Study To Understand Efficacy And Safety Of Investigationa... | NCT01517373 | Trialant
NCT01517373
Sponsor
Pfizer
Status
Completed
Last Update Posted
Jan 31, 2017Estimated
Enrollment
304Actual
Phase
Phase 2
Conditions
Diabetes Mellitus, Type 2
Interventions
Placebo
PF-04937319 10 mg
PF-04937319 50 mg
PF-04937319 100 mg
Glimepiride
Countries
United States
Bulgaria
Canada
Hungary
India
Slovakia
Taiwan
Protocol Section
Identification Module
NCT ID
NCT01517373
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
B1621002
Secondary IDs
ID
Type
Description
Link
2011-005206-30
EudraCT Number
Brief Title
Study To Understand Efficacy And Safety Of Investigational Agent (PF-04937319) Compared To Approved Agent (Glimepiride) In Patients With Diabetes On Metformin
Official Title
A Phase 2, Randomized, Double-blinded, Placebo-controlled, Dose-ranging, Parallel Group Study To Evaluate Safety And Efficacy Of Pf-04937319 And Glimepiride 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
Feb 2012
Primary Completion Date
Jan 2013Actual
Completion Date
Jan 2013Actual
First Submitted Date
Jan 20, 2012
First Submission Date that Met QC Criteria
Jan 20, 2012
First Posted Date
Jan 25, 2012Estimated
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
This is a study to understand efficacy and safety of investigational agent (PF-04937319) compared to approved agent (glimepiride) in patients with diabetes on metformin
Detailed Description
Not provided
Conditions Module
Conditions
Diabetes Mellitus, Type 2
Keywords
T2DM
PF-04937319
Phase 2
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
304Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Placebo
Placebo Comparator
Placebo to match PF-04937319 and glimepiride
Drug: Placebo
PF-04937319 10 mg
Experimental
Drug: PF-04937319 10 mg
PF-04937319 50 mg
Experimental
Drug: PF-04937319 50 mg
PF-04937319 100 mg
Experimental
Drug: PF-04937319 100 mg
Glimepiride
Active Comparator
Drug: Glimepiride
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Placebo
Drug
Combination of tablets and capsules, a total of 3 pills/dose, 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 was reported.
Baseline (Day 1), Week 12
Secondary Outcomes
Measure
Description
Time Frame
Change From Baseline in Glycosylated Hemoglobin (HbA1C) at Week 2, 4, 6 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 less than 6.5 percent by the study-specific central laboratory used. Change from baseline in percentage of HbA1C was reported.
Baseline (Day 1), Week 2, 4, 6, 8
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Age 18-70 yrs, male and females, with T2DM, on metformin alone or in combination with 1 other oral agent
Exclusion Criteria:
Subjects with recent cardiovascular events, those with evidence of diabetic complications
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.
A total of 628 participants were consented. Of these, 361 participants transitioned to the run-in period and received sponsor provided background therapy of Metformin. Participants completed the run-in period were then randomized to receive either placebo, PF-04937319 (10, 50 or 100 milligram [mg]) or Glimepiride in treatment period.
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 10 mg
Drug
Combination of tablets and capsules, dose of 10 mg, a total of 3 pills/dose, administered once daily for 84-days
PF-04937319 10 mg
PF-04937319 50 mg
Drug
Combination of tablets and capsules, dose of 50 mg, a total of 3 pills/dose, administered once daily for 84-days
PF-04937319 50 mg
PF-04937319 100 mg
Drug
Combination of tablets and capsules, dose of 100 mg, a total of 3 pills/dose, administered once daily for 84-days
PF-04937319 100 mg
Glimepiride
Drug
Combination of tablets and capsules, dose of up to 6 mg, a total of 3 pills/dose, administered once daily for 84-days
Glimepiride
Change From Baseline in Fasting Plasma Glucose at Week 2, 4, 6, 8 and 12
Baseline (Day 1), Week 2, 4, 6, 8, 12
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 less than 6.5 percent by the study-specific central laboratory used and data are presented in categories of less than 6.5 percent and less than 7 percent.
Week 12
Number of Participants With Increase From Baseline Electrocardiogram (ECG) Data
Participants who met the criteria for increase from baseline in ECG data were reported. Criteria for increase from baseline data: PR interval (percent change of greater than or equal to [>=] 25/50% [if baseline value was >200 then percent change of >25% counts; if baseline value was <=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 of study treatment (up to 101 days)
Percentage of Participants With at Least 1 Hypoglycemic Events (HAE) Episode
A hypoglycemic event was identified by characteristic symptoms or blood glucose levels. HAE was 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 was identified by characteristic symptoms or blood glucose levels. Median of 1 and 2 events per participant was reported.
Baseline (Day 1) up to Week 14
Time to Each Recurrent Hypoglycemic Events (HAE) Episode Per Participant
Median recurrence time was not to be calculated when less than 50% of the participants in a given arm experienced 1 or more HAEs.
Baseline (Day 1) up to Week 14
Change From Baseline in Body Weight at Week 2, 4, 6, 8, 12 and 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
San Diego
California
92103
United States
Diablo Clinical Research, Inc.
Walnut Creek
California
94598
United States
Meridien Research
Bradenton
Florida
34208
United States
South Broward Research, LLC
Pembroke Pines
Florida
33027
United States
East-West Medical Research Institute
Honolulu
Hawaii
96814
United States
Clinical Research Center of Cape Cod, Inc.
Hyannis
Massachusetts
02601
United States
Diabetes & Endocrinology Consultants, PC
Morehead City
North Carolina
28557
United States
Sterling Research Group, Ltd.
Cincinnati
Ohio
45246
United States
Community Research
Cincinnati
Ohio
45255
United States
Coastal Carolina Research Center
Mt. Pleasant
South Carolina
29464
United States
Holston Medical Group
Bristol
Tennessee
37620
United States
Chattanooga Medical Research, LLC
Chattanooga
Tennessee
37404
United States
Diagnostic Center
Chattanooga
Tennessee
37404
United States
University Diabetes and Endocrine Consultants
Chattanooga
Tennessee
37411
United States
Clinical Research Associates, Inc.
Nashville
Tennessee
37203
United States
Bristol Clinical Research, LLC
Austin
Texas
78728
United States
DiscoveResearch, Inc.
Bryan
Texas
77802
United States
Dallas Diabetes and Endocrine Center
Dallas
Texas
75230
United States
Clinical Trials of Texas, Inc.
San Antonio
Texas
78229
United States
National Clinical Research - Norfolk, Inc.
Norfolk
Virginia
23502
United States
National Clinical Research - Richmond, Inc.
Richmond
Virginia
23294
United States
Aurora Advanced Healthcare, Inc.
Milwaukee
Wisconsin
53209
United States
MBAL Yulia Vrevska - Byala, Otdelenie po vatreshni bolesti
Byala
7100
Bulgaria
MBAL - Ruse AD, Vtoro otdelenie po vatreshni bolesti
Rousse
7002
Bulgaria
DKTs Akta Medika, Kabinet po endokrinologia
Sevlievo
5400
Bulgaria
UMBAL Aleksandrovska, Klinika po endokrinologia i bolesti na obmyanata
Sofia
1431
Bulgaria
VMA - MBAL - Sofia, Klinika po endokrinologia i bolesti na obmyanata
Sofia
1606
Bulgaria
UMBAL Stara Zagora, Klinika po endokrinologia i bolesti na obmyanata
Stara Zagora
6003
Bulgaria
Glover Medical Clinic
Langley
British Columbia
V3A 4H9
Canada
Ocean West Research Clinic Inc.
Surrey
British Columbia
V3S 2N6
Canada
Rivergrove Medical Clinic
Winnipeg
Manitoba
R2V 4W3
Canada
Aggarwal and Associates Limited
Brampton
Ontario
L6T 0G1
Canada
DCTM CLinical Trials Group Ltd.
Strathroy
Ontario
N7G 1Y7
Canada
Manna Research
Toronto
Ontario
M9W 4L6
Canada
Alpha Recherche Clinique
Québec
Quebec
G3K 2P8
Canada
Pro-Recherche
Saint Romuald
Quebec
G6W 5M6
Canada
Centre de cardiologie et de Recherche Clinique Pierre-Le Gardeur
Terrebonne
Quebec
J6V 1S8
Canada
Dr. Kenessey Albert Korhaz-Rendelointezet/Belgyogyaszat
Balassagyarmat
2660
Hungary
Synexus Magyarorszag Kft.
Budapest
1036
Hungary
Semmelweis Egyetem/I. sz. Belgyogyaszati Klinika
Budapest
1083
Hungary
Fejer Megyei Szent Gyorgy Korhaz/II. Belgyogyaszati Osztaly
Székesfehérvár
8000
Hungary
BGS Global Hospital
Bangalore
Karnataka
560060
India
Deenanath Mangeshkar Hospital & Research Centre
Pune
Maharashtra
411 004
India
Diabetes Unit, K.E.M. Hospital Research Centre
Pune
Maharashtra
411 011
India
Fakultna nemocnica s poliklinikou F.D. Roosevelta Banska Bystrica
Banská Bystrica
975 17
Slovakia
Interna A Diabetologicka Ambulancia
Moldava nad Bodvou
045 01
Slovakia
FUNKYSTUFF, s.r.o.
Nové Zámky
940 01
Slovakia
MEDIAB, s.r.o.
Pezinok
902 01
Slovakia
MEDIVASA, s.r.o.
Žilina
010 01
Slovakia
China Medical University Hospital
Taichung
404
Taiwan
National Taiwan University Hospital
Taipei
100
Taiwan
Taipei Medical University Hospital
Taipei
110
Taiwan
Placebo matched to PF-04937319 tablet and placebo matched to glimepiride oral capsule once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
FG002
PF-04937319 10 mg
PF-04937319 10 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 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.
FG004
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.
FG005
Glimepiride
Glimepiride capsule at a starting dose of 2 milligram per day (mg/day) up to a maximum dose of 6 mg/day along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
FG000361 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
COMPLETED
FG000304 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
NOT COMPLETED
FG00057 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
Type
Comment
Reasons
Death
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
Adverse Event
FG0005 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Did not meet eligibility criteria
FG00034 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Lost to Follow-up
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Withdrawal by Subject
FG00012 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Sponsor Decision
FG0003 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Other
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Treatment Period
Type
Comment
Milestone Data
STARTED
FG0000 subjects
FG00161 subjects
FG00260 subjects
FG00361 subjects
FG00461 subjects
FG00561 subjects
COMPLETED
FG0000 subjects
FG00157 subjects
FG00254 subjects
FG00354 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0014 subjects
FG0026 subjects
FG0037 subjects
FG004
Type
Comment
Reasons
Adverse Event
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 and placebo matched to glimepiride oral capsule once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
BG001
PF-04937319 10 mg
PF-04937319 10 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 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.
BG003
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.
BG004
Glimepiride
Glimepiride capsule at a starting dose of 2 milligram per day (mg/day) up to a maximum dose of 6 mg/day along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
BG005
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00061
BG00160
BG00261
BG00361
BG00461
BG005304
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
BG0008
BG0014
BG0028
BG003
Gender
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG00027
BG00126
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 was 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 and placebo matched to glimepiride oral capsule once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
OG001
PF-04937319 10 mg
PF-04937319 10 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 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.
OG003
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.
OG004
Glimepiride
Glimepiride capsule at a starting dose of 2 milligram per day (mg/day) up to a maximum dose of 6 mg/day along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
Units
Counts
Participants
OG00059
OG00157
OG00255
OG003
Title
Denominators
Categories
Baseline (n=59, 57, 55, 60, 60)
Title
Measurements
OG0007.90± 0.988
OG0017.97± 0.886
OG0027.91± 0.987
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
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,duration of type 2 diabetes mellitus (T2DM),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.
0.4468
p-value was 1-sided.
Least Squares (LS) Mean Difference
-0.02
Standard Error of the Mean
0.145
2-Sided
80
-0.21
0.17
Secondary
Change From Baseline in Glycosylated Hemoglobin (HbA1C) at Week 2, 4, 6 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 less than 6.5 percent by the study-specific central laboratory used. Change from baseline in percentage of HbA1C was 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, 6, 8
ID
Title
Description
OG000
Placebo
Placebo matched to PF-04937319 tablet and placebo matched to glimepiride oral capsule once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
OG001
PF-04937319 10 mg
PF-04937319 10 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 50 mg
Secondary
Change From Baseline in Fasting Plasma Glucose at Week 2, 4, 6, 8 and 12
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
milligram per deciliter (mg/dL)
Baseline (Day 1), Week 2, 4, 6, 8, 12
ID
Title
Description
OG000
Placebo
Placebo matched to PF-04937319 tablet and placebo matched to glimepiride oral capsule once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
OG001
PF-04937319 10 mg
PF-04937319 10 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 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.
OG003
PF-04937319 100 mg
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 less than 6.5 percent by the study-specific central laboratory used and data are presented in categories of less than 6.5 percent and less than 7 percent.
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.
Posted
Number
percentage of participants
Week 12
ID
Title
Description
OG000
Placebo
Placebo matched to PF-04937319 tablet and placebo matched to glimepiride oral capsule once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
OG001
PF-04937319 10 mg
PF-04937319 10 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 50 mg
Secondary
Number of Participants With Increase From Baseline Electrocardiogram (ECG) Data
Participants who met the criteria for increase from baseline in ECG data were reported. Criteria for increase from baseline data: PR interval (percent change of greater than or equal to [>=] 25/50% [if baseline value was >200 then percent change of >25% counts; if baseline value was <=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. N(number of participants analyzed)= participants who were evaluable for this measure.
Posted
Number
participants
Baseline (Day 1) up to Week 14
ID
Title
Description
OG000
Placebo
Placebo matched to PF-04937319 tablet and placebo matched to glimepiride oral capsule once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
OG001
PF-04937319 10 mg
PF-04937319 10 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 50 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' (number of participants analyzed) signifies participants for whom data was summarized for this measure
Posted
Number
participants
Baseline (Day 1) up to Week 14
ID
Title
Description
OG000
Placebo
Placebo matched to PF-04937319 tablet and placebo matched to glimepiride oral capsule once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
OG001
PF-04937319 10 mg
PF-04937319 10 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 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.
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 of study treatment (up to 101 days)
ID
Title
Description
OG000
Placebo
Placebo matched to PF-04937319 tablet and placebo matched to glimepiride oral capsule once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
OG001
PF-04937319 10 mg
PF-04937319 10 mg 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 was identified by characteristic symptoms or blood glucose levels. HAE was 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.
Posted
Number
percentage of participants
Baseline (Day 1) up to Week 14
ID
Title
Description
OG000
Placebo
Placebo matched to PF-04937319 tablet and placebo matched to glimepiride oral capsule once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
OG001
PF-04937319 10 mg
PF-04937319 10 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
Secondary
Number of Hypoglycemic Events (HAE) Episodes Per Participant
A hypoglycemic event was identified by characteristic symptoms or blood glucose levels. Median of 1 and 2 events per participant was reported.
Safety analysis set included all randomized participants who received at least 1 dose of study treatment.
Posted
Median
Full Range
events per participant
Baseline (Day 1) up to Week 14
ID
Title
Description
OG000
Placebo
Placebo matched to PF-04937319 tablet and placebo matched to glimepiride oral capsule once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
OG001
PF-04937319 10 mg
PF-04937319 10 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 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.
OG003
PF-04937319 100 mg
Secondary
Time to Each Recurrent Hypoglycemic Events (HAE) Episode Per Participant
Median recurrence time was not to be calculated when less than 50% of the participants in a given arm experienced 1 or more HAEs.
Data was not collected since this outcome measure was not analyzed due to infrequency of the occurrence of HAEs among the participants.
Posted
Baseline (Day 1) up to Week 14
ID
Title
Description
OG000
Placebo
Placebo matched to PF-04937319 tablet and placebo matched to glimepiride oral capsule once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
OG001
PF-04937319 10 mg
PF-04937319 10 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 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.
OG003
PF-04937319 100 mg
Secondary
Change From Baseline in Body Weight at Week 2, 4, 6, 8, 12 and 14
Safety analysis set 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.
Placebo matched to PF-04937319 tablet and placebo matched to glimepiride oral capsule once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
OG001
PF-04937319 10 mg
PF-04937319 10 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 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.
OG003
PF-04937319 100 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' (number of participants analyzed) signifies participants for whom data was summarized for this measure
Posted
Number
participants
Baseline (Day 1) up to Week 14
ID
Title
Description
OG000
Placebo
Placebo matched to PF-04937319 tablet and placebo matched to glimepiride oral capsule once daily along with background metformin 500 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.
4
361
63
361
EG001
Placebo
Placebo matched to PF-04937319 tablet and placebo matched to glimepiride oral capsule once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
0
61
26
61
EG002
PF-04937319 10 mg
PF-04937319 10 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
1
60
28
60
EG003
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.
2
61
31
61
EG004
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
61
29
61
EG005
Glimepiride
Glimepiride capsule at a starting dose of 2 milligram per day (mg/day) up to a maximum dose of 6 mg/day along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
1
61
36
61
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Aortic valve incompetence
Cardiac disorders
MedDRA 16.0
Non-systematic Assessment
EG0000 affected361 at risk
EG0010 affected61 at risk
EG0021 affected60 at risk
EG0030 affected61 at risk
EG0040 affected61 at risk
EG0050 affected61 at risk
Cardiac failure congestive
Cardiac disorders
MedDRA 16.0
Non-systematic Assessment
EG0000 affected361 at risk
EG0010 affected61 at risk
EG0020 affected60 at risk
EG003
Death
General disorders
MedDRA 16.0
Non-systematic Assessment
EG0001 affected361 at risk
EG0010 affected61 at risk
EG0020 affected60 at risk
EG003
Cellulitis
Infections and infestations
MedDRA 16.0
Non-systematic Assessment
EG0000 affected361 at risk
EG0010 affected61 at risk
EG0021 affected60 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 16.0
Non-systematic Assessment
EG0001 affected361 at risk
EG0010 affected61 at risk
EG0020 affected60 at risk
EG003
Sepsis syndrome
Infections and infestations
MedDRA 16.0
Non-systematic Assessment
EG0000 affected361 at risk
EG0010 affected61 at risk
EG0021 affected60 at risk
EG003
Ankle fracture
Injury, poisoning and procedural complications
MedDRA 16.0
Non-systematic Assessment
EG0000 affected361 at risk
EG0010 affected61 at risk
EG0020 affected60 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA 16.0
Non-systematic Assessment
EG0001 affected361 at risk
EG0010 affected61 at risk
EG0020 affected60 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA 16.0
Non-systematic Assessment
EG0001 affected361 at risk
EG0010 affected61 at risk
EG0020 affected60 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA 16.0
Non-systematic Assessment
EG0001 affected361 at risk
EG0010 affected61 at risk
EG0020 affected60 at risk
EG003
Presyncope
Nervous system disorders
MedDRA 16.0
Non-systematic Assessment
EG0001 affected361 at risk
EG0010 affected61 at risk
EG0020 affected60 at risk
EG003
Alcohol abuse
Psychiatric disorders
MedDRA 16.0
Non-systematic Assessment
EG0001 affected361 at risk
EG0010 affected61 at risk
EG0020 affected60 at risk
EG003
Chronic obstructive pulmonary disease
Respiratory, thoracic and mediastinal disorders
MedDRA 16.0
Non-systematic Assessment
EG0000 affected361 at risk
EG0010 affected61 at risk
EG0020 affected60 at risk
EG003
Aortic aneurysm
Vascular disorders
MedDRA 16.0
Non-systematic Assessment
EG0000 affected361 at risk
EG0010 affected61 at risk
EG0021 affected60 at risk
EG003
Deep vein thrombosis
Vascular disorders
MedDRA 16.0
Non-systematic Assessment
EG0000 affected361 at risk
EG0010 affected61 at risk
EG0020 affected60 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 affected361 at risk
EG0010 affected61 at risk
EG0020 affected60 at risk
EG0032 affected61 at risk
EG0040 affected61 at risk
EG0050 affected61 at risk
Leukocytosis
Blood and lymphatic system disorders
MedDRA 16.0
Non-systematic Assessment
EG0000 affected361 at risk
EG0010 affected61 at risk
EG0021 affected60 at risk
EG003
Leukopenia
Blood and lymphatic system disorders
MedDRA 16.0
Non-systematic Assessment
EG0000 affected361 at risk
EG0011 affected61 at risk
EG0020 affected60 at risk
EG003
Neutrophilia
Blood and lymphatic system disorders
MedDRA 16.0
Non-systematic Assessment
EG0000 affected361 at risk
EG0010 affected61 at risk
EG0021 affected60 at risk
EG003
Thrombocytosis
Blood and lymphatic system disorders
MedDRA 16.0
Non-systematic Assessment
EG0000 affected361 at risk
EG0010 affected61 at risk
EG0021 affected60 at risk
EG003
Myocardial ischaemia
Cardiac disorders
MedDRA 16.0
Non-systematic Assessment
EG0000 affected361 at risk
EG0010 affected61 at risk
EG0021 affected60 at risk
EG003
Palpitations
Cardiac disorders
MedDRA 16.0
Non-systematic Assessment
EG0000 affected361 at risk
EG0010 affected61 at risk
EG0021 affected60 at risk
EG003
Sinus tachycardia
Cardiac disorders
MedDRA 16.0
Non-systematic Assessment
EG0000 affected361 at risk
EG0010 affected61 at risk
EG0020 affected60 at risk
EG003
Ventricular extrasystoles
Cardiac disorders
MedDRA 16.0
Non-systematic Assessment
EG0000 affected361 at risk
EG0011 affected61 at risk
EG0021 affected60 at risk
EG003
Cerumen impaction
Ear and labyrinth disorders
MedDRA 16.0
Non-systematic Assessment
EG0000 affected361 at risk
EG0010 affected61 at risk
EG0021 affected60 at risk
EG003
Ear pain
Ear and labyrinth disorders
MedDRA 16.0
Non-systematic Assessment
EG0000 affected361 at risk
EG0010 affected61 at risk
EG0020 affected60 at risk
EG003
Vertigo
Ear and labyrinth disorders
MedDRA 16.0
Non-systematic Assessment
EG0000 affected361 at risk
EG0010 affected61 at risk
EG0021 affected60 at risk
EG003
Chalazion
Eye disorders
MedDRA 16.0
Non-systematic Assessment
EG0001 affected361 at risk
EG0010 affected61 at risk
EG0020 affected60 at risk
EG003
Conjunctivitis
Eye disorders
MedDRA 16.0
Non-systematic Assessment
EG0001 affected361 at risk
EG0011 affected61 at risk
EG0021 affected60 at risk
EG003
Eye pain
Eye disorders
MedDRA 16.0
Non-systematic Assessment
EG0000 affected361 at risk
EG0011 affected61 at risk
EG0020 affected60 at risk
EG003
Lacrimation decreased
Eye disorders
MedDRA 16.0
Non-systematic Assessment
EG0001 affected361 at risk
EG0010 affected61 at risk
EG0020 affected60 at risk
EG003
Vision blurred
Eye disorders
MedDRA 16.0
Non-systematic Assessment
EG0000 affected361 at risk
EG0010 affected61 at risk
EG0020 affected60 at risk
EG003
Abdominal discomfort
Gastrointestinal disorders
MedDRA 16.0
Non-systematic Assessment
EG0001 affected361 at risk
EG0010 affected61 at risk
EG0020 affected60 at risk
EG003
Abdominal distension
Gastrointestinal disorders
MedDRA 16.0
Non-systematic Assessment
EG0002 affected361 at risk
EG0010 affected61 at risk
EG0021 affected60 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA 16.0
Non-systematic Assessment
EG0001 affected361 at risk
EG0010 affected61 at risk
EG0020 affected60 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA 16.0
Non-systematic Assessment
EG0000 affected361 at risk
EG0010 affected61 at risk
EG0021 affected60 at risk
EG003
Bowel movement irregularity
Gastrointestinal disorders
MedDRA 16.0
Non-systematic Assessment
EG0000 affected361 at risk
EG0010 affected61 at risk
EG0020 affected60 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA 16.0
Non-systematic Assessment
EG0000 affected361 at risk
EG0010 affected61 at risk
EG0020 affected60 at risk
EG003
Dental caries
Gastrointestinal disorders
MedDRA 16.0
Non-systematic Assessment
EG0000 affected361 at risk
EG0010 affected61 at risk
EG0020 affected60 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 16.0
Non-systematic Assessment
EG0006 affected361 at risk
EG0012 affected61 at risk
EG0024 affected60 at risk
EG003
Dry mouth
Gastrointestinal disorders
MedDRA 16.0
Non-systematic Assessment
EG0001 affected361 at risk
EG0010 affected61 at risk
EG0020 affected60 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDRA 16.0
Non-systematic Assessment
EG0000 affected361 at risk
EG0010 affected61 at risk
EG0020 affected60 at risk
EG003
Eructation
Gastrointestinal disorders
MedDRA 16.0
Non-systematic Assessment
EG0000 affected361 at risk
EG0010 affected61 at risk
EG0020 affected60 at risk
EG003
Flatulence
Gastrointestinal disorders
MedDRA 16.0
Non-systematic Assessment
EG0001 affected361 at risk
EG0010 affected61 at risk
EG0021 affected60 at risk
EG003
Frequent bowel movements
Gastrointestinal disorders
MedDRA 16.0
Non-systematic Assessment
EG0000 affected361 at risk
EG0010 affected61 at risk
EG0020 affected60 at risk
EG003
Gastrooesophageal reflux disease
Gastrointestinal disorders
MedDRA 16.0
Non-systematic Assessment
EG0000 affected361 at risk
EG0010 affected61 at risk
EG0020 affected60 at risk
EG003
Haematochezia
Gastrointestinal disorders
MedDRA 16.0
Non-systematic Assessment
EG0000 affected361 at risk
EG0010 affected61 at risk
EG0020 affected60 at risk
EG003
Hyperchlorhydria
Gastrointestinal disorders
MedDRA 16.0
Non-systematic Assessment
EG0000 affected361 at risk
EG0012 affected61 at risk
EG0020 affected60 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 16.0
Non-systematic Assessment
EG0002 affected361 at risk
EG0012 affected61 at risk
EG0022 affected60 at risk
EG003
Toothache
Gastrointestinal disorders
MedDRA 16.0
Non-systematic Assessment
EG0000 affected361 at risk
EG0010 affected61 at risk
EG0022 affected60 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 16.0
Non-systematic Assessment
EG0000 affected361 at risk
EG0011 affected61 at risk
EG0020 affected60 at risk
EG003
Fatigue
General disorders
MedDRA 16.0
Non-systematic Assessment
EG0002 affected361 at risk
EG0011 affected61 at risk
EG0021 affected60 at risk
EG003
Irritability
General disorders
MedDRA 16.0
Non-systematic Assessment
EG0000 affected361 at risk
EG0011 affected61 at risk
EG0020 affected60 at risk
EG003
Pain
General disorders
MedDRA 16.0
Non-systematic Assessment
EG0000 affected361 at risk
EG0011 affected61 at risk
EG0020 affected60 at risk
EG003
Thirst
General disorders
MedDRA 16.0
Non-systematic Assessment
EG0000 affected361 at risk
EG0010 affected61 at risk
EG0020 affected60 at risk
EG003
Drug hypersensitivity
Immune system disorders
MedDRA 16.0
Non-systematic Assessment
EG0000 affected361 at risk
EG0010 affected61 at risk
EG0020 affected60 at risk
EG003
Abscess intestinal
Infections and infestations
MedDRA 16.0
Non-systematic Assessment
EG0001 affected361 at risk
EG0010 affected61 at risk
EG0020 affected60 at risk
EG003
Bronchitis
Infections and infestations
MedDRA 16.0
Non-systematic Assessment
EG0000 affected361 at risk
EG0010 affected61 at risk
EG0020 affected60 at risk
EG003
Cellulitis
Infections and infestations
MedDRA 16.0
Non-systematic Assessment
EG0000 affected361 at risk
EG0010 affected61 at risk
EG0021 affected60 at risk
EG003
Cystitis
Infections and infestations
MedDRA 16.0
Non-systematic Assessment
EG0001 affected361 at risk
EG0011 affected61 at risk
EG0020 affected60 at risk
EG003
Dermatophytosis
Infections and infestations
MedDRA 16.0
Non-systematic Assessment
EG0000 affected361 at risk
EG0010 affected61 at risk
EG0020 affected60 at risk
EG003
Folliculitis
Infections and infestations
MedDRA 16.0
Non-systematic Assessment
EG0001 affected361 at risk
EG0010 affected61 at risk
EG0020 affected60 at risk
EG003
Fungal infection
Infections and infestations
MedDRA 16.0
Non-systematic Assessment
EG0000 affected361 at risk
EG0011 affected61 at risk
EG0020 affected60 at risk
EG003
Furuncle
Infections and infestations
MedDRA 16.0
Non-systematic Assessment
EG0000 affected361 at risk
EG0010 affected61 at risk
EG0021 affected60 at risk
EG003
Gastritis viral
Infections and infestations
MedDRA 16.0
Non-systematic Assessment
EG0001 affected361 at risk
EG0010 affected61 at risk
EG0020 affected60 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA 16.0
Non-systematic Assessment
EG0001 affected361 at risk
EG0011 affected61 at risk
EG0021 affected60 at risk
EG003
Gastrointestinal viral infection
Infections and infestations
MedDRA 16.0
Non-systematic Assessment
EG0000 affected361 at risk
EG0010 affected61 at risk
EG0021 affected60 at risk
EG003
Hordeolum
Infections and infestations
MedDRA 16.0
Non-systematic Assessment
EG0001 affected361 at risk
EG0010 affected61 at risk
EG0020 affected60 at risk
EG003
Influenza
Infections and infestations
MedDRA 16.0
Non-systematic Assessment
EG0001 affected361 at risk
EG0010 affected61 at risk
EG0020 affected60 at risk
EG003
Laryngitis
Infections and infestations
MedDRA 16.0
Non-systematic Assessment
EG0000 affected361 at risk
EG0010 affected61 at risk
EG0020 affected60 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA 16.0
Non-systematic Assessment
EG0003 affected361 at risk
EG0012 affected61 at risk
EG0023 affected60 at risk
EG003
Oral herpes
Infections and infestations
MedDRA 16.0
Non-systematic Assessment
EG0000 affected361 at risk
EG0010 affected61 at risk
EG0020 affected60 at risk
EG003
Orchitis
Infections and infestations
MedDRA 16.0
Non-systematic Assessment
EG0001 affected361 at risk
EG0010 affected61 at risk
EG0021 affected60 at risk
EG003
Rectal abscess
Infections and infestations
MedDRA 16.0
Non-systematic Assessment
EG0000 affected361 at risk
EG0010 affected61 at risk
EG0021 affected60 at risk
EG003
Rhinitis
Infections and infestations
MedDRA 16.0
Non-systematic Assessment
EG0000 affected361 at risk
EG0011 affected61 at risk
EG0020 affected60 at risk
EG003
Subcutaneous abscess
Infections and infestations
MedDRA 16.0
Non-systematic Assessment
EG0000 affected361 at risk
EG0011 affected61 at risk
EG0020 affected60 at risk
EG003
Tinea pedis
Infections and infestations
MedDRA 16.0
Non-systematic Assessment
EG0000 affected361 at risk
EG0010 affected61 at risk
EG0021 affected60 at risk
EG003
Tooth abscess
Infections and infestations
MedDRA 16.0
Non-systematic Assessment
EG0000 affected361 at risk
EG0010 affected61 at risk
EG0020 affected60 at risk
EG003
Tooth infection
Infections and infestations
MedDRA 16.0
Non-systematic Assessment
EG0000 affected361 at risk
EG0010 affected61 at risk
EG0020 affected60 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA 16.0
Non-systematic Assessment
EG0004 affected361 at risk
EG0011 affected61 at risk
EG0023 affected60 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 16.0
Non-systematic Assessment
EG0001 affected361 at risk
EG0011 affected61 at risk
EG0021 affected60 at risk
EG003
Vaginal infection
Infections and infestations
MedDRA 16.0
Non-systematic Assessment
EG0000 affected361 at risk
EG0010 affected61 at risk
EG0020 affected60 at risk
EG003
Vaginitis bacterial
Infections and infestations
MedDRA 16.0
Non-systematic Assessment
EG0000 affected361 at risk
EG0010 affected61 at risk
EG0020 affected60 at risk
EG003
Viral pharyngitis
Infections and infestations
MedDRA 16.0
Non-systematic Assessment
EG0000 affected361 at risk
EG0010 affected61 at risk
EG0021 affected60 at risk
EG003
Arthropod bite
Injury, poisoning and procedural complications
MedDRA 16.0
Non-systematic Assessment
EG0001 affected361 at risk
EG0010 affected61 at risk
EG0021 affected60 at risk
EG003
Epicondylitis
Injury, poisoning and procedural complications
MedDRA 16.0
Non-systematic Assessment
EG0000 affected361 at risk
EG0010 affected61 at risk
EG0021 affected60 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA 16.0
Non-systematic Assessment
EG0000 affected361 at risk
EG0011 affected61 at risk
EG0020 affected60 at risk
EG003
Foot fracture
Injury, poisoning and procedural complications
MedDRA 16.0
Non-systematic Assessment
EG0001 affected361 at risk
EG0010 affected61 at risk
EG0020 affected60 at risk
EG003
Laceration
Injury, poisoning and procedural complications
MedDRA 16.0
Non-systematic Assessment
EG0000 affected361 at risk
EG0010 affected61 at risk
EG0022 affected60 at risk
EG003
Ligament sprain
Injury, poisoning and procedural complications
MedDRA 16.0
Non-systematic Assessment
EG0000 affected361 at risk
EG0010 affected61 at risk
EG0020 affected60 at risk
EG003
Post-traumatic neck syndrome
Injury, poisoning and procedural complications
MedDRA 16.0
Non-systematic Assessment
EG0000 affected361 at risk
EG0010 affected61 at risk
EG0020 affected60 at risk
EG003
Road traffic accident
Injury, poisoning and procedural complications
MedDRA 16.0
Non-systematic Assessment
EG0000 affected361 at risk
EG0010 affected61 at risk
EG0020 affected60 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA 16.0
Non-systematic Assessment
EG0000 affected361 at risk
EG0011 affected61 at risk
EG0020 affected60 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA 16.0
Non-systematic Assessment
EG0000 affected361 at risk
EG0011 affected61 at risk
EG0020 affected60 at risk
EG003
Blood bilirubin increased
Investigations
MedDRA 16.0
Non-systematic Assessment
EG0000 affected361 at risk
EG0010 affected61 at risk
EG0021 affected60 at risk
EG003
Blood creatine phosphokinase increased
Investigations
MedDRA 16.0
Non-systematic Assessment
EG0001 affected361 at risk
EG0011 affected61 at risk
EG0020 affected60 at risk
EG003
Blood glucose increased
Investigations
MedDRA 16.0
Non-systematic Assessment
EG0001 affected361 at risk
EG0010 affected61 at risk
EG0020 affected60 at risk
EG003
Electrocardiogram QT prolonged
Investigations
MedDRA 16.0
Non-systematic Assessment
EG0000 affected361 at risk
EG0011 affected61 at risk
EG0020 affected60 at risk
EG003
Electrocardiogram T wave inversion
Investigations
MedDRA 16.0
Non-systematic Assessment
EG0001 affected361 at risk
EG0010 affected61 at risk
EG0020 affected60 at risk
EG003
Glucose urine present
Investigations
MedDRA 16.0
Non-systematic Assessment
EG0001 affected361 at risk
EG0010 affected61 at risk
EG0020 affected60 at risk
EG003
Haemoglobin decreased
Investigations
MedDRA 16.0
Non-systematic Assessment
EG0001 affected361 at risk
EG0010 affected61 at risk
EG0020 affected60 at risk
EG003
Hepatic enzyme increased
Investigations
MedDRA 16.0
Non-systematic Assessment
EG0001 affected361 at risk
EG0010 affected61 at risk
EG0020 affected60 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA 16.0
Non-systematic Assessment
EG0001 affected361 at risk
EG0010 affected61 at risk
EG0021 affected60 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA 16.0
Non-systematic Assessment
EG0005 affected361 at risk
EG0010 affected61 at risk
EG0020 affected60 at risk
EG003
Hyperkalaemia
Metabolism and nutrition disorders
MedDRA 16.0
Non-systematic Assessment
EG0001 affected361 at risk
EG0010 affected61 at risk
EG0021 affected60 at risk
EG003
Hypertriglyceridaemia
Metabolism and nutrition disorders
MedDRA 16.0
Non-systematic Assessment
EG0001 affected361 at risk
EG0011 affected61 at risk
EG0021 affected60 at risk
EG003
Hyperuricaemia
Metabolism and nutrition disorders
MedDRA 16.0
Non-systematic Assessment
EG0001 affected361 at risk
EG0010 affected61 at risk
EG0021 affected60 at risk
EG003
Hypochloraemia
Metabolism and nutrition disorders
MedDRA 16.0
Non-systematic Assessment
EG0000 affected361 at risk
EG0011 affected61 at risk
EG0021 affected60 at risk
EG003
Hypoglycaemia
Metabolism and nutrition disorders
MedDRA 16.0
Non-systematic Assessment
EG0003 affected361 at risk
EG0013 affected61 at risk
EG0022 affected60 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA 16.0
Non-systematic Assessment
EG0000 affected361 at risk
EG0010 affected61 at risk
EG0020 affected60 at risk
EG003
Hypolipidaemia
Metabolism and nutrition disorders
MedDRA 16.0
Non-systematic Assessment
EG0001 affected361 at risk
EG0010 affected61 at risk
EG0021 affected60 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRA 16.0
Non-systematic Assessment
EG0000 affected361 at risk
EG0011 affected61 at risk
EG0021 affected60 at risk
EG003
Increased appetite
Metabolism and nutrition disorders
MedDRA 16.0
Non-systematic Assessment
EG0000 affected361 at risk
EG0010 affected61 at risk
EG0020 affected60 at risk
EG003
Vitamin D deficiency
Metabolism and nutrition disorders
MedDRA 16.0
Non-systematic Assessment
EG0001 affected361 at risk
EG0010 affected61 at risk
EG0020 affected60 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 16.0
Non-systematic Assessment
EG0000 affected361 at risk
EG0011 affected61 at risk
EG0020 affected60 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 16.0
Non-systematic Assessment
EG0000 affected361 at risk
EG0011 affected61 at risk
EG0021 affected60 at risk
EG003
Bursitis
Musculoskeletal and connective tissue disorders
MedDRA 16.0
Non-systematic Assessment
EG0000 affected361 at risk
EG0010 affected61 at risk
EG0020 affected60 at risk
EG003
Flank pain
Musculoskeletal and connective tissue disorders
MedDRA 16.0
Non-systematic Assessment
EG0000 affected361 at risk
EG0011 affected61 at risk
EG0020 affected60 at risk
EG003
Haemarthrosis
Musculoskeletal and connective tissue disorders
MedDRA 16.0
Non-systematic Assessment
EG0000 affected361 at risk
EG0010 affected61 at risk
EG0020 affected60 at risk
EG003
Intervertebral disc protrusion
Musculoskeletal and connective tissue disorders
MedDRA 16.0
Non-systematic Assessment
EG0000 affected361 at risk
EG0010 affected61 at risk
EG0021 affected60 at risk
EG003
Muscle spasms
Musculoskeletal and connective tissue disorders
MedDRA 16.0
Non-systematic Assessment
EG0000 affected361 at risk
EG0011 affected61 at risk
EG0020 affected60 at risk
EG003
Musculoskeletal chest pain
Musculoskeletal and connective tissue disorders
MedDRA 16.0
Non-systematic Assessment
EG0000 affected361 at risk
EG0010 affected61 at risk
EG0021 affected60 at risk
EG003
Musculoskeletal pain
Musculoskeletal and connective tissue disorders
MedDRA 16.0
Non-systematic Assessment
EG0001 affected361 at risk
EG0010 affected61 at risk
EG0020 affected60 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA 16.0
Non-systematic Assessment
EG0001 affected361 at risk
EG0010 affected61 at risk
EG0020 affected60 at risk
EG003
Neck pain
Musculoskeletal and connective tissue disorders
MedDRA 16.0
Non-systematic Assessment
EG0001 affected361 at risk
EG0011 affected61 at risk
EG0021 affected60 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA 16.0
Non-systematic Assessment
EG0001 affected361 at risk
EG0010 affected61 at risk
EG0020 affected60 at risk
EG003
Pain in jaw
Musculoskeletal and connective tissue disorders
MedDRA 16.0
Non-systematic Assessment
EG0001 affected361 at risk
EG0012 affected61 at risk
EG0020 affected60 at risk
EG003
Plantar fasciitis
Musculoskeletal and connective tissue disorders
MedDRA 16.0
Non-systematic Assessment
EG0001 affected361 at risk
EG0010 affected61 at risk
EG0021 affected60 at risk
EG003
Polyarthritis
Musculoskeletal and connective tissue disorders
MedDRA 16.0
Non-systematic Assessment
EG0000 affected361 at risk
EG0010 affected61 at risk
EG0020 affected60 at risk
EG003
Rotator cuff syndrome
Musculoskeletal and connective tissue disorders
MedDRA 16.0
Non-systematic Assessment
EG0000 affected361 at risk
EG0010 affected61 at risk
EG0020 affected60 at risk
EG003
Tendonitis
Musculoskeletal and connective tissue disorders
MedDRA 16.0
Non-systematic Assessment
EG0000 affected361 at risk
EG0010 affected61 at risk
EG0020 affected60 at risk
EG003
Benign intracranial hypertension
Nervous system disorders
MedDRA 16.0
Non-systematic Assessment
EG0000 affected361 at risk
EG0010 affected61 at risk
EG0020 affected60 at risk
EG003
Dizziness
Nervous system disorders
MedDRA 16.0
Non-systematic Assessment
EG0002 affected361 at risk
EG0011 affected61 at risk
EG0022 affected60 at risk
EG003
Headache
Nervous system disorders
MedDRA 16.0
Non-systematic Assessment
EG0003 affected361 at risk
EG0012 affected61 at risk
EG0021 affected60 at risk
EG003
Hypoaesthesia
Nervous system disorders
MedDRA 16.0
Non-systematic Assessment
EG0000 affected361 at risk
EG0011 affected61 at risk
EG0020 affected60 at risk
EG003
Memory impairment
Nervous system disorders
MedDRA 16.0
Non-systematic Assessment
EG0000 affected361 at risk
EG0011 affected61 at risk
EG0020 affected60 at risk
EG003
Migraine
Nervous system disorders
MedDRA 16.0
Non-systematic Assessment
EG0000 affected361 at risk
EG0011 affected61 at risk
EG0020 affected60 at risk
EG003
Nerve compression
Nervous system disorders
MedDRA 16.0
Non-systematic Assessment
EG0000 affected361 at risk
EG0010 affected61 at risk
EG0020 affected60 at risk
EG003
Paraesthesia
Nervous system disorders
MedDRA 16.0
Non-systematic Assessment
EG0000 affected361 at risk
EG0011 affected61 at risk
EG0020 affected60 at risk
EG003
Radicular pain
Nervous system disorders
MedDRA 16.0
Non-systematic Assessment
EG0000 affected361 at risk
EG0010 affected61 at risk
EG0020 affected60 at risk
EG003
Sinus headache
Nervous system disorders
MedDRA 16.0
Non-systematic Assessment
EG0000 affected361 at risk
EG0010 affected61 at risk
EG0021 affected60 at risk
EG003
Tension headache
Nervous system disorders
MedDRA 16.0
Non-systematic Assessment
EG0000 affected361 at risk
EG0010 affected61 at risk
EG0020 affected60 at risk
EG003
Anxiety
Psychiatric disorders
MedDRA 16.0
Non-systematic Assessment
EG0000 affected361 at risk
EG0010 affected61 at risk
EG0020 affected60 at risk
EG003
Depressed mood
Psychiatric disorders
MedDRA 16.0
Non-systematic Assessment
EG0001 affected361 at risk
EG0010 affected61 at risk
EG0020 affected60 at risk
EG003
Depression
Psychiatric disorders
MedDRA 16.0
Non-systematic Assessment
EG0000 affected361 at risk
EG0011 affected61 at risk
EG0021 affected60 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA 16.0
Non-systematic Assessment
EG0002 affected361 at risk
EG0010 affected61 at risk
EG0020 affected60 at risk
EG003
Haematuria
Renal and urinary disorders
MedDRA 16.0
Non-systematic Assessment
EG0001 affected361 at risk
EG0010 affected61 at risk
EG0020 affected60 at risk
EG003
Microalbuminuria
Renal and urinary disorders
MedDRA 16.0
Non-systematic Assessment
EG0000 affected361 at risk
EG0010 affected61 at risk
EG0020 affected60 at risk
EG003
Nephrolithiasis
Renal and urinary disorders
MedDRA 16.0
Non-systematic Assessment
EG0002 affected361 at risk
EG0010 affected61 at risk
EG0020 affected60 at risk
EG003
Nocturia
Renal and urinary disorders
MedDRA 16.0
Non-systematic Assessment
EG0000 affected361 at risk
EG0010 affected61 at risk
EG0020 affected60 at risk
EG003
Polyuria
Renal and urinary disorders
MedDRA 16.0
Non-systematic Assessment
EG0000 affected361 at risk
EG0010 affected61 at risk
EG0020 affected60 at risk
EG003
Proteinuria
Renal and urinary disorders
MedDRA 16.0
Non-systematic Assessment
EG0001 affected361 at risk
EG0010 affected61 at risk
EG0020 affected60 at risk
EG003
Balanitis
Reproductive system and breast disorders
MedDRA 16.0
Non-systematic Assessment
EG0001 affected361 at risk
EG0011 affected61 at risk
EG0020 affected60 at risk
EG003
Vulvovaginal pruritus
Reproductive system and breast disorders
MedDRA 16.0
Non-systematic Assessment
EG0000 affected361 at risk
EG0010 affected61 at risk
EG0020 affected60 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA 16.0
Non-systematic Assessment
EG0001 affected361 at risk
EG0010 affected61 at risk
EG0020 affected60 at risk
EG003
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA 16.0
Non-systematic Assessment
EG0001 affected361 at risk
EG0010 affected61 at risk
EG0021 affected60 at risk
EG003
Respiratory tract congestion
Respiratory, thoracic and mediastinal disorders
MedDRA 16.0
Non-systematic Assessment
EG0000 affected361 at risk
EG0010 affected61 at risk
EG0020 affected60 at risk
EG003
Sinus congestion
Respiratory, thoracic and mediastinal disorders
MedDRA 16.0
Non-systematic Assessment
EG0000 affected361 at risk
EG0010 affected61 at risk
EG0020 affected60 at risk
EG003
Throat irritation
Respiratory, thoracic and mediastinal disorders
MedDRA 16.0
Non-systematic Assessment
EG0000 affected361 at risk
EG0010 affected61 at risk
EG0020 affected60 at risk
EG003
Actinic keratosis
Skin and subcutaneous tissue disorders
MedDRA 16.0
Non-systematic Assessment
EG0000 affected361 at risk
EG0011 affected61 at risk
EG0020 affected60 at risk
EG003
Alopecia
Skin and subcutaneous tissue disorders
MedDRA 16.0
Non-systematic Assessment
EG0000 affected361 at risk
EG0010 affected61 at risk
EG0021 affected60 at risk
EG003
Dermal cyst
Skin and subcutaneous tissue disorders
MedDRA 16.0
Non-systematic Assessment
EG0000 affected361 at risk
EG0011 affected61 at risk
EG0020 affected60 at risk
EG003
Dermatitis
Skin and subcutaneous tissue disorders
MedDRA 16.0
Non-systematic Assessment
EG0000 affected361 at risk
EG0010 affected61 at risk
EG0021 affected60 at risk
EG003
Dermatitis contact
Skin and subcutaneous tissue disorders
MedDRA 16.0
Non-systematic Assessment
EG0001 affected361 at risk
EG0010 affected61 at risk
EG0020 affected60 at risk
EG003
Ecchymosis
Skin and subcutaneous tissue disorders
MedDRA 16.0
Non-systematic Assessment
EG0001 affected361 at risk
EG0010 affected61 at risk
EG0021 affected60 at risk
EG003
Eczema
Skin and subcutaneous tissue disorders
MedDRA 16.0
Non-systematic Assessment
EG0000 affected361 at risk
EG0011 affected61 at risk
EG0020 affected60 at risk
EG003
Hyperhidrosis
Skin and subcutaneous tissue disorders
MedDRA 16.0
Non-systematic Assessment
EG0002 affected361 at risk
EG0010 affected61 at risk
EG0020 affected60 at risk
EG003
Ingrowing nail
Skin and subcutaneous tissue disorders
MedDRA 16.0
Non-systematic Assessment
EG0000 affected361 at risk
EG0011 affected61 at risk
EG0020 affected60 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedDRA 16.0
Non-systematic Assessment
EG0001 affected361 at risk
EG0010 affected61 at risk
EG0020 affected60 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA 16.0
Non-systematic Assessment
EG0001 affected361 at risk
EG0011 affected61 at risk
EG0021 affected60 at risk
EG003
Seborrhoeic dermatitis
Skin and subcutaneous tissue disorders
MedDRA 16.0
Non-systematic Assessment
EG0000 affected361 at risk
EG0010 affected61 at risk
EG0020 affected60 at risk
EG003
Skin lesion
Skin and subcutaneous tissue disorders
MedDRA 16.0
Non-systematic Assessment
EG0000 affected361 at risk
EG0011 affected61 at risk
EG0020 affected60 at risk
EG003
Skin ulcer
Skin and subcutaneous tissue disorders
MedDRA 16.0
Non-systematic Assessment
EG0000 affected361 at risk
EG0010 affected61 at risk
EG0021 affected60 at risk
EG003
Swelling face
Skin and subcutaneous tissue disorders
MedDRA 16.0
Non-systematic Assessment
EG0000 affected361 at risk
EG0011 affected61 at risk
EG0020 affected60 at risk
EG003
Haematoma
Vascular disorders
MedDRA 16.0
Non-systematic Assessment
EG0000 affected361 at risk
EG0010 affected61 at risk
EG0020 affected60 at risk
EG003
Haemorrhage
Vascular disorders
MedDRA 16.0
Non-systematic Assessment
EG0000 affected361 at risk
EG0011 affected61 at risk
EG0020 affected60 at risk
EG003
Hot flush
Vascular disorders
MedDRA 16.0
Non-systematic Assessment
EG0000 affected361 at risk
EG0010 affected61 at risk
EG0020 affected60 at risk
EG003
Hypertension
Vascular disorders
MedDRA 16.0
Non-systematic Assessment
EG0000 affected361 at risk
EG0011 affected61 at risk
EG0022 affected60 at risk
EG003
Peripheral coldness
Vascular disorders
MedDRA 16.0
Non-systematic Assessment
EG0000 affected361 at risk
EG0010 affected61 at risk
EG0020 affected60 at risk
EG003
Thrombophlebitis
Vascular disorders
MedDRA 16.0
Non-systematic Assessment
EG0001 affected361 at risk
EG0010 affected61 at risk
EG0020 affected60 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.
Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM 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.
0.0218
p-value was 1-sided.
LS Mean Difference
-0.30
Standard Error of the Mean
0.146
2-Sided
80
-0.48
-0.11
No
Superiority or Other
OG000
OG003
Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM 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.
0.0006
p-value was 1-sided.
LS Mean Difference
-0.47
Standard Error of the Mean
0.144
2-Sided
80
-0.65
-0.28
No
Superiority or Other
OG000
OG004
Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM 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.
<0.0001
p-value was 1-sided.
LS Mean Difference
-0.83
Standard Error of the Mean
0.144
2-Sided
80
-1.02
-0.65
No
Superiority or Other
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.
OG003
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.
OG004
Glimepiride
Glimepiride capsule at a starting dose of 2 milligram per day (mg/day) up to a maximum dose of 6 mg/day along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
Units
Counts
Participants
OG00058
OG00157
OG00255
OG00358
OG00460
Title
Denominators
Categories
Week 4 (n=58, 57, 55, 58, 60)
Title
Measurements
OG000-0.08± 0.590
OG001-0.07± 0.422
OG002-0.22± 0.431
OG003-0.32± 0.532
OG004-0.54± 0.379
Week 6 (n=57, 55, 55, 58, 55)
Title
Measurements
OG000-0.14± 0.676
OG001-0.14± 0.545
OG002-0.22± 0.494
OG003
Week 8 (n=58, 55, 53, 57, 55)
Title
Measurements
OG000-0.19± 0.756
OG001-0.17± 0.628
OG002-0.38± 0.575
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% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.
t-test, 1 sided
0.6112
P-value was 1-sided.
LS Mean Difference
0.02
Standard Error of the Mean
0.087
2-Sided
80
-0.09
0.14
No
Superiority or Other
OG000
OG002
Week 4: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.
t-test, 1 sided
0.0550
P-value was 1-sided.
LS Mean Difference
-0.14
Standard Error of the Mean
0.088
2-Sided
80
-0.25
-0.03
No
Superiority or Other
OG000
OG003
Week 4: Treatment difference and 80%CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.
t-test, 1 sided
0.0032
P-value was 1-sided.
LS Mean Difference
-0.24
Standard Error of the Mean
0.086
2-Sided
80
-0.35
-0.13
No
Superiority or Other
OG000
OG004
Week 4: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, 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
-0.44
Standard Error of the Mean
0.086
2-Sided
80
-0.55
-0.33
No
Superiority or Other
OG000
OG001
Week 6: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.
t-test, 1 sided
0.6146
P-value was 1-sided.
LS Mean Difference
0.03
Standard Error of the Mean
0.101
2-Sided
80
-0.10
0.16
No
Superiority or Other
OG000
OG002
Week 6: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.
t-test, 1 sided
0.2606
P-value was 1-sided.
LS Mean Difference
-0.07
Standard Error of the Mean
0.101
2-Sided
80
-0.19
0.06
No
Superiority or Other
OG000
OG003
Week 6: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.
t-test, 1 sided
0.0006
P-value was 1-sided.
LS Mean Difference
-0.32
Standard Error of the Mean
0.099
2-Sided
80
-0.45
-0.20
No
Superiority or Other
OG000
OG004
Week 6: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, 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
-0.57
Standard Error of the Mean
0.100
2-Sided
80
-0.70
-0.44
No
Superiority or Other
OG000
OG001
Week 8: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.
t-test, 1 sided
0.6618
P-value was 1-sided.
LS Mean Difference
0.05
Standard Error of the Mean
0.118
2-Sided
80
-0.10
0.20
No
Superiority or Other
OG000
OG002
Week 8: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.
t-test, 1 sided
0.0878
P-value was 1-sided.
LS Mean Difference
-0.16
Standard Error of the Mean
0.119
2-Sided
80
-0.31
-0.01
No
Superiority or Other
OG000
OG003
Week 8: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.
t-test, 1 sided
0.0022
P-value was 1-sided.
LS Mean Difference
-0.34
Standard Error of the Mean
0.117
2-Sided
80
-0.49
-0.19
No
Superiority or Other
OG000
OG004
Week 8: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, 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
-0.66
Standard Error of the Mean
0.117
2-Sided
80
-0.81
-0.51
No
Superiority or Other
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.
OG004
Glimepiride
Glimepiride capsule at a starting dose of 2 milligram per day (mg/day) up to a maximum dose of 6 mg/day along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
Units
Counts
Participants
OG00060
OG00159
OG00260
OG00361
OG00461
Title
Denominators
Categories
Baseline (n=60, 59, 60, 61, 61)
Title
Measurements
OG000161.3± 30.74
OG001168.7± 43.01
OG002174.7± 36.43
OG003160.4± 37.03
OG004163.7± 35.99
Change at Week 2 (n=60, 59, 60, 61, 59)
Title
Measurements
OG0003.1± 23.89
OG001-2.0± 46.24
OG002-7.9± 29.29
OG003
Change at Week 4 (n=59, 58, 56, 59, 60)
Title
Measurements
OG000-0.5± 27.66
OG001-8.4± 41.99
OG002-7.7± 27.49
OG003
Change at Week 6 (n=58, 56, 56, 59, 57)
Title
Measurements
OG000-2.6± 31.40
OG001-6.9± 41.80
OG002-7.2± 24.63
OG003
Change at Week 8 (n=59, 56, 54, 58, 57)
Title
Measurements
OG0000.9± 29.70
OG001-7.0± 43.93
OG002-13.0± 27.48
OG003
Change at Week 12 (n=57, 54, 54, 55, 55)
Title
Measurements
OG0003.4± 31.29
OG001-6.2± 45.22
OG002-9.9± 37.09
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% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.
t-test, 1 sided
0.3446
P-value was 1-sided.
LS Mean Difference
-2.09
Standard Error of the Mean
5.222
2-Sided
80
-8.80
4.62
No
Superiority or Other
OG000
OG002
Week 2: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.
t-test, 1 sided
0.1204
P-value was 1-sided.
LS Mean Difference
-6.12
Standard Error of the Mean
5.210
2-Sided
80
-12.81
0.57
No
Superiority or Other
OG000
OG003
Week 2: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.
t-test, 1 sided
0.0041
P-value was 1-sided.
LS Mean Difference
-13.74
Standard Error of the Mean
5.166
2-Sided
80
-20.37
-7.10
No
Superiority or Other
OG000
OG004
Week 2: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, 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
-21.34
Standard Error of the Mean
5.192
2-Sided
80
-28.01
-14.67
No
Superiority or Other
OG000
OG001
Week 4: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.
t-test, 1 sided
0.1616
P-value was 1-sided.
LS Mean Difference
-5.14
Standard Error of the Mean
5.191
2-Sided
80
-11.80
1.53
No
Superiority or Other
OG000
OG002
Week 4: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.
t-test, 1 sided
0.1974
P-value was 1-sided.
LS Mean Difference
-4.45
Standard Error of the Mean
5.219
2-Sided
80
-11.15
2.26
No
Superiority or Other
OG000
OG003
Week 4: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.
t-test, 1 sided
0.0122
P-value was 1-sided.
LS Mean Difference
-11.62
Standard Error of the Mean
5.140
2-Sided
80
-18.22
-5.02
No
Superiority or Other
OG000
OG004
Week 4: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, 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
-24.79
Standard Error of the Mean
5.129
2-Sided
80
-31.37
-18.20
No
Superiority or Other
OG000
OG001
Week 6: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.
t-test, 1 sided
0.3645
P-value was 1-sided.
LS Mean Difference
-1.97
Standard Error of the Mean
5.674
2-Sided
80
-9.26
5.32
No
Superiority or Other
OG000
OG002
Week 6: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.
t-test, 1 sided
0.3672
P-value was 1-sided.
LS Mean Difference
-1.93
Standard Error of the Mean
5.676
2-Sided
80
-9.22
5.36
No
Superiority or Other
OG000
OG003
Week 6: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.
t-test, 1 sided
0.0906
P-value was 1-sided.
LS Mean Difference
-7.50
Standard Error of the Mean
5.598
2-Sided
80
-14.69
-0.31
No
Superiority or Other
OG000
OG004
Week 6: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.
t-test, 1 sided
0.0003
P-value was 1-sided.
LS Mean Difference
-19.69
Standard Error of the Mean
5.624
2-Sided
80
-26.91
-12.46
No
Superiority or Other
OG000
OG001
Week 8: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.
t-test, 1 sided
0.1748
P-value was 1-sided.
LS Mean Difference
-5.18
Standard Error of the Mean
5.534
2-Sided
80
-12.29
1.93
No
Superiority or Other
OG000
OG002
Week 8: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.
t-test, 1 sided
0.0297
P-value was 1-sided.
LS Mean Difference
-10.54
Standard Error of the Mean
5.566
2-Sided
80
-17.69
-3.38
No
Superiority or Other
OG000
OG003
Week 8: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.
t-test, 1 sided
0.0118
P-value was 1-sided.
LS Mean Difference
-12.44
Standard Error of the Mean
5.469
2-Sided
80
-19.47
-5.41
No
Superiority or Other
OG000
OG004
Week 8: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, 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
-27.00
Standard Error of the Mean
5.480
2-Sided
80
-34.04
-19.96
No
Superiority or Other
OG000
OG001
Week 12: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.
t-test, 1 sided
0.1012
P-value was 1-sided.
LS Mean Difference
-8.03
Standard Error of the Mean
6.281
2-Sided
80
-16.10
0.04
No
Superiority or Other
OG000
OG002
Week 12: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.
t-test, 1 sided
0.0409
LS Mean Difference
-10.99
Standard Error of the Mean
6.287
2-Sided
80
-19.07
-2.91
No
Superiority or Other
OG000
OG003
Week 12: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.
t-test, 1 sided
0.0089
LS Mean Difference
-14.87
Standard Error of the Mean
6.232
2-Sided
80
-22.88
-6.86
No
Superiority or Other
OG000
OG004
Week 12: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, 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
-25.93
Standard Error of the Mean
6.233
2-Sided
80
-33.93
-17.92
No
Superiority or Other
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.
OG003
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.
OG004
Glimepiride
Glimepiride capsule at a starting dose of 2 milligram per day (mg/day) up to a maximum dose of 6 mg/day along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
Units
Counts
Participants
OG00057
OG00154
OG00254
OG00355
OG00455
Title
Denominators
Categories
Less Than 6.5 Percent
Title
Measurements
OG0007.0
OG00113
OG00218.5
OG00327.3
OG00418.2
Less Than 7 Percent
Title
Measurements
OG00026.3
OG00131.5
OG00227.8
OG003
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.
OG003
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.
OG004
Glimepiride
Glimepiride capsule at a starting dose of 2 milligram per day (mg/day) up to a maximum dose of 6 mg/day along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
Units
Counts
Participants
OG00060
OG00159
OG00259
OG00361
OG00461
Title
Denominators
Categories
PR interval: Percent change of >=25/50%
Title
Measurements
OG0000
OG0010
OG0021
OG0030
OG0040
QRS interval: Percent change of >=50%
Title
Measurements
OG0000
OG0011
OG0021
OG003
QTcF interval: Change of >=30 to <60 msec
Title
Measurements
OG0006
OG0015
OG0028
OG003
QTcF interval: Change of >=60 msec
Title
Measurements
OG0002
OG0012
OG0022
OG003
OG003
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.
OG004
Glimepiride
Glimepiride capsule at a starting dose of 2 milligram per day (mg/day) up to a maximum dose of 6 mg/day along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
Units
Counts
Participants
OG00060
OG00160
OG00260
OG00361
OG00461
Title
Denominators
Categories
Increase in systolic BP (>=30 mmHg)
Title
Measurements
OG0002
OG0011
OG0023
OG0033
OG0045
Increase in diastolic BP (>=20 mmHg)
Title
Measurements
OG0001
OG0013
OG0020
OG003
Decrease in systolic BP (>=30 mmHg)
Title
Measurements
OG0005
OG0013
OG0023
OG003
Decrease in diastolic BP (>=20 mmHg)
Title
Measurements
OG0004
OG0013
OG0022
OG003
OG002
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.
OG003
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.
OG004
Glimepiride
Glimepiride capsule at a starting dose of 2 milligram per day (mg/day) up to a maximum dose of 6 mg/day along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
Units
Counts
Participants
OG00061
OG00160
OG00261
OG00361
OG00461
Title
Denominators
Categories
AEs
Title
Measurements
OG00026
OG00128
OG00231
OG00329
OG00436
SAEs
Title
Measurements
OG0000
OG0011
OG0022
OG003
OG002
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.
OG003
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.
OG004
Glimepiride
Glimepiride capsule at a starting dose of 2 milligram per day (mg/day) up to a maximum dose of 6 mg/day along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
Units
Counts
Participants
OG00061
OG00160
OG00261
OG00361
OG00461
Title
Denominators
Categories
Title
Measurements
OG0004.9
OG0013.3
OG0024.9
OG0036.6
OG00434.4
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.
OG004
Glimepiride
Glimepiride capsule at a starting dose of 2 milligram per day (mg/day) up to a maximum dose of 6 mg/day along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
Units
Counts
Participants
OG00061
OG00160
OG00261
OG00361
OG00461
Title
Denominators
Categories
Title
Measurements
OG0000(0 to 5)
OG0010(0 to 2)
OG0020(0 to 6)
OG0030(0 to 9)
OG0040(0 to 65)
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.
OG004
Glimepiride
Glimepiride capsule at a starting dose of 2 milligram per day (mg/day) up to a maximum dose of 6 mg/day along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
Units
Counts
Participants
OG0000
OG0010
OG0020
OG0030
OG0040
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.
OG004
Glimepiride
Glimepiride capsule at a starting dose of 2 milligram per day (mg/day) up to a maximum dose of 6 mg/day along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
Units
Counts
Participants
OG00059
OG00157
OG00258
OG00361
OG00460
Title
Denominators
Categories
Baseline (n=59, 57, 58, 61, 60)
Title
Measurements
OG00089.859± 21.9513
OG00189.518± 20.5752
OG00289.860± 21.4376
OG00387.530± 19.2248
OG00490.388± 17.9358
Change at Week 2 (n=59, 57, 58, 61, 58)
Title
Measurements
OG000-0.402± 1.0127
OG001-0.069± 1.1309
OG002-0.028± 1.0557
OG003
Change at Week 4 (n=58, 56, 55, 59, 60)
Title
Measurements
OG000-0.620± 1.2025
OG001-0.378± 1.2415
OG002-0.074± 1.2356
OG003
Change at Week 6 (n=57, 54, 55, 59, 56)
Title
Measurements
OG000-0.564± 1.3880
OG001-0.604± 1.3153
OG002-0.228± 1.6697
OG003
Change at Week 8 (n=58, 54, 53, 58, 56)
Title
Measurements
OG000-1.082± 1.7217
OG001-0.522± 1.5396
OG002-0.311± 2.2260
OG003
Change at Week 12 (n=56, 52, 53, 55, 54)
Title
Measurements
OG000-1.529± 2.0906
OG001-0.685± 1.7244
OG002-0.961± 2.6114
OG003
Change at Week 14 (n=55, 51, 53, 55, 53)
Title
Measurements
OG000-1.478± 2.0389
OG001-0.472± 2.0387
OG002-0.978± 2.7040
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, duration of type 2 diabetes mellitus (T2DM), time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.
t-test, 2 sided
0.0898
P-value was 2-sided.
LS Mean Difference
0.33
Standard Error of the Mean
0.196
2-Sided
80
0.08
0.59
No
Superiority or Other
OG000
OG002
Week 2: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.
t-test, 2 sided
0.0555
P-value was 2-sided.
LS Mean Difference
0.37
Standard Error of the Mean
0.195
2-Sided
80
0.12
0.62
No
Superiority or Other
OG000
OG003
Week 2: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.
t-test, 2 sided
0.0585
P-value was 2-sided.
LS Mean Difference
0.37
Standard Error of the Mean
0.193
2-Sided
80
0.12
0.61
No
Superiority or Other
OG000
OG004
Week 2: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.
t-test, 2 sided
0.0454
P-value was 2-sided.
LS Mean Difference
0.39
Standard Error of the Mean
0.194
2-Sided
80
0.14
0.64
No
Superiority or Other
OG000
OG001
Week 4: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.
t-test, 2 sided
0.2819
P-value was 2-sided.
LS Mean Difference
0.25
Standard Error of the Mean
0.235
2-Sided
80
-0.05
0.55
No
Superiority or Other
OG000
OG002
Week 4: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.
t-test, 2 sided
0.0319
P-value was 2-sided.
LS Mean Difference
0.51
Standard Error of the Mean
0.235
2-Sided
80
0.20
0.81
No
Superiority or Other
OG000
OG003
Week 4: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.
t-test, 2 sided
0.1835
P-value was 2-sided.
LS Mean Difference
0.31
Standard Error of the Mean
0.231
2-Sided
80
0.01
0.60
No
Superiority or Other
OG000
Week 4: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.
t-test, 2 sided
0.0001
P-value was 2-sided.
LS Mean Difference
0.93
Standard Error of the Mean
0.231
2-Sided
80
0.63
1.22
No
Superiority or Other
OG000
OG001
Week 6: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.
t-test, 2 sided
0.9689
P-value was 2-sided.
LS Mean Difference
-0.01
Standard Error of the Mean
0.266
2-Sided
80
-0.35
0.33
No
Superiority or Other
OG000
OG002
Week 6: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.
t-test, 2 sided
0.2221
P-value was 2-sided.
LS Mean Difference
0.32
Standard Error of the Mean
0.265
2-Sided
80
-0.02
0.67
No
Superiority or Other
OG000
OG003
Week 6: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.
t-test, 2 sided
0.2774
P-value was 2-sided.
LS Mean Difference
0.28
Standard Error of the Mean
0.261
2-Sided
80
-0.05
0.62
No
Superiority or Other
OG000
OG004
Week 6: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.
t-test, 2 sided
<0.0001
P-value was 2-sided.
LS Mean Difference
1.09
Standard Error of the Mean
0.263
2-Sided
80
0.76
1.43
No
Superiority or Other
OG000
OG001
Week 8: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.
t-test, 2 sided
0.0667
P-value was 2-sided.
LS Mean Difference
0.58
Standard Error of the Mean
0.314
2-Sided
80
0.17
0.98
No
Superiority or Other
OG000
OG002
Week 8: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.
t-test, 2 sided
0.0133
P-value was 2-sided.
LS Mean Difference
0.78
Standard Error of the Mean
0.314
2-Sided
80
0.38
1.19
No
Superiority or Other
OG000
OG003
Week 8: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.
t-test, 2 sided
0.0260
P-value was 2-sided.
LS Mean Difference
0.69
Standard Error of the Mean
0.308
2-Sided
80
0.29
1.08
No
Superiority or Other
OG000
OG004
Week 8: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.
t-test, 2 sided
<0.0001
P-value was 2-sided.
LS Mean Difference
1.63
Standard Error of the Mean
0.310
2-Sided
80
1.23
2.02
No
Superiority or Other
OG000
OG001
Week 12: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.
t-test, 2 sided
0.0335
P-value was 2-sided.
LS Mean Difference
0.80
Standard Error of the Mean
0.374
2-Sided
80
0.32
1.28
No
Superiority or Other
OG000
OG002
Week 12: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.
t-test, 2 sided
0.1557
P-value was 2-sided.
LS Mean Difference
0.53
Standard Error of the Mean
0.373
2-Sided
80
0.05
1.01
No
Superiority or Other
OG000
OG003
Week 12: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.
t-test, 2 sided
0.0132
P-value was 2-sided.
LS Mean Difference
0.92
Standard Error of the Mean
0.368
2-Sided
80
0.45
1.39
No
Superiority or Other
OG000
OG004
Week 12: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.
t-test, 2 sided
<0.0001
P-value was 2-sided.
LS Mean Difference
2.68
Standard Error of the Mean
0.370
2-Sided
80
2.20
3.15
No
Superiority or Other
OG000
OG001
Week 14 (Follow-up): Treatment difference and 80% CI were based on LS mean. A MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.
t-test, 2 sided
0.0158
P-value was 2-sided.
LS Mean Difference
0.96
Standard Error of the Mean
0.394
2-Sided
80
0.45
1.46
No
Superiority or Other
OG000
OG002
Week 14 (Follow-up): Treatment difference and 80% CI were based on LS mean. A MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.
t-test, 2 sided
0.2132
P-value was 2-sided.
LS Mean Difference
0.49
Standard Error of the Mean
0.392
2-Sided
80
-0.01
0.99
No
Superiority or Other
OG000
OG003
Week 14 (Follow-up): Treatment difference and 80% CI were based on LS mean. A MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.
t-test, 2 sided
0.0263
P-value was 2-sided.
LS Mean Difference
0.86
Standard Error of the Mean
0.387
2-Sided
80
0.37
1.36
No
Superiority or Other
OG000
OG004
Week 14 (Follow-up): Treatment difference and 80% CI were based on LS mean. A MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.
t-test, 2 sided
<0.0001
P-value was 2-sided.
LS Mean Difference
2.62
Standard Error of the Mean
0.390
2-Sided
80
2.12
3.12
No
Superiority or Other
OG001
PF-04937319 10 mg
PF-04937319 10 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 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.
OG003
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.
OG004
Glimepiride
Glimepiride capsule at a starting dose of 2 milligram per day (mg/day) up to a maximum dose of 6 mg/day along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.