Trial Outcomes & Findings for MK0431 and Pioglitazone Co-Administration Factorial Study in Patients With Type 2 Diabetes Mellitus (0431-102 AM2) (NCT NCT00722371)
NCT ID: NCT00722371
Last Updated: 2017-05-12
Results Overview
A1C represents the percentage of glycosylated hemoglobin.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
1615 participants
Primary outcome timeframe
Baseline and Week 24
Results posted on
2017-05-12
Participant Flow
Participant milestones
| Measure |
Sitagliptin 100 mg
Sitagliptin 100 mg and matching placebo to pioglitazone once daily for 54 weeks.
|
Pioglitazone 15 mg
Pioglitazone 15 mg and matching placebo to sitagliptin once daily for 54 weeks.
|
Pioglitazone 30 mg
Pioglitazone 30 mg and matching placebo to sitagliptin once daily for 54 weeks.
|
Pioglitazone 45 mg
Pioglitazone 45 mg and matching placebo to sitagliptin once daily for 54 weeks.
|
Sitagliptin 100 mg/ Pioglitazone 15 mg
Sitagliptin 100 mg and pioglitazone 15 mg once daily for 54 weeks.
|
Sitagliptin 100 mg/ Pioglitazone 30 mg
Sitagliptin 100 mg and pioglitazone 30 mg once daily for 54 weeks.
|
Sitagliptin 100 mg/ Pioglitazone 45 mg
Sitagliptin 100 mg and pioglitazone 45 mg once daily for 54 weeks.
|
|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
231
|
230
|
233
|
230
|
230
|
231
|
230
|
|
Overall Study
COMPLETED
|
175
|
158
|
168
|
167
|
182
|
178
|
179
|
|
Overall Study
NOT COMPLETED
|
56
|
72
|
65
|
63
|
48
|
53
|
51
|
Reasons for withdrawal
| Measure |
Sitagliptin 100 mg
Sitagliptin 100 mg and matching placebo to pioglitazone once daily for 54 weeks.
|
Pioglitazone 15 mg
Pioglitazone 15 mg and matching placebo to sitagliptin once daily for 54 weeks.
|
Pioglitazone 30 mg
Pioglitazone 30 mg and matching placebo to sitagliptin once daily for 54 weeks.
|
Pioglitazone 45 mg
Pioglitazone 45 mg and matching placebo to sitagliptin once daily for 54 weeks.
|
Sitagliptin 100 mg/ Pioglitazone 15 mg
Sitagliptin 100 mg and pioglitazone 15 mg once daily for 54 weeks.
|
Sitagliptin 100 mg/ Pioglitazone 30 mg
Sitagliptin 100 mg and pioglitazone 30 mg once daily for 54 weeks.
|
Sitagliptin 100 mg/ Pioglitazone 45 mg
Sitagliptin 100 mg and pioglitazone 45 mg once daily for 54 weeks.
|
|---|---|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
6
|
13
|
9
|
10
|
6
|
8
|
4
|
|
Overall Study
Contraindication
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Overall Study
Creatinine / Creatinine clearance
|
2
|
1
|
2
|
3
|
2
|
1
|
1
|
|
Overall Study
Excluded medication
|
0
|
1
|
1
|
0
|
0
|
0
|
1
|
|
Overall Study
Hyperglycemia
|
2
|
6
|
4
|
2
|
5
|
1
|
1
|
|
Overall Study
Hypoglycemia
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Lack of Efficacy
|
4
|
6
|
6
|
6
|
2
|
3
|
0
|
|
Overall Study
Lost to Follow-up
|
11
|
14
|
21
|
13
|
8
|
16
|
13
|
|
Overall Study
Physician Decision
|
5
|
2
|
2
|
5
|
2
|
3
|
4
|
|
Overall Study
Pregnancy
|
1
|
1
|
0
|
0
|
0
|
1
|
0
|
|
Overall Study
Protocol Violation
|
6
|
1
|
0
|
1
|
4
|
2
|
1
|
|
Overall Study
Withdrawal by Subject
|
18
|
27
|
19
|
23
|
19
|
18
|
26
|
Baseline Characteristics
MK0431 and Pioglitazone Co-Administration Factorial Study in Patients With Type 2 Diabetes Mellitus (0431-102 AM2)
Baseline characteristics by cohort
| Measure |
Sitagliptin 100 mg
n=231 Participants
Sitagliptin 100 mg and matching placebo to pioglitazone once daily for 54 weeks.
|
Pioglitazone 15 mg
n=230 Participants
Pioglitazone 15 mg and matching placebo to sitagliptin once daily for 54 weeks.
|
Pioglitazone 30 mg
n=233 Participants
Pioglitazone 30 mg and matching placebo to sitagliptin once daily for 54 weeks.
|
Pioglitazone 45 mg
n=230 Participants
Pioglitazone 45 mg and matching placebo to sitagliptin once daily for 54 weeks.
|
Sitagliptin 100 mg/ Pioglitazone 15 mg
n=230 Participants
Sitagliptin 100 mg and pioglitazone 15 mg once daily for 54 weeks.
|
Sitagliptin 100 mg/ Pioglitazone 30 mg
n=231 Participants
Sitagliptin 100 mg and pioglitazone 30 mg once daily for 54 weeks.
|
Sitagliptin 100 mg/ Pioglitazone 45 mg
n=230 Participants
Sitagliptin 100 mg and pioglitazone 45 mg once daily for 54 weeks.
|
Total
n=1615 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|
|
Age, Customized
<=20 years
|
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
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
|
Age, Customized
21 to 30 years
|
5 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
8 Participants
n=8 Participants
|
4 Participants
n=8 Participants
|
35 Participants
n=24 Participants
|
|
Age, Customized
31 to 40 years
|
37 Participants
n=5 Participants
|
39 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
20 Participants
n=4 Participants
|
17 Participants
n=21 Participants
|
34 Participants
n=8 Participants
|
15 Participants
n=8 Participants
|
195 Participants
n=24 Participants
|
|
Age, Customized
41 to 50 years
|
64 Participants
n=5 Participants
|
73 Participants
n=7 Participants
|
60 Participants
n=5 Participants
|
70 Participants
n=4 Participants
|
73 Participants
n=21 Participants
|
60 Participants
n=8 Participants
|
68 Participants
n=8 Participants
|
468 Participants
n=24 Participants
|
|
Age, Customized
51 to 60 years
|
83 Participants
n=5 Participants
|
67 Participants
n=7 Participants
|
88 Participants
n=5 Participants
|
76 Participants
n=4 Participants
|
80 Participants
n=21 Participants
|
75 Participants
n=8 Participants
|
87 Participants
n=8 Participants
|
556 Participants
n=24 Participants
|
|
Age, Customized
61 to 70 years
|
31 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
45 Participants
n=5 Participants
|
53 Participants
n=4 Participants
|
44 Participants
n=21 Participants
|
49 Participants
n=8 Participants
|
51 Participants
n=8 Participants
|
307 Participants
n=24 Participants
|
|
Age, Customized
>70 years
|
11 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
11 Participants
n=21 Participants
|
5 Participants
n=8 Participants
|
5 Participants
n=8 Participants
|
54 Participants
n=24 Participants
|
|
Sex: Female, Male
Female
|
95 Participants
n=5 Participants
|
82 Participants
n=7 Participants
|
106 Participants
n=5 Participants
|
117 Participants
n=4 Participants
|
112 Participants
n=21 Participants
|
96 Participants
n=8 Participants
|
95 Participants
n=8 Participants
|
703 Participants
n=24 Participants
|
|
Sex: Female, Male
Male
|
136 Participants
n=5 Participants
|
148 Participants
n=7 Participants
|
127 Participants
n=5 Participants
|
113 Participants
n=4 Participants
|
118 Participants
n=21 Participants
|
135 Participants
n=8 Participants
|
135 Participants
n=8 Participants
|
912 Participants
n=24 Participants
|
PRIMARY outcome
Timeframe: Baseline and Week 24Population: Full Analysis Set with last observation carried forward (LOCF). Reasons for exclusion included no baseline data and/or no post-baseline data.
A1C represents the percentage of glycosylated hemoglobin.
Outcome measures
| Measure |
Sitagliptin 100 mg
n=172 Participants
Sitagliptin 100 mg and matching placebo to pioglitazone once daily for 54 weeks.
|
Pioglitazone 15 mg
n=163 Participants
Pioglitazone 15 mg and matching placebo to sitagliptin once daily for 54 weeks.
|
Pioglitazone 30 mg
n=181 Participants
Pioglitazone 30 mg and matching placebo to sitagliptin once daily for 54 weeks.
|
Pioglitazone 45 mg
n=171 Participants
Pioglitazone 45 mg and matching placebo to sitagliptin once daily for 54 weeks.
|
Sitagliptin 100 mg/ Pioglitazone 15 mg
n=179 Participants
Sitagliptin 100 mg and pioglitazone 15 mg once daily for 54 weeks.
|
Sitagliptin 100 mg/ Pioglitazone 30 mg
n=173 Participants
Sitagliptin 100 mg and pioglitazone 30 mg once daily for 54 weeks.
|
Sitagliptin 100 mg/ Pioglitazone 45 mg
n=188 Participants
Sitagliptin 100 mg and pioglitazone 45 mg once daily for 54 weeks.
|
|---|---|---|---|---|---|---|---|
|
Change From Baseline in Hemoglobin A1C (A1C) at Week 24
|
-1.09 Percentage of glycosylated hemoglobin
Interval -1.29 to -0.89
|
-0.88 Percentage of glycosylated hemoglobin
Interval -1.09 to -0.68
|
-1.21 Percentage of glycosylated hemoglobin
Interval -1.41 to -1.02
|
-1.20 Percentage of glycosylated hemoglobin
Interval -1.4 to -1.0
|
-1.53 Percentage of glycosylated hemoglobin
Interval -1.73 to -1.34
|
-1.63 Percentage of glycosylated hemoglobin
Interval -1.82 to -1.43
|
-1.81 Percentage of glycosylated hemoglobin
Interval -2.0 to -1.62
|
PRIMARY outcome
Timeframe: Baseline and Week 54Population: Full Analysis Set with LOCF. Reasons for exclusion included no baseline data and/or no post-baseline data.
A1C represents the percentage of glycosylated hemoglobin.
Outcome measures
| Measure |
Sitagliptin 100 mg
n=172 Participants
Sitagliptin 100 mg and matching placebo to pioglitazone once daily for 54 weeks.
|
Pioglitazone 15 mg
n=163 Participants
Pioglitazone 15 mg and matching placebo to sitagliptin once daily for 54 weeks.
|
Pioglitazone 30 mg
n=181 Participants
Pioglitazone 30 mg and matching placebo to sitagliptin once daily for 54 weeks.
|
Pioglitazone 45 mg
n=171 Participants
Pioglitazone 45 mg and matching placebo to sitagliptin once daily for 54 weeks.
|
Sitagliptin 100 mg/ Pioglitazone 15 mg
n=179 Participants
Sitagliptin 100 mg and pioglitazone 15 mg once daily for 54 weeks.
|
Sitagliptin 100 mg/ Pioglitazone 30 mg
n=173 Participants
Sitagliptin 100 mg and pioglitazone 30 mg once daily for 54 weeks.
|
Sitagliptin 100 mg/ Pioglitazone 45 mg
n=188 Participants
Sitagliptin 100 mg and pioglitazone 45 mg once daily for 54 weeks.
|
|---|---|---|---|---|---|---|---|
|
Change From Baseline in A1C at Week 54
|
-0.93 Percent of glycosylated hemoglobin
Interval -1.15 to -0.72
|
-0.74 Percent of glycosylated hemoglobin
Interval -0.96 to -0.53
|
-1.16 Percent of glycosylated hemoglobin
Interval -1.37 to -0.95
|
-1.23 Percent of glycosylated hemoglobin
Interval -1.45 to -1.02
|
-1.45 Percent of glycosylated hemoglobin
Interval -1.65 to -1.24
|
-1.49 Percent of glycosylated hemoglobin
Interval -1.71 to -1.28
|
-1.78 Percent of glycosylated hemoglobin
Interval -1.99 to -1.58
|
SECONDARY outcome
Timeframe: Baseline and Week 24Population: Full Analysis Set with LOCF. Reasons for exclusion included no baseline data and/or no post-baseline data.
Outcome measures
| Measure |
Sitagliptin 100 mg
n=179 Participants
Sitagliptin 100 mg and matching placebo to pioglitazone once daily for 54 weeks.
|
Pioglitazone 15 mg
n=176 Participants
Pioglitazone 15 mg and matching placebo to sitagliptin once daily for 54 weeks.
|
Pioglitazone 30 mg
n=185 Participants
Pioglitazone 30 mg and matching placebo to sitagliptin once daily for 54 weeks.
|
Pioglitazone 45 mg
n=181 Participants
Pioglitazone 45 mg and matching placebo to sitagliptin once daily for 54 weeks.
|
Sitagliptin 100 mg/ Pioglitazone 15 mg
n=189 Participants
Sitagliptin 100 mg and pioglitazone 15 mg once daily for 54 weeks.
|
Sitagliptin 100 mg/ Pioglitazone 30 mg
n=181 Participants
Sitagliptin 100 mg and pioglitazone 30 mg once daily for 54 weeks.
|
Sitagliptin 100 mg/ Pioglitazone 45 mg
n=193 Participants
Sitagliptin 100 mg and pioglitazone 45 mg once daily for 54 weeks.
|
|---|---|---|---|---|---|---|---|
|
Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24
|
-24.3 mg/dL
Interval -32.0 to -16.5
|
-19.5 mg/dL
Interval -27.2 to -11.7
|
-29.9 mg/dL
Interval -37.6 to -22.3
|
-37.4 mg/dL
Interval -45.1 to -29.7
|
-41.0 mg/dL
Interval -48.5 to -33.5
|
-46.9 mg/dL
Interval -54.6 to -39.3
|
-52.0 mg/dL
Interval -59.6 to -44.5
|
SECONDARY outcome
Timeframe: Baseline and Week 24Population: Full Analysis Set with LOCF. Reasons for exclusion included no baseline data and/or no post-baseline data.
PMG was measured using the Meal Tolerance Test (MTT).
Outcome measures
| Measure |
Sitagliptin 100 mg
n=141 Participants
Sitagliptin 100 mg and matching placebo to pioglitazone once daily for 54 weeks.
|
Pioglitazone 15 mg
n=128 Participants
Pioglitazone 15 mg and matching placebo to sitagliptin once daily for 54 weeks.
|
Pioglitazone 30 mg
n=158 Participants
Pioglitazone 30 mg and matching placebo to sitagliptin once daily for 54 weeks.
|
Pioglitazone 45 mg
n=136 Participants
Pioglitazone 45 mg and matching placebo to sitagliptin once daily for 54 weeks.
|
Sitagliptin 100 mg/ Pioglitazone 15 mg
n=149 Participants
Sitagliptin 100 mg and pioglitazone 15 mg once daily for 54 weeks.
|
Sitagliptin 100 mg/ Pioglitazone 30 mg
n=143 Participants
Sitagliptin 100 mg and pioglitazone 30 mg once daily for 54 weeks.
|
Sitagliptin 100 mg/ Pioglitazone 45 mg
n=154 Participants
Sitagliptin 100 mg and pioglitazone 45 mg once daily for 54 weeks.
|
|---|---|---|---|---|---|---|---|
|
Change From Baseline in 2-Hour Post-meal Glucose (PMG) at Week 24
|
-51.1 mg/dL
Interval -64.0 to -38.2
|
-30.6 mg/dL
Interval -44.0 to -17.3
|
-52.5 mg/dL
Interval -64.9 to -40.2
|
-66.6 mg/dL
Interval -79.8 to -53.5
|
-69.2 mg/dL
Interval -81.7 to -56.7
|
-85.5 mg/dL
Interval -98.4 to -72.6
|
-93.8 mg/dL
Interval -106.4 to -81.2
|
SECONDARY outcome
Timeframe: Baseline and Week 54Population: Full Analysis Set with LOCF. Reasons for exclusion included no baseline data and/or no post-baseline data.
Outcome measures
| Measure |
Sitagliptin 100 mg
n=179 Participants
Sitagliptin 100 mg and matching placebo to pioglitazone once daily for 54 weeks.
|
Pioglitazone 15 mg
n=176 Participants
Pioglitazone 15 mg and matching placebo to sitagliptin once daily for 54 weeks.
|
Pioglitazone 30 mg
n=185 Participants
Pioglitazone 30 mg and matching placebo to sitagliptin once daily for 54 weeks.
|
Pioglitazone 45 mg
n=181 Participants
Pioglitazone 45 mg and matching placebo to sitagliptin once daily for 54 weeks.
|
Sitagliptin 100 mg/ Pioglitazone 15 mg
n=189 Participants
Sitagliptin 100 mg and pioglitazone 15 mg once daily for 54 weeks.
|
Sitagliptin 100 mg/ Pioglitazone 30 mg
n=181 Participants
Sitagliptin 100 mg and pioglitazone 30 mg once daily for 54 weeks.
|
Sitagliptin 100 mg/ Pioglitazone 45 mg
n=193 Participants
Sitagliptin 100 mg and pioglitazone 45 mg once daily for 54 weeks.
|
|---|---|---|---|---|---|---|---|
|
Change From Baseline in FPG at Week 54
|
-13.1 mg/dL
Interval -21.6 to -4.5
|
-10.5 mg/dL
Interval -19.0 to -2.0
|
-24.0 mg/dL
Interval -32.4 to -15.5
|
-33.3 mg/dL
Interval -41.8 to -24.8
|
-33.9 mg/dL
Interval -42.2 to -25.7
|
-37.1 mg/dL
Interval -45.5 to -28.6
|
-47.8 mg/dL
Interval -56.1 to -39.5
|
SECONDARY outcome
Timeframe: Baseline and Week 54Population: Full Analysis Set with LOCF. Reasons for exclusion included no baseline data and/or no post-baseline data.
PMG was measured using the Meal Tolerance Test (MTT).
Outcome measures
| Measure |
Sitagliptin 100 mg
n=145 Participants
Sitagliptin 100 mg and matching placebo to pioglitazone once daily for 54 weeks.
|
Pioglitazone 15 mg
n=131 Participants
Pioglitazone 15 mg and matching placebo to sitagliptin once daily for 54 weeks.
|
Pioglitazone 30 mg
n=158 Participants
Pioglitazone 30 mg and matching placebo to sitagliptin once daily for 54 weeks.
|
Pioglitazone 45 mg
n=141 Participants
Pioglitazone 45 mg and matching placebo to sitagliptin once daily for 54 weeks.
|
Sitagliptin 100 mg/ Pioglitazone 15 mg
n=150 Participants
Sitagliptin 100 mg and pioglitazone 15 mg once daily for 54 weeks.
|
Sitagliptin 100 mg/ Pioglitazone 30 mg
n=143 Participants
Sitagliptin 100 mg and pioglitazone 30 mg once daily for 54 weeks.
|
Sitagliptin 100 mg/ Pioglitazone 45 mg
n=157 Participants
Sitagliptin 100 mg and pioglitazone 45 mg once daily for 54 weeks.
|
|---|---|---|---|---|---|---|---|
|
Change From Baseline in 2-Hour PMG at Week 54
|
-37.0 mg/dL
Interval -50.2 to -23.7
|
-26.7 mg/dL
Interval -40.5 to -13.0
|
-46.8 mg/dL
Interval -59.6 to -34.1
|
-58.2 mg/dL
Interval -71.6 to -44.7
|
-64.7 mg/dL
Interval -77.6 to -51.8
|
-69.7 mg/dL
Interval -83.1 to -56.4
|
-88.2 mg/dL
Interval -101.2 to -75.3
|
Adverse Events
Sitagliptin 100 mg
Serious events: 14 serious events
Other events: 60 other events
Deaths: 0 deaths
Pioglitazone 15 mg
Serious events: 10 serious events
Other events: 41 other events
Deaths: 0 deaths
Pioglitazone 30 mg
Serious events: 5 serious events
Other events: 45 other events
Deaths: 0 deaths
Pioglitazone 45 mg
Serious events: 11 serious events
Other events: 55 other events
Deaths: 0 deaths
Sitagliptin 100 mg/ Pioglitazone 15 mg
Serious events: 12 serious events
Other events: 48 other events
Deaths: 0 deaths
Sitagliptin 100 mg/ Pioglitazone 30 mg
Serious events: 15 serious events
Other events: 56 other events
Deaths: 0 deaths
Sitagliptin 100 mg/ Pioglitazone 45 mg
Serious events: 7 serious events
Other events: 46 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Sitagliptin 100 mg
n=231 participants at risk
Sitagliptin 100 mg and matching placebo to pioglitazone once daily for 54 weeks.
|
Pioglitazone 15 mg
n=230 participants at risk
Pioglitazone 15 mg and matching placebo to sitagliptin once daily for 54 weeks.
|
Pioglitazone 30 mg
n=233 participants at risk
Pioglitazone 30 mg and matching placebo to sitagliptin once daily for 54 weeks.
|
Pioglitazone 45 mg
n=230 participants at risk
Pioglitazone 45 mg and matching placebo to sitagliptin once daily for 54 weeks.
|
Sitagliptin 100 mg/ Pioglitazone 15 mg
n=230 participants at risk
Sitagliptin 100 mg and pioglitazone 15 mg once daily for 54 weeks.
|
Sitagliptin 100 mg/ Pioglitazone 30 mg
n=231 participants at risk
Sitagliptin 100 mg and pioglitazone 30 mg once daily for 54 weeks.
|
Sitagliptin 100 mg/ Pioglitazone 45 mg
n=230 participants at risk
Sitagliptin 100 mg and pioglitazone 45 mg once daily for 54 weeks.
|
|---|---|---|---|---|---|---|---|
|
Vascular disorders
Arteriosclerosis
|
0.87%
2/231 • Number of events 2
|
0.00%
0/230
|
0.00%
0/233
|
0.00%
0/230
|
0.00%
0/230
|
0.00%
0/231
|
0.00%
0/230
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/231
|
0.00%
0/230
|
0.00%
0/233
|
0.43%
1/230 • Number of events 1
|
0.43%
1/230 • Number of events 2
|
0.00%
0/231
|
0.00%
0/230
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/231
|
0.00%
0/230
|
0.00%
0/233
|
0.00%
0/230
|
0.43%
1/230 • Number of events 1
|
0.00%
0/231
|
0.00%
0/230
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/231
|
0.00%
0/230
|
0.00%
0/233
|
0.00%
0/230
|
0.00%
0/230
|
0.00%
0/231
|
0.43%
1/230 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/231
|
0.00%
0/230
|
0.00%
0/233
|
0.00%
0/230
|
0.43%
1/230 • Number of events 1
|
0.00%
0/231
|
0.00%
0/230
|
|
Cardiac disorders
Angina unstable
|
0.00%
0/231
|
0.00%
0/230
|
0.00%
0/233
|
0.00%
0/230
|
0.00%
0/230
|
0.43%
1/231 • Number of events 1
|
0.00%
0/230
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/231
|
0.00%
0/230
|
0.00%
0/233
|
0.00%
0/230
|
0.00%
0/230
|
0.87%
2/231 • Number of events 2
|
0.00%
0/230
|
|
Cardiac disorders
Atrial flutter
|
0.00%
0/231
|
0.00%
0/230
|
0.00%
0/233
|
0.00%
0/230
|
0.00%
0/230
|
0.00%
0/231
|
0.43%
1/230 • Number of events 1
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/231
|
0.00%
0/230
|
0.00%
0/233
|
0.00%
0/230
|
0.00%
0/230
|
0.43%
1/231 • Number of events 1
|
0.00%
0/230
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/231
|
0.00%
0/230
|
0.00%
0/233
|
0.00%
0/230
|
0.00%
0/230
|
0.00%
0/231
|
0.43%
1/230 • Number of events 1
|
|
Cardiac disorders
Coronary artery disease
|
0.87%
2/231 • Number of events 2
|
0.00%
0/230
|
0.00%
0/233
|
0.00%
0/230
|
0.43%
1/230 • Number of events 1
|
0.00%
0/231
|
0.00%
0/230
|
|
Cardiac disorders
Mitral valve disease
|
0.00%
0/231
|
0.00%
0/230
|
0.00%
0/233
|
0.00%
0/230
|
0.00%
0/230
|
0.00%
0/231
|
0.43%
1/230 • Number of events 1
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/231
|
0.00%
0/230
|
0.00%
0/233
|
0.00%
0/230
|
0.43%
1/230 • Number of events 1
|
0.87%
2/231 • Number of events 2
|
0.00%
0/230
|
|
Cardiac disorders
Myocardial ischaemia
|
0.43%
1/231 • Number of events 1
|
0.00%
0/230
|
0.00%
0/233
|
0.00%
0/230
|
0.43%
1/230 • Number of events 1
|
0.00%
0/231
|
0.00%
0/230
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.43%
1/231 • Number of events 1
|
0.00%
0/230
|
0.00%
0/233
|
0.00%
0/230
|
0.00%
0/230
|
0.00%
0/231
|
0.00%
0/230
|
|
Eye disorders
Optic ischaemic neuropathy
|
0.00%
0/231
|
0.00%
0/230
|
0.00%
0/233
|
0.43%
1/230 • Number of events 1
|
0.00%
0/230
|
0.00%
0/231
|
0.00%
0/230
|
|
Gastrointestinal disorders
Anal fissure
|
0.00%
0/231
|
0.00%
0/230
|
0.00%
0/233
|
0.00%
0/230
|
0.00%
0/230
|
0.00%
0/231
|
0.43%
1/230 • Number of events 1
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/231
|
0.00%
0/230
|
0.00%
0/233
|
0.00%
0/230
|
0.43%
1/230 • Number of events 1
|
0.00%
0/231
|
0.00%
0/230
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.00%
0/231
|
0.43%
1/230 • Number of events 1
|
0.00%
0/233
|
0.00%
0/230
|
0.00%
0/230
|
0.00%
0/231
|
0.00%
0/230
|
|
Gastrointestinal disorders
Varices oesophageal
|
0.43%
1/231 • Number of events 2
|
0.00%
0/230
|
0.00%
0/233
|
0.00%
0/230
|
0.00%
0/230
|
0.00%
0/231
|
0.00%
0/230
|
|
General disorders
Non-cardiac chest pain
|
0.43%
1/231 • Number of events 1
|
0.00%
0/230
|
0.00%
0/233
|
0.00%
0/230
|
0.00%
0/230
|
0.43%
1/231 • Number of events 1
|
0.43%
1/230 • Number of events 1
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/231
|
0.00%
0/230
|
0.00%
0/233
|
0.00%
0/230
|
0.43%
1/230 • Number of events 1
|
0.00%
0/231
|
0.00%
0/230
|
|
Immune system disorders
Drug hypersensitivity
|
0.00%
0/231
|
0.00%
0/230
|
0.00%
0/233
|
0.43%
1/230 • Number of events 1
|
0.00%
0/230
|
0.00%
0/231
|
0.00%
0/230
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/231
|
0.00%
0/230
|
0.00%
0/233
|
0.00%
0/230
|
0.00%
0/230
|
0.43%
1/231 • Number of events 1
|
0.00%
0/230
|
|
Infections and infestations
Appendicitis
|
0.00%
0/231
|
0.00%
0/230
|
0.00%
0/233
|
0.00%
0/230
|
0.43%
1/230 • Number of events 1
|
0.43%
1/231 • Number of events 1
|
0.00%
0/230
|
|
Infections and infestations
Bronchopneumonia
|
0.00%
0/231
|
0.00%
0/230
|
0.00%
0/233
|
0.00%
0/230
|
0.43%
1/230 • Number of events 1
|
0.00%
0/231
|
0.00%
0/230
|
|
Infections and infestations
Cellulitis
|
0.00%
0/231
|
0.00%
0/230
|
0.00%
0/233
|
0.00%
0/230
|
0.00%
0/230
|
0.43%
1/231 • Number of events 1
|
0.00%
0/230
|
|
Infections and infestations
Dengue fever
|
0.00%
0/231
|
0.00%
0/230
|
0.00%
0/233
|
0.43%
1/230 • Number of events 1
|
0.00%
0/230
|
0.00%
0/231
|
0.00%
0/230
|
|
Infections and infestations
Endocarditis
|
0.00%
0/231
|
0.00%
0/230
|
0.00%
0/233
|
0.00%
0/230
|
0.00%
0/230
|
0.00%
0/231
|
0.43%
1/230 • Number of events 1
|
|
Infections and infestations
Escherichia urinary tract infection
|
0.00%
0/231
|
0.00%
0/230
|
0.00%
0/233
|
0.00%
0/230
|
0.00%
0/230
|
0.43%
1/231 • Number of events 1
|
0.00%
0/230
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/231
|
0.00%
0/230
|
0.00%
0/233
|
0.00%
0/230
|
0.43%
1/230 • Number of events 1
|
0.00%
0/231
|
0.00%
0/230
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/231
|
0.00%
0/230
|
0.00%
0/233
|
0.43%
1/230 • Number of events 1
|
0.00%
0/230
|
0.43%
1/231 • Number of events 1
|
0.00%
0/230
|
|
Infections and infestations
Lobar pneumonia
|
0.00%
0/231
|
0.00%
0/230
|
0.00%
0/233
|
0.43%
1/230 • Number of events 1
|
0.00%
0/230
|
0.00%
0/231
|
0.00%
0/230
|
|
Infections and infestations
Pneumonia
|
0.00%
0/231
|
0.43%
1/230 • Number of events 1
|
0.00%
0/233
|
0.43%
1/230 • Number of events 1
|
0.43%
1/230 • Number of events 1
|
0.00%
0/231
|
0.00%
0/230
|
|
Infections and infestations
Tuberculosis
|
0.43%
1/231 • Number of events 1
|
0.00%
0/230
|
0.00%
0/233
|
0.00%
0/230
|
0.00%
0/230
|
0.00%
0/231
|
0.00%
0/230
|
|
Infections and infestations
Wound infection
|
0.00%
0/231
|
0.00%
0/230
|
0.00%
0/233
|
0.00%
0/230
|
0.43%
1/230 • Number of events 1
|
0.00%
0/231
|
0.00%
0/230
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.43%
1/231 • Number of events 1
|
0.43%
1/230 • Number of events 1
|
0.00%
0/233
|
0.00%
0/230
|
0.00%
0/230
|
0.43%
1/231 • Number of events 1
|
0.00%
0/230
|
|
Injury, poisoning and procedural complications
Multiple injuries
|
0.00%
0/231
|
0.00%
0/230
|
0.43%
1/233 • Number of events 1
|
0.00%
0/230
|
0.43%
1/230 • Number of events 1
|
0.00%
0/231
|
0.00%
0/230
|
|
Injury, poisoning and procedural complications
Splenic haematoma
|
0.00%
0/231
|
0.00%
0/230
|
0.00%
0/233
|
0.00%
0/230
|
0.00%
0/230
|
0.43%
1/231 • Number of events 1
|
0.00%
0/230
|
|
Injury, poisoning and procedural complications
Tendon rupture
|
0.00%
0/231
|
0.43%
1/230 • Number of events 1
|
0.00%
0/233
|
0.00%
0/230
|
0.00%
0/230
|
0.00%
0/231
|
0.00%
0/230
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.00%
0/231
|
0.00%
0/230
|
0.00%
0/233
|
0.00%
0/230
|
0.00%
0/230
|
0.43%
1/231 • Number of events 1
|
0.00%
0/230
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/231
|
0.00%
0/230
|
0.00%
0/233
|
0.00%
0/230
|
0.00%
0/230
|
0.00%
0/231
|
0.43%
1/230 • Number of events 2
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/231
|
0.00%
0/230
|
0.00%
0/233
|
0.00%
0/230
|
0.00%
0/230
|
0.00%
0/231
|
0.43%
1/230 • Number of events 1
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/231
|
0.00%
0/230
|
0.43%
1/233 • Number of events 1
|
0.00%
0/230
|
0.00%
0/230
|
0.00%
0/231
|
0.00%
0/230
|
|
Metabolism and nutrition disorders
Type 1 diabetes mellitus
|
0.00%
0/231
|
0.43%
1/230 • Number of events 1
|
0.00%
0/233
|
0.00%
0/230
|
0.00%
0/230
|
0.00%
0/231
|
0.00%
0/230
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/231
|
0.00%
0/230
|
0.00%
0/233
|
0.00%
0/230
|
0.00%
0/230
|
0.43%
1/231 • Number of events 1
|
0.00%
0/230
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.00%
0/231
|
0.00%
0/230
|
0.00%
0/233
|
0.00%
0/230
|
0.43%
1/230 • Number of events 1
|
0.00%
0/231
|
0.00%
0/230
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.43%
1/231 • Number of events 1
|
0.00%
0/230
|
0.00%
0/233
|
0.00%
0/230
|
0.00%
0/230
|
0.00%
0/231
|
0.00%
0/230
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/231
|
0.00%
0/230
|
0.00%
0/233
|
0.00%
0/230
|
0.00%
0/230
|
0.00%
0/231
|
0.43%
1/230 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.00%
0/231
|
0.43%
1/230 • Number of events 1
|
0.00%
0/233
|
0.00%
0/230
|
0.00%
0/230
|
0.00%
0/231
|
0.00%
0/230
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer
|
0.00%
0/231
|
0.00%
0/230
|
0.00%
0/233
|
0.43%
1/230 • Number of events 1
|
0.00%
0/230
|
0.00%
0/231
|
0.00%
0/230
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.00%
0/231
|
0.00%
0/230
|
0.00%
0/233
|
0.43%
1/230 • Number of events 1
|
0.00%
0/230
|
0.00%
0/231
|
0.00%
0/230
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
|
0.00%
0/231
|
0.00%
0/230
|
0.00%
0/233
|
0.43%
1/230 • Number of events 1
|
0.00%
0/230
|
0.00%
0/231
|
0.00%
0/230
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myelodysplastic syndrome
|
0.00%
0/231
|
0.43%
1/230 • Number of events 1
|
0.00%
0/233
|
0.00%
0/230
|
0.00%
0/230
|
0.00%
0/231
|
0.00%
0/230
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma metastatic
|
0.00%
0/231
|
0.00%
0/230
|
0.00%
0/233
|
0.00%
0/230
|
0.00%
0/230
|
0.43%
1/231 • Number of events 1
|
0.00%
0/230
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.00%
0/231
|
0.00%
0/230
|
0.00%
0/233
|
0.00%
0/230
|
0.43%
1/230 • Number of events 1
|
0.43%
1/231 • Number of events 1
|
0.43%
1/230 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer stage III
|
0.00%
0/231
|
0.43%
1/230 • Number of events 1
|
0.00%
0/233
|
0.00%
0/230
|
0.00%
0/230
|
0.00%
0/231
|
0.00%
0/230
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of skin
|
0.43%
1/231 • Number of events 1
|
0.00%
0/230
|
0.00%
0/233
|
0.00%
0/230
|
0.00%
0/230
|
0.00%
0/231
|
0.00%
0/230
|
|
Nervous system disorders
Cerebral infarction
|
0.00%
0/231
|
0.00%
0/230
|
0.43%
1/233 • Number of events 1
|
0.00%
0/230
|
0.00%
0/230
|
0.00%
0/231
|
0.00%
0/230
|
|
Nervous system disorders
Cerebral ischaemia
|
0.43%
1/231 • Number of events 1
|
0.00%
0/230
|
0.00%
0/233
|
0.00%
0/230
|
0.00%
0/230
|
0.00%
0/231
|
0.00%
0/230
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/231
|
0.43%
1/230 • Number of events 1
|
0.00%
0/233
|
0.00%
0/230
|
0.00%
0/230
|
0.43%
1/231 • Number of events 1
|
0.00%
0/230
|
|
Nervous system disorders
Complicated migraine
|
0.00%
0/231
|
0.00%
0/230
|
0.00%
0/233
|
0.00%
0/230
|
0.43%
1/230 • Number of events 1
|
0.00%
0/231
|
0.00%
0/230
|
|
Nervous system disorders
Convulsion
|
0.43%
1/231 • Number of events 1
|
0.00%
0/230
|
0.00%
0/233
|
0.00%
0/230
|
0.00%
0/230
|
0.00%
0/231
|
0.00%
0/230
|
|
Nervous system disorders
Dizziness
|
0.00%
0/231
|
0.00%
0/230
|
0.43%
1/233 • Number of events 1
|
0.00%
0/230
|
0.00%
0/230
|
0.00%
0/231
|
0.00%
0/230
|
|
Nervous system disorders
Epilepsy
|
0.43%
1/231 • Number of events 1
|
0.00%
0/230
|
0.00%
0/233
|
0.00%
0/230
|
0.00%
0/230
|
0.00%
0/231
|
0.00%
0/230
|
|
Nervous system disorders
Haemorrhage intracranial
|
0.00%
0/231
|
0.00%
0/230
|
0.00%
0/233
|
0.00%
0/230
|
0.43%
1/230 • Number of events 1
|
0.00%
0/231
|
0.00%
0/230
|
|
Nervous system disorders
Headache
|
0.43%
1/231 • Number of events 1
|
0.00%
0/230
|
0.00%
0/233
|
0.00%
0/230
|
0.00%
0/230
|
0.00%
0/231
|
0.00%
0/230
|
|
Nervous system disorders
Sciatica
|
0.00%
0/231
|
0.00%
0/230
|
0.43%
1/233 • Number of events 1
|
0.00%
0/230
|
0.00%
0/230
|
0.00%
0/231
|
0.43%
1/230 • Number of events 1
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/231
|
0.00%
0/230
|
0.00%
0/233
|
0.43%
1/230 • Number of events 1
|
0.00%
0/230
|
0.00%
0/231
|
0.00%
0/230
|
|
Vascular disorders
Hypertensive emergency
|
0.00%
0/231
|
0.43%
1/230 • Number of events 1
|
0.00%
0/233
|
0.00%
0/230
|
0.00%
0/230
|
0.00%
0/231
|
0.00%
0/230
|
Other adverse events
| Measure |
Sitagliptin 100 mg
n=231 participants at risk
Sitagliptin 100 mg and matching placebo to pioglitazone once daily for 54 weeks.
|
Pioglitazone 15 mg
n=230 participants at risk
Pioglitazone 15 mg and matching placebo to sitagliptin once daily for 54 weeks.
|
Pioglitazone 30 mg
n=233 participants at risk
Pioglitazone 30 mg and matching placebo to sitagliptin once daily for 54 weeks.
|
Pioglitazone 45 mg
n=230 participants at risk
Pioglitazone 45 mg and matching placebo to sitagliptin once daily for 54 weeks.
|
Sitagliptin 100 mg/ Pioglitazone 15 mg
n=230 participants at risk
Sitagliptin 100 mg and pioglitazone 15 mg once daily for 54 weeks.
|
Sitagliptin 100 mg/ Pioglitazone 30 mg
n=231 participants at risk
Sitagliptin 100 mg and pioglitazone 30 mg once daily for 54 weeks.
|
Sitagliptin 100 mg/ Pioglitazone 45 mg
n=230 participants at risk
Sitagliptin 100 mg and pioglitazone 45 mg once daily for 54 weeks.
|
|---|---|---|---|---|---|---|---|
|
Infections and infestations
Nasopharyngitis
|
5.6%
13/231 • Number of events 13
|
4.3%
10/230 • Number of events 11
|
5.2%
12/233 • Number of events 16
|
3.9%
9/230 • Number of events 10
|
5.2%
12/230 • Number of events 15
|
6.5%
15/231 • Number of events 19
|
3.5%
8/230 • Number of events 10
|
|
Infections and infestations
Upper respiratory tract infection
|
4.3%
10/231 • Number of events 13
|
2.6%
6/230 • Number of events 6
|
3.4%
8/233 • Number of events 9
|
5.2%
12/230 • Number of events 12
|
4.8%
11/230 • Number of events 13
|
3.9%
9/231 • Number of events 11
|
4.8%
11/230 • Number of events 13
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
10.8%
25/231 • Number of events 57
|
8.7%
20/230 • Number of events 30
|
9.4%
22/233 • Number of events 78
|
8.7%
20/230 • Number of events 81
|
8.7%
20/230 • Number of events 45
|
11.3%
26/231 • Number of events 100
|
10.4%
24/230 • Number of events 93
|
|
Nervous system disorders
Headache
|
7.4%
17/231 • Number of events 18
|
2.6%
6/230 • Number of events 8
|
3.9%
9/233 • Number of events 9
|
4.8%
11/230 • Number of events 12
|
3.5%
8/230 • Number of events 8
|
6.1%
14/231 • Number of events 18
|
2.2%
5/230 • Number of events 5
|
|
Vascular disorders
Hypertension
|
3.0%
7/231 • Number of events 8
|
2.2%
5/230 • Number of events 5
|
1.7%
4/233 • Number of events 4
|
4.3%
10/230 • Number of events 11
|
5.7%
13/230 • Number of events 13
|
2.6%
6/231 • Number of events 9
|
0.00%
0/230
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp
Phone: 1-800-672-6372
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee The sponsor must have the opportunity to review all proposed abstracts, manuscripts, or presentations regarding this study 60 days prior to submission for publication/presentation.
- Publication restrictions are in place
Restriction type: OTHER