Study To Understand Efficacy And Safety Of Investigational Agent (PF-04937319) Compared To Approved Agent (Glimepiride) In Patients With Diabetes On Metformin

• Sponsor: Pfizer (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01517373
• Collaborator: (none)
• Enrollment: 304
• Locations: 53
• Arms: 5
• Duration (Months): 11
• Patients Per Site: 5.7
• Patients Per Site Per Month: 0.5

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Diabetes Mellitus, Type 2	Drug: Placebo; Drug: PF-04937319 10 mg; Drug: PF-04937319 50 mg; Drug: PF-04937319 100 mg; Drug: Glimepiride	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 304 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Treatment
• 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
• Study Start Date: Feb 1, 2012
• Actual Primary Completion Date: Jan 1, 2013
• Actual Study Completion Date: Jan 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Placebo Placebo to match PF-04937319 and glimepiride	Drug: Placebo; Combination of tablets and capsules, a total of 3 pills/dose, administered once daily for 84-days
Experimental: PF-04937319 10 mg	Drug: PF-04937319 10 mg; Combination of tablets and capsules, dose of 10 mg, a total of 3 pills/dose, administered once daily for 84-days
Experimental: PF-04937319 50 mg	Drug: PF-04937319 50 mg; Combination of tablets and capsules, dose of 50 mg, a total of 3 pills/dose, administered once daily for 84-days
Experimental: PF-04937319 100 mg	Drug: PF-04937319 100 mg; Combination of tablets and capsules, dose of 100 mg, a total of 3 pills/dose, administered once daily for 84-days
Active Comparator: Glimepiride	Drug: Glimepiride; Combination of tablets and capsules, dose of up to 6 mg, a total of 3 pills/dose, administered once daily for 84-days

Outcome Measures

Primary Outcome Measures

1. Change From Baseline in Glycosylated Hemoglobin (HbA1C) at Week 12 [Baseline (Day 1), 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.

Secondary Outcome Measures

1. Change From Baseline in Glycosylated Hemoglobin (HbA1C) at Week 2, 4, 6 and 8 [Baseline (Day 1), Week 2, 4, 6, 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.

2. Change From Baseline in Fasting Plasma Glucose at Week 2, 4, 6, 8 and 12 [Baseline (Day 1), Week 2, 4, 6, 8, 12]

3. Percentage of Participants Achieving Less Than 6.5 Percent and Less Than 7 Percent Glycosylated Hemoglobin (HbA1c) Levels at Week 12 [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.

4. Number of Participants With Increase From Baseline Electrocardiogram (ECG) Data [Baseline (Day 1) up to Week 14]

   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).

5. Number of Participants With Increase/Decrease From Baseline Vital Signs Data [Baseline (Day 1) up to Week 14]

   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.

6. Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) [Baseline (Day 1) up to 14 days after last dose of study treatment (up to 101 days)]

   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.

7. Percentage of Participants With at Least 1 Hypoglycemic Events (HAE) Episode [Baseline (Day 1) up to Week 14]

   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.

8. Number of Hypoglycemic Events (HAE) Episodes Per Participant [Baseline (Day 1) up to Week 14]

   A hypoglycemic event was identified by characteristic symptoms or blood glucose levels. Median of 1 and 2 events per participant was reported.

9. Time to Each Recurrent Hypoglycemic Events (HAE) Episode Per Participant [Baseline (Day 1) up to Week 14]

   Median recurrence time was not to be calculated when less than 50% of the participants in a given arm experienced 1 or more HAEs.

10. Change From Baseline in Body Weight at Week 2, 4, 6, 8, 12 and 14 [Baseline (Day 1), Week 2, 4, 6, 8, 12, 14 (follow-up)]

11. Number of Participants With Abnormal Laboratory Values [Baseline (Day 1) up to Week 14]

    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).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Sierra Clinical Research	Roseville	California	United States	95661
2	California Research Foundation	San Diego	California	United States	92103
3	Diablo Clinical Research, Inc.	Walnut Creek	California	United States	94598
4	Meridien Research	Bradenton	Florida	United States	34208
5	South Broward Research, LLC	Pembroke Pines	Florida	United States	33027
6	East-West Medical Research Institute	Honolulu	Hawaii	United States	96814
7	Clinical Research Center of Cape Cod, Inc.	Hyannis	Massachusetts	United States	02601
8	Diabetes & Endocrinology Consultants, PC	Morehead City	North Carolina	United States	28557
9	Sterling Research Group, Ltd.	Cincinnati	Ohio	United States	45246
10	Community Research	Cincinnati	Ohio	United States	45255
11	Coastal Carolina Research Center	Mount Pleasant	South Carolina	United States	29464
12	Holston Medical Group	Bristol	Tennessee	United States	37620
13	Chattanooga Medical Research, LLC	Chattanooga	Tennessee	United States	37404
14	Diagnostic Center	Chattanooga	Tennessee	United States	37404
15	University Diabetes and Endocrine Consultants	Chattanooga	Tennessee	United States	37411
16	Clinical Research Associates, Inc.	Nashville	Tennessee	United States	37203
17	Bristol Clinical Research, LLC	Austin	Texas	United States	78728
18	DiscoveResearch, Inc.	Bryan	Texas	United States	77802
19	Dallas Diabetes and Endocrine Center	Dallas	Texas	United States	75230
20	Clinical Trials of Texas, Inc.	San Antonio	Texas	United States	78229
21	National Clinical Research - Norfolk, Inc.	Norfolk	Virginia	United States	23502
22	National Clinical Research - Richmond, Inc.	Richmond	Virginia	United States	23294
23	Aurora Advanced Healthcare, Inc.	Milwaukee	Wisconsin	United States	53209
24	MBAL Yulia Vrevska - Byala, Otdelenie po vatreshni bolesti	Byala		Bulgaria	7100
25	MBAL - Ruse AD, Vtoro otdelenie po vatreshni bolesti	Ruse		Bulgaria	7002
26	DKTs Akta Medika, Kabinet po endokrinologia	Sevlievo		Bulgaria	5400
27	UMBAL Aleksandrovska, Klinika po endokrinologia i bolesti na obmyanata	Sofia		Bulgaria	1431
28	VMA - MBAL - Sofia, Klinika po endokrinologia i bolesti na obmyanata	Sofia		Bulgaria	1606
29	UMBAL Stara Zagora, Klinika po endokrinologia i bolesti na obmyanata	Stara Zagora		Bulgaria	6003
30	Glover Medical Clinic	Langley	British Columbia	Canada	V3A 4H9
31	Ocean West Research Clinic Inc.	Surrey	British Columbia	Canada	V3S 2N6
32	Rivergrove Medical Clinic	Winnipeg	Manitoba	Canada	R2V 4W3
33	Aggarwal and Associates Limited	Brampton	Ontario	Canada	L6T 0G1
34	DCTM CLinical Trials Group Ltd.	Strathroy	Ontario	Canada	N7G 1Y7
35	Manna Research	Toronto	Ontario	Canada	M9W 4L6
36	Pro-Recherche	St-Romuald	Quebec	Canada	G6W 5M6
37	Centre de cardiologie et de Recherche Clinique Pierre-Le Gardeur	Terrebonne	Quebec	Canada	J6V 1S8
38	Alpha Recherche Clinique	Quebec		Canada	G3K 2P8
39	Dr. Kenessey Albert Korhaz-Rendelointezet/Belgyogyaszat	Balassagyarmat		Hungary	2660
40	Synexus Magyarorszag Kft.	Budapest		Hungary	1036
41	Semmelweis Egyetem/I. sz. Belgyogyaszati Klinika	Budapest		Hungary	1083
42	Fejer Megyei Szent Gyorgy Korhaz/II. Belgyogyaszati Osztaly	Szekesfehervar		Hungary	8000
43	BGS Global Hospital	Bangalore	Karnataka	India	560060
44	Deenanath Mangeshkar Hospital & Research Centre	Pune	Maharashtra	India	411 004
45	Diabetes Unit, K.E.M. Hospital Research Centre	Pune	Maharashtra	India	411 011
46	Fakultna nemocnica s poliklinikou F.D. Roosevelta Banska Bystrica	Banska Bystrica		Slovakia	975 17
47	Interna A Diabetologicka Ambulancia	Moldava Nad Bodvou		Slovakia	045 01
48	FUNKYSTUFF, s.r.o.	Nove Zamky		Slovakia	940 01
49	MEDIAB, s.r.o.	Pezinok		Slovakia	902 01
50	MEDIVASA, s.r.o.	Zilina		Slovakia	010 01
51	China Medical University Hospital	Taichung		Taiwan	404
52	National Taiwan University Hospital	Taipei		Taiwan	100
53	Taipei Medical University Hospital	Taipei		Taiwan	110

Sponsors and Collaborators

• Pfizer

Investigators

• Study Director: Pfizer CT.gov Call Center, Pfizer

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• To obtain contact information for a study center near you, click here.

Publications

None provided.

• Responsible Party: Pfizer
• ClinicalTrials.gov Identifier: NCT01517373
• Other Study ID Numbers: B1621002; 2011-005206-30
• First Posted: Jan 25, 2012
• Last Update Posted: Jan 31, 2017
• Last Verified: Dec 1, 2016

• Keywords provided by Pfizer: T2DM; PF-04937319; Phase 2
• Additional relevant MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2; Glimepiride

Study Results

Participant Flow

Pre-assignment Detail	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.

Arm/Group Title	Metformin 500 mg	Placebo	PF-04937319 10 mg	PF-04937319 50 mg	PF-04937319 100 mg	Glimepiride
Arm/Group Description	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.	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.	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.	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.	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.	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.
Period Title: Run-in Period
STARTED	361	0	0	0	0	0
COMPLETED	304	0	0	0	0	0
NOT COMPLETED	57	0	0	0	0	0
Period Title: Run-in Period
STARTED	0	61	60	61	61	61
COMPLETED	0	57	54	54	55	54
NOT COMPLETED	0	4	6	7	6	7

Baseline Characteristics

Arm/Group Title	Placebo	PF-04937319 10 mg	PF-04937319 50 mg	PF-04937319 100 mg	Glimepiride	Total
Arm/Group Description	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.	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.	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.	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.	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.	Total of all reporting groups
Overall Participants	61	60	61	61	61	304
Age, Customized (participants) [Number]
>=18 to =<44 years	8 13.1%	4 6.7%	8 13.1%	11 18%	7 11.5%	38 12.5%
>=45 to =<64 years	45 73.8%	48 80%	40 65.6%	35 57.4%	48 78.7%	216 71.1%
>64 years	8 13.1%	8 13.3%	13 21.3%	15 24.6%	6 9.8%	50 16.4%
Gender (Count of Participants)
Female	27 44.3%	26 43.3%	24 39.3%	32 52.5%	22 36.1%	131 43.1%
Male	34 55.7%	34 56.7%	37 60.7%	29 47.5%	39 63.9%	173 56.9%

Outcome Measures

1. Primary Outcome

Title	Change From Baseline in Glycosylated Hemoglobin (HbA1C) at Week 12
Description	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.
Time Frame	Baseline (Day 1), Week 12

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Placebo	PF-04937319 10 mg	PF-04937319 50 mg	PF-04937319 100 mg	Glimepiride
Arm/Group Description	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.	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.	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.	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.	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.
Measure Participants	59	57	55	60	60
Baseline (n=59, 57, 55, 60, 60)	7.90 (0.988)	7.97 (0.886)	7.91 (0.987)	7.88 (0.969)	8.12 (0.884)
Change at Week 12 (n=56, 53, 53, 54, 54)	-0.13 (0.789)	-0.18 (0.804)	-0.45 (0.733)	-0.64 (0.797)	-1.01 (0.709)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, PF-04937319 10 mg
	Comments	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.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.4468
	Comments	p-value was 1-sided.
	Method	t-test, 1 sided
	Comments	No adjustments were made for multiple comparisons among treatment groups.
Method of Estimation	Estimation Parameter	Least Squares (LS) Mean Difference
	Estimated Value	-0.02
	Confidence Interval	(2-Sided) 80%; -0.21 to 0.17
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.145
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo, PF-04937319 50 mg
	Comments	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.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0218
	Comments	p-value was 1-sided.
	Method	t-test, 1 sided
	Comments	No adjustments were made for multiple comparisons among treatment groups.
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-0.30
	Confidence Interval	(2-Sided) 80%; -0.48 to -0.11
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.146
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Placebo, PF-04937319 100 mg
	Comments	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.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0006
	Comments	p-value was 1-sided.
	Method	t-test, 1 sided
	Comments	No adjustments were made for multiple comparisons among treatment groups.
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-0.47
	Confidence Interval	(2-Sided) 80%; -0.65 to -0.28
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.144
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Placebo, Glimepiride
	Comments	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.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments	p-value was 1-sided.
	Method	t-test, 1 sided
	Comments	No adjustments were made for multiple comparisons among treatment groups.
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-0.83
	Confidence Interval	(2-Sided) 80%; -1.02 to -0.65
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.144
	Estimation Comments

2. Secondary Outcome

Title	Change From Baseline in Glycosylated Hemoglobin (HbA1C) at Week 2, 4, 6 and 8
Description	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.
Time Frame	Baseline (Day 1), Week 2, 4, 6, 8

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Placebo	PF-04937319 10 mg	PF-04937319 50 mg	PF-04937319 100 mg	Glimepiride
Arm/Group Description	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.	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.	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.	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.	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.
Measure Participants	58	57	55	58	60
Week 4 (n=58, 57, 55, 58, 60)	-0.08 (0.590)	-0.07 (0.422)	-0.22 (0.431)	-0.32 (0.532)	-0.54 (0.379)
Week 6 (n=57, 55, 55, 58, 55)	-0.14 (0.676)	-0.14 (0.545)	-0.22 (0.494)	-0.51 (0.479)	-0.78 (0.500)
Week 8 (n=58, 55, 53, 57, 55)	-0.19 (0.756)	-0.17 (0.628)	-0.38 (0.575)	-0.59 (0.571)	-0.89 (0.582)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, PF-04937319 10 mg
	Comments	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.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.6112
	Comments	P-value was 1-sided.
	Method	t-test, 1 sided
	Comments
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	0.02
	Confidence Interval	(2-Sided) 80%; -0.09 to 0.14
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.087
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo, PF-04937319 50 mg
	Comments	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.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0550
	Comments	P-value was 1-sided.
	Method	t-test, 1 sided
	Comments
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-0.14
	Confidence Interval	(2-Sided) 80%; -0.25 to -0.03
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.088
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Placebo, PF-04937319 100 mg
	Comments	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.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0032
	Comments	P-value was 1-sided.
	Method	t-test, 1 sided
	Comments
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-0.24
	Confidence Interval	(2-Sided) 80%; -0.35 to -0.13
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.086
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Placebo, Glimepiride
	Comments	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.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments	P-value was 1-sided.
	Method	t-test, 1 sided
	Comments
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-0.44
	Confidence Interval	(2-Sided) 80%; -0.55 to -0.33
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.086
	Estimation Comments

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Placebo, PF-04937319 10 mg
	Comments	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.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.6146
	Comments	P-value was 1-sided.
	Method	t-test, 1 sided
	Comments
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	0.03
	Confidence Interval	(2-Sided) 80%; -0.10 to 0.16
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.101
	Estimation Comments

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	Placebo, PF-04937319 50 mg
	Comments	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.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.2606
	Comments	P-value was 1-sided.
	Method	t-test, 1 sided
	Comments
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-0.07
	Confidence Interval	(2-Sided) 80%; -0.19 to 0.06
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.101
	Estimation Comments

Statistical Analysis 7

Statistical Analysis Overview	Comparison Group Selection	Placebo, PF-04937319 100 mg
	Comments	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.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0006
	Comments	P-value was 1-sided.
	Method	t-test, 1 sided
	Comments
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-0.32
	Confidence Interval	(2-Sided) 80%; -0.45 to -0.20
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.099
	Estimation Comments

Statistical Analysis 8

Statistical Analysis Overview	Comparison Group Selection	Placebo, Glimepiride
	Comments	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.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments	P-value was 1-sided.
	Method	t-test, 1 sided
	Comments
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-0.57
	Confidence Interval	(2-Sided) 80%; -0.70 to -0.44
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.100
	Estimation Comments

Statistical Analysis 9

Statistical Analysis Overview	Comparison Group Selection	Placebo, PF-04937319 10 mg
	Comments	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.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.6618
	Comments	P-value was 1-sided.
	Method	t-test, 1 sided
	Comments
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	0.05
	Confidence Interval	(2-Sided) 80%; -0.10 to 0.20
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.118
	Estimation Comments

Statistical Analysis 10

Statistical Analysis Overview	Comparison Group Selection	Placebo, PF-04937319 50 mg
	Comments	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.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0878
	Comments	P-value was 1-sided.
	Method	t-test, 1 sided
	Comments
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-0.16
	Confidence Interval	(2-Sided) 80%; -0.31 to -0.01
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.119
	Estimation Comments

Statistical Analysis 11

Statistical Analysis Overview	Comparison Group Selection	Placebo, PF-04937319 100 mg
	Comments	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.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0022
	Comments	P-value was 1-sided.
	Method	t-test, 1 sided
	Comments
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-0.34
	Confidence Interval	(2-Sided) 80%; -0.49 to -0.19
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.117
	Estimation Comments

Statistical Analysis 12

Statistical Analysis Overview	Comparison Group Selection	Placebo, Glimepiride
	Comments	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.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments	P-value was 1-sided.
	Method	t-test, 1 sided
	Comments
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-0.66
	Confidence Interval	(2-Sided) 80%; -0.81 to -0.51
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.117
	Estimation Comments

3. Secondary Outcome

Title	Change From Baseline in Fasting Plasma Glucose at Week 2, 4, 6, 8 and 12
Time Frame	Baseline (Day 1), Week 2, 4, 6, 8, 12

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Placebo	PF-04937319 10 mg	PF-04937319 50 mg	PF-04937319 100 mg	Glimepiride
Arm/Group Description	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.	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.	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.	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.	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.
Measure Participants	60	59	60	61	61
Baseline (n=60, 59, 60, 61, 61)	161.3 (30.74)	168.7 (43.01)	174.7 (36.43)	160.4 (37.03)	163.7 (35.99)
Change at Week 2 (n=60, 59, 60, 61, 59)	3.1 (23.89)	-2.0 (46.24)	-7.9 (29.29)	-10.5 (20.83)	-19.9 (25.68)
Change at Week 4 (n=59, 58, 56, 59, 60)	-0.5 (27.66)	-8.4 (41.99)	-7.7 (27.49)	-11.4 (22.84)	-26.2 (31.00)
Change at Week 6 (n=58, 56, 56, 59, 57)	-2.6 (31.40)	-6.9 (41.80)	-7.2 (24.63)	-10.4 (28.48)	-23.4 (35.01)
Change at Week 8 (n=59, 56, 54, 58, 57)	0.9 (29.70)	-7.0 (43.93)	-13.0 (27.48)	-13.0 (23.07)	-26.9 (32.08)
Change at Week 12 (n=57, 54, 54, 55, 55)	3.4 (31.29)	-6.2 (45.22)	-9.9 (37.09)	-10.3 (34.69)	-22.5 (30.86)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, PF-04937319 10 mg
	Comments	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.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.3446
	Comments	P-value was 1-sided.
	Method	t-test, 1 sided
	Comments
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-2.09
	Confidence Interval	(2-Sided) 80%; -8.80 to 4.62
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 5.222
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo, PF-04937319 50 mg
	Comments	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.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.1204
	Comments	P-value was 1-sided.
	Method	t-test, 1 sided
	Comments
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-6.12
	Confidence Interval	(2-Sided) 80%; -12.81 to 0.57
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 5.210
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Placebo, PF-04937319 100 mg
	Comments	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.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0041
	Comments	P-value was 1-sided.
	Method	t-test, 1 sided
	Comments
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-13.74
	Confidence Interval	(2-Sided) 80%; -20.37 to -7.10
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 5.166
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Placebo, Glimepiride
	Comments	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.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments	P-value was 1-sided.
	Method	t-test, 1 sided
	Comments
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-21.34
	Confidence Interval	(2-Sided) 80%; -28.01 to -14.67
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 5.192
	Estimation Comments

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Placebo, PF-04937319 10 mg
	Comments	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.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.1616
	Comments	P-value was 1-sided.
	Method	t-test, 1 sided
	Comments
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-5.14
	Confidence Interval	(2-Sided) 80%; -11.80 to 1.53
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 5.191
	Estimation Comments

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	Placebo, PF-04937319 50 mg
	Comments	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.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.1974
	Comments	P-value was 1-sided.
	Method	t-test, 1 sided
	Comments
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-4.45
	Confidence Interval	(2-Sided) 80%; -11.15 to 2.26
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 5.219
	Estimation Comments

Statistical Analysis 7

Statistical Analysis Overview	Comparison Group Selection	Placebo, PF-04937319 100 mg
	Comments	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.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0122
	Comments	P-value was 1-sided.
	Method	t-test, 1 sided
	Comments
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-11.62
	Confidence Interval	(2-Sided) 80%; -18.22 to -5.02
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 5.140
	Estimation Comments

Statistical Analysis 8

Statistical Analysis Overview	Comparison Group Selection	Placebo, Glimepiride
	Comments	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.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments	P-value was 1-sided.
	Method	t-test, 1 sided
	Comments
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-24.79
	Confidence Interval	(2-Sided) 80%; -31.37 to -18.20
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 5.129
	Estimation Comments

Statistical Analysis 9

Statistical Analysis Overview	Comparison Group Selection	Placebo, PF-04937319 10 mg
	Comments	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.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.3645
	Comments	P-value was 1-sided.
	Method	t-test, 1 sided
	Comments
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-1.97
	Confidence Interval	(2-Sided) 80%; -9.26 to 5.32
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 5.674
	Estimation Comments

Statistical Analysis 10

Statistical Analysis Overview	Comparison Group Selection	Placebo, PF-04937319 50 mg
	Comments	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.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.3672
	Comments	P-value was 1-sided.
	Method	t-test, 1 sided
	Comments
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-1.93
	Confidence Interval	(2-Sided) 80%; -9.22 to 5.36
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 5.676
	Estimation Comments

Statistical Analysis 11

Statistical Analysis Overview	Comparison Group Selection	Placebo, PF-04937319 100 mg
	Comments	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.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0906
	Comments	P-value was 1-sided.
	Method	t-test, 1 sided
	Comments
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-7.50
	Confidence Interval	(2-Sided) 80%; -14.69 to -0.31
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 5.598
	Estimation Comments

Statistical Analysis 12

Statistical Analysis Overview	Comparison Group Selection	Placebo, Glimepiride
	Comments	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.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0003
	Comments	P-value was 1-sided.
	Method	t-test, 1 sided
	Comments
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-19.69
	Confidence Interval	(2-Sided) 80%; -26.91 to -12.46
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 5.624
	Estimation Comments

Statistical Analysis 13

Statistical Analysis Overview	Comparison Group Selection	Placebo, PF-04937319 10 mg
	Comments	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.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.1748
	Comments	P-value was 1-sided.
	Method	t-test, 1 sided
	Comments
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-5.18
	Confidence Interval	(2-Sided) 80%; -12.29 to 1.93
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 5.534
	Estimation Comments

Statistical Analysis 14

Statistical Analysis Overview	Comparison Group Selection	Placebo, PF-04937319 50 mg
	Comments	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.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0297
	Comments	P-value was 1-sided.
	Method	t-test, 1 sided
	Comments
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-10.54
	Confidence Interval	(2-Sided) 80%; -17.69 to -3.38
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 5.566
	Estimation Comments

Statistical Analysis 15

Statistical Analysis Overview	Comparison Group Selection	Placebo, PF-04937319 100 mg
	Comments	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.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0118
	Comments	P-value was 1-sided.
	Method	t-test, 1 sided
	Comments
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-12.44
	Confidence Interval	(2-Sided) 80%; -19.47 to -5.41
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 5.469
	Estimation Comments

Statistical Analysis 16

Statistical Analysis Overview	Comparison Group Selection	Placebo, Glimepiride
	Comments	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.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments	P-value was 1-sided.
	Method	t-test, 1 sided
	Comments
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-27.00
	Confidence Interval	(2-Sided) 80%; -34.04 to -19.96
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 5.480
	Estimation Comments

Statistical Analysis 17

Statistical Analysis Overview	Comparison Group Selection	Placebo, PF-04937319 10 mg
	Comments	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.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.1012
	Comments	P-value was 1-sided.
	Method	t-test, 1 sided
	Comments
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-8.03
	Confidence Interval	(2-Sided) 80%; -16.10 to 0.04
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 6.281
	Estimation Comments

Statistical Analysis 18

Statistical Analysis Overview	Comparison Group Selection	Placebo, PF-04937319 50 mg
	Comments	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.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0409
	Comments
	Method	t-test, 1 sided
	Comments
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-10.99
	Confidence Interval	(2-Sided) 80%; -19.07 to -2.91
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 6.287
	Estimation Comments

Statistical Analysis 19

Statistical Analysis Overview	Comparison Group Selection	Placebo, PF-04937319 100 mg
	Comments	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.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0089
	Comments
	Method	t-test, 1 sided
	Comments
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-14.87
	Confidence Interval	(2-Sided) 80%; -22.88 to -6.86
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 6.232
	Estimation Comments

Statistical Analysis 20

Statistical Analysis Overview	Comparison Group Selection	Placebo, Glimepiride
	Comments	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.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments	P-value was 1-sided.
	Method	t-test, 1 sided
	Comments
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-25.93
	Confidence Interval	(2-Sided) 80%; -33.93 to -17.92
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 6.233
	Estimation Comments

4. Secondary Outcome

Title	Percentage of Participants Achieving Less Than 6.5 Percent and Less Than 7 Percent Glycosylated Hemoglobin (HbA1c) Levels at Week 12
Description	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.
Time Frame	Week 12

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Placebo	PF-04937319 10 mg	PF-04937319 50 mg	PF-04937319 100 mg	Glimepiride
Arm/Group Description	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.	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.	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.	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.	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.
Measure Participants	57	54	54	55	55
Less Than 6.5 Percent	7.0 11.5%	13 21.7%	18.5 30.3%	27.3 44.8%	18.2 29.8%
Less Than 7 Percent	26.3 43.1%	31.5 52.5%	27.8 45.6%	52.7 86.4%	45.5 74.6%

5. Secondary Outcome

Title	Number of Participants With Increase From Baseline Electrocardiogram (ECG) Data
Description	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).
Time Frame	Baseline (Day 1) up to Week 14

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Placebo	PF-04937319 10 mg	PF-04937319 50 mg	PF-04937319 100 mg	Glimepiride
Arm/Group Description	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.	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.	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.	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.	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.
Measure Participants	60	59	59	61	61
PR interval: Percent change of >=25/50%	0 0%	0 0%	1 1.6%	0 0%	0 0%
QRS interval: Percent change of >=50%	0 0%	1 1.7%	1 1.6%	2 3.3%	1 1.6%
QTcF interval: Change of >=30 to <60 msec	6 9.8%	5 8.3%	8 13.1%	6 9.8%	4 6.6%
QTcF interval: Change of >=60 msec	2 3.3%	2 3.3%	2 3.3%	2 3.3%	1 1.6%

6. Secondary Outcome

Title	Number of Participants With Increase/Decrease From Baseline Vital Signs Data
Description	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.
Time Frame	Baseline (Day 1) up to Week 14

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Placebo	PF-04937319 10 mg	PF-04937319 50 mg	PF-04937319 100 mg	Glimepiride
Arm/Group Description	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.	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.	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.	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.	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.
Measure Participants	60	60	60	61	61
Increase in systolic BP (>=30 mmHg)	2 3.3%	1 1.7%	3 4.9%	3 4.9%	5 8.2%
Increase in diastolic BP (>=20 mmHg)	1 1.6%	3 5%	0 0%	4 6.6%	2 3.3%
Decrease in systolic BP (>=30 mmHg)	5 8.2%	3 5%	3 4.9%	5 8.2%	1 1.6%
Decrease in diastolic BP (>=20 mmHg)	4 6.6%	3 5%	2 3.3%	6 9.8%	5 8.2%

7. Secondary Outcome

Title	Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)
Description	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.
Time Frame	Baseline (Day 1) up to 14 days after last dose of study treatment (up to 101 days)

Outcome Measure Data

Analysis Population Description

Safety analysis set included all randomized participants who received at least 1 dose of study treatment.

Arm/Group Title	Placebo	PF-04937319 10 mg	PF-04937319 50 mg	PF-04937319 100 mg	Glimepiride
Arm/Group Description	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.	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.	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.	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.	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.
Measure Participants	61	60	61	61	61
AEs	26 42.6%	28 46.7%	31 50.8%	29 47.5%	36 59%
SAEs	0 0%	1 1.7%	2 3.3%	1 1.6%	1 1.6%

8. Secondary Outcome

Title	Percentage of Participants With at Least 1 Hypoglycemic Events (HAE) Episode
Description	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.
Time Frame	Baseline (Day 1) up to Week 14

Outcome Measure Data

Analysis Population Description

Safety analysis set included all randomized participants who received at least 1 dose of study treatment.

Arm/Group Title	Placebo	PF-04937319 10 mg	PF-04937319 50 mg	PF-04937319 100 mg	Glimepiride
Arm/Group Description	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.	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.	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.	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.	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.
Measure Participants	61	60	61	61	61
Number [percentage of participants]	4.9 8%	3.3 5.5%	4.9 8%	6.6 10.8%	34.4 56.4%

9. Secondary Outcome

Title	Number of Hypoglycemic Events (HAE) Episodes Per Participant
Description	A hypoglycemic event was identified by characteristic symptoms or blood glucose levels. Median of 1 and 2 events per participant was reported.
Time Frame	Baseline (Day 1) up to Week 14

Outcome Measure Data

Analysis Population Description

Safety analysis set included all randomized participants who received at least 1 dose of study treatment.

Arm/Group Title	Placebo	PF-04937319 10 mg	PF-04937319 50 mg	PF-04937319 100 mg	Glimepiride
Arm/Group Description	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.	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.	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.	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.	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.
Measure Participants	61	60	61	61	61
Median (Full Range) [events per participant]	0	0	0	0	0

10. Secondary Outcome

Title	Time to Each Recurrent Hypoglycemic Events (HAE) Episode Per Participant
Description	Median recurrence time was not to be calculated when less than 50% of the participants in a given arm experienced 1 or more HAEs.
Time Frame	Baseline (Day 1) up to Week 14

Outcome Measure Data

Analysis Population Description

Data was not collected since this outcome measure was not analyzed due to infrequency of the occurrence of HAEs among the participants.

Arm/Group Title	Placebo	PF-04937319 10 mg	PF-04937319 50 mg	PF-04937319 100 mg	Glimepiride
Arm/Group Description	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.	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.	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.	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.	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.
Measure Participants	0	0	0	0	0

11. Secondary Outcome

Title	Change From Baseline in Body Weight at Week 2, 4, 6, 8, 12 and 14
Time Frame	Baseline (Day 1), Week 2, 4, 6, 8, 12, 14 (follow-up)

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Placebo	PF-04937319 10 mg	PF-04937319 50 mg	PF-04937319 100 mg	Glimepiride
Arm/Group Description	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.	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.	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.	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.	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.
Measure Participants	59	57	58	61	60
Baseline (n=59, 57, 58, 61, 60)	89.859 (21.9513)	89.518 (20.5752)	89.860 (21.4376)	87.530 (19.2248)	90.388 (17.9358)
Change at Week 2 (n=59, 57, 58, 61, 58)	-0.402 (1.0127)	-0.069 (1.1309)	-0.028 (1.0557)	-0.021 (0.9504)	-0.024 (1.1295)
Change at Week 4 (n=58, 56, 55, 59, 60)	-0.620 (1.2025)	-0.378 (1.2415)	-0.074 (1.2356)	-0.284 (1.2856)	0.310 (1.3831)
Change at Week 6 (n=57, 54, 55, 59, 56)	-0.564 (1.3880)	-0.604 (1.3153)	-0.228 (1.6697)	-0.290 (1.2669)	0.473 (1.4922)
Change at Week 8 (n=58, 54, 53, 58, 56)	-1.082 (1.7217)	-0.522 (1.5396)	-0.311 (2.2260)	-0.397 (1.1285)	0.493 (1.7023)
Change at Week 12 (n=56, 52, 53, 55, 54)	-1.529 (2.0906)	-0.685 (1.7244)	-0.961 (2.6114)	-0.545 (1.4004)	1.211 (1.8771)
Change at Week 14 (n=55, 51, 53, 55, 53)	-1.478 (2.0389)	-0.472 (2.0387)	-0.978 (2.7040)	-0.573 (1.6589)	1.234 (1.7481)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, PF-04937319 10 mg
	Comments	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.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0898
	Comments	P-value was 2-sided.
	Method	t-test, 2 sided
	Comments
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	0.33
	Confidence Interval	(2-Sided) 80%; 0.08 to 0.59
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.196
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo, PF-04937319 50 mg
	Comments	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.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0555
	Comments	P-value was 2-sided.
	Method	t-test, 2 sided
	Comments
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	0.37
	Confidence Interval	(2-Sided) 80%; 0.12 to 0.62
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.195
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Placebo, PF-04937319 100 mg
	Comments	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.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0585
	Comments	P-value was 2-sided.
	Method	t-test, 2 sided
	Comments
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	0.37
	Confidence Interval	(2-Sided) 80%; 0.12 to 0.61
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.193
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Placebo, Glimepiride
	Comments	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.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0454
	Comments	P-value was 2-sided.
	Method	t-test, 2 sided
	Comments
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	0.39
	Confidence Interval	(2-Sided) 80%; 0.14 to 0.64
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.194
	Estimation Comments

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Placebo, PF-04937319 10 mg
	Comments	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.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.2819
	Comments	P-value was 2-sided.
	Method	t-test, 2 sided
	Comments
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	0.25
	Confidence Interval	(2-Sided) 80%; -0.05 to 0.55
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.235
	Estimation Comments

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	Placebo, PF-04937319 50 mg
	Comments	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.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0319
	Comments	P-value was 2-sided.
	Method	t-test, 2 sided
	Comments
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	0.51
	Confidence Interval	(2-Sided) 80%; 0.20 to 0.81
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.235
	Estimation Comments

Statistical Analysis 7

Statistical Analysis Overview	Comparison Group Selection	Placebo, PF-04937319 100 mg
	Comments	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.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.1835
	Comments	P-value was 2-sided.
	Method	t-test, 2 sided
	Comments
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	0.31
	Confidence Interval	(2-Sided) 80%; 0.01 to 0.60
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.231
	Estimation Comments

Statistical Analysis 8

Statistical Analysis Overview	Comparison Group Selection	Placebo
	Comments	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.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0001
	Comments	P-value was 2-sided.
	Method	t-test, 2 sided
	Comments
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	0.93
	Confidence Interval	(2-Sided) 80%; 0.63 to 1.22
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.231
	Estimation Comments

Statistical Analysis 9

Statistical Analysis Overview	Comparison Group Selection	Placebo, PF-04937319 10 mg
	Comments	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.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.9689
	Comments	P-value was 2-sided.
	Method	t-test, 2 sided
	Comments
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-0.01
	Confidence Interval	(2-Sided) 80%; -0.35 to 0.33
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.266
	Estimation Comments

Statistical Analysis 10

Statistical Analysis Overview	Comparison Group Selection	Placebo, PF-04937319 50 mg
	Comments	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.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.2221
	Comments	P-value was 2-sided.
	Method	t-test, 2 sided
	Comments
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	0.32
	Confidence Interval	(2-Sided) 80%; -0.02 to 0.67
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.265
	Estimation Comments

Statistical Analysis 11

Statistical Analysis Overview	Comparison Group Selection	Placebo, PF-04937319 100 mg
	Comments	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.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.2774
	Comments	P-value was 2-sided.
	Method	t-test, 2 sided
	Comments
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	0.28
	Confidence Interval	(2-Sided) 80%; -0.05 to 0.62
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.261
	Estimation Comments

Statistical Analysis 12

Statistical Analysis Overview	Comparison Group Selection	Placebo, Glimepiride
	Comments	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.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments	P-value was 2-sided.
	Method	t-test, 2 sided
	Comments
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	1.09
	Confidence Interval	(2-Sided) 80%; 0.76 to 1.43
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.263
	Estimation Comments

Statistical Analysis 13

Statistical Analysis Overview	Comparison Group Selection	Placebo, PF-04937319 10 mg
	Comments	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.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0667
	Comments	P-value was 2-sided.
	Method	t-test, 2 sided
	Comments
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	0.58
	Confidence Interval	(2-Sided) 80%; 0.17 to 0.98
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.314
	Estimation Comments

Statistical Analysis 14

Statistical Analysis Overview	Comparison Group Selection	Placebo, PF-04937319 50 mg
	Comments	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.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0133
	Comments	P-value was 2-sided.
	Method	t-test, 2 sided
	Comments
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	0.78
	Confidence Interval	(2-Sided) 80%; 0.38 to 1.19
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.314
	Estimation Comments

Statistical Analysis 15

Statistical Analysis Overview	Comparison Group Selection	Placebo, PF-04937319 100 mg
	Comments	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.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0260
	Comments	P-value was 2-sided.
	Method	t-test, 2 sided
	Comments
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	0.69
	Confidence Interval	(2-Sided) 80%; 0.29 to 1.08
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.308
	Estimation Comments

Statistical Analysis 16

Statistical Analysis Overview	Comparison Group Selection	Placebo, Glimepiride
	Comments	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.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments	P-value was 2-sided.
	Method	t-test, 2 sided
	Comments
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	1.63
	Confidence Interval	(2-Sided) 80%; 1.23 to 2.02
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.310
	Estimation Comments

Statistical Analysis 17

Statistical Analysis Overview	Comparison Group Selection	Placebo, PF-04937319 10 mg
	Comments	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.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0335
	Comments	P-value was 2-sided.
	Method	t-test, 2 sided
	Comments
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	0.80
	Confidence Interval	(2-Sided) 80%; 0.32 to 1.28
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.374
	Estimation Comments

Statistical Analysis 18

Statistical Analysis Overview	Comparison Group Selection	Placebo, PF-04937319 50 mg
	Comments	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.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.1557
	Comments	P-value was 2-sided.
	Method	t-test, 2 sided
	Comments
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	0.53
	Confidence Interval	(2-Sided) 80%; 0.05 to 1.01
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.373
	Estimation Comments

Statistical Analysis 19

Statistical Analysis Overview	Comparison Group Selection	Placebo, PF-04937319 100 mg
	Comments	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.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0132
	Comments	P-value was 2-sided.
	Method	t-test, 2 sided
	Comments
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	0.92
	Confidence Interval	(2-Sided) 80%; 0.45 to 1.39
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.368
	Estimation Comments

Statistical Analysis 20

Statistical Analysis Overview	Comparison Group Selection	Placebo, Glimepiride
	Comments	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.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments	P-value was 2-sided.
	Method	t-test, 2 sided
	Comments
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	2.68
	Confidence Interval	(2-Sided) 80%; 2.20 to 3.15
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.370
	Estimation Comments

Statistical Analysis 21

Statistical Analysis Overview	Comparison Group Selection	Placebo, PF-04937319 10 mg
	Comments	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.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0158
	Comments	P-value was 2-sided.
	Method	t-test, 2 sided
	Comments
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	0.96
	Confidence Interval	(2-Sided) 80%; 0.45 to 1.46
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.394
	Estimation Comments

Statistical Analysis 22

Statistical Analysis Overview	Comparison Group Selection	Placebo, PF-04937319 50 mg
	Comments	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.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.2132
	Comments	P-value was 2-sided.
	Method	t-test, 2 sided
	Comments
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	0.49
	Confidence Interval	(2-Sided) 80%; -0.01 to 0.99
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.392
	Estimation Comments

Statistical Analysis 23

Statistical Analysis Overview	Comparison Group Selection	Placebo, PF-04937319 100 mg
	Comments	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.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0263
	Comments	P-value was 2-sided.
	Method	t-test, 2 sided
	Comments
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	0.86
	Confidence Interval	(2-Sided) 80%; 0.37 to 1.36
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.387
	Estimation Comments

Statistical Analysis 24

Statistical Analysis Overview	Comparison Group Selection	Placebo, Glimepiride
	Comments	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.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments	P-value was 2-sided.
	Method	t-test, 2 sided
	Comments
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	2.62
	Confidence Interval	(2-Sided) 80%; 2.12 to 3.12
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.390
	Estimation Comments

12. Secondary Outcome

Title	Number of Participants With Abnormal Laboratory Values
Description	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).
Time Frame	Baseline (Day 1) up to Week 14

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Placebo	PF-04937319 10 mg	PF-04937319 50 mg	PF-04937319 100 mg	Glimepiride
Arm/Group Description	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.	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.	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.	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.	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.
Measure Participants	60	60	60	61	61
Number [participants]	56 91.8%	52 86.7%	56 91.8%	54 88.5%	51 83.6%

Adverse Events

Adverse Event Reporting 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).
Arm/Group Title	Metformin 500 mg		Placebo		PF-04937319 10 mg		PF-04937319 50 mg		PF-04937319 100 mg		Glimepiride
Arm/Group Description	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.		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.		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.		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.		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.		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.
All Cause Mortality
	Metformin 500 mg		Placebo		PF-04937319 10 mg		PF-04937319 50 mg		PF-04937319 100 mg		Glimepiride
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Metformin 500 mg		Placebo		PF-04937319 10 mg		PF-04937319 50 mg		PF-04937319 100 mg		Glimepiride
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	4/361 (1.1%)		0/61 (0%)		1/60 (1.7%)		2/61 (3.3%)		1/61 (1.6%)		1/61 (1.6%)
Cardiac disorders
Aortic valve incompetence	0/361 (0%)		0/61 (0%)		1/60 (1.7%)		0/61 (0%)		0/61 (0%)		0/61 (0%)
Cardiac failure congestive	0/361 (0%)		0/61 (0%)		0/60 (0%)		0/61 (0%)		0/61 (0%)		1/61 (1.6%)
General disorders
Death	1/361 (0.3%)		0/61 (0%)		0/60 (0%)		0/61 (0%)		0/61 (0%)		0/61 (0%)
Infections and infestations
Cellulitis	0/361 (0%)		0/61 (0%)		1/60 (1.7%)		0/61 (0%)		0/61 (0%)		0/61 (0%)
Pneumonia	1/361 (0.3%)		0/61 (0%)		0/60 (0%)		0/61 (0%)		0/61 (0%)		0/61 (0%)
Sepsis syndrome	0/361 (0%)		0/61 (0%)		1/60 (1.7%)		0/61 (0%)		0/61 (0%)		0/61 (0%)
Injury, poisoning and procedural complications
Ankle fracture	0/361 (0%)		0/61 (0%)		0/60 (0%)		1/61 (1.6%)		0/61 (0%)		0/61 (0%)
Metabolism and nutrition disorders
Dehydration	1/361 (0.3%)		0/61 (0%)		0/60 (0%)		0/61 (0%)		0/61 (0%)		0/61 (0%)
Hyperglycaemia	1/361 (0.3%)		0/61 (0%)		0/60 (0%)		0/61 (0%)		0/61 (0%)		0/61 (0%)
Musculoskeletal and connective tissue disorders
Pain in extremity	1/361 (0.3%)		0/61 (0%)		0/60 (0%)		0/61 (0%)		0/61 (0%)		0/61 (0%)
Nervous system disorders
Presyncope	1/361 (0.3%)		0/61 (0%)		0/60 (0%)		0/61 (0%)		0/61 (0%)		0/61 (0%)
Psychiatric disorders
Alcohol abuse	1/361 (0.3%)		0/61 (0%)		0/60 (0%)		0/61 (0%)		0/61 (0%)		0/61 (0%)
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease	0/361 (0%)		0/61 (0%)		0/60 (0%)		0/61 (0%)		1/61 (1.6%)		0/61 (0%)
Vascular disorders
Aortic aneurysm	0/361 (0%)		0/61 (0%)		1/60 (1.7%)		0/61 (0%)		0/61 (0%)		0/61 (0%)
Deep vein thrombosis	0/361 (0%)		0/61 (0%)		0/60 (0%)		1/61 (1.6%)		0/61 (0%)		0/61 (0%)
Other (Not Including Serious) Adverse Events
	Metformin 500 mg		Placebo		PF-04937319 10 mg		PF-04937319 50 mg		PF-04937319 100 mg		Glimepiride
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	63/361 (17.5%)		26/61 (42.6%)		28/60 (46.7%)		31/61 (50.8%)		29/61 (47.5%)		36/61 (59%)
Blood and lymphatic system disorders
Anaemia	0/361 (0%)		0/61 (0%)		0/60 (0%)		2/61 (3.3%)		0/61 (0%)		0/61 (0%)
Leukocytosis	0/361 (0%)		0/61 (0%)		1/60 (1.7%)		0/61 (0%)		0/61 (0%)		0/61 (0%)
Leukopenia	0/361 (0%)		1/61 (1.6%)		0/60 (0%)		0/61 (0%)		0/61 (0%)		0/61 (0%)
Neutrophilia	0/361 (0%)		0/61 (0%)		1/60 (1.7%)		0/61 (0%)		0/61 (0%)		0/61 (0%)
Thrombocytosis	0/361 (0%)		0/61 (0%)		1/60 (1.7%)		0/61 (0%)		0/61 (0%)		0/61 (0%)
Cardiac disorders
Myocardial ischaemia	0/361 (0%)		0/61 (0%)		1/60 (1.7%)		0/61 (0%)		0/61 (0%)		0/61 (0%)
Palpitations	0/361 (0%)		0/61 (0%)		1/60 (1.7%)		0/61 (0%)		0/61 (0%)		0/61 (0%)
Sinus tachycardia	0/361 (0%)		0/61 (0%)		0/60 (0%)		0/61 (0%)		1/61 (1.6%)		0/61 (0%)
Ventricular extrasystoles	0/361 (0%)		1/61 (1.6%)		1/60 (1.7%)		0/61 (0%)		0/61 (0%)		0/61 (0%)
Ear and labyrinth disorders
Cerumen impaction	0/361 (0%)		0/61 (0%)		1/60 (1.7%)		0/61 (0%)		0/61 (0%)		0/61 (0%)
Ear pain	0/361 (0%)		0/61 (0%)		0/60 (0%)		0/61 (0%)		1/61 (1.6%)		0/61 (0%)
Vertigo	0/361 (0%)		0/61 (0%)		1/60 (1.7%)		0/61 (0%)		0/61 (0%)		0/61 (0%)
Eye disorders
Chalazion	1/361 (0.3%)		0/61 (0%)		0/60 (0%)		0/61 (0%)		1/61 (1.6%)		0/61 (0%)
Conjunctivitis	1/361 (0.3%)		1/61 (1.6%)		1/60 (1.7%)		1/61 (1.6%)		1/61 (1.6%)		0/61 (0%)
Eye pain	0/361 (0%)		1/61 (1.6%)		0/60 (0%)		0/61 (0%)		0/61 (0%)		0/61 (0%)
Lacrimation decreased	1/361 (0.3%)		0/61 (0%)		0/60 (0%)		1/61 (1.6%)		0/61 (0%)		0/61 (0%)
Vision blurred	0/361 (0%)		0/61 (0%)		0/60 (0%)		0/61 (0%)		0/61 (0%)		1/61 (1.6%)
Gastrointestinal disorders
Abdominal discomfort	1/361 (0.3%)		0/61 (0%)		0/60 (0%)		1/61 (1.6%)		0/61 (0%)		1/61 (1.6%)
Abdominal distension	2/361 (0.6%)		0/61 (0%)		1/60 (1.7%)		0/61 (0%)		1/61 (1.6%)		1/61 (1.6%)
Abdominal pain	1/361 (0.3%)		0/61 (0%)		0/60 (0%)		1/61 (1.6%)		0/61 (0%)		0/61 (0%)
Abdominal pain upper	0/361 (0%)		0/61 (0%)		1/60 (1.7%)		0/61 (0%)		0/61 (0%)		1/61 (1.6%)
Bowel movement irregularity	0/361 (0%)		0/61 (0%)		0/60 (0%)		0/61 (0%)		0/61 (0%)		1/61 (1.6%)
Constipation	0/361 (0%)		0/61 (0%)		0/60 (0%)		1/61 (1.6%)		0/61 (0%)		0/61 (0%)
Dental caries	0/361 (0%)		0/61 (0%)		0/60 (0%)		0/61 (0%)		1/61 (1.6%)		0/61 (0%)
Diarrhoea	6/361 (1.7%)		2/61 (3.3%)		4/60 (6.7%)		2/61 (3.3%)		2/61 (3.3%)		4/61 (6.6%)
Dry mouth	1/361 (0.3%)		0/61 (0%)		0/60 (0%)		0/61 (0%)		0/61 (0%)		1/61 (1.6%)
Dyspepsia	0/361 (0%)		0/61 (0%)		0/60 (0%)		0/61 (0%)		0/61 (0%)		1/61 (1.6%)
Eructation	0/361 (0%)		0/61 (0%)		0/60 (0%)		0/61 (0%)		0/61 (0%)		1/61 (1.6%)
Flatulence	1/361 (0.3%)		0/61 (0%)		1/60 (1.7%)		0/61 (0%)		0/61 (0%)		0/61 (0%)
Frequent bowel movements	0/361 (0%)		0/61 (0%)		0/60 (0%)		0/61 (0%)		1/61 (1.6%)		0/61 (0%)
Gastrooesophageal reflux disease	0/361 (0%)		0/61 (0%)		0/60 (0%)		0/61 (0%)		1/61 (1.6%)		0/61 (0%)
Haematochezia	0/361 (0%)		0/61 (0%)		0/60 (0%)		0/61 (0%)		0/61 (0%)		1/61 (1.6%)
Hyperchlorhydria	0/361 (0%)		2/61 (3.3%)		0/60 (0%)		1/61 (1.6%)		0/61 (0%)		0/61 (0%)
Nausea	2/361 (0.6%)		2/61 (3.3%)		2/60 (3.3%)		0/61 (0%)		1/61 (1.6%)		1/61 (1.6%)
Toothache	0/361 (0%)		0/61 (0%)		2/60 (3.3%)		0/61 (0%)		0/61 (0%)		0/61 (0%)
Vomiting	0/361 (0%)		1/61 (1.6%)		0/60 (0%)		1/61 (1.6%)		2/61 (3.3%)		0/61 (0%)
General disorders
Fatigue	2/361 (0.6%)		1/61 (1.6%)		1/60 (1.7%)		1/61 (1.6%)		1/61 (1.6%)		1/61 (1.6%)
Irritability	0/361 (0%)		1/61 (1.6%)		0/60 (0%)		0/61 (0%)		0/61 (0%)		0/61 (0%)
Pain	0/361 (0%)		1/61 (1.6%)		0/60 (0%)		0/61 (0%)		0/61 (0%)		0/61 (0%)
Thirst	0/361 (0%)		0/61 (0%)		0/60 (0%)		1/61 (1.6%)		0/61 (0%)		0/61 (0%)
Immune system disorders
Drug hypersensitivity	0/361 (0%)		0/61 (0%)		0/60 (0%)		1/61 (1.6%)		0/61 (0%)		0/61 (0%)
Infections and infestations
Abscess intestinal	1/361 (0.3%)		0/61 (0%)		0/60 (0%)		0/61 (0%)		0/61 (0%)		0/61 (0%)
Bronchitis	0/361 (0%)		0/61 (0%)		0/60 (0%)		1/61 (1.6%)		0/61 (0%)		1/61 (1.6%)
Cellulitis	0/361 (0%)		0/61 (0%)		1/60 (1.7%)		0/61 (0%)		0/61 (0%)		0/61 (0%)
Cystitis	1/361 (0.3%)		1/61 (1.6%)		0/60 (0%)		0/61 (0%)		0/61 (0%)		0/61 (0%)
Dermatophytosis	0/361 (0%)		0/61 (0%)		0/60 (0%)		1/61 (1.6%)		0/61 (0%)		0/61 (0%)
Folliculitis	1/361 (0.3%)		0/61 (0%)		0/60 (0%)		0/61 (0%)		2/61 (3.3%)		0/61 (0%)
Fungal infection	0/361 (0%)		1/61 (1.6%)		0/60 (0%)		0/61 (0%)		0/61 (0%)		0/61 (0%)
Furuncle	0/361 (0%)		0/61 (0%)		1/60 (1.7%)		0/61 (0%)		0/61 (0%)		0/61 (0%)
Gastritis viral	1/361 (0.3%)		0/61 (0%)		0/60 (0%)		0/61 (0%)		0/61 (0%)		0/61 (0%)
Gastroenteritis	1/361 (0.3%)		1/61 (1.6%)		1/60 (1.7%)		1/61 (1.6%)		1/61 (1.6%)		0/61 (0%)
Gastrointestinal viral infection	0/361 (0%)		0/61 (0%)		1/60 (1.7%)		0/61 (0%)		0/61 (0%)		0/61 (0%)
Hordeolum	1/361 (0.3%)		0/61 (0%)		0/60 (0%)		0/61 (0%)		1/61 (1.6%)		0/61 (0%)
Influenza	1/361 (0.3%)		0/61 (0%)		0/60 (0%)		2/61 (3.3%)		1/61 (1.6%)		0/61 (0%)
Laryngitis	0/361 (0%)		0/61 (0%)		0/60 (0%)		0/61 (0%)		0/61 (0%)		1/61 (1.6%)
Nasopharyngitis	3/361 (0.8%)		2/61 (3.3%)		3/60 (5%)		2/61 (3.3%)		1/61 (1.6%)		0/61 (0%)
Oral herpes	0/361 (0%)		0/61 (0%)		0/60 (0%)		0/61 (0%)		1/61 (1.6%)		0/61 (0%)
Orchitis	1/361 (0.3%)		0/61 (0%)		1/60 (1.7%)		0/61 (0%)		0/61 (0%)		0/61 (0%)
Rectal abscess	0/361 (0%)		0/61 (0%)		1/60 (1.7%)		0/61 (0%)		0/61 (0%)		0/61 (0%)
Rhinitis	0/361 (0%)		1/61 (1.6%)		0/60 (0%)		0/61 (0%)		0/61 (0%)		0/61 (0%)
Subcutaneous abscess	0/361 (0%)		1/61 (1.6%)		0/60 (0%)		0/61 (0%)		0/61 (0%)		0/61 (0%)
Tinea pedis	0/361 (0%)		0/61 (0%)		1/60 (1.7%)		0/61 (0%)		0/61 (0%)		0/61 (0%)
Tooth abscess	0/361 (0%)		0/61 (0%)		0/60 (0%)		0/61 (0%)		0/61 (0%)		1/61 (1.6%)
Tooth infection	0/361 (0%)		0/61 (0%)		0/60 (0%)		1/61 (1.6%)		0/61 (0%)		0/61 (0%)
Upper respiratory tract infection	4/361 (1.1%)		1/61 (1.6%)		3/60 (5%)		0/61 (0%)		2/61 (3.3%)		3/61 (4.9%)
Urinary tract infection	1/361 (0.3%)		1/61 (1.6%)		1/60 (1.7%)		2/61 (3.3%)		1/61 (1.6%)		1/61 (1.6%)
Vaginal infection	0/361 (0%)		0/61 (0%)		0/60 (0%)		1/61 (1.6%)		0/61 (0%)		0/61 (0%)
Vaginitis bacterial	0/361 (0%)		0/61 (0%)		0/60 (0%)		0/61 (0%)		1/61 (1.6%)		0/61 (0%)
Viral pharyngitis	0/361 (0%)		0/61 (0%)		1/60 (1.7%)		0/61 (0%)		0/61 (0%)		0/61 (0%)
Injury, poisoning and procedural complications
Arthropod bite	1/361 (0.3%)		0/61 (0%)		1/60 (1.7%)		0/61 (0%)		0/61 (0%)		0/61 (0%)
Epicondylitis	0/361 (0%)		0/61 (0%)		1/60 (1.7%)		0/61 (0%)		0/61 (0%)		0/61 (0%)
Fall	0/361 (0%)		1/61 (1.6%)		0/60 (0%)		0/61 (0%)		1/61 (1.6%)		0/61 (0%)
Foot fracture	1/361 (0.3%)		0/61 (0%)		0/60 (0%)		0/61 (0%)		0/61 (0%)		1/61 (1.6%)
Laceration	0/361 (0%)		0/61 (0%)		2/60 (3.3%)		0/61 (0%)		0/61 (0%)		0/61 (0%)
Ligament sprain	0/361 (0%)		0/61 (0%)		0/60 (0%)		0/61 (0%)		1/61 (1.6%)		0/61 (0%)
Post-traumatic neck syndrome	0/361 (0%)		0/61 (0%)		0/60 (0%)		1/61 (1.6%)		0/61 (0%)		0/61 (0%)
Road traffic accident	0/361 (0%)		0/61 (0%)		0/60 (0%)		0/61 (0%)		1/61 (1.6%)		0/61 (0%)
Investigations
Alanine aminotransferase increased	0/361 (0%)		1/61 (1.6%)		0/60 (0%)		0/61 (0%)		0/61 (0%)		0/61 (0%)
Aspartate aminotransferase increased	0/361 (0%)		1/61 (1.6%)		0/60 (0%)		0/61 (0%)		0/61 (0%)		0/61 (0%)
Blood bilirubin increased	0/361 (0%)		0/61 (0%)		1/60 (1.7%)		1/61 (1.6%)		0/61 (0%)		0/61 (0%)
Blood creatine phosphokinase increased	1/361 (0.3%)		1/61 (1.6%)		0/60 (0%)		0/61 (0%)		0/61 (0%)		0/61 (0%)
Blood glucose increased	1/361 (0.3%)		0/61 (0%)		0/60 (0%)		0/61 (0%)		0/61 (0%)		0/61 (0%)
Electrocardiogram QT prolonged	0/361 (0%)		1/61 (1.6%)		0/60 (0%)		0/61 (0%)		1/61 (1.6%)		0/61 (0%)
Electrocardiogram T wave inversion	1/361 (0.3%)		0/61 (0%)		0/60 (0%)		0/61 (0%)		0/61 (0%)		0/61 (0%)
Glucose urine present	1/361 (0.3%)		0/61 (0%)		0/60 (0%)		1/61 (1.6%)		0/61 (0%)		1/61 (1.6%)
Haemoglobin decreased	1/361 (0.3%)		0/61 (0%)		0/60 (0%)		0/61 (0%)		1/61 (1.6%)		0/61 (0%)
Hepatic enzyme increased	1/361 (0.3%)		0/61 (0%)		0/60 (0%)		0/61 (0%)		0/61 (0%)		0/61 (0%)
Metabolism and nutrition disorders
Decreased appetite	1/361 (0.3%)		0/61 (0%)		1/60 (1.7%)		0/61 (0%)		1/61 (1.6%)		0/61 (0%)
Hyperglycaemia	5/361 (1.4%)		0/61 (0%)		0/60 (0%)		1/61 (1.6%)		0/61 (0%)		0/61 (0%)
Hyperkalaemia	1/361 (0.3%)		0/61 (0%)		1/60 (1.7%)		0/61 (0%)		0/61 (0%)		0/61 (0%)
Hypertriglyceridaemia	1/361 (0.3%)		1/61 (1.6%)		1/60 (1.7%)		0/61 (0%)		0/61 (0%)		0/61 (0%)
Hyperuricaemia	1/361 (0.3%)		0/61 (0%)		1/60 (1.7%)		0/61 (0%)		1/61 (1.6%)		0/61 (0%)
Hypochloraemia	0/361 (0%)		1/61 (1.6%)		1/60 (1.7%)		0/61 (0%)		0/61 (0%)		0/61 (0%)
Hypoglycaemia	3/361 (0.8%)		3/61 (4.9%)		2/60 (3.3%)		3/61 (4.9%)		5/61 (8.2%)		21/61 (34.4%)
Hypokalaemia	0/361 (0%)		0/61 (0%)		0/60 (0%)		0/61 (0%)		1/61 (1.6%)		0/61 (0%)
Hypolipidaemia	1/361 (0.3%)		0/61 (0%)		1/60 (1.7%)		3/61 (4.9%)		0/61 (0%)		0/61 (0%)
Hyponatraemia	0/361 (0%)		1/61 (1.6%)		1/60 (1.7%)		0/61 (0%)		0/61 (0%)		0/61 (0%)
Increased appetite	0/361 (0%)		0/61 (0%)		0/60 (0%)		0/61 (0%)		0/61 (0%)		1/61 (1.6%)
Vitamin D deficiency	1/361 (0.3%)		0/61 (0%)		0/60 (0%)		0/61 (0%)		0/61 (0%)		1/61 (1.6%)
Musculoskeletal and connective tissue disorders
Arthralgia	0/361 (0%)		1/61 (1.6%)		0/60 (0%)		0/61 (0%)		0/61 (0%)		1/61 (1.6%)
Back pain	0/361 (0%)		1/61 (1.6%)		1/60 (1.7%)		1/61 (1.6%)		0/61 (0%)		1/61 (1.6%)
Bursitis	0/361 (0%)		0/61 (0%)		0/60 (0%)		0/61 (0%)		0/61 (0%)		1/61 (1.6%)
Flank pain	0/361 (0%)		1/61 (1.6%)		0/60 (0%)		0/61 (0%)		0/61 (0%)		0/61 (0%)
Haemarthrosis	0/361 (0%)		0/61 (0%)		0/60 (0%)		0/61 (0%)		1/61 (1.6%)		0/61 (0%)
Intervertebral disc protrusion	0/361 (0%)		0/61 (0%)		1/60 (1.7%)		0/61 (0%)		0/61 (0%)		0/61 (0%)
Muscle spasms	0/361 (0%)		1/61 (1.6%)		0/60 (0%)		0/61 (0%)		0/61 (0%)		0/61 (0%)
Musculoskeletal chest pain	0/361 (0%)		0/61 (0%)		1/60 (1.7%)		0/61 (0%)		0/61 (0%)		0/61 (0%)
Musculoskeletal pain	1/361 (0.3%)		0/61 (0%)		0/60 (0%)		1/61 (1.6%)		1/61 (1.6%)		3/61 (4.9%)
Myalgia	1/361 (0.3%)		0/61 (0%)		0/60 (0%)		0/61 (0%)		2/61 (3.3%)		0/61 (0%)
Neck pain	1/361 (0.3%)		1/61 (1.6%)		1/60 (1.7%)		0/61 (0%)		0/61 (0%)		0/61 (0%)
Pain in extremity	1/361 (0.3%)		0/61 (0%)		0/60 (0%)		1/61 (1.6%)		1/61 (1.6%)		0/61 (0%)
Pain in jaw	1/361 (0.3%)		2/61 (3.3%)		0/60 (0%)		0/61 (0%)		0/61 (0%)		0/61 (0%)
Plantar fasciitis	1/361 (0.3%)		0/61 (0%)		1/60 (1.7%)		0/61 (0%)		0/61 (0%)		0/61 (0%)
Polyarthritis	0/361 (0%)		0/61 (0%)		0/60 (0%)		1/61 (1.6%)		0/61 (0%)		0/61 (0%)
Rotator cuff syndrome	0/361 (0%)		0/61 (0%)		0/60 (0%)		0/61 (0%)		0/61 (0%)		1/61 (1.6%)
Tendonitis	0/361 (0%)		0/61 (0%)		0/60 (0%)		0/61 (0%)		1/61 (1.6%)		0/61 (0%)
Nervous system disorders
Benign intracranial hypertension	0/361 (0%)		0/61 (0%)		0/60 (0%)		1/61 (1.6%)		0/61 (0%)		0/61 (0%)
Dizziness	2/361 (0.6%)		1/61 (1.6%)		2/60 (3.3%)		1/61 (1.6%)		0/61 (0%)		1/61 (1.6%)
Headache	3/361 (0.8%)		2/61 (3.3%)		1/60 (1.7%)		2/61 (3.3%)		2/61 (3.3%)		0/61 (0%)
Hypoaesthesia	0/361 (0%)		1/61 (1.6%)		0/60 (0%)		1/61 (1.6%)		1/61 (1.6%)		0/61 (0%)
Memory impairment	0/361 (0%)		1/61 (1.6%)		0/60 (0%)		0/61 (0%)		0/61 (0%)		0/61 (0%)
Migraine	0/361 (0%)		1/61 (1.6%)		0/60 (0%)		0/61 (0%)		0/61 (0%)		0/61 (0%)
Nerve compression	0/361 (0%)		0/61 (0%)		0/60 (0%)		0/61 (0%)		0/61 (0%)		1/61 (1.6%)
Paraesthesia	0/361 (0%)		1/61 (1.6%)		0/60 (0%)		0/61 (0%)		1/61 (1.6%)		0/61 (0%)
Radicular pain	0/361 (0%)		0/61 (0%)		0/60 (0%)		0/61 (0%)		0/61 (0%)		1/61 (1.6%)
Sinus headache	0/361 (0%)		0/61 (0%)		1/60 (1.7%)		0/61 (0%)		0/61 (0%)		0/61 (0%)
Tension headache	0/361 (0%)		0/61 (0%)		0/60 (0%)		0/61 (0%)		0/61 (0%)		1/61 (1.6%)
Psychiatric disorders
Anxiety	0/361 (0%)		0/61 (0%)		0/60 (0%)		2/61 (3.3%)		0/61 (0%)		0/61 (0%)
Depressed mood	1/361 (0.3%)		0/61 (0%)		0/60 (0%)		1/61 (1.6%)		0/61 (0%)		0/61 (0%)
Depression	0/361 (0%)		1/61 (1.6%)		1/60 (1.7%)		0/61 (0%)		0/61 (0%)		0/61 (0%)
Insomnia	2/361 (0.6%)		0/61 (0%)		0/60 (0%)		0/61 (0%)		1/61 (1.6%)		0/61 (0%)
Renal and urinary disorders
Haematuria	1/361 (0.3%)		0/61 (0%)		0/60 (0%)		1/61 (1.6%)		0/61 (0%)		0/61 (0%)
Microalbuminuria	0/361 (0%)		0/61 (0%)		0/60 (0%)		1/61 (1.6%)		0/61 (0%)		0/61 (0%)
Nephrolithiasis	2/361 (0.6%)		0/61 (0%)		0/60 (0%)		0/61 (0%)		0/61 (0%)		0/61 (0%)
Nocturia	0/361 (0%)		0/61 (0%)		0/60 (0%)		1/61 (1.6%)		0/61 (0%)		0/61 (0%)
Polyuria	0/361 (0%)		0/61 (0%)		0/60 (0%)		1/61 (1.6%)		0/61 (0%)		0/61 (0%)
Proteinuria	1/361 (0.3%)		0/61 (0%)		0/60 (0%)		1/61 (1.6%)		1/61 (1.6%)		1/61 (1.6%)
Reproductive system and breast disorders
Balanitis	1/361 (0.3%)		1/61 (1.6%)		0/60 (0%)		0/61 (0%)		0/61 (0%)		0/61 (0%)
Vulvovaginal pruritus	0/361 (0%)		0/61 (0%)		0/60 (0%)		1/61 (1.6%)		0/61 (0%)		0/61 (0%)
Respiratory, thoracic and mediastinal disorders
Cough	1/361 (0.3%)		0/61 (0%)		0/60 (0%)		0/61 (0%)		2/61 (3.3%)		0/61 (0%)
Oropharyngeal pain	1/361 (0.3%)		0/61 (0%)		1/60 (1.7%)		1/61 (1.6%)		0/61 (0%)		2/61 (3.3%)
Respiratory tract congestion	0/361 (0%)		0/61 (0%)		0/60 (0%)		0/61 (0%)		0/61 (0%)		1/61 (1.6%)
Sinus congestion	0/361 (0%)		0/61 (0%)		0/60 (0%)		0/61 (0%)		0/61 (0%)		1/61 (1.6%)
Throat irritation	0/361 (0%)		0/61 (0%)		0/60 (0%)		0/61 (0%)		0/61 (0%)		1/61 (1.6%)
Skin and subcutaneous tissue disorders
Actinic keratosis	0/361 (0%)		1/61 (1.6%)		0/60 (0%)		0/61 (0%)		0/61 (0%)		0/61 (0%)
Alopecia	0/361 (0%)		0/61 (0%)		1/60 (1.7%)		0/61 (0%)		0/61 (0%)		0/61 (0%)
Dermal cyst	0/361 (0%)		1/61 (1.6%)		0/60 (0%)		0/61 (0%)		0/61 (0%)		0/61 (0%)
Dermatitis	0/361 (0%)		0/61 (0%)		1/60 (1.7%)		0/61 (0%)		0/61 (0%)		0/61 (0%)
Dermatitis contact	1/361 (0.3%)		0/61 (0%)		0/60 (0%)		0/61 (0%)		0/61 (0%)		0/61 (0%)
Ecchymosis	1/361 (0.3%)		0/61 (0%)		1/60 (1.7%)		0/61 (0%)		0/61 (0%)		0/61 (0%)
Eczema	0/361 (0%)		1/61 (1.6%)		0/60 (0%)		0/61 (0%)		0/61 (0%)		0/61 (0%)
Hyperhidrosis	2/361 (0.6%)		0/61 (0%)		0/60 (0%)		0/61 (0%)		1/61 (1.6%)		0/61 (0%)
Ingrowing nail	0/361 (0%)		1/61 (1.6%)		0/60 (0%)		0/61 (0%)		0/61 (0%)		0/61 (0%)
Pruritus	1/361 (0.3%)		0/61 (0%)		0/60 (0%)		1/61 (1.6%)		2/61 (3.3%)		0/61 (0%)
Rash	1/361 (0.3%)		1/61 (1.6%)		1/60 (1.7%)		0/61 (0%)		1/61 (1.6%)		0/61 (0%)
Seborrhoeic dermatitis	0/361 (0%)		0/61 (0%)		0/60 (0%)		1/61 (1.6%)		0/61 (0%)		0/61 (0%)
Skin lesion	0/361 (0%)		1/61 (1.6%)		0/60 (0%)		0/61 (0%)		1/61 (1.6%)		0/61 (0%)
Skin ulcer	0/361 (0%)		0/61 (0%)		1/60 (1.7%)		0/61 (0%)		0/61 (0%)		0/61 (0%)
Swelling face	0/361 (0%)		1/61 (1.6%)		0/60 (0%)		0/61 (0%)		0/61 (0%)		0/61 (0%)
Vascular disorders
Haematoma	0/361 (0%)		0/61 (0%)		0/60 (0%)		0/61 (0%)		1/61 (1.6%)		0/61 (0%)
Haemorrhage	0/361 (0%)		1/61 (1.6%)		0/60 (0%)		0/61 (0%)		0/61 (0%)		0/61 (0%)
Hot flush	0/361 (0%)		0/61 (0%)		0/60 (0%)		0/61 (0%)		0/61 (0%)		1/61 (1.6%)
Hypertension	0/361 (0%)		1/61 (1.6%)		2/60 (3.3%)		0/61 (0%)		2/61 (3.3%)		0/61 (0%)
Peripheral coldness	0/361 (0%)		0/61 (0%)		0/60 (0%)		0/61 (0%)		1/61 (1.6%)		0/61 (0%)
Thrombophlebitis	1/361 (0.3%)		0/61 (0%)		0/60 (0%)		0/61 (0%)		1/61 (1.6%)		0/61 (0%)

Limitations/Caveats

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Principal Investigators are NOT employed by the organization sponsoring the study.

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.