Trial Outcomes & Findings for A 12-week Study To Evaluate PF-06291874 Once a Day in Adults With T2DM Inadequately Controlled On Metformin (NCT NCT02554877)
NCT ID: NCT02554877
Last Updated: 2017-08-07
Results Overview
HbA1c was a form of hemoglobin which was measured primarily to identify the average plasma glucose concentration over prolonged periods of time. Baseline was defined as the last pre-dose measurement prior to first double blind dosing for the study.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
206 participants
Primary outcome timeframe
Baseline, Week 12
Results posted on
2017-08-07
Participant Flow
Participant milestones
| Measure |
Placebo
Four (4) tablets of placebo matched to PF-06291874 and at least 1 stable dose of open label metformin were orally administered with a standard morning meal once daily for 12 weeks.
|
PF-06291874 30 mg
Two (2) placebo tablets, one 5-mg and one 25-mg of PF-06291874 tablets and at least 1 stable dose of open label metformin were orally administered with a standard morning meal once daily for 12 weeks.
|
PF-06291874 60 mg
Two (2) 5-mg and two 25-mg of PF-06291874 tablets and at least 1 stable dose of open label metformin were orally administered with a standard morning meal once daily for 12 weeks.
|
PF-06291874 100 mg
Four (4) 25-mg of PF-06291874 tablets and at least 1 stable dose of open label metformin were orally administered with a standard morning meal once daily for 12 weeks.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
51
|
51
|
52
|
52
|
|
Overall Study
COMPLETED
|
39
|
44
|
46
|
45
|
|
Overall Study
NOT COMPLETED
|
12
|
7
|
6
|
7
|
Reasons for withdrawal
| Measure |
Placebo
Four (4) tablets of placebo matched to PF-06291874 and at least 1 stable dose of open label metformin were orally administered with a standard morning meal once daily for 12 weeks.
|
PF-06291874 30 mg
Two (2) placebo tablets, one 5-mg and one 25-mg of PF-06291874 tablets and at least 1 stable dose of open label metformin were orally administered with a standard morning meal once daily for 12 weeks.
|
PF-06291874 60 mg
Two (2) 5-mg and two 25-mg of PF-06291874 tablets and at least 1 stable dose of open label metformin were orally administered with a standard morning meal once daily for 12 weeks.
|
PF-06291874 100 mg
Four (4) 25-mg of PF-06291874 tablets and at least 1 stable dose of open label metformin were orally administered with a standard morning meal once daily for 12 weeks.
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
2
|
0
|
0
|
1
|
|
Overall Study
Lost to Follow-up
|
1
|
1
|
1
|
2
|
|
Overall Study
Did not meet entrance criteria
|
0
|
0
|
1
|
0
|
|
Overall Study
No longer met eligibility criteria
|
1
|
0
|
1
|
1
|
|
Overall Study
Protocol Violation
|
3
|
1
|
1
|
0
|
|
Overall Study
Other
|
1
|
3
|
0
|
3
|
|
Overall Study
Insufficient clinical response
|
4
|
0
|
0
|
0
|
|
Overall Study
No longer willing to participate
|
0
|
2
|
2
|
0
|
Baseline Characteristics
A 12-week Study To Evaluate PF-06291874 Once a Day in Adults With T2DM Inadequately Controlled On Metformin
Baseline characteristics by cohort
| Measure |
Placebo
n=51 Participants
Four (4) tablets of placebo matched to PF-06291874 and at least 1 stable dose of open label metformin were orally administered with a standard morning meal once daily for 12 weeks.
|
PF-06291874 30 mg
n=51 Participants
Two (2) placebo tablets, one 5-mg and one 25-mg of PF-06291874 tablets and at least 1 stable dose of open label metformin were orally administered with a standard morning meal once daily for 12 weeks.
|
PF-06291874 60 mg
n=52 Participants
Two (2) 5-mg and two 25-mg of PF-06291874 tablets and at least 1 stable dose of open label metformin were orally administered with a standard morning meal once daily for 12 weeks.
|
PF-06291874 100 mg
n=52 Participants
Four (4) 25-mg of PF-06291874 tablets and at least 1 stable dose of open label metformin were orally administered with a standard morning meal once daily for 12 weeks.
|
Total
n=206 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
56.6 years
STANDARD_DEVIATION 6.3 • n=5 Participants
|
58.1 years
STANDARD_DEVIATION 6.9 • n=7 Participants
|
57.1 years
STANDARD_DEVIATION 7.1 • n=5 Participants
|
57.4 years
STANDARD_DEVIATION 7.9 • n=4 Participants
|
57.3 years
STANDARD_DEVIATION 7 • n=21 Participants
|
|
Sex: Female, Male
Female
|
22 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
21 Participants
n=4 Participants
|
87 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
29 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
31 Participants
n=4 Participants
|
119 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 12Population: All participants randomized and who received at least 1 dose of randomized treatment, participants were assigned to the randomized treatment regardless of what treatment was received.
HbA1c was a form of hemoglobin which was measured primarily to identify the average plasma glucose concentration over prolonged periods of time. Baseline was defined as the last pre-dose measurement prior to first double blind dosing for the study.
Outcome measures
| Measure |
Placebo
n=39 Participants
Four (4) tablets of placebo matched to PF-06291874 and at least 1 stable dose of open label metformin were orally administered with a standard morning meal once daily for 12 weeks.
|
PF-06291874 30 mg
n=44 Participants
Two (2) placebo tablets, one 5-mg and one 25-mg of PF-06291874 tablets and at least 1 stable dose of open label metformin were orally administered with a standard morning meal once daily for 12 weeks.
|
PF-06291874 60 mg
n=46 Participants
Two (2) 5-mg and two 25-mg of PF-06291874 tablets and at least 1 stable dose of open label metformin were orally administered with a standard morning meal once daily for 12 weeks.
|
PF-06291874 100 mg
n=45 Participants
Four (4) 25-mg of PF-06291874 tablets and at least 1 stable dose of open label metformin were orally administered with a standard morning meal once daily for 12 weeks.
|
|---|---|---|---|---|
|
Change From Baseline in Glycosylated Hemoglobin (HbA1c) (%) at Week 12 as Compared to Placebo
|
0.18 percentage of HbA1c
Standard Deviation 0.834
|
-0.68 percentage of HbA1c
Standard Deviation 0.778
|
-0.91 percentage of HbA1c
Standard Deviation 0.765
|
-0.92 percentage of HbA1c
Standard Deviation 0.809
|
SECONDARY outcome
Timeframe: Baseline, Weeks 2, 4, 8Population: All participants randomized and who received at least 1 dose of randomized treatment, participants were assigned to the randomized treatment regardless of what treatment was received.n represented the available number of participants for analysis at post-baseline days.
HbA1c was a form of hemoglobin which was measured primarily to identify the average plasma glucose concentration over prolonged periods of time. Baseline was defined as the last pre-dose measurement prior to first double blind dosing for the study. n represented the available number of participants for analysis at post-baseline days.
Outcome measures
| Measure |
Placebo
n=51 Participants
Four (4) tablets of placebo matched to PF-06291874 and at least 1 stable dose of open label metformin were orally administered with a standard morning meal once daily for 12 weeks.
|
PF-06291874 30 mg
n=51 Participants
Two (2) placebo tablets, one 5-mg and one 25-mg of PF-06291874 tablets and at least 1 stable dose of open label metformin were orally administered with a standard morning meal once daily for 12 weeks.
|
PF-06291874 60 mg
n=52 Participants
Two (2) 5-mg and two 25-mg of PF-06291874 tablets and at least 1 stable dose of open label metformin were orally administered with a standard morning meal once daily for 12 weeks.
|
PF-06291874 100 mg
n=52 Participants
Four (4) 25-mg of PF-06291874 tablets and at least 1 stable dose of open label metformin were orally administered with a standard morning meal once daily for 12 weeks.
|
|---|---|---|---|---|
|
Change From Baseline in HbA1c (%) at Weeks 2, 4, and 8
Week 2 HbA1c(%)Change from Baseline(n=46,48,48,47)
|
0.10 percentage of HbA1c
Standard Deviation 0.363
|
-0.30 percentage of HbA1c
Standard Deviation 0.383
|
-0.30 percentage of HbA1c
Standard Deviation 0.341
|
-0.31 percentage of HbA1c
Standard Deviation 0.260
|
|
Change From Baseline in HbA1c (%) at Weeks 2, 4, and 8
Week 4 HbA1c(%)Change from Baseline(n=45,47,47,47)
|
0.12 percentage of HbA1c
Standard Deviation 0.426
|
-0.53 percentage of HbA1c
Standard Deviation 0.546
|
-0.57 percentage of HbA1c
Standard Deviation 0.444
|
-0.49 percentage of HbA1c
Standard Deviation 0.371
|
|
Change From Baseline in HbA1c (%) at Weeks 2, 4, and 8
Week 8 HbA1c(%)Change from Baseline(n=40,45,47,45)
|
0.15 percentage of HbA1c
Standard Deviation 0.653
|
-0.65 percentage of HbA1c
Standard Deviation 0.617
|
-0.90 percentage of HbA1c
Standard Deviation 0.612
|
-0.82 percentage of HbA1c
Standard Deviation 0.512
|
SECONDARY outcome
Timeframe: Baseline, Weeks 2,4,8 and 12Population: All participants randomized and who had received at least 1 dose of randomized treatment. n represented the available number of participants for analysis at post-baseline days.
Fasting plasma glucose response changed from baseline at Weeks 2,4,8 and 12. Baseline was defined as the average of the measurements obtained during Day 14 visit window and Day 1 pre-dose measurement. n represented the available number of participants for analysis at post-baseline days.
Outcome measures
| Measure |
Placebo
n=51 Participants
Four (4) tablets of placebo matched to PF-06291874 and at least 1 stable dose of open label metformin were orally administered with a standard morning meal once daily for 12 weeks.
|
PF-06291874 30 mg
n=51 Participants
Two (2) placebo tablets, one 5-mg and one 25-mg of PF-06291874 tablets and at least 1 stable dose of open label metformin were orally administered with a standard morning meal once daily for 12 weeks.
|
PF-06291874 60 mg
n=52 Participants
Two (2) 5-mg and two 25-mg of PF-06291874 tablets and at least 1 stable dose of open label metformin were orally administered with a standard morning meal once daily for 12 weeks.
|
PF-06291874 100 mg
n=52 Participants
Four (4) 25-mg of PF-06291874 tablets and at least 1 stable dose of open label metformin were orally administered with a standard morning meal once daily for 12 weeks.
|
|---|---|---|---|---|
|
Change From Baseline in Fasting Plasma Glucose at Weeks 2, 4, 8, and 12
Week 2 Change from Baseline(n=49,48,48,47)
|
11.0 mg/dL
Standard Deviation 28.5
|
-25.2 mg/dL
Standard Deviation 26.95
|
-32.4 mg/dL
Standard Deviation 35.31
|
-32.5 mg/dL
Standard Deviation 32.26
|
|
Change From Baseline in Fasting Plasma Glucose at Weeks 2, 4, 8, and 12
Week 4 Change from Baseline(n=45,47,47,47)
|
3.4 mg/dL
Standard Deviation 29.22
|
-26.8 mg/dL
Standard Deviation 29.68
|
-34.7 mg/dL
Standard Deviation 39.15
|
-30.9 mg/dL
Standard Deviation 32.55
|
|
Change From Baseline in Fasting Plasma Glucose at Weeks 2, 4, 8, and 12
Week 8 Change from Baseline(n=39,44,47,45)
|
-1.8 mg/dL
Standard Deviation 42.57
|
-19.9 mg/dL
Standard Deviation 35.93
|
-35.4 mg/dL
Standard Deviation 32.5
|
-31.8 mg/dL
Standard Deviation 26.57
|
|
Change From Baseline in Fasting Plasma Glucose at Weeks 2, 4, 8, and 12
Week 12 Change from Baseline(n=39,43,46,45)
|
-0.6 mg/dL
Standard Deviation 31.64
|
-18.5 mg/dL
Standard Deviation 30.19
|
-32.8 mg/dL
Standard Deviation 35.24
|
-31.9 mg/dL
Standard Deviation 35.56
|
SECONDARY outcome
Timeframe: Week 12Population: All participants randomized and who received at least 1 dose of randomized treatment, participants were assigned to the randomized treatment regardless of what treatment was received.
HbA1c was a form of hemoglobin which was measured primarily to identify the average plasma glucose concentration over prolonged periods of time.
Outcome measures
| Measure |
Placebo
n=39 Participants
Four (4) tablets of placebo matched to PF-06291874 and at least 1 stable dose of open label metformin were orally administered with a standard morning meal once daily for 12 weeks.
|
PF-06291874 30 mg
n=44 Participants
Two (2) placebo tablets, one 5-mg and one 25-mg of PF-06291874 tablets and at least 1 stable dose of open label metformin were orally administered with a standard morning meal once daily for 12 weeks.
|
PF-06291874 60 mg
n=46 Participants
Two (2) 5-mg and two 25-mg of PF-06291874 tablets and at least 1 stable dose of open label metformin were orally administered with a standard morning meal once daily for 12 weeks.
|
PF-06291874 100 mg
n=45 Participants
Four (4) 25-mg of PF-06291874 tablets and at least 1 stable dose of open label metformin were orally administered with a standard morning meal once daily for 12 weeks.
|
|---|---|---|---|---|
|
Percentage of Participants Achieving Glycosylated Hemoglobin (HbA1c) <7% as Well as <6.5% at Week 12.
HbA1c <6.5%
|
5.13 % (percentage of participants)
Interval 0.63 to 17.32
|
11.36 % (percentage of participants)
Interval 3.79 to 24.56
|
13.04 % (percentage of participants)
Interval 4.94 to 26.26
|
22.22 % (percentage of participants)
Interval 11.2 to 37.09
|
|
Percentage of Participants Achieving Glycosylated Hemoglobin (HbA1c) <7% as Well as <6.5% at Week 12.
HbA1c <7%
|
15.38 % (percentage of participants)
Interval 5.86 to 30.53
|
29.55 % (percentage of participants)
Interval 16.76 to 45.2
|
34.78 % (percentage of participants)
Interval 21.35 to 50.25
|
55.56 % (percentage of participants)
Interval 40.0 to 70.36
|
SECONDARY outcome
Timeframe: Baseline up to 98 daysPopulation: The safety analysis set was used, which defined as all participants who received at least 1 dose of study drug.
The total number of participants with laboratory test abnormalities (without regard to baseline abnormality) was assessed. Clinical laboratory tests included hematology, chemistry, urinalysis, and some other tests.
Outcome measures
| Measure |
Placebo
n=51 Participants
Four (4) tablets of placebo matched to PF-06291874 and at least 1 stable dose of open label metformin were orally administered with a standard morning meal once daily for 12 weeks.
|
PF-06291874 30 mg
n=49 Participants
Two (2) placebo tablets, one 5-mg and one 25-mg of PF-06291874 tablets and at least 1 stable dose of open label metformin were orally administered with a standard morning meal once daily for 12 weeks.
|
PF-06291874 60 mg
n=51 Participants
Two (2) 5-mg and two 25-mg of PF-06291874 tablets and at least 1 stable dose of open label metformin were orally administered with a standard morning meal once daily for 12 weeks.
|
PF-06291874 100 mg
n=50 Participants
Four (4) 25-mg of PF-06291874 tablets and at least 1 stable dose of open label metformin were orally administered with a standard morning meal once daily for 12 weeks.
|
|---|---|---|---|---|
|
Number of Participants With Laboratory Test Abnormalities
|
49 participants
|
42 participants
|
40 participants
|
38 participants
|
SECONDARY outcome
Timeframe: Baseline up to Day 98Population: The safety analysis set was used, which defined as all participants who received at least 1 dose of study drug.
ECG criteria of potential clinical concern were 1), time from ECG Q wave to the end of the S wave corresponding to ventricle depolarization (QRS interval): \>=140 milliseconds (msec); \>=50% increase from baseline; 2), the interval between the start of the P wave and the start of the QRS complex, corresponding to the time between the onset of the atrial depolarization and onset of ventricular depolarization (PR interval): \>=300 msec; \>=25 percent (%) increase when baseline \>200 msec; or increase \>=50% when baseline less than or equal to (\<=)200 msec; 3), time from ECG Q wave to the end of the T wave corresponding to electrical systole corrected for heart rate using Fridericia's formula (QTcF interval): absolute value \>=450 - \<480 msec, \>=480-\<500 msec, \>=500 msec; increase from baseline \>=30 - \<60, \>=60 msec.
Outcome measures
| Measure |
Placebo
n=51 Participants
Four (4) tablets of placebo matched to PF-06291874 and at least 1 stable dose of open label metformin were orally administered with a standard morning meal once daily for 12 weeks.
|
PF-06291874 30 mg
n=48 Participants
Two (2) placebo tablets, one 5-mg and one 25-mg of PF-06291874 tablets and at least 1 stable dose of open label metformin were orally administered with a standard morning meal once daily for 12 weeks.
|
PF-06291874 60 mg
n=50 Participants
Two (2) 5-mg and two 25-mg of PF-06291874 tablets and at least 1 stable dose of open label metformin were orally administered with a standard morning meal once daily for 12 weeks.
|
PF-06291874 100 mg
n=50 Participants
Four (4) 25-mg of PF-06291874 tablets and at least 1 stable dose of open label metformin were orally administered with a standard morning meal once daily for 12 weeks.
|
|---|---|---|---|---|
|
Number of Participants With Change From Baseline and Absolute Values in 12-lead Electrocardiograms (ECGs) Meeting Categorical Summarization Criteria
Maximum PR interval >=300 msec
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Change From Baseline and Absolute Values in 12-lead Electrocardiograms (ECGs) Meeting Categorical Summarization Criteria
Maximum QRS interval >=140 msec
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
|
Number of Participants With Change From Baseline and Absolute Values in 12-lead Electrocardiograms (ECGs) Meeting Categorical Summarization Criteria
Maximum QTcF interval 450-<480 msec
|
4 participants
|
4 participants
|
2 participants
|
2 participants
|
|
Number of Participants With Change From Baseline and Absolute Values in 12-lead Electrocardiograms (ECGs) Meeting Categorical Summarization Criteria
Maximum PR interval increase >=25%/50%
|
0 participants
|
0 participants
|
1 participants
|
1 participants
|
|
Number of Participants With Change From Baseline and Absolute Values in 12-lead Electrocardiograms (ECGs) Meeting Categorical Summarization Criteria
Maximum QRS complex increase >=50%
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Change From Baseline and Absolute Values in 12-lead Electrocardiograms (ECGs) Meeting Categorical Summarization Criteria
Maximum QTcF interval increase 30<=-<60 msec
|
1 participants
|
0 participants
|
3 participants
|
5 participants
|
|
Number of Participants With Change From Baseline and Absolute Values in 12-lead Electrocardiograms (ECGs) Meeting Categorical Summarization Criteria
Maximum QTcF interval >=500 msec
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Change From Baseline and Absolute Values in 12-lead Electrocardiograms (ECGs) Meeting Categorical Summarization Criteria
Maximum QTcF interval increase >=60 msec
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Change From Baseline and Absolute Values in 12-lead Electrocardiograms (ECGs) Meeting Categorical Summarization Criteria
Maximum QTcF interval 480-<500 msec
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Baseline up to Day 98Population: The safety analysis set was used, which defined as all participants who received at least 1 dose of study drug.
Vital signs included seated supine systolic and diastolic blood pressure (BP) and pulse rate. Vital signs criteria of potential clinical concern were 1), BP: systolic (SBP) greater than or equal to (\>=) 30 millimeters of mercury (mm Hg) change from baseline, systolic less than (\<) 90 mm Hg; diastolic BP (DBP) \>=20 mm Hg change from baseline, diastolic \<50 mm Hg; 2), pulse rate \<40 or greater than (\>) 120 beats per minute (bpm).
Outcome measures
| Measure |
Placebo
n=51 Participants
Four (4) tablets of placebo matched to PF-06291874 and at least 1 stable dose of open label metformin were orally administered with a standard morning meal once daily for 12 weeks.
|
PF-06291874 30 mg
n=49 Participants
Two (2) placebo tablets, one 5-mg and one 25-mg of PF-06291874 tablets and at least 1 stable dose of open label metformin were orally administered with a standard morning meal once daily for 12 weeks.
|
PF-06291874 60 mg
n=51 Participants
Two (2) 5-mg and two 25-mg of PF-06291874 tablets and at least 1 stable dose of open label metformin were orally administered with a standard morning meal once daily for 12 weeks.
|
PF-06291874 100 mg
n=50 Participants
Four (4) 25-mg of PF-06291874 tablets and at least 1 stable dose of open label metformin were orally administered with a standard morning meal once daily for 12 weeks.
|
|---|---|---|---|---|
|
Number of Participants With Change From Baseline and Absolute Values in Vital Signs Meeting Categorical Summarization Criteria
Decrease: Sitting SBP >=20 mm Hg
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
|
Number of Participants With Change From Baseline and Absolute Values in Vital Signs Meeting Categorical Summarization Criteria
Decrease: Sitting SBP >=30 mm Hg
|
1 participants
|
2 participants
|
1 participants
|
0 participants
|
|
Number of Participants With Change From Baseline and Absolute Values in Vital Signs Meeting Categorical Summarization Criteria
Sitting SBP <90 mm Hg
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Change From Baseline and Absolute Values in Vital Signs Meeting Categorical Summarization Criteria
Sitting DBP <50mm Hg
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Change From Baseline and Absolute Values in Vital Signs Meeting Categorical Summarization Criteria
Sitting Pulse Rate <40 bpm
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Change From Baseline and Absolute Values in Vital Signs Meeting Categorical Summarization Criteria
Sitting Pulse Rate >120 bpm
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Change From Baseline and Absolute Values in Vital Signs Meeting Categorical Summarization Criteria
Increase: Sitting SBP >=30 mm Hg
|
0 participants
|
3 participants
|
1 participants
|
4 participants
|
|
Number of Participants With Change From Baseline and Absolute Values in Vital Signs Meeting Categorical Summarization Criteria
Increase: Sitting Systolic BP >=20 mm Hg
|
0 participants
|
1 participants
|
0 participants
|
3 participants
|
SECONDARY outcome
Timeframe: Baseline up to Day 119Population: The safety analysis set was used, which defined as all participants who received at least 1 dose of study drug.
An adverse event (AE) was any untoward medical occurrence in a participant administered a study drug; the event need not necessarily have a causal relationship with the treatment. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reasons: death; life threatening (immediate risk of death); initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect. An HAE was identified by characteristic symptoms or blood glucose levels. Any events occurring following start of treatment (defined as blinded therapy, including single blind placebo administration on Day 14) or increasing in severity were counted as treatment emergent AE.
Outcome measures
| Measure |
Placebo
n=51 Participants
Four (4) tablets of placebo matched to PF-06291874 and at least 1 stable dose of open label metformin were orally administered with a standard morning meal once daily for 12 weeks.
|
PF-06291874 30 mg
n=51 Participants
Two (2) placebo tablets, one 5-mg and one 25-mg of PF-06291874 tablets and at least 1 stable dose of open label metformin were orally administered with a standard morning meal once daily for 12 weeks.
|
PF-06291874 60 mg
n=52 Participants
Two (2) 5-mg and two 25-mg of PF-06291874 tablets and at least 1 stable dose of open label metformin were orally administered with a standard morning meal once daily for 12 weeks.
|
PF-06291874 100 mg
n=52 Participants
Four (4) 25-mg of PF-06291874 tablets and at least 1 stable dose of open label metformin were orally administered with a standard morning meal once daily for 12 weeks.
|
|---|---|---|---|---|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Hypoglycemic Adverse Events (HAEs).
AEs
|
22 participants
|
20 participants
|
18 participants
|
27 participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Hypoglycemic Adverse Events (HAEs).
SAEs
|
2 participants
|
1 participants
|
0 participants
|
2 participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Hypoglycemic Adverse Events (HAEs).
HAEs
|
5 participants
|
1 participants
|
1 participants
|
2 participants
|
SECONDARY outcome
Timeframe: Baseline, Weeks 2, 4, 8 and 12Population: All participants randomized and who received at least 1 dose of randomized treatment, participants were assigned to the randomized treatment regardless of what treatment was received. n represented the available number of participants for analysis at post-baseline days.
Fasting low density lipoprotein-cholesterol (LDL-C) percent change from baseline (defined as the mean of Day 14 and Day 1 pre-dose) at Weeks 2,4,8 and 12. n represented the available number of participants for analysis at post-baseline days.
Outcome measures
| Measure |
Placebo
n=51 Participants
Four (4) tablets of placebo matched to PF-06291874 and at least 1 stable dose of open label metformin were orally administered with a standard morning meal once daily for 12 weeks.
|
PF-06291874 30 mg
n=51 Participants
Two (2) placebo tablets, one 5-mg and one 25-mg of PF-06291874 tablets and at least 1 stable dose of open label metformin were orally administered with a standard morning meal once daily for 12 weeks.
|
PF-06291874 60 mg
n=52 Participants
Two (2) 5-mg and two 25-mg of PF-06291874 tablets and at least 1 stable dose of open label metformin were orally administered with a standard morning meal once daily for 12 weeks.
|
PF-06291874 100 mg
n=52 Participants
Four (4) 25-mg of PF-06291874 tablets and at least 1 stable dose of open label metformin were orally administered with a standard morning meal once daily for 12 weeks.
|
|---|---|---|---|---|
|
Percent Changes From Baseline for Fasting Low Density Lipoprotein-Cholesterol (LDL-C) at Weeks 2, 4, 8 and 12
Week 2 Percent Change from Baseline(n=49,47,48,47)
|
0.68 % (percent change)
Standard Deviation 16.301
|
-1.41 % (percent change)
Standard Deviation 17.832
|
-0.64 % (percent change)
Standard Deviation 17.154
|
2.16 % (percent change)
Standard Deviation 16.846
|
|
Percent Changes From Baseline for Fasting Low Density Lipoprotein-Cholesterol (LDL-C) at Weeks 2, 4, 8 and 12
Week 4 Percent Change from Baseline(n=45,47,47,47)
|
3.29 % (percent change)
Standard Deviation 18.485
|
0.46 % (percent change)
Standard Deviation 12.752
|
-0.62 % (percent change)
Standard Deviation 18.522
|
-2.07 % (percent change)
Standard Deviation 15.170
|
|
Percent Changes From Baseline for Fasting Low Density Lipoprotein-Cholesterol (LDL-C) at Weeks 2, 4, 8 and 12
Week 8 Percent Change from Baseline(n=40,45,47,45)
|
5.31 % (percent change)
Standard Deviation 21.244
|
2.17 % (percent change)
Standard Deviation 15.503
|
1.32 % (percent change)
Standard Deviation 17.448
|
1.92 % (percent change)
Standard Deviation 17.030
|
|
Percent Changes From Baseline for Fasting Low Density Lipoprotein-Cholesterol (LDL-C) at Weeks 2, 4, 8 and 12
Week12 Percent Change from Baseline(n=39,43,46,45)
|
0.13 % (percent change)
Standard Deviation 18.680
|
1.77 % (percent change)
Standard Deviation 17.278
|
4.20 % (percent change)
Standard Deviation 18.315
|
1.16 % (percent change)
Standard Deviation 19.061
|
SECONDARY outcome
Timeframe: Baseline, Weeks 2, 4, 8 and 12Population: All participants randomized and who received at least 1 dose of randomized treatment, participants were assigned to the randomized treatment regardless of what treatment was received. n represented the available number of participants for analysis at post-baseline days.
Triglycerides percent change from baseline (defined as the mean of Day 14 and Day 1 pre-dose) at Weeks 2,4,8 and 12. n represented the available number of participants for analysis at post-baseline days. Triglycerides MMRM was not appropriate as the data were very skewed and not normally distributed, therefore per SAP non-parametric analysis were reported, presenting medians and CIs for medians, instead. If the data had many outliers even after the log transformation the following non parametric analysis was presented instead of the MMRM. An outlier was defined as any data point falling outside of 3.5 x standard deviations the median.
Outcome measures
| Measure |
Placebo
n=51 Participants
Four (4) tablets of placebo matched to PF-06291874 and at least 1 stable dose of open label metformin were orally administered with a standard morning meal once daily for 12 weeks.
|
PF-06291874 30 mg
n=51 Participants
Two (2) placebo tablets, one 5-mg and one 25-mg of PF-06291874 tablets and at least 1 stable dose of open label metformin were orally administered with a standard morning meal once daily for 12 weeks.
|
PF-06291874 60 mg
n=52 Participants
Two (2) 5-mg and two 25-mg of PF-06291874 tablets and at least 1 stable dose of open label metformin were orally administered with a standard morning meal once daily for 12 weeks.
|
PF-06291874 100 mg
n=52 Participants
Four (4) 25-mg of PF-06291874 tablets and at least 1 stable dose of open label metformin were orally administered with a standard morning meal once daily for 12 weeks.
|
|---|---|---|---|---|
|
Percent Changes From Baseline for Triglycerides at Weeks 2, 4, 8 and 12
Week 2 Percent Change from Baseline(n=49,48,48,47)
|
5.45 % (percent change)
Interval -56.7 to 126.3
|
10.55 % (percent change)
Interval -44.0 to 138.5
|
8.32 % (percent change)
Interval -32.6 to 189.0
|
22.58 % (percent change)
Interval -37.5 to 144.7
|
|
Percent Changes From Baseline for Triglycerides at Weeks 2, 4, 8 and 12
Week 4 Percent Change from Baseline(n=44,47,47,47)
|
3.74 % (percent change)
Interval -59.0 to 224.1
|
6.45 % (percent change)
Interval -48.2 to 121.4
|
6.67 % (percent change)
Interval -44.8 to 169.8
|
1.18 % (percent change)
Interval -35.7 to 107.2
|
|
Percent Changes From Baseline for Triglycerides at Weeks 2, 4, 8 and 12
Week 8 Percent Change from Baseline(n=40,45,47,45)
|
6.72 % (percent change)
Interval -37.7 to 155.2
|
5.08 % (percent change)
Interval -36.9 to 103.9
|
2.13 % (percent change)
Interval -52.1 to 178.1
|
9.47 % (percent change)
Interval -49.3 to 140.0
|
|
Percent Changes From Baseline for Triglycerides at Weeks 2, 4, 8 and 12
Week12 Percent Change from Baseline(n=39,44,46,45)
|
-0.72 % (percent change)
Interval -38.4 to 154.0
|
7.13 % (percent change)
Interval -47.7 to 186.7
|
-1.85 % (percent change)
Interval -48.0 to 147.8
|
5.26 % (percent change)
Interval -47.9 to 112.6
|
SECONDARY outcome
Timeframe: Baseline, Weeks 2, 4, 8 and 12Population: All participants randomized and who received at least 1 dose of randomized treatment, participants were assigned to the randomized treatment regardless of what treatment was received. n represented the available number of participants for analysis at post-baseline days.
Total cholesterol percent change from baseline (defined as the mean of Day 14 and Day 1 pre-dose) on Weeks 2,4,8 and 12. n represented the available number of participants for analysis at post-baseline days.
Outcome measures
| Measure |
Placebo
n=51 Participants
Four (4) tablets of placebo matched to PF-06291874 and at least 1 stable dose of open label metformin were orally administered with a standard morning meal once daily for 12 weeks.
|
PF-06291874 30 mg
n=51 Participants
Two (2) placebo tablets, one 5-mg and one 25-mg of PF-06291874 tablets and at least 1 stable dose of open label metformin were orally administered with a standard morning meal once daily for 12 weeks.
|
PF-06291874 60 mg
n=52 Participants
Two (2) 5-mg and two 25-mg of PF-06291874 tablets and at least 1 stable dose of open label metformin were orally administered with a standard morning meal once daily for 12 weeks.
|
PF-06291874 100 mg
n=52 Participants
Four (4) 25-mg of PF-06291874 tablets and at least 1 stable dose of open label metformin were orally administered with a standard morning meal once daily for 12 weeks.
|
|---|---|---|---|---|
|
Percent Changes From Baseline for Total Cholesterol at Weeks 2, 4, 8 and 12
Week12 Percent Change from Baseline(n=39,44,46,45)
|
-0.87 % (percent change)
Standard Deviation 13.238
|
2.28 % (percent change)
Standard Deviation 12.260
|
3.00 % (percent change)
Standard Deviation 13.952
|
2.03 % (percent change)
Standard Deviation 13.986
|
|
Percent Changes From Baseline for Total Cholesterol at Weeks 2, 4, 8 and 12
Week 2 Percent Change from Baseline(n=49,48,48,47)
|
0.16 % (percent change)
Standard Deviation 11.863
|
0.39 % (percent change)
Standard Deviation 12.606
|
1.02 % (percent change)
Standard Deviation 12.058
|
4.05 % (percent change)
Standard Deviation 13.900
|
|
Percent Changes From Baseline for Total Cholesterol at Weeks 2, 4, 8 and 12
Week 4 Percent Change from Baseline(n=44,47,47,47)
|
2.65 % (percent change)
Standard Deviation 14.642
|
1.69 % (percent change)
Standard Deviation 8.763
|
0.36 % (percent change)
Standard Deviation 13.732
|
0.44 % (percent change)
Standard Deviation 11.674
|
|
Percent Changes From Baseline for Total Cholesterol at Weeks 2, 4, 8 and 12
Week 8 Percent Change from Baseline(n=40,45,47,45)
|
3.30 % (percent change)
Standard Deviation 14.354
|
1.53 % (percent change)
Standard Deviation 10.569
|
-0.11 % (percent change)
Standard Deviation 12.692
|
2.77 % (percent change)
Standard Deviation 10.860
|
SECONDARY outcome
Timeframe: Baseline, Weeks 2, 4, 8 and 12Population: All participants randomized and who received at least 1 dose of randomized treatment, participants were assigned to the randomized treatment regardless of what treatment was received. n represented the available number of participants for analysis at post-baseline days.
High density lipoprotein-cholesterol (HDL-C) percent change from baseline (defined as the mean of Day 14 and Day 1 pre-dose) at Weeks 2,4,8 and 12. n represented the available number of participants for analysis at post-baseline days.
Outcome measures
| Measure |
Placebo
n=51 Participants
Four (4) tablets of placebo matched to PF-06291874 and at least 1 stable dose of open label metformin were orally administered with a standard morning meal once daily for 12 weeks.
|
PF-06291874 30 mg
n=51 Participants
Two (2) placebo tablets, one 5-mg and one 25-mg of PF-06291874 tablets and at least 1 stable dose of open label metformin were orally administered with a standard morning meal once daily for 12 weeks.
|
PF-06291874 60 mg
n=52 Participants
Two (2) 5-mg and two 25-mg of PF-06291874 tablets and at least 1 stable dose of open label metformin were orally administered with a standard morning meal once daily for 12 weeks.
|
PF-06291874 100 mg
n=52 Participants
Four (4) 25-mg of PF-06291874 tablets and at least 1 stable dose of open label metformin were orally administered with a standard morning meal once daily for 12 weeks.
|
|---|---|---|---|---|
|
Percent Changes From Baseline for High Density Lipoprotein-Cholesterol (HDL-C) at Weeks 2, 4, 8 and 12
Week12 Percent Change from Baseline(n=39,44,46,45)
|
-2.62 % (percent change)
Standard Deviation 13.237
|
3.65 % (percent change)
Standard Deviation 12.889
|
4.51 % (percent change)
Standard Deviation 10.598
|
7.57 % (percent change)
Standard Deviation 15.226
|
|
Percent Changes From Baseline for High Density Lipoprotein-Cholesterol (HDL-C) at Weeks 2, 4, 8 and 12
Week 2 Percent Change from Baseline(n=49,48,48,47)
|
-0.14 % (percent change)
Standard Deviation 8.086
|
0.08 % (percent change)
Standard Deviation 9.345
|
2.60 % (percent change)
Standard Deviation 10.739
|
8.13 % (percent change)
Standard Deviation 13.554
|
|
Percent Changes From Baseline for High Density Lipoprotein-Cholesterol (HDL-C) at Weeks 2, 4, 8 and 12
Week 4 Percent Change from Baseline(n=44,47,47,47)
|
0.51 % (percent change)
Standard Deviation 11.391
|
0.79 % (percent change)
Standard Deviation 10.626
|
3.98 % (percent change)
Standard Deviation 14.288
|
8.16 % (percent change)
Standard Deviation 11.776
|
|
Percent Changes From Baseline for High Density Lipoprotein-Cholesterol (HDL-C) at Weeks 2, 4, 8 and 12
Week 8 Percent Change from Baseline(n=40,45,47,45)
|
-1.91 % (percent change)
Standard Deviation 11.736
|
1.24 % (percent change)
Standard Deviation 10.292
|
2.15 % (percent change)
Standard Deviation 10.724
|
7.71 % (percent change)
Standard Deviation 13.768
|
SECONDARY outcome
Timeframe: Baseline, Weeks 2, 4, 8 and 12Population: All participants randomized and who received at least 1 dose of randomized treatment, participants were assigned to the randomized treatment regardless of what treatment was received. n represented the available number of participants for analysis at post-baseline days.
Non-HDL-C percent change from baseline (defined as the mean of Day 14 and Day 1 pre-dose) on Weeks 2,4,8 and 12. n represented the available number of participants for analysis at post-baseline days.
Outcome measures
| Measure |
Placebo
n=51 Participants
Four (4) tablets of placebo matched to PF-06291874 and at least 1 stable dose of open label metformin were orally administered with a standard morning meal once daily for 12 weeks.
|
PF-06291874 30 mg
n=51 Participants
Two (2) placebo tablets, one 5-mg and one 25-mg of PF-06291874 tablets and at least 1 stable dose of open label metformin were orally administered with a standard morning meal once daily for 12 weeks.
|
PF-06291874 60 mg
n=52 Participants
Two (2) 5-mg and two 25-mg of PF-06291874 tablets and at least 1 stable dose of open label metformin were orally administered with a standard morning meal once daily for 12 weeks.
|
PF-06291874 100 mg
n=52 Participants
Four (4) 25-mg of PF-06291874 tablets and at least 1 stable dose of open label metformin were orally administered with a standard morning meal once daily for 12 weeks.
|
|---|---|---|---|---|
|
Percent Changes From Baseline for Non-High Density Lipoprotein (HDL) Cholesterol at Weeks 2, 4, 8 and 12
Week 2 Percent Change from Baseline(n=49,48,48,47)
|
0.51 % (percent change)
Standard Deviation 16.195
|
1.00 % (percent change)
Standard Deviation 16.675
|
0.63 % (percent change)
Standard Deviation 14.870
|
2.73 % (percent change)
Standard Deviation 18.427
|
|
Percent Changes From Baseline for Non-High Density Lipoprotein (HDL) Cholesterol at Weeks 2, 4, 8 and 12
Week 4 Percent Change from Baseline(n=44,47,47,47)
|
4.18 % (percent change)
Standard Deviation 21.486
|
1.88 % (percent change)
Standard Deviation 11.961
|
-0.47 % (percent change)
Standard Deviation 17.972
|
-2.40 % (percent change)
Standard Deviation 13.877
|
|
Percent Changes From Baseline for Non-High Density Lipoprotein (HDL) Cholesterol at Weeks 2, 4, 8 and 12
Week 8 Percent Change from Baseline(n=40,45,47,45)
|
5.24 % (percent change)
Standard Deviation 19.222
|
1.76 % (percent change)
Standard Deviation 14.128
|
-0.52 % (percent change)
Standard Deviation 16.014
|
0.88 % (percent change)
Standard Deviation 13.765
|
|
Percent Changes From Baseline for Non-High Density Lipoprotein (HDL) Cholesterol at Weeks 2, 4, 8 and 12
Week12 Percent Change from Baseline(n=39,44,46,45)
|
-0.48 % (percent change)
Standard Deviation 16.711
|
2.09 % (percent change)
Standard Deviation 16.451
|
2.67 % (percent change)
Standard Deviation 18.098
|
-0.25 % (percent change)
Standard Deviation 17.666
|
SECONDARY outcome
Timeframe: Baseline, Weeks 2, 4, 8 and 12Population: All participants randomized and who received at least 1 dose of randomized treatment, participants were assigned to the randomized treatment regardless of what treatment was received. n represented the available number of participants for analysis at post-baseline days.
The body weight change from baseline (defined as the mean of Day 14 and Day 1 pre-dose) at Weeks 2,4,8 and 12. n represented the available number of participants for analysis at post-baseline days.
Outcome measures
| Measure |
Placebo
n=51 Participants
Four (4) tablets of placebo matched to PF-06291874 and at least 1 stable dose of open label metformin were orally administered with a standard morning meal once daily for 12 weeks.
|
PF-06291874 30 mg
n=51 Participants
Two (2) placebo tablets, one 5-mg and one 25-mg of PF-06291874 tablets and at least 1 stable dose of open label metformin were orally administered with a standard morning meal once daily for 12 weeks.
|
PF-06291874 60 mg
n=52 Participants
Two (2) 5-mg and two 25-mg of PF-06291874 tablets and at least 1 stable dose of open label metformin were orally administered with a standard morning meal once daily for 12 weeks.
|
PF-06291874 100 mg
n=52 Participants
Four (4) 25-mg of PF-06291874 tablets and at least 1 stable dose of open label metformin were orally administered with a standard morning meal once daily for 12 weeks.
|
|---|---|---|---|---|
|
Changes From Baseline in Body Weight at Weeks 2, 4, 8, and 12.
Week 2 Change from Baseline(n=49,48,48,47)
|
-0.15 kg
Standard Deviation 1.347
|
0.15 kg
Standard Deviation 1.234
|
-0.15 kg
Standard Deviation 1.253
|
0.65 kg
Standard Deviation 3.342
|
|
Changes From Baseline in Body Weight at Weeks 2, 4, 8, and 12.
Week 4 Change from Baseline(n=45,47,47,47)
|
-0.76 kg
Standard Deviation 3.302
|
0.55 kg
Standard Deviation 1.231
|
0.28 kg
Standard Deviation 1.219
|
0.56 kg
Standard Deviation 2.925
|
|
Changes From Baseline in Body Weight at Weeks 2, 4, 8, and 12.
Week 8 Change from Baseline(n=41,45,47,45)
|
-0.61 kg
Standard Deviation 1.517
|
0.44 kg
Standard Deviation 1.694
|
0.26 kg
Standard Deviation 1.775
|
0.55 kg
Standard Deviation 2.786
|
|
Changes From Baseline in Body Weight at Weeks 2, 4, 8, and 12.
Week 12 Change from Baseline(n=39,44,46,45)
|
-0.79 kg
Standard Deviation 1.892
|
0.49 kg
Standard Deviation 2.119
|
0.31 kg
Standard Deviation 2.135
|
0.41 kg
Standard Deviation 3.216
|
Adverse Events
Placebo
Serious events: 2 serious events
Other events: 6 other events
Deaths: 0 deaths
PF-06291874 30 mg
Serious events: 1 serious events
Other events: 5 other events
Deaths: 0 deaths
PF-06291874 60 mg
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
PF-06291874 100 mg
Serious events: 2 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=51 participants at risk
Four (4) tablets of placebo matched to PF-06291874 and at least 1 stable dose of open label metformin were orally administered with a standard morning meal once daily for 12 weeks.
|
PF-06291874 30 mg
n=51 participants at risk
Two (2) placebo tablets, one 5-mg and one 25-mg of PF-06291874 tablets and at least 1 stable dose of open label metformin were orally administered with a standard morning meal once daily for 12 weeks.
|
PF-06291874 60 mg
n=52 participants at risk
Two (2) 5-mg and two 25-mg of PF-06291874 tablets and at least 1 stable dose of open label metformin were orally administered with a standard morning meal once daily for 12 weeks.
|
PF-06291874 100 mg
n=52 participants at risk
Four (4) 25-mg of PF-06291874 tablets and at least 1 stable dose of open label metformin were orally administered with a standard morning meal once daily for 12 weeks.
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Gastritis erosive
|
0.00%
0/51 • Baseline up to Day 119
The same event might have appeared as both an AE and an SAE. However, what is presented are distinct events. An event might have been categorized as serious in 1 participant and as non-serious in another participant, or 1 participant might have experienced both a serious and non-serious event during the study.
|
0.00%
0/51 • Baseline up to Day 119
The same event might have appeared as both an AE and an SAE. However, what is presented are distinct events. An event might have been categorized as serious in 1 participant and as non-serious in another participant, or 1 participant might have experienced both a serious and non-serious event during the study.
|
0.00%
0/52 • Baseline up to Day 119
The same event might have appeared as both an AE and an SAE. However, what is presented are distinct events. An event might have been categorized as serious in 1 participant and as non-serious in another participant, or 1 participant might have experienced both a serious and non-serious event during the study.
|
1.9%
1/52 • Baseline up to Day 119
The same event might have appeared as both an AE and an SAE. However, what is presented are distinct events. An event might have been categorized as serious in 1 participant and as non-serious in another participant, or 1 participant might have experienced both a serious and non-serious event during the study.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
2.0%
1/51 • Baseline up to Day 119
The same event might have appeared as both an AE and an SAE. However, what is presented are distinct events. An event might have been categorized as serious in 1 participant and as non-serious in another participant, or 1 participant might have experienced both a serious and non-serious event during the study.
|
0.00%
0/51 • Baseline up to Day 119
The same event might have appeared as both an AE and an SAE. However, what is presented are distinct events. An event might have been categorized as serious in 1 participant and as non-serious in another participant, or 1 participant might have experienced both a serious and non-serious event during the study.
|
0.00%
0/52 • Baseline up to Day 119
The same event might have appeared as both an AE and an SAE. However, what is presented are distinct events. An event might have been categorized as serious in 1 participant and as non-serious in another participant, or 1 participant might have experienced both a serious and non-serious event during the study.
|
0.00%
0/52 • Baseline up to Day 119
The same event might have appeared as both an AE and an SAE. However, what is presented are distinct events. An event might have been categorized as serious in 1 participant and as non-serious in another participant, or 1 participant might have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
Abscess
|
0.00%
0/51 • Baseline up to Day 119
The same event might have appeared as both an AE and an SAE. However, what is presented are distinct events. An event might have been categorized as serious in 1 participant and as non-serious in another participant, or 1 participant might have experienced both a serious and non-serious event during the study.
|
0.00%
0/51 • Baseline up to Day 119
The same event might have appeared as both an AE and an SAE. However, what is presented are distinct events. An event might have been categorized as serious in 1 participant and as non-serious in another participant, or 1 participant might have experienced both a serious and non-serious event during the study.
|
0.00%
0/52 • Baseline up to Day 119
The same event might have appeared as both an AE and an SAE. However, what is presented are distinct events. An event might have been categorized as serious in 1 participant and as non-serious in another participant, or 1 participant might have experienced both a serious and non-serious event during the study.
|
1.9%
1/52 • Baseline up to Day 119
The same event might have appeared as both an AE and an SAE. However, what is presented are distinct events. An event might have been categorized as serious in 1 participant and as non-serious in another participant, or 1 participant might have experienced both a serious and non-serious event during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Brain neoplasm benign
|
2.0%
1/51 • Baseline up to Day 119
The same event might have appeared as both an AE and an SAE. However, what is presented are distinct events. An event might have been categorized as serious in 1 participant and as non-serious in another participant, or 1 participant might have experienced both a serious and non-serious event during the study.
|
0.00%
0/51 • Baseline up to Day 119
The same event might have appeared as both an AE and an SAE. However, what is presented are distinct events. An event might have been categorized as serious in 1 participant and as non-serious in another participant, or 1 participant might have experienced both a serious and non-serious event during the study.
|
0.00%
0/52 • Baseline up to Day 119
The same event might have appeared as both an AE and an SAE. However, what is presented are distinct events. An event might have been categorized as serious in 1 participant and as non-serious in another participant, or 1 participant might have experienced both a serious and non-serious event during the study.
|
0.00%
0/52 • Baseline up to Day 119
The same event might have appeared as both an AE and an SAE. However, what is presented are distinct events. An event might have been categorized as serious in 1 participant and as non-serious in another participant, or 1 participant might have experienced both a serious and non-serious event during the study.
|
|
Psychiatric disorders
Adjustment disorder
|
0.00%
0/51 • Baseline up to Day 119
The same event might have appeared as both an AE and an SAE. However, what is presented are distinct events. An event might have been categorized as serious in 1 participant and as non-serious in another participant, or 1 participant might have experienced both a serious and non-serious event during the study.
|
2.0%
1/51 • Baseline up to Day 119
The same event might have appeared as both an AE and an SAE. However, what is presented are distinct events. An event might have been categorized as serious in 1 participant and as non-serious in another participant, or 1 participant might have experienced both a serious and non-serious event during the study.
|
0.00%
0/52 • Baseline up to Day 119
The same event might have appeared as both an AE and an SAE. However, what is presented are distinct events. An event might have been categorized as serious in 1 participant and as non-serious in another participant, or 1 participant might have experienced both a serious and non-serious event during the study.
|
0.00%
0/52 • Baseline up to Day 119
The same event might have appeared as both an AE and an SAE. However, what is presented are distinct events. An event might have been categorized as serious in 1 participant and as non-serious in another participant, or 1 participant might have experienced both a serious and non-serious event during the study.
|
Other adverse events
| Measure |
Placebo
n=51 participants at risk
Four (4) tablets of placebo matched to PF-06291874 and at least 1 stable dose of open label metformin were orally administered with a standard morning meal once daily for 12 weeks.
|
PF-06291874 30 mg
n=51 participants at risk
Two (2) placebo tablets, one 5-mg and one 25-mg of PF-06291874 tablets and at least 1 stable dose of open label metformin were orally administered with a standard morning meal once daily for 12 weeks.
|
PF-06291874 60 mg
n=52 participants at risk
Two (2) 5-mg and two 25-mg of PF-06291874 tablets and at least 1 stable dose of open label metformin were orally administered with a standard morning meal once daily for 12 weeks.
|
PF-06291874 100 mg
n=52 participants at risk
Four (4) 25-mg of PF-06291874 tablets and at least 1 stable dose of open label metformin were orally administered with a standard morning meal once daily for 12 weeks.
|
|---|---|---|---|---|
|
Infections and infestations
Upper respiratory tract infection
|
5.9%
3/51 • Baseline up to Day 119
The same event might have appeared as both an AE and an SAE. However, what is presented are distinct events. An event might have been categorized as serious in 1 participant and as non-serious in another participant, or 1 participant might have experienced both a serious and non-serious event during the study.
|
5.9%
3/51 • Baseline up to Day 119
The same event might have appeared as both an AE and an SAE. However, what is presented are distinct events. An event might have been categorized as serious in 1 participant and as non-serious in another participant, or 1 participant might have experienced both a serious and non-serious event during the study.
|
0.00%
0/52 • Baseline up to Day 119
The same event might have appeared as both an AE and an SAE. However, what is presented are distinct events. An event might have been categorized as serious in 1 participant and as non-serious in another participant, or 1 participant might have experienced both a serious and non-serious event during the study.
|
5.8%
3/52 • Baseline up to Day 119
The same event might have appeared as both an AE and an SAE. However, what is presented are distinct events. An event might have been categorized as serious in 1 participant and as non-serious in another participant, or 1 participant might have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
Urinary tract infection
|
7.8%
4/51 • Baseline up to Day 119
The same event might have appeared as both an AE and an SAE. However, what is presented are distinct events. An event might have been categorized as serious in 1 participant and as non-serious in another participant, or 1 participant might have experienced both a serious and non-serious event during the study.
|
3.9%
2/51 • Baseline up to Day 119
The same event might have appeared as both an AE and an SAE. However, what is presented are distinct events. An event might have been categorized as serious in 1 participant and as non-serious in another participant, or 1 participant might have experienced both a serious and non-serious event during the study.
|
3.8%
2/52 • Baseline up to Day 119
The same event might have appeared as both an AE and an SAE. However, what is presented are distinct events. An event might have been categorized as serious in 1 participant and as non-serious in another participant, or 1 participant might have experienced both a serious and non-serious event during the study.
|
7.7%
4/52 • Baseline up to Day 119
The same event might have appeared as both an AE and an SAE. However, what is presented are distinct events. An event might have been categorized as serious in 1 participant and as non-serious in another participant, or 1 participant might have experienced both a serious and non-serious 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