Trial Outcomes & Findings for Use of Sitagliptin to Decrease Microalbuminuria (NCT NCT02048904)
NCT ID: NCT02048904
Last Updated: 2017-08-10
Results Overview
Decrease in microalbuminuria level
TERMINATED
PHASE4
142 participants
Six months
2017-08-10
Participant Flow
Total enrollment at time of termination of study was 142 participants. However, study was terminated during the enrollment period due to difficulties at the study site. All data collected from participants remains untabulated and no analysis is expected.
65 participants had completed study by time of study termination.
Participant milestones
| Measure |
Sitagliptin or Placebo
100 mg/day for 3 months or 1 pill/day for 3 months
Sitagliptin: Sitagliptin 100 mg/day for 3 months or Placebo: Placebo 1 pill/day for 3 months
|
|---|---|
|
Overall Study
STARTED
|
142
|
|
Overall Study
COMPLETED
|
65
|
|
Overall Study
NOT COMPLETED
|
77
|
Reasons for withdrawal
| Measure |
Sitagliptin or Placebo
100 mg/day for 3 months or 1 pill/day for 3 months
Sitagliptin: Sitagliptin 100 mg/day for 3 months or Placebo: Placebo 1 pill/day for 3 months
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
7
|
|
Overall Study
Physician Decision
|
70
|
Baseline Characteristics
Total enrollment was 142 participants, with 65 completing. However, data was not analyzed and results are unavailable as investigator and study coordinator no longer work at the institution and did not make information available. Study was terminated prematurely.
Baseline characteristics by cohort
Baseline data not reported
PRIMARY outcome
Timeframe: Six monthsPopulation: Zero participants were analyzed due to early termination of study related to technical/operational difficulties at the study site.
Decrease in microalbuminuria level
Outcome measures
Outcome data not reported
Adverse Events
Sitagliptin or Placebo
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Principal Investigator
University of Missouri
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place