Trial Outcomes & Findings for The Effect of Sitagliptin in Type 2 Diabetes Mellitus With Inadequate Glycemic Control (MK0431-118) (NCT NCT00832624)
NCT ID: NCT00832624
Last Updated: 2017-05-23
Results Overview
Glycosylated hemoglobin (HbA1c) was to be measured as the percentage of hemoglobin that has glucose bound to it; however, the study was terminated early therefore no laboratory tests were performed, and no outcome data was collected.
TERMINATED
PHASE4
10 participants
Baseline and Week 18
2017-05-23
Participant Flow
Recruitment process occurred in the Hospital Regional de Taguatinga between November, 26 2008 and May, 27 2009. First Patient in: 26-Nov-2008; Last patient in: 27- May- 2009
Patients between 18 and 75 years old with type 2 diabetes mellitus (T2DM) and inadequate glycemic control, who had not taken medication for at least 2 months or using a single drug for diabetes mellitus were enrolled in the study. Insulin-dependent patients were excluded from the study.
Participant milestones
| Measure |
Sitagliptin 100 mg
Sitagliptin, 100 mg, 1 Tablet, once a day, for 18 weeks
|
|---|---|
|
Overall Study
STARTED
|
10
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
10
|
Reasons for withdrawal
| Measure |
Sitagliptin 100 mg
Sitagliptin, 100 mg, 1 Tablet, once a day, for 18 weeks
|
|---|---|
|
Overall Study
Study Terminated
|
10
|
Baseline Characteristics
The Effect of Sitagliptin in Type 2 Diabetes Mellitus With Inadequate Glycemic Control (MK0431-118)
Baseline characteristics by cohort
| Measure |
Sitagliptin 100 mg
n=10 Participants
Sitagliptin, 100 mg, 1 Tablet, once a day, for 18 weeks
|
|---|---|
|
Age, Continuous
|
51.7 years
STANDARD_DEVIATION 14.0 • n=5 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
Brazil
|
10 participants
n=5 Participants
|
|
Weight
|
71.59 Kilograms
STANDARD_DEVIATION 11.55 • n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and Week 18Population: The study was terminated early and no data were analyzed for this outcome.
Glycosylated hemoglobin (HbA1c) was to be measured as the percentage of hemoglobin that has glucose bound to it; however, the study was terminated early therefore no laboratory tests were performed, and no outcome data was collected.
Outcome measures
Outcome data not reported
Adverse Events
Sitagliptin 100 mg
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 Merck agreements may vary with individual investigators, but will not prohibit any investigator from publishing. Merck supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER