Trial Outcomes & Findings for A Pooled Analysis of the Safety and Efficacy of MK-0431A and MK-0431A XR in Pediatric Participants With Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Metformin Therapy (Alone or in Combination With Insulin) (MK-0431A-170/MK-0431A-289) (NCT NCT01760447)
NCT ID: NCT01760447
Last Updated: 2022-09-23
Results Overview
Glycated hemoglobin (A1C) is a blood marker used to report average blood glucose levels over prolonged periods of time. Percentage A1C is the ratio of glycated hemoglobin to total hemoglobin x 100. Mean change from baseline at Week 20 was estimated from a longitudinal data analysis model.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
223 participants
Primary outcome timeframe
Baseline and Week 20
Results posted on
2022-09-23
Participant Flow
The study recruited participants in clinics/clinical offices in 28 countries. One participant who was randomized to the arm "Sitagliptin/Metformin" withdrew prior to treatment, then was re-randomized into the study. Only the second randomization is counted for Participant Flow and All-Cause Mortality, so this participant is not counted twice.
The Pre-Assignment Period included a one-week single-blind placebo run-in prior to randomization during which participants received metformin with sitagliptin/metformin placebo or metformin XR with sitagliptin/metformin XR placebo each day.
Participant milestones
| Measure |
Sitagliptin/Metformin
Participants received one tablet of sitagliptin/metformin and one tablet of metformin-placebo, administered twice daily prior to the morning and evening meals, for up to 20 weeks in the base study alone, or for up to 54 weeks if the participant also entered the extension study. Participants in this arm were enrolled in protocol MK-0431A-170.
|
Metformin
Participants received one tablet of metformin and one tablet of placebo to sitagliptin/metformin, administered twice daily prior to the morning and evening meals, for up to 20 weeks in the base study alone, or for up to 54 weeks if the participant also entered the extension study. Participants in this arm were enrolled in protocol MK-0431A-170.
|
Sitagliptin/Metformin XR
Participants received two tablets of sitagliptin/metformin XR and two tablets of metformin XR placebo, administered once daily with a meal, for up to 54 weeks. Participants in this arm were enrolled in protocol MK-0431A-289.
|
Metformin XR
Participants received two tablets of metformin XR and two tablets of placebo to sitagliptin/metformin XR, administered once daily with a meal, for up to 54 weeks. Participants in this arm were enrolled in protocol MK-0431A-289.
|
|---|---|---|---|---|
|
Weeks 0-20
STARTED
|
62
|
62
|
47
|
51
|
|
Weeks 0-20
Treated
|
62
|
62
|
45
|
51
|
|
Weeks 0-20
COMPLETED
|
59
|
62
|
42
|
47
|
|
Weeks 0-20
NOT COMPLETED
|
3
|
0
|
5
|
4
|
|
Weeks 20-54
STARTED
|
28
|
30
|
42
|
47
|
|
Weeks 20-54
COMPLETED
|
25
|
28
|
39
|
43
|
|
Weeks 20-54
NOT COMPLETED
|
3
|
2
|
3
|
4
|
Reasons for withdrawal
| Measure |
Sitagliptin/Metformin
Participants received one tablet of sitagliptin/metformin and one tablet of metformin-placebo, administered twice daily prior to the morning and evening meals, for up to 20 weeks in the base study alone, or for up to 54 weeks if the participant also entered the extension study. Participants in this arm were enrolled in protocol MK-0431A-170.
|
Metformin
Participants received one tablet of metformin and one tablet of placebo to sitagliptin/metformin, administered twice daily prior to the morning and evening meals, for up to 20 weeks in the base study alone, or for up to 54 weeks if the participant also entered the extension study. Participants in this arm were enrolled in protocol MK-0431A-170.
|
Sitagliptin/Metformin XR
Participants received two tablets of sitagliptin/metformin XR and two tablets of metformin XR placebo, administered once daily with a meal, for up to 54 weeks. Participants in this arm were enrolled in protocol MK-0431A-289.
|
Metformin XR
Participants received two tablets of metformin XR and two tablets of placebo to sitagliptin/metformin XR, administered once daily with a meal, for up to 54 weeks. Participants in this arm were enrolled in protocol MK-0431A-289.
|
|---|---|---|---|---|
|
Weeks 0-20
Consent withdrawn by Parent/Guardian
|
0
|
0
|
1
|
3
|
|
Weeks 0-20
Withdrawal by Subject
|
2
|
0
|
1
|
0
|
|
Weeks 0-20
Lost to Follow-up
|
1
|
0
|
1
|
1
|
|
Weeks 0-20
Randomized but not treated
|
0
|
0
|
2
|
0
|
|
Weeks 20-54
Consent withdrawn by Parent/Guardian
|
1
|
1
|
1
|
0
|
|
Weeks 20-54
Withdrawal by Subject
|
2
|
1
|
1
|
2
|
|
Weeks 20-54
Lost to Follow-up
|
0
|
0
|
1
|
2
|
Baseline Characteristics
A Pooled Analysis of the Safety and Efficacy of MK-0431A and MK-0431A XR in Pediatric Participants With Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Metformin Therapy (Alone or in Combination With Insulin) (MK-0431A-170/MK-0431A-289)
Baseline characteristics by cohort
| Measure |
Sitagliptin/Metformin
n=62 Participants
Participants received one tablet of sitagliptin/metformin and one tablet of metformin-placebo, administered twice daily prior to the morning and evening meals, for up to 20 weeks in the base study alone, or for up to 54 weeks if the participant also entered the extension study. Participants in this arm were enrolled in protocol MK-0431A-170.
|
Metformin
n=62 Participants
Participants received one tablet of metformin and one tablet of placebo to sitagliptin/metformin, administered twice daily prior to the morning and evening meals, for up to 20 weeks in the base study alone, or for up to 54 weeks if the participant also entered the extension study. Participants in this arm were enrolled in protocol MK-0431A-170.
|
Sitagliptin/Metformin XR
n=45 Participants
Participants received two tablets of sitagliptin/metformin XR and two tablets of metformin XR placebo, administered once daily with a meal, for up to 54 weeks. Participants in this arm were enrolled in protocol MK-0431A-289.
|
Metformin XR
n=51 Participants
Participants received two tablets of metformin XR and two tablets of placebo to sitagliptin/metformin XR, administered once daily with a meal, for up to 54 weeks. Participants in this arm were enrolled in protocol MK-0431A-289.
|
Total
n=220 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
14.4 years
STANDARD_DEVIATION 2.2 • n=5 Participants
|
13.9 years
STANDARD_DEVIATION 1.8 • n=7 Participants
|
14.8 years
STANDARD_DEVIATION 1.9 • n=5 Participants
|
14.9 years
STANDARD_DEVIATION 1.6 • n=4 Participants
|
14.4 years
STANDARD_DEVIATION 1.9 • n=21 Participants
|
|
Age, Customized
In utero
|
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
|
|
Age, Customized
Preterm newborn infants (gestational age < 37 wks)
|
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
|
|
Age, Customized
Newborns (0-27 days)
|
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
|
|
Age, Customized
Infants and toddlers (28 days-23 months)
|
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
|
|
Age, Customized
Children (2-11 years)
|
10 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
21 Participants
n=21 Participants
|
|
Age, Customized
Adolescents (12-17 years)
|
52 Participants
n=5 Participants
|
55 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
50 Participants
n=4 Participants
|
199 Participants
n=21 Participants
|
|
Age, Customized
Adults (18-64 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
|
|
Age, Customized
From 65-84 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
|
|
Age, Customized
85 years and over
|
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
|
|
Sex: Female, Male
Female
|
41 Participants
n=5 Participants
|
40 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
32 Participants
n=4 Participants
|
145 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
21 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
19 Participants
n=4 Participants
|
75 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
23 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
20 Participants
n=4 Participants
|
77 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
35 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
28 Participants
n=4 Participants
|
128 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
15 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
13 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
21 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
64 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
10 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
24 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
27 Participants
n=4 Participants
|
96 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
14 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
35 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
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
|
|
Glycated Hemoglobin (A1C)
|
8.02 Percentage
STANDARD_DEVIATION 1.22 • n=5 Participants
|
8.13 Percentage
STANDARD_DEVIATION 1.08 • n=7 Participants
|
7.87 Percentage
STANDARD_DEVIATION 0.94 • n=5 Participants
|
7.97 Percentage
STANDARD_DEVIATION 1.05 • n=4 Participants
|
8.0 Percentage
STANDARD_DEVIATION 1.1 • n=21 Participants
|
PRIMARY outcome
Timeframe: Baseline and Week 20Population: The analysis population includes all randomized participants who received ≥1 dose of study medication and who had at least 1 measurement of A1C. As defined in the protocols, these analyses were conducted in participants pooled from protocols MK-0431A-170 and MK-0431A-289, pooled according to receipt of experimental drug or placebo comparator.
Glycated hemoglobin (A1C) is a blood marker used to report average blood glucose levels over prolonged periods of time. Percentage A1C is the ratio of glycated hemoglobin to total hemoglobin x 100. Mean change from baseline at Week 20 was estimated from a longitudinal data analysis model.
Outcome measures
| Measure |
Sitagliptin/Metformin and Sitagliptin/Metformin XR Pooled
n=107 Participants
This reporting group contains the pooled population of treated participants from the experimental-drug groups "Sitagliptin/Metformin" (from protocol MK-0431A-170) and "Sitagliptin/Metformin XR" (from protocol MK-0431A-289).
|
Metformin and Metformin XR Pooled
n=113 Participants
This reporting group contains the pooled population of treated participants from the placebo groups "Metformin" (from protocol MK-0431A-170) and "Metformin XR" (from protocol MK-0431A-289).
|
Sitagliptin/Metformin XR
Participants received two tablets of sitagliptin/metformin XR and two tablets of metformin XR placebo, administered once daily with a meal, for up to 54 weeks. Participants in this arm were enrolled in protocol MK-0431A-289.
|
Metformin XR
Participants received two tablets of metformin XR and two tablets of placebo to sitagliptin/metformin XR, administered once daily with a meal, for up to 54 weeks. Participants in this arm were enrolled in protocol MK-0431A-289.
|
Sitagliptin/Metformin and Sitagliptin/Metformin XR Pooled
This reporting group contains the pooled population of treated participants from the experimental-drug groups "Sitagliptin/Metformin" (from protocol MK-0431A-170) and "Sitagliptin/Metformin XR" (from protocol MK-0431A-289).
|
Metformin and Metformin XR Pooled
This reporting group contains the pooled population of treated participants from the placebo groups "Metformin" (from protocol MK-0431A-170) and "Metformin XR" (from protocol MK-0431A-289).
|
|---|---|---|---|---|---|---|
|
Change From Baseline in A1C at Week 20
|
-0.58 Percentage of glycated hemoglobin
Interval -0.94 to -0.22
|
-0.09 Percentage of glycated hemoglobin
Interval -0.43 to 0.26
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to Week 20Population: The analysis population includes all randomized participants who received ≥1 dose of study medication.
The number of participants experiencing ≥1 adverse event during Weeks 0-20 was reported. An adverse event is defined as any untoward medical occurrence in a person administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
Outcome measures
| Measure |
Sitagliptin/Metformin and Sitagliptin/Metformin XR Pooled
n=62 Participants
This reporting group contains the pooled population of treated participants from the experimental-drug groups "Sitagliptin/Metformin" (from protocol MK-0431A-170) and "Sitagliptin/Metformin XR" (from protocol MK-0431A-289).
|
Metformin and Metformin XR Pooled
n=62 Participants
This reporting group contains the pooled population of treated participants from the placebo groups "Metformin" (from protocol MK-0431A-170) and "Metformin XR" (from protocol MK-0431A-289).
|
Sitagliptin/Metformin XR
n=45 Participants
Participants received two tablets of sitagliptin/metformin XR and two tablets of metformin XR placebo, administered once daily with a meal, for up to 54 weeks. Participants in this arm were enrolled in protocol MK-0431A-289.
|
Metformin XR
n=51 Participants
Participants received two tablets of metformin XR and two tablets of placebo to sitagliptin/metformin XR, administered once daily with a meal, for up to 54 weeks. Participants in this arm were enrolled in protocol MK-0431A-289.
|
Sitagliptin/Metformin and Sitagliptin/Metformin XR Pooled
n=107 Participants
This reporting group contains the pooled population of treated participants from the experimental-drug groups "Sitagliptin/Metformin" (from protocol MK-0431A-170) and "Sitagliptin/Metformin XR" (from protocol MK-0431A-289).
|
Metformin and Metformin XR Pooled
n=113 Participants
This reporting group contains the pooled population of treated participants from the placebo groups "Metformin" (from protocol MK-0431A-170) and "Metformin XR" (from protocol MK-0431A-289).
|
|---|---|---|---|---|---|---|
|
Number of Participants Who Experienced ≥1 Adverse Event During Weeks 0-20
|
42 Participants
|
46 Participants
|
29 Participants
|
30 Participants
|
71 Participants
|
76 Participants
|
PRIMARY outcome
Timeframe: Up to Week 20Population: The analysis population includes all randomized participants who received ≥1 dose of study medication.
The number of participants who discontinued from study drug due to an adverse event during Weeks 0-20 was reported. An adverse event is defined as any untoward medical occurrence in a person administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
Outcome measures
| Measure |
Sitagliptin/Metformin and Sitagliptin/Metformin XR Pooled
n=62 Participants
This reporting group contains the pooled population of treated participants from the experimental-drug groups "Sitagliptin/Metformin" (from protocol MK-0431A-170) and "Sitagliptin/Metformin XR" (from protocol MK-0431A-289).
|
Metformin and Metformin XR Pooled
n=62 Participants
This reporting group contains the pooled population of treated participants from the placebo groups "Metformin" (from protocol MK-0431A-170) and "Metformin XR" (from protocol MK-0431A-289).
|
Sitagliptin/Metformin XR
n=45 Participants
Participants received two tablets of sitagliptin/metformin XR and two tablets of metformin XR placebo, administered once daily with a meal, for up to 54 weeks. Participants in this arm were enrolled in protocol MK-0431A-289.
|
Metformin XR
n=51 Participants
Participants received two tablets of metformin XR and two tablets of placebo to sitagliptin/metformin XR, administered once daily with a meal, for up to 54 weeks. Participants in this arm were enrolled in protocol MK-0431A-289.
|
Sitagliptin/Metformin and Sitagliptin/Metformin XR Pooled
n=107 Participants
This reporting group contains the pooled population of treated participants from the experimental-drug groups "Sitagliptin/Metformin" (from protocol MK-0431A-170) and "Sitagliptin/Metformin XR" (from protocol MK-0431A-289).
|
Metformin and Metformin XR Pooled
n=113 Participants
This reporting group contains the pooled population of treated participants from the placebo groups "Metformin" (from protocol MK-0431A-170) and "Metformin XR" (from protocol MK-0431A-289).
|
|---|---|---|---|---|---|---|
|
Number of Participants Who Discontinued Study Drug Due to Experiencing an Adverse Event During Weeks 0-20
|
1 Participants
|
2 Participants
|
2 Participants
|
2 Participants
|
3 Participants
|
4 Participants
|
PRIMARY outcome
Timeframe: Up to approximately Week 56Population: The analysis population includes all randomized participants who received ≥1 dose of study medication and continued in the study beyond Week 20.
The number of participants experiencing ≥1 adverse event during Weeks 0-56 were reported. An adverse event is defined as any untoward medical occurrence in a person administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
Outcome measures
| Measure |
Sitagliptin/Metformin and Sitagliptin/Metformin XR Pooled
n=28 Participants
This reporting group contains the pooled population of treated participants from the experimental-drug groups "Sitagliptin/Metformin" (from protocol MK-0431A-170) and "Sitagliptin/Metformin XR" (from protocol MK-0431A-289).
|
Metformin and Metformin XR Pooled
n=30 Participants
This reporting group contains the pooled population of treated participants from the placebo groups "Metformin" (from protocol MK-0431A-170) and "Metformin XR" (from protocol MK-0431A-289).
|
Sitagliptin/Metformin XR
n=42 Participants
Participants received two tablets of sitagliptin/metformin XR and two tablets of metformin XR placebo, administered once daily with a meal, for up to 54 weeks. Participants in this arm were enrolled in protocol MK-0431A-289.
|
Metformin XR
n=47 Participants
Participants received two tablets of metformin XR and two tablets of placebo to sitagliptin/metformin XR, administered once daily with a meal, for up to 54 weeks. Participants in this arm were enrolled in protocol MK-0431A-289.
|
Sitagliptin/Metformin and Sitagliptin/Metformin XR Pooled
n=70 Participants
This reporting group contains the pooled population of treated participants from the experimental-drug groups "Sitagliptin/Metformin" (from protocol MK-0431A-170) and "Sitagliptin/Metformin XR" (from protocol MK-0431A-289).
|
Metformin and Metformin XR Pooled
n=77 Participants
This reporting group contains the pooled population of treated participants from the placebo groups "Metformin" (from protocol MK-0431A-170) and "Metformin XR" (from protocol MK-0431A-289).
|
|---|---|---|---|---|---|---|
|
Number of Participants Who Experienced ≥1 Adverse Event During Weeks 0-56
|
26 Participants
|
27 Participants
|
36 Participants
|
39 Participants
|
62 Participants
|
66 Participants
|
PRIMARY outcome
Timeframe: Up to Week 54Population: The analysis population includes all randomized participants who received ≥1 dose of study medication and continued in the study beyond Week 20.
The number of participants who discontinued from study drug due to an adverse event during Weeks 0-54 was reported. An adverse event is defined as any untoward medical occurrence in a person administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
Outcome measures
| Measure |
Sitagliptin/Metformin and Sitagliptin/Metformin XR Pooled
n=28 Participants
This reporting group contains the pooled population of treated participants from the experimental-drug groups "Sitagliptin/Metformin" (from protocol MK-0431A-170) and "Sitagliptin/Metformin XR" (from protocol MK-0431A-289).
|
Metformin and Metformin XR Pooled
n=30 Participants
This reporting group contains the pooled population of treated participants from the placebo groups "Metformin" (from protocol MK-0431A-170) and "Metformin XR" (from protocol MK-0431A-289).
|
Sitagliptin/Metformin XR
n=42 Participants
Participants received two tablets of sitagliptin/metformin XR and two tablets of metformin XR placebo, administered once daily with a meal, for up to 54 weeks. Participants in this arm were enrolled in protocol MK-0431A-289.
|
Metformin XR
n=47 Participants
Participants received two tablets of metformin XR and two tablets of placebo to sitagliptin/metformin XR, administered once daily with a meal, for up to 54 weeks. Participants in this arm were enrolled in protocol MK-0431A-289.
|
Sitagliptin/Metformin and Sitagliptin/Metformin XR Pooled
n=70 Participants
This reporting group contains the pooled population of treated participants from the experimental-drug groups "Sitagliptin/Metformin" (from protocol MK-0431A-170) and "Sitagliptin/Metformin XR" (from protocol MK-0431A-289).
|
Metformin and Metformin XR Pooled
n=77 Participants
This reporting group contains the pooled population of treated participants from the placebo groups "Metformin" (from protocol MK-0431A-170) and "Metformin XR" (from protocol MK-0431A-289).
|
|---|---|---|---|---|---|---|
|
Number of Participants Who Discontinued Study Drug Due to Experiencing an Adverse Event During Weeks 0-54
|
1 Participants
|
1 Participants
|
1 Participants
|
3 Participants
|
2 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: Baseline and Week 54Population: The analysis population includes all randomized participants who received ≥1 dose of study medication, had ≥1 measurement of A1C, and continued in the study beyond Week 20. As defined in the protocols, these analyses were conducted in participants pooled from protocols MK-0431A-170 and -289, pooled by receipt of experimental drug or placebo.
A1C is a blood marker used to report average blood glucose levels over prolonged periods of time. Percentage A1C is the ratio of glycated hemoglobin to total hemoglobin x 100. Mean change from baseline at Week 54 was estimated from a longitudinal data analysis model.
Outcome measures
| Measure |
Sitagliptin/Metformin and Sitagliptin/Metformin XR Pooled
n=70 Participants
This reporting group contains the pooled population of treated participants from the experimental-drug groups "Sitagliptin/Metformin" (from protocol MK-0431A-170) and "Sitagliptin/Metformin XR" (from protocol MK-0431A-289).
|
Metformin and Metformin XR Pooled
n=77 Participants
This reporting group contains the pooled population of treated participants from the placebo groups "Metformin" (from protocol MK-0431A-170) and "Metformin XR" (from protocol MK-0431A-289).
|
Sitagliptin/Metformin XR
Participants received two tablets of sitagliptin/metformin XR and two tablets of metformin XR placebo, administered once daily with a meal, for up to 54 weeks. Participants in this arm were enrolled in protocol MK-0431A-289.
|
Metformin XR
Participants received two tablets of metformin XR and two tablets of placebo to sitagliptin/metformin XR, administered once daily with a meal, for up to 54 weeks. Participants in this arm were enrolled in protocol MK-0431A-289.
|
Sitagliptin/Metformin and Sitagliptin/Metformin XR Pooled
This reporting group contains the pooled population of treated participants from the experimental-drug groups "Sitagliptin/Metformin" (from protocol MK-0431A-170) and "Sitagliptin/Metformin XR" (from protocol MK-0431A-289).
|
Metformin and Metformin XR Pooled
This reporting group contains the pooled population of treated participants from the placebo groups "Metformin" (from protocol MK-0431A-170) and "Metformin XR" (from protocol MK-0431A-289).
|
|---|---|---|---|---|---|---|
|
Change From Baseline in A1C at Week 54
|
0.35 Percentage of glycated hemoglobin
Interval -0.48 to 1.19
|
0.73 Percentage of glycated hemoglobin
Interval -0.08 to 1.54
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline and Week 20Population: The analysis population includes all randomized participants who received ≥1 dose of study medication, and who had at least 1 measurement of FPG. As defined in the protocols, these analyses were conducted in participants pooled from protocols MK-0431A-170 and MK-0431A-289, pooled according to receipt of experimental drug or placebo comparator.
Blood glucose was measured on a fasting basis. Mean change from baseline at Week 20 was estimated from a longitudinal data analysis model.
Outcome measures
| Measure |
Sitagliptin/Metformin and Sitagliptin/Metformin XR Pooled
n=107 Participants
This reporting group contains the pooled population of treated participants from the experimental-drug groups "Sitagliptin/Metformin" (from protocol MK-0431A-170) and "Sitagliptin/Metformin XR" (from protocol MK-0431A-289).
|
Metformin and Metformin XR Pooled
n=113 Participants
This reporting group contains the pooled population of treated participants from the placebo groups "Metformin" (from protocol MK-0431A-170) and "Metformin XR" (from protocol MK-0431A-289).
|
Sitagliptin/Metformin XR
Participants received two tablets of sitagliptin/metformin XR and two tablets of metformin XR placebo, administered once daily with a meal, for up to 54 weeks. Participants in this arm were enrolled in protocol MK-0431A-289.
|
Metformin XR
Participants received two tablets of metformin XR and two tablets of placebo to sitagliptin/metformin XR, administered once daily with a meal, for up to 54 weeks. Participants in this arm were enrolled in protocol MK-0431A-289.
|
Sitagliptin/Metformin and Sitagliptin/Metformin XR Pooled
This reporting group contains the pooled population of treated participants from the experimental-drug groups "Sitagliptin/Metformin" (from protocol MK-0431A-170) and "Sitagliptin/Metformin XR" (from protocol MK-0431A-289).
|
Metformin and Metformin XR Pooled
This reporting group contains the pooled population of treated participants from the placebo groups "Metformin" (from protocol MK-0431A-170) and "Metformin XR" (from protocol MK-0431A-289).
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Fasting Plasma Glucose (FPG) at Week 20
|
-2.5 mg/dL
Interval -16.7 to 11.7
|
8.3 mg/dL
Interval -5.0 to 21.6
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline and Week 54Population: The analysis population includes all randomized participants who received ≥1 dose of study medication, had ≥1 measurement of FPG, and continued in the study beyond Week 20. As defined in the protocols, these analyses were conducted in participants pooled from protocols MK-0431A-170 and -289, pooled by receipt of experimental drug or placebo.
Blood glucose was measured on a fasting basis. Mean change from baseline at Week 54 was estimated from a longitudinal data analysis model.
Outcome measures
| Measure |
Sitagliptin/Metformin and Sitagliptin/Metformin XR Pooled
n=70 Participants
This reporting group contains the pooled population of treated participants from the experimental-drug groups "Sitagliptin/Metformin" (from protocol MK-0431A-170) and "Sitagliptin/Metformin XR" (from protocol MK-0431A-289).
|
Metformin and Metformin XR Pooled
n=77 Participants
This reporting group contains the pooled population of treated participants from the placebo groups "Metformin" (from protocol MK-0431A-170) and "Metformin XR" (from protocol MK-0431A-289).
|
Sitagliptin/Metformin XR
Participants received two tablets of sitagliptin/metformin XR and two tablets of metformin XR placebo, administered once daily with a meal, for up to 54 weeks. Participants in this arm were enrolled in protocol MK-0431A-289.
|
Metformin XR
Participants received two tablets of metformin XR and two tablets of placebo to sitagliptin/metformin XR, administered once daily with a meal, for up to 54 weeks. Participants in this arm were enrolled in protocol MK-0431A-289.
|
Sitagliptin/Metformin and Sitagliptin/Metformin XR Pooled
This reporting group contains the pooled population of treated participants from the experimental-drug groups "Sitagliptin/Metformin" (from protocol MK-0431A-170) and "Sitagliptin/Metformin XR" (from protocol MK-0431A-289).
|
Metformin and Metformin XR Pooled
This reporting group contains the pooled population of treated participants from the placebo groups "Metformin" (from protocol MK-0431A-170) and "Metformin XR" (from protocol MK-0431A-289).
|
|---|---|---|---|---|---|---|
|
Change From Baseline in FPG at Week 54
|
16.8 mg/dL
Interval -8.4 to 42.0
|
16.9 mg/dL
Interval -7.0 to 40.8
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 20Population: The analysis population includes all randomized participants who received ≥1 dose of study medication. As defined in the protocols, these analyses were conducted in participants pooled from protocols MK-0431A-170 and MK-0431A-289, pooled according to receipt of experimental drug or placebo comparator.
Glycated hemoglobin (A1C) is a blood marker used to report average blood glucose levels over prolonged periods of time. Percentage A1C is the ratio of glycated hemoglobin to total hemoglobin x 100. Percentage of participants with A1C at goal (\<7.0%) at Week 20 was presented.
Outcome measures
| Measure |
Sitagliptin/Metformin and Sitagliptin/Metformin XR Pooled
n=107 Participants
This reporting group contains the pooled population of treated participants from the experimental-drug groups "Sitagliptin/Metformin" (from protocol MK-0431A-170) and "Sitagliptin/Metformin XR" (from protocol MK-0431A-289).
|
Metformin and Metformin XR Pooled
n=113 Participants
This reporting group contains the pooled population of treated participants from the placebo groups "Metformin" (from protocol MK-0431A-170) and "Metformin XR" (from protocol MK-0431A-289).
|
Sitagliptin/Metformin XR
Participants received two tablets of sitagliptin/metformin XR and two tablets of metformin XR placebo, administered once daily with a meal, for up to 54 weeks. Participants in this arm were enrolled in protocol MK-0431A-289.
|
Metformin XR
Participants received two tablets of metformin XR and two tablets of placebo to sitagliptin/metformin XR, administered once daily with a meal, for up to 54 weeks. Participants in this arm were enrolled in protocol MK-0431A-289.
|
Sitagliptin/Metformin and Sitagliptin/Metformin XR Pooled
This reporting group contains the pooled population of treated participants from the experimental-drug groups "Sitagliptin/Metformin" (from protocol MK-0431A-170) and "Sitagliptin/Metformin XR" (from protocol MK-0431A-289).
|
Metformin and Metformin XR Pooled
This reporting group contains the pooled population of treated participants from the placebo groups "Metformin" (from protocol MK-0431A-170) and "Metformin XR" (from protocol MK-0431A-289).
|
|---|---|---|---|---|---|---|
|
Percentage of Participants With A1C at Goal (<7.0%) at Week 20
|
43.0 Percentage of participants
|
31.0 Percentage of participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 20Population: The analysis population includes all randomized participants who received ≥1 dose of study medication. As defined in the protocols, these analyses were conducted in participants pooled from protocols MK-0431A-170 and MK-0431A-289, pooled according to receipt of experimental drug or placebo comparator.
Glycated hemoglobin (A1C) is a blood marker used to report average blood glucose levels over prolonged periods of time. Percentage A1C is the ratio of glycated hemoglobin to total hemoglobin x 100. Percentage of participants with A1C at goal (\<6.5%) at Week 20 was presented.
Outcome measures
| Measure |
Sitagliptin/Metformin and Sitagliptin/Metformin XR Pooled
n=107 Participants
This reporting group contains the pooled population of treated participants from the experimental-drug groups "Sitagliptin/Metformin" (from protocol MK-0431A-170) and "Sitagliptin/Metformin XR" (from protocol MK-0431A-289).
|
Metformin and Metformin XR Pooled
n=113 Participants
This reporting group contains the pooled population of treated participants from the placebo groups "Metformin" (from protocol MK-0431A-170) and "Metformin XR" (from protocol MK-0431A-289).
|
Sitagliptin/Metformin XR
Participants received two tablets of sitagliptin/metformin XR and two tablets of metformin XR placebo, administered once daily with a meal, for up to 54 weeks. Participants in this arm were enrolled in protocol MK-0431A-289.
|
Metformin XR
Participants received two tablets of metformin XR and two tablets of placebo to sitagliptin/metformin XR, administered once daily with a meal, for up to 54 weeks. Participants in this arm were enrolled in protocol MK-0431A-289.
|
Sitagliptin/Metformin and Sitagliptin/Metformin XR Pooled
This reporting group contains the pooled population of treated participants from the experimental-drug groups "Sitagliptin/Metformin" (from protocol MK-0431A-170) and "Sitagliptin/Metformin XR" (from protocol MK-0431A-289).
|
Metformin and Metformin XR Pooled
This reporting group contains the pooled population of treated participants from the placebo groups "Metformin" (from protocol MK-0431A-170) and "Metformin XR" (from protocol MK-0431A-289).
|
|---|---|---|---|---|---|---|
|
Percentage of Participants With A1C at Goal (<6.5%) at Week 20
|
29.0 Percentage of participants
|
20.4 Percentage of participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 54Population: The analysis population includes all randomized participants who received ≥1 dose of study medication and continued in the study beyond Week 20. As defined in the protocols, these analyses were conducted in participants pooled from protocols MK-0431A-170 and MK-0431A-289, pooled according to receipt of experimental drug or placebo comparator.
Glycated hemoglobin (A1C) is a blood marker used to report average blood glucose levels over prolonged periods of time. Percentage A1C is the ratio of glycated hemoglobin to total hemoglobin x 100. Percentage of participants with A1C at goal (\<7.0%) at Week 54 was presented.
Outcome measures
| Measure |
Sitagliptin/Metformin and Sitagliptin/Metformin XR Pooled
n=70 Participants
This reporting group contains the pooled population of treated participants from the experimental-drug groups "Sitagliptin/Metformin" (from protocol MK-0431A-170) and "Sitagliptin/Metformin XR" (from protocol MK-0431A-289).
|
Metformin and Metformin XR Pooled
n=77 Participants
This reporting group contains the pooled population of treated participants from the placebo groups "Metformin" (from protocol MK-0431A-170) and "Metformin XR" (from protocol MK-0431A-289).
|
Sitagliptin/Metformin XR
Participants received two tablets of sitagliptin/metformin XR and two tablets of metformin XR placebo, administered once daily with a meal, for up to 54 weeks. Participants in this arm were enrolled in protocol MK-0431A-289.
|
Metformin XR
Participants received two tablets of metformin XR and two tablets of placebo to sitagliptin/metformin XR, administered once daily with a meal, for up to 54 weeks. Participants in this arm were enrolled in protocol MK-0431A-289.
|
Sitagliptin/Metformin and Sitagliptin/Metformin XR Pooled
This reporting group contains the pooled population of treated participants from the experimental-drug groups "Sitagliptin/Metformin" (from protocol MK-0431A-170) and "Sitagliptin/Metformin XR" (from protocol MK-0431A-289).
|
Metformin and Metformin XR Pooled
This reporting group contains the pooled population of treated participants from the placebo groups "Metformin" (from protocol MK-0431A-170) and "Metformin XR" (from protocol MK-0431A-289).
|
|---|---|---|---|---|---|---|
|
Percentage of Participants With A1C at Goal (<7.0%) at Week 54
|
31.4 Percentage of participants
|
27.3 Percentage of participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 54Population: The analysis population includes all randomized participants who received ≥1 dose of study medication and continued in the study beyond Week 20. As defined in the protocols, these analyses were conducted in participants pooled from protocols MK-0431A-170 and MK-0431A-289, pooled according to receipt of experimental drug or placebo comparator.
Glycated hemoglobin (A1C) is a blood marker used to report average blood glucose levels over prolonged periods of time. Percentage A1C is the ratio of glycated hemoglobin to total hemoglobin x 100. Percentage of participants with A1C at goal (\<6.5%) at Week 54 was presented.
Outcome measures
| Measure |
Sitagliptin/Metformin and Sitagliptin/Metformin XR Pooled
n=70 Participants
This reporting group contains the pooled population of treated participants from the experimental-drug groups "Sitagliptin/Metformin" (from protocol MK-0431A-170) and "Sitagliptin/Metformin XR" (from protocol MK-0431A-289).
|
Metformin and Metformin XR Pooled
n=77 Participants
This reporting group contains the pooled population of treated participants from the placebo groups "Metformin" (from protocol MK-0431A-170) and "Metformin XR" (from protocol MK-0431A-289).
|
Sitagliptin/Metformin XR
Participants received two tablets of sitagliptin/metformin XR and two tablets of metformin XR placebo, administered once daily with a meal, for up to 54 weeks. Participants in this arm were enrolled in protocol MK-0431A-289.
|
Metformin XR
Participants received two tablets of metformin XR and two tablets of placebo to sitagliptin/metformin XR, administered once daily with a meal, for up to 54 weeks. Participants in this arm were enrolled in protocol MK-0431A-289.
|
Sitagliptin/Metformin and Sitagliptin/Metformin XR Pooled
This reporting group contains the pooled population of treated participants from the experimental-drug groups "Sitagliptin/Metformin" (from protocol MK-0431A-170) and "Sitagliptin/Metformin XR" (from protocol MK-0431A-289).
|
Metformin and Metformin XR Pooled
This reporting group contains the pooled population of treated participants from the placebo groups "Metformin" (from protocol MK-0431A-170) and "Metformin XR" (from protocol MK-0431A-289).
|
|---|---|---|---|---|---|---|
|
Percentage of Participants With A1C at Goal (<6.5%) at Week 54
|
18.6 Percentage of participants
|
19.5 Percentage of participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to Week 20Population: The analysis population includes all randomized participants who received ≥1 dose of study medication.
Percentage of participants who initiated glycemic rescue therapy prior to Week 20 was reported.
Outcome measures
| Measure |
Sitagliptin/Metformin and Sitagliptin/Metformin XR Pooled
n=62 Participants
This reporting group contains the pooled population of treated participants from the experimental-drug groups "Sitagliptin/Metformin" (from protocol MK-0431A-170) and "Sitagliptin/Metformin XR" (from protocol MK-0431A-289).
|
Metformin and Metformin XR Pooled
n=62 Participants
This reporting group contains the pooled population of treated participants from the placebo groups "Metformin" (from protocol MK-0431A-170) and "Metformin XR" (from protocol MK-0431A-289).
|
Sitagliptin/Metformin XR
n=45 Participants
Participants received two tablets of sitagliptin/metformin XR and two tablets of metformin XR placebo, administered once daily with a meal, for up to 54 weeks. Participants in this arm were enrolled in protocol MK-0431A-289.
|
Metformin XR
n=51 Participants
Participants received two tablets of metformin XR and two tablets of placebo to sitagliptin/metformin XR, administered once daily with a meal, for up to 54 weeks. Participants in this arm were enrolled in protocol MK-0431A-289.
|
Sitagliptin/Metformin and Sitagliptin/Metformin XR Pooled
n=107 Participants
This reporting group contains the pooled population of treated participants from the experimental-drug groups "Sitagliptin/Metformin" (from protocol MK-0431A-170) and "Sitagliptin/Metformin XR" (from protocol MK-0431A-289).
|
Metformin and Metformin XR Pooled
n=113 Participants
This reporting group contains the pooled population of treated participants from the placebo groups "Metformin" (from protocol MK-0431A-170) and "Metformin XR" (from protocol MK-0431A-289).
|
|---|---|---|---|---|---|---|
|
Percentage of Participants Initiating Glycemic Rescue Therapy by Week 20
|
3.2 Percentage of participants
|
19.4 Percentage of participants
|
4.4 Percentage of participants
|
13.7 Percentage of participants
|
3.7 Percentage of participants
|
16.8 Percentage of participants
|
SECONDARY outcome
Timeframe: Week 20 up to Week 54Population: The analysis population includes all randomized participants who received ≥1 dose of study medication and continued in the study beyond Week 20 without initiating glycemic rescue therapy before Week 20. As defined in the protocols, these analyses were on participants pooled from protocols MK-0431A-170 and -289, pooled by receipt of drug or placebo.
Percentage of participants who initiated insulin glargine therapy from Weeks 20 through 54 was reported.
Outcome measures
| Measure |
Sitagliptin/Metformin and Sitagliptin/Metformin XR Pooled
n=66 Participants
This reporting group contains the pooled population of treated participants from the experimental-drug groups "Sitagliptin/Metformin" (from protocol MK-0431A-170) and "Sitagliptin/Metformin XR" (from protocol MK-0431A-289).
|
Metformin and Metformin XR Pooled
n=64 Participants
This reporting group contains the pooled population of treated participants from the placebo groups "Metformin" (from protocol MK-0431A-170) and "Metformin XR" (from protocol MK-0431A-289).
|
Sitagliptin/Metformin XR
Participants received two tablets of sitagliptin/metformin XR and two tablets of metformin XR placebo, administered once daily with a meal, for up to 54 weeks. Participants in this arm were enrolled in protocol MK-0431A-289.
|
Metformin XR
Participants received two tablets of metformin XR and two tablets of placebo to sitagliptin/metformin XR, administered once daily with a meal, for up to 54 weeks. Participants in this arm were enrolled in protocol MK-0431A-289.
|
Sitagliptin/Metformin and Sitagliptin/Metformin XR Pooled
This reporting group contains the pooled population of treated participants from the experimental-drug groups "Sitagliptin/Metformin" (from protocol MK-0431A-170) and "Sitagliptin/Metformin XR" (from protocol MK-0431A-289).
|
Metformin and Metformin XR Pooled
This reporting group contains the pooled population of treated participants from the placebo groups "Metformin" (from protocol MK-0431A-170) and "Metformin XR" (from protocol MK-0431A-289).
|
|---|---|---|---|---|---|---|
|
Percentage of Participants Initiating Insulin Glargine During Weeks 20-54
|
22.7 Percentage of participants
|
26.6 Percentage of participants
|
—
|
—
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: BaselinePopulation: The analysis population includes all randomized participants who received ≥1 dose of study medication and had a baseline measurement of A1C. Baseline A1C data for non-pooled arms are listed in the Baseline Characteristics module.
Glycated hemoglobin (A1C) is a blood marker used to report average blood glucose levels over prolonged periods of time. Percentage A1C is the ratio of glycated hemoglobin to total hemoglobin x 100.
Outcome measures
| Measure |
Sitagliptin/Metformin and Sitagliptin/Metformin XR Pooled
n=107 Participants
This reporting group contains the pooled population of treated participants from the experimental-drug groups "Sitagliptin/Metformin" (from protocol MK-0431A-170) and "Sitagliptin/Metformin XR" (from protocol MK-0431A-289).
|
Metformin and Metformin XR Pooled
n=113 Participants
This reporting group contains the pooled population of treated participants from the placebo groups "Metformin" (from protocol MK-0431A-170) and "Metformin XR" (from protocol MK-0431A-289).
|
Sitagliptin/Metformin XR
Participants received two tablets of sitagliptin/metformin XR and two tablets of metformin XR placebo, administered once daily with a meal, for up to 54 weeks. Participants in this arm were enrolled in protocol MK-0431A-289.
|
Metformin XR
Participants received two tablets of metformin XR and two tablets of placebo to sitagliptin/metformin XR, administered once daily with a meal, for up to 54 weeks. Participants in this arm were enrolled in protocol MK-0431A-289.
|
Sitagliptin/Metformin and Sitagliptin/Metformin XR Pooled
This reporting group contains the pooled population of treated participants from the experimental-drug groups "Sitagliptin/Metformin" (from protocol MK-0431A-170) and "Sitagliptin/Metformin XR" (from protocol MK-0431A-289).
|
Metformin and Metformin XR Pooled
This reporting group contains the pooled population of treated participants from the placebo groups "Metformin" (from protocol MK-0431A-170) and "Metformin XR" (from protocol MK-0431A-289).
|
|---|---|---|---|---|---|---|
|
Baseline A1C
|
7.96 Percentage of glycated hemoglobin
Standard Deviation 1.11
|
8.06 Percentage of glycated hemoglobin
Standard Deviation 1.07
|
—
|
—
|
—
|
—
|
Adverse Events
Sitagliptin/Metformin
Serious events: 4 serious events
Other events: 34 other events
Deaths: 1 deaths
Metformin
Serious events: 3 serious events
Other events: 40 other events
Deaths: 0 deaths
Sitagliptin/Metformin XR
Serious events: 3 serious events
Other events: 30 other events
Deaths: 0 deaths
Metformin XR
Serious events: 3 serious events
Other events: 36 other events
Deaths: 0 deaths
Sitagliptin/Metformin and Sitagliptin/Metformin XR Pooled
Serious events: 7 serious events
Other events: 64 other events
Deaths: 1 deaths
Metformin and Metformin XR Pooled
Serious events: 6 serious events
Other events: 76 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Sitagliptin/Metformin
n=62 participants at risk
Participants received one tablet of sitagliptin/metformin and one tablet of metformin-placebo, administered twice daily prior to the morning and evening meals, for up to 20 weeks in the base study alone, or for up to 54 weeks if the participant also entered the extension study. Participants in this arm were enrolled in protocol MK-0431A-170.
|
Metformin
n=62 participants at risk
Participants received one tablet of metformin and one tablet of placebo to sitagliptin/metformin, administered twice daily prior to the morning and evening meals, for up to 20 weeks in the base study alone, or for up to 54 weeks if the participant also entered the extension study. Participants in this arm were enrolled in protocol MK-0431A-170.
|
Sitagliptin/Metformin XR
n=45 participants at risk
Participants received two tablets of sitagliptin/metformin XR and two tablets of metformin XR placebo, administered once daily with a meal, for up to 54 weeks. Participants in this arm were enrolled in protocol MK-0431A-289.
|
Metformin XR
n=51 participants at risk
Participants received two tablets of metformin XR and two tablets of placebo to sitagliptin/metformin XR, administered once daily with a meal, for up to 54 weeks. Participants in this arm were enrolled in protocol MK-0431A-289.
|
Sitagliptin/Metformin and Sitagliptin/Metformin XR Pooled
n=107 participants at risk
This reporting group contains the pooled population of treated participants from the experimental-drug groups "Sitagliptin/Metformin" (from protocol MK-0431A-170) and "Sitagliptin/Metformin XR" (from protocol MK-0431A-289).
|
Metformin and Metformin XR Pooled
n=113 participants at risk
This reporting group contains the pooled population of treated participants from the placebo groups "Metformin" (from protocol MK-0431A-170) and "Metformin XR" (from protocol MK-0431A-289).
|
|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/62 • Up to 56 weeks for non-serious adverse events. Up to approximately 76 weeks for serious adverse events. Up to approximately 78 weeks for all-cause mortality.
"Sitagliptin/Metformin and Sitagliptin/Metformin XR Pooled" = "Sitagliptin/Metformin" plus "Sitagliptin/Metformin XR." "Metformin and Metformin XR Pooled" = "Metformin" plus "Metformin XR." Non-serious and serious adverse events are recorded for all treated participants. All-cause mortality is recorded for all randomized participants.
|
0.00%
0/62 • Up to 56 weeks for non-serious adverse events. Up to approximately 76 weeks for serious adverse events. Up to approximately 78 weeks for all-cause mortality.
"Sitagliptin/Metformin and Sitagliptin/Metformin XR Pooled" = "Sitagliptin/Metformin" plus "Sitagliptin/Metformin XR." "Metformin and Metformin XR Pooled" = "Metformin" plus "Metformin XR." Non-serious and serious adverse events are recorded for all treated participants. All-cause mortality is recorded for all randomized participants.
|
0.00%
0/45 • Up to 56 weeks for non-serious adverse events. Up to approximately 76 weeks for serious adverse events. Up to approximately 78 weeks for all-cause mortality.
"Sitagliptin/Metformin and Sitagliptin/Metformin XR Pooled" = "Sitagliptin/Metformin" plus "Sitagliptin/Metformin XR." "Metformin and Metformin XR Pooled" = "Metformin" plus "Metformin XR." Non-serious and serious adverse events are recorded for all treated participants. All-cause mortality is recorded for all randomized participants.
|
2.0%
1/51 • Number of events 1 • Up to 56 weeks for non-serious adverse events. Up to approximately 76 weeks for serious adverse events. Up to approximately 78 weeks for all-cause mortality.
"Sitagliptin/Metformin and Sitagliptin/Metformin XR Pooled" = "Sitagliptin/Metformin" plus "Sitagliptin/Metformin XR." "Metformin and Metformin XR Pooled" = "Metformin" plus "Metformin XR." Non-serious and serious adverse events are recorded for all treated participants. All-cause mortality is recorded for all randomized participants.
|
0.00%
0/107 • Up to 56 weeks for non-serious adverse events. Up to approximately 76 weeks for serious adverse events. Up to approximately 78 weeks for all-cause mortality.
"Sitagliptin/Metformin and Sitagliptin/Metformin XR Pooled" = "Sitagliptin/Metformin" plus "Sitagliptin/Metformin XR." "Metformin and Metformin XR Pooled" = "Metformin" plus "Metformin XR." Non-serious and serious adverse events are recorded for all treated participants. All-cause mortality is recorded for all randomized participants.
|
0.88%
1/113 • Number of events 1 • Up to 56 weeks for non-serious adverse events. Up to approximately 76 weeks for serious adverse events. Up to approximately 78 weeks for all-cause mortality.
"Sitagliptin/Metformin and Sitagliptin/Metformin XR Pooled" = "Sitagliptin/Metformin" plus "Sitagliptin/Metformin XR." "Metformin and Metformin XR Pooled" = "Metformin" plus "Metformin XR." Non-serious and serious adverse events are recorded for all treated participants. All-cause mortality is recorded for all randomized participants.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/62 • Up to 56 weeks for non-serious adverse events. Up to approximately 76 weeks for serious adverse events. Up to approximately 78 weeks for all-cause mortality.
"Sitagliptin/Metformin and Sitagliptin/Metformin XR Pooled" = "Sitagliptin/Metformin" plus "Sitagliptin/Metformin XR." "Metformin and Metformin XR Pooled" = "Metformin" plus "Metformin XR." Non-serious and serious adverse events are recorded for all treated participants. All-cause mortality is recorded for all randomized participants.
|
0.00%
0/62 • Up to 56 weeks for non-serious adverse events. Up to approximately 76 weeks for serious adverse events. Up to approximately 78 weeks for all-cause mortality.
"Sitagliptin/Metformin and Sitagliptin/Metformin XR Pooled" = "Sitagliptin/Metformin" plus "Sitagliptin/Metformin XR." "Metformin and Metformin XR Pooled" = "Metformin" plus "Metformin XR." Non-serious and serious adverse events are recorded for all treated participants. All-cause mortality is recorded for all randomized participants.
|
2.2%
1/45 • Number of events 1 • Up to 56 weeks for non-serious adverse events. Up to approximately 76 weeks for serious adverse events. Up to approximately 78 weeks for all-cause mortality.
"Sitagliptin/Metformin and Sitagliptin/Metformin XR Pooled" = "Sitagliptin/Metformin" plus "Sitagliptin/Metformin XR." "Metformin and Metformin XR Pooled" = "Metformin" plus "Metformin XR." Non-serious and serious adverse events are recorded for all treated participants. All-cause mortality is recorded for all randomized participants.
|
0.00%
0/51 • Up to 56 weeks for non-serious adverse events. Up to approximately 76 weeks for serious adverse events. Up to approximately 78 weeks for all-cause mortality.
"Sitagliptin/Metformin and Sitagliptin/Metformin XR Pooled" = "Sitagliptin/Metformin" plus "Sitagliptin/Metformin XR." "Metformin and Metformin XR Pooled" = "Metformin" plus "Metformin XR." Non-serious and serious adverse events are recorded for all treated participants. All-cause mortality is recorded for all randomized participants.
|
0.93%
1/107 • Number of events 1 • Up to 56 weeks for non-serious adverse events. Up to approximately 76 weeks for serious adverse events. Up to approximately 78 weeks for all-cause mortality.
"Sitagliptin/Metformin and Sitagliptin/Metformin XR Pooled" = "Sitagliptin/Metformin" plus "Sitagliptin/Metformin XR." "Metformin and Metformin XR Pooled" = "Metformin" plus "Metformin XR." Non-serious and serious adverse events are recorded for all treated participants. All-cause mortality is recorded for all randomized participants.
|
0.00%
0/113 • Up to 56 weeks for non-serious adverse events. Up to approximately 76 weeks for serious adverse events. Up to approximately 78 weeks for all-cause mortality.
"Sitagliptin/Metformin and Sitagliptin/Metformin XR Pooled" = "Sitagliptin/Metformin" plus "Sitagliptin/Metformin XR." "Metformin and Metformin XR Pooled" = "Metformin" plus "Metformin XR." Non-serious and serious adverse events are recorded for all treated participants. All-cause mortality is recorded for all randomized participants.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/62 • Up to 56 weeks for non-serious adverse events. Up to approximately 76 weeks for serious adverse events. Up to approximately 78 weeks for all-cause mortality.
"Sitagliptin/Metformin and Sitagliptin/Metformin XR Pooled" = "Sitagliptin/Metformin" plus "Sitagliptin/Metformin XR." "Metformin and Metformin XR Pooled" = "Metformin" plus "Metformin XR." Non-serious and serious adverse events are recorded for all treated participants. All-cause mortality is recorded for all randomized participants.
|
0.00%
0/62 • Up to 56 weeks for non-serious adverse events. Up to approximately 76 weeks for serious adverse events. Up to approximately 78 weeks for all-cause mortality.
"Sitagliptin/Metformin and Sitagliptin/Metformin XR Pooled" = "Sitagliptin/Metformin" plus "Sitagliptin/Metformin XR." "Metformin and Metformin XR Pooled" = "Metformin" plus "Metformin XR." Non-serious and serious adverse events are recorded for all treated participants. All-cause mortality is recorded for all randomized participants.
|
0.00%
0/45 • Up to 56 weeks for non-serious adverse events. Up to approximately 76 weeks for serious adverse events. Up to approximately 78 weeks for all-cause mortality.
"Sitagliptin/Metformin and Sitagliptin/Metformin XR Pooled" = "Sitagliptin/Metformin" plus "Sitagliptin/Metformin XR." "Metformin and Metformin XR Pooled" = "Metformin" plus "Metformin XR." Non-serious and serious adverse events are recorded for all treated participants. All-cause mortality is recorded for all randomized participants.
|
2.0%
1/51 • Number of events 1 • Up to 56 weeks for non-serious adverse events. Up to approximately 76 weeks for serious adverse events. Up to approximately 78 weeks for all-cause mortality.
"Sitagliptin/Metformin and Sitagliptin/Metformin XR Pooled" = "Sitagliptin/Metformin" plus "Sitagliptin/Metformin XR." "Metformin and Metformin XR Pooled" = "Metformin" plus "Metformin XR." Non-serious and serious adverse events are recorded for all treated participants. All-cause mortality is recorded for all randomized participants.
|
0.00%
0/107 • Up to 56 weeks for non-serious adverse events. Up to approximately 76 weeks for serious adverse events. Up to approximately 78 weeks for all-cause mortality.
"Sitagliptin/Metformin and Sitagliptin/Metformin XR Pooled" = "Sitagliptin/Metformin" plus "Sitagliptin/Metformin XR." "Metformin and Metformin XR Pooled" = "Metformin" plus "Metformin XR." Non-serious and serious adverse events are recorded for all treated participants. All-cause mortality is recorded for all randomized participants.
|
0.88%
1/113 • Number of events 1 • Up to 56 weeks for non-serious adverse events. Up to approximately 76 weeks for serious adverse events. Up to approximately 78 weeks for all-cause mortality.
"Sitagliptin/Metformin and Sitagliptin/Metformin XR Pooled" = "Sitagliptin/Metformin" plus "Sitagliptin/Metformin XR." "Metformin and Metformin XR Pooled" = "Metformin" plus "Metformin XR." Non-serious and serious adverse events are recorded for all treated participants. All-cause mortality is recorded for all randomized participants.
|
|
Immune system disorders
Type I hypersensitivity
|
1.6%
1/62 • Number of events 1 • Up to 56 weeks for non-serious adverse events. Up to approximately 76 weeks for serious adverse events. Up to approximately 78 weeks for all-cause mortality.
"Sitagliptin/Metformin and Sitagliptin/Metformin XR Pooled" = "Sitagliptin/Metformin" plus "Sitagliptin/Metformin XR." "Metformin and Metformin XR Pooled" = "Metformin" plus "Metformin XR." Non-serious and serious adverse events are recorded for all treated participants. All-cause mortality is recorded for all randomized participants.
|
0.00%
0/62 • Up to 56 weeks for non-serious adverse events. Up to approximately 76 weeks for serious adverse events. Up to approximately 78 weeks for all-cause mortality.
"Sitagliptin/Metformin and Sitagliptin/Metformin XR Pooled" = "Sitagliptin/Metformin" plus "Sitagliptin/Metformin XR." "Metformin and Metformin XR Pooled" = "Metformin" plus "Metformin XR." Non-serious and serious adverse events are recorded for all treated participants. All-cause mortality is recorded for all randomized participants.
|
0.00%
0/45 • Up to 56 weeks for non-serious adverse events. Up to approximately 76 weeks for serious adverse events. Up to approximately 78 weeks for all-cause mortality.
"Sitagliptin/Metformin and Sitagliptin/Metformin XR Pooled" = "Sitagliptin/Metformin" plus "Sitagliptin/Metformin XR." "Metformin and Metformin XR Pooled" = "Metformin" plus "Metformin XR." Non-serious and serious adverse events are recorded for all treated participants. All-cause mortality is recorded for all randomized participants.
|
0.00%
0/51 • Up to 56 weeks for non-serious adverse events. Up to approximately 76 weeks for serious adverse events. Up to approximately 78 weeks for all-cause mortality.
"Sitagliptin/Metformin and Sitagliptin/Metformin XR Pooled" = "Sitagliptin/Metformin" plus "Sitagliptin/Metformin XR." "Metformin and Metformin XR Pooled" = "Metformin" plus "Metformin XR." Non-serious and serious adverse events are recorded for all treated participants. All-cause mortality is recorded for all randomized participants.
|
0.93%
1/107 • Number of events 1 • Up to 56 weeks for non-serious adverse events. Up to approximately 76 weeks for serious adverse events. Up to approximately 78 weeks for all-cause mortality.
"Sitagliptin/Metformin and Sitagliptin/Metformin XR Pooled" = "Sitagliptin/Metformin" plus "Sitagliptin/Metformin XR." "Metformin and Metformin XR Pooled" = "Metformin" plus "Metformin XR." Non-serious and serious adverse events are recorded for all treated participants. All-cause mortality is recorded for all randomized participants.
|
0.00%
0/113 • Up to 56 weeks for non-serious adverse events. Up to approximately 76 weeks for serious adverse events. Up to approximately 78 weeks for all-cause mortality.
"Sitagliptin/Metformin and Sitagliptin/Metformin XR Pooled" = "Sitagliptin/Metformin" plus "Sitagliptin/Metformin XR." "Metformin and Metformin XR Pooled" = "Metformin" plus "Metformin XR." Non-serious and serious adverse events are recorded for all treated participants. All-cause mortality is recorded for all randomized participants.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/62 • Up to 56 weeks for non-serious adverse events. Up to approximately 76 weeks for serious adverse events. Up to approximately 78 weeks for all-cause mortality.
"Sitagliptin/Metformin and Sitagliptin/Metformin XR Pooled" = "Sitagliptin/Metformin" plus "Sitagliptin/Metformin XR." "Metformin and Metformin XR Pooled" = "Metformin" plus "Metformin XR." Non-serious and serious adverse events are recorded for all treated participants. All-cause mortality is recorded for all randomized participants.
|
0.00%
0/62 • Up to 56 weeks for non-serious adverse events. Up to approximately 76 weeks for serious adverse events. Up to approximately 78 weeks for all-cause mortality.
"Sitagliptin/Metformin and Sitagliptin/Metformin XR Pooled" = "Sitagliptin/Metformin" plus "Sitagliptin/Metformin XR." "Metformin and Metformin XR Pooled" = "Metformin" plus "Metformin XR." Non-serious and serious adverse events are recorded for all treated participants. All-cause mortality is recorded for all randomized participants.
|
2.2%
1/45 • Number of events 1 • Up to 56 weeks for non-serious adverse events. Up to approximately 76 weeks for serious adverse events. Up to approximately 78 weeks for all-cause mortality.
"Sitagliptin/Metformin and Sitagliptin/Metformin XR Pooled" = "Sitagliptin/Metformin" plus "Sitagliptin/Metformin XR." "Metformin and Metformin XR Pooled" = "Metformin" plus "Metformin XR." Non-serious and serious adverse events are recorded for all treated participants. All-cause mortality is recorded for all randomized participants.
|
0.00%
0/51 • Up to 56 weeks for non-serious adverse events. Up to approximately 76 weeks for serious adverse events. Up to approximately 78 weeks for all-cause mortality.
"Sitagliptin/Metformin and Sitagliptin/Metformin XR Pooled" = "Sitagliptin/Metformin" plus "Sitagliptin/Metformin XR." "Metformin and Metformin XR Pooled" = "Metformin" plus "Metformin XR." Non-serious and serious adverse events are recorded for all treated participants. All-cause mortality is recorded for all randomized participants.
|
0.93%
1/107 • Number of events 1 • Up to 56 weeks for non-serious adverse events. Up to approximately 76 weeks for serious adverse events. Up to approximately 78 weeks for all-cause mortality.
"Sitagliptin/Metformin and Sitagliptin/Metformin XR Pooled" = "Sitagliptin/Metformin" plus "Sitagliptin/Metformin XR." "Metformin and Metformin XR Pooled" = "Metformin" plus "Metformin XR." Non-serious and serious adverse events are recorded for all treated participants. All-cause mortality is recorded for all randomized participants.
|
0.00%
0/113 • Up to 56 weeks for non-serious adverse events. Up to approximately 76 weeks for serious adverse events. Up to approximately 78 weeks for all-cause mortality.
"Sitagliptin/Metformin and Sitagliptin/Metformin XR Pooled" = "Sitagliptin/Metformin" plus "Sitagliptin/Metformin XR." "Metformin and Metformin XR Pooled" = "Metformin" plus "Metformin XR." Non-serious and serious adverse events are recorded for all treated participants. All-cause mortality is recorded for all randomized participants.
|
|
Infections and infestations
H1N1 influenza
|
0.00%
0/62 • Up to 56 weeks for non-serious adverse events. Up to approximately 76 weeks for serious adverse events. Up to approximately 78 weeks for all-cause mortality.
"Sitagliptin/Metformin and Sitagliptin/Metformin XR Pooled" = "Sitagliptin/Metformin" plus "Sitagliptin/Metformin XR." "Metformin and Metformin XR Pooled" = "Metformin" plus "Metformin XR." Non-serious and serious adverse events are recorded for all treated participants. All-cause mortality is recorded for all randomized participants.
|
0.00%
0/62 • Up to 56 weeks for non-serious adverse events. Up to approximately 76 weeks for serious adverse events. Up to approximately 78 weeks for all-cause mortality.
"Sitagliptin/Metformin and Sitagliptin/Metformin XR Pooled" = "Sitagliptin/Metformin" plus "Sitagliptin/Metformin XR." "Metformin and Metformin XR Pooled" = "Metformin" plus "Metformin XR." Non-serious and serious adverse events are recorded for all treated participants. All-cause mortality is recorded for all randomized participants.
|
0.00%
0/45 • Up to 56 weeks for non-serious adverse events. Up to approximately 76 weeks for serious adverse events. Up to approximately 78 weeks for all-cause mortality.
"Sitagliptin/Metformin and Sitagliptin/Metformin XR Pooled" = "Sitagliptin/Metformin" plus "Sitagliptin/Metformin XR." "Metformin and Metformin XR Pooled" = "Metformin" plus "Metformin XR." Non-serious and serious adverse events are recorded for all treated participants. All-cause mortality is recorded for all randomized participants.
|
2.0%
1/51 • Number of events 1 • Up to 56 weeks for non-serious adverse events. Up to approximately 76 weeks for serious adverse events. Up to approximately 78 weeks for all-cause mortality.
"Sitagliptin/Metformin and Sitagliptin/Metformin XR Pooled" = "Sitagliptin/Metformin" plus "Sitagliptin/Metformin XR." "Metformin and Metformin XR Pooled" = "Metformin" plus "Metformin XR." Non-serious and serious adverse events are recorded for all treated participants. All-cause mortality is recorded for all randomized participants.
|
0.00%
0/107 • Up to 56 weeks for non-serious adverse events. Up to approximately 76 weeks for serious adverse events. Up to approximately 78 weeks for all-cause mortality.
"Sitagliptin/Metformin and Sitagliptin/Metformin XR Pooled" = "Sitagliptin/Metformin" plus "Sitagliptin/Metformin XR." "Metformin and Metformin XR Pooled" = "Metformin" plus "Metformin XR." Non-serious and serious adverse events are recorded for all treated participants. All-cause mortality is recorded for all randomized participants.
|
0.88%
1/113 • Number of events 1 • Up to 56 weeks for non-serious adverse events. Up to approximately 76 weeks for serious adverse events. Up to approximately 78 weeks for all-cause mortality.
"Sitagliptin/Metformin and Sitagliptin/Metformin XR Pooled" = "Sitagliptin/Metformin" plus "Sitagliptin/Metformin XR." "Metformin and Metformin XR Pooled" = "Metformin" plus "Metformin XR." Non-serious and serious adverse events are recorded for all treated participants. All-cause mortality is recorded for all randomized participants.
|
|
Infections and infestations
Pyelonephritis
|
1.6%
1/62 • Number of events 1 • Up to 56 weeks for non-serious adverse events. Up to approximately 76 weeks for serious adverse events. Up to approximately 78 weeks for all-cause mortality.
"Sitagliptin/Metformin and Sitagliptin/Metformin XR Pooled" = "Sitagliptin/Metformin" plus "Sitagliptin/Metformin XR." "Metformin and Metformin XR Pooled" = "Metformin" plus "Metformin XR." Non-serious and serious adverse events are recorded for all treated participants. All-cause mortality is recorded for all randomized participants.
|
0.00%
0/62 • Up to 56 weeks for non-serious adverse events. Up to approximately 76 weeks for serious adverse events. Up to approximately 78 weeks for all-cause mortality.
"Sitagliptin/Metformin and Sitagliptin/Metformin XR Pooled" = "Sitagliptin/Metformin" plus "Sitagliptin/Metformin XR." "Metformin and Metformin XR Pooled" = "Metformin" plus "Metformin XR." Non-serious and serious adverse events are recorded for all treated participants. All-cause mortality is recorded for all randomized participants.
|
0.00%
0/45 • Up to 56 weeks for non-serious adverse events. Up to approximately 76 weeks for serious adverse events. Up to approximately 78 weeks for all-cause mortality.
"Sitagliptin/Metformin and Sitagliptin/Metformin XR Pooled" = "Sitagliptin/Metformin" plus "Sitagliptin/Metformin XR." "Metformin and Metformin XR Pooled" = "Metformin" plus "Metformin XR." Non-serious and serious adverse events are recorded for all treated participants. All-cause mortality is recorded for all randomized participants.
|
0.00%
0/51 • Up to 56 weeks for non-serious adverse events. Up to approximately 76 weeks for serious adverse events. Up to approximately 78 weeks for all-cause mortality.
"Sitagliptin/Metformin and Sitagliptin/Metformin XR Pooled" = "Sitagliptin/Metformin" plus "Sitagliptin/Metformin XR." "Metformin and Metformin XR Pooled" = "Metformin" plus "Metformin XR." Non-serious and serious adverse events are recorded for all treated participants. All-cause mortality is recorded for all randomized participants.
|
0.93%
1/107 • Number of events 1 • Up to 56 weeks for non-serious adverse events. Up to approximately 76 weeks for serious adverse events. Up to approximately 78 weeks for all-cause mortality.
"Sitagliptin/Metformin and Sitagliptin/Metformin XR Pooled" = "Sitagliptin/Metformin" plus "Sitagliptin/Metformin XR." "Metformin and Metformin XR Pooled" = "Metformin" plus "Metformin XR." Non-serious and serious adverse events are recorded for all treated participants. All-cause mortality is recorded for all randomized participants.
|
0.00%
0/113 • Up to 56 weeks for non-serious adverse events. Up to approximately 76 weeks for serious adverse events. Up to approximately 78 weeks for all-cause mortality.
"Sitagliptin/Metformin and Sitagliptin/Metformin XR Pooled" = "Sitagliptin/Metformin" plus "Sitagliptin/Metformin XR." "Metformin and Metformin XR Pooled" = "Metformin" plus "Metformin XR." Non-serious and serious adverse events are recorded for all treated participants. All-cause mortality is recorded for all randomized participants.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/62 • Up to 56 weeks for non-serious adverse events. Up to approximately 76 weeks for serious adverse events. Up to approximately 78 weeks for all-cause mortality.
"Sitagliptin/Metformin and Sitagliptin/Metformin XR Pooled" = "Sitagliptin/Metformin" plus "Sitagliptin/Metformin XR." "Metformin and Metformin XR Pooled" = "Metformin" plus "Metformin XR." Non-serious and serious adverse events are recorded for all treated participants. All-cause mortality is recorded for all randomized participants.
|
0.00%
0/62 • Up to 56 weeks for non-serious adverse events. Up to approximately 76 weeks for serious adverse events. Up to approximately 78 weeks for all-cause mortality.
"Sitagliptin/Metformin and Sitagliptin/Metformin XR Pooled" = "Sitagliptin/Metformin" plus "Sitagliptin/Metformin XR." "Metformin and Metformin XR Pooled" = "Metformin" plus "Metformin XR." Non-serious and serious adverse events are recorded for all treated participants. All-cause mortality is recorded for all randomized participants.
|
2.2%
1/45 • Number of events 1 • Up to 56 weeks for non-serious adverse events. Up to approximately 76 weeks for serious adverse events. Up to approximately 78 weeks for all-cause mortality.
"Sitagliptin/Metformin and Sitagliptin/Metformin XR Pooled" = "Sitagliptin/Metformin" plus "Sitagliptin/Metformin XR." "Metformin and Metformin XR Pooled" = "Metformin" plus "Metformin XR." Non-serious and serious adverse events are recorded for all treated participants. All-cause mortality is recorded for all randomized participants.
|
0.00%
0/51 • Up to 56 weeks for non-serious adverse events. Up to approximately 76 weeks for serious adverse events. Up to approximately 78 weeks for all-cause mortality.
"Sitagliptin/Metformin and Sitagliptin/Metformin XR Pooled" = "Sitagliptin/Metformin" plus "Sitagliptin/Metformin XR." "Metformin and Metformin XR Pooled" = "Metformin" plus "Metformin XR." Non-serious and serious adverse events are recorded for all treated participants. All-cause mortality is recorded for all randomized participants.
|
0.93%
1/107 • Number of events 1 • Up to 56 weeks for non-serious adverse events. Up to approximately 76 weeks for serious adverse events. Up to approximately 78 weeks for all-cause mortality.
"Sitagliptin/Metformin and Sitagliptin/Metformin XR Pooled" = "Sitagliptin/Metformin" plus "Sitagliptin/Metformin XR." "Metformin and Metformin XR Pooled" = "Metformin" plus "Metformin XR." Non-serious and serious adverse events are recorded for all treated participants. All-cause mortality is recorded for all randomized participants.
|
0.00%
0/113 • Up to 56 weeks for non-serious adverse events. Up to approximately 76 weeks for serious adverse events. Up to approximately 78 weeks for all-cause mortality.
"Sitagliptin/Metformin and Sitagliptin/Metformin XR Pooled" = "Sitagliptin/Metformin" plus "Sitagliptin/Metformin XR." "Metformin and Metformin XR Pooled" = "Metformin" plus "Metformin XR." Non-serious and serious adverse events are recorded for all treated participants. All-cause mortality is recorded for all randomized participants.
|
|
Investigations
Blood glucose increased
|
0.00%
0/62 • Up to 56 weeks for non-serious adverse events. Up to approximately 76 weeks for serious adverse events. Up to approximately 78 weeks for all-cause mortality.
"Sitagliptin/Metformin and Sitagliptin/Metformin XR Pooled" = "Sitagliptin/Metformin" plus "Sitagliptin/Metformin XR." "Metformin and Metformin XR Pooled" = "Metformin" plus "Metformin XR." Non-serious and serious adverse events are recorded for all treated participants. All-cause mortality is recorded for all randomized participants.
|
1.6%
1/62 • Number of events 1 • Up to 56 weeks for non-serious adverse events. Up to approximately 76 weeks for serious adverse events. Up to approximately 78 weeks for all-cause mortality.
"Sitagliptin/Metformin and Sitagliptin/Metformin XR Pooled" = "Sitagliptin/Metformin" plus "Sitagliptin/Metformin XR." "Metformin and Metformin XR Pooled" = "Metformin" plus "Metformin XR." Non-serious and serious adverse events are recorded for all treated participants. All-cause mortality is recorded for all randomized participants.
|
0.00%
0/45 • Up to 56 weeks for non-serious adverse events. Up to approximately 76 weeks for serious adverse events. Up to approximately 78 weeks for all-cause mortality.
"Sitagliptin/Metformin and Sitagliptin/Metformin XR Pooled" = "Sitagliptin/Metformin" plus "Sitagliptin/Metformin XR." "Metformin and Metformin XR Pooled" = "Metformin" plus "Metformin XR." Non-serious and serious adverse events are recorded for all treated participants. All-cause mortality is recorded for all randomized participants.
|
0.00%
0/51 • Up to 56 weeks for non-serious adverse events. Up to approximately 76 weeks for serious adverse events. Up to approximately 78 weeks for all-cause mortality.
"Sitagliptin/Metformin and Sitagliptin/Metformin XR Pooled" = "Sitagliptin/Metformin" plus "Sitagliptin/Metformin XR." "Metformin and Metformin XR Pooled" = "Metformin" plus "Metformin XR." Non-serious and serious adverse events are recorded for all treated participants. All-cause mortality is recorded for all randomized participants.
|
0.00%
0/107 • Up to 56 weeks for non-serious adverse events. Up to approximately 76 weeks for serious adverse events. Up to approximately 78 weeks for all-cause mortality.
"Sitagliptin/Metformin and Sitagliptin/Metformin XR Pooled" = "Sitagliptin/Metformin" plus "Sitagliptin/Metformin XR." "Metformin and Metformin XR Pooled" = "Metformin" plus "Metformin XR." Non-serious and serious adverse events are recorded for all treated participants. All-cause mortality is recorded for all randomized participants.
|
0.88%
1/113 • Number of events 1 • Up to 56 weeks for non-serious adverse events. Up to approximately 76 weeks for serious adverse events. Up to approximately 78 weeks for all-cause mortality.
"Sitagliptin/Metformin and Sitagliptin/Metformin XR Pooled" = "Sitagliptin/Metformin" plus "Sitagliptin/Metformin XR." "Metformin and Metformin XR Pooled" = "Metformin" plus "Metformin XR." Non-serious and serious adverse events are recorded for all treated participants. All-cause mortality is recorded for all randomized participants.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/62 • Up to 56 weeks for non-serious adverse events. Up to approximately 76 weeks for serious adverse events. Up to approximately 78 weeks for all-cause mortality.
"Sitagliptin/Metformin and Sitagliptin/Metformin XR Pooled" = "Sitagliptin/Metformin" plus "Sitagliptin/Metformin XR." "Metformin and Metformin XR Pooled" = "Metformin" plus "Metformin XR." Non-serious and serious adverse events are recorded for all treated participants. All-cause mortality is recorded for all randomized participants.
|
1.6%
1/62 • Number of events 1 • Up to 56 weeks for non-serious adverse events. Up to approximately 76 weeks for serious adverse events. Up to approximately 78 weeks for all-cause mortality.
"Sitagliptin/Metformin and Sitagliptin/Metformin XR Pooled" = "Sitagliptin/Metformin" plus "Sitagliptin/Metformin XR." "Metformin and Metformin XR Pooled" = "Metformin" plus "Metformin XR." Non-serious and serious adverse events are recorded for all treated participants. All-cause mortality is recorded for all randomized participants.
|
0.00%
0/45 • Up to 56 weeks for non-serious adverse events. Up to approximately 76 weeks for serious adverse events. Up to approximately 78 weeks for all-cause mortality.
"Sitagliptin/Metformin and Sitagliptin/Metformin XR Pooled" = "Sitagliptin/Metformin" plus "Sitagliptin/Metformin XR." "Metformin and Metformin XR Pooled" = "Metformin" plus "Metformin XR." Non-serious and serious adverse events are recorded for all treated participants. All-cause mortality is recorded for all randomized participants.
|
2.0%
1/51 • Number of events 1 • Up to 56 weeks for non-serious adverse events. Up to approximately 76 weeks for serious adverse events. Up to approximately 78 weeks for all-cause mortality.
"Sitagliptin/Metformin and Sitagliptin/Metformin XR Pooled" = "Sitagliptin/Metformin" plus "Sitagliptin/Metformin XR." "Metformin and Metformin XR Pooled" = "Metformin" plus "Metformin XR." Non-serious and serious adverse events are recorded for all treated participants. All-cause mortality is recorded for all randomized participants.
|
0.00%
0/107 • Up to 56 weeks for non-serious adverse events. Up to approximately 76 weeks for serious adverse events. Up to approximately 78 weeks for all-cause mortality.
"Sitagliptin/Metformin and Sitagliptin/Metformin XR Pooled" = "Sitagliptin/Metformin" plus "Sitagliptin/Metformin XR." "Metformin and Metformin XR Pooled" = "Metformin" plus "Metformin XR." Non-serious and serious adverse events are recorded for all treated participants. All-cause mortality is recorded for all randomized participants.
|
1.8%
2/113 • Number of events 2 • Up to 56 weeks for non-serious adverse events. Up to approximately 76 weeks for serious adverse events. Up to approximately 78 weeks for all-cause mortality.
"Sitagliptin/Metformin and Sitagliptin/Metformin XR Pooled" = "Sitagliptin/Metformin" plus "Sitagliptin/Metformin XR." "Metformin and Metformin XR Pooled" = "Metformin" plus "Metformin XR." Non-serious and serious adverse events are recorded for all treated participants. All-cause mortality is recorded for all randomized participants.
|
|
Musculoskeletal and connective tissue disorders
Synovial cyst
|
1.6%
1/62 • Number of events 1 • Up to 56 weeks for non-serious adverse events. Up to approximately 76 weeks for serious adverse events. Up to approximately 78 weeks for all-cause mortality.
"Sitagliptin/Metformin and Sitagliptin/Metformin XR Pooled" = "Sitagliptin/Metformin" plus "Sitagliptin/Metformin XR." "Metformin and Metformin XR Pooled" = "Metformin" plus "Metformin XR." Non-serious and serious adverse events are recorded for all treated participants. All-cause mortality is recorded for all randomized participants.
|
0.00%
0/62 • Up to 56 weeks for non-serious adverse events. Up to approximately 76 weeks for serious adverse events. Up to approximately 78 weeks for all-cause mortality.
"Sitagliptin/Metformin and Sitagliptin/Metformin XR Pooled" = "Sitagliptin/Metformin" plus "Sitagliptin/Metformin XR." "Metformin and Metformin XR Pooled" = "Metformin" plus "Metformin XR." Non-serious and serious adverse events are recorded for all treated participants. All-cause mortality is recorded for all randomized participants.
|
0.00%
0/45 • Up to 56 weeks for non-serious adverse events. Up to approximately 76 weeks for serious adverse events. Up to approximately 78 weeks for all-cause mortality.
"Sitagliptin/Metformin and Sitagliptin/Metformin XR Pooled" = "Sitagliptin/Metformin" plus "Sitagliptin/Metformin XR." "Metformin and Metformin XR Pooled" = "Metformin" plus "Metformin XR." Non-serious and serious adverse events are recorded for all treated participants. All-cause mortality is recorded for all randomized participants.
|
0.00%
0/51 • Up to 56 weeks for non-serious adverse events. Up to approximately 76 weeks for serious adverse events. Up to approximately 78 weeks for all-cause mortality.
"Sitagliptin/Metformin and Sitagliptin/Metformin XR Pooled" = "Sitagliptin/Metformin" plus "Sitagliptin/Metformin XR." "Metformin and Metformin XR Pooled" = "Metformin" plus "Metformin XR." Non-serious and serious adverse events are recorded for all treated participants. All-cause mortality is recorded for all randomized participants.
|
0.93%
1/107 • Number of events 1 • Up to 56 weeks for non-serious adverse events. Up to approximately 76 weeks for serious adverse events. Up to approximately 78 weeks for all-cause mortality.
"Sitagliptin/Metformin and Sitagliptin/Metformin XR Pooled" = "Sitagliptin/Metformin" plus "Sitagliptin/Metformin XR." "Metformin and Metformin XR Pooled" = "Metformin" plus "Metformin XR." Non-serious and serious adverse events are recorded for all treated participants. All-cause mortality is recorded for all randomized participants.
|
0.00%
0/113 • Up to 56 weeks for non-serious adverse events. Up to approximately 76 weeks for serious adverse events. Up to approximately 78 weeks for all-cause mortality.
"Sitagliptin/Metformin and Sitagliptin/Metformin XR Pooled" = "Sitagliptin/Metformin" plus "Sitagliptin/Metformin XR." "Metformin and Metformin XR Pooled" = "Metformin" plus "Metformin XR." Non-serious and serious adverse events are recorded for all treated participants. All-cause mortality is recorded for all randomized participants.
|
|
Nervous system disorders
Epilepsy
|
0.00%
0/62 • Up to 56 weeks for non-serious adverse events. Up to approximately 76 weeks for serious adverse events. Up to approximately 78 weeks for all-cause mortality.
"Sitagliptin/Metformin and Sitagliptin/Metformin XR Pooled" = "Sitagliptin/Metformin" plus "Sitagliptin/Metformin XR." "Metformin and Metformin XR Pooled" = "Metformin" plus "Metformin XR." Non-serious and serious adverse events are recorded for all treated participants. All-cause mortality is recorded for all randomized participants.
|
1.6%
1/62 • Number of events 1 • Up to 56 weeks for non-serious adverse events. Up to approximately 76 weeks for serious adverse events. Up to approximately 78 weeks for all-cause mortality.
"Sitagliptin/Metformin and Sitagliptin/Metformin XR Pooled" = "Sitagliptin/Metformin" plus "Sitagliptin/Metformin XR." "Metformin and Metformin XR Pooled" = "Metformin" plus "Metformin XR." Non-serious and serious adverse events are recorded for all treated participants. All-cause mortality is recorded for all randomized participants.
|
0.00%
0/45 • Up to 56 weeks for non-serious adverse events. Up to approximately 76 weeks for serious adverse events. Up to approximately 78 weeks for all-cause mortality.
"Sitagliptin/Metformin and Sitagliptin/Metformin XR Pooled" = "Sitagliptin/Metformin" plus "Sitagliptin/Metformin XR." "Metformin and Metformin XR Pooled" = "Metformin" plus "Metformin XR." Non-serious and serious adverse events are recorded for all treated participants. All-cause mortality is recorded for all randomized participants.
|
0.00%
0/51 • Up to 56 weeks for non-serious adverse events. Up to approximately 76 weeks for serious adverse events. Up to approximately 78 weeks for all-cause mortality.
"Sitagliptin/Metformin and Sitagliptin/Metformin XR Pooled" = "Sitagliptin/Metformin" plus "Sitagliptin/Metformin XR." "Metformin and Metformin XR Pooled" = "Metformin" plus "Metformin XR." Non-serious and serious adverse events are recorded for all treated participants. All-cause mortality is recorded for all randomized participants.
|
0.00%
0/107 • Up to 56 weeks for non-serious adverse events. Up to approximately 76 weeks for serious adverse events. Up to approximately 78 weeks for all-cause mortality.
"Sitagliptin/Metformin and Sitagliptin/Metformin XR Pooled" = "Sitagliptin/Metformin" plus "Sitagliptin/Metformin XR." "Metformin and Metformin XR Pooled" = "Metformin" plus "Metformin XR." Non-serious and serious adverse events are recorded for all treated participants. All-cause mortality is recorded for all randomized participants.
|
0.88%
1/113 • Number of events 1 • Up to 56 weeks for non-serious adverse events. Up to approximately 76 weeks for serious adverse events. Up to approximately 78 weeks for all-cause mortality.
"Sitagliptin/Metformin and Sitagliptin/Metformin XR Pooled" = "Sitagliptin/Metformin" plus "Sitagliptin/Metformin XR." "Metformin and Metformin XR Pooled" = "Metformin" plus "Metformin XR." Non-serious and serious adverse events are recorded for all treated participants. All-cause mortality is recorded for all randomized participants.
|
|
Psychiatric disorders
Suicide attempt
|
0.00%
0/62 • Up to 56 weeks for non-serious adverse events. Up to approximately 76 weeks for serious adverse events. Up to approximately 78 weeks for all-cause mortality.
"Sitagliptin/Metformin and Sitagliptin/Metformin XR Pooled" = "Sitagliptin/Metformin" plus "Sitagliptin/Metformin XR." "Metformin and Metformin XR Pooled" = "Metformin" plus "Metformin XR." Non-serious and serious adverse events are recorded for all treated participants. All-cause mortality is recorded for all randomized participants.
|
0.00%
0/62 • Up to 56 weeks for non-serious adverse events. Up to approximately 76 weeks for serious adverse events. Up to approximately 78 weeks for all-cause mortality.
"Sitagliptin/Metformin and Sitagliptin/Metformin XR Pooled" = "Sitagliptin/Metformin" plus "Sitagliptin/Metformin XR." "Metformin and Metformin XR Pooled" = "Metformin" plus "Metformin XR." Non-serious and serious adverse events are recorded for all treated participants. All-cause mortality is recorded for all randomized participants.
|
0.00%
0/45 • Up to 56 weeks for non-serious adverse events. Up to approximately 76 weeks for serious adverse events. Up to approximately 78 weeks for all-cause mortality.
"Sitagliptin/Metformin and Sitagliptin/Metformin XR Pooled" = "Sitagliptin/Metformin" plus "Sitagliptin/Metformin XR." "Metformin and Metformin XR Pooled" = "Metformin" plus "Metformin XR." Non-serious and serious adverse events are recorded for all treated participants. All-cause mortality is recorded for all randomized participants.
|
2.0%
1/51 • Number of events 1 • Up to 56 weeks for non-serious adverse events. Up to approximately 76 weeks for serious adverse events. Up to approximately 78 weeks for all-cause mortality.
"Sitagliptin/Metformin and Sitagliptin/Metformin XR Pooled" = "Sitagliptin/Metformin" plus "Sitagliptin/Metformin XR." "Metformin and Metformin XR Pooled" = "Metformin" plus "Metformin XR." Non-serious and serious adverse events are recorded for all treated participants. All-cause mortality is recorded for all randomized participants.
|
0.00%
0/107 • Up to 56 weeks for non-serious adverse events. Up to approximately 76 weeks for serious adverse events. Up to approximately 78 weeks for all-cause mortality.
"Sitagliptin/Metformin and Sitagliptin/Metformin XR Pooled" = "Sitagliptin/Metformin" plus "Sitagliptin/Metformin XR." "Metformin and Metformin XR Pooled" = "Metformin" plus "Metformin XR." Non-serious and serious adverse events are recorded for all treated participants. All-cause mortality is recorded for all randomized participants.
|
0.88%
1/113 • Number of events 1 • Up to 56 weeks for non-serious adverse events. Up to approximately 76 weeks for serious adverse events. Up to approximately 78 weeks for all-cause mortality.
"Sitagliptin/Metformin and Sitagliptin/Metformin XR Pooled" = "Sitagliptin/Metformin" plus "Sitagliptin/Metformin XR." "Metformin and Metformin XR Pooled" = "Metformin" plus "Metformin XR." Non-serious and serious adverse events are recorded for all treated participants. All-cause mortality is recorded for all randomized participants.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
1.6%
1/62 • Number of events 1 • Up to 56 weeks for non-serious adverse events. Up to approximately 76 weeks for serious adverse events. Up to approximately 78 weeks for all-cause mortality.
"Sitagliptin/Metformin and Sitagliptin/Metformin XR Pooled" = "Sitagliptin/Metformin" plus "Sitagliptin/Metformin XR." "Metformin and Metformin XR Pooled" = "Metformin" plus "Metformin XR." Non-serious and serious adverse events are recorded for all treated participants. All-cause mortality is recorded for all randomized participants.
|
0.00%
0/62 • Up to 56 weeks for non-serious adverse events. Up to approximately 76 weeks for serious adverse events. Up to approximately 78 weeks for all-cause mortality.
"Sitagliptin/Metformin and Sitagliptin/Metformin XR Pooled" = "Sitagliptin/Metformin" plus "Sitagliptin/Metformin XR." "Metformin and Metformin XR Pooled" = "Metformin" plus "Metformin XR." Non-serious and serious adverse events are recorded for all treated participants. All-cause mortality is recorded for all randomized participants.
|
0.00%
0/45 • Up to 56 weeks for non-serious adverse events. Up to approximately 76 weeks for serious adverse events. Up to approximately 78 weeks for all-cause mortality.
"Sitagliptin/Metformin and Sitagliptin/Metformin XR Pooled" = "Sitagliptin/Metformin" plus "Sitagliptin/Metformin XR." "Metformin and Metformin XR Pooled" = "Metformin" plus "Metformin XR." Non-serious and serious adverse events are recorded for all treated participants. All-cause mortality is recorded for all randomized participants.
|
0.00%
0/51 • Up to 56 weeks for non-serious adverse events. Up to approximately 76 weeks for serious adverse events. Up to approximately 78 weeks for all-cause mortality.
"Sitagliptin/Metformin and Sitagliptin/Metformin XR Pooled" = "Sitagliptin/Metformin" plus "Sitagliptin/Metformin XR." "Metformin and Metformin XR Pooled" = "Metformin" plus "Metformin XR." Non-serious and serious adverse events are recorded for all treated participants. All-cause mortality is recorded for all randomized participants.
|
0.93%
1/107 • Number of events 1 • Up to 56 weeks for non-serious adverse events. Up to approximately 76 weeks for serious adverse events. Up to approximately 78 weeks for all-cause mortality.
"Sitagliptin/Metformin and Sitagliptin/Metformin XR Pooled" = "Sitagliptin/Metformin" plus "Sitagliptin/Metformin XR." "Metformin and Metformin XR Pooled" = "Metformin" plus "Metformin XR." Non-serious and serious adverse events are recorded for all treated participants. All-cause mortality is recorded for all randomized participants.
|
0.00%
0/113 • Up to 56 weeks for non-serious adverse events. Up to approximately 76 weeks for serious adverse events. Up to approximately 78 weeks for all-cause mortality.
"Sitagliptin/Metformin and Sitagliptin/Metformin XR Pooled" = "Sitagliptin/Metformin" plus "Sitagliptin/Metformin XR." "Metformin and Metformin XR Pooled" = "Metformin" plus "Metformin XR." Non-serious and serious adverse events are recorded for all treated participants. All-cause mortality is recorded for all randomized participants.
|
|
General disorders
Death
|
1.6%
1/62 • Number of events 1 • Up to 56 weeks for non-serious adverse events. Up to approximately 76 weeks for serious adverse events. Up to approximately 78 weeks for all-cause mortality.
"Sitagliptin/Metformin and Sitagliptin/Metformin XR Pooled" = "Sitagliptin/Metformin" plus "Sitagliptin/Metformin XR." "Metformin and Metformin XR Pooled" = "Metformin" plus "Metformin XR." Non-serious and serious adverse events are recorded for all treated participants. All-cause mortality is recorded for all randomized participants.
|
0.00%
0/62 • Up to 56 weeks for non-serious adverse events. Up to approximately 76 weeks for serious adverse events. Up to approximately 78 weeks for all-cause mortality.
"Sitagliptin/Metformin and Sitagliptin/Metformin XR Pooled" = "Sitagliptin/Metformin" plus "Sitagliptin/Metformin XR." "Metformin and Metformin XR Pooled" = "Metformin" plus "Metformin XR." Non-serious and serious adverse events are recorded for all treated participants. All-cause mortality is recorded for all randomized participants.
|
0.00%
0/45 • Up to 56 weeks for non-serious adverse events. Up to approximately 76 weeks for serious adverse events. Up to approximately 78 weeks for all-cause mortality.
"Sitagliptin/Metformin and Sitagliptin/Metformin XR Pooled" = "Sitagliptin/Metformin" plus "Sitagliptin/Metformin XR." "Metformin and Metformin XR Pooled" = "Metformin" plus "Metformin XR." Non-serious and serious adverse events are recorded for all treated participants. All-cause mortality is recorded for all randomized participants.
|
0.00%
0/51 • Up to 56 weeks for non-serious adverse events. Up to approximately 76 weeks for serious adverse events. Up to approximately 78 weeks for all-cause mortality.
"Sitagliptin/Metformin and Sitagliptin/Metformin XR Pooled" = "Sitagliptin/Metformin" plus "Sitagliptin/Metformin XR." "Metformin and Metformin XR Pooled" = "Metformin" plus "Metformin XR." Non-serious and serious adverse events are recorded for all treated participants. All-cause mortality is recorded for all randomized participants.
|
0.93%
1/107 • Number of events 1 • Up to 56 weeks for non-serious adverse events. Up to approximately 76 weeks for serious adverse events. Up to approximately 78 weeks for all-cause mortality.
"Sitagliptin/Metformin and Sitagliptin/Metformin XR Pooled" = "Sitagliptin/Metformin" plus "Sitagliptin/Metformin XR." "Metformin and Metformin XR Pooled" = "Metformin" plus "Metformin XR." Non-serious and serious adverse events are recorded for all treated participants. All-cause mortality is recorded for all randomized participants.
|
0.00%
0/113 • Up to 56 weeks for non-serious adverse events. Up to approximately 76 weeks for serious adverse events. Up to approximately 78 weeks for all-cause mortality.
"Sitagliptin/Metformin and Sitagliptin/Metformin XR Pooled" = "Sitagliptin/Metformin" plus "Sitagliptin/Metformin XR." "Metformin and Metformin XR Pooled" = "Metformin" plus "Metformin XR." Non-serious and serious adverse events are recorded for all treated participants. All-cause mortality is recorded for all randomized participants.
|
Other adverse events
| Measure |
Sitagliptin/Metformin
n=62 participants at risk
Participants received one tablet of sitagliptin/metformin and one tablet of metformin-placebo, administered twice daily prior to the morning and evening meals, for up to 20 weeks in the base study alone, or for up to 54 weeks if the participant also entered the extension study. Participants in this arm were enrolled in protocol MK-0431A-170.
|
Metformin
n=62 participants at risk
Participants received one tablet of metformin and one tablet of placebo to sitagliptin/metformin, administered twice daily prior to the morning and evening meals, for up to 20 weeks in the base study alone, or for up to 54 weeks if the participant also entered the extension study. Participants in this arm were enrolled in protocol MK-0431A-170.
|
Sitagliptin/Metformin XR
n=45 participants at risk
Participants received two tablets of sitagliptin/metformin XR and two tablets of metformin XR placebo, administered once daily with a meal, for up to 54 weeks. Participants in this arm were enrolled in protocol MK-0431A-289.
|
Metformin XR
n=51 participants at risk
Participants received two tablets of metformin XR and two tablets of placebo to sitagliptin/metformin XR, administered once daily with a meal, for up to 54 weeks. Participants in this arm were enrolled in protocol MK-0431A-289.
|
Sitagliptin/Metformin and Sitagliptin/Metformin XR Pooled
n=107 participants at risk
This reporting group contains the pooled population of treated participants from the experimental-drug groups "Sitagliptin/Metformin" (from protocol MK-0431A-170) and "Sitagliptin/Metformin XR" (from protocol MK-0431A-289).
|
Metformin and Metformin XR Pooled
n=113 participants at risk
This reporting group contains the pooled population of treated participants from the placebo groups "Metformin" (from protocol MK-0431A-170) and "Metformin XR" (from protocol MK-0431A-289).
|
|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
3.2%
2/62 • Number of events 2 • Up to 56 weeks for non-serious adverse events. Up to approximately 76 weeks for serious adverse events. Up to approximately 78 weeks for all-cause mortality.
"Sitagliptin/Metformin and Sitagliptin/Metformin XR Pooled" = "Sitagliptin/Metformin" plus "Sitagliptin/Metformin XR." "Metformin and Metformin XR Pooled" = "Metformin" plus "Metformin XR." Non-serious and serious adverse events are recorded for all treated participants. All-cause mortality is recorded for all randomized participants.
|
6.5%
4/62 • Number of events 4 • Up to 56 weeks for non-serious adverse events. Up to approximately 76 weeks for serious adverse events. Up to approximately 78 weeks for all-cause mortality.
"Sitagliptin/Metformin and Sitagliptin/Metformin XR Pooled" = "Sitagliptin/Metformin" plus "Sitagliptin/Metformin XR." "Metformin and Metformin XR Pooled" = "Metformin" plus "Metformin XR." Non-serious and serious adverse events are recorded for all treated participants. All-cause mortality is recorded for all randomized participants.
|
8.9%
4/45 • Number of events 4 • Up to 56 weeks for non-serious adverse events. Up to approximately 76 weeks for serious adverse events. Up to approximately 78 weeks for all-cause mortality.
"Sitagliptin/Metformin and Sitagliptin/Metformin XR Pooled" = "Sitagliptin/Metformin" plus "Sitagliptin/Metformin XR." "Metformin and Metformin XR Pooled" = "Metformin" plus "Metformin XR." Non-serious and serious adverse events are recorded for all treated participants. All-cause mortality is recorded for all randomized participants.
|
7.8%
4/51 • Number of events 4 • Up to 56 weeks for non-serious adverse events. Up to approximately 76 weeks for serious adverse events. Up to approximately 78 weeks for all-cause mortality.
"Sitagliptin/Metformin and Sitagliptin/Metformin XR Pooled" = "Sitagliptin/Metformin" plus "Sitagliptin/Metformin XR." "Metformin and Metformin XR Pooled" = "Metformin" plus "Metformin XR." Non-serious and serious adverse events are recorded for all treated participants. All-cause mortality is recorded for all randomized participants.
|
5.6%
6/107 • Number of events 6 • Up to 56 weeks for non-serious adverse events. Up to approximately 76 weeks for serious adverse events. Up to approximately 78 weeks for all-cause mortality.
"Sitagliptin/Metformin and Sitagliptin/Metformin XR Pooled" = "Sitagliptin/Metformin" plus "Sitagliptin/Metformin XR." "Metformin and Metformin XR Pooled" = "Metformin" plus "Metformin XR." Non-serious and serious adverse events are recorded for all treated participants. All-cause mortality is recorded for all randomized participants.
|
7.1%
8/113 • Number of events 8 • Up to 56 weeks for non-serious adverse events. Up to approximately 76 weeks for serious adverse events. Up to approximately 78 weeks for all-cause mortality.
"Sitagliptin/Metformin and Sitagliptin/Metformin XR Pooled" = "Sitagliptin/Metformin" plus "Sitagliptin/Metformin XR." "Metformin and Metformin XR Pooled" = "Metformin" plus "Metformin XR." Non-serious and serious adverse events are recorded for all treated participants. All-cause mortality is recorded for all randomized participants.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
1.6%
1/62 • Number of events 2 • Up to 56 weeks for non-serious adverse events. Up to approximately 76 weeks for serious adverse events. Up to approximately 78 weeks for all-cause mortality.
"Sitagliptin/Metformin and Sitagliptin/Metformin XR Pooled" = "Sitagliptin/Metformin" plus "Sitagliptin/Metformin XR." "Metformin and Metformin XR Pooled" = "Metformin" plus "Metformin XR." Non-serious and serious adverse events are recorded for all treated participants. All-cause mortality is recorded for all randomized participants.
|
3.2%
2/62 • Number of events 2 • Up to 56 weeks for non-serious adverse events. Up to approximately 76 weeks for serious adverse events. Up to approximately 78 weeks for all-cause mortality.
"Sitagliptin/Metformin and Sitagliptin/Metformin XR Pooled" = "Sitagliptin/Metformin" plus "Sitagliptin/Metformin XR." "Metformin and Metformin XR Pooled" = "Metformin" plus "Metformin XR." Non-serious and serious adverse events are recorded for all treated participants. All-cause mortality is recorded for all randomized participants.
|
0.00%
0/45 • Up to 56 weeks for non-serious adverse events. Up to approximately 76 weeks for serious adverse events. Up to approximately 78 weeks for all-cause mortality.
"Sitagliptin/Metformin and Sitagliptin/Metformin XR Pooled" = "Sitagliptin/Metformin" plus "Sitagliptin/Metformin XR." "Metformin and Metformin XR Pooled" = "Metformin" plus "Metformin XR." Non-serious and serious adverse events are recorded for all treated participants. All-cause mortality is recorded for all randomized participants.
|
5.9%
3/51 • Number of events 4 • Up to 56 weeks for non-serious adverse events. Up to approximately 76 weeks for serious adverse events. Up to approximately 78 weeks for all-cause mortality.
"Sitagliptin/Metformin and Sitagliptin/Metformin XR Pooled" = "Sitagliptin/Metformin" plus "Sitagliptin/Metformin XR." "Metformin and Metformin XR Pooled" = "Metformin" plus "Metformin XR." Non-serious and serious adverse events are recorded for all treated participants. All-cause mortality is recorded for all randomized participants.
|
0.93%
1/107 • Number of events 2 • Up to 56 weeks for non-serious adverse events. Up to approximately 76 weeks for serious adverse events. Up to approximately 78 weeks for all-cause mortality.
"Sitagliptin/Metformin and Sitagliptin/Metformin XR Pooled" = "Sitagliptin/Metformin" plus "Sitagliptin/Metformin XR." "Metformin and Metformin XR Pooled" = "Metformin" plus "Metformin XR." Non-serious and serious adverse events are recorded for all treated participants. All-cause mortality is recorded for all randomized participants.
|
4.4%
5/113 • Number of events 6 • Up to 56 weeks for non-serious adverse events. Up to approximately 76 weeks for serious adverse events. Up to approximately 78 weeks for all-cause mortality.
"Sitagliptin/Metformin and Sitagliptin/Metformin XR Pooled" = "Sitagliptin/Metformin" plus "Sitagliptin/Metformin XR." "Metformin and Metformin XR Pooled" = "Metformin" plus "Metformin XR." Non-serious and serious adverse events are recorded for all treated participants. All-cause mortality is recorded for all randomized participants.
|
|
Gastrointestinal disorders
Diarrhoea
|
11.3%
7/62 • Number of events 8 • Up to 56 weeks for non-serious adverse events. Up to approximately 76 weeks for serious adverse events. Up to approximately 78 weeks for all-cause mortality.
"Sitagliptin/Metformin and Sitagliptin/Metformin XR Pooled" = "Sitagliptin/Metformin" plus "Sitagliptin/Metformin XR." "Metformin and Metformin XR Pooled" = "Metformin" plus "Metformin XR." Non-serious and serious adverse events are recorded for all treated participants. All-cause mortality is recorded for all randomized participants.
|
6.5%
4/62 • Number of events 4 • Up to 56 weeks for non-serious adverse events. Up to approximately 76 weeks for serious adverse events. Up to approximately 78 weeks for all-cause mortality.
"Sitagliptin/Metformin and Sitagliptin/Metformin XR Pooled" = "Sitagliptin/Metformin" plus "Sitagliptin/Metformin XR." "Metformin and Metformin XR Pooled" = "Metformin" plus "Metformin XR." Non-serious and serious adverse events are recorded for all treated participants. All-cause mortality is recorded for all randomized participants.
|
2.2%
1/45 • Number of events 1 • Up to 56 weeks for non-serious adverse events. Up to approximately 76 weeks for serious adverse events. Up to approximately 78 weeks for all-cause mortality.
"Sitagliptin/Metformin and Sitagliptin/Metformin XR Pooled" = "Sitagliptin/Metformin" plus "Sitagliptin/Metformin XR." "Metformin and Metformin XR Pooled" = "Metformin" plus "Metformin XR." Non-serious and serious adverse events are recorded for all treated participants. All-cause mortality is recorded for all randomized participants.
|
5.9%
3/51 • Number of events 10 • Up to 56 weeks for non-serious adverse events. Up to approximately 76 weeks for serious adverse events. Up to approximately 78 weeks for all-cause mortality.
"Sitagliptin/Metformin and Sitagliptin/Metformin XR Pooled" = "Sitagliptin/Metformin" plus "Sitagliptin/Metformin XR." "Metformin and Metformin XR Pooled" = "Metformin" plus "Metformin XR." Non-serious and serious adverse events are recorded for all treated participants. All-cause mortality is recorded for all randomized participants.
|
7.5%
8/107 • Number of events 9 • Up to 56 weeks for non-serious adverse events. Up to approximately 76 weeks for serious adverse events. Up to approximately 78 weeks for all-cause mortality.
"Sitagliptin/Metformin and Sitagliptin/Metformin XR Pooled" = "Sitagliptin/Metformin" plus "Sitagliptin/Metformin XR." "Metformin and Metformin XR Pooled" = "Metformin" plus "Metformin XR." Non-serious and serious adverse events are recorded for all treated participants. All-cause mortality is recorded for all randomized participants.
|
6.2%
7/113 • Number of events 14 • Up to 56 weeks for non-serious adverse events. Up to approximately 76 weeks for serious adverse events. Up to approximately 78 weeks for all-cause mortality.
"Sitagliptin/Metformin and Sitagliptin/Metformin XR Pooled" = "Sitagliptin/Metformin" plus "Sitagliptin/Metformin XR." "Metformin and Metformin XR Pooled" = "Metformin" plus "Metformin XR." Non-serious and serious adverse events are recorded for all treated participants. All-cause mortality is recorded for all randomized participants.
|
|
Gastrointestinal disorders
Nausea
|
3.2%
2/62 • Number of events 5 • Up to 56 weeks for non-serious adverse events. Up to approximately 76 weeks for serious adverse events. Up to approximately 78 weeks for all-cause mortality.
"Sitagliptin/Metformin and Sitagliptin/Metformin XR Pooled" = "Sitagliptin/Metformin" plus "Sitagliptin/Metformin XR." "Metformin and Metformin XR Pooled" = "Metformin" plus "Metformin XR." Non-serious and serious adverse events are recorded for all treated participants. All-cause mortality is recorded for all randomized participants.
|
8.1%
5/62 • Number of events 5 • Up to 56 weeks for non-serious adverse events. Up to approximately 76 weeks for serious adverse events. Up to approximately 78 weeks for all-cause mortality.
"Sitagliptin/Metformin and Sitagliptin/Metformin XR Pooled" = "Sitagliptin/Metformin" plus "Sitagliptin/Metformin XR." "Metformin and Metformin XR Pooled" = "Metformin" plus "Metformin XR." Non-serious and serious adverse events are recorded for all treated participants. All-cause mortality is recorded for all randomized participants.
|
8.9%
4/45 • Number of events 6 • Up to 56 weeks for non-serious adverse events. Up to approximately 76 weeks for serious adverse events. Up to approximately 78 weeks for all-cause mortality.
"Sitagliptin/Metformin and Sitagliptin/Metformin XR Pooled" = "Sitagliptin/Metformin" plus "Sitagliptin/Metformin XR." "Metformin and Metformin XR Pooled" = "Metformin" plus "Metformin XR." Non-serious and serious adverse events are recorded for all treated participants. All-cause mortality is recorded for all randomized participants.
|
3.9%
2/51 • Number of events 3 • Up to 56 weeks for non-serious adverse events. Up to approximately 76 weeks for serious adverse events. Up to approximately 78 weeks for all-cause mortality.
"Sitagliptin/Metformin and Sitagliptin/Metformin XR Pooled" = "Sitagliptin/Metformin" plus "Sitagliptin/Metformin XR." "Metformin and Metformin XR Pooled" = "Metformin" plus "Metformin XR." Non-serious and serious adverse events are recorded for all treated participants. All-cause mortality is recorded for all randomized participants.
|
5.6%
6/107 • Number of events 11 • Up to 56 weeks for non-serious adverse events. Up to approximately 76 weeks for serious adverse events. Up to approximately 78 weeks for all-cause mortality.
"Sitagliptin/Metformin and Sitagliptin/Metformin XR Pooled" = "Sitagliptin/Metformin" plus "Sitagliptin/Metformin XR." "Metformin and Metformin XR Pooled" = "Metformin" plus "Metformin XR." Non-serious and serious adverse events are recorded for all treated participants. All-cause mortality is recorded for all randomized participants.
|
6.2%
7/113 • Number of events 8 • Up to 56 weeks for non-serious adverse events. Up to approximately 76 weeks for serious adverse events. Up to approximately 78 weeks for all-cause mortality.
"Sitagliptin/Metformin and Sitagliptin/Metformin XR Pooled" = "Sitagliptin/Metformin" plus "Sitagliptin/Metformin XR." "Metformin and Metformin XR Pooled" = "Metformin" plus "Metformin XR." Non-serious and serious adverse events are recorded for all treated participants. All-cause mortality is recorded for all randomized participants.
|
|
Infections and infestations
Gastroenteritis
|
8.1%
5/62 • Number of events 6 • Up to 56 weeks for non-serious adverse events. Up to approximately 76 weeks for serious adverse events. Up to approximately 78 weeks for all-cause mortality.
"Sitagliptin/Metformin and Sitagliptin/Metformin XR Pooled" = "Sitagliptin/Metformin" plus "Sitagliptin/Metformin XR." "Metformin and Metformin XR Pooled" = "Metformin" plus "Metformin XR." Non-serious and serious adverse events are recorded for all treated participants. All-cause mortality is recorded for all randomized participants.
|
4.8%
3/62 • Number of events 3 • Up to 56 weeks for non-serious adverse events. Up to approximately 76 weeks for serious adverse events. Up to approximately 78 weeks for all-cause mortality.
"Sitagliptin/Metformin and Sitagliptin/Metformin XR Pooled" = "Sitagliptin/Metformin" plus "Sitagliptin/Metformin XR." "Metformin and Metformin XR Pooled" = "Metformin" plus "Metformin XR." Non-serious and serious adverse events are recorded for all treated participants. All-cause mortality is recorded for all randomized participants.
|
6.7%
3/45 • Number of events 3 • Up to 56 weeks for non-serious adverse events. Up to approximately 76 weeks for serious adverse events. Up to approximately 78 weeks for all-cause mortality.
"Sitagliptin/Metformin and Sitagliptin/Metformin XR Pooled" = "Sitagliptin/Metformin" plus "Sitagliptin/Metformin XR." "Metformin and Metformin XR Pooled" = "Metformin" plus "Metformin XR." Non-serious and serious adverse events are recorded for all treated participants. All-cause mortality is recorded for all randomized participants.
|
3.9%
2/51 • Number of events 2 • Up to 56 weeks for non-serious adverse events. Up to approximately 76 weeks for serious adverse events. Up to approximately 78 weeks for all-cause mortality.
"Sitagliptin/Metformin and Sitagliptin/Metformin XR Pooled" = "Sitagliptin/Metformin" plus "Sitagliptin/Metformin XR." "Metformin and Metformin XR Pooled" = "Metformin" plus "Metformin XR." Non-serious and serious adverse events are recorded for all treated participants. All-cause mortality is recorded for all randomized participants.
|
7.5%
8/107 • Number of events 9 • Up to 56 weeks for non-serious adverse events. Up to approximately 76 weeks for serious adverse events. Up to approximately 78 weeks for all-cause mortality.
"Sitagliptin/Metformin and Sitagliptin/Metformin XR Pooled" = "Sitagliptin/Metformin" plus "Sitagliptin/Metformin XR." "Metformin and Metformin XR Pooled" = "Metformin" plus "Metformin XR." Non-serious and serious adverse events are recorded for all treated participants. All-cause mortality is recorded for all randomized participants.
|
4.4%
5/113 • Number of events 5 • Up to 56 weeks for non-serious adverse events. Up to approximately 76 weeks for serious adverse events. Up to approximately 78 weeks for all-cause mortality.
"Sitagliptin/Metformin and Sitagliptin/Metformin XR Pooled" = "Sitagliptin/Metformin" plus "Sitagliptin/Metformin XR." "Metformin and Metformin XR Pooled" = "Metformin" plus "Metformin XR." Non-serious and serious adverse events are recorded for all treated participants. All-cause mortality is recorded for all randomized participants.
|
|
Infections and infestations
Influenza
|
1.6%
1/62 • Number of events 1 • Up to 56 weeks for non-serious adverse events. Up to approximately 76 weeks for serious adverse events. Up to approximately 78 weeks for all-cause mortality.
"Sitagliptin/Metformin and Sitagliptin/Metformin XR Pooled" = "Sitagliptin/Metformin" plus "Sitagliptin/Metformin XR." "Metformin and Metformin XR Pooled" = "Metformin" plus "Metformin XR." Non-serious and serious adverse events are recorded for all treated participants. All-cause mortality is recorded for all randomized participants.
|
6.5%
4/62 • Number of events 5 • Up to 56 weeks for non-serious adverse events. Up to approximately 76 weeks for serious adverse events. Up to approximately 78 weeks for all-cause mortality.
"Sitagliptin/Metformin and Sitagliptin/Metformin XR Pooled" = "Sitagliptin/Metformin" plus "Sitagliptin/Metformin XR." "Metformin and Metformin XR Pooled" = "Metformin" plus "Metformin XR." Non-serious and serious adverse events are recorded for all treated participants. All-cause mortality is recorded for all randomized participants.
|
4.4%
2/45 • Number of events 3 • Up to 56 weeks for non-serious adverse events. Up to approximately 76 weeks for serious adverse events. Up to approximately 78 weeks for all-cause mortality.
"Sitagliptin/Metformin and Sitagliptin/Metformin XR Pooled" = "Sitagliptin/Metformin" plus "Sitagliptin/Metformin XR." "Metformin and Metformin XR Pooled" = "Metformin" plus "Metformin XR." Non-serious and serious adverse events are recorded for all treated participants. All-cause mortality is recorded for all randomized participants.
|
5.9%
3/51 • Number of events 5 • Up to 56 weeks for non-serious adverse events. Up to approximately 76 weeks for serious adverse events. Up to approximately 78 weeks for all-cause mortality.
"Sitagliptin/Metformin and Sitagliptin/Metformin XR Pooled" = "Sitagliptin/Metformin" plus "Sitagliptin/Metformin XR." "Metformin and Metformin XR Pooled" = "Metformin" plus "Metformin XR." Non-serious and serious adverse events are recorded for all treated participants. All-cause mortality is recorded for all randomized participants.
|
2.8%
3/107 • Number of events 4 • Up to 56 weeks for non-serious adverse events. Up to approximately 76 weeks for serious adverse events. Up to approximately 78 weeks for all-cause mortality.
"Sitagliptin/Metformin and Sitagliptin/Metformin XR Pooled" = "Sitagliptin/Metformin" plus "Sitagliptin/Metformin XR." "Metformin and Metformin XR Pooled" = "Metformin" plus "Metformin XR." Non-serious and serious adverse events are recorded for all treated participants. All-cause mortality is recorded for all randomized participants.
|
6.2%
7/113 • Number of events 10 • Up to 56 weeks for non-serious adverse events. Up to approximately 76 weeks for serious adverse events. Up to approximately 78 weeks for all-cause mortality.
"Sitagliptin/Metformin and Sitagliptin/Metformin XR Pooled" = "Sitagliptin/Metformin" plus "Sitagliptin/Metformin XR." "Metformin and Metformin XR Pooled" = "Metformin" plus "Metformin XR." Non-serious and serious adverse events are recorded for all treated participants. All-cause mortality is recorded for all randomized participants.
|
|
Infections and infestations
Nasopharyngitis
|
11.3%
7/62 • Number of events 11 • Up to 56 weeks for non-serious adverse events. Up to approximately 76 weeks for serious adverse events. Up to approximately 78 weeks for all-cause mortality.
"Sitagliptin/Metformin and Sitagliptin/Metformin XR Pooled" = "Sitagliptin/Metformin" plus "Sitagliptin/Metformin XR." "Metformin and Metformin XR Pooled" = "Metformin" plus "Metformin XR." Non-serious and serious adverse events are recorded for all treated participants. All-cause mortality is recorded for all randomized participants.
|
11.3%
7/62 • Number of events 7 • Up to 56 weeks for non-serious adverse events. Up to approximately 76 weeks for serious adverse events. Up to approximately 78 weeks for all-cause mortality.
"Sitagliptin/Metformin and Sitagliptin/Metformin XR Pooled" = "Sitagliptin/Metformin" plus "Sitagliptin/Metformin XR." "Metformin and Metformin XR Pooled" = "Metformin" plus "Metformin XR." Non-serious and serious adverse events are recorded for all treated participants. All-cause mortality is recorded for all randomized participants.
|
2.2%
1/45 • Number of events 2 • Up to 56 weeks for non-serious adverse events. Up to approximately 76 weeks for serious adverse events. Up to approximately 78 weeks for all-cause mortality.
"Sitagliptin/Metformin and Sitagliptin/Metformin XR Pooled" = "Sitagliptin/Metformin" plus "Sitagliptin/Metformin XR." "Metformin and Metformin XR Pooled" = "Metformin" plus "Metformin XR." Non-serious and serious adverse events are recorded for all treated participants. All-cause mortality is recorded for all randomized participants.
|
3.9%
2/51 • Number of events 3 • Up to 56 weeks for non-serious adverse events. Up to approximately 76 weeks for serious adverse events. Up to approximately 78 weeks for all-cause mortality.
"Sitagliptin/Metformin and Sitagliptin/Metformin XR Pooled" = "Sitagliptin/Metformin" plus "Sitagliptin/Metformin XR." "Metformin and Metformin XR Pooled" = "Metformin" plus "Metformin XR." Non-serious and serious adverse events are recorded for all treated participants. All-cause mortality is recorded for all randomized participants.
|
7.5%
8/107 • Number of events 13 • Up to 56 weeks for non-serious adverse events. Up to approximately 76 weeks for serious adverse events. Up to approximately 78 weeks for all-cause mortality.
"Sitagliptin/Metformin and Sitagliptin/Metformin XR Pooled" = "Sitagliptin/Metformin" plus "Sitagliptin/Metformin XR." "Metformin and Metformin XR Pooled" = "Metformin" plus "Metformin XR." Non-serious and serious adverse events are recorded for all treated participants. All-cause mortality is recorded for all randomized participants.
|
8.0%
9/113 • Number of events 10 • Up to 56 weeks for non-serious adverse events. Up to approximately 76 weeks for serious adverse events. Up to approximately 78 weeks for all-cause mortality.
"Sitagliptin/Metformin and Sitagliptin/Metformin XR Pooled" = "Sitagliptin/Metformin" plus "Sitagliptin/Metformin XR." "Metformin and Metformin XR Pooled" = "Metformin" plus "Metformin XR." Non-serious and serious adverse events are recorded for all treated participants. All-cause mortality is recorded for all randomized participants.
|
|
Infections and infestations
Pharyngitis
|
1.6%
1/62 • Number of events 1 • Up to 56 weeks for non-serious adverse events. Up to approximately 76 weeks for serious adverse events. Up to approximately 78 weeks for all-cause mortality.
"Sitagliptin/Metformin and Sitagliptin/Metformin XR Pooled" = "Sitagliptin/Metformin" plus "Sitagliptin/Metformin XR." "Metformin and Metformin XR Pooled" = "Metformin" plus "Metformin XR." Non-serious and serious adverse events are recorded for all treated participants. All-cause mortality is recorded for all randomized participants.
|
4.8%
3/62 • Number of events 3 • Up to 56 weeks for non-serious adverse events. Up to approximately 76 weeks for serious adverse events. Up to approximately 78 weeks for all-cause mortality.
"Sitagliptin/Metformin and Sitagliptin/Metformin XR Pooled" = "Sitagliptin/Metformin" plus "Sitagliptin/Metformin XR." "Metformin and Metformin XR Pooled" = "Metformin" plus "Metformin XR." Non-serious and serious adverse events are recorded for all treated participants. All-cause mortality is recorded for all randomized participants.
|
2.2%
1/45 • Number of events 1 • Up to 56 weeks for non-serious adverse events. Up to approximately 76 weeks for serious adverse events. Up to approximately 78 weeks for all-cause mortality.
"Sitagliptin/Metformin and Sitagliptin/Metformin XR Pooled" = "Sitagliptin/Metformin" plus "Sitagliptin/Metformin XR." "Metformin and Metformin XR Pooled" = "Metformin" plus "Metformin XR." Non-serious and serious adverse events are recorded for all treated participants. All-cause mortality is recorded for all randomized participants.
|
9.8%
5/51 • Number of events 6 • Up to 56 weeks for non-serious adverse events. Up to approximately 76 weeks for serious adverse events. Up to approximately 78 weeks for all-cause mortality.
"Sitagliptin/Metformin and Sitagliptin/Metformin XR Pooled" = "Sitagliptin/Metformin" plus "Sitagliptin/Metformin XR." "Metformin and Metformin XR Pooled" = "Metformin" plus "Metformin XR." Non-serious and serious adverse events are recorded for all treated participants. All-cause mortality is recorded for all randomized participants.
|
1.9%
2/107 • Number of events 2 • Up to 56 weeks for non-serious adverse events. Up to approximately 76 weeks for serious adverse events. Up to approximately 78 weeks for all-cause mortality.
"Sitagliptin/Metformin and Sitagliptin/Metformin XR Pooled" = "Sitagliptin/Metformin" plus "Sitagliptin/Metformin XR." "Metformin and Metformin XR Pooled" = "Metformin" plus "Metformin XR." Non-serious and serious adverse events are recorded for all treated participants. All-cause mortality is recorded for all randomized participants.
|
7.1%
8/113 • Number of events 9 • Up to 56 weeks for non-serious adverse events. Up to approximately 76 weeks for serious adverse events. Up to approximately 78 weeks for all-cause mortality.
"Sitagliptin/Metformin and Sitagliptin/Metformin XR Pooled" = "Sitagliptin/Metformin" plus "Sitagliptin/Metformin XR." "Metformin and Metformin XR Pooled" = "Metformin" plus "Metformin XR." Non-serious and serious adverse events are recorded for all treated participants. All-cause mortality is recorded for all randomized participants.
|
|
Infections and infestations
Upper respiratory tract infection
|
14.5%
9/62 • Number of events 11 • Up to 56 weeks for non-serious adverse events. Up to approximately 76 weeks for serious adverse events. Up to approximately 78 weeks for all-cause mortality.
"Sitagliptin/Metformin and Sitagliptin/Metformin XR Pooled" = "Sitagliptin/Metformin" plus "Sitagliptin/Metformin XR." "Metformin and Metformin XR Pooled" = "Metformin" plus "Metformin XR." Non-serious and serious adverse events are recorded for all treated participants. All-cause mortality is recorded for all randomized participants.
|
9.7%
6/62 • Number of events 8 • Up to 56 weeks for non-serious adverse events. Up to approximately 76 weeks for serious adverse events. Up to approximately 78 weeks for all-cause mortality.
"Sitagliptin/Metformin and Sitagliptin/Metformin XR Pooled" = "Sitagliptin/Metformin" plus "Sitagliptin/Metformin XR." "Metformin and Metformin XR Pooled" = "Metformin" plus "Metformin XR." Non-serious and serious adverse events are recorded for all treated participants. All-cause mortality is recorded for all randomized participants.
|
11.1%
5/45 • Number of events 9 • Up to 56 weeks for non-serious adverse events. Up to approximately 76 weeks for serious adverse events. Up to approximately 78 weeks for all-cause mortality.
"Sitagliptin/Metformin and Sitagliptin/Metformin XR Pooled" = "Sitagliptin/Metformin" plus "Sitagliptin/Metformin XR." "Metformin and Metformin XR Pooled" = "Metformin" plus "Metformin XR." Non-serious and serious adverse events are recorded for all treated participants. All-cause mortality is recorded for all randomized participants.
|
5.9%
3/51 • Number of events 5 • Up to 56 weeks for non-serious adverse events. Up to approximately 76 weeks for serious adverse events. Up to approximately 78 weeks for all-cause mortality.
"Sitagliptin/Metformin and Sitagliptin/Metformin XR Pooled" = "Sitagliptin/Metformin" plus "Sitagliptin/Metformin XR." "Metformin and Metformin XR Pooled" = "Metformin" plus "Metformin XR." Non-serious and serious adverse events are recorded for all treated participants. All-cause mortality is recorded for all randomized participants.
|
13.1%
14/107 • Number of events 20 • Up to 56 weeks for non-serious adverse events. Up to approximately 76 weeks for serious adverse events. Up to approximately 78 weeks for all-cause mortality.
"Sitagliptin/Metformin and Sitagliptin/Metformin XR Pooled" = "Sitagliptin/Metformin" plus "Sitagliptin/Metformin XR." "Metformin and Metformin XR Pooled" = "Metformin" plus "Metformin XR." Non-serious and serious adverse events are recorded for all treated participants. All-cause mortality is recorded for all randomized participants.
|
8.0%
9/113 • Number of events 13 • Up to 56 weeks for non-serious adverse events. Up to approximately 76 weeks for serious adverse events. Up to approximately 78 weeks for all-cause mortality.
"Sitagliptin/Metformin and Sitagliptin/Metformin XR Pooled" = "Sitagliptin/Metformin" plus "Sitagliptin/Metformin XR." "Metformin and Metformin XR Pooled" = "Metformin" plus "Metformin XR." Non-serious and serious adverse events are recorded for all treated participants. All-cause mortality is recorded for all randomized participants.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/62 • Up to 56 weeks for non-serious adverse events. Up to approximately 76 weeks for serious adverse events. Up to approximately 78 weeks for all-cause mortality.
"Sitagliptin/Metformin and Sitagliptin/Metformin XR Pooled" = "Sitagliptin/Metformin" plus "Sitagliptin/Metformin XR." "Metformin and Metformin XR Pooled" = "Metformin" plus "Metformin XR." Non-serious and serious adverse events are recorded for all treated participants. All-cause mortality is recorded for all randomized participants.
|
8.1%
5/62 • Number of events 6 • Up to 56 weeks for non-serious adverse events. Up to approximately 76 weeks for serious adverse events. Up to approximately 78 weeks for all-cause mortality.
"Sitagliptin/Metformin and Sitagliptin/Metformin XR Pooled" = "Sitagliptin/Metformin" plus "Sitagliptin/Metformin XR." "Metformin and Metformin XR Pooled" = "Metformin" plus "Metformin XR." Non-serious and serious adverse events are recorded for all treated participants. All-cause mortality is recorded for all randomized participants.
|
6.7%
3/45 • Number of events 3 • Up to 56 weeks for non-serious adverse events. Up to approximately 76 weeks for serious adverse events. Up to approximately 78 weeks for all-cause mortality.
"Sitagliptin/Metformin and Sitagliptin/Metformin XR Pooled" = "Sitagliptin/Metformin" plus "Sitagliptin/Metformin XR." "Metformin and Metformin XR Pooled" = "Metformin" plus "Metformin XR." Non-serious and serious adverse events are recorded for all treated participants. All-cause mortality is recorded for all randomized participants.
|
2.0%
1/51 • Number of events 1 • Up to 56 weeks for non-serious adverse events. Up to approximately 76 weeks for serious adverse events. Up to approximately 78 weeks for all-cause mortality.
"Sitagliptin/Metformin and Sitagliptin/Metformin XR Pooled" = "Sitagliptin/Metformin" plus "Sitagliptin/Metformin XR." "Metformin and Metformin XR Pooled" = "Metformin" plus "Metformin XR." Non-serious and serious adverse events are recorded for all treated participants. All-cause mortality is recorded for all randomized participants.
|
2.8%
3/107 • Number of events 3 • Up to 56 weeks for non-serious adverse events. Up to approximately 76 weeks for serious adverse events. Up to approximately 78 weeks for all-cause mortality.
"Sitagliptin/Metformin and Sitagliptin/Metformin XR Pooled" = "Sitagliptin/Metformin" plus "Sitagliptin/Metformin XR." "Metformin and Metformin XR Pooled" = "Metformin" plus "Metformin XR." Non-serious and serious adverse events are recorded for all treated participants. All-cause mortality is recorded for all randomized participants.
|
5.3%
6/113 • Number of events 7 • Up to 56 weeks for non-serious adverse events. Up to approximately 76 weeks for serious adverse events. Up to approximately 78 weeks for all-cause mortality.
"Sitagliptin/Metformin and Sitagliptin/Metformin XR Pooled" = "Sitagliptin/Metformin" plus "Sitagliptin/Metformin XR." "Metformin and Metformin XR Pooled" = "Metformin" plus "Metformin XR." Non-serious and serious adverse events are recorded for all treated participants. All-cause mortality is recorded for all randomized participants.
|
|
Investigations
Alanine aminotransferase increased
|
3.2%
2/62 • Number of events 3 • Up to 56 weeks for non-serious adverse events. Up to approximately 76 weeks for serious adverse events. Up to approximately 78 weeks for all-cause mortality.
"Sitagliptin/Metformin and Sitagliptin/Metformin XR Pooled" = "Sitagliptin/Metformin" plus "Sitagliptin/Metformin XR." "Metformin and Metformin XR Pooled" = "Metformin" plus "Metformin XR." Non-serious and serious adverse events are recorded for all treated participants. All-cause mortality is recorded for all randomized participants.
|
4.8%
3/62 • Number of events 3 • Up to 56 weeks for non-serious adverse events. Up to approximately 76 weeks for serious adverse events. Up to approximately 78 weeks for all-cause mortality.
"Sitagliptin/Metformin and Sitagliptin/Metformin XR Pooled" = "Sitagliptin/Metformin" plus "Sitagliptin/Metformin XR." "Metformin and Metformin XR Pooled" = "Metformin" plus "Metformin XR." Non-serious and serious adverse events are recorded for all treated participants. All-cause mortality is recorded for all randomized participants.
|
6.7%
3/45 • Number of events 3 • Up to 56 weeks for non-serious adverse events. Up to approximately 76 weeks for serious adverse events. Up to approximately 78 weeks for all-cause mortality.
"Sitagliptin/Metformin and Sitagliptin/Metformin XR Pooled" = "Sitagliptin/Metformin" plus "Sitagliptin/Metformin XR." "Metformin and Metformin XR Pooled" = "Metformin" plus "Metformin XR." Non-serious and serious adverse events are recorded for all treated participants. All-cause mortality is recorded for all randomized participants.
|
5.9%
3/51 • Number of events 3 • Up to 56 weeks for non-serious adverse events. Up to approximately 76 weeks for serious adverse events. Up to approximately 78 weeks for all-cause mortality.
"Sitagliptin/Metformin and Sitagliptin/Metformin XR Pooled" = "Sitagliptin/Metformin" plus "Sitagliptin/Metformin XR." "Metformin and Metformin XR Pooled" = "Metformin" plus "Metformin XR." Non-serious and serious adverse events are recorded for all treated participants. All-cause mortality is recorded for all randomized participants.
|
4.7%
5/107 • Number of events 6 • Up to 56 weeks for non-serious adverse events. Up to approximately 76 weeks for serious adverse events. Up to approximately 78 weeks for all-cause mortality.
"Sitagliptin/Metformin and Sitagliptin/Metformin XR Pooled" = "Sitagliptin/Metformin" plus "Sitagliptin/Metformin XR." "Metformin and Metformin XR Pooled" = "Metformin" plus "Metformin XR." Non-serious and serious adverse events are recorded for all treated participants. All-cause mortality is recorded for all randomized participants.
|
5.3%
6/113 • Number of events 6 • Up to 56 weeks for non-serious adverse events. Up to approximately 76 weeks for serious adverse events. Up to approximately 78 weeks for all-cause mortality.
"Sitagliptin/Metformin and Sitagliptin/Metformin XR Pooled" = "Sitagliptin/Metformin" plus "Sitagliptin/Metformin XR." "Metformin and Metformin XR Pooled" = "Metformin" plus "Metformin XR." Non-serious and serious adverse events are recorded for all treated participants. All-cause mortality is recorded for all randomized participants.
|
|
Investigations
Blood creatine phosphokinase increased
|
4.8%
3/62 • Number of events 3 • Up to 56 weeks for non-serious adverse events. Up to approximately 76 weeks for serious adverse events. Up to approximately 78 weeks for all-cause mortality.
"Sitagliptin/Metformin and Sitagliptin/Metformin XR Pooled" = "Sitagliptin/Metformin" plus "Sitagliptin/Metformin XR." "Metformin and Metformin XR Pooled" = "Metformin" plus "Metformin XR." Non-serious and serious adverse events are recorded for all treated participants. All-cause mortality is recorded for all randomized participants.
|
1.6%
1/62 • Number of events 1 • Up to 56 weeks for non-serious adverse events. Up to approximately 76 weeks for serious adverse events. Up to approximately 78 weeks for all-cause mortality.
"Sitagliptin/Metformin and Sitagliptin/Metformin XR Pooled" = "Sitagliptin/Metformin" plus "Sitagliptin/Metformin XR." "Metformin and Metformin XR Pooled" = "Metformin" plus "Metformin XR." Non-serious and serious adverse events are recorded for all treated participants. All-cause mortality is recorded for all randomized participants.
|
6.7%
3/45 • Number of events 3 • Up to 56 weeks for non-serious adverse events. Up to approximately 76 weeks for serious adverse events. Up to approximately 78 weeks for all-cause mortality.
"Sitagliptin/Metformin and Sitagliptin/Metformin XR Pooled" = "Sitagliptin/Metformin" plus "Sitagliptin/Metformin XR." "Metformin and Metformin XR Pooled" = "Metformin" plus "Metformin XR." Non-serious and serious adverse events are recorded for all treated participants. All-cause mortality is recorded for all randomized participants.
|
2.0%
1/51 • Number of events 1 • Up to 56 weeks for non-serious adverse events. Up to approximately 76 weeks for serious adverse events. Up to approximately 78 weeks for all-cause mortality.
"Sitagliptin/Metformin and Sitagliptin/Metformin XR Pooled" = "Sitagliptin/Metformin" plus "Sitagliptin/Metformin XR." "Metformin and Metformin XR Pooled" = "Metformin" plus "Metformin XR." Non-serious and serious adverse events are recorded for all treated participants. All-cause mortality is recorded for all randomized participants.
|
5.6%
6/107 • Number of events 6 • Up to 56 weeks for non-serious adverse events. Up to approximately 76 weeks for serious adverse events. Up to approximately 78 weeks for all-cause mortality.
"Sitagliptin/Metformin and Sitagliptin/Metformin XR Pooled" = "Sitagliptin/Metformin" plus "Sitagliptin/Metformin XR." "Metformin and Metformin XR Pooled" = "Metformin" plus "Metformin XR." Non-serious and serious adverse events are recorded for all treated participants. All-cause mortality is recorded for all randomized participants.
|
1.8%
2/113 • Number of events 2 • Up to 56 weeks for non-serious adverse events. Up to approximately 76 weeks for serious adverse events. Up to approximately 78 weeks for all-cause mortality.
"Sitagliptin/Metformin and Sitagliptin/Metformin XR Pooled" = "Sitagliptin/Metformin" plus "Sitagliptin/Metformin XR." "Metformin and Metformin XR Pooled" = "Metformin" plus "Metformin XR." Non-serious and serious adverse events are recorded for all treated participants. All-cause mortality is recorded for all randomized participants.
|
|
Investigations
Blood glucose increased
|
4.8%
3/62 • Number of events 4 • Up to 56 weeks for non-serious adverse events. Up to approximately 76 weeks for serious adverse events. Up to approximately 78 weeks for all-cause mortality.
"Sitagliptin/Metformin and Sitagliptin/Metformin XR Pooled" = "Sitagliptin/Metformin" plus "Sitagliptin/Metformin XR." "Metformin and Metformin XR Pooled" = "Metformin" plus "Metformin XR." Non-serious and serious adverse events are recorded for all treated participants. All-cause mortality is recorded for all randomized participants.
|
0.00%
0/62 • Up to 56 weeks for non-serious adverse events. Up to approximately 76 weeks for serious adverse events. Up to approximately 78 weeks for all-cause mortality.
"Sitagliptin/Metformin and Sitagliptin/Metformin XR Pooled" = "Sitagliptin/Metformin" plus "Sitagliptin/Metformin XR." "Metformin and Metformin XR Pooled" = "Metformin" plus "Metformin XR." Non-serious and serious adverse events are recorded for all treated participants. All-cause mortality is recorded for all randomized participants.
|
4.4%
2/45 • Number of events 2 • Up to 56 weeks for non-serious adverse events. Up to approximately 76 weeks for serious adverse events. Up to approximately 78 weeks for all-cause mortality.
"Sitagliptin/Metformin and Sitagliptin/Metformin XR Pooled" = "Sitagliptin/Metformin" plus "Sitagliptin/Metformin XR." "Metformin and Metformin XR Pooled" = "Metformin" plus "Metformin XR." Non-serious and serious adverse events are recorded for all treated participants. All-cause mortality is recorded for all randomized participants.
|
5.9%
3/51 • Number of events 5 • Up to 56 weeks for non-serious adverse events. Up to approximately 76 weeks for serious adverse events. Up to approximately 78 weeks for all-cause mortality.
"Sitagliptin/Metformin and Sitagliptin/Metformin XR Pooled" = "Sitagliptin/Metformin" plus "Sitagliptin/Metformin XR." "Metformin and Metformin XR Pooled" = "Metformin" plus "Metformin XR." Non-serious and serious adverse events are recorded for all treated participants. All-cause mortality is recorded for all randomized participants.
|
4.7%
5/107 • Number of events 6 • Up to 56 weeks for non-serious adverse events. Up to approximately 76 weeks for serious adverse events. Up to approximately 78 weeks for all-cause mortality.
"Sitagliptin/Metformin and Sitagliptin/Metformin XR Pooled" = "Sitagliptin/Metformin" plus "Sitagliptin/Metformin XR." "Metformin and Metformin XR Pooled" = "Metformin" plus "Metformin XR." Non-serious and serious adverse events are recorded for all treated participants. All-cause mortality is recorded for all randomized participants.
|
2.7%
3/113 • Number of events 5 • Up to 56 weeks for non-serious adverse events. Up to approximately 76 weeks for serious adverse events. Up to approximately 78 weeks for all-cause mortality.
"Sitagliptin/Metformin and Sitagliptin/Metformin XR Pooled" = "Sitagliptin/Metformin" plus "Sitagliptin/Metformin XR." "Metformin and Metformin XR Pooled" = "Metformin" plus "Metformin XR." Non-serious and serious adverse events are recorded for all treated participants. All-cause mortality is recorded for all randomized participants.
|
|
Investigations
Creatinine renal clearance increased
|
6.5%
4/62 • Number of events 4 • Up to 56 weeks for non-serious adverse events. Up to approximately 76 weeks for serious adverse events. Up to approximately 78 weeks for all-cause mortality.
"Sitagliptin/Metformin and Sitagliptin/Metformin XR Pooled" = "Sitagliptin/Metformin" plus "Sitagliptin/Metformin XR." "Metformin and Metformin XR Pooled" = "Metformin" plus "Metformin XR." Non-serious and serious adverse events are recorded for all treated participants. All-cause mortality is recorded for all randomized participants.
|
0.00%
0/62 • Up to 56 weeks for non-serious adverse events. Up to approximately 76 weeks for serious adverse events. Up to approximately 78 weeks for all-cause mortality.
"Sitagliptin/Metformin and Sitagliptin/Metformin XR Pooled" = "Sitagliptin/Metformin" plus "Sitagliptin/Metformin XR." "Metformin and Metformin XR Pooled" = "Metformin" plus "Metformin XR." Non-serious and serious adverse events are recorded for all treated participants. All-cause mortality is recorded for all randomized participants.
|
0.00%
0/45 • Up to 56 weeks for non-serious adverse events. Up to approximately 76 weeks for serious adverse events. Up to approximately 78 weeks for all-cause mortality.
"Sitagliptin/Metformin and Sitagliptin/Metformin XR Pooled" = "Sitagliptin/Metformin" plus "Sitagliptin/Metformin XR." "Metformin and Metformin XR Pooled" = "Metformin" plus "Metformin XR." Non-serious and serious adverse events are recorded for all treated participants. All-cause mortality is recorded for all randomized participants.
|
0.00%
0/51 • Up to 56 weeks for non-serious adverse events. Up to approximately 76 weeks for serious adverse events. Up to approximately 78 weeks for all-cause mortality.
"Sitagliptin/Metformin and Sitagliptin/Metformin XR Pooled" = "Sitagliptin/Metformin" plus "Sitagliptin/Metformin XR." "Metformin and Metformin XR Pooled" = "Metformin" plus "Metformin XR." Non-serious and serious adverse events are recorded for all treated participants. All-cause mortality is recorded for all randomized participants.
|
3.7%
4/107 • Number of events 4 • Up to 56 weeks for non-serious adverse events. Up to approximately 76 weeks for serious adverse events. Up to approximately 78 weeks for all-cause mortality.
"Sitagliptin/Metformin and Sitagliptin/Metformin XR Pooled" = "Sitagliptin/Metformin" plus "Sitagliptin/Metformin XR." "Metformin and Metformin XR Pooled" = "Metformin" plus "Metformin XR." Non-serious and serious adverse events are recorded for all treated participants. All-cause mortality is recorded for all randomized participants.
|
0.00%
0/113 • Up to 56 weeks for non-serious adverse events. Up to approximately 76 weeks for serious adverse events. Up to approximately 78 weeks for all-cause mortality.
"Sitagliptin/Metformin and Sitagliptin/Metformin XR Pooled" = "Sitagliptin/Metformin" plus "Sitagliptin/Metformin XR." "Metformin and Metformin XR Pooled" = "Metformin" plus "Metformin XR." Non-serious and serious adverse events are recorded for all treated participants. All-cause mortality is recorded for all randomized participants.
|
|
Investigations
Urine albumin/creatinine ratio increased
|
6.5%
4/62 • Number of events 5 • Up to 56 weeks for non-serious adverse events. Up to approximately 76 weeks for serious adverse events. Up to approximately 78 weeks for all-cause mortality.
"Sitagliptin/Metformin and Sitagliptin/Metformin XR Pooled" = "Sitagliptin/Metformin" plus "Sitagliptin/Metformin XR." "Metformin and Metformin XR Pooled" = "Metformin" plus "Metformin XR." Non-serious and serious adverse events are recorded for all treated participants. All-cause mortality is recorded for all randomized participants.
|
3.2%
2/62 • Number of events 2 • Up to 56 weeks for non-serious adverse events. Up to approximately 76 weeks for serious adverse events. Up to approximately 78 weeks for all-cause mortality.
"Sitagliptin/Metformin and Sitagliptin/Metformin XR Pooled" = "Sitagliptin/Metformin" plus "Sitagliptin/Metformin XR." "Metformin and Metformin XR Pooled" = "Metformin" plus "Metformin XR." Non-serious and serious adverse events are recorded for all treated participants. All-cause mortality is recorded for all randomized participants.
|
0.00%
0/45 • Up to 56 weeks for non-serious adverse events. Up to approximately 76 weeks for serious adverse events. Up to approximately 78 weeks for all-cause mortality.
"Sitagliptin/Metformin and Sitagliptin/Metformin XR Pooled" = "Sitagliptin/Metformin" plus "Sitagliptin/Metformin XR." "Metformin and Metformin XR Pooled" = "Metformin" plus "Metformin XR." Non-serious and serious adverse events are recorded for all treated participants. All-cause mortality is recorded for all randomized participants.
|
0.00%
0/51 • Up to 56 weeks for non-serious adverse events. Up to approximately 76 weeks for serious adverse events. Up to approximately 78 weeks for all-cause mortality.
"Sitagliptin/Metformin and Sitagliptin/Metformin XR Pooled" = "Sitagliptin/Metformin" plus "Sitagliptin/Metformin XR." "Metformin and Metformin XR Pooled" = "Metformin" plus "Metformin XR." Non-serious and serious adverse events are recorded for all treated participants. All-cause mortality is recorded for all randomized participants.
|
3.7%
4/107 • Number of events 5 • Up to 56 weeks for non-serious adverse events. Up to approximately 76 weeks for serious adverse events. Up to approximately 78 weeks for all-cause mortality.
"Sitagliptin/Metformin and Sitagliptin/Metformin XR Pooled" = "Sitagliptin/Metformin" plus "Sitagliptin/Metformin XR." "Metformin and Metformin XR Pooled" = "Metformin" plus "Metformin XR." Non-serious and serious adverse events are recorded for all treated participants. All-cause mortality is recorded for all randomized participants.
|
1.8%
2/113 • Number of events 2 • Up to 56 weeks for non-serious adverse events. Up to approximately 76 weeks for serious adverse events. Up to approximately 78 weeks for all-cause mortality.
"Sitagliptin/Metformin and Sitagliptin/Metformin XR Pooled" = "Sitagliptin/Metformin" plus "Sitagliptin/Metformin XR." "Metformin and Metformin XR Pooled" = "Metformin" plus "Metformin XR." Non-serious and serious adverse events are recorded for all treated participants. All-cause mortality is recorded for all randomized participants.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
4.8%
3/62 • Number of events 3 • Up to 56 weeks for non-serious adverse events. Up to approximately 76 weeks for serious adverse events. Up to approximately 78 weeks for all-cause mortality.
"Sitagliptin/Metformin and Sitagliptin/Metformin XR Pooled" = "Sitagliptin/Metformin" plus "Sitagliptin/Metformin XR." "Metformin and Metformin XR Pooled" = "Metformin" plus "Metformin XR." Non-serious and serious adverse events are recorded for all treated participants. All-cause mortality is recorded for all randomized participants.
|
8.1%
5/62 • Number of events 6 • Up to 56 weeks for non-serious adverse events. Up to approximately 76 weeks for serious adverse events. Up to approximately 78 weeks for all-cause mortality.
"Sitagliptin/Metformin and Sitagliptin/Metformin XR Pooled" = "Sitagliptin/Metformin" plus "Sitagliptin/Metformin XR." "Metformin and Metformin XR Pooled" = "Metformin" plus "Metformin XR." Non-serious and serious adverse events are recorded for all treated participants. All-cause mortality is recorded for all randomized participants.
|
6.7%
3/45 • Number of events 3 • Up to 56 weeks for non-serious adverse events. Up to approximately 76 weeks for serious adverse events. Up to approximately 78 weeks for all-cause mortality.
"Sitagliptin/Metformin and Sitagliptin/Metformin XR Pooled" = "Sitagliptin/Metformin" plus "Sitagliptin/Metformin XR." "Metformin and Metformin XR Pooled" = "Metformin" plus "Metformin XR." Non-serious and serious adverse events are recorded for all treated participants. All-cause mortality is recorded for all randomized participants.
|
7.8%
4/51 • Number of events 4 • Up to 56 weeks for non-serious adverse events. Up to approximately 76 weeks for serious adverse events. Up to approximately 78 weeks for all-cause mortality.
"Sitagliptin/Metformin and Sitagliptin/Metformin XR Pooled" = "Sitagliptin/Metformin" plus "Sitagliptin/Metformin XR." "Metformin and Metformin XR Pooled" = "Metformin" plus "Metformin XR." Non-serious and serious adverse events are recorded for all treated participants. All-cause mortality is recorded for all randomized participants.
|
5.6%
6/107 • Number of events 6 • Up to 56 weeks for non-serious adverse events. Up to approximately 76 weeks for serious adverse events. Up to approximately 78 weeks for all-cause mortality.
"Sitagliptin/Metformin and Sitagliptin/Metformin XR Pooled" = "Sitagliptin/Metformin" plus "Sitagliptin/Metformin XR." "Metformin and Metformin XR Pooled" = "Metformin" plus "Metformin XR." Non-serious and serious adverse events are recorded for all treated participants. All-cause mortality is recorded for all randomized participants.
|
8.0%
9/113 • Number of events 10 • Up to 56 weeks for non-serious adverse events. Up to approximately 76 weeks for serious adverse events. Up to approximately 78 weeks for all-cause mortality.
"Sitagliptin/Metformin and Sitagliptin/Metformin XR Pooled" = "Sitagliptin/Metformin" plus "Sitagliptin/Metformin XR." "Metformin and Metformin XR Pooled" = "Metformin" plus "Metformin XR." Non-serious and serious adverse events are recorded for all treated participants. All-cause mortality is recorded for all randomized participants.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
16.1%
10/62 • Number of events 106 • Up to 56 weeks for non-serious adverse events. Up to approximately 76 weeks for serious adverse events. Up to approximately 78 weeks for all-cause mortality.
"Sitagliptin/Metformin and Sitagliptin/Metformin XR Pooled" = "Sitagliptin/Metformin" plus "Sitagliptin/Metformin XR." "Metformin and Metformin XR Pooled" = "Metformin" plus "Metformin XR." Non-serious and serious adverse events are recorded for all treated participants. All-cause mortality is recorded for all randomized participants.
|
9.7%
6/62 • Number of events 15 • Up to 56 weeks for non-serious adverse events. Up to approximately 76 weeks for serious adverse events. Up to approximately 78 weeks for all-cause mortality.
"Sitagliptin/Metformin and Sitagliptin/Metformin XR Pooled" = "Sitagliptin/Metformin" plus "Sitagliptin/Metformin XR." "Metformin and Metformin XR Pooled" = "Metformin" plus "Metformin XR." Non-serious and serious adverse events are recorded for all treated participants. All-cause mortality is recorded for all randomized participants.
|
20.0%
9/45 • Number of events 70 • Up to 56 weeks for non-serious adverse events. Up to approximately 76 weeks for serious adverse events. Up to approximately 78 weeks for all-cause mortality.
"Sitagliptin/Metformin and Sitagliptin/Metformin XR Pooled" = "Sitagliptin/Metformin" plus "Sitagliptin/Metformin XR." "Metformin and Metformin XR Pooled" = "Metformin" plus "Metformin XR." Non-serious and serious adverse events are recorded for all treated participants. All-cause mortality is recorded for all randomized participants.
|
19.6%
10/51 • Number of events 45 • Up to 56 weeks for non-serious adverse events. Up to approximately 76 weeks for serious adverse events. Up to approximately 78 weeks for all-cause mortality.
"Sitagliptin/Metformin and Sitagliptin/Metformin XR Pooled" = "Sitagliptin/Metformin" plus "Sitagliptin/Metformin XR." "Metformin and Metformin XR Pooled" = "Metformin" plus "Metformin XR." Non-serious and serious adverse events are recorded for all treated participants. All-cause mortality is recorded for all randomized participants.
|
17.8%
19/107 • Number of events 176 • Up to 56 weeks for non-serious adverse events. Up to approximately 76 weeks for serious adverse events. Up to approximately 78 weeks for all-cause mortality.
"Sitagliptin/Metformin and Sitagliptin/Metformin XR Pooled" = "Sitagliptin/Metformin" plus "Sitagliptin/Metformin XR." "Metformin and Metformin XR Pooled" = "Metformin" plus "Metformin XR." Non-serious and serious adverse events are recorded for all treated participants. All-cause mortality is recorded for all randomized participants.
|
14.2%
16/113 • Number of events 60 • Up to 56 weeks for non-serious adverse events. Up to approximately 76 weeks for serious adverse events. Up to approximately 78 weeks for all-cause mortality.
"Sitagliptin/Metformin and Sitagliptin/Metformin XR Pooled" = "Sitagliptin/Metformin" plus "Sitagliptin/Metformin XR." "Metformin and Metformin XR Pooled" = "Metformin" plus "Metformin XR." Non-serious and serious adverse events are recorded for all treated participants. All-cause mortality is recorded for all randomized participants.
|
|
Nervous system disorders
Headache
|
4.8%
3/62 • Number of events 4 • Up to 56 weeks for non-serious adverse events. Up to approximately 76 weeks for serious adverse events. Up to approximately 78 weeks for all-cause mortality.
"Sitagliptin/Metformin and Sitagliptin/Metformin XR Pooled" = "Sitagliptin/Metformin" plus "Sitagliptin/Metformin XR." "Metformin and Metformin XR Pooled" = "Metformin" plus "Metformin XR." Non-serious and serious adverse events are recorded for all treated participants. All-cause mortality is recorded for all randomized participants.
|
12.9%
8/62 • Number of events 10 • Up to 56 weeks for non-serious adverse events. Up to approximately 76 weeks for serious adverse events. Up to approximately 78 weeks for all-cause mortality.
"Sitagliptin/Metformin and Sitagliptin/Metformin XR Pooled" = "Sitagliptin/Metformin" plus "Sitagliptin/Metformin XR." "Metformin and Metformin XR Pooled" = "Metformin" plus "Metformin XR." Non-serious and serious adverse events are recorded for all treated participants. All-cause mortality is recorded for all randomized participants.
|
4.4%
2/45 • Number of events 4 • Up to 56 weeks for non-serious adverse events. Up to approximately 76 weeks for serious adverse events. Up to approximately 78 weeks for all-cause mortality.
"Sitagliptin/Metformin and Sitagliptin/Metformin XR Pooled" = "Sitagliptin/Metformin" plus "Sitagliptin/Metformin XR." "Metformin and Metformin XR Pooled" = "Metformin" plus "Metformin XR." Non-serious and serious adverse events are recorded for all treated participants. All-cause mortality is recorded for all randomized participants.
|
19.6%
10/51 • Number of events 15 • Up to 56 weeks for non-serious adverse events. Up to approximately 76 weeks for serious adverse events. Up to approximately 78 weeks for all-cause mortality.
"Sitagliptin/Metformin and Sitagliptin/Metformin XR Pooled" = "Sitagliptin/Metformin" plus "Sitagliptin/Metformin XR." "Metformin and Metformin XR Pooled" = "Metformin" plus "Metformin XR." Non-serious and serious adverse events are recorded for all treated participants. All-cause mortality is recorded for all randomized participants.
|
4.7%
5/107 • Number of events 8 • Up to 56 weeks for non-serious adverse events. Up to approximately 76 weeks for serious adverse events. Up to approximately 78 weeks for all-cause mortality.
"Sitagliptin/Metformin and Sitagliptin/Metformin XR Pooled" = "Sitagliptin/Metformin" plus "Sitagliptin/Metformin XR." "Metformin and Metformin XR Pooled" = "Metformin" plus "Metformin XR." Non-serious and serious adverse events are recorded for all treated participants. All-cause mortality is recorded for all randomized participants.
|
15.9%
18/113 • Number of events 25 • Up to 56 weeks for non-serious adverse events. Up to approximately 76 weeks for serious adverse events. Up to approximately 78 weeks for all-cause mortality.
"Sitagliptin/Metformin and Sitagliptin/Metformin XR Pooled" = "Sitagliptin/Metformin" plus "Sitagliptin/Metformin XR." "Metformin and Metformin XR Pooled" = "Metformin" plus "Metformin XR." Non-serious and serious adverse events are recorded for all treated participants. All-cause mortality is recorded for all randomized participants.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
3.2%
2/62 • Number of events 2 • Up to 56 weeks for non-serious adverse events. Up to approximately 76 weeks for serious adverse events. Up to approximately 78 weeks for all-cause mortality.
"Sitagliptin/Metformin and Sitagliptin/Metformin XR Pooled" = "Sitagliptin/Metformin" plus "Sitagliptin/Metformin XR." "Metformin and Metformin XR Pooled" = "Metformin" plus "Metformin XR." Non-serious and serious adverse events are recorded for all treated participants. All-cause mortality is recorded for all randomized participants.
|
4.8%
3/62 • Number of events 4 • Up to 56 weeks for non-serious adverse events. Up to approximately 76 weeks for serious adverse events. Up to approximately 78 weeks for all-cause mortality.
"Sitagliptin/Metformin and Sitagliptin/Metformin XR Pooled" = "Sitagliptin/Metformin" plus "Sitagliptin/Metformin XR." "Metformin and Metformin XR Pooled" = "Metformin" plus "Metformin XR." Non-serious and serious adverse events are recorded for all treated participants. All-cause mortality is recorded for all randomized participants.
|
6.7%
3/45 • Number of events 3 • Up to 56 weeks for non-serious adverse events. Up to approximately 76 weeks for serious adverse events. Up to approximately 78 weeks for all-cause mortality.
"Sitagliptin/Metformin and Sitagliptin/Metformin XR Pooled" = "Sitagliptin/Metformin" plus "Sitagliptin/Metformin XR." "Metformin and Metformin XR Pooled" = "Metformin" plus "Metformin XR." Non-serious and serious adverse events are recorded for all treated participants. All-cause mortality is recorded for all randomized participants.
|
3.9%
2/51 • Number of events 2 • Up to 56 weeks for non-serious adverse events. Up to approximately 76 weeks for serious adverse events. Up to approximately 78 weeks for all-cause mortality.
"Sitagliptin/Metformin and Sitagliptin/Metformin XR Pooled" = "Sitagliptin/Metformin" plus "Sitagliptin/Metformin XR." "Metformin and Metformin XR Pooled" = "Metformin" plus "Metformin XR." Non-serious and serious adverse events are recorded for all treated participants. All-cause mortality is recorded for all randomized participants.
|
4.7%
5/107 • Number of events 5 • Up to 56 weeks for non-serious adverse events. Up to approximately 76 weeks for serious adverse events. Up to approximately 78 weeks for all-cause mortality.
"Sitagliptin/Metformin and Sitagliptin/Metformin XR Pooled" = "Sitagliptin/Metformin" plus "Sitagliptin/Metformin XR." "Metformin and Metformin XR Pooled" = "Metformin" plus "Metformin XR." Non-serious and serious adverse events are recorded for all treated participants. All-cause mortality is recorded for all randomized participants.
|
4.4%
5/113 • Number of events 6 • Up to 56 weeks for non-serious adverse events. Up to approximately 76 weeks for serious adverse events. Up to approximately 78 weeks for all-cause mortality.
"Sitagliptin/Metformin and Sitagliptin/Metformin XR Pooled" = "Sitagliptin/Metformin" plus "Sitagliptin/Metformin XR." "Metformin and Metformin XR Pooled" = "Metformin" plus "Metformin XR." Non-serious and serious adverse events are recorded for all treated participants. All-cause mortality is recorded for all randomized participants.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
3.2%
2/62 • Number of events 2 • Up to 56 weeks for non-serious adverse events. Up to approximately 76 weeks for serious adverse events. Up to approximately 78 weeks for all-cause mortality.
"Sitagliptin/Metformin and Sitagliptin/Metformin XR Pooled" = "Sitagliptin/Metformin" plus "Sitagliptin/Metformin XR." "Metformin and Metformin XR Pooled" = "Metformin" plus "Metformin XR." Non-serious and serious adverse events are recorded for all treated participants. All-cause mortality is recorded for all randomized participants.
|
1.6%
1/62 • Number of events 1 • Up to 56 weeks for non-serious adverse events. Up to approximately 76 weeks for serious adverse events. Up to approximately 78 weeks for all-cause mortality.
"Sitagliptin/Metformin and Sitagliptin/Metformin XR Pooled" = "Sitagliptin/Metformin" plus "Sitagliptin/Metformin XR." "Metformin and Metformin XR Pooled" = "Metformin" plus "Metformin XR." Non-serious and serious adverse events are recorded for all treated participants. All-cause mortality is recorded for all randomized participants.
|
6.7%
3/45 • Number of events 3 • Up to 56 weeks for non-serious adverse events. Up to approximately 76 weeks for serious adverse events. Up to approximately 78 weeks for all-cause mortality.
"Sitagliptin/Metformin and Sitagliptin/Metformin XR Pooled" = "Sitagliptin/Metformin" plus "Sitagliptin/Metformin XR." "Metformin and Metformin XR Pooled" = "Metformin" plus "Metformin XR." Non-serious and serious adverse events are recorded for all treated participants. All-cause mortality is recorded for all randomized participants.
|
2.0%
1/51 • Number of events 6 • Up to 56 weeks for non-serious adverse events. Up to approximately 76 weeks for serious adverse events. Up to approximately 78 weeks for all-cause mortality.
"Sitagliptin/Metformin and Sitagliptin/Metformin XR Pooled" = "Sitagliptin/Metformin" plus "Sitagliptin/Metformin XR." "Metformin and Metformin XR Pooled" = "Metformin" plus "Metformin XR." Non-serious and serious adverse events are recorded for all treated participants. All-cause mortality is recorded for all randomized participants.
|
4.7%
5/107 • Number of events 5 • Up to 56 weeks for non-serious adverse events. Up to approximately 76 weeks for serious adverse events. Up to approximately 78 weeks for all-cause mortality.
"Sitagliptin/Metformin and Sitagliptin/Metformin XR Pooled" = "Sitagliptin/Metformin" plus "Sitagliptin/Metformin XR." "Metformin and Metformin XR Pooled" = "Metformin" plus "Metformin XR." Non-serious and serious adverse events are recorded for all treated participants. All-cause mortality is recorded for all randomized participants.
|
1.8%
2/113 • Number of events 7 • Up to 56 weeks for non-serious adverse events. Up to approximately 76 weeks for serious adverse events. Up to approximately 78 weeks for all-cause mortality.
"Sitagliptin/Metformin and Sitagliptin/Metformin XR Pooled" = "Sitagliptin/Metformin" plus "Sitagliptin/Metformin XR." "Metformin and Metformin XR Pooled" = "Metformin" plus "Metformin XR." Non-serious and serious adverse events are recorded for all treated participants. All-cause mortality is recorded for all randomized participants.
|
Additional Information
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. Any information identified by the sponsor as confidential must be deleted prior to submission. Sponsor review can be expedited to meet publication timelines.
- Publication restrictions are in place
Restriction type: OTHER