Trial Outcomes & Findings for Sitagliptin Dose Determination Study (NCT NCT01530178)
NCT ID: NCT01530178
Last Updated: 2018-07-16
Results Overview
The current trial is designed to detect a significant difference in the mean glucose levels in the treatment group
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
8 participants
Primary outcome timeframe
1 Year
Results posted on
2018-07-16
Participant Flow
10 participants were screened. 2 did not meet the criteria. Patients were recruited from diabetes clinics, via fliers, and online postings on clinical trial sites.
Only 2 subjects underwent the study visit using sitagliptin 25mg. As we did not see a significant difference between the doses of 25 mg and 50 mg of Sitagliptin, we therefore continued the study visits for other subjects using only 50 mg and 100 mg of sitagliptin
Participant milestones
| Measure |
Placebo/Sitagliptin 25mg/Sitagliptin 50mg/Sitagliptin 100 mg
Each of the two study subjects underwent four study visits, three to four weeks apart; at each visit receiving either placebo, Sitagliptin 25 mg, Sitagliptin 50mg, or Sitagliptin 100mg.
|
Placebo/Sitagliptin 50mg/Sitagliptin 100 mg
Each of the six study subjects underwent three study visits, three to four weeks apart; at each visit receiving either placebo, Sitagliptin 50mg, or Sitagliptin 100mg.
|
|---|---|---|
|
Overall Study
STARTED
|
2
|
6
|
|
Overall Study
COMPLETED
|
2
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Sitagliptin Dose Determination Study
Baseline characteristics by cohort
| Measure |
Placebo/Sitagliptin 25mg/Sitagliptin 50mg/Sitagliptin 100 mg
n=2 Participants
Each of the two study subjects underwent four study visits, three to four weeks apart; at each visit receiving either placebo, Sitagliptin 25 mg, Sitagliptin 50mg, or Sitagliptin 100mg.
|
Placebo/Sitagliptin 50mg/Sitagliptin 100 mg
n=6 Participants
Each of the six study subjects underwent three study visits, three to four weeks apart; at each visit receiving either placebo, Sitagliptin 50mg, or Sitagliptin 100mg.
|
Total
n=8 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
23.8 years
STANDARD_DEVIATION 2.0 • n=5 Participants
|
23.6 years
STANDARD_DEVIATION 4.1 • n=7 Participants
|
23.7 years
STANDARD_DEVIATION 3.0 • n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
2 participants
n=5 Participants
|
6 participants
n=7 Participants
|
8 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 1 YearThe current trial is designed to detect a significant difference in the mean glucose levels in the treatment group
Outcome measures
| Measure |
Sitagliptin 25 mg
n=2 Participants
Only two out of eight study subjects underwent four study visits, three to four weeks apart; at each visit receiving either Sitagliptin 25 mg, sitagliptin 50mg, sitagliptin 100mg or Placebo
|
Sitagliptin 50 mg
n=8 Participants
Each of the eight study subjects underwent three study visits, three to four weeks apart; at each visit receiving either Sitagliptin 25mg, sitagliptin 50mg, sitagliptin 100mg, or placebo
|
Sitagliptin 100 mg
n=8 Participants
Each of the eight study subjects underwent three study visits, three to four weeks apart; at each visit receiving either sitagliptin 25mg, sitagliptin 50mg, sitagliptin 100mg, or placebo
|
Placebo
n=8 Participants
Each of the eight study subjects were treated with placebo
|
|---|---|---|---|---|
|
Better Targeted Blood Glucose Levels
|
184.1 mg/dl
Standard Deviation 28.3
|
179.4 mg/dl
Standard Deviation 36.6
|
153.6 mg/dl
Standard Deviation 22.4
|
181.5 mg/dl
Standard Deviation 45.1
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Sitagliptin 25 mg
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Sitagliptin 50 mg
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Sitagliptin 100 mg
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
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
- Publication restrictions are in place