190 • Adverse events were summarized by onset date occurring on or after the first dose of double-blind study medication and on or prior to 14 days after the permanent discontinuation of the double-blind study medication.
One participant was randomized to Metformin 850 mg but inadvertently received Pioglitazone 15 mg. Analyses performed on Efficacy Variables were based on Randomized Treatment; analyses on Safety Variables were based on Actual Treatment Received.
|
0.00%
0/209 • Adverse events were summarized by onset date occurring on or after the first dose of double-blind study medication and on or prior to 14 days after the permanent discontinuation of the double-blind study medication.
One participant was randomized to Metformin 850 mg but inadvertently received Pioglitazone 15 mg. Analyses performed on Efficacy Variables were based on Randomized Treatment; analyses on Safety Variables were based on Actual Treatment Received.
|
|
Gastrointestinal disorders
Diverticulum intestinal
|
0.50%
1/201 • Adverse events were summarized by onset date occurring on or after the first dose of double-blind study medication and on or prior to 14 days after the permanent discontinuation of the double-blind study medication.
One participant was randomized to Metformin 850 mg but inadvertently received Pioglitazone 15 mg. Analyses performed on Efficacy Variables were based on Randomized Treatment; analyses on Safety Variables were based on Actual Treatment Received.
|
0.00%
0/190 • Adverse events were summarized by onset date occurring on or after the first dose of double-blind study medication and on or prior to 14 days after the permanent discontinuation of the double-blind study medication.
One participant was randomized to Metformin 850 mg but inadvertently received Pioglitazone 15 mg. Analyses performed on Efficacy Variables were based on Randomized Treatment; analyses on Safety Variables were based on Actual Treatment Received.
|
0.00%
0/209 • Adverse events were summarized by onset date occurring on or after the first dose of double-blind study medication and on or prior to 14 days after the permanent discontinuation of the double-blind study medication.
One participant was randomized to Metformin 850 mg but inadvertently received Pioglitazone 15 mg. Analyses performed on Efficacy Variables were based on Randomized Treatment; analyses on Safety Variables were based on Actual Treatment Received.
|
|
Hepatobiliary disorders
Cholecystitis chronic
|
0.00%
0/201 • Adverse events were summarized by onset date occurring on or after the first dose of double-blind study medication and on or prior to 14 days after the permanent discontinuation of the double-blind study medication.
One participant was randomized to Metformin 850 mg but inadvertently received Pioglitazone 15 mg. Analyses performed on Efficacy Variables were based on Randomized Treatment; analyses on Safety Variables were based on Actual Treatment Received.
|
0.00%
0/190 • Adverse events were summarized by onset date occurring on or after the first dose of double-blind study medication and on or prior to 14 days after the permanent discontinuation of the double-blind study medication.
One participant was randomized to Metformin 850 mg but inadvertently received Pioglitazone 15 mg. Analyses performed on Efficacy Variables were based on Randomized Treatment; analyses on Safety Variables were based on Actual Treatment Received.
|
0.48%
1/209 • Adverse events were summarized by onset date occurring on or after the first dose of double-blind study medication and on or prior to 14 days after the permanent discontinuation of the double-blind study medication.
One participant was randomized to Metformin 850 mg but inadvertently received Pioglitazone 15 mg. Analyses performed on Efficacy Variables were based on Randomized Treatment; analyses on Safety Variables were based on Actual Treatment Received.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/201 • Adverse events were summarized by onset date occurring on or after the first dose of double-blind study medication and on or prior to 14 days after the permanent discontinuation of the double-blind study medication.
One participant was randomized to Metformin 850 mg but inadvertently received Pioglitazone 15 mg. Analyses performed on Efficacy Variables were based on Randomized Treatment; analyses on Safety Variables were based on Actual Treatment Received.
|
0.00%
0/190 • Adverse events were summarized by onset date occurring on or after the first dose of double-blind study medication and on or prior to 14 days after the permanent discontinuation of the double-blind study medication.
One participant was randomized to Metformin 850 mg but inadvertently received Pioglitazone 15 mg. Analyses performed on Efficacy Variables were based on Randomized Treatment; analyses on Safety Variables were based on Actual Treatment Received.
|
0.48%
1/209 • Adverse events were summarized by onset date occurring on or after the first dose of double-blind study medication and on or prior to 14 days after the permanent discontinuation of the double-blind study medication.
One participant was randomized to Metformin 850 mg but inadvertently received Pioglitazone 15 mg. Analyses performed on Efficacy Variables were based on Randomized Treatment; analyses on Safety Variables were based on Actual Treatment Received.
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/201 • Adverse events were summarized by onset date occurring on or after the first dose of double-blind study medication and on or prior to 14 days after the permanent discontinuation of the double-blind study medication.
One participant was randomized to Metformin 850 mg but inadvertently received Pioglitazone 15 mg. Analyses performed on Efficacy Variables were based on Randomized Treatment; analyses on Safety Variables were based on Actual Treatment Received.
|
0.00%
0/190 • Adverse events were summarized by onset date occurring on or after the first dose of double-blind study medication and on or prior to 14 days after the permanent discontinuation of the double-blind study medication.
One participant was randomized to Metformin 850 mg but inadvertently received Pioglitazone 15 mg. Analyses performed on Efficacy Variables were based on Randomized Treatment; analyses on Safety Variables were based on Actual Treatment Received.
|
0.48%
1/209 • Adverse events were summarized by onset date occurring on or after the first dose of double-blind study medication and on or prior to 14 days after the permanent discontinuation of the double-blind study medication.
One participant was randomized to Metformin 850 mg but inadvertently received Pioglitazone 15 mg. Analyses performed on Efficacy Variables were based on Randomized Treatment; analyses on Safety Variables were based on Actual Treatment Received.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/201 • Adverse events were summarized by onset date occurring on or after the first dose of double-blind study medication and on or prior to 14 days after the permanent discontinuation of the double-blind study medication.
One participant was randomized to Metformin 850 mg but inadvertently received Pioglitazone 15 mg. Analyses performed on Efficacy Variables were based on Randomized Treatment; analyses on Safety Variables were based on Actual Treatment Received.
|
0.00%
0/190 • Adverse events were summarized by onset date occurring on or after the first dose of double-blind study medication and on or prior to 14 days after the permanent discontinuation of the double-blind study medication.
One participant was randomized to Metformin 850 mg but inadvertently received Pioglitazone 15 mg. Analyses performed on Efficacy Variables were based on Randomized Treatment; analyses on Safety Variables were based on Actual Treatment Received.
|
0.48%
1/209 • Adverse events were summarized by onset date occurring on or after the first dose of double-blind study medication and on or prior to 14 days after the permanent discontinuation of the double-blind study medication.
One participant was randomized to Metformin 850 mg but inadvertently received Pioglitazone 15 mg. Analyses performed on Efficacy Variables were based on Randomized Treatment; analyses on Safety Variables were based on Actual Treatment Received.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.00%
0/201 • Adverse events were summarized by onset date occurring on or after the first dose of double-blind study medication and on or prior to 14 days after the permanent discontinuation of the double-blind study medication.
One participant was randomized to Metformin 850 mg but inadvertently received Pioglitazone 15 mg. Analyses performed on Efficacy Variables were based on Randomized Treatment; analyses on Safety Variables were based on Actual Treatment Received.
|
0.53%
1/190 • Adverse events were summarized by onset date occurring on or after the first dose of double-blind study medication and on or prior to 14 days after the permanent discontinuation of the double-blind study medication.
One participant was randomized to Metformin 850 mg but inadvertently received Pioglitazone 15 mg. Analyses performed on Efficacy Variables were based on Randomized Treatment; analyses on Safety Variables were based on Actual Treatment Received.
|
0.00%
0/209 • Adverse events were summarized by onset date occurring on or after the first dose of double-blind study medication and on or prior to 14 days after the permanent discontinuation of the double-blind study medication.
One participant was randomized to Metformin 850 mg but inadvertently received Pioglitazone 15 mg. Analyses performed on Efficacy Variables were based on Randomized Treatment; analyses on Safety Variables were based on Actual Treatment Received.
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
0.50%
1/201 • Adverse events were summarized by onset date occurring on or after the first dose of double-blind study medication and on or prior to 14 days after the permanent discontinuation of the double-blind study medication.
One participant was randomized to Metformin 850 mg but inadvertently received Pioglitazone 15 mg. Analyses performed on Efficacy Variables were based on Randomized Treatment; analyses on Safety Variables were based on Actual Treatment Received.
|
0.00%
0/190 • Adverse events were summarized by onset date occurring on or after the first dose of double-blind study medication and on or prior to 14 days after the permanent discontinuation of the double-blind study medication.
One participant was randomized to Metformin 850 mg but inadvertently received Pioglitazone 15 mg. Analyses performed on Efficacy Variables were based on Randomized Treatment; analyses on Safety Variables were based on Actual Treatment Received.
|
0.00%
0/209 • Adverse events were summarized by onset date occurring on or after the first dose of double-blind study medication and on or prior to 14 days after the permanent discontinuation of the double-blind study medication.
One participant was randomized to Metformin 850 mg but inadvertently received Pioglitazone 15 mg. Analyses performed on Efficacy Variables were based on Randomized Treatment; analyses on Safety Variables were based on Actual Treatment Received.
|
|
Reproductive system and breast disorders
Endometriosis
|
0.00%
0/201 • Adverse events were summarized by onset date occurring on or after the first dose of double-blind study medication and on or prior to 14 days after the permanent discontinuation of the double-blind study medication.
One participant was randomized to Metformin 850 mg but inadvertently received Pioglitazone 15 mg. Analyses performed on Efficacy Variables were based on Randomized Treatment; analyses on Safety Variables were based on Actual Treatment Received.
|
0.53%
1/190 • Adverse events were summarized by onset date occurring on or after the first dose of double-blind study medication and on or prior to 14 days after the permanent discontinuation of the double-blind study medication.
One participant was randomized to Metformin 850 mg but inadvertently received Pioglitazone 15 mg. Analyses performed on Efficacy Variables were based on Randomized Treatment; analyses on Safety Variables were based on Actual Treatment Received.
|
0.00%
0/209 • Adverse events were summarized by onset date occurring on or after the first dose of double-blind study medication and on or prior to 14 days after the permanent discontinuation of the double-blind study medication.
One participant was randomized to Metformin 850 mg but inadvertently received Pioglitazone 15 mg. Analyses performed on Efficacy Variables were based on Randomized Treatment; analyses on Safety Variables were based on Actual Treatment Received.
|
Other adverse events
| Measure |
Pioglitazone 15 mg/Metformin 850 mg BID
n=201 participants at risk
Pioglitazone 15 mg /metformin 850 mg combination tablets, orally, twice daily for up to 24 weeks
|
Pioglitazone 15 mg BID
n=190 participants at risk
Pioglitazone 15 mg, tablets, orally, twice daily for up to 24 weeks
|
Metformin 850 mg BID
n=209 participants at risk
Metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.
|
|---|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
9.0%
18/201 • Adverse events were summarized by onset date occurring on or after the first dose of double-blind study medication and on or prior to 14 days after the permanent discontinuation of the double-blind study medication.
One participant was randomized to Metformin 850 mg but inadvertently received Pioglitazone 15 mg. Analyses performed on Efficacy Variables were based on Randomized Treatment; analyses on Safety Variables were based on Actual Treatment Received.
|
2.6%
5/190 • Adverse events were summarized by onset date occurring on or after the first dose of double-blind study medication and on or prior to 14 days after the permanent discontinuation of the double-blind study medication.
One participant was randomized to Metformin 850 mg but inadvertently received Pioglitazone 15 mg. Analyses performed on Efficacy Variables were based on Randomized Treatment; analyses on Safety Variables were based on Actual Treatment Received.
|
15.3%
32/209 • Adverse events were summarized by onset date occurring on or after the first dose of double-blind study medication and on or prior to 14 days after the permanent discontinuation of the double-blind study medication.
One participant was randomized to Metformin 850 mg but inadvertently received Pioglitazone 15 mg. Analyses performed on Efficacy Variables were based on Randomized Treatment; analyses on Safety Variables were based on Actual Treatment Received.
|
|
Gastrointestinal disorders
Abdominal pain
|
2.0%
4/201 • Adverse events were summarized by onset date occurring on or after the first dose of double-blind study medication and on or prior to 14 days after the permanent discontinuation of the double-blind study medication.
One participant was randomized to Metformin 850 mg but inadvertently received Pioglitazone 15 mg. Analyses performed on Efficacy Variables were based on Randomized Treatment; analyses on Safety Variables were based on Actual Treatment Received.
|
1.6%
3/190 • Adverse events were summarized by onset date occurring on or after the first dose of double-blind study medication and on or prior to 14 days after the permanent discontinuation of the double-blind study medication.
One participant was randomized to Metformin 850 mg but inadvertently received Pioglitazone 15 mg. Analyses performed on Efficacy Variables were based on Randomized Treatment; analyses on Safety Variables were based on Actual Treatment Received.
|
3.3%
7/209 • Adverse events were summarized by onset date occurring on or after the first dose of double-blind study medication and on or prior to 14 days after the permanent discontinuation of the double-blind study medication.
One participant was randomized to Metformin 850 mg but inadvertently received Pioglitazone 15 mg. Analyses performed on Efficacy Variables were based on Randomized Treatment; analyses on Safety Variables were based on Actual Treatment Received.
|
|
General disorders
Oedema Peripheral
|
3.0%
6/201 • Adverse events were summarized by onset date occurring on or after the first dose of double-blind study medication and on or prior to 14 days after the permanent discontinuation of the double-blind study medication.
One participant was randomized to Metformin 850 mg but inadvertently received Pioglitazone 15 mg. Analyses performed on Efficacy Variables were based on Randomized Treatment; analyses on Safety Variables were based on Actual Treatment Received.
|
4.2%
8/190 • Adverse events were summarized by onset date occurring on or after the first dose of double-blind study medication and on or prior to 14 days after the permanent discontinuation of the double-blind study medication.
One participant was randomized to Metformin 850 mg but inadvertently received Pioglitazone 15 mg. Analyses performed on Efficacy Variables were based on Randomized Treatment; analyses on Safety Variables were based on Actual Treatment Received.
|
1.4%
3/209 • Adverse events were summarized by onset date occurring on or after the first dose of double-blind study medication and on or prior to 14 days after the permanent discontinuation of the double-blind study medication.
One participant was randomized to Metformin 850 mg but inadvertently received Pioglitazone 15 mg. Analyses performed on Efficacy Variables were based on Randomized Treatment; analyses on Safety Variables were based on Actual Treatment Received.
|
|
Infections and infestations
Pharyngitis
|
4.0%
8/201 • Adverse events were summarized by onset date occurring on or after the first dose of double-blind study medication and on or prior to 14 days after the permanent discontinuation of the double-blind study medication.
One participant was randomized to Metformin 850 mg but inadvertently received Pioglitazone 15 mg. Analyses performed on Efficacy Variables were based on Randomized Treatment; analyses on Safety Variables were based on Actual Treatment Received.
|
2.6%
5/190 • Adverse events were summarized by onset date occurring on or after the first dose of double-blind study medication and on or prior to 14 days after the permanent discontinuation of the double-blind study medication.
One participant was randomized to Metformin 850 mg but inadvertently received Pioglitazone 15 mg. Analyses performed on Efficacy Variables were based on Randomized Treatment; analyses on Safety Variables were based on Actual Treatment Received.
|
3.3%
7/209 • Adverse events were summarized by onset date occurring on or after the first dose of double-blind study medication and on or prior to 14 days after the permanent discontinuation of the double-blind study medication.
One participant was randomized to Metformin 850 mg but inadvertently received Pioglitazone 15 mg. Analyses performed on Efficacy Variables were based on Randomized Treatment; analyses on Safety Variables were based on Actual Treatment Received.
|
|
Infections and infestations
Urinary tract infection
|
3.0%
6/201 • Adverse events were summarized by onset date occurring on or after the first dose of double-blind study medication and on or prior to 14 days after the permanent discontinuation of the double-blind study medication.
One participant was randomized to Metformin 850 mg but inadvertently received Pioglitazone 15 mg. Analyses performed on Efficacy Variables were based on Randomized Treatment; analyses on Safety Variables were based on Actual Treatment Received.
|
2.6%
5/190 • Adverse events were summarized by onset date occurring on or after the first dose of double-blind study medication and on or prior to 14 days after the permanent discontinuation of the double-blind study medication.
One participant was randomized to Metformin 850 mg but inadvertently received Pioglitazone 15 mg. Analyses performed on Efficacy Variables were based on Randomized Treatment; analyses on Safety Variables were based on Actual Treatment Received.
|
4.3%
9/209 • Adverse events were summarized by onset date occurring on or after the first dose of double-blind study medication and on or prior to 14 days after the permanent discontinuation of the double-blind study medication.
One participant was randomized to Metformin 850 mg but inadvertently received Pioglitazone 15 mg. Analyses performed on Efficacy Variables were based on Randomized Treatment; analyses on Safety Variables were based on Actual Treatment Received.
|
|
Infections and infestations
Nasopharyngitis
|
4.0%
8/201 • Adverse events were summarized by onset date occurring on or after the first dose of double-blind study medication and on or prior to 14 days after the permanent discontinuation of the double-blind study medication.
One participant was randomized to Metformin 850 mg but inadvertently received Pioglitazone 15 mg. Analyses performed on Efficacy Variables were based on Randomized Treatment; analyses on Safety Variables were based on Actual Treatment Received.
|
1.6%
3/190 • Adverse events were summarized by onset date occurring on or after the first dose of double-blind study medication and on or prior to 14 days after the permanent discontinuation of the double-blind study medication.
One participant was randomized to Metformin 850 mg but inadvertently received Pioglitazone 15 mg. Analyses performed on Efficacy Variables were based on Randomized Treatment; analyses on Safety Variables were based on Actual Treatment Received.
|
2.4%
5/209 • Adverse events were summarized by onset date occurring on or after the first dose of double-blind study medication and on or prior to 14 days after the permanent discontinuation of the double-blind study medication.
One participant was randomized to Metformin 850 mg but inadvertently received Pioglitazone 15 mg. Analyses performed on Efficacy Variables were based on Randomized Treatment; analyses on Safety Variables were based on Actual Treatment Received.
|
|
Infections and infestations
Bronchitis
|
2.5%
5/201 • Adverse events were summarized by onset date occurring on or after the first dose of double-blind study medication and on or prior to 14 days after the permanent discontinuation of the double-blind study medication.
One participant was randomized to Metformin 850 mg but inadvertently received Pioglitazone 15 mg. Analyses performed on Efficacy Variables were based on Randomized Treatment; analyses on Safety Variables were based on Actual Treatment Received.
|
3.7%
7/190 • Adverse events were summarized by onset date occurring on or after the first dose of double-blind study medication and on or prior to 14 days after the permanent discontinuation of the double-blind study medication.
One participant was randomized to Metformin 850 mg but inadvertently received Pioglitazone 15 mg. Analyses performed on Efficacy Variables were based on Randomized Treatment; analyses on Safety Variables were based on Actual Treatment Received.
|
1.4%
3/209 • Adverse events were summarized by onset date occurring on or after the first dose of double-blind study medication and on or prior to 14 days after the permanent discontinuation of the double-blind study medication.
One participant was randomized to Metformin 850 mg but inadvertently received Pioglitazone 15 mg. Analyses performed on Efficacy Variables were based on Randomized Treatment; analyses on Safety Variables were based on Actual Treatment Received.
|
|
Investigations
Glycosylated haemoglobin
|
1.00%
2/201 • Adverse events were summarized by onset date occurring on or after the first dose of double-blind study medication and on or prior to 14 days after the permanent discontinuation of the double-blind study medication.
One participant was randomized to Metformin 850 mg but inadvertently received Pioglitazone 15 mg. Analyses performed on Efficacy Variables were based on Randomized Treatment; analyses on Safety Variables were based on Actual Treatment Received.
|
3.7%
7/190 • Adverse events were summarized by onset date occurring on or after the first dose of double-blind study medication and on or prior to 14 days after the permanent discontinuation of the double-blind study medication.
One participant was randomized to Metformin 850 mg but inadvertently received Pioglitazone 15 mg. Analyses performed on Efficacy Variables were based on Randomized Treatment; analyses on Safety Variables were based on Actual Treatment Received.
|
3.3%
7/209 • Adverse events were summarized by onset date occurring on or after the first dose of double-blind study medication and on or prior to 14 days after the permanent discontinuation of the double-blind study medication.
One participant was randomized to Metformin 850 mg but inadvertently received Pioglitazone 15 mg. Analyses performed on Efficacy Variables were based on Randomized Treatment; analyses on Safety Variables were based on Actual Treatment Received.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
2.0%
4/201 • Adverse events were summarized by onset date occurring on or after the first dose of double-blind study medication and on or prior to 14 days after the permanent discontinuation of the double-blind study medication.
One participant was randomized to Metformin 850 mg but inadvertently received Pioglitazone 15 mg. Analyses performed on Efficacy Variables were based on Randomized Treatment; analyses on Safety Variables were based on Actual Treatment Received.
|
4.2%
8/190 • Adverse events were summarized by onset date occurring on or after the first dose of double-blind study medication and on or prior to 14 days after the permanent discontinuation of the double-blind study medication.
One participant was randomized to Metformin 850 mg but inadvertently received Pioglitazone 15 mg. Analyses performed on Efficacy Variables were based on Randomized Treatment; analyses on Safety Variables were based on Actual Treatment Received.
|
2.9%
6/209 • Adverse events were summarized by onset date occurring on or after the first dose of double-blind study medication and on or prior to 14 days after the permanent discontinuation of the double-blind study medication.
One participant was randomized to Metformin 850 mg but inadvertently received Pioglitazone 15 mg. Analyses performed on Efficacy Variables were based on Randomized Treatment; analyses on Safety Variables were based on Actual Treatment Received.
|
|
Nervous system disorders
Headache
|
5.5%
11/201 • Adverse events were summarized by onset date occurring on or after the first dose of double-blind study medication and on or prior to 14 days after the permanent discontinuation of the double-blind study medication.
One participant was randomized to Metformin 850 mg but inadvertently received Pioglitazone 15 mg. Analyses performed on Efficacy Variables were based on Randomized Treatment; analyses on Safety Variables were based on Actual Treatment Received.
|
2.6%
5/190 • Adverse events were summarized by onset date occurring on or after the first dose of double-blind study medication and on or prior to 14 days after the permanent discontinuation of the double-blind study medication.
One participant was randomized to Metformin 850 mg but inadvertently received Pioglitazone 15 mg. Analyses performed on Efficacy Variables were based on Randomized Treatment; analyses on Safety Variables were based on Actual Treatment Received.
|
4.8%
10/209 • Adverse events were summarized by onset date occurring on or after the first dose of double-blind study medication and on or prior to 14 days after the permanent discontinuation of the double-blind study medication.
One participant was randomized to Metformin 850 mg but inadvertently received Pioglitazone 15 mg. Analyses performed on Efficacy Variables were based on Randomized Treatment; analyses on Safety Variables were based on Actual Treatment Received.
|
|
Nervous system disorders
Dizziness
|
3.0%
6/201 • Adverse events were summarized by onset date occurring on or after the first dose of double-blind study medication and on or prior to 14 days after the permanent discontinuation of the double-blind study medication.
One participant was randomized to Metformin 850 mg but inadvertently received Pioglitazone 15 mg. Analyses performed on Efficacy Variables were based on Randomized Treatment; analyses on Safety Variables were based on Actual Treatment Received.
|
1.6%
3/190 • Adverse events were summarized by onset date occurring on or after the first dose of double-blind study medication and on or prior to 14 days after the permanent discontinuation of the double-blind study medication.
One participant was randomized to Metformin 850 mg but inadvertently received Pioglitazone 15 mg. Analyses performed on Efficacy Variables were based on Randomized Treatment; analyses on Safety Variables were based on Actual Treatment Received.
|
1.9%
4/209 • Adverse events were summarized by onset date occurring on or after the first dose of double-blind study medication and on or prior to 14 days after the permanent discontinuation of the double-blind study medication.
One participant was randomized to Metformin 850 mg but inadvertently received Pioglitazone 15 mg. Analyses performed on Efficacy Variables were based on Randomized Treatment; analyses on Safety Variables were based on Actual Treatment Received.
|
|
Psychiatric disorders
Insomnia
|
3.0%
6/201 • Adverse events were summarized by onset date occurring on or after the first dose of double-blind study medication and on or prior to 14 days after the permanent discontinuation of the double-blind study medication.
One participant was randomized to Metformin 850 mg but inadvertently received Pioglitazone 15 mg. Analyses performed on Efficacy Variables were based on Randomized Treatment; analyses on Safety Variables were based on Actual Treatment Received.
|
1.1%
2/190 • Adverse events were summarized by onset date occurring on or after the first dose of double-blind study medication and on or prior to 14 days after the permanent discontinuation of the double-blind study medication.
One participant was randomized to Metformin 850 mg but inadvertently received Pioglitazone 15 mg. Analyses performed on Efficacy Variables were based on Randomized Treatment; analyses on Safety Variables were based on Actual Treatment Received.
|
0.96%
2/209 • Adverse events were summarized by onset date occurring on or after the first dose of double-blind study medication and on or prior to 14 days after the permanent discontinuation of the double-blind study medication.
One participant was randomized to Metformin 850 mg but inadvertently received Pioglitazone 15 mg. Analyses performed on Efficacy Variables were based on Randomized Treatment; analyses on Safety Variables were based on Actual Treatment Received.
|
Additional Information
Sr. VP Clinical Science
Takeda Global Research and Development Center, Inc.
Phone: 800-778-2860
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee The sponsor can review results communications prior to public release and can embargo trial results communications up to 150 days to permit actions necessary to preserve sponsor's intellectual property. Sponsor can request changes to the results communication only for the purpose of removing non study related information that is proprietary and confidential to sponsor. Sponsor can require delay of a results communication until the study has been completed at all participating sites.
- Publication restrictions are in place
Restriction type: OTHER