Trial Outcomes & Findings for A Study of the Current Medical Practice and Outcomes in the Treatment of Type 2 Diabetes Mellitus in an Office Setting (MK-0431-199) (NCT NCT01409213)
NCT ID: NCT01409213
Last Updated: 2015-08-27
Results Overview
Change from baseline was defined as mean HbA1c baseline value minus the mean HbA1c end of observation value.
COMPLETED
1523 participants
Baseline and end of Observation (up to Month 6)
2015-08-27
Participant Flow
Full analysis set (FAS) consisted of 1522 participants; one participant was excluded from the FAS due to missing data at baseline.
Participant milestones
| Measure |
All Enrolled Participants
|
|---|---|
|
Overall Study
STARTED
|
1523
|
|
Overall Study
COMPLETED
|
1523
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study of the Current Medical Practice and Outcomes in the Treatment of Type 2 Diabetes Mellitus in an Office Setting (MK-0431-199)
Baseline characteristics by cohort
| Measure |
All Enrolled Participants
n=1522 Participants
Full analysis set (FAS) consisted of 1522 participants; one participant was excluded from the FAS due to missing data at baseline.
|
|---|---|
|
Age, Continuous
|
64.0 years
STANDARD_DEVIATION 10.8 • n=93 Participants
|
|
Sex/Gender, Customized
Female
|
841 Participants
n=93 Participants
|
|
Sex/Gender, Customized
Male
|
680 Participants
n=93 Participants
|
|
Sex/Gender, Customized
Missing
|
1 Participants
n=93 Participants
|
|
Region of Enrollment
Germany
|
1522 participants
n=93 Participants
|
|
Hemoglobin A1c (HbA1c)
|
7.4 Percent of glycosylated hemoglobin
STANDARD_DEVIATION 1.1 • n=93 Participants
|
|
Fasting blood glucose (FBG)
|
146.9 mg/dL
STANDARD_DEVIATION 42.0 • n=93 Participants
|
PRIMARY outcome
Timeframe: Baseline and end of Observation (up to Month 6)Population: Participants from the full analysis set with available data.
Change from baseline was defined as mean HbA1c baseline value minus the mean HbA1c end of observation value.
Outcome measures
| Measure |
All Enrolled Participants
n=1522 Participants
All enrolled participants with available data.
|
|---|---|
|
Change From Baseline for Mean Hemoglobin A1c (HbA1C)
End of observation, n=1483
|
6.9 Percent of glycosylated hemoglobin
Standard Deviation 0.9
|
|
Change From Baseline for Mean Hemoglobin A1c (HbA1C)
Change from baseline, n=1480
|
-0.5 Percent of glycosylated hemoglobin
Standard Deviation 1.0
|
PRIMARY outcome
Timeframe: Baseline and end of Observation (up to Month 6)Population: Participants from the full analysis set with available data.
Change from baseline was defined as mean FBG baseline value minus mean FBG end of observation value.
Outcome measures
| Measure |
All Enrolled Participants
n=1346 Participants
All enrolled participants with available data.
|
|---|---|
|
Change From Baseline for Mean Fasting Blood Glucose (FBG)
End of observation; n=1346
|
127.8 mg/dL
Standard Deviation 34.7
|
|
Change From Baseline for Mean Fasting Blood Glucose (FBG)
Change from baseline, n=1244
|
-18.6 mg/dL
Standard Deviation 41.2
|
Adverse Events
All Enrolled Participants
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp.
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place