Trial Outcomes & Findings for Monotherapy Study in Patients With Type 2 Diabetes Mellitus (0431-021) (NCT NCT00087516)
NCT ID: NCT00087516
Last Updated: 2015-07-03
Results Overview
A1C is measured as a percent. Thus, this change from baseline reflects the Week 24 A1C percent minus the Week 0 A1C percent.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
741 participants
Primary outcome timeframe
Weeks 0-24
Results posted on
2015-07-03
Participant Flow
First Patient In: 08-Jul-2004; Last Patient Last Visit: 07-Feb-2007; One hundred eleven medical clinics worldwide (56 in the United States and Puerto Rico, 16 in 6 countries in Europe and 39 in 11 countries in the rest of the world).
Patients 18-75 years not on an antihyperglycemic agent (AHA) or on oral single AHA or low-dose combination therapy were eligible to participate. Following a screening diet/exercise period of variable duration, patients with hemoglobin A1c (A1C) 7-10% were eligible to enter a 2-week placebo run-in/wash-off period prior to randomization.
Participant milestones
| Measure |
Sitagliptin 100 mg/100 mg
The Sitagliptin 100 mg/100 mg group includes data from patients randomized to receive treatment with oral tablets of sitagliptin 100 mg q.d. (once daily) for up to 104 weeks (including the 24-week Phase A study period and 80-week Phase B study period).
|
Sitagliptin 200 mg/200 mg
The Sitagliptin 200 mg/200 mg group includes data from patients randomized to receive treatment with oral tablets of sitagliptin 200 mg q.d. for up to 104 weeks (including the 24-week Phase A study period and 80-week Phase B study period).
|
Placebo/Sitagliptin 100 mg
The Placebo/Sitagliptin 100 mg group includes data from patients randomized to receive treatment with oral tablets of sitagliptin-matching placebo tablets once daily during the 24-week Phase A study period followed by oral tablets of sitagliptin 100 mg q.d. during the 80-week Phase B study period.
|
Placebo/Sitagliptin 200 mg
The Placebo/Sitagliptin 200 mg group includes data from patients randomized to receive treatment with oral tablets of sitagliptin-matching placebo tablets once daily during the 24-week Phase A study period followed by oral tablets of sitagliptin 200 mg q.d. during the 80-week Phase B study period.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
238
|
250
|
130
|
123
|
|
Overall Study
COMPLETED
|
77
|
81
|
33
|
38
|
|
Overall Study
NOT COMPLETED
|
161
|
169
|
97
|
85
|
Reasons for withdrawal
| Measure |
Sitagliptin 100 mg/100 mg
The Sitagliptin 100 mg/100 mg group includes data from patients randomized to receive treatment with oral tablets of sitagliptin 100 mg q.d. (once daily) for up to 104 weeks (including the 24-week Phase A study period and 80-week Phase B study period).
|
Sitagliptin 200 mg/200 mg
The Sitagliptin 200 mg/200 mg group includes data from patients randomized to receive treatment with oral tablets of sitagliptin 200 mg q.d. for up to 104 weeks (including the 24-week Phase A study period and 80-week Phase B study period).
|
Placebo/Sitagliptin 100 mg
The Placebo/Sitagliptin 100 mg group includes data from patients randomized to receive treatment with oral tablets of sitagliptin-matching placebo tablets once daily during the 24-week Phase A study period followed by oral tablets of sitagliptin 100 mg q.d. during the 80-week Phase B study period.
|
Placebo/Sitagliptin 200 mg
The Placebo/Sitagliptin 200 mg group includes data from patients randomized to receive treatment with oral tablets of sitagliptin-matching placebo tablets once daily during the 24-week Phase A study period followed by oral tablets of sitagliptin 200 mg q.d. during the 80-week Phase B study period.
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
10
|
10
|
3
|
6
|
|
Overall Study
Lack of Efficacy
|
82
|
80
|
39
|
29
|
|
Overall Study
Lost to Follow-up
|
8
|
6
|
5
|
5
|
|
Overall Study
Protocol Violation
|
4
|
8
|
3
|
6
|
|
Overall Study
Withdrawal by Subject
|
16
|
27
|
11
|
12
|
|
Overall Study
Site terminated
|
0
|
2
|
1
|
0
|
|
Overall Study
Protocol specified discontinuation
|
35
|
33
|
33
|
26
|
|
Overall Study
Patient moved
|
3
|
2
|
1
|
0
|
|
Overall Study
Patient was non-compliant
|
3
|
1
|
0
|
0
|
|
Overall Study
Recommendation of Primary Care Physician
|
0
|
0
|
0
|
1
|
|
Overall Study
Other
|
0
|
0
|
1
|
0
|
Baseline Characteristics
Monotherapy Study in Patients With Type 2 Diabetes Mellitus (0431-021)
Baseline characteristics by cohort
| Measure |
Sitagliptin 100 mg
n=238 Participants
The Sitagliptin 100 mg/100 mg group includes data from patients randomized to receive treatment with oral tablets of sitagliptin 100 mg q.d. (once daily) for up to 104 weeks (including the 24-week Phase A study period and 80-week Phase B study period).
|
Sitagliptin 200 mg
n=250 Participants
The Sitagliptin 200 mg/200 mg group includes data from patients randomized to receive treatment with oral tablets of sitagliptin 200 mg q.d. for up to 104 weeks (including the 24-week Phase A study period and 80-week Phase B study period).
|
Placebo
n=253 Participants
The Placebo group includes data from patients randomized to receive treatment with oral tablets of sitagliptin-matching placebo tablets once daily during the 24-week Phase A study period followed by oral tablets of sitagliptin 100 or 200 mg q.d. during the 80-week Phase B study period.
|
Total
n=741 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
53.4 years
STANDARD_DEVIATION 9.5 • n=5 Participants
|
54.9 years
STANDARD_DEVIATION 10.1 • n=7 Participants
|
54.3 years
STANDARD_DEVIATION 10.1 • n=5 Participants
|
54.2 years
STANDARD_DEVIATION 9.9 • n=4 Participants
|
|
Sex: Female, Male
Female
|
102 Participants
n=5 Participants
|
133 Participants
n=7 Participants
|
123 Participants
n=5 Participants
|
358 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
136 Participants
n=5 Participants
|
117 Participants
n=7 Participants
|
130 Participants
n=5 Participants
|
383 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
White
|
122 participants
n=5 Participants
|
132 participants
n=7 Participants
|
127 participants
n=5 Participants
|
381 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Black
|
10 participants
n=5 Participants
|
12 participants
n=7 Participants
|
16 participants
n=5 Participants
|
38 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
58 participants
n=5 Participants
|
53 participants
n=7 Participants
|
64 participants
n=5 Participants
|
175 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Asian
|
32 participants
n=5 Participants
|
37 participants
n=7 Participants
|
34 participants
n=5 Participants
|
103 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Other
|
16 participants
n=5 Participants
|
16 participants
n=7 Participants
|
12 participants
n=5 Participants
|
44 participants
n=4 Participants
|
|
Fasting Plasma Glucose (FPG)
|
170.7 mg/dL
STANDARD_DEVIATION 43.0 • n=5 Participants
|
174.2 mg/dL
STANDARD_DEVIATION 46.2 • n=7 Participants
|
176.1 mg/dL
STANDARD_DEVIATION 41.8 • n=5 Participants
|
173.7 mg/dL
STANDARD_DEVIATION 43.7 • n=4 Participants
|
|
Hemoglobin A1c (A1C)
|
8.0 Percent
STANDARD_DEVIATION 0.9 • n=5 Participants
|
8.1 Percent
STANDARD_DEVIATION 0.9 • n=7 Participants
|
8.0 Percent
STANDARD_DEVIATION 0.8 • n=5 Participants
|
8.0 Percent
STANDARD_DEVIATION 0.9 • n=4 Participants
|
PRIMARY outcome
Timeframe: Weeks 0-24Population: The all-patients-treated population included all patients with at least one dose of double-blind study therapy, and with a baseline value and ≥1 post-baseline value for this outcome. Data following glycemic rescue were treated as missing. Missing data were handled using the last observation carrying forward method.
A1C is measured as a percent. Thus, this change from baseline reflects the Week 24 A1C percent minus the Week 0 A1C percent.
Outcome measures
| Measure |
Sitagliptin 100 mg
n=229 Participants
The Sitagliptin 100 mg/100 mg group includes data from patients randomized to receive treatment with oral tablets of sitagliptin 100 mg q.d. (once daily) for up to 104 weeks (including the 24-week Phase A study period and 80-week Phase B study period).
|
Sitagliptin 200 mg
n=238 Participants
The Sitagliptin 200 mg/200 mg group includes data from patients randomized to receive treatment with oral tablets of sitagliptin 200 mg q.d. for up to 104 weeks (including the 24-week Phase A study period and 80-week Phase B study period).
|
Placebo
n=244 Participants
The Placebo group includes data from patients randomized to receive treatment with oral tablets of sitagliptin-matching placebo tablets once daily during the 24-week Phase A study period followed by oral tablets of sitagliptin 100 or 200 mg q.d. during the 80-week Phase B study period.
|
Placebo/Sitagliptin 200 mg
The Placebo/Sitagliptin 200 mg group includes data from patients randomized to receive treatment with oral tablets of sitagliptin-matching placebo tablets once daily during the 24-week Phase A study period followed by oral tablets of sitagliptin 200 mg q.d. during the 80-week Phase B study period.
|
|---|---|---|---|---|
|
Change From Baseline in A1C at Week 24
|
-0.61 Percent
Interval -0.74 to -0.49
|
-0.76 Percent
Interval -0.88 to -0.64
|
0.18 Percent
Interval 0.06 to 0.3
|
—
|
SECONDARY outcome
Timeframe: Weeks 0-24Population: The all-patients-treated population included all patients with at least one dose of double-blind study therapy, and with a baseline value and ≥1 post-baseline value for this outcome. Data following glycemic rescue were treated as missing. Missing data were handled using the last observation carrying forward method.
Change from baseline at Week 24 is defined as Week 24 FPG minus Week 0 FPG.
Outcome measures
| Measure |
Sitagliptin 100 mg
n=234 Participants
The Sitagliptin 100 mg/100 mg group includes data from patients randomized to receive treatment with oral tablets of sitagliptin 100 mg q.d. (once daily) for up to 104 weeks (including the 24-week Phase A study period and 80-week Phase B study period).
|
Sitagliptin 200 mg
n=244 Participants
The Sitagliptin 200 mg/200 mg group includes data from patients randomized to receive treatment with oral tablets of sitagliptin 200 mg q.d. for up to 104 weeks (including the 24-week Phase A study period and 80-week Phase B study period).
|
Placebo
n=247 Participants
The Placebo group includes data from patients randomized to receive treatment with oral tablets of sitagliptin-matching placebo tablets once daily during the 24-week Phase A study period followed by oral tablets of sitagliptin 100 or 200 mg q.d. during the 80-week Phase B study period.
|
Placebo/Sitagliptin 200 mg
The Placebo/Sitagliptin 200 mg group includes data from patients randomized to receive treatment with oral tablets of sitagliptin-matching placebo tablets once daily during the 24-week Phase A study period followed by oral tablets of sitagliptin 200 mg q.d. during the 80-week Phase B study period.
|
|---|---|---|---|---|
|
Change From Baseline in FPG at Week 24
|
-12.4 mg/dL
Interval -17.4 to -7.4
|
-16.6 mg/dL
Interval -21.5 to -11.7
|
4.7 mg/dL
Interval -0.2 to 9.6
|
—
|
SECONDARY outcome
Timeframe: Weeks 0-24Population: The all-patients-treated population included all patients with at least one dose of double-blind study therapy, and with a baseline value and ≥1 post-baseline value for this outcome. Data following glycemic rescue were treated as missing. Missing data were handled using the last observation carrying forward method.
Change from baseline at Week 24 is defined as Week 24 2-hr PMG minus Week 0 2-hr PMG.
Outcome measures
| Measure |
Sitagliptin 100 mg
n=201 Participants
The Sitagliptin 100 mg/100 mg group includes data from patients randomized to receive treatment with oral tablets of sitagliptin 100 mg q.d. (once daily) for up to 104 weeks (including the 24-week Phase A study period and 80-week Phase B study period).
|
Sitagliptin 200 mg
n=205 Participants
The Sitagliptin 200 mg/200 mg group includes data from patients randomized to receive treatment with oral tablets of sitagliptin 200 mg q.d. for up to 104 weeks (including the 24-week Phase A study period and 80-week Phase B study period).
|
Placebo
n=204 Participants
The Placebo group includes data from patients randomized to receive treatment with oral tablets of sitagliptin-matching placebo tablets once daily during the 24-week Phase A study period followed by oral tablets of sitagliptin 100 or 200 mg q.d. during the 80-week Phase B study period.
|
Placebo/Sitagliptin 200 mg
The Placebo/Sitagliptin 200 mg group includes data from patients randomized to receive treatment with oral tablets of sitagliptin-matching placebo tablets once daily during the 24-week Phase A study period followed by oral tablets of sitagliptin 200 mg q.d. during the 80-week Phase B study period.
|
|---|---|---|---|---|
|
Change From Baseline in 2-hour Post-meal Glucose (2-hr PMG) at Week 24
|
-48.9 mg/dL
Interval -57.9 to -40.0
|
-56.3 mg/dL
Interval -65.2 to -47.5
|
-2.2 mg/dL
Interval -11.1 to 6.7
|
—
|
SECONDARY outcome
Timeframe: Weeks 0-104Population: The all-patients-treated population for Week 104 included all patients with at least one dose of double-blind study therapy after Week 24, and with a baseline value and ≥1 post-baseline value for this outcome. Data following glycemic rescue were treated as missing. Missing data were handled using the last observation carrying forward method.
A1C is measured as a percent. Thus, this change from baseline reflects the Week 104 A1C percent minus the Week 0 A1C percent.
Outcome measures
| Measure |
Sitagliptin 100 mg
n=188 Participants
The Sitagliptin 100 mg/100 mg group includes data from patients randomized to receive treatment with oral tablets of sitagliptin 100 mg q.d. (once daily) for up to 104 weeks (including the 24-week Phase A study period and 80-week Phase B study period).
|
Sitagliptin 200 mg
n=195 Participants
The Sitagliptin 200 mg/200 mg group includes data from patients randomized to receive treatment with oral tablets of sitagliptin 200 mg q.d. for up to 104 weeks (including the 24-week Phase A study period and 80-week Phase B study period).
|
Placebo
n=81 Participants
The Placebo group includes data from patients randomized to receive treatment with oral tablets of sitagliptin-matching placebo tablets once daily during the 24-week Phase A study period followed by oral tablets of sitagliptin 100 or 200 mg q.d. during the 80-week Phase B study period.
|
Placebo/Sitagliptin 200 mg
n=83 Participants
The Placebo/Sitagliptin 200 mg group includes data from patients randomized to receive treatment with oral tablets of sitagliptin-matching placebo tablets once daily during the 24-week Phase A study period followed by oral tablets of sitagliptin 200 mg q.d. during the 80-week Phase B study period.
|
|---|---|---|---|---|
|
Change From Baseline in A1C at Week 104
|
-0.27 Percent
Interval -0.41 to -0.13
|
-0.40 Percent
Interval -0.53 to -0.26
|
-0.32 Percent
Interval -0.53 to -0.11
|
-0.34 Percent
Interval -0.55 to -0.13
|
SECONDARY outcome
Timeframe: Weeks 0-104Population: The all-patients-treated population for Week 104, included all patients with at least one dose of double-blind study therapy after Week 24, and with a baseline value and ≥1 post-baseline value for this outcome. Data following glycemic rescue were treated as missing. Missing data were handled using the last observation carrying forward method.
Change from baseline at Week 104 is defined as Week 104 FPG minus Week 0 FPG.
Outcome measures
| Measure |
Sitagliptin 100 mg
n=190 Participants
The Sitagliptin 100 mg/100 mg group includes data from patients randomized to receive treatment with oral tablets of sitagliptin 100 mg q.d. (once daily) for up to 104 weeks (including the 24-week Phase A study period and 80-week Phase B study period).
|
Sitagliptin 200 mg
n=194 Participants
The Sitagliptin 200 mg/200 mg group includes data from patients randomized to receive treatment with oral tablets of sitagliptin 200 mg q.d. for up to 104 weeks (including the 24-week Phase A study period and 80-week Phase B study period).
|
Placebo
n=81 Participants
The Placebo group includes data from patients randomized to receive treatment with oral tablets of sitagliptin-matching placebo tablets once daily during the 24-week Phase A study period followed by oral tablets of sitagliptin 100 or 200 mg q.d. during the 80-week Phase B study period.
|
Placebo/Sitagliptin 200 mg
n=83 Participants
The Placebo/Sitagliptin 200 mg group includes data from patients randomized to receive treatment with oral tablets of sitagliptin-matching placebo tablets once daily during the 24-week Phase A study period followed by oral tablets of sitagliptin 200 mg q.d. during the 80-week Phase B study period.
|
|---|---|---|---|---|
|
Change From Baseline in FPG at Week 104
|
-1.8 mg/dL
Interval -7.3 to 3.7
|
-5.7 mg/dL
Interval -11.1 to -0.2
|
-4.1 mg/dL
Interval -12.5 to 4.3
|
-4.1 mg/dL
Interval -12.4 to 4.2
|
SECONDARY outcome
Timeframe: Weeks 0-104Population: The all-patients-treated population for Week 104, included all patients with at least one dose of double-blind study therapy after Week 24, and with a baseline value and ≥1 post-baseline value for this outcome. Data following glycemic rescue were treated as missing. Missing data were handled using the last observation carrying forward method.
Change from baseline at Week 104 is defined as Week 104 2-hr PMG minus Week 0 2-hr PMG.
Outcome measures
| Measure |
Sitagliptin 100 mg
n=165 Participants
The Sitagliptin 100 mg/100 mg group includes data from patients randomized to receive treatment with oral tablets of sitagliptin 100 mg q.d. (once daily) for up to 104 weeks (including the 24-week Phase A study period and 80-week Phase B study period).
|
Sitagliptin 200 mg
n=168 Participants
The Sitagliptin 200 mg/200 mg group includes data from patients randomized to receive treatment with oral tablets of sitagliptin 200 mg q.d. for up to 104 weeks (including the 24-week Phase A study period and 80-week Phase B study period).
|
Placebo
n=68 Participants
The Placebo group includes data from patients randomized to receive treatment with oral tablets of sitagliptin-matching placebo tablets once daily during the 24-week Phase A study period followed by oral tablets of sitagliptin 100 or 200 mg q.d. during the 80-week Phase B study period.
|
Placebo/Sitagliptin 200 mg
n=63 Participants
The Placebo/Sitagliptin 200 mg group includes data from patients randomized to receive treatment with oral tablets of sitagliptin-matching placebo tablets once daily during the 24-week Phase A study period followed by oral tablets of sitagliptin 200 mg q.d. during the 80-week Phase B study period.
|
|---|---|---|---|---|
|
Change From Baseline in 2-hr PMG at Week 104
|
-30.5 mg/dL
Interval -40.1 to -21.0
|
-41.5 mg/dL
Interval -51.0 to -32.1
|
-38.3 mg/dL
Interval -53.2 to -23.4
|
-35.5 mg/dL
Interval -50.9 to -20.1
|
Adverse Events
Sitagliptin 100 mg/100 mg
Serious events: 24 serious events
Other events: 127 other events
Deaths: 0 deaths
Sitagliptin 200 mg/200 mg
Serious events: 25 serious events
Other events: 137 other events
Deaths: 0 deaths
Placebo/Sitagliptin 100 mg
Serious events: 10 serious events
Other events: 70 other events
Deaths: 0 deaths
Placebo/Sitagliptin 200 mg
Serious events: 13 serious events
Other events: 65 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Sitagliptin 100 mg/100 mg
n=238 participants at risk
The Sitagliptin 100 mg/100 mg group includes data from patients randomized to receive treatment with oral tablets of sitagliptin 100 mg q.d. (once daily) for up to 104 weeks (including the 24-week Phase A study period and 80-week Phase B study period).
|
Sitagliptin 200 mg/200 mg
n=250 participants at risk
The Sitagliptin 200 mg/200 mg group includes data from patients randomized to receive treatment with oral tablets of sitagliptin 200 mg q.d. for up to 104 weeks (including the 24-week Phase A study period and 80-week Phase B study period).
|
Placebo/Sitagliptin 100 mg
n=130 participants at risk
The Placebo/Sitagliptin 100 mg group includes data from patients randomized to receive treatment with oral tablets of sitagliptin-matching placebo tablets once daily during the 24-week Phase A study period followed by oral tablets of sitagliptin 100 mg q.d. during the 80-week Phase B study period.
|
Placebo/Sitagliptin 200 mg
n=123 participants at risk
The Placebo/Sitagliptin 200 mg group includes data from patients randomized to receive treatment with oral tablets of sitagliptin-matching placebo tablets once daily during the 24-week Phase A study period followed by oral tablets of sitagliptin 200 mg q.d. during the 80-week Phase B study period.
|
|---|---|---|---|---|
|
Injury, poisoning and procedural complications
Skin Laceration
|
0.42%
1/238 • Weeks 0-104
|
0.00%
0/250 • Weeks 0-104
|
0.00%
0/130 • Weeks 0-104
|
0.00%
0/123 • Weeks 0-104
|
|
Investigations
Hepatic Enzyme Increased
|
0.42%
1/238 • Weeks 0-104
|
0.00%
0/250 • Weeks 0-104
|
0.00%
0/130 • Weeks 0-104
|
0.00%
0/123 • Weeks 0-104
|
|
Cardiac disorders
Angina Pectoris
|
0.84%
2/238 • Weeks 0-104
|
0.40%
1/250 • Weeks 0-104
|
0.00%
0/130 • Weeks 0-104
|
0.81%
1/123 • Weeks 0-104
|
|
Cardiac disorders
Angina Unstable
|
0.00%
0/238 • Weeks 0-104
|
0.40%
1/250 • Weeks 0-104
|
0.77%
1/130 • Weeks 0-104
|
0.00%
0/123 • Weeks 0-104
|
|
Cardiac disorders
Atrial Fibrillation
|
0.42%
1/238 • Weeks 0-104
|
0.40%
1/250 • Weeks 0-104
|
0.00%
0/130 • Weeks 0-104
|
0.00%
0/123 • Weeks 0-104
|
|
Cardiac disorders
Coronary Artery Disease
|
0.42%
1/238 • Weeks 0-104
|
0.40%
1/250 • Weeks 0-104
|
0.00%
0/130 • Weeks 0-104
|
0.00%
0/123 • Weeks 0-104
|
|
Cardiac disorders
Myocardial Infarction
|
0.00%
0/238 • Weeks 0-104
|
0.00%
0/250 • Weeks 0-104
|
0.00%
0/130 • Weeks 0-104
|
2.4%
3/123 • Weeks 0-104
|
|
Cardiac disorders
Myocardial Ischaemia
|
0.00%
0/238 • Weeks 0-104
|
0.00%
0/250 • Weeks 0-104
|
0.77%
1/130 • Weeks 0-104
|
0.00%
0/123 • Weeks 0-104
|
|
Eye disorders
Borderline Glaucoma
|
0.00%
0/238 • Weeks 0-104
|
0.00%
0/250 • Weeks 0-104
|
0.77%
1/130 • Weeks 0-104
|
0.00%
0/123 • Weeks 0-104
|
|
Eye disorders
Cataract
|
0.42%
1/238 • Weeks 0-104
|
0.00%
0/250 • Weeks 0-104
|
0.00%
0/130 • Weeks 0-104
|
0.00%
0/123 • Weeks 0-104
|
|
Gastrointestinal disorders
Abdominal Strangulated Hernia
|
0.42%
1/238 • Weeks 0-104
|
0.00%
0/250 • Weeks 0-104
|
0.00%
0/130 • Weeks 0-104
|
0.00%
0/123 • Weeks 0-104
|
|
Gastrointestinal disorders
Diarrhoea
|
0.42%
1/238 • Weeks 0-104
|
0.00%
0/250 • Weeks 0-104
|
0.00%
0/130 • Weeks 0-104
|
0.00%
0/123 • Weeks 0-104
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/238 • Weeks 0-104
|
0.00%
0/250 • Weeks 0-104
|
0.77%
1/130 • Weeks 0-104
|
0.00%
0/123 • Weeks 0-104
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/238 • Weeks 0-104
|
0.40%
1/250 • Weeks 0-104
|
0.00%
0/130 • Weeks 0-104
|
0.81%
1/123 • Weeks 0-104
|
|
Hepatobiliary disorders
Cholecystitis Acute
|
0.00%
0/238 • Weeks 0-104
|
0.40%
1/250 • Weeks 0-104
|
0.77%
1/130 • Weeks 0-104
|
0.00%
0/123 • Weeks 0-104
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/238 • Weeks 0-104
|
0.40%
1/250 • Weeks 0-104
|
0.77%
1/130 • Weeks 0-104
|
0.00%
0/123 • Weeks 0-104
|
|
Hepatobiliary disorders
Gallbladder Necrosis
|
0.42%
1/238 • Weeks 0-104
|
0.00%
0/250 • Weeks 0-104
|
0.00%
0/130 • Weeks 0-104
|
0.00%
0/123 • Weeks 0-104
|
|
Immune system disorders
Sarcoidosis
|
0.00%
0/238 • Weeks 0-104
|
0.00%
0/250 • Weeks 0-104
|
0.77%
1/130 • Weeks 0-104
|
1.6%
2/123 • Weeks 0-104
|
|
Infections and infestations
Abscess Of Salivary Gland
|
0.00%
0/238 • Weeks 0-104
|
0.40%
1/250 • Weeks 0-104
|
0.00%
0/130 • Weeks 0-104
|
0.00%
0/123 • Weeks 0-104
|
|
Infections and infestations
Appendicitis
|
0.42%
1/238 • Weeks 0-104
|
0.00%
0/250 • Weeks 0-104
|
0.00%
0/130 • Weeks 0-104
|
0.81%
1/123 • Weeks 0-104
|
|
Infections and infestations
Bronchitis Acute
|
0.00%
0/238 • Weeks 0-104
|
0.40%
1/250 • Weeks 0-104
|
0.00%
0/130 • Weeks 0-104
|
0.00%
0/123 • Weeks 0-104
|
|
Infections and infestations
Cellulitis
|
0.00%
0/238 • Weeks 0-104
|
0.40%
1/250 • Weeks 0-104
|
0.00%
0/130 • Weeks 0-104
|
0.00%
0/123 • Weeks 0-104
|
|
Infections and infestations
Lobar Pneumonia
|
0.42%
1/238 • Weeks 0-104
|
0.00%
0/250 • Weeks 0-104
|
0.00%
0/130 • Weeks 0-104
|
0.00%
0/123 • Weeks 0-104
|
|
Infections and infestations
Pneumonia
|
0.42%
1/238 • Weeks 0-104
|
0.00%
0/250 • Weeks 0-104
|
0.77%
1/130 • Weeks 0-104
|
0.00%
0/123 • Weeks 0-104
|
|
Infections and infestations
Pneumonia Legionella
|
0.00%
0/238 • Weeks 0-104
|
0.40%
1/250 • Weeks 0-104
|
0.00%
0/130 • Weeks 0-104
|
0.00%
0/123 • Weeks 0-104
|
|
Infections and infestations
Staphylococcal Abscess
|
0.00%
0/238 • Weeks 0-104
|
0.40%
1/250 • Weeks 0-104
|
0.00%
0/130 • Weeks 0-104
|
0.00%
0/123 • Weeks 0-104
|
|
Infections and infestations
Staphylococcal Infection
|
0.00%
0/238 • Weeks 0-104
|
0.00%
0/250 • Weeks 0-104
|
0.77%
1/130 • Weeks 0-104
|
0.00%
0/123 • Weeks 0-104
|
|
Infections and infestations
Urethritis
|
0.42%
1/238 • Weeks 0-104
|
0.00%
0/250 • Weeks 0-104
|
0.00%
0/130 • Weeks 0-104
|
0.00%
0/123 • Weeks 0-104
|
|
Injury, poisoning and procedural complications
Anaesthetic Complication
|
0.00%
0/238 • Weeks 0-104
|
0.40%
1/250 • Weeks 0-104
|
0.00%
0/130 • Weeks 0-104
|
0.00%
0/123 • Weeks 0-104
|
|
Injury, poisoning and procedural complications
Ankle Fracture
|
0.00%
0/238 • Weeks 0-104
|
0.00%
0/250 • Weeks 0-104
|
0.77%
1/130 • Weeks 0-104
|
0.00%
0/123 • Weeks 0-104
|
|
Injury, poisoning and procedural complications
Foreign Body Trauma
|
0.00%
0/238 • Weeks 0-104
|
0.40%
1/250 • Weeks 0-104
|
0.00%
0/130 • Weeks 0-104
|
0.00%
0/123 • Weeks 0-104
|
|
Injury, poisoning and procedural complications
Lung Injury
|
0.42%
1/238 • Weeks 0-104
|
0.00%
0/250 • Weeks 0-104
|
0.00%
0/130 • Weeks 0-104
|
0.00%
0/123 • Weeks 0-104
|
|
Injury, poisoning and procedural complications
Overdose
|
0.42%
1/238 • Weeks 0-104
|
0.00%
0/250 • Weeks 0-104
|
0.00%
0/130 • Weeks 0-104
|
0.00%
0/123 • Weeks 0-104
|
|
Injury, poisoning and procedural complications
Radial Nerve Injury
|
0.00%
0/238 • Weeks 0-104
|
0.40%
1/250 • Weeks 0-104
|
0.00%
0/130 • Weeks 0-104
|
0.00%
0/123 • Weeks 0-104
|
|
Injury, poisoning and procedural complications
Road Traffic Accident
|
0.00%
0/238 • Weeks 0-104
|
0.40%
1/250 • Weeks 0-104
|
0.00%
0/130 • Weeks 0-104
|
0.81%
1/123 • Weeks 0-104
|
|
Investigations
Lipase Increased
|
0.42%
1/238 • Weeks 0-104
|
0.00%
0/250 • Weeks 0-104
|
0.00%
0/130 • Weeks 0-104
|
0.00%
0/123 • Weeks 0-104
|
|
Musculoskeletal and connective tissue disorders
Cervical Spinal Stenosis
|
0.00%
0/238 • Weeks 0-104
|
0.00%
0/250 • Weeks 0-104
|
0.77%
1/130 • Weeks 0-104
|
0.00%
0/123 • Weeks 0-104
|
|
Musculoskeletal and connective tissue disorders
Intervertebral Disc Protrusion
|
0.00%
0/238 • Weeks 0-104
|
0.40%
1/250 • Weeks 0-104
|
0.00%
0/130 • Weeks 0-104
|
0.00%
0/123 • Weeks 0-104
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adrenal Neoplasm
|
0.42%
1/238 • Weeks 0-104
|
0.00%
0/250 • Weeks 0-104
|
0.00%
0/130 • Weeks 0-104
|
0.00%
0/123 • Weeks 0-104
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal Cell Carcinoma
|
0.00%
0/238 • Weeks 0-104
|
0.40%
1/250 • Weeks 0-104
|
0.00%
0/130 • Weeks 0-104
|
1.6%
2/123 • Weeks 0-104
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign Renal Neoplasm
|
0.00%
0/238 • Weeks 0-104
|
0.40%
1/250 • Weeks 0-104
|
0.00%
0/130 • Weeks 0-104
|
0.00%
0/123 • Weeks 0-104
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast Cancer
|
0.42%
1/238 • Weeks 0-104
|
0.40%
1/250 • Weeks 0-104
|
0.00%
0/130 • Weeks 0-104
|
0.81%
1/123 • Weeks 0-104
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon Cancer
|
0.42%
1/238 • Weeks 0-104
|
0.00%
0/250 • Weeks 0-104
|
0.00%
0/130 • Weeks 0-104
|
0.00%
0/123 • Weeks 0-104
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatic Neoplasm Malignant
|
0.00%
0/238 • Weeks 0-104
|
0.00%
0/250 • Weeks 0-104
|
0.00%
0/130 • Weeks 0-104
|
0.81%
1/123 • Weeks 0-104
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung Adenocarcinoma Stage IV
|
0.42%
1/238 • Weeks 0-104
|
0.00%
0/250 • Weeks 0-104
|
0.00%
0/130 • Weeks 0-104
|
0.00%
0/123 • Weeks 0-104
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Mesothelioma
|
0.00%
0/238 • Weeks 0-104
|
0.40%
1/250 • Weeks 0-104
|
0.00%
0/130 • Weeks 0-104
|
0.00%
0/123 • Weeks 0-104
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate Cancer
|
0.42%
1/238 • Weeks 0-104
|
0.00%
0/250 • Weeks 0-104
|
0.00%
0/130 • Weeks 0-104
|
0.00%
0/123 • Weeks 0-104
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal Cancer
|
0.00%
0/238 • Weeks 0-104
|
0.40%
1/250 • Weeks 0-104
|
0.00%
0/130 • Weeks 0-104
|
0.00%
0/123 • Weeks 0-104
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal Cancer Metastatic
|
0.00%
0/238 • Weeks 0-104
|
0.00%
0/250 • Weeks 0-104
|
0.77%
1/130 • Weeks 0-104
|
0.00%
0/123 • Weeks 0-104
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal Cell Carcinoma Stage Unspecified
|
0.00%
0/238 • Weeks 0-104
|
0.40%
1/250 • Weeks 0-104
|
0.00%
0/130 • Weeks 0-104
|
0.00%
0/123 • Weeks 0-104
|
|
Nervous system disorders
Headache
|
0.00%
0/238 • Weeks 0-104
|
0.00%
0/250 • Weeks 0-104
|
0.00%
0/130 • Weeks 0-104
|
0.81%
1/123 • Weeks 0-104
|
|
Nervous system disorders
Lacunar Infarction
|
0.00%
0/238 • Weeks 0-104
|
0.00%
0/250 • Weeks 0-104
|
0.77%
1/130 • Weeks 0-104
|
0.00%
0/123 • Weeks 0-104
|
|
Nervous system disorders
Transient Ischaemic Attack
|
0.00%
0/238 • Weeks 0-104
|
0.40%
1/250 • Weeks 0-104
|
0.00%
0/130 • Weeks 0-104
|
0.00%
0/123 • Weeks 0-104
|
|
Psychiatric disorders
Suicidal Behavior
|
0.42%
1/238 • Weeks 0-104
|
0.00%
0/250 • Weeks 0-104
|
0.00%
0/130 • Weeks 0-104
|
0.00%
0/123 • Weeks 0-104
|
|
Psychiatric disorders
Suicidal Ideation
|
0.42%
1/238 • Weeks 0-104
|
0.00%
0/250 • Weeks 0-104
|
0.00%
0/130 • Weeks 0-104
|
0.00%
0/123 • Weeks 0-104
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/238 • Weeks 0-104
|
0.40%
1/250 • Weeks 0-104
|
0.00%
0/130 • Weeks 0-104
|
0.00%
0/123 • Weeks 0-104
|
|
Reproductive system and breast disorders
Vaginal Cyst
|
0.00%
0/238 • Weeks 0-104
|
0.40%
1/250 • Weeks 0-104
|
0.00%
0/130 • Weeks 0-104
|
0.00%
0/123 • Weeks 0-104
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.42%
1/238 • Weeks 0-104
|
0.00%
0/250 • Weeks 0-104
|
0.00%
0/130 • Weeks 0-104
|
0.00%
0/123 • Weeks 0-104
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
0.00%
0/238 • Weeks 0-104
|
0.00%
0/250 • Weeks 0-104
|
0.00%
0/130 • Weeks 0-104
|
0.81%
1/123 • Weeks 0-104
|
|
Vascular disorders
Deep Vein Thrombosis
|
0.42%
1/238 • Weeks 0-104
|
0.00%
0/250 • Weeks 0-104
|
0.00%
0/130 • Weeks 0-104
|
0.00%
0/123 • Weeks 0-104
|
Other adverse events
| Measure |
Sitagliptin 100 mg/100 mg
n=238 participants at risk
The Sitagliptin 100 mg/100 mg group includes data from patients randomized to receive treatment with oral tablets of sitagliptin 100 mg q.d. (once daily) for up to 104 weeks (including the 24-week Phase A study period and 80-week Phase B study period).
|
Sitagliptin 200 mg/200 mg
n=250 participants at risk
The Sitagliptin 200 mg/200 mg group includes data from patients randomized to receive treatment with oral tablets of sitagliptin 200 mg q.d. for up to 104 weeks (including the 24-week Phase A study period and 80-week Phase B study period).
|
Placebo/Sitagliptin 100 mg
n=130 participants at risk
The Placebo/Sitagliptin 100 mg group includes data from patients randomized to receive treatment with oral tablets of sitagliptin-matching placebo tablets once daily during the 24-week Phase A study period followed by oral tablets of sitagliptin 100 mg q.d. during the 80-week Phase B study period.
|
Placebo/Sitagliptin 200 mg
n=123 participants at risk
The Placebo/Sitagliptin 200 mg group includes data from patients randomized to receive treatment with oral tablets of sitagliptin-matching placebo tablets once daily during the 24-week Phase A study period followed by oral tablets of sitagliptin 200 mg q.d. during the 80-week Phase B study period.
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Constipation
|
5.9%
14/238 • Weeks 0-104
|
4.4%
11/250 • Weeks 0-104
|
3.8%
5/130 • Weeks 0-104
|
4.1%
5/123 • Weeks 0-104
|
|
Gastrointestinal disorders
Diarrhoea
|
7.1%
17/238 • Weeks 0-104
|
6.8%
17/250 • Weeks 0-104
|
2.3%
3/130 • Weeks 0-104
|
5.7%
7/123 • Weeks 0-104
|
|
Gastrointestinal disorders
Nausea
|
2.9%
7/238 • Weeks 0-104
|
5.2%
13/250 • Weeks 0-104
|
2.3%
3/130 • Weeks 0-104
|
1.6%
2/123 • Weeks 0-104
|
|
Infections and infestations
Influenza
|
5.5%
13/238 • Weeks 0-104
|
8.8%
22/250 • Weeks 0-104
|
6.2%
8/130 • Weeks 0-104
|
8.9%
11/123 • Weeks 0-104
|
|
Infections and infestations
Nasopharyngitis
|
8.8%
21/238 • Weeks 0-104
|
7.6%
19/250 • Weeks 0-104
|
9.2%
12/130 • Weeks 0-104
|
8.9%
11/123 • Weeks 0-104
|
|
Infections and infestations
Sinusitis
|
2.9%
7/238 • Weeks 0-104
|
6.4%
16/250 • Weeks 0-104
|
3.8%
5/130 • Weeks 0-104
|
2.4%
3/123 • Weeks 0-104
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
15.1%
36/238 • Weeks 0-104
|
16.4%
41/250 • Weeks 0-104
|
13.1%
17/130 • Weeks 0-104
|
11.4%
14/123 • Weeks 0-104
|
|
Infections and infestations
Urinary Tract Infection
|
5.9%
14/238 • Weeks 0-104
|
7.2%
18/250 • Weeks 0-104
|
3.8%
5/130 • Weeks 0-104
|
4.1%
5/123 • Weeks 0-104
|
|
Investigations
Blood Glucose Increased
|
6.3%
15/238 • Weeks 0-104
|
5.6%
14/250 • Weeks 0-104
|
7.7%
10/130 • Weeks 0-104
|
8.9%
11/123 • Weeks 0-104
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
1.7%
4/238 • Weeks 0-104
|
5.6%
14/250 • Weeks 0-104
|
4.6%
6/130 • Weeks 0-104
|
9.8%
12/123 • Weeks 0-104
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
6.3%
15/238 • Weeks 0-104
|
6.4%
16/250 • Weeks 0-104
|
8.5%
11/130 • Weeks 0-104
|
4.9%
6/123 • Weeks 0-104
|
|
Nervous system disorders
Dizziness
|
10.5%
25/238 • Weeks 0-104
|
12.4%
31/250 • Weeks 0-104
|
11.5%
15/130 • Weeks 0-104
|
8.1%
10/123 • Weeks 0-104
|
|
Nervous system disorders
Headache
|
8.0%
19/238 • Weeks 0-104
|
6.8%
17/250 • Weeks 0-104
|
6.2%
8/130 • Weeks 0-104
|
6.5%
8/123 • Weeks 0-104
|
|
Vascular disorders
Hypertension
|
4.2%
10/238 • Weeks 0-104
|
6.0%
15/250 • Weeks 0-104
|
5.4%
7/130 • Weeks 0-104
|
2.4%
3/123 • Weeks 0-104
|
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