Trial Outcomes & Findings for Efficacy of Pioglitazone/Metformin Combination Therapy in Subjects With Type 2 Diabetes Mellitus and Dyslipidemia. (NCT NCT00770653)
NCT ID: NCT00770653
Last Updated: 2010-10-06
Results Overview
The increase in High-Density Lipoprotein (HDL) Cholesterol collected at week 24 or final visit and HDL-Cholesterol collected at baseline.
COMPLETED
PHASE3
305 participants
Baseline and Week 24.
2010-10-06
Participant Flow
Subjects were enrolled at 61 investigative sites in Germany from 03 April 2007 to 13 May 2009.
Subjects with type 2 diabetes with diabetic dyslipidemia, inadequately controlled by Metformin monotherapy were enrolled in one of two, twice-daily (BID) combination therapy treatment groups.
Participant milestones
| Measure |
Pioglitazone 15 mg and Metformin 850 mg BID
Pioglitazone 15 mg/metformin 850 mg combination tablets, orally, twice daily and glimepiride placebo-matching tablets, orally, once daily and metformin placebo-matching tablets, orally, twice daily for up to 24 weeks.
|
Glimepiride 2 mg and Metformin 850 mg BID
Pioglitazone/metformin placebo-matching combination tablets, orally, twice daily and glimepiride 2 mg, tablets, orally, once daily and metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
155
|
150
|
|
Overall Study
COMPLETED
|
123
|
121
|
|
Overall Study
NOT COMPLETED
|
32
|
29
|
Reasons for withdrawal
| Measure |
Pioglitazone 15 mg and Metformin 850 mg BID
Pioglitazone 15 mg/metformin 850 mg combination tablets, orally, twice daily and glimepiride placebo-matching tablets, orally, once daily and metformin placebo-matching tablets, orally, twice daily for up to 24 weeks.
|
Glimepiride 2 mg and Metformin 850 mg BID
Pioglitazone/metformin placebo-matching combination tablets, orally, twice daily and glimepiride 2 mg, tablets, orally, once daily and metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.
|
|---|---|---|
|
Overall Study
Adverse Event
|
13
|
5
|
|
Overall Study
Protocol Violation
|
8
|
6
|
|
Overall Study
Withdrawal by Subject
|
4
|
7
|
|
Overall Study
Lack of Compliance
|
1
|
4
|
|
Overall Study
Worsening of Glycosolated Hemoglobin
|
2
|
2
|
|
Overall Study
Fasting Glucose > 240 mg/dL
|
2
|
1
|
|
Overall Study
> Three Moderate Hypoglycemic Episodes
|
0
|
2
|
|
Overall Study
Lost to Follow-up
|
1
|
2
|
|
Overall Study
Physician Decision
|
1
|
0
|
Baseline Characteristics
Efficacy of Pioglitazone/Metformin Combination Therapy in Subjects With Type 2 Diabetes Mellitus and Dyslipidemia.
Baseline characteristics by cohort
| Measure |
Pioglitazone 15 mg and Metformin 850 mg BID
n=153 Participants
Pioglitazone 15 mg/metformin 850 mg combination tablets, orally, twice daily and glimepiride placebo-matching tablets, orally, once daily and metformin placebo-matching tablets, orally, twice daily for up to 24 weeks.
|
Glimepiride 2 mg and Metformin 850 mg BID
n=149 Participants
Pioglitazone/metformin placebo-matching combination tablets, orally, twice daily and glimepiride 2 mg, tablets, orally, once daily and metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.
|
Total
n=302 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
58.7 years
STANDARD_DEVIATION 10.0 • n=5 Participants
|
58.5 years
STANDARD_DEVIATION 9.6 • n=7 Participants
|
58.6 years
STANDARD_DEVIATION 9.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
54 Participants
n=5 Participants
|
55 Participants
n=7 Participants
|
109 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
99 Participants
n=5 Participants
|
94 Participants
n=7 Participants
|
193 Participants
n=5 Participants
|
|
Region of Enrollment
Germany
|
153 participants
n=5 Participants
|
149 participants
n=7 Participants
|
302 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and Week 24.Population: Analysis was performed on participants with at least one valid baseline and post-baseline measurement. This condition was not fulfilled in 17 participants who were excluded from the all-participants-randomized set, leading to a full-analysis-set of 288 (146 vs. 142). Last observation carried forward was used (LOCF) in case of premature termination.
The increase in High-Density Lipoprotein (HDL) Cholesterol collected at week 24 or final visit and HDL-Cholesterol collected at baseline.
Outcome measures
| Measure |
Pioglitazone 15 mg and Metformin 850 mg BID
n=146 Participants
Pioglitazone 15 mg/metformin 850 mg combination tablets, orally, twice daily and glimepiride placebo-matching tablets, orally, once daily and metformin placebo-matching tablets, orally, twice daily for up to 24 weeks.
|
Glimepiride 2 mg and Metformin 850 mg BID
n=142 Participants
Pioglitazone/metformin placebo-matching combination tablets, orally, twice daily and glimepiride 2 mg, tablets, orally, once daily and metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.
|
|---|---|---|
|
The Mean Increase From Baseline in High-Density Lipoprotein Cholesterol.
|
3.2 mg/dL
Standard Error 9.7
|
-0.3 mg/dL
Standard Error 11.0
|
SECONDARY outcome
Timeframe: Baseline and Week 24.Population: Analyses was performed for the full analysis and per-protocol set. This condition was not fulfilled in some participants who were excluded. Last observation carried forward was used (LOCF) in case of premature termination.
The change between HDL-Cholesterol collected at week 24 or final visit and HDL-Cholesterol collected at baseline.
Outcome measures
| Measure |
Pioglitazone 15 mg and Metformin 850 mg BID
n=143 Participants
Pioglitazone 15 mg/metformin 850 mg combination tablets, orally, twice daily and glimepiride placebo-matching tablets, orally, once daily and metformin placebo-matching tablets, orally, twice daily for up to 24 weeks.
|
Glimepiride 2 mg and Metformin 850 mg BID
n=137 Participants
Pioglitazone/metformin placebo-matching combination tablets, orally, twice daily and glimepiride 2 mg, tablets, orally, once daily and metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.
|
|---|---|---|
|
Change From Baseline in High-Density Lipoprotein Cholesterol.
|
3.3 mg/dL
Standard Error 9.6
|
-0.4 mg/dL
Standard Error 11.1
|
SECONDARY outcome
Timeframe: Baseline and Week 24.Population: Analyses was performed for the full analysis and per-protocol set. This condition was not fulfilled in some participants who were excluded. Last observation carried forward was used (LOCF) in case of premature termination.
The change between High-Density Lipoprotein/Low-Density Lipoprotein Ratio collected at week 24 or final visit and High-Density Lipoprotein/Low-Density Lipoprotein Ratio collected at baseline.
Outcome measures
| Measure |
Pioglitazone 15 mg and Metformin 850 mg BID
n=141 Participants
Pioglitazone 15 mg/metformin 850 mg combination tablets, orally, twice daily and glimepiride placebo-matching tablets, orally, once daily and metformin placebo-matching tablets, orally, twice daily for up to 24 weeks.
|
Glimepiride 2 mg and Metformin 850 mg BID
n=132 Participants
Pioglitazone/metformin placebo-matching combination tablets, orally, twice daily and glimepiride 2 mg, tablets, orally, once daily and metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.
|
|---|---|---|
|
Change From Baseline in High-Density Lipoprotein/Low-Density Lipoprotein Ratio.
|
0.1 mg/dL
Standard Error 0.8
|
0.3 mg/dL
Standard Error 0.7
|
SECONDARY outcome
Timeframe: Baseline and Week 24.Population: Analyses was performed for the full analysis and per-protocol set. This condition was not fulfilled in some participants who were excluded. Last observation carried forward was used (LOCF) in case of premature termination.
The change between the value of Triglycerides collected at week 24 or final visit and Triglycerides collected at baseline.
Outcome measures
| Measure |
Pioglitazone 15 mg and Metformin 850 mg BID
n=146 Participants
Pioglitazone 15 mg/metformin 850 mg combination tablets, orally, twice daily and glimepiride placebo-matching tablets, orally, once daily and metformin placebo-matching tablets, orally, twice daily for up to 24 weeks.
|
Glimepiride 2 mg and Metformin 850 mg BID
n=142 Participants
Pioglitazone/metformin placebo-matching combination tablets, orally, twice daily and glimepiride 2 mg, tablets, orally, once daily and metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.
|
|---|---|---|
|
Change From Baseline in Triglycerides.
|
-40.9 mg/dL
Standard Error 113.8
|
-16.7 mg/dL
Standard Error 121.6
|
SECONDARY outcome
Timeframe: Baseline and Week 24.Population: Analyses was performed for the full analysis and per-protocol set. The number of participants for analysis was derived from a subgroup of participants from the Mainz, Germany study site. Last observation carried forward was used (LOCF) in case of premature termination.
The change between the value of Low-Density Lipoprotein Subfractions collected at week 24 or final visit and Low-Density Lipoprotein Subfractions collected at baseline.
Outcome measures
| Measure |
Pioglitazone 15 mg and Metformin 850 mg BID
n=11 Participants
Pioglitazone 15 mg/metformin 850 mg combination tablets, orally, twice daily and glimepiride placebo-matching tablets, orally, once daily and metformin placebo-matching tablets, orally, twice daily for up to 24 weeks.
|
Glimepiride 2 mg and Metformin 850 mg BID
n=11 Participants
Pioglitazone/metformin placebo-matching combination tablets, orally, twice daily and glimepiride 2 mg, tablets, orally, once daily and metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.
|
|---|---|---|
|
Change From Baseline in Low-Density Lipoprotein Subfractions.
|
6.2 mg/dL
Standard Error 17.5
|
6.1 mg/dL
Standard Error 26.4
|
SECONDARY outcome
Timeframe: Baseline and Week 24.Population: Analyses was performed for the full analysis and per-protocol set. The number of participants for analysis was derived from a subgroup of participants from the Mainz, Germany study site. Last observation carried forward was used (LOCF) in case of premature termination.
The change between Low-Density Lipoprotein Cholesterol collected at week 24 or final visit and Low-Density Lipoprotein Cholesterol collected at baseline.
Outcome measures
| Measure |
Pioglitazone 15 mg and Metformin 850 mg BID
n=143 Participants
Pioglitazone 15 mg/metformin 850 mg combination tablets, orally, twice daily and glimepiride placebo-matching tablets, orally, once daily and metformin placebo-matching tablets, orally, twice daily for up to 24 weeks.
|
Glimepiride 2 mg and Metformin 850 mg BID
n=132 Participants
Pioglitazone/metformin placebo-matching combination tablets, orally, twice daily and glimepiride 2 mg, tablets, orally, once daily and metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.
|
|---|---|---|
|
Change From Baseline in Low-Density Lipoprotein Cholesterol.
|
9.7 mg/dL
Standard Error 34.7
|
11.2 mg/dL
Standard Error 25.3
|
SECONDARY outcome
Timeframe: Baseline and Week 24.Population: Analyses was performed for the full analysis and per-protocol set. This condition was not fulfilled in some participants who were excluded. Last observation carried forward was used (LOCF) in case of premature termination.
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 week 24 or final visit and Glycosylated Hemoglobin collected at baseline.
Outcome measures
| Measure |
Pioglitazone 15 mg and Metformin 850 mg BID
n=139 Participants
Pioglitazone 15 mg/metformin 850 mg combination tablets, orally, twice daily and glimepiride placebo-matching tablets, orally, once daily and metformin placebo-matching tablets, orally, twice daily for up to 24 weeks.
|
Glimepiride 2 mg and Metformin 850 mg BID
n=136 Participants
Pioglitazone/metformin placebo-matching combination tablets, orally, twice daily and glimepiride 2 mg, tablets, orally, once daily and metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.
|
|---|---|---|
|
Change From Baseline in Glycosylated Hemoglobin.
|
-0.83 mg/dL
Standard Error 0.87
|
-0.95 mg/dL
Standard Error 0.85
|
SECONDARY outcome
Timeframe: Baseline and Week 24.Population: Analyses was performed for the full analysis and per-protocol set. This condition was not fulfilled in some participants who were excluded. Last observation carried forward was used (LOCF) in case of premature termination.
The change between Fasting Intact Proinsulin collected at week 24 or final visit and Fasting Intact Proinsulin collected at baseline.
Outcome measures
| Measure |
Pioglitazone 15 mg and Metformin 850 mg BID
n=144 Participants
Pioglitazone 15 mg/metformin 850 mg combination tablets, orally, twice daily and glimepiride placebo-matching tablets, orally, once daily and metformin placebo-matching tablets, orally, twice daily for up to 24 weeks.
|
Glimepiride 2 mg and Metformin 850 mg BID
n=137 Participants
Pioglitazone/metformin placebo-matching combination tablets, orally, twice daily and glimepiride 2 mg, tablets, orally, once daily and metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.
|
|---|---|---|
|
Change From Baseline in Fasting Intact Proinsulin.
|
-5.18 pmol/L
Standard Error 11.89
|
-0.11 pmol/L
Standard Error 9.84
|
SECONDARY outcome
Timeframe: Baseline and Week 24.Population: Analyses was performed for the full analysis and per-protocol set. This condition was not fulfilled in some participants who were excluded. Last observation carried forward was used (LOCF) in case of premature termination.
The change between Fasting Glucose collected at week 24 or final visit and Fasting Glucose collected at baseline.
Outcome measures
| Measure |
Pioglitazone 15 mg and Metformin 850 mg BID
n=145 Participants
Pioglitazone 15 mg/metformin 850 mg combination tablets, orally, twice daily and glimepiride placebo-matching tablets, orally, once daily and metformin placebo-matching tablets, orally, twice daily for up to 24 weeks.
|
Glimepiride 2 mg and Metformin 850 mg BID
n=139 Participants
Pioglitazone/metformin placebo-matching combination tablets, orally, twice daily and glimepiride 2 mg, tablets, orally, once daily and metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.
|
|---|---|---|
|
Change From Baseline in Fasting Glucose.
|
-21.6 mg/dL
Standard Error 38.6
|
-21.1 mg/dL
Standard Error 40.4
|
SECONDARY outcome
Timeframe: Baseline and Week 24.Population: Analyses was performed for the full analysis and per-protocol set. This condition was not fulfilled in some participants who were excluded. Last observation carried forward was used (LOCF) in case of premature termination.
The change between Adiponectin collected at week 24 or final visit and Adiponectin collected at baseline.
Outcome measures
| Measure |
Pioglitazone 15 mg and Metformin 850 mg BID
n=146 Participants
Pioglitazone 15 mg/metformin 850 mg combination tablets, orally, twice daily and glimepiride placebo-matching tablets, orally, once daily and metformin placebo-matching tablets, orally, twice daily for up to 24 weeks.
|
Glimepiride 2 mg and Metformin 850 mg BID
n=139 Participants
Pioglitazone/metformin placebo-matching combination tablets, orally, twice daily and glimepiride 2 mg, tablets, orally, once daily and metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.
|
|---|---|---|
|
Change From Baseline in Adiponectin.
|
6.79 μg/mL
Standard Error 6.38
|
0.72 μg/mL
Standard Error 2.73
|
SECONDARY outcome
Timeframe: Baseline and Week 24.Population: Analyses was performed for the full analysis and per-protocol set. This condition was not fulfilled in some participants who were excluded. Last observation carried forward was used (LOCF) in case of premature termination.
The change between the value of High Sensitivity C-reactive Protein collected at week 24 or final visit and High Sensitivity C-reactive Protein collected at baseline.
Outcome measures
| Measure |
Pioglitazone 15 mg and Metformin 850 mg BID
n=141 Participants
Pioglitazone 15 mg/metformin 850 mg combination tablets, orally, twice daily and glimepiride placebo-matching tablets, orally, once daily and metformin placebo-matching tablets, orally, twice daily for up to 24 weeks.
|
Glimepiride 2 mg and Metformin 850 mg BID
n=135 Participants
Pioglitazone/metformin placebo-matching combination tablets, orally, twice daily and glimepiride 2 mg, tablets, orally, once daily and metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.
|
|---|---|---|
|
Change From Baseline in High Sensitivity C-reactive Protein (Original).
|
-0.21 mg/L
Standard Error 8.98
|
-0.04 mg/L
Standard Error 9.53
|
SECONDARY outcome
Timeframe: Baseline and Week 24.Population: Analyses was performed for the full analysis and per-protocol set. This condition was not fulfilled in some participants who were excluded. Last observation carried forward was used (LOCF) in case of premature termination.
The change between the value of High Sensitivity C-reactive Protein less than or equal to 10 mg/L collected at week 24 or final visit and High Sensitivity C-reactive Protein less than or equal to 10 mg/L collected at baseline.
Outcome measures
| Measure |
Pioglitazone 15 mg and Metformin 850 mg BID
n=123 Participants
Pioglitazone 15 mg/metformin 850 mg combination tablets, orally, twice daily and glimepiride placebo-matching tablets, orally, once daily and metformin placebo-matching tablets, orally, twice daily for up to 24 weeks.
|
Glimepiride 2 mg and Metformin 850 mg BID
n=113 Participants
Pioglitazone/metformin placebo-matching combination tablets, orally, twice daily and glimepiride 2 mg, tablets, orally, once daily and metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.
|
|---|---|---|
|
Change From Baseline in High Sensitivity C-reactive Protein (≤ 10 mg/L).
|
-0.87 mg/L
Standard Deviation 1.88
|
0.00 mg/L
Standard Deviation 1.83
|
SECONDARY outcome
Timeframe: Baseline and Week 24.Population: Analyses was performed for the full analysis and per-protocol set. This condition was not fulfilled in some participants who were excluded. Last observation carried forward was used (LOCF) in case of premature termination.
The change between Systolic Blood Pressure measured at week 24 or final visit and Systolic Blood Pressure measured at baseline.
Outcome measures
| Measure |
Pioglitazone 15 mg and Metformin 850 mg BID
n=146 Participants
Pioglitazone 15 mg/metformin 850 mg combination tablets, orally, twice daily and glimepiride placebo-matching tablets, orally, once daily and metformin placebo-matching tablets, orally, twice daily for up to 24 weeks.
|
Glimepiride 2 mg and Metformin 850 mg BID
n=142 Participants
Pioglitazone/metformin placebo-matching combination tablets, orally, twice daily and glimepiride 2 mg, tablets, orally, once daily and metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.
|
|---|---|---|
|
Change From Baseline in Systolic Blood Pressure.
|
-2.5 mmHg
Standard Error 14.8
|
0.5 mmHg
Standard Error 13.8
|
SECONDARY outcome
Timeframe: Baseline and Week 24.Population: Analyses was performed for the full analysis and per-protocol set. This condition was not fulfilled in some participants who were excluded. Last observation carried forward was used (LOCF) in case of premature termination.
The change between Diastolic Blood Pressure measured at week 24 or final visit and Diastolic Blood Pressure measured at baseline.
Outcome measures
| Measure |
Pioglitazone 15 mg and Metformin 850 mg BID
n=146 Participants
Pioglitazone 15 mg/metformin 850 mg combination tablets, orally, twice daily and glimepiride placebo-matching tablets, orally, once daily and metformin placebo-matching tablets, orally, twice daily for up to 24 weeks.
|
Glimepiride 2 mg and Metformin 850 mg BID
n=142 Participants
Pioglitazone/metformin placebo-matching combination tablets, orally, twice daily and glimepiride 2 mg, tablets, orally, once daily and metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.
|
|---|---|---|
|
Change From Baseline in Diastolic Blood Pressure.
|
-1.3 mmHg
Standard Deviation 8.7
|
-0.1 mmHg
Standard Deviation 8.8
|
SECONDARY outcome
Timeframe: Baseline and Week 24.Population: Analyses was performed for the full analysis and per-protocol set. This condition was not fulfilled in some participants who were excluded. Last observation carried forward was used (LOCF) in case of premature termination.
The change between the Intake of study medication greater than 80% at week 24 or final visit and Baseline and the Intake of study medication greater than 80% at baseline.
Outcome measures
| Measure |
Pioglitazone 15 mg and Metformin 850 mg BID
n=146 Participants
Pioglitazone 15 mg/metformin 850 mg combination tablets, orally, twice daily and glimepiride placebo-matching tablets, orally, once daily and metformin placebo-matching tablets, orally, twice daily for up to 24 weeks.
|
Glimepiride 2 mg and Metformin 850 mg BID
n=142 Participants
Pioglitazone/metformin placebo-matching combination tablets, orally, twice daily and glimepiride 2 mg, tablets, orally, once daily and metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.
|
|---|---|---|
|
Intake of Study Medication Greater Than 80% and Less Than 120%.
|
136 participants
|
137 participants
|
SECONDARY outcome
Timeframe: Baseline and Week 24.Population: Analyses was performed for the full analysis and per-protocol set. The number of participants for analysis was derived from a subgroup of participants from Schwerin, Berlin, Hanover and Münster study sites. Last observation carried forward was used (LOCF) in case of premature termination.
The change between the value of Nitrotyrosine collected at week 24 or final visit and Nitrotyrosine collected at baseline.
Outcome measures
| Measure |
Pioglitazone 15 mg and Metformin 850 mg BID
n=23 Participants
Pioglitazone 15 mg/metformin 850 mg combination tablets, orally, twice daily and glimepiride placebo-matching tablets, orally, once daily and metformin placebo-matching tablets, orally, twice daily for up to 24 weeks.
|
Glimepiride 2 mg and Metformin 850 mg BID
n=20 Participants
Pioglitazone/metformin placebo-matching combination tablets, orally, twice daily and glimepiride 2 mg, tablets, orally, once daily and metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.
|
|---|---|---|
|
Change From Baseline in Nitrotyrosine.
|
-2.7 nmol/L
Standard Error 93.2
|
32.5 nmol/L
Standard Error 147.2
|
SECONDARY outcome
Timeframe: Baseline and Week 24.Population: Analyses was performed for the full analysis and per-protocol set. The number of participants for analysis was derived from a subgroup of participants from Schwerin, Berlin, Hanover and Münster study sites. Last observation carried forward was used (LOCF) in case of premature termination.
The change between the value of Soluble CD40 Ligand collected at week 24 or final visit and Soluble CD40 Ligand collected at baseline.
Outcome measures
| Measure |
Pioglitazone 15 mg and Metformin 850 mg BID
n=16 Participants
Pioglitazone 15 mg/metformin 850 mg combination tablets, orally, twice daily and glimepiride placebo-matching tablets, orally, once daily and metformin placebo-matching tablets, orally, twice daily for up to 24 weeks.
|
Glimepiride 2 mg and Metformin 850 mg BID
n=18 Participants
Pioglitazone/metformin placebo-matching combination tablets, orally, twice daily and glimepiride 2 mg, tablets, orally, once daily and metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.
|
|---|---|---|
|
Change From Baseline in Soluble CD40 Ligand.
|
-40.7 pg/mL
Standard Error 248.6
|
102.4 pg/mL
Standard Error 379.8
|
SECONDARY outcome
Timeframe: Baseline and Week 24.Population: Analyses was performed for the full analysis and per-protocol set. The number of participants for analysis was derived from a subgroup of participants from Schwerin, Berlin, Hanover and Münster study sites. Last observation carried forward was used (LOCF) in case of premature termination.
The change between the value of Baseline in Matrix Metallo Proteinase-9 collected at week 24 or final visit and Baseline in Matrix Metallo Proteinase-9 collected at baseline.
Outcome measures
| Measure |
Pioglitazone 15 mg and Metformin 850 mg BID
n=23 Participants
Pioglitazone 15 mg/metformin 850 mg combination tablets, orally, twice daily and glimepiride placebo-matching tablets, orally, once daily and metformin placebo-matching tablets, orally, twice daily for up to 24 weeks.
|
Glimepiride 2 mg and Metformin 850 mg BID
n=20 Participants
Pioglitazone/metformin placebo-matching combination tablets, orally, twice daily and glimepiride 2 mg, tablets, orally, once daily and metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.
|
|---|---|---|
|
Change From Baseline in Matrix Metallo Proteinase-9.
|
31.4 ng/mL
Standard Error 228.3
|
51.6 ng/mL
Standard Error 216.4
|
SECONDARY outcome
Timeframe: Baseline and Week 24.Population: Analyses was performed for the full analysis and per-protocol set. The number of participants for analysis was derived from a subgroup of participants from Schwerin, Berlin, Hanover and Münster study sites. Last observation carried forward was used (LOCF) in case of premature termination.
The change between the value of Baseline in Soluble Intracellular Adhesion molecule at week 24 or final visit and Baseline in Soluble Intracellular Adhesion molecule collected at baseline.
Outcome measures
| Measure |
Pioglitazone 15 mg and Metformin 850 mg BID
n=23 Participants
Pioglitazone 15 mg/metformin 850 mg combination tablets, orally, twice daily and glimepiride placebo-matching tablets, orally, once daily and metformin placebo-matching tablets, orally, twice daily for up to 24 weeks.
|
Glimepiride 2 mg and Metformin 850 mg BID
n=20 Participants
Pioglitazone/metformin placebo-matching combination tablets, orally, twice daily and glimepiride 2 mg, tablets, orally, once daily and metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.
|
|---|---|---|
|
Change From Baseline in Soluble Intracellular Adhesion Molecule.
|
-13.0 ng/mL
Standard Error 46.9
|
-3.2 ng/mL
Standard Error 50.0
|
SECONDARY outcome
Timeframe: Baseline and Week 24.Population: Analyses was performed for the full analysis and per-protocol set. The number of participants for analysis was derived from a subgroup of participants from Schwerin, Berlin, Hanover and Münster study sites. Last observation carried forward was used (LOCF) in case of premature termination.
The change between the value of Soluble Vascular Cell Adhesion Molecule collected at week 24 or final visit and Soluble Vascular Cell Adhesion Molecule collected at baseline.
Outcome measures
| Measure |
Pioglitazone 15 mg and Metformin 850 mg BID
n=22 Participants
Pioglitazone 15 mg/metformin 850 mg combination tablets, orally, twice daily and glimepiride placebo-matching tablets, orally, once daily and metformin placebo-matching tablets, orally, twice daily for up to 24 weeks.
|
Glimepiride 2 mg and Metformin 850 mg BID
n=20 Participants
Pioglitazone/metformin placebo-matching combination tablets, orally, twice daily and glimepiride 2 mg, tablets, orally, once daily and metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.
|
|---|---|---|
|
Change From Baseline in Soluble Vascular Cell Adhesion Molecule.
|
11.6 ng/mL
Standard Error 160.6
|
3.3 ng/mL
Standard Error 115.4
|
SECONDARY outcome
Timeframe: Baseline and Week 24.Population: Analyses was performed for the full analysis and per-protocol set. The number of participants for analysis was derived from a subgroup of participants from Schwerin, Berlin, Hanover and Münster study sites. Last observation carried forward was used (LOCF) in case of premature termination.
The change between the value of Thromboxane B2 collected at week 24 or final visit and Thromboxane B2 collected at baseline.
Outcome measures
| Measure |
Pioglitazone 15 mg and Metformin 850 mg BID
n=19 Participants
Pioglitazone 15 mg/metformin 850 mg combination tablets, orally, twice daily and glimepiride placebo-matching tablets, orally, once daily and metformin placebo-matching tablets, orally, twice daily for up to 24 weeks.
|
Glimepiride 2 mg and Metformin 850 mg BID
n=20 Participants
Pioglitazone/metformin placebo-matching combination tablets, orally, twice daily and glimepiride 2 mg, tablets, orally, once daily and metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.
|
|---|---|---|
|
Change From Baseline in Thromboxane B2.
|
-216.4 pg/mL
Standard Error 842.9
|
527.8 pg/mL
Standard Error 1190.4
|
SECONDARY outcome
Timeframe: Baseline and Week 24.Population: Analyses was performed for the full analysis and per-protocol set. The number of participants for analysis was derived from a subgroup of participants from the Mainz, Germany study site. Last observation carried forward was used (LOCF) in case of premature termination.
The change between the value of Platelet Function by PFA 100 collected at week 24 or final visit and Platelet Function by PFA 100 collected at baseline.
Outcome measures
| Measure |
Pioglitazone 15 mg and Metformin 850 mg BID
n=3 Participants
Pioglitazone 15 mg/metformin 850 mg combination tablets, orally, twice daily and glimepiride placebo-matching tablets, orally, once daily and metformin placebo-matching tablets, orally, twice daily for up to 24 weeks.
|
Glimepiride 2 mg and Metformin 850 mg BID
n=5 Participants
Pioglitazone/metformin placebo-matching combination tablets, orally, twice daily and glimepiride 2 mg, tablets, orally, once daily and metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.
|
|---|---|---|
|
Change From Baseline in Platelet Function.
|
-30.3 sec
Standard Error 44.3
|
-1.0 sec
Standard Error 102.5
|
SECONDARY outcome
Timeframe: Baseline and Week 24.Population: Analyses was performed for the full analysis and per-protocol set. The number of participants for analysis was derived from a subgroup of participants from Schwerin, Berlin, Hanover and Münster study sites. Last observation carried forward was used (LOCF) in case of premature termination.
The change between the value of E-Selectin collected at week 24 or final visit and E-Selectin collected at baseline.
Outcome measures
| Measure |
Pioglitazone 15 mg and Metformin 850 mg BID
n=23 Participants
Pioglitazone 15 mg/metformin 850 mg combination tablets, orally, twice daily and glimepiride placebo-matching tablets, orally, once daily and metformin placebo-matching tablets, orally, twice daily for up to 24 weeks.
|
Glimepiride 2 mg and Metformin 850 mg BID
n=20 Participants
Pioglitazone/metformin placebo-matching combination tablets, orally, twice daily and glimepiride 2 mg, tablets, orally, once daily and metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.
|
|---|---|---|
|
Change From Baseline in E-Selectin.
|
-3.7 ng/mL
Standard Error 4.8
|
-0.5 ng/mL
Standard Error 3.4
|
SECONDARY outcome
Timeframe: Baseline and Week 24.Population: Analyses was performed for the full analysis and per-protocol set. The number of participants for analysis was derived from a subgroup of participants from Schwerin, Berlin, Hanover and Münster study sites. Last observation carried forward was used (LOCF) in case of premature termination.
The change between the value of Von-Willebrand Factor collected at week 24 or final visit and Von-Willebrand Factor collected at baseline.
Outcome measures
| Measure |
Pioglitazone 15 mg and Metformin 850 mg BID
n=24 Participants
Pioglitazone 15 mg/metformin 850 mg combination tablets, orally, twice daily and glimepiride placebo-matching tablets, orally, once daily and metformin placebo-matching tablets, orally, twice daily for up to 24 weeks.
|
Glimepiride 2 mg and Metformin 850 mg BID
n=20 Participants
Pioglitazone/metformin placebo-matching combination tablets, orally, twice daily and glimepiride 2 mg, tablets, orally, once daily and metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.
|
|---|---|---|
|
Change From Baseline in Von-Willebrand Factor.
|
-19.5 percent
Standard Error 32.0
|
1.4 percent
Standard Error 33.2
|
SECONDARY outcome
Timeframe: Baseline and Week 24.Population: Analyses was performed for the full analysis and per-protocol set. The number of participants for analysis was derived from a subgroup of participants from the Mainz, Germany study site. Last observation carried forward was used (LOCF) in case of premature termination.
The change between the 0.30 percent value of Erythrocyte (Red Blood Cell) Deformability collected at week 24 or final visit and Erythrocyte Deformability collected at baseline.
Outcome measures
| Measure |
Pioglitazone 15 mg and Metformin 850 mg BID
n=11 Participants
Pioglitazone 15 mg/metformin 850 mg combination tablets, orally, twice daily and glimepiride placebo-matching tablets, orally, once daily and metformin placebo-matching tablets, orally, twice daily for up to 24 weeks.
|
Glimepiride 2 mg and Metformin 850 mg BID
n=12 Participants
Pioglitazone/metformin placebo-matching combination tablets, orally, twice daily and glimepiride 2 mg, tablets, orally, once daily and metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.
|
|---|---|---|
|
Change From Baseline in Erythrocyte Deformability (0.30%).
|
1.3 percent
Standard Deviation 2.1
|
-0.4 percent
Standard Deviation 1.7
|
SECONDARY outcome
Timeframe: Baseline and Week 24.Population: Analyses was performed for the full analysis and per-protocol set. The number of participants for analysis was derived from a subgroup of participants from the Mainz, Germany study site. Last observation carried forward was used (LOCF) in case of premature termination.
The change between the 0.60 percent value of Erythrocyte (Red Blood Cell) Deformability collected at week 24 or final visit and Erythrocyte Deformability collected at baseline.
Outcome measures
| Measure |
Pioglitazone 15 mg and Metformin 850 mg BID
n=11 Participants
Pioglitazone 15 mg/metformin 850 mg combination tablets, orally, twice daily and glimepiride placebo-matching tablets, orally, once daily and metformin placebo-matching tablets, orally, twice daily for up to 24 weeks.
|
Glimepiride 2 mg and Metformin 850 mg BID
n=12 Participants
Pioglitazone/metformin placebo-matching combination tablets, orally, twice daily and glimepiride 2 mg, tablets, orally, once daily and metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.
|
|---|---|---|
|
Change From Baseline in Erythrocyte Deformability (0.60%)
|
2.4 percent
Standard Deviation 1.3
|
-0.5 percent
Standard Deviation 1.1
|
SECONDARY outcome
Timeframe: Baseline and Week 24.Population: Analyses was performed for the full analysis and per-protocol set. The number of participants for analysis was derived from a subgroup of participants from the Mainz, Germany study site. Last observation carried forward was used (LOCF) in case of premature termination.
The change between the 1.20 percent value of Erythrocyte (Red Blood Cell) Deformability collected at week 24 or final visit and Erythrocyte Deformability collected at baseline.
Outcome measures
| Measure |
Pioglitazone 15 mg and Metformin 850 mg BID
n=11 Participants
Pioglitazone 15 mg/metformin 850 mg combination tablets, orally, twice daily and glimepiride placebo-matching tablets, orally, once daily and metformin placebo-matching tablets, orally, twice daily for up to 24 weeks.
|
Glimepiride 2 mg and Metformin 850 mg BID
n=12 Participants
Pioglitazone/metformin placebo-matching combination tablets, orally, twice daily and glimepiride 2 mg, tablets, orally, once daily and metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.
|
|---|---|---|
|
Change From Baseline in Erythrocyte Deformability (1.20).
|
3.2 percent
Standard Deviation 2.2
|
-1.1 percent
Standard Deviation 2.5
|
SECONDARY outcome
Timeframe: Baseline and Week 24.Population: Analyses was performed for the full analysis and per-protocol set. The number of participants for analysis was derived from a subgroup of participants from the Mainz, Germany study site. Last observation carried forward was used (LOCF) in case of premature termination.
The change between the 3.00 percent value of Erythrocyte (Red Blood Cell) Deformability collected at week 24 or final visit and Erythrocyte Deformability collected at baseline.
Outcome measures
| Measure |
Pioglitazone 15 mg and Metformin 850 mg BID
n=11 Participants
Pioglitazone 15 mg/metformin 850 mg combination tablets, orally, twice daily and glimepiride placebo-matching tablets, orally, once daily and metformin placebo-matching tablets, orally, twice daily for up to 24 weeks.
|
Glimepiride 2 mg and Metformin 850 mg BID
n=12 Participants
Pioglitazone/metformin placebo-matching combination tablets, orally, twice daily and glimepiride 2 mg, tablets, orally, once daily and metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.
|
|---|---|---|
|
Change From Baseline in Erythrocyte Deformability (3.00).
|
3.3 percent
Standard Deviation 2.8
|
-.15 percent
Standard Deviation 3.1
|
SECONDARY outcome
Timeframe: Baseline and Week 24.Population: Analyses was performed for the full analysis and per-protocol set. The number of participants for analysis was derived from a subgroup of participants from the Mainz, Germany study site. Last observation carried forward was used (LOCF) in case of premature termination.
The change between the 6.00 percent value of Erythrocyte (Red Blood Cell) Deformability collected at week 24 or final visit and Erythrocyte Deformability collected at baseline.
Outcome measures
| Measure |
Pioglitazone 15 mg and Metformin 850 mg BID
n=11 Participants
Pioglitazone 15 mg/metformin 850 mg combination tablets, orally, twice daily and glimepiride placebo-matching tablets, orally, once daily and metformin placebo-matching tablets, orally, twice daily for up to 24 weeks.
|
Glimepiride 2 mg and Metformin 850 mg BID
n=12 Participants
Pioglitazone/metformin placebo-matching combination tablets, orally, twice daily and glimepiride 2 mg, tablets, orally, once daily and metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.
|
|---|---|---|
|
Change From Baseline in Erythrocyte Deformability (6.00).
|
3.1 percent
Standard Deviation 2.9
|
-1.4 percent
Standard Deviation 2.9
|
SECONDARY outcome
Timeframe: Baseline and Week 24.Population: Analyses was performed for the full analysis and per-protocol set. The number of participants for analysis was derived from a subgroup of participants from the Mainz, Germany study site. Last observation carried forward was used (LOCF) in case of premature termination.
The change between the 12.00 percent value of Erythrocyte (Red Blood Cell) Deformability collected at week 24 or final visit and Erythrocyte Deformability collected at baseline.
Outcome measures
| Measure |
Pioglitazone 15 mg and Metformin 850 mg BID
n=11 Participants
Pioglitazone 15 mg/metformin 850 mg combination tablets, orally, twice daily and glimepiride placebo-matching tablets, orally, once daily and metformin placebo-matching tablets, orally, twice daily for up to 24 weeks.
|
Glimepiride 2 mg and Metformin 850 mg BID
n=12 Participants
Pioglitazone/metformin placebo-matching combination tablets, orally, twice daily and glimepiride 2 mg, tablets, orally, once daily and metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.
|
|---|---|---|
|
Change From Baseline in Erythrocyte Deformability (12.00).
|
2.7 percent
Standard Deviation 2.8
|
-1.3 percent
Standard Deviation 2.9
|
SECONDARY outcome
Timeframe: Baseline and Week 24.Population: Analyses was performed for the full analysis and per-protocol set. The number of participants for analysis was derived from a subgroup of participants from the Mainz, Germany study site. Last observation carried forward was used (LOCF) in case of premature termination.
The change between the 30.00 percent value of Erythrocyte (Red Blood Cell) Deformability collected at week 24 or final visit and Erythrocyte Deformability collected at baseline.
Outcome measures
| Measure |
Pioglitazone 15 mg and Metformin 850 mg BID
n=11 Participants
Pioglitazone 15 mg/metformin 850 mg combination tablets, orally, twice daily and glimepiride placebo-matching tablets, orally, once daily and metformin placebo-matching tablets, orally, twice daily for up to 24 weeks.
|
Glimepiride 2 mg and Metformin 850 mg BID
n=12 Participants
Pioglitazone/metformin placebo-matching combination tablets, orally, twice daily and glimepiride 2 mg, tablets, orally, once daily and metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.
|
|---|---|---|
|
Change From Baseline in Erythrocyte Deformability (30.00).
|
2.5 percent
Standard Deviation 2.6
|
-1.3 percent
Standard Deviation 3.5
|
SECONDARY outcome
Timeframe: Baseline and Week 24.Population: Analyses was performed for the full analysis and per-protocol set. The number of participants for analysis was derived from a subgroup of participants from the Mainz, Germany study site. Last observation carried forward was used (LOCF) in case of premature termination.
The change between the 60.00 percent value of Erythrocyte (Red Blood Cell) Deformability collected at week 24 or final visit and Erythrocyte Deformability collected at baseline.
Outcome measures
| Measure |
Pioglitazone 15 mg and Metformin 850 mg BID
n=11 Participants
Pioglitazone 15 mg/metformin 850 mg combination tablets, orally, twice daily and glimepiride placebo-matching tablets, orally, once daily and metformin placebo-matching tablets, orally, twice daily for up to 24 weeks.
|
Glimepiride 2 mg and Metformin 850 mg BID
n=12 Participants
Pioglitazone/metformin placebo-matching combination tablets, orally, twice daily and glimepiride 2 mg, tablets, orally, once daily and metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.
|
|---|---|---|
|
Change From Baseline in Erythrocyte Deformability (60.00).
|
2.7 percent
Standard Deviation 2.6
|
-1.3 percent
Standard Deviation 3.9
|
Adverse Events
Pioglitazone 15 mg and Metformin 850 mg BID
Glimepiride 2 mg and Metformin 850 mg BID
Serious adverse events
| Measure |
Pioglitazone 15 mg and Metformin 850 mg BID
n=153 participants at risk
Pioglitazone 15 mg/metformin 850 mg combination tablets, orally, twice daily and glimepiride placebo-matching tablets, orally, once daily and metformin placebo-matching tablets, orally, twice daily for up to 24 weeks.
|
Glimepiride 2 mg and Metformin 850 mg BID
n=149 participants at risk
Pioglitazone/metformin placebo-matching combination tablets, orally, twice daily and glimepiride 2 mg, tablets, orally, once daily and metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal adhesions
|
0.00%
0/153 • 1 year and 11 months. Treatment-emergent adverse events are defined as those occurring after signature of consent form and no more than 14 days after the end of the study.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Irrespective of the relation to study treatment, any event spontaneously reported by the participant or observed by the investigator was recorded.
|
0.67%
1/149 • 1 year and 11 months. Treatment-emergent adverse events are defined as those occurring after signature of consent form and no more than 14 days after the end of the study.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Irrespective of the relation to study treatment, any event spontaneously reported by the participant or observed by the investigator was recorded.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign breast neoplasm
|
0.65%
1/153 • 1 year and 11 months. Treatment-emergent adverse events are defined as those occurring after signature of consent form and no more than 14 days after the end of the study.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Irrespective of the relation to study treatment, any event spontaneously reported by the participant or observed by the investigator was recorded.
|
0.00%
0/149 • 1 year and 11 months. Treatment-emergent adverse events are defined as those occurring after signature of consent form and no more than 14 days after the end of the study.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Irrespective of the relation to study treatment, any event spontaneously reported by the participant or observed by the investigator was recorded.
|
|
Cardiac disorders
Cardiac failure
|
1.3%
2/153 • 1 year and 11 months. Treatment-emergent adverse events are defined as those occurring after signature of consent form and no more than 14 days after the end of the study.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Irrespective of the relation to study treatment, any event spontaneously reported by the participant or observed by the investigator was recorded.
|
0.00%
0/149 • 1 year and 11 months. Treatment-emergent adverse events are defined as those occurring after signature of consent form and no more than 14 days after the end of the study.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Irrespective of the relation to study treatment, any event spontaneously reported by the participant or observed by the investigator was recorded.
|
|
Cardiac disorders
Cardiomegaly
|
0.65%
1/153 • 1 year and 11 months. Treatment-emergent adverse events are defined as those occurring after signature of consent form and no more than 14 days after the end of the study.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Irrespective of the relation to study treatment, any event spontaneously reported by the participant or observed by the investigator was recorded.
|
0.00%
0/149 • 1 year and 11 months. Treatment-emergent adverse events are defined as those occurring after signature of consent form and no more than 14 days after the end of the study.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Irrespective of the relation to study treatment, any event spontaneously reported by the participant or observed by the investigator was recorded.
|
|
Nervous system disorders
Carotid artery stenosis
|
0.00%
0/153 • 1 year and 11 months. Treatment-emergent adverse events are defined as those occurring after signature of consent form and no more than 14 days after the end of the study.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Irrespective of the relation to study treatment, any event spontaneously reported by the participant or observed by the investigator was recorded.
|
0.67%
1/149 • 1 year and 11 months. Treatment-emergent adverse events are defined as those occurring after signature of consent form and no more than 14 days after the end of the study.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Irrespective of the relation to study treatment, any event spontaneously reported by the participant or observed by the investigator was recorded.
|
|
General disorders
Chest pain
|
0.65%
1/153 • 1 year and 11 months. Treatment-emergent adverse events are defined as those occurring after signature of consent form and no more than 14 days after the end of the study.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Irrespective of the relation to study treatment, any event spontaneously reported by the participant or observed by the investigator was recorded.
|
0.00%
0/149 • 1 year and 11 months. Treatment-emergent adverse events are defined as those occurring after signature of consent form and no more than 14 days after the end of the study.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Irrespective of the relation to study treatment, any event spontaneously reported by the participant or observed by the investigator was recorded.
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/153 • 1 year and 11 months. Treatment-emergent adverse events are defined as those occurring after signature of consent form and no more than 14 days after the end of the study.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Irrespective of the relation to study treatment, any event spontaneously reported by the participant or observed by the investigator was recorded.
|
0.67%
1/149 • 1 year and 11 months. Treatment-emergent adverse events are defined as those occurring after signature of consent form and no more than 14 days after the end of the study.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Irrespective of the relation to study treatment, any event spontaneously reported by the participant or observed by the investigator was recorded.
|
|
Psychiatric disorders
Depression
|
0.65%
1/153 • 1 year and 11 months. Treatment-emergent adverse events are defined as those occurring after signature of consent form and no more than 14 days after the end of the study.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Irrespective of the relation to study treatment, any event spontaneously reported by the participant or observed by the investigator was recorded.
|
0.00%
0/149 • 1 year and 11 months. Treatment-emergent adverse events are defined as those occurring after signature of consent form and no more than 14 days after the end of the study.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Irrespective of the relation to study treatment, any event spontaneously reported by the participant or observed by the investigator was recorded.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.65%
1/153 • 1 year and 11 months. Treatment-emergent adverse events are defined as those occurring after signature of consent form and no more than 14 days after the end of the study.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Irrespective of the relation to study treatment, any event spontaneously reported by the participant or observed by the investigator was recorded.
|
0.00%
0/149 • 1 year and 11 months. Treatment-emergent adverse events are defined as those occurring after signature of consent form and no more than 14 days after the end of the study.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Irrespective of the relation to study treatment, any event spontaneously reported by the participant or observed by the investigator was recorded.
|
|
Hepatobiliary disorders
Hepatic failure
|
0.65%
1/153 • 1 year and 11 months. Treatment-emergent adverse events are defined as those occurring after signature of consent form and no more than 14 days after the end of the study.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Irrespective of the relation to study treatment, any event spontaneously reported by the participant or observed by the investigator was recorded.
|
0.00%
0/149 • 1 year and 11 months. Treatment-emergent adverse events are defined as those occurring after signature of consent form and no more than 14 days after the end of the study.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Irrespective of the relation to study treatment, any event spontaneously reported by the participant or observed by the investigator was recorded.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.65%
1/153 • 1 year and 11 months. Treatment-emergent adverse events are defined as those occurring after signature of consent form and no more than 14 days after the end of the study.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Irrespective of the relation to study treatment, any event spontaneously reported by the participant or observed by the investigator was recorded.
|
0.00%
0/149 • 1 year and 11 months. Treatment-emergent adverse events are defined as those occurring after signature of consent form and no more than 14 days after the end of the study.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Irrespective of the relation to study treatment, any event spontaneously reported by the participant or observed by the investigator was recorded.
|
|
Vascular disorders
Hypertensive crisis
|
0.00%
0/153 • 1 year and 11 months. Treatment-emergent adverse events are defined as those occurring after signature of consent form and no more than 14 days after the end of the study.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Irrespective of the relation to study treatment, any event spontaneously reported by the participant or observed by the investigator was recorded.
|
0.67%
1/149 • 1 year and 11 months. Treatment-emergent adverse events are defined as those occurring after signature of consent form and no more than 14 days after the end of the study.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Irrespective of the relation to study treatment, any event spontaneously reported by the participant or observed by the investigator was recorded.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.65%
1/153 • 1 year and 11 months. Treatment-emergent adverse events are defined as those occurring after signature of consent form and no more than 14 days after the end of the study.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Irrespective of the relation to study treatment, any event spontaneously reported by the participant or observed by the investigator was recorded.
|
0.00%
0/149 • 1 year and 11 months. Treatment-emergent adverse events are defined as those occurring after signature of consent form and no more than 14 days after the end of the study.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Irrespective of the relation to study treatment, any event spontaneously reported by the participant or observed by the investigator was recorded.
|
|
Metabolism and nutrition disorders
Lactic acidosis
|
0.65%
1/153 • 1 year and 11 months. Treatment-emergent adverse events are defined as those occurring after signature of consent form and no more than 14 days after the end of the study.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Irrespective of the relation to study treatment, any event spontaneously reported by the participant or observed by the investigator was recorded.
|
0.00%
0/149 • 1 year and 11 months. Treatment-emergent adverse events are defined as those occurring after signature of consent form and no more than 14 days after the end of the study.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Irrespective of the relation to study treatment, any event spontaneously reported by the participant or observed by the investigator was recorded.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.65%
1/153 • 1 year and 11 months. Treatment-emergent adverse events are defined as those occurring after signature of consent form and no more than 14 days after the end of the study.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Irrespective of the relation to study treatment, any event spontaneously reported by the participant or observed by the investigator was recorded.
|
0.00%
0/149 • 1 year and 11 months. Treatment-emergent adverse events are defined as those occurring after signature of consent form and no more than 14 days after the end of the study.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Irrespective of the relation to study treatment, any event spontaneously reported by the participant or observed by the investigator was recorded.
|
|
Psychiatric disorders
Mental disorder due to a general medical condition
|
0.65%
1/153 • 1 year and 11 months. Treatment-emergent adverse events are defined as those occurring after signature of consent form and no more than 14 days after the end of the study.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Irrespective of the relation to study treatment, any event spontaneously reported by the participant or observed by the investigator was recorded.
|
0.00%
0/149 • 1 year and 11 months. Treatment-emergent adverse events are defined as those occurring after signature of consent form and no more than 14 days after the end of the study.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Irrespective of the relation to study treatment, any event spontaneously reported by the participant or observed by the investigator was recorded.
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
0.00%
0/153 • 1 year and 11 months. Treatment-emergent adverse events are defined as those occurring after signature of consent form and no more than 14 days after the end of the study.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Irrespective of the relation to study treatment, any event spontaneously reported by the participant or observed by the investigator was recorded.
|
0.67%
1/149 • 1 year and 11 months. Treatment-emergent adverse events are defined as those occurring after signature of consent form and no more than 14 days after the end of the study.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Irrespective of the relation to study treatment, any event spontaneously reported by the participant or observed by the investigator was recorded.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.00%
0/153 • 1 year and 11 months. Treatment-emergent adverse events are defined as those occurring after signature of consent form and no more than 14 days after the end of the study.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Irrespective of the relation to study treatment, any event spontaneously reported by the participant or observed by the investigator was recorded.
|
0.67%
1/149 • 1 year and 11 months. Treatment-emergent adverse events are defined as those occurring after signature of consent form and no more than 14 days after the end of the study.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Irrespective of the relation to study treatment, any event spontaneously reported by the participant or observed by the investigator was recorded.
|
|
Renal and urinary disorders
Renal failure acute
|
0.65%
1/153 • 1 year and 11 months. Treatment-emergent adverse events are defined as those occurring after signature of consent form and no more than 14 days after the end of the study.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Irrespective of the relation to study treatment, any event spontaneously reported by the participant or observed by the investigator was recorded.
|
0.00%
0/149 • 1 year and 11 months. Treatment-emergent adverse events are defined as those occurring after signature of consent form and no more than 14 days after the end of the study.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Irrespective of the relation to study treatment, any event spontaneously reported by the participant or observed by the investigator was recorded.
|
|
Gastrointestinal disorders
Subileus
|
0.00%
0/153 • 1 year and 11 months. Treatment-emergent adverse events are defined as those occurring after signature of consent form and no more than 14 days after the end of the study.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Irrespective of the relation to study treatment, any event spontaneously reported by the participant or observed by the investigator was recorded.
|
0.67%
1/149 • 1 year and 11 months. Treatment-emergent adverse events are defined as those occurring after signature of consent form and no more than 14 days after the end of the study.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Irrespective of the relation to study treatment, any event spontaneously reported by the participant or observed by the investigator was recorded.
|
|
Cardiac disorders
Tachycardia
|
0.65%
1/153 • 1 year and 11 months. Treatment-emergent adverse events are defined as those occurring after signature of consent form and no more than 14 days after the end of the study.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Irrespective of the relation to study treatment, any event spontaneously reported by the participant or observed by the investigator was recorded.
|
0.00%
0/149 • 1 year and 11 months. Treatment-emergent adverse events are defined as those occurring after signature of consent form and no more than 14 days after the end of the study.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Irrespective of the relation to study treatment, any event spontaneously reported by the participant or observed by the investigator was recorded.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.65%
1/153 • 1 year and 11 months. Treatment-emergent adverse events are defined as those occurring after signature of consent form and no more than 14 days after the end of the study.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Irrespective of the relation to study treatment, any event spontaneously reported by the participant or observed by the investigator was recorded.
|
0.00%
0/149 • 1 year and 11 months. Treatment-emergent adverse events are defined as those occurring after signature of consent form and no more than 14 days after the end of the study.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Irrespective of the relation to study treatment, any event spontaneously reported by the participant or observed by the investigator was recorded.
|
|
Investigations
Tumour marker increased
|
0.65%
1/153 • 1 year and 11 months. Treatment-emergent adverse events are defined as those occurring after signature of consent form and no more than 14 days after the end of the study.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Irrespective of the relation to study treatment, any event spontaneously reported by the participant or observed by the investigator was recorded.
|
0.00%
0/149 • 1 year and 11 months. Treatment-emergent adverse events are defined as those occurring after signature of consent form and no more than 14 days after the end of the study.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Irrespective of the relation to study treatment, any event spontaneously reported by the participant or observed by the investigator was recorded.
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/153 • 1 year and 11 months. Treatment-emergent adverse events are defined as those occurring after signature of consent form and no more than 14 days after the end of the study.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Irrespective of the relation to study treatment, any event spontaneously reported by the participant or observed by the investigator was recorded.
|
0.67%
1/149 • 1 year and 11 months. Treatment-emergent adverse events are defined as those occurring after signature of consent form and no more than 14 days after the end of the study.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Irrespective of the relation to study treatment, any event spontaneously reported by the participant or observed by the investigator was recorded.
|
Other adverse events
| Measure |
Pioglitazone 15 mg and Metformin 850 mg BID
n=153 participants at risk
Pioglitazone 15 mg/metformin 850 mg combination tablets, orally, twice daily and glimepiride placebo-matching tablets, orally, once daily and metformin placebo-matching tablets, orally, twice daily for up to 24 weeks.
|
Glimepiride 2 mg and Metformin 850 mg BID
n=149 participants at risk
Pioglitazone/metformin placebo-matching combination tablets, orally, twice daily and glimepiride 2 mg, tablets, orally, once daily and metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
5.2%
8/153 • 1 year and 11 months. Treatment-emergent adverse events are defined as those occurring after signature of consent form and no more than 14 days after the end of the study.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Irrespective of the relation to study treatment, any event spontaneously reported by the participant or observed by the investigator was recorded.
|
2.0%
3/149 • 1 year and 11 months. Treatment-emergent adverse events are defined as those occurring after signature of consent form and no more than 14 days after the end of the study.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Irrespective of the relation to study treatment, any event spontaneously reported by the participant or observed by the investigator was recorded.
|
|
Gastrointestinal disorders
Diarrhoea
|
9.2%
14/153 • 1 year and 11 months. Treatment-emergent adverse events are defined as those occurring after signature of consent form and no more than 14 days after the end of the study.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Irrespective of the relation to study treatment, any event spontaneously reported by the participant or observed by the investigator was recorded.
|
9.4%
14/149 • 1 year and 11 months. Treatment-emergent adverse events are defined as those occurring after signature of consent form and no more than 14 days after the end of the study.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Irrespective of the relation to study treatment, any event spontaneously reported by the participant or observed by the investigator was recorded.
|
|
Nervous system disorders
Headache
|
4.6%
7/153 • 1 year and 11 months. Treatment-emergent adverse events are defined as those occurring after signature of consent form and no more than 14 days after the end of the study.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Irrespective of the relation to study treatment, any event spontaneously reported by the participant or observed by the investigator was recorded.
|
4.7%
7/149 • 1 year and 11 months. Treatment-emergent adverse events are defined as those occurring after signature of consent form and no more than 14 days after the end of the study.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Irrespective of the relation to study treatment, any event spontaneously reported by the participant or observed by the investigator was recorded.
|
|
Infections and infestations
Nasopharyngitis
|
15.7%
24/153 • 1 year and 11 months. Treatment-emergent adverse events are defined as those occurring after signature of consent form and no more than 14 days after the end of the study.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Irrespective of the relation to study treatment, any event spontaneously reported by the participant or observed by the investigator was recorded.
|
22.1%
33/149 • 1 year and 11 months. Treatment-emergent adverse events are defined as those occurring after signature of consent form and no more than 14 days after the end of the study.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Irrespective of the relation to study treatment, any event spontaneously reported by the participant or observed by the investigator was recorded.
|
|
General disorders
Oedema peripheral
|
5.2%
8/153 • 1 year and 11 months. Treatment-emergent adverse events are defined as those occurring after signature of consent form and no more than 14 days after the end of the study.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Irrespective of the relation to study treatment, any event spontaneously reported by the participant or observed by the investigator was recorded.
|
2.7%
4/149 • 1 year and 11 months. Treatment-emergent adverse events are defined as those occurring after signature of consent form and no more than 14 days after the end of the study.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Irrespective of the relation to study treatment, any event spontaneously reported by the participant or observed by the investigator was recorded.
|
Additional Information
Medical Director
Takeda Pharma GmbH, Aachen (Germany)
Results disclosure agreements
- Principal investigator is a sponsor employee The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 14 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.
- Publication restrictions are in place
Restriction type: OTHER