Phase 2 Study To Evaluate Safety And Efficacy Of Investig... | NCT01475461 | Trialant
NCT01475461
Sponsor
Pfizer
Status
Completed
Last Update Posted
Jan 31, 2017Estimated
Enrollment
345Actual
Phase
Phase 2
Conditions
Type 2 Diabetes Mellitus
Interventions
Placebo
PF-04937319 - 3mg
PF-04937319 - 20mg
PF-04937319 - 50mg
PF-04937319 - 100mg
Sitagliptin - 100mg
Countries
United States
Hungary
India
Philippines
Romania
Slovakia
South Africa
Taiwan
Protocol Section
Identification Module
NCT ID
NCT01475461
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
B1621007
Secondary IDs
ID
Type
Description
Link
2011-004002-25
EudraCT Number
Brief Title
Phase 2 Study To Evaluate Safety And Efficacy Of Investigational Drug - PF04937319 In Patients With Type 2 Diabetes
Official Title
A Phase 2, Randomized, Double-blinded, Placebo-controlled, Dose-ranging, Parallel Group Study To Evaluate Safety And Efficacy Of Pf-04937319 And Sitagliptin On Glycemic Control In Adult Patients With Type 2 Diabetes Mellitus Inadequately Controlled On Metformin
Acronym
Not provided
Organization
PfizerINDUSTRY
Status Module
Record Verification Date
Dec 2016
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Nov 2011
Primary Completion Date
Jan 2013Actual
Completion Date
Jan 2013Actual
First Submitted Date
Sep 15, 2011
First Submission Date that Met QC Criteria
Nov 16, 2011
First Posted Date
Nov 21, 2011Estimated
Results Waived
Not provided
Results First Submitted Date
Dec 6, 2016
Results First Submitted that Met QC Criteria
Dec 6, 2016
Results First Posted Date
Jan 31, 2017Estimated
Certification/Extension (aka Delayed Results) First Submitted Date
Apr 21, 2014
Certification/Extension First Submitted that Passed QC Review
Apr 21, 2014
Certification/Extension First Posted Date
May 9, 2014Estimated
Last Update Submitted Date
Dec 6, 2016
Last Update Posted Date
Jan 31, 2017Estimated
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
PfizerINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
Is FDA Regulated Drug
Not provided
Is FDA Regulated Device
Not provided
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
B1621007 is designed to study the safety and efficacy of PF-04937319 in patients with type 2 diabetes
Detailed Description
Not provided
Conditions Module
Conditions
Type 2 Diabetes Mellitus
Keywords
Phase 2
type 2 diabetes mellitus
PF-04937319
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
345Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Placebo
Placebo Comparator
Drug: Placebo
PF-04937319 - Dose 1
Experimental
Drug: PF-04937319 - 3mg
PF-04937319 - Dose 2
Experimental
Drug: PF-04937319 - 20mg
PF-04937319 - Dose 3
Experimental
Drug: PF-04937319 - 50mg
PF-04937319 - Dose 4
Experimental
Drug: PF-04937319 - 100mg
Sitagliptin
Active Comparator
Drug: Sitagliptin - 100mg
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Placebo
Drug
double-dummy placebo tablets administered once-daily for 84-days
Placebo
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Change From Baseline in Glycosylated Hemoglobin (HbA1C) at Week 12
HbA1c is a form of hemoglobin which is measured primarily to identify the average glycemic control over prolonged periods of time. The normal range for the HbA1c test, was identified as less than (<) 6.5 percent (%) by the study-specific central laboratory used. Change from baseline in percentage of HbA1c in participants were reported.
Baseline (Day 1), Week 12
Secondary Outcomes
Measure
Description
Time Frame
Change From Baseline in Glycosylated Hemoglobin (HbA1C) at Week 2, 4 and 8
HbA1c is a form of hemoglobin which is measured primarily to identify the average glycemic control over prolonged periods of time. The normal range for the HbA1c test, was identified as <6.5 percent by the study-specific central laboratory used. Change from baseline in percentage of HbA1c in participants were reported.
Baseline(Day 1), Week 2, 4, 8
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
patients with type 2 diabetes, on metformin, age between 18-55 yrs, male or female
Exclusion Criteria:
patients with type 1 diabetes, medically unstable, unacceptable clinical laboratory test results at screening
Amin NB, Aggarwal N, Pall D, Paragh G, Denney WS, Le V, Riggs M, Calle RA. Two dose-ranging studies with PF-04937319, a systemic partial activator of glucokinase, as add-on therapy to metformin in adults with type 2 diabetes. Diabetes Obes Metab. 2015 Aug;17(8):751-9. doi: 10.1111/dom.12474. Epub 2015 May 11.
See Also Links
Label
URL
To obtain contact information for a study center near you, click here.
Total 615 participants were consented,of which 376 participants entered to run-in period to receive sponsor provided Metformin, 345 participants then randomized to study treatment,of these 335 were treated. Results were collected for 335 participants as data from 1 site (10 participants) were excluded due to major good clinical practice violations.
Recruitment Details
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Metformin 500 mg
Metformin 500 milligram (mg) immediate release tablet used as standardized, pre-specified background therapy in all participants initiated at the run-in visit and continued till follow-up visit.
FG001
Placebo
Periods
Title
Milestones
Reasons Not Completed
Run-in Period
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
0
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
No data available
No data is available for this block.
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
Triple
Masking Description
Not provided
Who Masked
ParticipantCare ProviderInvestigator
PF-04937319 - 3mg
Drug
PF-04937319 3mg administered as tablets once-daily for 84-days
PF-04937319 - Dose 1
PF-04937319 - 20mg
Drug
PF-04937319 20mg administered as tablets once-daily for 84-days
PF-04937319 - Dose 2
PF-04937319 - 50mg
Drug
PF-04937319 50mg administered as tablets once-daily for 84-days
PF-04937319 - Dose 3
PF-04937319 - 100mg
Drug
PF-04937319 100mg administered as tablets once-daily for 84-days
PF-04937319 - Dose 4
Sitagliptin - 100mg
Drug
Sitagliptin 100mg administered as tablets once-daily for 84-days
Sitagliptin
Change From Baseline in Fasting Plasma Glucose at Week 1, 2, 4, 8, 12 and 14
Baseline (Day 1), Week 1, 2, 4, 8, 12, 14
Percentage of Participants Achieving Less Than 6.5 Percent and Less Than 7 Percent Glycosylated Hemoglobin (HbA1c) Levels at Week 12
HbA1c is a form of hemoglobin which is measured primarily to identify the average glycemic control over prolonged periods of time. The normal range for the HbA1c test, was identified as <6.5 percent by the study-specific central laboratory used and data are presented in categories of <6.5 percent and <7 percent.
Week 12
Number of Participants With Increase From Baseline Electrocardiogram (ECG)Data
Criteria for increase from baseline data: PR interval (percent change of greater than or equal to [>=] 25/50% [if baseline>200 then percent change of >25% counts; if baseline <=200 then percent change of >50% counts]; QRS complex (percent change of >=50%); QT Fridericia's correction (QTcF) interval (change of >=30 to <60 millisecond [msec], and change of >=60 msec).
Baseline (Day 1) up to Week 14
Number of Participants With Increase/Decrease From Baseline Vital Signs Data
Participants who met the criteria for increase or decrease in vital signs data were reported. Criteria for increase or decrease from baseline vital signs data: sitting systolic blood pressure (BP) of >=30 millimeter of mercury (mmHg); sitting diastolic BP of >=20 mmHg and pulse rate was based on investigator's discretion.
Baseline (Day 1) up to Week 14
Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 14 days after last dose that were absent before treatment or that worsened relative to pretreatment state. AEs included both serious and non-serious adverse events.
Baseline (Day 1) up to 14 days after last dose (up to 101 days)
Percentage of Participants With at Least 1 Hypoglycemic Events (HAE) Episode
A hypoglycemic event (HAE) was identified by characteristic symptoms or blood glucose levels. HAE is defined as 1 of the given definitions: Characteristic symptoms of HAE with no home glucose monitoring performed where clinical picture included prompt resolution with food intake, subcutaneous glucagon, or intravenous glucose; or characteristic symptoms of HAE with home glucose monitoring measurement =< 70 milligram per deciliter (mg/dL) using ACCU-CHEK plasma-referenced home glucometers or =<74 mg/dL using International Federation of Clinical Chemistry (IFCC) referenced ACCU-CHEK or central laboratory glucometers; or any laboratory glucose value, meeting the following criterion with or without accompanying symptoms: =<49 mg/dL using ACCU-CHEK plasma-referenced home glucometers or =<53 mg/dL using IFCC referenced ACCU-CHEK or central laboratory glucometers.
Baseline (Day 1) up to Week 14
Number of Hypoglycemic Events (HAE) Episodes Per Participant
A hypoglycemic event (HAE) was identified by characteristic symptoms or blood glucose levels. Median number of events per participant was reported
Baseline (Day 1) up to Week 14
Change From Baseline in Body Weight at Week 2, 4, 8, 12 and 14
Baseline (Day 1), Week 2, 4, 8 , 12 , 14
Number of Participants With Abnormal Laboratory Values
Hemoglobin,hematocrit,red blood cells(RBC) count:less than [<]0.8*lower limit of normal[LLN],platelets:<0.5*LLN/greater than [>]1.75*upper limit of normal [ULN],white blood cells(WBC):<0.6*LLN or >1.5*ULN,lymphocytes,total neutrophils:<0.8*LLN or >1.2*ULN, basophils,eosinophil,monocytes:>1.2*ULN;aspartate aminotransferase,alanine aminotransferase, alkaline phosphatase:>0.3*ULN,total protein,albumin:<0.8*LLN or >1.2*ULN;total bilirubin,direct bilirubin,indirect bilirubin:>1.5*ULN;triglycerides,cholesterol:>1.3*ULN, HDL:<0.8*LLN, LDL:>1.2*ULN,blood urea nitrogen,creatinine:>1.3*ULN,uric acid:>1.2*ULN;sodium: <0.95*LLN or >1.05*ULN,potassium,chloride,calcium,bicarbonate:<0.9*LLN or >1.1*ULN;creatine kinase:>2.0*ULN;glucose:<0.6*LLN or >1.5*ULN,urine WBC and RBC:>= 20/High Power Field [HPF]),urine epithelial cells (>=1 HPF),urine bacteria >20 high-powered field;qualitative urine glucose,urine blood to Hgb ratio (>=1);urine(protein,nitrite,mucus,leukocyte >=1 in urine dipstick test).
Baseline (Day 1) up to Week 14
Los Angeles
California
90057
United States
Encompass Clinical Research
Spring Valley
California
91978
United States
The Family Doctors of Belleview
Belleview
Florida
34420
United States
Swiss Medical Research
Miami
Florida
33135
United States
Renstar Medical Research
Ocala
Florida
34471
United States
Rockdale Medical Research Associates
Conyers
Georgia
30094
United States
Solaris Clinical Research
Meridian
Idaho
83646
United States
Central Kentucky Research Associates, Inc.
Mount Sterling
Kentucky
40353
United States
Mount Sterling Clinic
Mount Sterling
Kentucky
40353
United States
The Office of Dr. Matthew S. Barton, MD
Las Vegas
Nevada
89144
United States
TKL Research, Inc.
Paramus
New Jersey
07652
United States
Rochester Clinical Research, Inc.
Rochester
New York
14609
United States
Lillestol Research, LLC
Fargo
North Dakota
58103
United States
PriMed Clinical Research
Kettering
Ohio
45429
United States
PriMed Physicians
Kettering
Ohio
45429
United States
Lynn Health Science Institute
Oklahoma City
Oklahoma
73112
United States
Medical Research South, LLC
Charleston
South Carolina
29407
United States
Newton Family Medicine
Charleston
South Carolina
29407
United States
Austin Center for Clinical Research
Austin
Texas
78756
United States
Texas Center for Drug Development, Inc.
Houston
Texas
77081
United States
Plano Primary Care Clinic
Plano
Texas
75024
United States
Pioneer Research Solutions, Inc.
Sugar Land
Texas
77479
United States
Martin Diagnostic Clinic
Tomball
Texas
77375
United States
DRC Kft.
Balatonfüred
8230
Hungary
Dr. Rethy Pal Korhaz-Rendelointezet
Békéscsaba
5600
Hungary
Qualiclinic Kft.
Budapest
1036
Hungary
Debreceni Egyetem Orvos- es Egeszsegtudomanyi Centrum
Far Eastern Memorial Hospital, Division of Endocrinology and Metabolism
New Taipei City
220
Taiwan
Taichung Veterans General Hospital, Division of Metabolism and Endocrinology
Taichung
40705
Taiwan
Chi Mei Medical Center
Tainan
710
Taiwan
Placebo matched to PF-04937319 tablet orally once daily and placebo matched to sitagliptin tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
FG002
PF-04937319 3 mg
PF-04937319 3 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
FG003
PF-04937319 20 mg
PF-04937319 20 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
FG004
PF-04937319 50 mg
PF-04937319 50 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
FG005
PF-04937319 100 mg
PF-04937319 100 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
FG006
Sitagliptin 100 mg
Sitagliptin 100 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
FG000376 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
COMPLETED
FG000335 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
NOT COMPLETED
FG00041 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
Type
Comment
Reasons
Not meet eligibility criteria
FG00016 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
Lost to Follow-up
FG0007 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Withdrawal by Subject
FG00011 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Other
FG0003 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Protocol Violation
FG0004 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Treatment Period
Type
Comment
Milestone Data
STARTED
FG0000 subjects
FG00157 subjects
FG00257 subjects
FG00354 subjects
FG00456 subjects
FG00556 subjects
FG00655 subjects
COMPLETED
FG0000 subjects
FG00148 subjects
FG00253 subjects
FG00346 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0019 subjects
FG0024 subjects
FG0038 subjects
FG004
Type
Comment
Reasons
Death
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
Baseline analysis population included all randomized participants who received at least 1 dose of study treatment.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Placebo
Placebo matched to PF-04937319 tablet orally once daily and placebo matched to sitagliptin tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
BG001
PF-04937319 3 mg
PF-04937319 3 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
BG002
PF-04937319 20 mg
PF-04937319 20 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
BG003
PF-04937319 50 mg
PF-04937319 50 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
BG004
PF-04937319 100 mg
PF-04937319 100 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
BG005
Sitagliptin 100 mg
Sitagliptin 100 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
BG006
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00057
BG00157
BG00254
BG00356
BG00456
BG00555
BG006335
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Customized
Number
Participants
Title
Denominators
Categories
>=18 to =<44 years
Title
Measurements
BG00015
BG00117
BG00214
BG003
Gender
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG00021
BG00129
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Change From Baseline in Glycosylated Hemoglobin (HbA1C) at Week 12
HbA1c is a form of hemoglobin which is measured primarily to identify the average glycemic control over prolonged periods of time. The normal range for the HbA1c test, was identified as less than (<) 6.5 percent (%) by the study-specific central laboratory used. Change from baseline in percentage of HbA1c in participants were reported.
Full analysis set (FAS) included all randomized participants who received at least 1 dose of study treatment. Here, 'N' (number of participants analyzed) signifies participants for whom data was summarized for this measure and 'n' signifies participants evaluable at given time points for each group.
Posted
Mean
Standard Deviation
percentage of hemoglobin
Baseline (Day 1), Week 12
ID
Title
Description
OG000
Placebo
Placebo matched to PF-04937319 tablet orally once daily and placebo matched to sitagliptin tablet orally once daily along with background metformin 500 milligram (mg) immediate release tablets or as per standard clinical practice, for 12 weeks.
OG001
PF-04937319 3 mg
PF-04937319 3 mg tablet orally once daily along with background metformin 500 milligram (mg) immediate release tablets or as per standard clinical practice, for 12 weeks.
OG002
PF-04937319 20 mg
PF-04937319 20 mg tablet orally once daily along with background metformin 500 milligram (mg) immediate release tablets or as per standard clinical practice, for 12 weeks.
OG003
PF-04937319 50 mg
PF-04937319 50 mg tablet orally once daily along with background metformin 500 milligram (mg) immediate release tablets or as per standard clinical practice, for 12 weeks.
OG004
PF-04937319 100 mg
PF-04937319 100 mg tablet orally once daily along with background metformin 500 milligram (mg) immediate release tablets or as per standard clinical practice, for 12 weeks.
OG005
Sitagliptin
Sitagliptin 100 mg tablet orally once daily along with background metformin 500 milligram (mg) immediate release tablets or as per standard clinical practice, for 12 weeks.
Units
Counts
Participants
OG00050
OG00155
OG00248
OG003
Title
Denominators
Categories
Baseline (n=50,55,48,55,53,53)
Title
Measurements
OG0008.01± 1.099
OG0018.00± 1.031
OG0027.80± 0.965
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Week 12: Treatment difference and 80 percent(%) confidence interval (CI) were based on least squares (LS) mean. A mixed model repeated measure (MMRM) analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant. Null hypothesis stated there was no difference between PF 04937319 and placebo, alternative hypothesis stated PF 04937319 was superior to placebo.
t-test, 1 sided
No adjustments were made for multiple comparisons among treatment groups.
0.5206
p-value was 1-sided.
Least squares (LS) Mean Difference
0.01
Standard Error of the Mean
0.172
2-Sided
80
-0.21
0.23
Secondary
Change From Baseline in Glycosylated Hemoglobin (HbA1C) at Week 2, 4 and 8
HbA1c is a form of hemoglobin which is measured primarily to identify the average glycemic control over prolonged periods of time. The normal range for the HbA1c test, was identified as <6.5 percent by the study-specific central laboratory used. Change from baseline in percentage of HbA1c in participants were reported.
FAS: All randomized participants who received at least 1 dose of study treatment. Here, 'N' signifies participants for whom data was summarized for this measure and 'n' signifies participants who were evaluable at given time points for each group. Data for Week 2 had not been reported because as per protocol it was not intended to be collected.
Posted
Mean
Standard Deviation
percentage of hemoglobin
Baseline(Day 1), Week 2, 4, 8
ID
Title
Description
OG000
Placebo
Placebo matched to PF-04937319 tablet orally once daily and placebo matched to sitagliptin tablet orally once daily along with background metformin 500 milligram (mg) immediate release tablets or as per standard clinical practice, for 12 weeks.
OG001
PF-04937319 3 mg
PF-04937319 3 mg tablet orally once daily along with background metformin 500 milligram (mg) immediate release tablets or as per standard clinical practice, for 12 weeks.
OG002
Secondary
Change From Baseline in Fasting Plasma Glucose at Week 1, 2, 4, 8, 12 and 14
FAS: All randomized participants who received at least 1 dose of study treatment. Here, 'N' signifies participants for whom data was summarized for this measure and 'n' signifies participants who were evaluable at given time points for each group. Data for Week 1 had not been reported because as per protocol it was not intended to be collected.
Posted
Mean
Standard Deviation
milligram per deciliter (mg/dL)
Baseline (Day 1), Week 1, 2, 4, 8, 12, 14
ID
Title
Description
OG000
Placebo
Placebo matched to PF-04937319 tablet orally once daily and placebo matched to sitagliptin tablet orally once daily along with background metformin 500 milligram (mg) immediate release tablets or as per standard clinical practice, for 12 weeks.
OG001
PF-04937319 3 mg
PF-04937319 3 mg tablet orally once daily along with background metformin 500 milligram (mg) immediate release tablets or as per standard clinical practice, for 12 weeks.
OG002
PF-04937319 20 mg
PF-04937319 20 mg tablet orally once daily along with background metformin 500 milligram (mg) immediate release tablets or as per standard clinical practice, for 12 weeks.
Secondary
Percentage of Participants Achieving Less Than 6.5 Percent and Less Than 7 Percent Glycosylated Hemoglobin (HbA1c) Levels at Week 12
HbA1c is a form of hemoglobin which is measured primarily to identify the average glycemic control over prolonged periods of time. The normal range for the HbA1c test, was identified as <6.5 percent by the study-specific central laboratory used and data are presented in categories of <6.5 percent and <7 percent.
FAS: All randomized participants who received at least 1 dose of study treatment. Here, 'N' signifies participants for whom data was summarized for this measure.
Posted
Number
percentage of participants
Week 12
ID
Title
Description
OG000
Placebo
Placebo matched to PF-04937319 tablet orally once daily and placebo matched to sitagliptin tablet orally once daily along with background metformin 500 milligram (mg) immediate release tablets or as per standard clinical practice, for 12 weeks.
OG001
PF-04937319 3 mg
PF-04937319 3 mg tablet orally once daily along with background metformin 500 milligram (mg) immediate release tablets or as per standard clinical practice, for 12 weeks.
OG002
PF-04937319 20 mg
PF-04937319 20 mg tablet orally once daily along with background metformin 500 milligram (mg) immediate release tablets or as per standard clinical practice, for 12 weeks.
Secondary
Number of Participants With Increase From Baseline Electrocardiogram (ECG)Data
Criteria for increase from baseline data: PR interval (percent change of greater than or equal to [>=] 25/50% [if baseline>200 then percent change of >25% counts; if baseline <=200 then percent change of >50% counts]; QRS complex (percent change of >=50%); QT Fridericia's correction (QTcF) interval (change of >=30 to <60 millisecond [msec], and change of >=60 msec).
Safety analysis set included all randomized participants who received at least 1 dose of study treatment. Here, 'N' signifies participants for whom data was collected for this measure.
Posted
Number
participants
Baseline (Day 1) up to Week 14
ID
Title
Description
OG000
Placebo
Placebo matched to PF-04937319 tablet orally once daily and placebo matched to sitagliptin tablet orally once daily along with background metformin 500 milligram (mg) immediate release tablets or as per standard clinical practice, for 12 weeks.
OG001
PF-04937319 3 mg
PF-04937319 3 mg tablet orally once daily along with background metformin 500 milligram (mg) immediate release tablets or as per standard clinical practice, for 12 weeks.
OG002
PF-04937319 20 mg
Secondary
Number of Participants With Increase/Decrease From Baseline Vital Signs Data
Participants who met the criteria for increase or decrease in vital signs data were reported. Criteria for increase or decrease from baseline vital signs data: sitting systolic blood pressure (BP) of >=30 millimeter of mercury (mmHg); sitting diastolic BP of >=20 mmHg and pulse rate was based on investigator's discretion.
Safety analysis set included all randomized participants who received at least 1 dose of study treatment. Here, 'N' signifies participants for whom data was collected for this measure.
Posted
Number
participants
Baseline (Day 1) up to Week 14
ID
Title
Description
OG000
Placebo
Placebo matched to PF-04937319 tablet orally once daily and placebo matched to sitagliptin tablet orally once daily along with background metformin 500 milligram (mg) immediate release tablets or as per standard clinical practice, for 12 weeks.
OG001
PF-04937319 3 mg
PF-04937319 3 mg tablet orally once daily along with background metformin 500 milligram (mg) immediate release tablets or as per standard clinical practice, for 12 weeks.
OG002
PF-04937319 20 mg
PF-04937319 20 mg tablet orally once daily along with background metformin 500 milligram (mg) immediate release tablets or as per standard clinical practice, for 12 weeks.
Secondary
Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 14 days after last dose that were absent before treatment or that worsened relative to pretreatment state. AEs included both serious and non-serious adverse events.
Safety analysis set included all randomized participants who received at least 1 dose of study treatment.
Posted
Number
participants
Baseline (Day 1) up to 14 days after last dose (up to 101 days)
ID
Title
Description
OG000
Metformin 500 mg
Metformin 500 milligram (mg) immediate release tablet used as standardized, pre-specified background therapy in all participants initiated at the run-in visit and continued till follow-up visit.
OG001
Placebo
Placebo matched to PF-04937319 tablet orally once daily and placebo matched to sitagliptin tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
Secondary
Percentage of Participants With at Least 1 Hypoglycemic Events (HAE) Episode
A hypoglycemic event (HAE) was identified by characteristic symptoms or blood glucose levels. HAE is defined as 1 of the given definitions: Characteristic symptoms of HAE with no home glucose monitoring performed where clinical picture included prompt resolution with food intake, subcutaneous glucagon, or intravenous glucose; or characteristic symptoms of HAE with home glucose monitoring measurement =< 70 milligram per deciliter (mg/dL) using ACCU-CHEK plasma-referenced home glucometers or =<74 mg/dL using International Federation of Clinical Chemistry (IFCC) referenced ACCU-CHEK or central laboratory glucometers; or any laboratory glucose value, meeting the following criterion with or without accompanying symptoms: =<49 mg/dL using ACCU-CHEK plasma-referenced home glucometers or =<53 mg/dL using IFCC referenced ACCU-CHEK or central laboratory glucometers.
Safety analysis set included all randomized participants who received at least 1 dose of study treatment. Here, 'N' signifies participants for whom data was collected for this measure.
Posted
Number
percentage of participants
Baseline (Day 1) up to Week 14
ID
Title
Description
OG000
Metformin 500 mg
Metformin 500 milligram (mg) immediate release tablet used as standardized, pre-specified background therapy in all participants initiated at the run-in visit and continued till follow-up visit.
OG001
Placebo
Secondary
Number of Hypoglycemic Events (HAE) Episodes Per Participant
A hypoglycemic event (HAE) was identified by characteristic symptoms or blood glucose levels. Median number of events per participant was reported
Safety analysis set included all randomized participants who received at least 1 dose of study treatment. Here, 'N' signifies participants for whom data was collected for this measure.
Posted
Median
Full Range
events per participant
Baseline (Day 1) up to Week 14
ID
Title
Description
OG000
Metformin 500 mg
Metformin 500 milligram (mg) immediate release tablet used as standardized, pre-specified background therapy in all participants initiated at the run-in visit and continued till follow-up visit.
OG001
Placebo
Placebo matched to PF-04937319 tablet orally once daily and placebo matched to sitagliptin tablet orally once daily along with background metformin 500 milligram (mg) immediate release tablets or as per standard clinical practice, for 12 weeks.
OG002
PF-04937319 3 mg
PF-04937319 3 mg tablet orally once daily along with background metformin 500 milligram (mg) immediate release tablets or as per standard clinical practice, for 12 weeks.
Secondary
Change From Baseline in Body Weight at Week 2, 4, 8, 12 and 14
Safety analysis set included all randomized participants who received at least 1 dose of study treatment. Here, 'N' signifies participants for whom data was collected for this measure and n=participants who were evaluable at given time points for each group.
Posted
Mean
Standard Deviation
kilogram (kg)
Baseline (Day 1), Week 2, 4, 8 , 12 , 14
ID
Title
Description
OG000
Placebo
Placebo matched to PF-04937319 tablet orally once daily and placebo matched to sitagliptin tablet orally once daily along with background metformin 500 milligram (mg) immediate release tablets or as per standard clinical practice, for 12 weeks.
OG001
PF-04937319 3 mg
PF-04937319 3 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
OG002
PF-04937319 20 mg
PF-04937319 20 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
OG003
PF-04937319 50 mg
Secondary
Number of Participants With Abnormal Laboratory Values
Hemoglobin,hematocrit,red blood cells(RBC) count:less than [<]0.8*lower limit of normal[LLN],platelets:<0.5*LLN/greater than [>]1.75*upper limit of normal [ULN],white blood cells(WBC):<0.6*LLN or >1.5*ULN,lymphocytes,total neutrophils:<0.8*LLN or >1.2*ULN, basophils,eosinophil,monocytes:>1.2*ULN;aspartate aminotransferase,alanine aminotransferase, alkaline phosphatase:>0.3*ULN,total protein,albumin:<0.8*LLN or >1.2*ULN;total bilirubin,direct bilirubin,indirect bilirubin:>1.5*ULN;triglycerides,cholesterol:>1.3*ULN, HDL:<0.8*LLN, LDL:>1.2*ULN,blood urea nitrogen,creatinine:>1.3*ULN,uric acid:>1.2*ULN;sodium: <0.95*LLN or >1.05*ULN,potassium,chloride,calcium,bicarbonate:<0.9*LLN or >1.1*ULN;creatine kinase:>2.0*ULN;glucose:<0.6*LLN or >1.5*ULN,urine WBC and RBC:>= 20/High Power Field [HPF]),urine epithelial cells (>=1 HPF),urine bacteria >20 high-powered field;qualitative urine glucose,urine blood to Hgb ratio (>=1);urine(protein,nitrite,mucus,leukocyte >=1 in urine dipstick test).
Safety analysis set included all randomized participants who received at least 1 dose of study treatment. Here, 'N' signifies participants for whom data was collected for this measure.
Posted
Number
participants
Baseline (Day 1) up to Week 14
ID
Title
Description
OG000
Placebo
Placebo matched to PF-04937319 tablet orally once daily and placebo matched to sitagliptin tablet orally once daily along with background metformin 500 milligram (mg) immediate release tablets or as per standard clinical practice, for 12 weeks.
Time Frame
Not provided
Description
Same event may appear as both AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and nonserious in another subject, or 1 subject may have experienced both serious and nonserious event during study. AEs were also collected during the course of run-in period (metformin background therapy).
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Metformin 500 mg
Metformin 500 milligram (mg) immediate release tablet used as standardized, pre-specified background therapy in all participants initiated at the run-in visit and continued till follow-up visit.
0
376
37
376
EG001
Placebo
Placebo matched to PF-04937319 tablet orally once daily and placebo matched to sitagliptin tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
1
57
19
57
EG002
PF-04937319 3 mg
PF-04937319 3 mg tablet orally once daily along with background metformin 500 milligram (mg) immediate release tablets or as per standard clinical practice, for 12 weeks.
0
57
19
57
EG003
PF-04937319 20 mg
PF-04937319 20 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
1
54
19
54
EG004
PF-04937319 50 mg
PF-04937319 50 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
0
56
16
56
EG005
PF-04937319 100 mg
PF-04937319 100 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
1
56
24
56
EG006
Sitagliptin 100 mg
Sitagliptin 100 mg tablet orally tablet once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
0
55
18
55
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Myocardial infarction
Cardiac disorders
MedDRA 16.0
Non-systematic Assessment
EG0000 affected376 at risk
EG0010 affected57 at risk
EG0020 affected57 at risk
EG0031 affected54 at risk
EG0040 affected56 at risk
EG0050 affected56 at risk
EG0060 affected55 at risk
Anal abscess
Infections and infestations
MedDRA 16.0
Non-systematic Assessment
EG0000 affected376 at risk
EG0011 affected57 at risk
EG0020 affected57 at risk
EG003
Meningitis viral
Infections and infestations
MedDRA 16.0
Non-systematic Assessment
EG0000 affected376 at risk
EG0010 affected57 at risk
EG0020 affected57 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA 16.0
Non-systematic Assessment
EG0000 affected376 at risk
EG0010 affected57 at risk
EG0021 affected57 at risk
EG0030 affected54 at risk
EG0041 affected56 at risk
EG0051 affected56 at risk
EG0060 affected55 at risk
Iron deficiency anaemia
Blood and lymphatic system disorders
MedDRA 16.0
Non-systematic Assessment
EG0000 affected376 at risk
EG0010 affected57 at risk
EG0020 affected57 at risk
EG003
Leukocytosis
Blood and lymphatic system disorders
MedDRA 16.0
Non-systematic Assessment
EG0001 affected376 at risk
EG0010 affected57 at risk
EG0020 affected57 at risk
EG003
Bundle branch block right
Cardiac disorders
MedDRA 16.0
Non-systematic Assessment
EG0001 affected376 at risk
EG0010 affected57 at risk
EG0020 affected57 at risk
EG003
Type IIb hyperlipidaemia
Congenital, familial and genetic disorders
MedDRA 16.0
Non-systematic Assessment
EG0000 affected376 at risk
EG0010 affected57 at risk
EG0020 affected57 at risk
EG003
Type IV hyperlipidaemia
Congenital, familial and genetic disorders
MedDRA 16.0
Non-systematic Assessment
EG0003 affected376 at risk
EG0011 affected57 at risk
EG0021 affected57 at risk
EG003
Vertigo
Ear and labyrinth disorders
MedDRA 16.0
Non-systematic Assessment
EG0000 affected376 at risk
EG0010 affected57 at risk
EG0020 affected57 at risk
EG003
Hypothyroidism
Endocrine disorders
MedDRA 16.0
Non-systematic Assessment
EG0000 affected376 at risk
EG0010 affected57 at risk
EG0020 affected57 at risk
EG003
Dry eye
Eye disorders
MedDRA 16.0
Non-systematic Assessment
EG0000 affected376 at risk
EG0010 affected57 at risk
EG0020 affected57 at risk
EG003
Eye inflammation
Eye disorders
MedDRA 16.0
Non-systematic Assessment
EG0001 affected376 at risk
EG0011 affected57 at risk
EG0020 affected57 at risk
EG003
Abdominal distension
Gastrointestinal disorders
MedDRA 16.0
Non-systematic Assessment
EG0000 affected376 at risk
EG0010 affected57 at risk
EG0020 affected57 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA 16.0
Non-systematic Assessment
EG0000 affected376 at risk
EG0011 affected57 at risk
EG0021 affected57 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA 16.0
Non-systematic Assessment
EG0000 affected376 at risk
EG0011 affected57 at risk
EG0020 affected57 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 16.0
Non-systematic Assessment
EG0001 affected376 at risk
EG0010 affected57 at risk
EG0021 affected57 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDRA 16.0
Non-systematic Assessment
EG0000 affected376 at risk
EG0010 affected57 at risk
EG0020 affected57 at risk
EG003
Enteritis
Gastrointestinal disorders
MedDRA 16.0
Non-systematic Assessment
EG0000 affected376 at risk
EG0010 affected57 at risk
EG0020 affected57 at risk
EG003
Faeces discoloured
Gastrointestinal disorders
MedDRA 16.0
Non-systematic Assessment
EG0000 affected376 at risk
EG0010 affected57 at risk
EG0020 affected57 at risk
EG003
Gastritis
Gastrointestinal disorders
MedDRA 16.0
Non-systematic Assessment
EG0000 affected376 at risk
EG0010 affected57 at risk
EG0020 affected57 at risk
EG003
Gastrooesophageal reflux disease
Gastrointestinal disorders
MedDRA 16.0
Non-systematic Assessment
EG0000 affected376 at risk
EG0010 affected57 at risk
EG0020 affected57 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 16.0
Non-systematic Assessment
EG0001 affected376 at risk
EG0010 affected57 at risk
EG0020 affected57 at risk
EG003
Toothache
Gastrointestinal disorders
MedDRA 16.0
Non-systematic Assessment
EG0000 affected376 at risk
EG0010 affected57 at risk
EG0022 affected57 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 16.0
Non-systematic Assessment
EG0002 affected376 at risk
EG0011 affected57 at risk
EG0020 affected57 at risk
EG003
Asthenia
General disorders
MedDRA 16.0
Non-systematic Assessment
EG0001 affected376 at risk
EG0010 affected57 at risk
EG0020 affected57 at risk
EG003
Malaise
General disorders
MedDRA 16.0
Non-systematic Assessment
EG0002 affected376 at risk
EG0010 affected57 at risk
EG0021 affected57 at risk
EG003
Pain
General disorders
MedDRA 16.0
Non-systematic Assessment
EG0000 affected376 at risk
EG0011 affected57 at risk
EG0020 affected57 at risk
EG003
Pyrexia
General disorders
MedDRA 16.0
Non-systematic Assessment
EG0000 affected376 at risk
EG0011 affected57 at risk
EG0020 affected57 at risk
EG003
Hepatitis
Hepatobiliary disorders
MedDRA 16.0
Non-systematic Assessment
EG0000 affected376 at risk
EG0010 affected57 at risk
EG0020 affected57 at risk
EG003
Hyperbilirubinaemia
Hepatobiliary disorders
MedDRA 16.0
Non-systematic Assessment
EG0000 affected376 at risk
EG0010 affected57 at risk
EG0021 affected57 at risk
EG003
Abscess neck
Infections and infestations
MedDRA 16.0
Non-systematic Assessment
EG0000 affected376 at risk
EG0010 affected57 at risk
EG0020 affected57 at risk
EG003
Acute sinusitis
Infections and infestations
MedDRA 16.0
Non-systematic Assessment
EG0000 affected376 at risk
EG0011 affected57 at risk
EG0020 affected57 at risk
EG003
Anal abscess
Infections and infestations
MedDRA 16.0
Non-systematic Assessment
EG0000 affected376 at risk
EG0011 affected57 at risk
EG0020 affected57 at risk
EG003
Asymptomatic bacteriuria
Infections and infestations
MedDRA 16.0
Non-systematic Assessment
EG0000 affected376 at risk
EG0010 affected57 at risk
EG0020 affected57 at risk
EG003
Body tinea
Infections and infestations
MedDRA 16.0
Non-systematic Assessment
EG0000 affected376 at risk
EG0010 affected57 at risk
EG0020 affected57 at risk
EG003
Bronchitis
Infections and infestations
MedDRA 16.0
Non-systematic Assessment
EG0001 affected376 at risk
EG0010 affected57 at risk
EG0021 affected57 at risk
EG003
Conjunctivitis bacterial
Infections and infestations
MedDRA 16.0
Non-systematic Assessment
EG0001 affected376 at risk
EG0010 affected57 at risk
EG0021 affected57 at risk
EG003
Folliculitis
Infections and infestations
MedDRA 16.0
Non-systematic Assessment
EG0000 affected376 at risk
EG0010 affected57 at risk
EG0020 affected57 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA 16.0
Non-systematic Assessment
EG0001 affected376 at risk
EG0011 affected57 at risk
EG0020 affected57 at risk
EG003
Gastroenteritis viral
Infections and infestations
MedDRA 16.0
Non-systematic Assessment
EG0000 affected376 at risk
EG0010 affected57 at risk
EG0021 affected57 at risk
EG003
Gingivitis
Infections and infestations
MedDRA 16.0
Non-systematic Assessment
EG0001 affected376 at risk
EG0010 affected57 at risk
EG0020 affected57 at risk
EG003
Helicobacter infection
Infections and infestations
MedDRA 16.0
Non-systematic Assessment
EG0000 affected376 at risk
EG0010 affected57 at risk
EG0021 affected57 at risk
EG003
Influenza
Infections and infestations
MedDRA 16.0
Non-systematic Assessment
EG0001 affected376 at risk
EG0010 affected57 at risk
EG0020 affected57 at risk
EG003
Laryngitis
Infections and infestations
MedDRA 16.0
Non-systematic Assessment
EG0000 affected376 at risk
EG0010 affected57 at risk
EG0020 affected57 at risk
EG003
Malaria
Infections and infestations
MedDRA 16.0
Non-systematic Assessment
EG0000 affected376 at risk
EG0010 affected57 at risk
EG0021 affected57 at risk
EG003
Mastitis
Infections and infestations
MedDRA 16.0
Non-systematic Assessment
EG0001 affected376 at risk
EG0010 affected57 at risk
EG0020 affected57 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA 16.0
Non-systematic Assessment
EG0000 affected376 at risk
EG0011 affected57 at risk
EG0020 affected57 at risk
EG003
Osteomyelitis
Infections and infestations
MedDRA 16.0
Non-systematic Assessment
EG0000 affected376 at risk
EG0010 affected57 at risk
EG0021 affected57 at risk
EG003
Otitis externa
Infections and infestations
MedDRA 16.0
Non-systematic Assessment
EG0000 affected376 at risk
EG0010 affected57 at risk
EG0021 affected57 at risk
EG003
Otitis media
Infections and infestations
MedDRA 16.0
Non-systematic Assessment
EG0000 affected376 at risk
EG0010 affected57 at risk
EG0020 affected57 at risk
EG003
Paronychia
Infections and infestations
MedDRA 16.0
Non-systematic Assessment
EG0001 affected376 at risk
EG0010 affected57 at risk
EG0020 affected57 at risk
EG003
Pharyngitis
Infections and infestations
MedDRA 16.0
Non-systematic Assessment
EG0003 affected376 at risk
EG0010 affected57 at risk
EG0020 affected57 at risk
EG003
Pyelonephritis
Infections and infestations
MedDRA 16.0
Non-systematic Assessment
EG0001 affected376 at risk
EG0010 affected57 at risk
EG0020 affected57 at risk
EG003
Respiratory tract infection viral
Infections and infestations
MedDRA 16.0
Non-systematic Assessment
EG0001 affected376 at risk
EG0010 affected57 at risk
EG0020 affected57 at risk
EG003
Sinusitis
Infections and infestations
MedDRA 16.0
Non-systematic Assessment
EG0001 affected376 at risk
EG0010 affected57 at risk
EG0020 affected57 at risk
EG003
Subcutaneous abscess
Infections and infestations
MedDRA 16.0
Non-systematic Assessment
EG0000 affected376 at risk
EG0010 affected57 at risk
EG0020 affected57 at risk
EG003
Tonsillitis
Infections and infestations
MedDRA 16.0
Non-systematic Assessment
EG0000 affected376 at risk
EG0010 affected57 at risk
EG0020 affected57 at risk
EG003
Tooth abscess
Infections and infestations
MedDRA 16.0
Non-systematic Assessment
EG0001 affected376 at risk
EG0010 affected57 at risk
EG0020 affected57 at risk
EG003
Tooth infection
Infections and infestations
MedDRA 16.0
Non-systematic Assessment
EG0000 affected376 at risk
EG0010 affected57 at risk
EG0021 affected57 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA 16.0
Non-systematic Assessment
EG0000 affected376 at risk
EG0012 affected57 at risk
EG0021 affected57 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 16.0
Non-systematic Assessment
EG0002 affected376 at risk
EG0011 affected57 at risk
EG0021 affected57 at risk
EG003
Viral infection
Infections and infestations
MedDRA 16.0
Non-systematic Assessment
EG0000 affected376 at risk
EG0010 affected57 at risk
EG0020 affected57 at risk
EG003
Viral upper respiratory tract infection
Infections and infestations
MedDRA 16.0
Non-systematic Assessment
EG0000 affected376 at risk
EG0010 affected57 at risk
EG0020 affected57 at risk
EG003
Muscle strain
Injury, poisoning and procedural complications
MedDRA 16.0
Non-systematic Assessment
EG0000 affected376 at risk
EG0010 affected57 at risk
EG0021 affected57 at risk
EG003
Blood bilirubin increased
Investigations
MedDRA 16.0
Non-systematic Assessment
EG0000 affected376 at risk
EG0010 affected57 at risk
EG0020 affected57 at risk
EG003
Blood pressure increased
Investigations
MedDRA 16.0
Non-systematic Assessment
EG0000 affected376 at risk
EG0010 affected57 at risk
EG0020 affected57 at risk
EG003
Blood triglycerides increased
Investigations
MedDRA 16.0
Non-systematic Assessment
EG0000 affected376 at risk
EG0011 affected57 at risk
EG0020 affected57 at risk
EG003
Electrocardiogram ST segment elevation
Investigations
MedDRA 16.0
Non-systematic Assessment
EG0000 affected376 at risk
EG0011 affected57 at risk
EG0020 affected57 at risk
EG003
Haemoglobin decreased
Investigations
MedDRA 16.0
Non-systematic Assessment
EG0000 affected376 at risk
EG0012 affected57 at risk
EG0021 affected57 at risk
EG003
Hepatic enzyme increased
Investigations
MedDRA 16.0
Non-systematic Assessment
EG0000 affected376 at risk
EG0011 affected57 at risk
EG0020 affected57 at risk
EG003
Platelet count increased
Investigations
MedDRA 16.0
Non-systematic Assessment
EG0000 affected376 at risk
EG0010 affected57 at risk
EG0020 affected57 at risk
EG003
Vitamin B12 decreased
Investigations
MedDRA 16.0
Non-systematic Assessment
EG0000 affected376 at risk
EG0010 affected57 at risk
EG0021 affected57 at risk
EG003
Weight decreased
Investigations
MedDRA 16.0
Non-systematic Assessment
EG0001 affected376 at risk
EG0010 affected57 at risk
EG0020 affected57 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA 16.0
Non-systematic Assessment
EG0001 affected376 at risk
EG0010 affected57 at risk
EG0021 affected57 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA 16.0
Non-systematic Assessment
EG0002 affected376 at risk
EG0010 affected57 at risk
EG0020 affected57 at risk
EG003
Hyperlipidaemia
Metabolism and nutrition disorders
MedDRA 16.0
Non-systematic Assessment
EG0000 affected376 at risk
EG0010 affected57 at risk
EG0020 affected57 at risk
EG003
Hyperuricaemia
Metabolism and nutrition disorders
MedDRA 16.0
Non-systematic Assessment
EG0001 affected376 at risk
EG0010 affected57 at risk
EG0020 affected57 at risk
EG003
Hypoglycaemia
Metabolism and nutrition disorders
MedDRA 16.0
Non-systematic Assessment
EG0000 affected376 at risk
EG0010 affected57 at risk
EG0020 affected57 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA 16.0
Non-systematic Assessment
EG0000 affected376 at risk
EG0011 affected57 at risk
EG0020 affected57 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRA 16.0
Non-systematic Assessment
EG0000 affected376 at risk
EG0010 affected57 at risk
EG0020 affected57 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 16.0
Non-systematic Assessment
EG0001 affected376 at risk
EG0010 affected57 at risk
EG0022 affected57 at risk
EG003
Arthritis
Musculoskeletal and connective tissue disorders
MedDRA 16.0
Non-systematic Assessment
EG0000 affected376 at risk
EG0010 affected57 at risk
EG0020 affected57 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 16.0
Non-systematic Assessment
EG0001 affected376 at risk
EG0011 affected57 at risk
EG0020 affected57 at risk
EG003
Bone pain
Musculoskeletal and connective tissue disorders
MedDRA 16.0
Non-systematic Assessment
EG0000 affected376 at risk
EG0010 affected57 at risk
EG0020 affected57 at risk
EG003
Joint swelling
Musculoskeletal and connective tissue disorders
MedDRA 16.0
Non-systematic Assessment
EG0001 affected376 at risk
EG0010 affected57 at risk
EG0021 affected57 at risk
EG003
Muscle spasms
Musculoskeletal and connective tissue disorders
MedDRA 16.0
Non-systematic Assessment
EG0001 affected376 at risk
EG0010 affected57 at risk
EG0020 affected57 at risk
EG003
Musculoskeletal chest pain
Musculoskeletal and connective tissue disorders
MedDRA 16.0
Non-systematic Assessment
EG0001 affected376 at risk
EG0011 affected57 at risk
EG0020 affected57 at risk
EG003
Musculoskeletal pain
Musculoskeletal and connective tissue disorders
MedDRA 16.0
Non-systematic Assessment
EG0001 affected376 at risk
EG0010 affected57 at risk
EG0020 affected57 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA 16.0
Non-systematic Assessment
EG0001 affected376 at risk
EG0010 affected57 at risk
EG0020 affected57 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA 16.0
Non-systematic Assessment
EG0001 affected376 at risk
EG0010 affected57 at risk
EG0020 affected57 at risk
EG003
Diabetic neuropathy
Nervous system disorders
MedDRA 16.0
Non-systematic Assessment
EG0000 affected376 at risk
EG0010 affected57 at risk
EG0021 affected57 at risk
EG003
Dizziness
Nervous system disorders
MedDRA 16.0
Non-systematic Assessment
EG0003 affected376 at risk
EG0010 affected57 at risk
EG0020 affected57 at risk
EG003
Facial paresis
Nervous system disorders
MedDRA 16.0
Non-systematic Assessment
EG0000 affected376 at risk
EG0010 affected57 at risk
EG0020 affected57 at risk
EG003
Headache
Nervous system disorders
MedDRA 16.0
Non-systematic Assessment
EG0002 affected376 at risk
EG0010 affected57 at risk
EG0020 affected57 at risk
EG003
Migraine
Nervous system disorders
MedDRA 16.0
Non-systematic Assessment
EG0001 affected376 at risk
EG0010 affected57 at risk
EG0020 affected57 at risk
EG003
Polyneuropathy
Nervous system disorders
MedDRA 16.0
Non-systematic Assessment
EG0000 affected376 at risk
EG0011 affected57 at risk
EG0020 affected57 at risk
EG003
Sciatica
Nervous system disorders
MedDRA 16.0
Non-systematic Assessment
EG0000 affected376 at risk
EG0010 affected57 at risk
EG0020 affected57 at risk
EG003
Syncope
Nervous system disorders
MedDRA 16.0
Non-systematic Assessment
EG0001 affected376 at risk
EG0010 affected57 at risk
EG0020 affected57 at risk
EG003
Haematuria
Renal and urinary disorders
MedDRA 16.0
Non-systematic Assessment
EG0000 affected376 at risk
EG0010 affected57 at risk
EG0020 affected57 at risk
EG003
Nephrolithiasis
Renal and urinary disorders
MedDRA 16.0
Non-systematic Assessment
EG0001 affected376 at risk
EG0010 affected57 at risk
EG0020 affected57 at risk
EG003
Nephropathy
Renal and urinary disorders
MedDRA 16.0
Non-systematic Assessment
EG0001 affected376 at risk
EG0010 affected57 at risk
EG0020 affected57 at risk
EG003
Polyuria
Renal and urinary disorders
MedDRA 16.0
Non-systematic Assessment
EG0001 affected376 at risk
EG0010 affected57 at risk
EG0020 affected57 at risk
EG003
Proteinuria
Renal and urinary disorders
MedDRA 16.0
Non-systematic Assessment
EG0000 affected376 at risk
EG0010 affected57 at risk
EG0020 affected57 at risk
EG003
Pyuria
Renal and urinary disorders
MedDRA 16.0
Non-systematic Assessment
EG0001 affected376 at risk
EG0010 affected57 at risk
EG0020 affected57 at risk
EG003
Erectile dysfunction
Reproductive system and breast disorders
MedDRA 16.0
Non-systematic Assessment
EG0000 affected376 at risk
EG0010 affected57 at risk
EG0020 affected57 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA 16.0
Systematic Assessment
EG0002 affected376 at risk
EG0011 affected57 at risk
EG0020 affected57 at risk
EG003
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA 16.0
Non-systematic Assessment
EG0001 affected376 at risk
EG0012 affected57 at risk
EG0021 affected57 at risk
EG003
Dermatitis contact
Skin and subcutaneous tissue disorders
MedDRA 16.0
Non-systematic Assessment
EG0000 affected376 at risk
EG0010 affected57 at risk
EG0020 affected57 at risk
EG003
Eczema
Skin and subcutaneous tissue disorders
MedDRA 16.0
Non-systematic Assessment
EG0001 affected376 at risk
EG0010 affected57 at risk
EG0020 affected57 at risk
EG003
Hyperhidrosis
Skin and subcutaneous tissue disorders
MedDRA 16.0
Non-systematic Assessment
EG0000 affected376 at risk
EG0010 affected57 at risk
EG0020 affected57 at risk
EG003
Psoriasis
Skin and subcutaneous tissue disorders
MedDRA 16.0
Non-systematic Assessment
EG0000 affected376 at risk
EG0010 affected57 at risk
EG0021 affected57 at risk
EG003
Hypertension
Vascular disorders
MedDRA 16.0
Non-systematic Assessment
EG0000 affected376 at risk
EG0011 affected57 at risk
EG0022 affected57 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
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.
Week 12: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant. Null hypothesis stated there was no difference between PF 04937319 and placebo, alternative hypothesis stated PF 04937319 was superior to placebo
t-test, 1 sided
No adjustments were made for multiple comparisons among treatment groups.
0.1645
p-value was 1-sided.
LS Mean Difference
-0.17
Standard Error of the Mean
0.178
2-Sided
80
-0.40
0.05
No
Superiority or Other
OG000
OG003
Week 12: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant. Null hypothesis stated there was no difference between PF 04937319 and placebo, alternative hypothesis stated PF 04937319 was superior to placebo.
t-test, 1 sided
No adjustments were made for multiple comparisons among treatment groups.
0.1592
p-value was 1-sided.
LS Mean Difference
-0.17
Standard Error of the Mean
0.172
2-Sided
80
-0.39
0.05
No
Superiority or Other
OG000
OG004
Week 12: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant. Null hypothesis stated there was no difference between PF 04937319 and placebo, alternative hypothesis stated PF 04937319 was superior to placebo.
t-test, 1 sided
0.0049
p-value was 1-sided.
LS Mean Difference
-0.45
Standard Error of the Mean
0.174
2-Sided
80
-0.68
-0.23
No
Superiority or Other
OG000
OG005
Week 12: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant. Null hypothesis stated there was no difference between PF 04937319 and placebo, alternative hypothesis stated PF 04937319 was superior to placebo.
t-test, 1 sided
0.0068
p-value was 1-sided.
LS Mean Difference
-0.43
Standard Error of the Mean
0.173
2-Sided
80
-0.65
-0.21
No
Superiority or Other
PF-04937319 20 mg
PF-04937319 20 mg tablet orally once daily along with background metformin 500 milligram (mg) immediate release tablets or as per standard clinical practice, for 12 weeks.
OG003
PF-04937319 50 mg
PF-04937319 50 mg tablet orally once daily along with background metformin 500 milligram (mg) immediate release tablets or as per standard clinical practice, for 12 weeks.
OG004
PF-04937319 100 mg
PF-04937319 100 mg tablet orally once daily along with background metformin 500 milligram (mg) immediate release tablets or as per standard clinical practice, for 12 weeks.
OG005
Sitagliptin
Sitagliptin 100 mg tablet orally once daily along with background metformin 500 milligram (mg) immediate release tablets or as per standard clinical practice, for 12 weeks.
Units
Counts
Participants
OG00050
OG00155
OG00248
OG00355
OG00453
OG00553
Title
Denominators
Categories
Change at Week 4 (n= 50, 55, 48, 55, 53, 53)
Title
Measurements
OG000-0.20± 0.397
OG001-0.24± 0.568
OG002-0.32± 0.520
OG003-0.35± 0.601
OG004-0.50± 0.470
OG005-0.52± 0.503
Change at Week 8 (n=48, 53, 45, 52, 50, 51)
Title
Measurements
OG000-0.36± 0.664
OG001-0.32± 0.781
OG002-0.46± 0.803
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Week 4: Treatment difference and 80 percent(%) confidence interval (CI) were based on least squares (LS) mean. A mixed model repeated measure (MMRM) analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.
t-test, 1 sided
0.3434
p-value was 1-sided.
LS Mean Difference
-0.04
Standard Error of the Mean
0.097
2-Sided
80
-0.16
0.09
No
Superiority or Other
OG000
OG002
Week 4: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline, as the covariates, time was repeated for participant.
t-test, 1 sided
0.0892
p-value was 1-sided.
LS Mean Difference
-0.14
Standard Error of the Mean
0.101
2-Sided
80
-0.27
-0.01
No
Superiority or Other
OG000
OG003
Week 4: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline, as the covariates, time was repeated for participant.
t-test, 1 sided
0.0826
p-value was 1-sided.
LS Mean Difference
-0.14
Standard Error of the Mean
0.097
2-Sided
80
-0.26
-0.01
No
Superiority or Other
OG000
OG004
Week 4: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline, as the covariates, time was repeated for participant.
t-test, 1 sided
0.0031
p-value was 1-sided.
LS Mean Difference
-0.27
Standard Error of the Mean
0.098
2-Sided
80
-0.40
-0.15
No
Superiority or Other
OG000
OG005
Week 4: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.
t-test, 1 sided
0.0005
p-value was 1-sided.
LS Mean Difference
-0.33
Standard Error of the Mean
0.098
2-Sided
80
-0.45
-0.20
No
Superiority or Other
OG000
OG001
Week 8: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.
t-test, 1 sided
0.5133
p-value was 1-sided.
LS Mean Difference
0.00
Standard Error of the Mean
0.144
2-Sided
80
-0.18
0.19
No
Superiority or Other
OG000
OG002
Week 8: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.
t-test, 1 sided
0.1873
p-value was 1-sided.
LS Mean Difference
-0.13
Standard Error of the Mean
0.150
2-Sided
80
-0.33
0.06
No
Superiority or Other
OG000
OG003
Week 8: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.
t-test, 1 sided
0.2120
p-value was 1-sided.
LS Mean Difference
-0.12
Standard Error of the Mean
0.145
2-Sided
80
-0.30
0.07
No
Superiority or Other
OG000
OG004
Week 8: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline, as the covariates, time was repeated for participant.
t-test, 1 sided
0.0001
p-value was 1-sided.
LS Mean Difference
-0.54
Standard Error of the Mean
0.146
2-Sided
80
-0.73
-0.35
No
Superiority or Other
OG000
OG005
Week 8: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.
t-test, 1 sided
0.0021
p-value was 1-sided.
LS Mean Difference
-0.42
Standard Error of the Mean
0.146
2-Sided
80
-0.61
-0.23
No
Superiority or Other
OG003
PF-04937319 50 mg
PF-04937319 50 mg tablet orally once daily along with background metformin 500 milligram (mg) immediate release tablets or as per standard clinical practice, for 12 weeks.
OG004
PF-04937319 100 mg
PF-04937319 100 mg tablet orally once daily along with background metformin 500 milligram (mg) immediate release tablets or as per standard clinical practice, for 12 weeks.
OG005
Sitagliptin
Sitagliptin 100 mg tablet orally once daily along with background metformin 500 milligram (mg) immediate release tablets or as per standard clinical practice, for 12 weeks.
Units
Counts
Participants
OG00056
OG00156
OG00252
OG00356
OG00455
OG00555
Title
Denominators
Categories
Baseline (n=56, 56, 52, 56, 55, 55)
Title
Measurements
OG000168.3± 42.99
OG001159.8± 40.43
OG002155.1± 37.74
OG003166.1± 42.56
OG004164.8± 41.14
OG005160.7± 35.87
Change at Week 2 (n=54, 56, 50, 56, 54, 55)
Title
Measurements
OG000-5.2± 26.22
OG0010.7± 26.21
OG002-3.2± 19.67
OG003
Change at Week 4 (n=52, 56, 51, 55, 54, 53)
Title
Measurements
OG000-1.8± 31.25
OG001-0.3± 23.21
OG002-0.2± 21.29
OG003
Change at Week 8 (n=50, 54, 47, 52, 51, 52)
Title
Measurements
OG000-3.1± 37.03
OG0010.7± 26.83
OG002-2.5± 27.49
OG003
Change at Week 12 (n=48, 53, 47, 52, 51, 53)
Title
Measurements
OG000-7.5± 31.21
OG001-2.5± 28.58
OG002-3.8± 31.62
OG003
Change at Week 14 (n=45, 53, 46, 52, 51, 53)
Title
Measurements
OG000-5.9± 33.18
OG001-3.5± 28.43
OG002-3.1± 32.62
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Week 2: Treatment difference and 80 percent(%) confidence interval (CI) were based on least squares (LS) mean. A mixed model repeated measure (MMRM) analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.
t-test, 1 sided
0.7240
p-value was 1-sided.
LS Mean Difference
2.87
Standard Error of the Mean
4.823
2-Sided
80
-3.32
9.07
No
Superiority or Other
OG000
OG002
Week 2: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.
t-test, 1 sided
0.3608
p-value was 1-sided.
LS Mean Difference
-1.77
Standard Error of the Mean
4.952
2-Sided
80
-8.13
4.59
No
Superiority or Other
OG000
OG003
Week 2: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.
t-test, 1 sided
0.2511
p-value was 1-sided.
LS Mean Difference
-3.24
Standard Error of the Mean
4.816
2-Sided
80
-9.42
2.95
No
Superiority or Other
OG000
OG004
Week 2: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.
t-test, 1 sided
0.0673
p-value was 1-sided.
LS Mean Difference
-7.28
Standard Error of the Mean
4.851
2-Sided
80
-13.51
-1.05
No
Superiority or Other
OG000
OG005
Week 2: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.
t-test, 1 sided
0.0106
p-value was 1-sided.
LS Mean Difference
-11.22
Standard Error of the Mean
4.843
2-Sided
80
-17.44
-5.00
No
Superiority or Other
OG000
OG001
Week 4: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.
t-test, 1 sided
0.4127
p-value was 1-sided.
LS Mean Difference
-1.13
Standard Error of the Mean
5.138
2-Sided
80
-7.73
5.47
No
Superiority or Other
OG000
OG002
Week 4: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.
t-test, 1 sided
0.3604
p-value was 1-sided.
LS Mean Difference
-1.88
Standard Error of the Mean
5.261
2-Sided
80
-8.64
4.87
No
Superiority or Other
OG000
OG003
Week 4: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.
t-test, 1 sided
0.0770
p-value was 1-sided.
LS Mean Difference
-7.35
Standard Error of the Mean
5.147
2-Sided
80
-13.96
-0.74
No
Superiority or Other
OG000
OG004
Week 4: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.
t-test, 1 sided
0.0451
p-value was 1-sided.
LS Mean Difference
-8.79
Standard Error of the Mean
5.171
2-Sided
80
-15.43
-2.15
No
Superiority or Other
OG000
OG005
Week 4: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.
t-test, 1 sided
0.0001
p-value was 1-sided.
LS Mean Difference
-19.90
Standard Error of the Mean
5.191
2-Sided
80
-26.57
-13.23
No
Superiority or Other
OG000
OG001
Week 8: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.
t-test, 1 sided
0.5783
p-value was 1-sided.
LS Mean Difference
1.11
Standard Error of the Mean
5.599
2-Sided
80
-6.08
8.30
No
Superiority or Other
OG000
OG002
Week 8: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.
t-test, 1 sided
0.3604
p-value was 1-sided.
LS Mean Difference
-2.07
Standard Error of the Mean
5.785
2-Sided
80
-9.50
5.36
No
Superiority or Other
OG000
OG003
Week 8: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.
t-test, 1 sided
0.0161
p-value was 1-sided.
LS Mean Difference
-12.12
Standard Error of the Mean
5.636
2-Sided
80
-19.36
-4.88
No
Superiority or Other
OG000
OG004
Week 8: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.
t-test, 1 sided
0.2185
p-value was 1-sided.
LS Mean Difference
-4.41
Standard Error of the Mean
5.663
2-Sided
80
-11.68
2.87
No
Superiority or Other
OG000
OG005
Week 8: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.
t-test, 1 sided
0.0034
p-value was 1-sided.
LS Mean Difference
-15.41
Standard Error of the Mean
5.649
2-Sided
80
-22.67
-8.16
No
Superiority or Other
OG000
OG001
Week 12: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.
t-test, 1 sided
0.5727
p-value was 1-sided.
LS Mean Difference
1.17
Standard Error of the Mean
6.387
2-Sided
80
-7.03
9.37
No
Superiority or Other
OG000
OG002
Week 12: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.
t-test, 1 sided
0.4961
p-value was 1-sided.
LS Mean Difference
-0.06
Standard Error of the Mean
6.578
2-Sided
80
-8.51
8.38
No
Superiority or Other
OG000
OG003
Week 12: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.
t-test, 1 sided
0.2616
p-value was 1-sided.
LS Mean Difference
-4.10
Standard Error of the Mean
6.411
2-Sided
80
-12.33
4.14
No
Superiority or Other
OG000
OG004
Week 12: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.
t-test, 1 sided
0.9197
p-value was 1-sided.
LS Mean Difference
9.06
Standard Error of the Mean
6.441
2-Sided
80
0.79
17.34
No
Superiority or Other
OG000
OG005
Week 12: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.
t-test, 1 sided
0.0860
p-value was 1-sided.
LS Mean Difference
-8.76
Standard Error of the Mean
6.398
2-Sided
80
-16.98
-0.54
No
Superiority or Other
OG000
OG001
Week 14: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.
t-test, 1 sided
0.5132
p-value was 1-sided.
LS Mean Difference
0.22
Standard Error of the Mean
6.476
2-Sided
80
-8.10
8.53
No
Superiority or Other
OG000
OG002
Week 14: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.
t-test, 1 sided
0.6560
p-value was 1-sided.
LS Mean Difference
2.68
Standard Error of the Mean
6.676
2-Sided
80
-5.89
11.26
No
Superiority or Other
OG000
OG003
Week 14: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.
t-test, 1 sided
0.8285
p-value was 1-sided.
LS Mean Difference
6.17
Standard Error of the Mean
6.496
2-Sided
80
-2.17
14.52
No
Superiority or Other
OG000
OG004
Week 14: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.
t-test, 1 sided
0.9925
p-value was 1-sided.
LS Mean Difference
15.98
Standard Error of the Mean
6.527
2-Sided
80
7.59
24.36
No
Superiority or Other
OG000
OG005
Week 14: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.
t-test, 1 sided
0.6010
p-value was 1-sided.
LS Mean Difference
1.66
Standard Error of the Mean
6.487
2-Sided
80
-6.67
10.00
No
Superiority or Other
OG003
PF-04937319 50 mg
PF-04937319 50 mg tablet orally once daily along with background metformin 500 milligram (mg) immediate release tablets or as per standard clinical practice, for 12 weeks.
OG004
PF-04937319 100 mg
PF-04937319 100 mg tablet orally once daily along with background metformin 500 milligram (mg) immediate release tablets or as per standard clinical practice, for 12 weeks.
OG005
Sitagliptin
Sitagliptin 100 mg tablet orally once daily along with background metformin 500 milligram (mg) immediate release tablets or as per standard clinical practice, for 12 weeks.
Units
Counts
Participants
OG00048
OG00153
OG00247
OG00352
OG00451
OG00553
Title
Denominators
Categories
<6.5 percent
Title
Measurements
OG00012.5
OG0019.4
OG00219.1
OG00315.4
OG00417.6
OG00532.1
<7 percent
Title
Measurements
OG00022.9
OG00126.4
OG00242.6
OG003
PF-04937319 20 mg tablet orally once daily along with background metformin 500 milligram (mg) immediate release tablets or as per standard clinical practice, for 12 weeks.
OG003
PF-04937319 50 mg
PF-04937319 50 mg tablet orally once daily along with background metformin 500 milligram (mg) immediate release tablets or as per standard clinical practice, for 12 weeks.
OG004
PF-04937319 100 mg
PF-04937319 100 mg tablet orally once daily along with background metformin 500 milligram (mg) immediate release tablets or as per standard clinical practice, for 12 weeks.
OG005
Sitagliptin
Sitagliptin 100 mg tablet orally once daily along with background metformin 500 milligram (mg) immediate release tablets or as per standard clinical practice, for 12 weeks.
Units
Counts
Participants
OG00053
OG00157
OG00252
OG00356
OG00455
OG00554
Title
Denominators
Categories
PR interval: Percent change of >=25/50%
Title
Measurements
OG0000
OG0011
OG0020
OG0030
OG0041
OG0052
QRS interval: Percent change of >=50%
Title
Measurements
OG0000
OG0011
OG0021
OG003
QTcF interval: Change of >=30 to <60 msec
Title
Measurements
OG0007
OG0015
OG0023
OG003
QTcF interval: Change of >=60 msec
Title
Measurements
OG0001
OG0010
OG0020
OG003
OG003
PF-04937319 50 mg
PF-04937319 50 mg tablet orally once daily along with background metformin 500 milligram (mg) immediate release tablets or as per standard clinical practice, for 12 weeks.
OG004
PF-04937319 100 mg
PF-04937319 100 mg tablet orally once daily along with background metformin 500 milligram (mg) immediate release tablets or as per standard clinical practice, for 12 weeks.
OG005
Sitagliptin
Sitagliptin 100 mg tablet orally once daily along with background metformin 500 milligram (mg) immediate release tablets or as per standard clinical practice, for 12 weeks.
Units
Counts
Participants
OG00056
OG00157
OG00253
OG00356
OG00455
OG00555
Title
Denominators
Categories
Increase in systolic BP (>=30 mmHg)
Title
Measurements
OG0001
OG0012
OG0022
OG0031
OG0043
OG0052
Increase in diastolic BP (>=20 mmHg)
Title
Measurements
OG0001
OG0014
OG0020
OG003
Decrease in systolic BP (>=30 mmHg)
Title
Measurements
OG0001
OG0012
OG0021
OG003
Decrease in diastolic BP (>=20 mmHg)
Title
Measurements
OG0002
OG0011
OG0026
OG003
OG002
PF-04937319 3 mg
PF-04937319 3 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
OG003
PF-04937319 20 mg
PF-04937319 20 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
OG004
PF-04937319 50 mg
PF-04937319 50 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
OG005
PF-04937319 100 mg
PF-04937319 100 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
OG006
Sitagliptin 100 mg
Sitagliptin 100 mg tablet orally tablet once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
Units
Counts
Participants
OG000376
OG00157
OG00257
OG00354
OG00456
OG00556
OG00655
Title
Denominators
Categories
AEs
Title
Measurements
OG00037
OG00119
OG00219
OG00319
OG00416
OG00524
OG00618
SAEs
Title
Measurements
OG0000
OG0011
OG0020
OG003
Placebo matched to PF-04937319 tablet orally once daily and placebo matched to sitagliptin tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
OG002
PF-04937319 3 mg
PF-04937319 3 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
OG003
PF-04937319 20 mg
PF-04937319 20 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
OG004
PF-04937319 50 mg
PF-04937319 50 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
OG005
PF-04937319 100 mg
PF-04937319 100 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
OG006
Sitagliptin 100 mg
Sitagliptin 100 mg tablet orally tablet once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
Units
Counts
Participants
OG000376
OG00157
OG00257
OG00354
OG00456
OG00556
OG00655
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0020
OG0031
OG0040
OG0052
OG0061
OG003
PF-04937319 20 mg
PF-04937319 20 mg tablet orally once daily along with background metformin 500 milligram (mg) immediate release tablets or as per standard clinical practice, for 12 weeks.
OG004
PF-04937319 50 mg
PF-04937319 50 mg tablet orally once daily along with background metformin 500 milligram (mg) immediate release tablets or as per standard clinical practice, for 12 weeks.
OG005
PF-04937319 100 mg
PF-04937319 100 mg tablet orally once daily along with background metformin 500 milligram (mg) immediate release tablets or as per standard clinical practice, for 12 weeks.
OG006
Sitagliptin 100 mg
Sitagliptin 100 mg tablet orally once daily along with background metformin 500 milligram (mg) immediate release tablets or as per standard clinical practice, for 12 weeks.
Units
Counts
Participants
OG000376
OG00157
OG00257
OG00354
OG00456
OG00556
OG00656
Title
Denominators
Categories
Title
Measurements
OG0000(0 to 0)
OG0010(0 to 0)
OG0020(0 to 0)
OG0030(0 to 2)
OG0040(0 to 0)
OG0050(0 to 1)
OG0060(0 to 2)
PF-04937319 50 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
OG004
PF-04937319 100 mg
PF-04937319 100 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
OG005
Sitagliptin 100 mg
Sitagliptin 100 mg tablet orally once daily along with background metformin 500 milligram (mg) immediate release tablets or as per standard clinical practice, for 12 weeks.
Units
Counts
Participants
OG00055
OG00155
OG00250
OG00356
OG00454
OG00555
Title
Denominators
Categories
Baseline (n=55, 55, 50, 56, 54, 55)
Title
Measurements
OG00086.446± 19.1859
OG00187.865± 23.7732
OG00288.371± 17.3923
OG00388.066± 20.3446
OG00491.239± 21.2731
OG00587.025± 21.2567
Change at Week 2 (n=54, 55, 49, 56, 53, 55)
Title
Measurements
OG000-0.239± 0.7264
OG0010.435± 5.2348
OG002-0.052± 1.0570
OG003
Change at Week 4 (n=51, 55, 49, 55, 53, 53)
Title
Measurements
OG000-0.704± 1.5651
OG0010.214± 5.1426
OG002-0.192± 1.4649
OG003
Change at Week 8 (n=49, 53, 45, 52, 50, 52)
Title
Measurements
OG000-0.823± 1.6750
OG001-0.003± 5.0869
OG002-0.510± 1.7467
OG003
Change at Week 12 (n=47, 52, 45, 52, 50, 53)
Title
Measurements
OG000-0.804± 2.0119
OG001-0.142± 4.8928
OG002-0.455± 1.9213
OG003
Change at Week 14 (n=44, 52, 44, 52, 50, 53)
Title
Measurements
OG000-0.588± 2.0994
OG0010.011± 0.6634
OG002-0.613± 0.3149
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Week 2: Treatment difference and 80 percent (%) confidence interval (CI) were based on least squares (LS) mean. A mixed model repeated measure (MMRM) analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.
t-test, 2 sided
0.0913
P-value was 2-sided.
LS Mean Difference
0.76
Standard Error of the Mean
0.449
2-Sided
80
0.18
1.34
No
Superiority or Other
OG000
OG002
Week 2: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.
t-test, 2 sided
0.5236
P-value was 2-sided.
LS Mean Difference
0.29
Standard Error of the Mean
0.461
2-Sided
80
-0.30
0.89
No
Superiority or Other
OG000
OG003
Week 2: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.
t-test, 2 sided
0.9244
P-value was 2-sided.
LS Mean Difference
0.04
Standard Error of the Mean
0.447
2-Sided
80
-0.53
0.62
No
Superiority or Other
OG000
OG004
Week 2: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.
t-test, 2 sided
0.5066
P-value was 2-sided.
LS Mean Difference
0.30
Standard Error of the Mean
0.452
2-Sided
80
-0.28
0.88
No
Superiority or Other
OG000
OG005
Week 2: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.
t-test, 2 sided
0.8947
P-value was 2-sided.
LS Mean Difference
-0.06
Standard Error of the Mean
0.449
2-Sided
80
-0.64
0.52
No
Superiority or Other
OG000
OG001
Week 4: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.
t-test, 2 sided
0.0577
P-value was 2-sided.
LS Mean Difference
0.91
Standard Error of the Mean
0.478
2-Sided
80
0.30
1.52
No
Superiority or Other
OG000
OG002
Week 4: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.
t-test, 2 sided
0.3012
P-value was 2-sided.
LS Mean Difference
0.51
Standard Error of the Mean
0.490
2-Sided
80
-0.12
1.14
No
Superiority or Other
OG000
OG003
Week 4: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.
t-test, 2 sided
0.3165
P-value was 2-sided.
LS Mean Difference
0.48
Standard Error of the Mean
0.476
2-Sided
80
-0.13
1.09
No
Superiority or Other
OG000
OG004
Week 4: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.
t-test, 2 sided
0.5191
P-value was 2-sided.
LS Mean Difference
0.31
Standard Error of the Mean
0.481
2-Sided
80
-0.31
0.93
No
Superiority or Other
OG000
OG005
Week 4: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.
t-test, 2 sided
0.5107
P-value was 2-sided.
LS Mean Difference
0.32
Standard Error of the Mean
0.479
2-Sided
80
-0.30
0.93
No
Superiority or Other
OG000
OG001
Week 8: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.
t-test, 2 sided
0.1054
P-value was 2-sided.
LS Mean Difference
0.79
Standard Error of the Mean
0.488
2-Sided
80
0.17
1.42
No
Superiority or Other
OG000
OG002
Week 8: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.
t-test, 2 sided
0.5341
P-value was 2-sided.
LS Mean Difference
0.31
Standard Error of the Mean
0.502
2-Sided
80
-0.33
0.96
No
Superiority or Other
OG000
OG003
Week 8: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.
t-test, 2 sided
0.2782
P-value was 2-sided.
LS Mean Difference
0.53
Standard Error of the Mean
0.487
2-Sided
80
-0.10
1.15
No
Superiority or Other
OG000
OG004
Week 8: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.
t-test, 2 sided
0.5331
P-value was 2-sided.
LS Mean Difference
0.31
Standard Error of the Mean
0.492
2-Sided
80
-0.32
0.94
No
Superiority or Other
OG000
OG005
Week 8: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.
t-test, 2 sided
0.9070
P-value was 2-sided.
LS Mean Difference
0.06
Standard Error of the Mean
0.489
2-Sided
80
-0.57
0.68
No
Superiority or Other
OG000
OG001
Week 12: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.
t-test, 2 sided
0.1757
P-value was 2-sided.
LS Mean Difference
0.69
Standard Error of the Mean
0.512
2-Sided
80
0.04
1.35
No
Superiority or Other
OG000
OG002
Week 12: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.
t-test, 2 sided
0.4083
P-value was 2-sided.
LS Mean Difference
0.44
Standard Error of the Mean
0.527
2-Sided
80
-0.24
1.11
No
Superiority or Other
OG000
OG003
Week 12: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.
t-test, 2 sided
0.3150
P-value was 2-sided.
LS Mean Difference
0.51
Standard Error of the Mean
0.511
2-Sided
80
-0.14
1.17
No
Superiority or Other
OG000
OG004
Week 12: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.
t-test, 2 sided
0.6631
P-value was 2-sided.
LS Mean Difference
0.23
Standard Error of the Mean
0.516
2-Sided
80
-0.44
0.89
No
Superiority or Other
OG000
OG005
Week 12: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.
t-test, 2 sided
0.8694
P-value was 2-sided.
LS Mean Difference
-0.08
Standard Error of the Mean
0.512
2-Sided
80
-0.74
0.57
No
Superiority or Other
OG000
OG001
Week 14: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.
t-test, 2 sided
0.2031
P-value was 2-sided.
LS Mean Difference
0.70
Standard Error of the Mean
0.545
2-Sided
80
0.00
1.40
No
Superiority or Other
OG000
OG002
Week 14: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.
t-test, 2 sided
0.7137
P-value was 2-sided.
LS Mean Difference
0.21
Standard Error of the Mean
0.563
2-Sided
80
-0.52
0.93
No
Superiority or Other
OG000
OG003
Week 14: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.
t-test, 2 sided
0.6810
P-value was 2-sided.
LS Mean Difference
0.22
Standard Error of the Mean
0.545
2-Sided
80
-0.48
0.92
No
Superiority or Other
OG000
OG004
Week 14: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.
t-test, 2 sided
0.6921
P-value was 2-sided.
LS Mean Difference
-0.22
Standard Error of the Mean
0.550
2-Sided
80
-0.92
0.49
No
Superiority or Other
OG000
OG004
Week 14 (Follow-up): Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.
t-test, 2 sided
0.3702
P-value was 2-sided.
LS Mean difference
-0.49
Standard Error of the Mean
0.545
2-Sided
80
-1.19
0.21
No
Superiority or Other
OG001
PF-04937319 3 mg
PF-04937319 3 mg tablet orally once daily along with background metformin 500 milligram (mg) immediate release tablets or as per standard clinical practice, for 12 weeks.
OG002
PF-04937319 20 mg
PF-04937319 20 mg tablet orally once daily along with background metformin 500 milligram (mg) immediate release tablets or as per standard clinical practice, for 12 weeks.
OG003
PF-04937319 50 mg
PF-04937319 50 mg tablet orally once daily along with background metformin 500 milligram (mg) immediate release tablets or as per standard clinical practice, for 12 weeks.
OG004
PF-04937319 100 mg
PF-04937319 100 mg tablet orally once daily along with background metformin 500 milligram (mg) immediate release tablets or as per standard clinical practice, for 12 weeks.
OG005
Sitagliptin 100 mg
Sitagliptin 100 mg tablet orally once daily along with background metformin 500 milligram (mg) immediate release tablets or as per standard clinical practice, for 12 weeks.