Study Of Safety And Efficacy Of PF-04991532 In Subjects W... | NCT01336738

Label	Type	Description	Intervention Names
Placebo	Placebo Comparator	Matching placebo for PF-04991532 and Sitagliptin	Drug: Placebo
150 mg PF-04991532	Experimental		Drug: 150 mg PF-04991532
450 mg PF-04991532	Experimental		Drug: 450 mg PF-04991532
750 mg PF-04991532	Experimental		Drug: 750 mg PF-04991532
Sitagliptin 100 mg	Active Comparator		Drug: Sitagliptin 100 mg

Name	Type	Description	Arm Group Labels	Other Names
Placebo	Drug	Tablets (n=6), 0 mg, once daily for 84 days	Placebo
150 mg PF-04991532

Measure	Description	Time Frame
Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 12	HbA1c is a form of hemoglobin which is measured primarily to identify the average plasma glucose concentration over prolonged periods of time. The normal range for the HbA1c test is between 4 percent (%) and 5.6%. HbA1c levels between 5.7% and 6.4% indicate increased risk of diabetes and levels of 6.5% or higher indicate diabetes.	Baseline, Week 12

Measure	Description	Time Frame
Change From Baseline in Fasting Plasma Glucose at Week 1, 2, 4, 8 and 12		Baseline, Week 1, 2, 4, 8, 12
Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 1, 2, 4 and 8	HbA1c is a form of hemoglobin which is measured primarily to identify the average plasma glucose concentration over prolonged periods of time. The normal range for the HbA1c test is between 4% and 5.6%. HbA1c levels between 5.7% and 6.4% indicate increased risk of diabetes and levels of 6.5% or higher indicate diabetes.

Name	Affiliation	Role
Pfizer CT.gov Call Center	Pfizer	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Pfizer Investigational Site		Jonesboro	Arkansas	72401	United States
Pfizer Investigational Site

Label	URL
To obtain contact information for a study center near you, click here.	View source

ID	Title	Description
FG000	PF-04991532 150 mg	PF-04991532 150 milligram (mg) (1 PF-04991532 150 mg tablet and 4 placebo tablets matched to PF-04991532 150 mg) orally once daily and 1 placebo tablet matched to sitagliptin 100 mg orally once daily, along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 12

HbA1c is a form of hemoglobin which is measured primarily to identify the average plasma glucose concentration over prolonged periods of time. The normal range for the HbA1c test is between 4 percent (%) and 5.6%. HbA1c levels between 5.7% and 6.4% indicate increased risk of diabetes and levels of 6.5% or higher indicate diabetes.

Full analysis set (FAS) included all randomized participants who received at least 1 dose of study medication. Here 'n' signifies participants who were evaluable at specific time point for each treatment arm, respectively.

Posted

Mean

Standard Deviation

percentage of hemoglobin

Baseline, Week 12

ID	Title	Description
OG000	PF-04991532 150 mg	PF-04991532 150 milligram (mg) (1 PF-04991532 150 mg tablet and 4 placebo tablets matched to PF-04991532 150 mg) orally once daily and 1 placebo tablet matched to sitagliptin 100 mg orally once daily, along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
OG001	PF-04991532 450 mg	PF-04991532 450 mg (3 PF-04991532 150 mg tablets and 2 placebo tablets matched to PF-04991532 150 mg) orally once daily and 1 placebo tablet matched to sitagliptin 100 mg orally once daily, along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
OG002	PF-04991532 750 mg	PF-04991532 750 mg (5 PF-04991532 150 mg tablets) orally once daily and 1 placebo tablet matched to sitagliptin 100 mg orally once daily, along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
OG003	Sitagliptin 100 mg	Five placebo tablets matched to PF-04991532 150 mg and 1 sitagliptin 100 mg tablet orally once daily, along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
OG004	Placebo	Five placebo tablets matched to PF-04991532 150 mg and 1 placebo matched to sitagliptin 100 mg tablet orally once daily, along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.

Units	Counts
Participants	OG00052 OG00153 OG00252 OG003

Title

Denominators

Categories

Baseline (n=52, 53, 52, 54, 53)

Title	Measurements
	OG0008.34± 0.906 OG0018.19± 0.947 OG0027.96± 1.030 OG003

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG004	Treatment difference and 80% confidence interval (CI) were based on LS mean. A mixed model repeated measure (MMRM) analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline, baseline-by-time interaction as the covariates, time was repeated for participant.	Mixed Models Analysis		0.6803	One-sided p-value was calculated.	Least Squares (LS) Mean Difference	0.08	Standard Error of the Mean	0.164	2-Sided	80	-0.13	0.29				No	Superiority or Other

Secondary

Change From Baseline in Fasting Plasma Glucose at Week 1, 2, 4, 8 and 12

FAS included all randomized participants who received at least 1 dose of study medication. Here 'n' signifies participants who were evaluable at specific time point for each treatment arm, respectively.

Posted

Mean

Standard Deviation

milligram/deciliter (mg/dL)

Baseline, Week 1, 2, 4, 8, 12

ID	Title	Description
OG000	PF-04991532 150 mg	PF-04991532 150 milligram (mg) (1 PF-04991532 150 mg tablet and 4 placebo tablets matched to PF-04991532 150 mg) orally once daily and 1 placebo tablet matched to sitagliptin 100 mg orally once daily, along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
OG001	PF-04991532 450 mg	PF-04991532 450 mg (3 PF-04991532 150 mg tablets and 2 placebo tablets matched to PF-04991532 150 mg) orally once daily and 1 placebo tablet matched to sitagliptin 100 mg orally once daily, along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
OG002	PF-04991532 750 mg	PF-04991532 750 mg (5 PF-04991532 150 mg tablets) orally once daily and 1 placebo tablet matched to sitagliptin 100 mg orally once daily, along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.

Secondary

Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 1, 2, 4 and 8

HbA1c is a form of hemoglobin which is measured primarily to identify the average plasma glucose concentration over prolonged periods of time. The normal range for the HbA1c test is between 4% and 5.6%. HbA1c levels between 5.7% and 6.4% indicate increased risk of diabetes and levels of 6.5% or higher indicate diabetes.

Posted

Mean

Standard Deviation

percentage of hemoglobin

Baseline, Week 1, 2, 4, 8

ID	Title	Description
OG000	PF-04991532 150 mg	PF-04991532 150 milligram (mg) (1 PF-04991532 150 mg tablet and 4 placebo tablets matched to PF-04991532 150 mg) orally once daily and 1 placebo tablet matched to sitagliptin 100 mg orally once daily, along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
OG001	PF-04991532 450 mg	PF-04991532 450 mg (3 PF-04991532 150 mg tablets and 2 placebo tablets matched to PF-04991532 150 mg) orally once daily and 1 placebo tablet matched to sitagliptin 100 mg orally once daily, along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.

Secondary

Percentage of Participants Achieving Less Than (<) 6.5% or <7% Glycosylated Hemoglobin (HbA1c) Levels

HbA1c is a form of hemoglobin which is measured primarily to identify the average plasma glucose concentration over prolonged periods of time. The normal range for the HbA1c test is between 4% and 5.6%. HbA1c levels between 5.7% and 6.4% indicate increased risk of diabetes and levels of 6.5% or higher indicate diabetes.

FAS included all randomized participants who received at least 1 dose of study medication. Here, N (number of participants analyzed) signify those who were evaluable for this measure.

Posted

Number

percentage of participants

Week 12

ID	Title	Description
OG000	PF-04991532 150 mg	PF-04991532 150 milligram (mg) (1 PF-04991532 150 mg tablet and 4 placebo tablets matched to PF-04991532 150 mg) orally once daily and 1 placebo tablet matched to sitagliptin 100 mg orally once daily, along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
OG001	PF-04991532 450 mg	PF-04991532 450 mg (3 PF-04991532 150 mg tablets and 2 placebo tablets matched to PF-04991532 150 mg) orally once daily and 1 placebo tablet matched to sitagliptin 100 mg orally once daily, along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.

Secondary

Change From Baseline in Body Weight at Week 1, 2, 4, 8 and 12

Overweight or obesity increases the risk for developing diabetes. The treatment of diabetes has been the recommendation to lose weight. As weight loss progresses and is maintained, an improvement of glycemia may be evidenced by a reduction in HbA1c.

Posted

Mean

Standard Deviation

kilogram (kg)

Baseline, Week 1, 2, 4, 8, 12

ID	Title	Description
OG000	PF-04991532 150 mg	PF-04991532 150 milligram (mg) (1 PF-04991532 150 mg tablet and 4 placebo tablets matched to PF-04991532 150 mg) orally once daily and 1 placebo tablet matched to sitagliptin 100 mg orally once daily, along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
OG001	PF-04991532 450 mg	PF-04991532 450 mg (3 PF-04991532 150 mg tablets and 2 placebo tablets matched to PF-04991532 150 mg) orally once daily and 1 placebo tablet matched to sitagliptin 100 mg orally once daily, along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.

Secondary

Percentage of Participants With Greater Than or Equal to (>=) 1% or >= 2% Body Weight Gain From Baseline

Overweight or obesity increases the risk for developing diabetes. Participants with >= 1% or >= 2% body weight gain from baseline signifies a higher risk of diabetes.

FAS included all randomized participants who received at least 1 dose of study medication. Here, N (number of participants analyzed) signify those who were evaluable for this measure.

Posted

Number

percentage of participants

Week 12

ID	Title	Description
OG000	PF-04991532 150 mg	PF-04991532 150 milligram (mg) (1 PF-04991532 150 mg tablet and 4 placebo tablets matched to PF-04991532 150 mg) orally once daily and 1 placebo tablet matched to sitagliptin 100 mg orally once daily, along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
OG001	PF-04991532 450 mg	PF-04991532 450 mg (3 PF-04991532 150 mg tablets and 2 placebo tablets matched to PF-04991532 150 mg) orally once daily and 1 placebo tablet matched to sitagliptin 100 mg orally once daily, along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
OG002	PF-04991532 750 mg

Secondary

Percentage of Participants With Greater Than or Equal to (>=) 1% or >= 2% Body Weight Loss From Baseline

The treatment of diabetes has been the recommendation to lose weight. As weight loss progresses and is maintained, an improvement of glycemia may be evidenced by a reduction in HbA1c. Participants with >= 1% or >= 2% body weight loss from baseline signifies an improvement of glycemia.

FAS included all randomized participants who received at least 1 dose of study medication. Here, N (number of participants analyzed) signify those who were evaluable for this measure.

Posted

Number

percentage of participants

Week 12

ID	Title	Description
OG000	PF-04991532 150 mg	PF-04991532 150 milligram (mg) (1 PF-04991532 150 mg tablet and 4 placebo tablets matched to PF-04991532 150 mg) orally once daily and 1 placebo tablet matched to sitagliptin 100 mg orally once daily, along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
OG001	PF-04991532 450 mg	PF-04991532 450 mg (3 PF-04991532 150 mg tablets and 2 placebo tablets matched to PF-04991532 150 mg) orally once daily and 1 placebo tablet matched to sitagliptin 100 mg orally once daily, along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Diarrhoea	Gastrointestinal disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 affected52 at risk EG0011 affected54 at risk EG0027 affected53 at risk EG0032 affected54 at risk EG0040 affected53 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA 15.0	Non-systematic Assessment	EG0002 affected52 at risk EG0010 affected54 at risk EG0021 affected53 at risk EG003
Nausea	Gastrointestinal disorders	MedDRA 15.0	Non-systematic Assessment	EG0002 affected52 at risk EG0014 affected54 at risk EG0024 affected53 at risk EG003
Toothache	Gastrointestinal disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 affected52 at risk EG0010 affected54 at risk EG0022 affected53 at risk EG003
Vomiting	Gastrointestinal disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 affected52 at risk EG0012 affected54 at risk EG0021 affected53 at risk EG003
Influenza	Infections and infestations	MedDRA 15.0	Non-systematic Assessment	EG0002 affected52 at risk EG0011 affected54 at risk EG0020 affected53 at risk EG003
Nasopharyngitis	Infections and infestations	MedDRA 15.0	Non-systematic Assessment	EG0002 affected52 at risk EG0012 affected54 at risk EG0023 affected53 at risk EG003
Pharyngitis	Infections and infestations	MedDRA 15.0	Non-systematic Assessment	EG0000 affected52 at risk EG0010 affected54 at risk EG0022 affected53 at risk EG003
Sinusitis	Infections and infestations	MedDRA 15.0	Non-systematic Assessment	EG0001 affected52 at risk EG0010 affected54 at risk EG0021 affected53 at risk EG003
Upper respiratory tract infection	Infections and infestations	MedDRA 15.0	Non-systematic Assessment	EG0000 affected52 at risk EG0015 affected54 at risk EG0021 affected53 at risk EG003
Urinary tract infection	Infections and infestations	MedDRA 15.0	Non-systematic Assessment	EG0002 affected52 at risk EG0010 affected54 at risk EG0021 affected53 at risk EG003
Contusion	Injury, poisoning and procedural complications	MedDRA 15.0	Non-systematic Assessment	EG0000 affected52 at risk EG0012 affected54 at risk EG0020 affected53 at risk EG003
Blood glucose increased	Investigations	MedDRA 15.0	Non-systematic Assessment	EG0000 affected52 at risk EG0010 affected54 at risk EG0020 affected53 at risk EG003
Dyslipidaemia	Metabolism and nutrition disorders	MedDRA 15.0	Non-systematic Assessment	EG0002 affected52 at risk EG0012 affected54 at risk EG0021 affected53 at risk EG003
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA 15.0	Non-systematic Assessment	EG0003 affected52 at risk EG0011 affected54 at risk EG0023 affected53 at risk EG003
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 affected52 at risk EG0012 affected54 at risk EG0020 affected53 at risk EG003
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 affected52 at risk EG0010 affected54 at risk EG0020 affected53 at risk EG003
Headache	Nervous system disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 affected52 at risk EG0011 affected54 at risk EG0023 affected53 at risk EG003
Insomnia	Psychiatric disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 affected52 at risk EG0010 affected54 at risk EG0020 affected53 at risk EG003
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 affected52 at risk EG0011 affected54 at risk EG0021 affected53 at risk EG003
Hypertension	Vascular disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 affected52 at risk EG0013 affected54 at risk EG0020 affected53 at risk EG003

Group IDs	Group Description	Statistical Method	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	Tested Non-Inferiority	Non-Inferiority Type
OG000 OG004	Week 1: Treatment difference and 95% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.	Mixed Models Analysis	0.4757	Two-sided p-value was calculated.	LS Mean Difference	3.78	Standard Error of the Mean	5.292	2-Sided	95	-6.64	14.20	No	Superiority or Other
OG001 OG004	Week 1: Treatment difference and 95% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.	Mixed Models Analysis	0.8031	Two-sided p-value was calculated.	LS Mean Difference	1.32	Standard Error of the Mean	5.296	2-Sided	95	-9.11	11.75	No	Superiority or Other
OG002 OG004	Week 1: Treatment difference and 95% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.	Mixed Models Analysis	0.5490	Two-sided p-value was calculated.	LS Mean Difference	-3.22	Standard Error of the Mean	5.364	2-Sided	95	-13.78	7.34	No	Superiority or Other
OG003 OG004	Week 1: Treatment difference and 95% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.	Mixed Models Analysis	0.0051	Two-sided p-value was calculated.	LS Mean Difference	-15.07	Standard Error of the Mean	5.340	2-Sided	95	-25.58	-4.55	No	Superiority or Other
OG000 OG004	Week 2: Treatment difference and 95% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.	Mixed Models Analysis	0.6291	Two-sided p-value was calculated.	LS Mean Difference	-2.43	Standard Error of the Mean	5.020	2-Sided	95	-12.31	7.46	No	Superiority or Other
OG001 OG004	Week 2: Treatment difference and 95% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.	Mixed Models Analysis	0.4396	Two-sided p-value was calculated.	LS Mean Difference	3.87	Standard Error of the Mean	5.001	2-Sided	95	-5.98	13.72	No	Superiority or Other
OG002 OG004	Week 2: Treatment difference and 95% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.	Mixed Models Analysis	0.1934	Two-sided p-value was calculated.	LS Mean Difference	-6.56	Standard Error of the Mean	5.030	2-Sided	95	-16.46	3.34	No	Superiority or Other
OG003 OG004	Week 2: Treatment difference and 95% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.	Mixed Models Analysis	0.0007	Two-sided p-value was calculated.	LS Mean Difference	-17.32	Standard Error of the Mean	5.039	2-Sided	95	-27.24	-7.40	No	Superiority or Other
OG000 OG004	Week 4: Treatment difference and 95% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.	Mixed Models Analysis	0.5479	Two-sided p-value was calculated.	LS Mean Difference	3.13	Standard Error of the Mean	5.201	2-Sided	95	-7.11	13.37	No	Superiority or Other
OG001 OG004	Week 4: Treatment difference and 95% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.	Mixed Models Analysis	0.4276	Two-sided p-value was calculated.	LS Mean Difference	-4.14	Standard Error of the Mean	5.209	2-Sided	95	-14.39	6.12	No	Superiority or Other
OG002 OG004	Week 4: Treatment difference and 95% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.	Mixed Models Analysis	0.1596	Two-sided p-value was calculated.	LS Mean Difference	-7.38	Standard Error of the Mean	5.235	2-Sided	95	-17.69	2.92	No	Superiority or Other
OG003 OG004	Week 4: Treatment difference and 95% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.	Mixed Models Analysis	<0.0001	Two-sided p-value was calculated.	LS Mean Difference	-22.83	Standard Error of the Mean	5.198	2-Sided	95	-33.06	-12.60	No	Superiority or Other
OG000 OG004	Week 8: Treatment difference and 95% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.	Mixed Models Analysis	0.8509	Two-sided p-value was calculated.	LS Mean Difference	-1.10	Standard Error of the Mean	5.855	2-Sided	95	-12.63	10.43	No	Superiority or Other
OG001 OG004	Week 8: Treatment difference and 95% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.	Mixed Models Analysis	0.1505	Two-sided p-value was calculated.	LS Mean Difference	-8.53	Standard Error of the Mean	5.913	2-Sided	95	-20.17	3.12	No	Superiority or Other
OG002 OG004	Week 8: Treatment difference and 95% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.	Mixed Models Analysis	0.2662	Two-sided p-value was calculated.	LS Mean Difference	-6.62	Standard Error of the Mean	5.940	2-Sided	95	-18.31	5.08	No	Superiority or Other
OG003 OG004	Week 8: Treatment difference and 95% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.	Mixed Models Analysis	0.0003	Two-sided p-value was calculated.	LS Mean Difference	-21.52	Standard Error of the Mean	5.818	2-Sided	95	-32.97	-10.07	No	Superiority or Other
OG000 OG004	Week 12: Treatment difference and 95% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.	Mixed Models Analysis	0.7724	Two-sided p-value was calculated.	LS Mean Difference	-2.01	Standard Error of the Mean	6.940	2-Sided	95	-15.68	11.66	No	Superiority or Other
OG001 OG004	Week 12: Treatment difference and 95% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.	Mixed Models Analysis	0.9202	Two-sided p-value was calculated.	LS Mean Difference	-0.70	Standard Error of the Mean	6.986	2-Sided	95	-14.47	13.07	No	Superiority or Other
OG002 OG004	Week 12: Treatment difference and 95% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.	Mixed Models Analysis	0.8183	Two-sided p-value was calculated.	LS Mean Difference	-1.61	Standard Error of the Mean	6.998	2-Sided	95	-15.40	12.18	No	Superiority or Other
OG003 OG004	Week 12: Treatment difference and 95% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.	Mixed Models Analysis	0.0003	Two-sided p-value was calculated.	LS Mean Difference	-24.96	Standard Error of the Mean	6.821	2-Sided	95	-38.40	-11.53	No	Superiority or Other

ID	Term
D003920	Diabetes Mellitus
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D004700	Endocrine System Diseases

ID	Term
C571532	6-(3-cyclopentyl-2-(4-(trifluoromethyl)-1H-imidazol-1-yl)propanamido)nicotinic acid
D000068900	Sitagliptin Phosphate

ID	Term
D014230	Triazoles
D001393	Azoles
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds
D011719	Pyrazines

ID	Title	Description
BG000	PF-04991532 150 mg	PF-04991532 150 milligram (mg) (1 PF-04991532 150 mg tablet and 4 placebo tablets matched to PF-04991532 150 mg) orally once daily and 1 placebo tablet matched to sitagliptin 100 mg orally once daily, along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
BG001	PF-04991532 450 mg	PF-04991532 450 mg (3 PF-04991532 150 mg tablets and 2 placebo tablets matched to PF-04991532 150 mg) orally once daily and 1 placebo tablet matched to sitagliptin 100 mg orally once daily, along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
BG002	PF-04991532 750 mg	PF-04991532 750 mg (5 PF-04991532 150 mg tablets) orally once daily and 1 placebo tablet matched to sitagliptin 100 mg orally once daily, along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
BG003	Sitagliptin 100 mg	Five placebo tablets matched to PF-04991532 150 mg and 1 sitagliptin 100 mg tablet orally once daily, along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
BG004	Placebo	Five placebo tablets matched to PF-04991532 150 mg and 1 placebo matched to sitagliptin 100 mg tablet orally once daily, along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
BG005	Total	Total of all reporting groups

ID	Title	Description	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	PF-04991532 150 mg	PF-04991532 150 milligram (mg) (1 PF-04991532 150 mg tablet and 4 placebo tablets matched to PF-04991532 150 mg) orally once daily and 1 placebo tablet matched to sitagliptin 100 mg orally once daily, along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.	52	17	52
EG001	PF-04991532 450 mg	PF-04991532 450 mg (3 PF-04991532 150 mg tablets and 2 placebo tablets matched to PF-04991532 150 mg) orally once daily and 1 placebo tablet matched to sitagliptin 100 mg orally once daily, along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.	54	20	54
EG002	PF-04991532 750 mg	PF-04991532 750 mg (5 PF-04991532 150 mg tablets) orally once daily and 1 placebo tablet matched to sitagliptin 100 mg orally once daily, along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.	53	23	53
EG003	Sitagliptin 100 mg	Five placebo tablets matched to PF-04991532 150 mg and 1 sitagliptin 100 mg tablet orally once daily, along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.	54	14	54
EG004	Placebo	Five placebo tablets matched to PF-04991532 150 mg and 1 placebo matched to sitagliptin 100 mg tablet orally once daily, along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.	53	16	53