Trial Outcomes & Findings for Study of Safety and Efficacy of PF-04991532 in Subjects With Type 2 Diabetes (NCT NCT01338870)
NCT ID: NCT01338870
Last Updated: 2013-04-23
Results Overview
HbA1c is a form of hemoglobin which is measured primarily to identify the average plasma glucose concentration over prolonged periods of time. The normal range for the HbA1c test is between 4 percent (%) and 5.6%. HbA1c levels between 5.7% and 6.4% indicate increased risk of diabetes and levels of 6.5% or higher indicate diabetes.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
301 participants
Primary outcome timeframe
Baseline, Week 12
Results posted on
2013-04-23
Participant Flow
All participants received placebo matched to PF-04991532 or placebo matched to sitagliptin tablet orally twice daily along with background metformin immediate release tablets, during the 2-week run-in period. Compliant participants were then randomized to study treatments for 12 weeks.
Participant milestones
| Measure |
Placebo
Placebo matched to PF-04991532 tablets orally twice daily or placebo matched to sitagliptin tablet orally twice daily along with background metformin 500 milligram (mg) immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
|
PF-04991532 25 mg
PF-04991532 25 mg tablet orally twice daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
|
PF-04991532 75 mg
PF-04991532 75 mg tablet orally twice daily along background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
|
PF-04991532 150 mg
PF-04991532 150 mg tablet orally twice daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
|
PF-04991532 300 mg
PF-04991532 300 mg tablet orally twice daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
|
Sitagliptin 100 mg
Sitagliptin 100 mg tablet orally once daily as morning dose and placebo matched to sitagliptin tablet orally once daily as evening dose along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
50
|
49
|
50
|
50
|
52
|
50
|
|
Overall Study
COMPLETED
|
41
|
37
|
39
|
41
|
46
|
44
|
|
Overall Study
NOT COMPLETED
|
9
|
12
|
11
|
9
|
6
|
6
|
Reasons for withdrawal
| Measure |
Placebo
Placebo matched to PF-04991532 tablets orally twice daily or placebo matched to sitagliptin tablet orally twice daily along with background metformin 500 milligram (mg) immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
|
PF-04991532 25 mg
PF-04991532 25 mg tablet orally twice daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
|
PF-04991532 75 mg
PF-04991532 75 mg tablet orally twice daily along background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
|
PF-04991532 150 mg
PF-04991532 150 mg tablet orally twice daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
|
PF-04991532 300 mg
PF-04991532 300 mg tablet orally twice daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
|
Sitagliptin 100 mg
Sitagliptin 100 mg tablet orally once daily as morning dose and placebo matched to sitagliptin tablet orally once daily as evening dose along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
|
|---|---|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
1
|
0
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
2
|
3
|
4
|
0
|
0
|
2
|
|
Overall Study
Other
|
3
|
3
|
3
|
2
|
0
|
2
|
|
Overall Study
Protocol Violation
|
0
|
2
|
2
|
2
|
1
|
1
|
|
Overall Study
Adverse Event
|
4
|
4
|
1
|
5
|
4
|
1
|
Baseline Characteristics
Study of Safety and Efficacy of PF-04991532 in Subjects With Type 2 Diabetes
Baseline characteristics by cohort
| Measure |
Placebo
n=50 Participants
Placebo matched to PF-04991532 tablets orally twice daily or placebo matched to sitagliptin tablet orally twice daily along with background metformin 500 milligram (mg) immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
|
PF-04991532 25 mg
n=49 Participants
PF-04991532 25 mg tablet orally twice daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
|
PF-04991532 75 mg
n=50 Participants
PF-04991532 75 mg tablet orally twice daily along background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
|
PF-04991532 150 mg
n=50 Participants
PF-04991532 150 mg tablet orally twice daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
|
PF-04991532 300 mg
n=52 Participants
PF-04991532 300 mg tablet orally twice daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
|
Sitagliptin 100 mg
n=50 Participants
Sitagliptin 100 mg tablet orally once daily as morning dose and placebo matched to sitagliptin tablet orally once daily as evening dose along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
|
Total
n=301 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age Continuous
|
55.7 years
STANDARD_DEVIATION 8.8 • n=5 Participants
|
59.2 years
STANDARD_DEVIATION 6.8 • n=7 Participants
|
56.1 years
STANDARD_DEVIATION 8.6 • n=5 Participants
|
57.2 years
STANDARD_DEVIATION 8.7 • n=4 Participants
|
56.0 years
STANDARD_DEVIATION 7.7 • n=21 Participants
|
55.6 years
STANDARD_DEVIATION 9.0 • n=10 Participants
|
56.6 years
STANDARD_DEVIATION 8.3 • n=115 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
20 Participants
n=4 Participants
|
30 Participants
n=21 Participants
|
15 Participants
n=10 Participants
|
132 Participants
n=115 Participants
|
|
Sex: Female, Male
Male
|
34 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
30 Participants
n=4 Participants
|
22 Participants
n=21 Participants
|
35 Participants
n=10 Participants
|
169 Participants
n=115 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 12Population: Full analysis set (FAS) included all randomized participants who received at least 1 dose of study medication. Here 'n' signifies participants who were evaluable at specific time point for each treatment arm respectively.
HbA1c is a form of hemoglobin which is measured primarily to identify the average plasma glucose concentration over prolonged periods of time. The normal range for the HbA1c test is between 4 percent (%) and 5.6%. HbA1c levels between 5.7% and 6.4% indicate increased risk of diabetes and levels of 6.5% or higher indicate diabetes.
Outcome measures
| Measure |
Placebo
n=50 Participants
Placebo matched to PF-04991532 tablets orally twice daily or placebo matched to sitagliptin tablet orally twice daily along with background metformin 500 milligram (mg) immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
|
PF-04991532 25 mg
n=49 Participants
PF-04991532 25 mg tablet orally twice daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
|
PF-04991532 75 mg
n=50 Participants
PF-04991532 75 mg tablet orally twice daily along background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
|
PF-04991532 150 mg
n=50 Participants
PF-04991532 150 mg tablet orally twice daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
|
PF-04991532 300 mg
n=52 Participants
PF-04991532 300 mg tablet orally twice daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
|
Sitagliptin 100 mg
n=50 Participants
Sitagliptin 100 mg tablet orally once daily as morning dose and placebo matched to sitagliptin tablet orally once daily as evening dose along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 12
Baseline (n= 50, 49, 50, 50, 52, 50)
|
8.11 percentage of hemoglobin
Standard Deviation 1.255
|
7.90 percentage of hemoglobin
Standard Deviation 0.939
|
7.86 percentage of hemoglobin
Standard Deviation 0.998
|
7.93 percentage of hemoglobin
Standard Deviation 1.018
|
8.01 percentage of hemoglobin
Standard Deviation 1.064
|
8.05 percentage of hemoglobin
Standard Deviation 0.958
|
|
Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 12
Change at Week 12 (n= 42, 37, 39, 40, 46, 44)
|
-0.30 percentage of hemoglobin
Standard Deviation 0.681
|
-0.15 percentage of hemoglobin
Standard Deviation 0.593
|
-0.51 percentage of hemoglobin
Standard Deviation 0.847
|
-0.36 percentage of hemoglobin
Standard Deviation 0.828
|
-0.79 percentage of hemoglobin
Standard Deviation 0.743
|
-0.65 percentage of hemoglobin
Standard Deviation 0.754
|
SECONDARY outcome
Timeframe: Baseline, Week 1, 2, 4, 8, 12Population: FAS included all randomized participants who received at least 1 dose of study medication. Here 'n' signifies participants who were evaluable at specific time point for each treatment arm respectively.
Outcome measures
| Measure |
Placebo
n=50 Participants
Placebo matched to PF-04991532 tablets orally twice daily or placebo matched to sitagliptin tablet orally twice daily along with background metformin 500 milligram (mg) immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
|
PF-04991532 25 mg
n=49 Participants
PF-04991532 25 mg tablet orally twice daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
|
PF-04991532 75 mg
n=50 Participants
PF-04991532 75 mg tablet orally twice daily along background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
|
PF-04991532 150 mg
n=50 Participants
PF-04991532 150 mg tablet orally twice daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
|
PF-04991532 300 mg
n=52 Participants
PF-04991532 300 mg tablet orally twice daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
|
Sitagliptin 100 mg
n=50 Participants
Sitagliptin 100 mg tablet orally once daily as morning dose and placebo matched to sitagliptin tablet orally once daily as evening dose along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Fasting Plasma Glucose at Week 1, 2, 4, 8 and 12
Change at Week 4 (n= 46, 42, 44, 45, 48, 49)
|
2.00 milligram/deciliter (mg/dL)
Standard Deviation 36.067
|
6.08 milligram/deciliter (mg/dL)
Standard Deviation 24.687
|
-6.56 milligram/deciliter (mg/dL)
Standard Deviation 32.880
|
3.61 milligram/deciliter (mg/dL)
Standard Deviation 36.385
|
-19.84 milligram/deciliter (mg/dL)
Standard Deviation 31.334
|
-18.90 milligram/deciliter (mg/dL)
Standard Deviation 28.434
|
|
Change From Baseline in Fasting Plasma Glucose at Week 1, 2, 4, 8 and 12
Change at Week 12 (n= 42, 37, 38, 40, 46, 44)
|
3.41 milligram/deciliter (mg/dL)
Standard Deviation 34.430
|
8.06 milligram/deciliter (mg/dL)
Standard Deviation 23.298
|
-6.55 milligram/deciliter (mg/dL)
Standard Deviation 31.919
|
6.20 milligram/deciliter (mg/dL)
Standard Deviation 38.122
|
-16.80 milligram/deciliter (mg/dL)
Standard Deviation 35.765
|
-16.07 milligram/deciliter (mg/dL)
Standard Deviation 31.298
|
|
Change From Baseline in Fasting Plasma Glucose at Week 1, 2, 4, 8 and 12
Baseline (n= 50, 49, 50, 50 ,52, 50)
|
168.41 milligram/deciliter (mg/dL)
Standard Deviation 51.859
|
167.71 milligram/deciliter (mg/dL)
Standard Deviation 52.401
|
161.43 milligram/deciliter (mg/dL)
Standard Deviation 43.009
|
163.38 milligram/deciliter (mg/dL)
Standard Deviation 44.976
|
168.87 milligram/deciliter (mg/dL)
Standard Deviation 47.630
|
170.42 milligram/deciliter (mg/dL)
Standard Deviation 41.366
|
|
Change From Baseline in Fasting Plasma Glucose at Week 1, 2, 4, 8 and 12
Change at Week 1 (n= 48, 47, 47, 46, 46, 45)
|
3.69 milligram/deciliter (mg/dL)
Standard Deviation 24.632
|
-0.70 milligram/deciliter (mg/dL)
Standard Deviation 26.644
|
-3.29 milligram/deciliter (mg/dL)
Standard Deviation 20.131
|
-3.75 milligram/deciliter (mg/dL)
Standard Deviation 19.486
|
-15.35 milligram/deciliter (mg/dL)
Standard Deviation 35.673
|
-18.59 milligram/deciliter (mg/dL)
Standard Deviation 30.637
|
|
Change From Baseline in Fasting Plasma Glucose at Week 1, 2, 4, 8 and 12
Change at Week 2 (n= 44, 44, 45, 45, 47, 48)
|
-1.31 milligram/deciliter (mg/dL)
Standard Deviation 21.746
|
1.05 milligram/deciliter (mg/dL)
Standard Deviation 22.186
|
-3.84 milligram/deciliter (mg/dL)
Standard Deviation 24.007
|
-1.68 milligram/deciliter (mg/dL)
Standard Deviation 26.966
|
-16.68 milligram/deciliter (mg/dL)
Standard Deviation 43.620
|
-20.13 milligram/deciliter (mg/dL)
Standard Deviation 32.632
|
|
Change From Baseline in Fasting Plasma Glucose at Week 1, 2, 4, 8 and 12
Change at Week 8 (n= 43, 40, 41, 42, 46, 45)
|
5.63 milligram/deciliter (mg/dL)
Standard Deviation 26.183
|
9.42 milligram/deciliter (mg/dL)
Standard Deviation 28.172
|
-4.98 milligram/deciliter (mg/dL)
Standard Deviation 30.696
|
4.43 milligram/deciliter (mg/dL)
Standard Deviation 28.491
|
-14.24 milligram/deciliter (mg/dL)
Standard Deviation 42.128
|
-17.84 milligram/deciliter (mg/dL)
Standard Deviation 28.715
|
SECONDARY outcome
Timeframe: Baseline, Week 1, 2, 4, 8Population: FAS included all randomized participants who received at least 1 dose of study medication. Here, N (number of participants analyzed) signify those who were evaluable for this measure and 'n' signifies participants who were evaluable at specific time point for each treatment arm respectively.
HbA1c is a form of hemoglobin which is measured primarily to identify the average plasma glucose concentration over prolonged periods of time. The normal range for the HbA1c test is between 4% and 5.6%. HbA1c levels between 5.7% and 6.4% indicate increased risk of diabetes and levels of 6.5% or higher indicate diabetes.
Outcome measures
| Measure |
Placebo
n=48 Participants
Placebo matched to PF-04991532 tablets orally twice daily or placebo matched to sitagliptin tablet orally twice daily along with background metformin 500 milligram (mg) immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
|
PF-04991532 25 mg
n=47 Participants
PF-04991532 25 mg tablet orally twice daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
|
PF-04991532 75 mg
n=47 Participants
PF-04991532 75 mg tablet orally twice daily along background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
|
PF-04991532 150 mg
n=46 Participants
PF-04991532 150 mg tablet orally twice daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
|
PF-04991532 300 mg
n=48 Participants
PF-04991532 300 mg tablet orally twice daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
|
Sitagliptin 100 mg
n=49 Participants
Sitagliptin 100 mg tablet orally once daily as morning dose and placebo matched to sitagliptin tablet orally once daily as evening dose along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 1, 2, 4 and 8
Change at Week 1 (n= 48, 47, 47, 46, 46, 47)
|
0.03 percentage of hemoglobin
Standard Deviation 0.496
|
-0.01 percentage of hemoglobin
Standard Deviation 0.190
|
-0.07 percentage of hemoglobin
Standard Deviation 0.182
|
-0.06 percentage of hemoglobin
Standard Deviation 0.227
|
-0.02 percentage of hemoglobin
Standard Deviation 0.210
|
-0.14 percentage of hemoglobin
Standard Deviation 0.223
|
|
Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 1, 2, 4 and 8
Change at Week 2 (n= 45, 44, 45, 45, 47, 48)
|
-0.02 percentage of hemoglobin
Standard Deviation 0.481
|
-0.10 percentage of hemoglobin
Standard Deviation 0.236
|
-0.08 percentage of hemoglobin
Standard Deviation 0.230
|
-0.06 percentage of hemoglobin
Standard Deviation 0.342
|
-0.17 percentage of hemoglobin
Standard Deviation 0.275
|
-0.21 percentage of hemoglobin
Standard Deviation 0.357
|
|
Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 1, 2, 4 and 8
Change at Week 4 (n= 46, 42, 44, 45, 48, 49)
|
-0.14 percentage of hemoglobin
Standard Deviation 0.558
|
-0.15 percentage of hemoglobin
Standard Deviation 0.326
|
-0.26 percentage of hemoglobin
Standard Deviation 0.436
|
-0.32 percentage of hemoglobin
Standard Deviation 0.525
|
-0.37 percentage of hemoglobin
Standard Deviation 0.395
|
-0.40 percentage of hemoglobin
Standard Deviation 0.463
|
|
Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 1, 2, 4 and 8
Change at Week 8 (n= 43, 40, 41, 42, 45, 45)
|
-0.26 percentage of hemoglobin
Standard Deviation 0.615
|
-0.14 percentage of hemoglobin
Standard Deviation 0.492
|
-0.40 percentage of hemoglobin
Standard Deviation 0.697
|
-0.42 percentage of hemoglobin
Standard Deviation 0.708
|
-0.58 percentage of hemoglobin
Standard Deviation 0.607
|
-0.54 percentage of hemoglobin
Standard Deviation 0.696
|
SECONDARY outcome
Timeframe: Week 12Population: FAS included all randomized participants who received at least 1 dose of study medication. Here, N (number of participants analyzed) signify those who were evaluable for this measure.
HbA1c is a form of hemoglobin which is measured primarily to identify the average plasma glucose concentration over prolonged periods of time. The normal range for the HbA1c test is between 4% and 5.6%. HbA1c levels between 5.7% and 6.4% indicate increased risk of diabetes, and levels of 6.5% or higher indicate diabetes.
Outcome measures
| Measure |
Placebo
n=42 Participants
Placebo matched to PF-04991532 tablets orally twice daily or placebo matched to sitagliptin tablet orally twice daily along with background metformin 500 milligram (mg) immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
|
PF-04991532 25 mg
n=37 Participants
PF-04991532 25 mg tablet orally twice daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
|
PF-04991532 75 mg
n=39 Participants
PF-04991532 75 mg tablet orally twice daily along background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
|
PF-04991532 150 mg
n=40 Participants
PF-04991532 150 mg tablet orally twice daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
|
PF-04991532 300 mg
n=46 Participants
PF-04991532 300 mg tablet orally twice daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
|
Sitagliptin 100 mg
n=44 Participants
Sitagliptin 100 mg tablet orally once daily as morning dose and placebo matched to sitagliptin tablet orally once daily as evening dose along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants Achieving Less Than (<) 6.5% or <7% Glycosylated Hemoglobin (HbA1c) Levels
< 6.5%
|
11.9 percentage of participants
|
8.1 percentage of participants
|
15.4 percentage of participants
|
17.5 percentage of participants
|
17.4 percentage of participants
|
15.9 percentage of participants
|
|
Percentage of Participants Achieving Less Than (<) 6.5% or <7% Glycosylated Hemoglobin (HbA1c) Levels
< 7%
|
23.8 percentage of participants
|
29.7 percentage of participants
|
38.5 percentage of participants
|
35.0 percentage of participants
|
43.5 percentage of participants
|
36.4 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Week 1, 2, 4, 8, 12Population: FAS included all randomized participants who received at least 1 dose of study medication. Here 'n' signifies participants who were evaluable at specific time point for each treatment arm respectively.
Overweight or obesity increases the risk for developing diabetes. The treatment of diabetes has been the recommendation to lose weight. As weight loss progresses and is maintained, an improvement of glycemia may be evidenced by a reduction in HbA1c.
Outcome measures
| Measure |
Placebo
n=50 Participants
Placebo matched to PF-04991532 tablets orally twice daily or placebo matched to sitagliptin tablet orally twice daily along with background metformin 500 milligram (mg) immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
|
PF-04991532 25 mg
n=49 Participants
PF-04991532 25 mg tablet orally twice daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
|
PF-04991532 75 mg
n=50 Participants
PF-04991532 75 mg tablet orally twice daily along background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
|
PF-04991532 150 mg
n=50 Participants
PF-04991532 150 mg tablet orally twice daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
|
PF-04991532 300 mg
n=52 Participants
PF-04991532 300 mg tablet orally twice daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
|
Sitagliptin 100 mg
n=50 Participants
Sitagliptin 100 mg tablet orally once daily as morning dose and placebo matched to sitagliptin tablet orally once daily as evening dose along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Body Weight at Week 1, 2, 4, 8 and 12
Baseline (n= 50, 49, 50, 50, 52, 50)
|
89.69 kilogram (kg)
Standard Deviation 17.571
|
87.24 kilogram (kg)
Standard Deviation 19.805
|
85.69 kilogram (kg)
Standard Deviation 19.805
|
85.44 kilogram (kg)
Standard Deviation 18.305
|
91.61 kilogram (kg)
Standard Deviation 21.822
|
91.00 kilogram (kg)
Standard Deviation 21.013
|
|
Change From Baseline in Body Weight at Week 1, 2, 4, 8 and 12
Change at Week 1 (n= 48, 47, 47, 46, 47, 47)
|
0.01 kilogram (kg)
Standard Deviation 0.792
|
-0.20 kilogram (kg)
Standard Deviation 1.170
|
0.14 kilogram (kg)
Standard Deviation 1.600
|
-0.20 kilogram (kg)
Standard Deviation 0.861
|
-0.20 kilogram (kg)
Standard Deviation 1.168
|
-0.33 kilogram (kg)
Standard Deviation 2.089
|
|
Change From Baseline in Body Weight at Week 1, 2, 4, 8 and 12
Change at Week 2 (n= 45, 44, 45, 45, 47, 48)
|
0.31 kilogram (kg)
Standard Deviation 2.041
|
-0.49 kilogram (kg)
Standard Deviation 1.462
|
0.07 kilogram (kg)
Standard Deviation 1.510
|
-0.25 kilogram (kg)
Standard Deviation 1.086
|
-0.03 kilogram (kg)
Standard Deviation 1.414
|
-0.32 kilogram (kg)
Standard Deviation 2.488
|
|
Change From Baseline in Body Weight at Week 1, 2, 4, 8 and 12
Change at Week 4 (n= 46, 42, 44, 45, 48, 49)
|
-0.10 kilogram (kg)
Standard Deviation 1.255
|
-0.55 kilogram (kg)
Standard Deviation 1.576
|
0.20 kilogram (kg)
Standard Deviation 1.594
|
-0.27 kilogram (kg)
Standard Deviation 1.381
|
-0.58 kilogram (kg)
Standard Deviation 1.401
|
-0.30 kilogram (kg)
Standard Deviation 2.276
|
|
Change From Baseline in Body Weight at Week 1, 2, 4, 8 and 12
Change at Week 8 (n= 43, 40, 41, 42, 46, 45)
|
-0.21 kilogram (kg)
Standard Deviation 1.848
|
-0.57 kilogram (kg)
Standard Deviation 1.488
|
-0.04 kilogram (kg)
Standard Deviation 2.318
|
-0.64 kilogram (kg)
Standard Deviation 1.538
|
-0.67 kilogram (kg)
Standard Deviation 1.649
|
-0.61 kilogram (kg)
Standard Deviation 2.648
|
|
Change From Baseline in Body Weight at Week 1, 2, 4, 8 and 12
Change at Week 12 (n= 42, 37, 39, 41, 46, 44)
|
-0.30 kilogram (kg)
Standard Deviation 1.869
|
-0.71 kilogram (kg)
Standard Deviation 1.980
|
-0.15 kilogram (kg)
Standard Deviation 2.757
|
-0.83 kilogram (kg)
Standard Deviation 2.099
|
-0.75 kilogram (kg)
Standard Deviation 2.087
|
-0.83 kilogram (kg)
Standard Deviation 3.026
|
SECONDARY outcome
Timeframe: Week 12Population: FAS included all randomized participants who received at least 1 dose of study medication. Here, N (number of participants analyzed) signify those who were evaluable for this measure.
Overweight or obesity increases the risk for developing diabetes. Participants with \>= 1% or \>= 2% gain in body weight from baseline signifies a higher risk of diabetes.
Outcome measures
| Measure |
Placebo
n=42 Participants
Placebo matched to PF-04991532 tablets orally twice daily or placebo matched to sitagliptin tablet orally twice daily along with background metformin 500 milligram (mg) immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
|
PF-04991532 25 mg
n=37 Participants
PF-04991532 25 mg tablet orally twice daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
|
PF-04991532 75 mg
n=39 Participants
PF-04991532 75 mg tablet orally twice daily along background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
|
PF-04991532 150 mg
n=41 Participants
PF-04991532 150 mg tablet orally twice daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
|
PF-04991532 300 mg
n=46 Participants
PF-04991532 300 mg tablet orally twice daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
|
Sitagliptin 100 mg
n=44 Participants
Sitagliptin 100 mg tablet orally once daily as morning dose and placebo matched to sitagliptin tablet orally once daily as evening dose along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants With Greater Than or Equal to (>=) 1% or >= 2% Gain in Body Weight From Baseline
>= 1%
|
23.81 percentage of participants
|
27.03 percentage of participants
|
38.46 percentage of participants
|
21.95 percentage of participants
|
15.22 percentage of participants
|
31.82 percentage of participants
|
|
Percentage of Participants With Greater Than or Equal to (>=) 1% or >= 2% Gain in Body Weight From Baseline
>= 2%
|
2.38 percentage of participants
|
2.70 percentage of participants
|
15.38 percentage of participants
|
7.32 percentage of participants
|
6.52 percentage of participants
|
15.91 percentage of participants
|
SECONDARY outcome
Timeframe: Week 12Population: FAS included all randomized participants who received at least 1 dose of study medication. Here, N (number of participants analyzed) signify those who were evaluable for this measure.
The treatment of diabetes has been the recommendation to lose weight. As weight loss progresses and is maintained, an improvement of glycemia may be evidenced by a reduction in HbA1c. Participants with \>= 1% or \>= 2% loss in body weight from baseline signifies an improvement of glycemia.
Outcome measures
| Measure |
Placebo
n=42 Participants
Placebo matched to PF-04991532 tablets orally twice daily or placebo matched to sitagliptin tablet orally twice daily along with background metformin 500 milligram (mg) immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
|
PF-04991532 25 mg
n=37 Participants
PF-04991532 25 mg tablet orally twice daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
|
PF-04991532 75 mg
n=39 Participants
PF-04991532 75 mg tablet orally twice daily along background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
|
PF-04991532 150 mg
n=41 Participants
PF-04991532 150 mg tablet orally twice daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
|
PF-04991532 300 mg
n=46 Participants
PF-04991532 300 mg tablet orally twice daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
|
Sitagliptin 100 mg
n=44 Participants
Sitagliptin 100 mg tablet orally once daily as morning dose and placebo matched to sitagliptin tablet orally once daily as evening dose along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants With Greater Than or Equal to (>=) 1% or >= 2% Loss in Body Weight From Baseline
>= 1%
|
38.10 percentage of participants
|
35.14 percentage of participants
|
30.77 percentage of participants
|
48.78 percentage of participants
|
41.30 percentage of participants
|
40.91 percentage of participants
|
|
Percentage of Participants With Greater Than or Equal to (>=) 1% or >= 2% Loss in Body Weight From Baseline
>= 2%
|
23.81 percentage of participants
|
27.03 percentage of participants
|
17.95 percentage of participants
|
26.83 percentage of participants
|
30.43 percentage of participants
|
29.55 percentage of participants
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths
PF-04991532 25 mg
Serious events: 0 serious events
Other events: 16 other events
Deaths: 0 deaths
PF-04991532 75 mg
Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths
PF-04991532 150 mg
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
PF-04991532 300 mg
Serious events: 0 serious events
Other events: 15 other events
Deaths: 0 deaths
Sitagliptin 100 mg
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo
n=50 participants at risk
Placebo matched to PF-04991532 tablets orally twice daily or placebo matched to sitagliptin tablet orally twice daily along with background metformin 500 milligram (mg) immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
|
PF-04991532 25 mg
n=49 participants at risk
PF-04991532 25 mg tablet orally twice daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
|
PF-04991532 75 mg
n=50 participants at risk
PF-04991532 75 mg tablet orally twice daily along background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
|
PF-04991532 150 mg
n=50 participants at risk
PF-04991532 150 mg tablet orally twice daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
|
PF-04991532 300 mg
n=52 participants at risk
PF-04991532 300 mg tablet orally twice daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
|
Sitagliptin 100 mg
n=50 participants at risk
Sitagliptin 100 mg tablet orally once daily as morning dose and placebo matched to sitagliptin tablet orally once daily as evening dose along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
|
|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
4.0%
2/50
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/49
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
6.0%
3/50
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.0%
1/50
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
3.8%
2/52
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/50
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/50
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.0%
1/49
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/50
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.0%
1/50
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
1.9%
1/52
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
8.0%
4/50
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Pharyngitis
|
2.0%
1/50
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
4.1%
2/49
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
4.0%
2/50
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.0%
1/50
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
7.7%
4/52
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/50
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Upper respiratory tract infection
|
6.0%
3/50
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.0%
1/49
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
6.0%
3/50
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
4.0%
2/50
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
3.8%
2/52
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.0%
1/50
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Urinary tract infection
|
10.0%
5/50
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.0%
1/49
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
4.0%
2/50
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
6.0%
3/50
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/52
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
4.0%
2/50
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
6.0%
3/50
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
10.2%
5/49
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/50
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
6.0%
3/50
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
1.9%
1/52
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.0%
1/50
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/50
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.0%
1/49
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/50
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.0%
1/50
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
1.9%
1/52
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
6.0%
3/50
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/50
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
6.1%
3/49
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/50
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/50
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
1.9%
1/52
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/50
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Headache
|
0.00%
0/50
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
8.2%
4/49
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
8.0%
4/50
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.0%
1/50
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
5.8%
3/52
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.0%
1/50
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Vascular disorders
Hypertension
|
2.0%
1/50
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.0%
1/49
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
4.0%
2/50
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/50
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
5.8%
3/52
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/50
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
- Publication restrictions are in place
Restriction type: OTHER