Trial Outcomes & Findings for Study Of Safety And Efficacy Of PF-04991532 In Subjects With Type 2 Diabetes Mellitus (NCT NCT01336738)
NCT ID: NCT01336738
Last Updated: 2013-08-06
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
266 participants
Primary outcome timeframe
Baseline, Week 12
Results posted on
2013-08-06
Participant Flow
All participants received placebo matched to PF-04991532 or placebo matched to sitagliptin tablet orally once 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 |
PF-04991532 150 mg
PF-04991532 150 milligram (mg) (1 PF-04991532 150 mg tablet and 4 placebo tablets matched to PF-04991532 150 mg) orally once daily and 1 placebo tablet matched to sitagliptin 100 mg orally once 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 450 mg
PF-04991532 450 mg (3 PF-04991532 150 mg tablets and 2 placebo tablets matched to PF-04991532 150 mg) orally once daily and 1 placebo tablet matched to sitagliptin 100 mg orally once 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 750 mg
PF-04991532 750 mg (5 PF-04991532 150 mg tablets) orally once daily and 1 placebo tablet matched to sitagliptin 100 mg orally once 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
Five placebo tablets matched to PF-04991532 150 mg and 1 sitagliptin 100 mg tablet orally once 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.
|
Placebo
Five placebo tablets matched to PF-04991532 150 mg and 1 placebo matched to sitagliptin 100 mg tablet orally once 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.
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
52
|
54
|
53
|
54
|
53
|
|
Overall Study
COMPLETED
|
45
|
45
|
45
|
47
|
43
|
|
Overall Study
NOT COMPLETED
|
7
|
9
|
8
|
7
|
10
|
Reasons for withdrawal
| Measure |
PF-04991532 150 mg
PF-04991532 150 milligram (mg) (1 PF-04991532 150 mg tablet and 4 placebo tablets matched to PF-04991532 150 mg) orally once daily and 1 placebo tablet matched to sitagliptin 100 mg orally once 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 450 mg
PF-04991532 450 mg (3 PF-04991532 150 mg tablets and 2 placebo tablets matched to PF-04991532 150 mg) orally once daily and 1 placebo tablet matched to sitagliptin 100 mg orally once 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 750 mg
PF-04991532 750 mg (5 PF-04991532 150 mg tablets) orally once daily and 1 placebo tablet matched to sitagliptin 100 mg orally once 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
Five placebo tablets matched to PF-04991532 150 mg and 1 sitagliptin 100 mg tablet orally once 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.
|
Placebo
Five placebo tablets matched to PF-04991532 150 mg and 1 placebo matched to sitagliptin 100 mg tablet orally once 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.
|
|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
3
|
2
|
1
|
3
|
|
Overall Study
Lost to Follow-up
|
2
|
1
|
2
|
2
|
2
|
|
Overall Study
Did not meet entrance criteria
|
0
|
1
|
0
|
0
|
0
|
|
Overall Study
Protocol Violation
|
0
|
1
|
0
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
2
|
0
|
2
|
1
|
1
|
|
Overall Study
Other
|
3
|
3
|
2
|
3
|
4
|
Baseline Characteristics
Study Of Safety And Efficacy Of PF-04991532 In Subjects With Type 2 Diabetes Mellitus
Baseline characteristics by cohort
| Measure |
PF-04991532 150 mg
n=52 Participants
PF-04991532 150 milligram (mg) (1 PF-04991532 150 mg tablet and 4 placebo tablets matched to PF-04991532 150 mg) orally once daily and 1 placebo tablet matched to sitagliptin 100 mg orally once 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 450 mg
n=54 Participants
PF-04991532 450 mg (3 PF-04991532 150 mg tablets and 2 placebo tablets matched to PF-04991532 150 mg) orally once daily and 1 placebo tablet matched to sitagliptin 100 mg orally once 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 750 mg
n=53 Participants
PF-04991532 750 mg (5 PF-04991532 150 mg tablets) orally once daily and 1 placebo tablet matched to sitagliptin 100 mg orally once 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=54 Participants
Five placebo tablets matched to PF-04991532 150 mg and 1 sitagliptin 100 mg tablet orally once 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.
|
Placebo
n=53 Participants
Five placebo tablets matched to PF-04991532 150 mg and 1 placebo matched to sitagliptin 100 mg tablet orally once 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.
|
Total
n=266 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age Continuous
|
55.3 years
STANDARD_DEVIATION 9.9 • n=5 Participants
|
55.1 years
STANDARD_DEVIATION 9.3 • n=7 Participants
|
55.5 years
STANDARD_DEVIATION 7.3 • n=5 Participants
|
57.8 years
STANDARD_DEVIATION 8.3 • n=4 Participants
|
55.6 years
STANDARD_DEVIATION 8.5 • n=21 Participants
|
55.9 years
STANDARD_DEVIATION 8.7 • n=8 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
23 Participants
n=4 Participants
|
14 Participants
n=21 Participants
|
94 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
36 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
31 Participants
n=4 Participants
|
39 Participants
n=21 Participants
|
172 Participants
n=8 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 |
PF-04991532 150 mg
n=52 Participants
PF-04991532 150 milligram (mg) (1 PF-04991532 150 mg tablet and 4 placebo tablets matched to PF-04991532 150 mg) orally once daily and 1 placebo tablet matched to sitagliptin 100 mg orally once 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 450 mg
n=53 Participants
PF-04991532 450 mg (3 PF-04991532 150 mg tablets and 2 placebo tablets matched to PF-04991532 150 mg) orally once daily and 1 placebo tablet matched to sitagliptin 100 mg orally once 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 750 mg
n=52 Participants
PF-04991532 750 mg (5 PF-04991532 150 mg tablets) orally once daily and 1 placebo tablet matched to sitagliptin 100 mg orally once 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=54 Participants
Five placebo tablets matched to PF-04991532 150 mg and 1 sitagliptin 100 mg tablet orally once 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.
|
Placebo
n=53 Participants
Five placebo tablets matched to PF-04991532 150 mg and 1 placebo matched to sitagliptin 100 mg tablet orally once 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.
|
|---|---|---|---|---|---|
|
Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 12
Baseline (n=52, 53, 52, 54, 53)
|
8.34 percentage of hemoglobin
Standard Deviation 0.906
|
8.19 percentage of hemoglobin
Standard Deviation 0.947
|
7.96 percentage of hemoglobin
Standard Deviation 1.030
|
7.97 percentage of hemoglobin
Standard Deviation 1.086
|
8.55 percentage of hemoglobin
Standard Deviation 1.351
|
|
Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 12
Change at Week 12 (n=44, 44, 43, 48, 43)
|
-0.17 percentage of hemoglobin
Standard Deviation 0.922
|
-0.57 percentage of hemoglobin
Standard Deviation 0.753
|
-0.70 percentage of hemoglobin
Standard Deviation 0.790
|
-0.78 percentage of hemoglobin
Standard Deviation 0.721
|
-0.21 percentage of hemoglobin
Standard Deviation 0.921
|
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 |
PF-04991532 150 mg
n=52 Participants
PF-04991532 150 milligram (mg) (1 PF-04991532 150 mg tablet and 4 placebo tablets matched to PF-04991532 150 mg) orally once daily and 1 placebo tablet matched to sitagliptin 100 mg orally once 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 450 mg
n=53 Participants
PF-04991532 450 mg (3 PF-04991532 150 mg tablets and 2 placebo tablets matched to PF-04991532 150 mg) orally once daily and 1 placebo tablet matched to sitagliptin 100 mg orally once 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 750 mg
n=52 Participants
PF-04991532 750 mg (5 PF-04991532 150 mg tablets) orally once daily and 1 placebo tablet matched to sitagliptin 100 mg orally once 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=54 Participants
Five placebo tablets matched to PF-04991532 150 mg and 1 sitagliptin 100 mg tablet orally once 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.
|
Placebo
n=53 Participants
Five placebo tablets matched to PF-04991532 150 mg and 1 placebo matched to sitagliptin 100 mg tablet orally once 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.
|
|---|---|---|---|---|---|
|
Change From Baseline in Fasting Plasma Glucose at Week 1, 2, 4, 8 and 12
Baseline (n=52, 53, 52, 54, 53)
|
172.68 milligram/deciliter (mg/dL)
Standard Deviation 39.612
|
169.16 milligram/deciliter (mg/dL)
Standard Deviation 41.703
|
159.11 milligram/deciliter (mg/dL)
Standard Deviation 44.878
|
158.38 milligram/deciliter (mg/dL)
Standard Deviation 42.502
|
183.61 milligram/deciliter (mg/dL)
Standard Deviation 57.517
|
|
Change From Baseline in Fasting Plasma Glucose at Week 1, 2, 4, 8 and 12
Change at Week 1 (n=50, 51, 49, 49, 51)
|
0.87 milligram/deciliter (mg/dL)
Standard Deviation 27.059
|
1.63 milligram/deciliter (mg/dL)
Standard Deviation 25.373
|
-1.55 milligram/deciliter (mg/dL)
Standard Deviation 19.826
|
-13.72 milligram/deciliter (mg/dL)
Standard Deviation 24.445
|
-4.21 milligram/deciliter (mg/dL)
Standard Deviation 33.274
|
|
Change From Baseline in Fasting Plasma Glucose at Week 1, 2, 4, 8 and 12
Change at Week 2 (n=50, 51, 51, 50, 47)
|
-4.48 milligram/deciliter (mg/dL)
Standard Deviation 23.488
|
4.13 milligram/deciliter (mg/dL)
Standard Deviation 30.662
|
-5.26 milligram/deciliter (mg/dL)
Standard Deviation 21.466
|
-15.70 milligram/deciliter (mg/dL)
Standard Deviation 29.704
|
-3.72 milligram/deciliter (mg/dL)
Standard Deviation 27.797
|
|
Change From Baseline in Fasting Plasma Glucose at Week 1, 2, 4, 8 and 12
Change at Week 4 (n=49, 49, 49, 50, 45)
|
1.13 milligram/deciliter (mg/dL)
Standard Deviation 28.589
|
-5.14 milligram/deciliter (mg/dL)
Standard Deviation 29.757
|
-6.68 milligram/deciliter (mg/dL)
Standard Deviation 20.582
|
-21.86 milligram/deciliter (mg/dL)
Standard Deviation 29.063
|
-4.28 milligram/deciliter (mg/dL)
Standard Deviation 34.304
|
|
Change From Baseline in Fasting Plasma Glucose at Week 1, 2, 4, 8 and 12
Change at Week 8 (n=46, 44, 44, 47, 45)
|
3.69 milligram/deciliter (mg/dL)
Standard Deviation 29.232
|
-1.49 milligram/deciliter (mg/dL)
Standard Deviation 33.421
|
2.95 milligram/deciliter (mg/dL)
Standard Deviation 21.892
|
-14.05 milligram/deciliter (mg/dL)
Standard Deviation 21.646
|
2.18 milligram/deciliter (mg/dL)
Standard Deviation 37.322
|
|
Change From Baseline in Fasting Plasma Glucose at Week 1, 2, 4, 8 and 12
Change at Week 12 (n=45, 44, 44, 48, 43)
|
0.08 milligram/deciliter (mg/dL)
Standard Deviation 36.122
|
5.87 milligram/deciliter (mg/dL)
Standard Deviation 33.092
|
6.86 milligram/deciliter (mg/dL)
Standard Deviation 28.602
|
-17.64 milligram/deciliter (mg/dL)
Standard Deviation 30.779
|
-0.03 milligram/deciliter (mg/dL)
Standard Deviation 45.784
|
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' 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 |
PF-04991532 150 mg
n=52 Participants
PF-04991532 150 milligram (mg) (1 PF-04991532 150 mg tablet and 4 placebo tablets matched to PF-04991532 150 mg) orally once daily and 1 placebo tablet matched to sitagliptin 100 mg orally once 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 450 mg
n=53 Participants
PF-04991532 450 mg (3 PF-04991532 150 mg tablets and 2 placebo tablets matched to PF-04991532 150 mg) orally once daily and 1 placebo tablet matched to sitagliptin 100 mg orally once 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 750 mg
n=52 Participants
PF-04991532 750 mg (5 PF-04991532 150 mg tablets) orally once daily and 1 placebo tablet matched to sitagliptin 100 mg orally once 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=54 Participants
Five placebo tablets matched to PF-04991532 150 mg and 1 sitagliptin 100 mg tablet orally once 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.
|
Placebo
n=53 Participants
Five placebo tablets matched to PF-04991532 150 mg and 1 placebo matched to sitagliptin 100 mg tablet orally once 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.
|
|---|---|---|---|---|---|
|
Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 1, 2, 4 and 8
Change at Week 1 (n=50, 51, 49, 49, 48)
|
-0.04 percentage of hemoglobin
Standard Deviation 0.227
|
-0.03 percentage of hemoglobin
Standard Deviation 0.210
|
-0.13 percentage of hemoglobin
Standard Deviation 0.217
|
-0.07 percentage of hemoglobin
Standard Deviation 0.200
|
-0.02 percentage of hemoglobin
Standard Deviation 0.287
|
|
Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 1, 2, 4 and 8
Change at Week 2 (n=50, 52, 49, 49, 47)
|
-0.04 percentage of hemoglobin
Standard Deviation 0.349
|
-0.14 percentage of hemoglobin
Standard Deviation 0.288
|
-0.18 percentage of hemoglobin
Standard Deviation 0.271
|
-0.23 percentage of hemoglobin
Standard Deviation 0.311
|
-0.07 percentage of hemoglobin
Standard Deviation 0.372
|
|
Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 1, 2, 4 and 8
Change at Week 4 (n=48, 49, 48, 50, 46)
|
-0.22 percentage of hemoglobin
Standard Deviation 0.475
|
-0.34 percentage of hemoglobin
Standard Deviation 0.392
|
-0.40 percentage of hemoglobin
Standard Deviation 0.421
|
-0.42 percentage of hemoglobin
Standard Deviation 0.483
|
-0.16 percentage of hemoglobin
Standard Deviation 0.591
|
|
Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 1, 2, 4 and 8
Change at Week 8 (n=45, 44, 45, 47, 45)
|
-0.21 percentage of hemoglobin
Standard Deviation 0.728
|
-0.50 percentage of hemoglobin
Standard Deviation 0.562
|
-0.66 percentage of hemoglobin
Standard Deviation 0.772
|
-0.71 percentage of hemoglobin
Standard Deviation 0.713
|
-0.22 percentage of hemoglobin
Standard Deviation 0.762
|
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 |
PF-04991532 150 mg
n=44 Participants
PF-04991532 150 milligram (mg) (1 PF-04991532 150 mg tablet and 4 placebo tablets matched to PF-04991532 150 mg) orally once daily and 1 placebo tablet matched to sitagliptin 100 mg orally once 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 450 mg
n=44 Participants
PF-04991532 450 mg (3 PF-04991532 150 mg tablets and 2 placebo tablets matched to PF-04991532 150 mg) orally once daily and 1 placebo tablet matched to sitagliptin 100 mg orally once 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 750 mg
n=43 Participants
PF-04991532 750 mg (5 PF-04991532 150 mg tablets) orally once daily and 1 placebo tablet matched to sitagliptin 100 mg orally once 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=48 Participants
Five placebo tablets matched to PF-04991532 150 mg and 1 sitagliptin 100 mg tablet orally once 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.
|
Placebo
n=43 Participants
Five placebo tablets matched to PF-04991532 150 mg and 1 placebo matched to sitagliptin 100 mg tablet orally once 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.
|
|---|---|---|---|---|---|
|
Percentage of Participants Achieving Less Than (<) 6.5% or <7% Glycosylated Hemoglobin (HbA1c) Levels
< 6.5%
|
4.5 percentage of participants
|
9.1 percentage of participants
|
23.3 percentage of participants
|
14.6 percentage of participants
|
11.6 percentage of participants
|
|
Percentage of Participants Achieving Less Than (<) 6.5% or <7% Glycosylated Hemoglobin (HbA1c) Levels
< 7%
|
13.6 percentage of participants
|
36.4 percentage of participants
|
60.5 percentage of participants
|
39.6 percentage of participants
|
16.3 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 |
PF-04991532 150 mg
n=52 Participants
PF-04991532 150 milligram (mg) (1 PF-04991532 150 mg tablet and 4 placebo tablets matched to PF-04991532 150 mg) orally once daily and 1 placebo tablet matched to sitagliptin 100 mg orally once 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 450 mg
n=53 Participants
PF-04991532 450 mg (3 PF-04991532 150 mg tablets and 2 placebo tablets matched to PF-04991532 150 mg) orally once daily and 1 placebo tablet matched to sitagliptin 100 mg orally once 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 750 mg
n=52 Participants
PF-04991532 750 mg (5 PF-04991532 150 mg tablets) orally once daily and 1 placebo tablet matched to sitagliptin 100 mg orally once 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=54 Participants
Five placebo tablets matched to PF-04991532 150 mg and 1 sitagliptin 100 mg tablet orally once 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.
|
Placebo
n=53 Participants
Five placebo tablets matched to PF-04991532 150 mg and 1 placebo matched to sitagliptin 100 mg tablet orally once 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.
|
|---|---|---|---|---|---|
|
Change From Baseline in Body Weight at Week 1, 2, 4, 8 and 12
Change at Week 1 (n=50, 51, 49, 51, 51)
|
-0.10 kilogram (kg)
Standard Deviation 1.176
|
-0.31 kilogram (kg)
Standard Deviation 1.091
|
-0.34 kilogram (kg)
Standard Deviation 1.100
|
0.14 kilogram (kg)
Standard Deviation 0.982
|
-0.33 kilogram (kg)
Standard Deviation 1.050
|
|
Change From Baseline in Body Weight at Week 1, 2, 4, 8 and 12
Baseline (n=52, 53, 52, 54, 53)
|
92.57 kilogram (kg)
Standard Deviation 19.957
|
88.91 kilogram (kg)
Standard Deviation 22.781
|
86.08 kilogram (kg)
Standard Deviation 17.787
|
87.48 kilogram (kg)
Standard Deviation 19.883
|
87.43 kilogram (kg)
Standard Deviation 19.351
|
|
Change From Baseline in Body Weight at Week 1, 2, 4, 8 and 12
Change at Week 2 (n=50, 52, 51, 50, 48)
|
-0.12 kilogram (kg)
Standard Deviation 1.189
|
-0.33 kilogram (kg)
Standard Deviation 1.175
|
-0.38 kilogram (kg)
Standard Deviation 1.115
|
-0.00 kilogram (kg)
Standard Deviation 1.364
|
-0.37 kilogram (kg)
Standard Deviation 0.885
|
|
Change From Baseline in Body Weight at Week 1, 2, 4, 8 and 12
Change at Week 4 (n=49, 49, 49, 50, 46)
|
-0.18 kilogram (kg)
Standard Deviation 1.357
|
-0.72 kilogram (kg)
Standard Deviation 1.499
|
-0.34 kilogram (kg)
Standard Deviation 1.486
|
0.15 kilogram (kg)
Standard Deviation 1.170
|
-0.52 kilogram (kg)
Standard Deviation 1.139
|
|
Change From Baseline in Body Weight at Week 1, 2, 4, 8 and 12
Change at Week 8 (n=46, 44, 45, 48, 45)
|
-0.27 kilogram (kg)
Standard Deviation 1.865
|
-0.66 kilogram (kg)
Standard Deviation 2.047
|
-0.45 kilogram (kg)
Standard Deviation 2.026
|
-0.21 kilogram (kg)
Standard Deviation 2.059
|
-0.60 kilogram (kg)
Standard Deviation 1.444
|
|
Change From Baseline in Body Weight at Week 1, 2, 4, 8 and 12
Change at Week 12 (n=45, 44, 45, 48, 43)
|
-0.91 kilogram (kg)
Standard Deviation 1.880
|
-0.82 kilogram (kg)
Standard Deviation 2.126
|
-0.90 kilogram (kg)
Standard Deviation 2.421
|
-0.22 kilogram (kg)
Standard Deviation 1.993
|
-0.95 kilogram (kg)
Standard Deviation 2.058
|
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% body weight gain from baseline signifies a higher risk of diabetes.
Outcome measures
| Measure |
PF-04991532 150 mg
n=45 Participants
PF-04991532 150 milligram (mg) (1 PF-04991532 150 mg tablet and 4 placebo tablets matched to PF-04991532 150 mg) orally once daily and 1 placebo tablet matched to sitagliptin 100 mg orally once 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 450 mg
n=44 Participants
PF-04991532 450 mg (3 PF-04991532 150 mg tablets and 2 placebo tablets matched to PF-04991532 150 mg) orally once daily and 1 placebo tablet matched to sitagliptin 100 mg orally once 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 750 mg
n=45 Participants
PF-04991532 750 mg (5 PF-04991532 150 mg tablets) orally once daily and 1 placebo tablet matched to sitagliptin 100 mg orally once 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=48 Participants
Five placebo tablets matched to PF-04991532 150 mg and 1 sitagliptin 100 mg tablet orally once 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.
|
Placebo
n=43 Participants
Five placebo tablets matched to PF-04991532 150 mg and 1 placebo matched to sitagliptin 100 mg tablet orally once 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.
|
|---|---|---|---|---|---|
|
Percentage of Participants With Greater Than or Equal to (>=) 1% or >= 2% Body Weight Gain From Baseline
>= 1%
|
17.78 percentage of participants
|
18.18 percentage of participants
|
15.56 percentage of participants
|
29.17 percentage of participants
|
23.26 percentage of participants
|
|
Percentage of Participants With Greater Than or Equal to (>=) 1% or >= 2% Body Weight Gain From Baseline
>= 2%
|
6.67 percentage of participants
|
11.36 percentage of participants
|
11.11 percentage of participants
|
14.58 percentage of participants
|
6.98 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% body weight loss from baseline signifies an improvement of glycemia.
Outcome measures
| Measure |
PF-04991532 150 mg
n=45 Participants
PF-04991532 150 milligram (mg) (1 PF-04991532 150 mg tablet and 4 placebo tablets matched to PF-04991532 150 mg) orally once daily and 1 placebo tablet matched to sitagliptin 100 mg orally once 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 450 mg
n=44 Participants
PF-04991532 450 mg (3 PF-04991532 150 mg tablets and 2 placebo tablets matched to PF-04991532 150 mg) orally once daily and 1 placebo tablet matched to sitagliptin 100 mg orally once 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 750 mg
n=45 Participants
PF-04991532 750 mg (5 PF-04991532 150 mg tablets) orally once daily and 1 placebo tablet matched to sitagliptin 100 mg orally once 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=48 Participants
Five placebo tablets matched to PF-04991532 150 mg and 1 sitagliptin 100 mg tablet orally once 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.
|
Placebo
n=43 Participants
Five placebo tablets matched to PF-04991532 150 mg and 1 placebo matched to sitagliptin 100 mg tablet orally once 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.
|
|---|---|---|---|---|---|
|
Percentage of Participants With Greater Than or Equal to (>=) 1% or >= 2% Body Weight Loss From Baseline
>= 1%
|
55.56 percentage of participants
|
47.73 percentage of participants
|
46.67 percentage of participants
|
29.17 percentage of participants
|
41.86 percentage of participants
|
|
Percentage of Participants With Greater Than or Equal to (>=) 1% or >= 2% Body Weight Loss From Baseline
>= 2%
|
26.67 percentage of participants
|
34.09 percentage of participants
|
31.11 percentage of participants
|
18.75 percentage of participants
|
34.88 percentage of participants
|
Adverse Events
PF-04991532 150 mg
Serious events: 0 serious events
Other events: 17 other events
Deaths: 0 deaths
PF-04991532 450 mg
Serious events: 0 serious events
Other events: 20 other events
Deaths: 0 deaths
PF-04991532 750 mg
Serious events: 0 serious events
Other events: 23 other events
Deaths: 0 deaths
Sitagliptin 100 mg
Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 16 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
PF-04991532 150 mg
n=52 participants at risk
PF-04991532 150 milligram (mg) (1 PF-04991532 150 mg tablet and 4 placebo tablets matched to PF-04991532 150 mg) orally once daily and 1 placebo tablet matched to sitagliptin 100 mg orally once 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 450 mg
n=54 participants at risk
PF-04991532 450 mg (3 PF-04991532 150 mg tablets and 2 placebo tablets matched to PF-04991532 150 mg) orally once daily and 1 placebo tablet matched to sitagliptin 100 mg orally once 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 750 mg
n=53 participants at risk
PF-04991532 750 mg (5 PF-04991532 150 mg tablets) orally once daily and 1 placebo tablet matched to sitagliptin 100 mg orally once 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=54 participants at risk
Five placebo tablets matched to PF-04991532 150 mg and 1 sitagliptin 100 mg tablet orally once 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.
|
Placebo
n=53 participants at risk
Five placebo tablets matched to PF-04991532 150 mg and 1 placebo matched to sitagliptin 100 mg tablet orally once 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.
|
|---|---|---|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
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.
|
1.9%
1/54
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.
|
13.2%
7/53
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.
|
3.7%
2/54
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%
0/53
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.
|
|
Gastrointestinal disorders
Dyspepsia
|
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%
0/54
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%
1/53
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%
1/54
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%
0/53
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.
|
|
Gastrointestinal disorders
Nausea
|
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.
|
7.4%
4/54
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.
|
7.5%
4/53
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.
|
3.7%
2/54
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%
0/53
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.
|
|
Gastrointestinal disorders
Toothache
|
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%
0/54
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%
2/53
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%
0/54
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%
0/53
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.
|
|
Gastrointestinal disorders
Vomiting
|
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.
|
3.7%
2/54
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%
1/53
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%
0/54
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%
1/53
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
Influenza
|
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.
|
1.9%
1/54
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%
0/53
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%
0/54
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%
1/53
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
|
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.
|
3.7%
2/54
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.
|
5.7%
3/53
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%
0/54
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%
2/53
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
|
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.
|
0.00%
0/54
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%
2/53
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%
1/54
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%
0/53
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
Sinusitis
|
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%
0/54
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%
1/53
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.
|
3.7%
2/54
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%
2/53
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
|
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.
|
9.3%
5/54
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%
1/53
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%
1/54
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%
2/53
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
|
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%
0/54
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%
1/53
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%
1/54
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%
2/53
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.
|
|
Injury, poisoning and procedural complications
Contusion
|
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.
|
3.7%
2/54
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%
0/53
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%
0/54
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%
0/53
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.
|
|
Investigations
Blood glucose increased
|
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.
|
0.00%
0/54
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%
0/53
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%
0/54
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%
2/53
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
Dyslipidaemia
|
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.
|
3.7%
2/54
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%
1/53
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%
0/54
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%
0/53
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
|
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.
|
1.9%
1/54
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.
|
5.7%
3/53
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%
0/54
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%
2/53
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
|
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.
|
3.7%
2/54
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%
0/53
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.
|
3.7%
2/54
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%
1/53
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.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
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.
|
0.00%
0/54
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%
0/53
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.
|
3.7%
2/54
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%
1/53
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
|
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.
|
1.9%
1/54
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.
|
5.7%
3/53
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%
1/54
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%
1/53
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.
|
|
Psychiatric disorders
Insomnia
|
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.
|
0.00%
0/54
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%
0/53
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.
|
5.6%
3/54
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%
0/53
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.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
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.
|
1.9%
1/54
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%
1/53
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%
1/54
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%
2/53
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
|
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.
|
5.6%
3/54
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%
0/53
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%
0/54
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%
1/53
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