Trial Outcomes & Findings for Sitagliptin Dose Comparison Study in Patients With Type 2 Diabetes (MK-0431-077)(COMPLETED) (NCT NCT00541229)
NCT ID: NCT00541229
Last Updated: 2017-05-12
Results Overview
The 24-hour WMG was calculated as the area under the 24-hour glucose curve (AUC(0-24 hr)) divided by 24 using linear trapezoidal method.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
103 participants
Primary outcome timeframe
Day 7 of Treatment Period I. Due to a carry-over effect that was observed between treatment periods, efficacy results are presented from Treatment Period I only.
Results posted on
2017-05-12
Participant Flow
First Patient In: 17-Oct-2007; Last Patient Last Visit: 01-Jul-2008; Seventeen medical clinics worldwide (8 in the United States, 8 in Europe and 1 in Mexico).
Following a 4-week (wk) diet/exercise (and wash-off period for patients on antihyperglycemic agent \[AHA\]), patients with fasting plasma glucose (FPG) 130-250 mg/dL were eligible to enter a 2-wk placebo run-in period prior to randomization.
Participant milestones
| Measure |
Placebo / 100 mg / 200 mg
Placebo / 100 mg / 200 mg Group includes patients receiving once daily administration of the following treatments: sitagliptin-matching placebo in Treatment Period I, sitagliptin 100 mg in Treatment Period II (after Washout Period I), and sitagliptin 200 mg in Treatment Period III (after Washout Period II)
|
100 mg / 200 mg / Placebo
100 mg / 200 mg / Placebo Group includes patients receiving once daily administration of the following treatments: sitagliptin 100 mg in Treatment Period I, sitagliptin 200 mg in Treatment Period II (after Washout Period I), and sitagliptin-matching placebo in Treatment Period III (after Washout Period II)
|
200 mg / Placebo / 100 mg
200 mg / Placebo / 100 mg Group includes patients receiving once daily administration of the following treatments: sitagliptin 200 mg in Treatment Period I, sitagliptin-matching placebo in Treatment Period II (after Washout Period I), and sitagliptin 100 mg in Treatment Period III (after Washout Period II)
|
Placebo / 200 mg / 100 mg
Placebo / 200 mg / 100 mg Group includes patients receiving once daily administration of the following treatments: sitagliptin-matching placebo in Treatment Period I, sitagliptin 200 mg in Treatment Period II (after Washout Period I), and sitagliptin 100 mg in Treatment Period III (after Washout Period II)
|
100 mg / Placebo / 200 mg
100 mg / Placebo / 200 mg Group includes patients receiving once daily administration of the following treatments: sitagliptin 100 mg in Treatment Period I, sitagliptin-matching placebo in Treatment Period II (after Washout Period I), and sitagliptin 200 mg in Treatment Period III (after Washout Period II)
|
200 mg / 100 mg / Placebo
200 mg / 100 mg / Placebo includes patients receiving once daily administration of the following treatments: sitagliptin 200 mg in Treatment Period I, sitagliptin 100 mg in Treatment Period II (after Washout Period I), and sitagliptin-matching placebo in Treatment Period III (after Washout Period II)
|
|---|---|---|---|---|---|---|
|
Treatment Period I (Week 1)
STARTED
|
17
|
16
|
20
|
18
|
14
|
18
|
|
Treatment Period I (Week 1)
COMPLETED
|
17
|
15
|
17
|
17
|
14
|
16
|
|
Treatment Period I (Week 1)
NOT COMPLETED
|
0
|
1
|
3
|
1
|
0
|
2
|
|
Washout Period I (Week 2-5)
STARTED
|
17
|
15
|
17
|
17
|
14
|
16
|
|
Washout Period I (Week 2-5)
COMPLETED
|
13
|
13
|
13
|
13
|
13
|
11
|
|
Washout Period I (Week 2-5)
NOT COMPLETED
|
4
|
2
|
4
|
4
|
1
|
5
|
|
Treatment Period II (Week 6)
STARTED
|
13
|
13
|
13
|
13
|
13
|
11
|
|
Treatment Period II (Week 6)
COMPLETED
|
11
|
12
|
12
|
12
|
11
|
8
|
|
Treatment Period II (Week 6)
NOT COMPLETED
|
2
|
1
|
1
|
1
|
2
|
3
|
|
Washout Period II (Week 7-10)
STARTED
|
11
|
12
|
12
|
12
|
11
|
8
|
|
Washout Period II (Week 7-10)
COMPLETED
|
7
|
8
|
10
|
8
|
7
|
5
|
|
Washout Period II (Week 7-10)
NOT COMPLETED
|
4
|
4
|
2
|
4
|
4
|
3
|
|
Treatment Period III (Week 11)
STARTED
|
7
|
8
|
10
|
8
|
7
|
5
|
|
Treatment Period III (Week 11)
COMPLETED
|
7
|
8
|
9
|
8
|
6
|
4
|
|
Treatment Period III (Week 11)
NOT COMPLETED
|
0
|
0
|
1
|
0
|
1
|
1
|
Reasons for withdrawal
| Measure |
Placebo / 100 mg / 200 mg
Placebo / 100 mg / 200 mg Group includes patients receiving once daily administration of the following treatments: sitagliptin-matching placebo in Treatment Period I, sitagliptin 100 mg in Treatment Period II (after Washout Period I), and sitagliptin 200 mg in Treatment Period III (after Washout Period II)
|
100 mg / 200 mg / Placebo
100 mg / 200 mg / Placebo Group includes patients receiving once daily administration of the following treatments: sitagliptin 100 mg in Treatment Period I, sitagliptin 200 mg in Treatment Period II (after Washout Period I), and sitagliptin-matching placebo in Treatment Period III (after Washout Period II)
|
200 mg / Placebo / 100 mg
200 mg / Placebo / 100 mg Group includes patients receiving once daily administration of the following treatments: sitagliptin 200 mg in Treatment Period I, sitagliptin-matching placebo in Treatment Period II (after Washout Period I), and sitagliptin 100 mg in Treatment Period III (after Washout Period II)
|
Placebo / 200 mg / 100 mg
Placebo / 200 mg / 100 mg Group includes patients receiving once daily administration of the following treatments: sitagliptin-matching placebo in Treatment Period I, sitagliptin 200 mg in Treatment Period II (after Washout Period I), and sitagliptin 100 mg in Treatment Period III (after Washout Period II)
|
100 mg / Placebo / 200 mg
100 mg / Placebo / 200 mg Group includes patients receiving once daily administration of the following treatments: sitagliptin 100 mg in Treatment Period I, sitagliptin-matching placebo in Treatment Period II (after Washout Period I), and sitagliptin 200 mg in Treatment Period III (after Washout Period II)
|
200 mg / 100 mg / Placebo
200 mg / 100 mg / Placebo includes patients receiving once daily administration of the following treatments: sitagliptin 200 mg in Treatment Period I, sitagliptin 100 mg in Treatment Period II (after Washout Period I), and sitagliptin-matching placebo in Treatment Period III (after Washout Period II)
|
|---|---|---|---|---|---|---|
|
Treatment Period I (Week 1)
Physician Decision
|
0
|
0
|
1
|
0
|
0
|
0
|
|
Treatment Period I (Week 1)
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
0
|
1
|
|
Treatment Period I (Week 1)
Protocol Specified Criteria
|
0
|
0
|
0
|
0
|
0
|
1
|
|
Treatment Period I (Week 1)
Study Terminated by Sponsor
|
0
|
1
|
2
|
1
|
0
|
0
|
|
Washout Period I (Week 2-5)
Adverse Event
|
1
|
0
|
1
|
0
|
0
|
0
|
|
Washout Period I (Week 2-5)
Physician Decision
|
0
|
0
|
0
|
1
|
0
|
0
|
|
Washout Period I (Week 2-5)
Protocol Violation
|
0
|
0
|
0
|
0
|
0
|
1
|
|
Washout Period I (Week 2-5)
Study Terminated by Sponsor
|
3
|
2
|
3
|
3
|
1
|
4
|
|
Treatment Period II (Week 6)
Protocol Violation
|
0
|
0
|
0
|
0
|
1
|
1
|
|
Treatment Period II (Week 6)
Study Terminated by Sponsor
|
2
|
1
|
1
|
1
|
1
|
2
|
|
Washout Period II (Week 7-10)
Protocol Violation
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Washout Period II (Week 7-10)
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
1
|
0
|
|
Washout Period II (Week 7-10)
Study Terminated by Sponsor
|
3
|
4
|
2
|
4
|
3
|
3
|
|
Treatment Period III (Week 11)
Adverse Event
|
0
|
0
|
0
|
0
|
1
|
0
|
|
Treatment Period III (Week 11)
Protocol Specified Criteria
|
0
|
0
|
0
|
0
|
0
|
1
|
|
Treatment Period III (Week 11)
Study Terminated by Sponsor
|
0
|
0
|
1
|
0
|
0
|
0
|
Baseline Characteristics
Sitagliptin Dose Comparison Study in Patients With Type 2 Diabetes (MK-0431-077)(COMPLETED)
Baseline characteristics by cohort
| Measure |
Placebo / 100 mg / 200 mg
n=17 Participants
Placebo / 100 mg / 200 mg Group includes patients receiving once daily administration of the following treatments: sitagliptin-matching placebo in Treatment Period I, sitagliptin 100 mg in Treatment Period II (after Washout Period I), and sitagliptin 200 mg in Treatment Period III (after Washout Period II)
|
100 mg / 200 mg / Placebo
n=16 Participants
100 mg / 200 mg / Placebo Group includes patients receiving once daily administration of the following treatments: sitagliptin 100 mg in Treatment Period I, sitagliptin 200 mg in Treatment Period II (after Washout Period I), and sitagliptin-matching placebo in Treatment Period III (after Washout Period II)
|
200 mg / Placebo / 100 mg
n=20 Participants
200 mg / Placebo / 100 mg Group includes patients receiving once daily administration of the following treatments: sitagliptin 200 mg in Treatment Period I, sitagliptin-matching placebo in Treatment Period II (after Washout Period I), and sitagliptin 100 mg in Treatment Period III (after Washout Period II)
|
Placebo / 200 mg / 100 mg
n=18 Participants
Placebo / 200 mg / 100 mg Group includes patients receiving once daily administration of the following treatments: sitagliptin-matching placebo in Treatment Period I, sitagliptin 200 mg in Treatment Period II (after Washout Period I), and sitagliptin 100 mg in Treatment Period III (after Washout Period II)
|
100 mg / Placebo / 200 mg
n=14 Participants
100 mg / Placebo / 200 mg Group includes patients receiving once daily administration of the following treatments: sitagliptin 100 mg in Treatment Period I, sitagliptin-matching placebo in Treatment Period II (after Washout Period I), and sitagliptin 200 mg in Treatment Period III (after Washout Period II)
|
200 mg / 100 mg / Placebo
n=18 Participants
200 mg / 100 mg / Placebo includes patients receiving once daily administration of the following treatments: sitagliptin 200 mg in Treatment Period I, sitagliptin 100 mg in Treatment Period II (after Washout Period I), and sitagliptin-matching placebo in Treatment Period III (after Washout Period II)
|
Total
n=103 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
54.5 years
STANDARD_DEVIATION 8.4 • n=5 Participants
|
56.6 years
STANDARD_DEVIATION 5.8 • n=7 Participants
|
55.7 years
STANDARD_DEVIATION 7.2 • n=5 Participants
|
55.3 years
STANDARD_DEVIATION 8.3 • n=4 Participants
|
50.0 years
STANDARD_DEVIATION 10.0 • n=21 Participants
|
48.6 years
STANDARD_DEVIATION 9.6 • n=10 Participants
|
53.5 years
STANDARD_DEVIATION 8.6 • n=115 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
3 Participants
n=10 Participants
|
28 Participants
n=115 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
10 Participants
n=21 Participants
|
15 Participants
n=10 Participants
|
75 Participants
n=115 Participants
|
|
Race/Ethnicity, Customized
White
|
12 participants
n=5 Participants
|
14 participants
n=7 Participants
|
15 participants
n=5 Participants
|
15 participants
n=4 Participants
|
11 participants
n=21 Participants
|
12 participants
n=10 Participants
|
79 participants
n=115 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
0 participants
n=21 Participants
|
1 participants
n=10 Participants
|
1 participants
n=115 Participants
|
|
Race/Ethnicity, Customized
Other
|
5 participants
n=5 Participants
|
2 participants
n=7 Participants
|
5 participants
n=5 Participants
|
3 participants
n=4 Participants
|
3 participants
n=21 Participants
|
5 participants
n=10 Participants
|
23 participants
n=115 Participants
|
|
Fasting Plasma Glucose
|
179.3 mg/dL
STANDARD_DEVIATION 32.1 • n=5 Participants
|
167.0 mg/dL
STANDARD_DEVIATION 41.1 • n=7 Participants
|
184.0 mg/dL
STANDARD_DEVIATION 42.1 • n=5 Participants
|
173.2 mg/dL
STANDARD_DEVIATION 43.2 • n=4 Participants
|
158.5 mg/dL
STANDARD_DEVIATION 17.3 • n=21 Participants
|
166.0 mg/dL
STANDARD_DEVIATION 36.5 • n=10 Participants
|
172.0 mg/dL
STANDARD_DEVIATION 36.9 • n=115 Participants
|
PRIMARY outcome
Timeframe: Day 7 of Treatment Period I. Due to a carry-over effect that was observed between treatment periods, efficacy results are presented from Treatment Period I only.Population: The per-protocol (PP) population consisted of all patients randomized who had a measurement at Day 7 in Treatment Period I and did not have any major protocol violations. Missing data were not imputed.
The 24-hour WMG was calculated as the area under the 24-hour glucose curve (AUC(0-24 hr)) divided by 24 using linear trapezoidal method.
Outcome measures
| Measure |
Sitagliptin 200mg
n=28 Participants
Sitagliptin 200 mg group included the Treatment Period I data from patients randomized to treatment sequence Sitagliptin 200 mg/Sitagliptin 100 mg/placebo and treatment sequence Sitagliptin 200 mg/ placebo/ Sitagliptin 100 mg.
|
Sitagliptin 100mg
n=26 Participants
Sitagliptin 100 mg group included the Treatment Period I data from patients randomized to treatment sequence Sitagliptin 100 mg/Sitagliptin 200 mg/placebo and treatment sequence Sitagliptin 100 mg/ placebo/ Sitagliptin 200 mg.
|
Placebo
n=30 Participants
Placebo group included the Treatment Period I data from patients randomized to treatment sequence placebo/Sitagliptin 100 mg/Sitagliptin 200 mg and treatment sequence placebo/Sitagliptin 200 mg/Sitagliptin 100 mg.
|
|---|---|---|---|
|
24-hour Weighted Mean Glucose (WMG)
|
169.1 mg/dL
Interval 153.8 to 184.4
|
159.0 mg/dL
Interval 143.1 to 174.9
|
200.9 mg/dL
Interval 186.1 to 215.7
|
Adverse Events
Sitagliptin 200 mg
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Sitagliptin 100 mg
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Sitagliptin 200 mg
n=78 participants at risk
Sitagliptin 200 mg Group included data from all randomized patients in treatment periods with once-daily administration of sitagliptin 200 mg. Due to the crossover design, patients are counted in the denominator for each treatment that they received. Patients are counted in the numerator for the treatment that they were receiving at the time when the AE occurred.
|
Sitagliptin 100 mg
n=72 participants at risk
Sitagliptin 100 mg Group included data from all randomized patients in treatment periods with once-daily administration of sitagliptin 100 mg. Due to the crossover design, patients are counted in the denominator for each treatment that they received. Patients are counted in the numerator for the treatment that they were receiving at the time when the AE occurred.
|
Placebo
n=74 participants at risk
Placebo Group included data from all randomized patients in treatment periods with once-daily administration of sitagliptin-matching placebo tablets. Due to the crossover design, patients are counted in the denominator for each treatment that they received. Patients are counted in the numerator for the treatment that they were receiving at the time when the AE occurred.
|
|---|---|---|---|
|
Nervous system disorders
Headache
|
5.1%
4/78
|
2.8%
2/72
|
5.4%
4/74
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp
Phone: 1-800-672-6372
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