Trial Outcomes & Findings for An Observational Study of Patient Cohorts Who Previously Received Long-term Treatment With Pioglitazone or Placebo in Addition to Existing Antidiabetic Medications (NCT NCT02678676)
NCT ID: NCT02678676
Last Updated: 2016-07-07
Results Overview
The composite macro-vascular event or death included all-cause mortality, non-fatal myocardial infarction, cardiac intervention, stroke, major leg amputation (above the ankle), bypass surgery or revascularization in the leg. The percentage of participants in the observational study population having first occurrence of macro-vascular event or death during the 10-year observational study period was analyzed. The data were analyzed using the Cox regression with respect to time to the first occurrence of macro-vascular event or death.
COMPLETED
3599 participants
Up to Year 10
2016-07-07
Participant Flow
Participants took part at 228 sites in 18 European countries including Austria, Belgium, Czech Republic, Denmark, Estonia, Finland, France, Germany, Hungary, Latvia, Lithuania, Netherlands, Norway, Poland, Slovakia, Sweden, Switzerland, and the United Kingdom from 02 November 2004 to 10 March 2015.
Participants with a historical diagnosis of Type 2 diabetes mellitus (T2DM) who were previously treated with pioglitazone or placebo in the PROactive study (NCT00174993) were enrolled in this observational study according to their originally assigned treatment group.
Participant milestones
| Measure |
Pioglitazone
Participants who were previously treated with pioglitazone 15, 30, or 45 milligram tablets, orally, once daily during the PROactive study (NCT00174993) were followed up to 10 years in this observational study.
|
Placebo
Participants who were previously treated with placebo-matching pioglitazone tablets, orally, once daily during the PROactive (NCT00174993) study were followed up to 10 years.
|
|---|---|---|
|
Overall Study
STARTED
|
1820
|
1779
|
|
Overall Study
COMPLETED
|
932
|
907
|
|
Overall Study
NOT COMPLETED
|
888
|
872
|
Reasons for withdrawal
| Measure |
Pioglitazone
Participants who were previously treated with pioglitazone 15, 30, or 45 milligram tablets, orally, once daily during the PROactive study (NCT00174993) were followed up to 10 years in this observational study.
|
Placebo
Participants who were previously treated with placebo-matching pioglitazone tablets, orally, once daily during the PROactive (NCT00174993) study were followed up to 10 years.
|
|---|---|---|
|
Overall Study
Death
|
619
|
649
|
|
Overall Study
Withdrawal by Subject
|
13
|
5
|
|
Overall Study
Lost to Follow-up
|
171
|
151
|
|
Overall Study
Unconfirmed for lost to follow-up
|
85
|
67
|
Baseline Characteristics
An Observational Study of Patient Cohorts Who Previously Received Long-term Treatment With Pioglitazone or Placebo in Addition to Existing Antidiabetic Medications
Baseline characteristics by cohort
| Measure |
Pioglitazone
n=1820 Participants
Participants who were previously treated with pioglitazone 15, 30, or 45 milligram tablets, orally, once daily during the PROactive study (NCT00174993) were followed up to 10 years in this observational study.
|
Placebo
n=1779 Participants
Participants who were previously treated with placebo-matching pioglitazone tablets, orally, once daily during the PROactive (NCT00174993) study were followed up to 10 years.
|
Total
n=3599 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
61.8 years
STANDARD_DEVIATION 7.51 • n=5 Participants
|
61.4 years
STANDARD_DEVIATION 7.80 • n=7 Participants
|
61.6 years
STANDARD_DEVIATION 7.66 • n=5 Participants
|
|
Sex: Female, Male
Female
|
632 Participants
n=5 Participants
|
626 Participants
n=7 Participants
|
1258 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1188 Participants
n=5 Participants
|
1153 Participants
n=7 Participants
|
2341 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
1794 Participants
n=5 Participants
|
1760 Participants
n=7 Participants
|
3554 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
7 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian/Oriental
|
18 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Region of Enrollment
Austria
|
45 Participants
n=5 Participants
|
47 Participants
n=7 Participants
|
92 Participants
n=5 Participants
|
|
Region of Enrollment
Belgium
|
21 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
|
Region of Enrollment
Czech Republic
|
40 Participants
n=5 Participants
|
40 Participants
n=7 Participants
|
80 Participants
n=5 Participants
|
|
Region of Enrollment
Denmark
|
32 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
59 Participants
n=5 Participants
|
|
Region of Enrollment
Estonia
|
50 Participants
n=5 Participants
|
53 Participants
n=7 Participants
|
103 Participants
n=5 Participants
|
|
Region of Enrollment
Finland
|
138 Participants
n=5 Participants
|
124 Participants
n=7 Participants
|
262 Participants
n=5 Participants
|
|
Region of Enrollment
France
|
28 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
58 Participants
n=5 Participants
|
|
Region of Enrollment
Germany
|
104 Participants
n=5 Participants
|
104 Participants
n=7 Participants
|
208 Participants
n=5 Participants
|
|
Region of Enrollment
Hungary
|
356 Participants
n=5 Participants
|
360 Participants
n=7 Participants
|
716 Participants
n=5 Participants
|
|
Region of Enrollment
Latvia
|
178 Participants
n=5 Participants
|
175 Participants
n=7 Participants
|
353 Participants
n=5 Participants
|
|
Region of Enrollment
Lithuania
|
120 Participants
n=5 Participants
|
115 Participants
n=7 Participants
|
235 Participants
n=5 Participants
|
|
Region of Enrollment
Netherlands
|
16 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
|
Region of Enrollment
Norway
|
44 Participants
n=5 Participants
|
47 Participants
n=7 Participants
|
91 Participants
n=5 Participants
|
|
Region of Enrollment
Poland
|
374 Participants
n=5 Participants
|
366 Participants
n=7 Participants
|
740 Participants
n=5 Participants
|
|
Region of Enrollment
Slovakia
|
39 Participants
n=5 Participants
|
42 Participants
n=7 Participants
|
81 Participants
n=5 Participants
|
|
Region of Enrollment
Sweden
|
56 Participants
n=5 Participants
|
58 Participants
n=7 Participants
|
114 Participants
n=5 Participants
|
|
Region of Enrollment
Switzerland
|
11 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Region of Enrollment
United Kingdom
|
168 Participants
n=5 Participants
|
148 Participants
n=7 Participants
|
316 Participants
n=5 Participants
|
|
Duration of T2DM
|
9.3 Years
STANDARD_DEVIATION 6.81 • n=5 Participants
|
9.3 Years
STANDARD_DEVIATION 6.96 • n=7 Participants
|
9.3 Years
STANDARD_DEVIATION 6.88 • n=5 Participants
|
|
Weight
|
87.72 Kilograms (kg)
STANDARD_DEVIATION 15.607 • n=5 Participants
|
88.62 Kilograms (kg)
STANDARD_DEVIATION 15.451 • n=7 Participants
|
88.17 Kilograms (kg)
STANDARD_DEVIATION 15.534 • n=5 Participants
|
|
Body mass index (BMI)
|
30.834 kilogram per square meter (kg/m^2)
STANDARD_DEVIATION 4.7978 • n=5 Participants
|
31.078 kilogram per square meter (kg/m^2)
STANDARD_DEVIATION 4.7135 • n=7 Participants
|
30.955 kilogram per square meter (kg/m^2)
STANDARD_DEVIATION 4.7572 • n=5 Participants
|
PRIMARY outcome
Timeframe: Up to Year 10Population: The observational study population consisted of participants who enrolled in this study after completing the final visit of PROactive study (NCT00174993).
The composite macro-vascular event or death included all-cause mortality, non-fatal myocardial infarction, cardiac intervention, stroke, major leg amputation (above the ankle), bypass surgery or revascularization in the leg. The percentage of participants in the observational study population having first occurrence of macro-vascular event or death during the 10-year observational study period was analyzed. The data were analyzed using the Cox regression with respect to time to the first occurrence of macro-vascular event or death.
Outcome measures
| Measure |
Pioglitazone
n=1820 Participants
Participants who were previously treated with pioglitazone 15, 30, or 45 milligram tablets, orally, once daily during the PROactive study (NCT00174993) were followed up to 10 years in this observational study.
|
Placebo
n=1779 Participants
Participants who were previously treated with placebo-matching pioglitazone tablets, orally, once daily during the PROactive (NCT00174993) study were followed up to 10 years.
|
|---|---|---|
|
Percentage of Participants With First Occurrence of Macro-vascular Event or Death
|
58 percentage of participants
NA
|
60.3 percentage of participants
NA
|
SECONDARY outcome
Timeframe: Up to Year 10Population: The observational study population consisted of participants who enrolled in this study after completing the final visit of PROactive study (NCT00174993).
Percentage of participants with incidences of at least 1 malignancy was reported. All malignancies included adrenal, biliary, bladder, brain, breast, cervix, colon/rectal, gastric, hematological, hepatic, lung, mesothelioma, metastases, oesophageal, oropharyngeal, ovarian/uterine, pancreas, prostate, renal, skin and others.
Outcome measures
| Measure |
Pioglitazone
n=1820 Participants
Participants who were previously treated with pioglitazone 15, 30, or 45 milligram tablets, orally, once daily during the PROactive study (NCT00174993) were followed up to 10 years in this observational study.
|
Placebo
n=1779 Participants
Participants who were previously treated with placebo-matching pioglitazone tablets, orally, once daily during the PROactive (NCT00174993) study were followed up to 10 years.
|
|---|---|---|
|
Incidences With Malignancies
|
12.9 percentage of participants
|
13.2 percentage of participants
|
Adverse Events
Pioglitazone
Placebo
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee No publication related to study results will be published prior to publication of a multi-center report submitted for publication within 18 months after conclusion or termination of a study at all study sites. Results publications will be submitted to sponsor for review 60 days in advance of publication. Sponsor can require removal of confidential information unrelated to study results. Sponsor can embargo a proposed publication for another 60 days to preserve intellectual property.
- Publication restrictions are in place
Restriction type: OTHER