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Study Of Safety And Efficacy Of PF-04991532 In Subjects With Type 2 Diabetes Mellitus

Sponsor
Pfizer (Industry)
Overall Status
Completed
CT.gov ID
NCT01336738
Collaborator
(none)
266
Enrollment
44
Locations
5
Arms
9
Duration (Months)
6
Patients Per Site
0.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

B2611002 is designed to study how safe and effective an investigational medication (PF-04991532) is in people with Type 2 diabetes. Subjects in the study will receive 1 of 5 treatments for 3 months. One of the treatments will be sitagliptin which is an approved drug, and another treatment will be placebo, which does not contain active ingredient.

Condition or Disease Intervention/Treatment Phase
  • Drug: Placebo
  • Drug: 150 mg PF-04991532
  • Drug: 450 mg PF-04991532
  • Drug: 750 mg PF-04991532
  • Drug: Sitagliptin 100 mg
 Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
266 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
A 12-Week, Phase 2, Randomized, Double-Blind, Placebo Controlled, Dose-Ranging, Parallel Group Study To Evaluate The Efficacy And Safety Of Once Daily Pf-04991532 And Sitagliptin In Adult Patients With Type 2 Diabetes Mellitus Inadequately Controlled On Metformin
Study Start Date :
Jun 1, 2011
Actual Primary Completion Date :
Mar 1, 2012
Actual Study Completion Date :
Mar 1, 2012

Arms and Interventions

Arm Intervention/Treatment
Placebo Comparator: Placebo

Matching placebo for PF-04991532 and Sitagliptin

Drug: Placebo
Tablets (n=6), 0 mg, once daily for 84 days
Experimental: 150 mg PF-04991532

Drug: 150 mg PF-04991532
Tablets (n=1), 150 mg + tablets (n=5), 0 mg, all once daily for 84 days
Experimental: 450 mg PF-04991532

Drug: 450 mg PF-04991532
Tablets (n=3), 150 mg + tablets (n=3), 0 mg, all once daily for 84 days
Experimental: 750 mg PF-04991532

Drug: 750 mg PF-04991532
Tablets (n=5), 150 mg + tablets (n=1), 0 mg, all once daily for 84 days
Active Comparator: Sitagliptin 100 mg

Drug: Sitagliptin 100 mg
Tablets (n=1), 100 mg strength + tablets (n=5), 0 mg, all once daily for 84 days

Outcome Measures

Primary Outcome Measures

  1. Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 12 [Baseline, 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.

Secondary Outcome Measures

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

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

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

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

  5. Percentage of Participants With Greater Than or Equal to (>=) 1% or >= 2% Body Weight Gain From Baseline [Week 12]

    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.

  6. Percentage of Participants With Greater Than or Equal to (>=) 1% or >= 2% Body Weight Loss From Baseline [Week 12]

    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.

Eligibility Criteria

Criteria

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

Subjects with type 2 diabetes on stable doses of background medicines for management of diabetes; aged 18-70 years; body mass index between 22.5 and 45.5 kg/m2

Exclusion Criteria:

Subjects with type 1 diabetes, heart attack or stroke in the past 6 months, uncontrolled blood pressure, significant kidney disease.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Pfizer Investigational Site Jonesboro Arkansas United States 72401
2 Pfizer Investigational Site Jonesboro Arkansas United States 72404
3 Pfizer Investigational Site Los Angeles California United States 90057
4 Pfizer Investigational Site Palm Springs California United States 92262
5 Pfizer Investigational Site Jacksonville Florida United States 32216
6 Pfizer Investigational Site Melbourne Florida United States 32901
7 Pfizer Investigational Site West Palm Beach Florida United States 33401
8 Pfizer Investigational Site Conyers Georgia United States 30094
9 Pfizer Investigational Site Chicago Illinois United States 60607
10 Pfizer Investigational Site Louisville Kentucky United States 40213
11 Pfizer Investigational Site Fall River Massachusetts United States 02720
12 Pfizer Investigational Site Brooklyn New York United States 11230
13 Pfizer Investigational Site Cary North Carolina United States 27518
14 Pfizer Investigational Site Wilmington North Carolina United States 28401
15 Pfizer Investigational Site Columbus Ohio United States 43213
16 Pfizer Investigational Site East Providence Rhode Island United States 02914
17 Pfizer Investigational Site East Providence Rhode Island United States 02915
18 Pfizer Investigational Site Mount Pleasant South Carolina United States 29464
19 Pfizer Investigational Site Bristol Tennessee United States 37620
20 Pfizer Investigational Site Kingsport Tennessee United States 37660
21 Pfizer Investigational Site Dallas Texas United States 75230
22 Pfizer Investigational Site Houston Texas United States 77036
23 Pfizer Investigational Site Houston Texas United States 77074
24 Pfizer Investigational Site Houston Texas United States 77081
25 Pfizer Investigational Site San Antonio Texas United States 78229
26 Pfizer Investigational Site Charlottesville Virginia United States 22911
27 Pfizer Investigational Site Kenosha Wisconsin United States 53142
28 Pfizer Investigational Site Milwaukee Wisconsin United States 53209
29 Pfizer Investigational Site Winnipeg Manitoba Canada R3E 3P4
30 Pfizer Investigational Site Strathroy Ontario Canada N7G 1Y7
31 Pfizer Investigational Site Thornhill Ontario Canada L4J 8L7
32 Pfizer Investigational Site Toronto Ontario Canada M9W 4L6
33 Pfizer Investigational Site Laval Quebec Canada H7T 2P5
34 Pfizer Investigational Site St-Romuald Quebec Canada G6W 5M6
35 Pfizer Investigational Site Budapest Hungary 1036
36 Pfizer Investigational Site Seoul Korea, Republic of 110-744
37 Pfizer Investigational Site Seoul Korea, Republic of 120-752
38 Pfizer Investigational Site Seoul Korea, Republic of 138-736
39 Pfizer Investigational Site Guadalajara Jalisco Mexico 44130
40 Pfizer Investigational Site Guadalajara Jalisco Mexico 44650
41 Pfizer Investigational Site Monterrey Nuevo Leon Mexico 64460
42 Pfizer Investigational Site Bratislava Slovakia 831 01
43 Pfizer Investigational Site Tainan Taiwan 710
44 Pfizer Investigational Site Taipei Taiwan 100

Sponsors and Collaborators

  • Pfizer

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Pfizer
ClinicalTrials.gov Identifier:
NCT01336738
Other Study ID Numbers:
  • B2611002
First Posted:
Apr 18, 2011
Last Update Posted:
Aug 6, 2013
Last Verified:
Jun 1, 2013
Keywords provided by Pfizer
Phase 2
safety and efficacy study with PF-04991532
Type 2 diabetes
Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Nicotinic Acids
Sitagliptin Phosphate
6-(3-cyclopentyl-2-(4-(trifluoromethyl)-1H-imidazol-1-yl)propanamido)nicotinic acid

Study Results

Participant Flow

Recruitment Details
Pre-assignment Detail All participants received placebo matched to PF-04991532 or placebo matched to sitagliptin tablet orally once daily along with background metformin immediate release tablets, during the 2-week run-in period. Compliant participants were then randomized to study treatments for 12 weeks.
Arm/Group Title PF-04991532 150 mg PF-04991532 450 mg PF-04991532 750 mg Sitagliptin 100 mg Placebo
Arm/Group Description 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. 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. 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. 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. 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.
Period Title: Overall Study
STARTED 52 54 53 54 53
COMPLETED 45 45 45 47 43
NOT COMPLETED 7 9 8 7 10

Baseline Characteristics

Arm/Group Title PF-04991532 150 mg PF-04991532 450 mg PF-04991532 750 mg Sitagliptin 100 mg Placebo Total
Arm/Group Description 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. 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. 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. 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. 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. Total of all reporting groups
Overall Participants 52 54 53 54 53 266
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]
55.3
(9.9)
55.1
(9.3)
55.5
(7.3)
57.8
(8.3)
55.6
(8.5)
55.9
(8.7)
Sex: Female, Male (Count of Participants)
Female
16
30.8%
24
44.4%
17
32.1%
23
42.6%
14
26.4%
94
35.3%
Male
36
69.2%
30
55.6%
36
67.9%
31
57.4%
39
73.6%
172
64.7%

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 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.
Time Frame Baseline, Week 12

Outcome Measure Data

Analysis Population Description
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.
Arm/Group Title PF-04991532 150 mg PF-04991532 450 mg PF-04991532 750 mg Sitagliptin 100 mg Placebo
Arm/Group Description 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. 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. 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. 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. 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.
Measure Participants 52 53 52 54 53
Baseline (n=52, 53, 52, 54, 53)
8.34
(0.906)
8.19
(0.947)
7.96
(1.030)
7.97
(1.086)
8.55
(1.351)
Change at Week 12 (n=44, 44, 43, 48, 43)
-0.17
(0.922)
-0.57
(0.753)
-0.70
(0.790)
-0.78
(0.721)
-0.21
(0.921)
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection PF-04991532 150 mg, Placebo
Comments 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.
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesis p-Value 0.6803
Comments One-sided p-value was calculated.
Method Mixed Models Analysis
Comments
Method of Estimation Estimation Parameter Least Squares (LS) Mean Difference
Estimated Value 0.08
Confidence Interval (2-Sided) 80%
-0.13 to 0.29
Parameter Dispersion Type: Standard Error of the Mean
Value: 0.164
Estimation Comments
Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection PF-04991532 450 mg, Placebo
Comments Treatment difference and 80% CI were based on LS mean. A 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.
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesis p-Value 0.0017
Comments One-sided p-value was calculated.
Method Mixed Models Analysis
Comments
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.49
Confidence Interval (2-Sided) 80%
-0.71 to -0.28
Parameter Dispersion Type: Standard Error of the Mean
Value: 0.166
Estimation Comments
Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection PF-04991532 750 mg, Placebo
Comments Treatment difference and 80% CI were based on LS mean. A 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.
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesis p-Value 0.0003
Comments One-sided p-value was calculated.
Method Mixed Models Analysis
Comments
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.58
Confidence Interval (2-Sided) 80%
-0.80 to -0.36
Parameter Dispersion Type: Standard Error of the Mean
Value: 0.168
Estimation Comments
Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Sitagliptin 100 mg, Placebo
Comments Treatment difference and 80% CI were based on LS mean. A 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.
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesis p-Value <0.0001
Comments One-sided p-value was calculated.
Method Mixed Models Analysis
Comments
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.71
Confidence Interval (2-Sided) 80%
-0.91 to -0.50
Parameter Dispersion Type: Standard Error of the Mean
Value: 0.162
Estimation Comments
2. Secondary Outcome
Title Change From Baseline in Fasting Plasma Glucose at Week 1, 2, 4, 8 and 12
Description
Time Frame Baseline, Week 1, 2, 4, 8, 12

Outcome Measure Data

Analysis Population Description
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.
Arm/Group Title PF-04991532 150 mg PF-04991532 450 mg PF-04991532 750 mg Sitagliptin 100 mg Placebo
Arm/Group Description 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. 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. 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. 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. 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.
Measure Participants 52 53 52 54 53
Baseline (n=52, 53, 52, 54, 53)
172.68
(39.612)
169.16
(41.703)
159.11
(44.878)
158.38
(42.502)
183.61
(57.517)
Change at Week 1 (n=50, 51, 49, 49, 51)
0.87
(27.059)
1.63
(25.373)
-1.55
(19.826)
-13.72
(24.445)
-4.21
(33.274)
Change at Week 2 (n=50, 51, 51, 50, 47)
-4.48
(23.488)
4.13
(30.662)
-5.26
(21.466)
-15.70
(29.704)
-3.72
(27.797)
Change at Week 4 (n=49, 49, 49, 50, 45)
1.13
(28.589)
-5.14
(29.757)
-6.68
(20.582)
-21.86
(29.063)
-4.28
(34.304)
Change at Week 8 (n=46, 44, 44, 47, 45)
3.69
(29.232)
-1.49
(33.421)
2.95
(21.892)
-14.05
(21.646)
2.18
(37.322)
Change at Week 12 (n=45, 44, 44, 48, 43)
0.08
(36.122)
5.87
(33.092)
6.86
(28.602)
-17.64
(30.779)
-0.03
(45.784)
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection PF-04991532 150 mg, Placebo
Comments 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.
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesis p-Value 0.4757
Comments Two-sided p-value was calculated.
Method Mixed Models Analysis
Comments
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 3.78
Confidence Interval (2-Sided) 95%
-6.64 to 14.20
Parameter Dispersion Type: Standard Error of the Mean
Value: 5.292
Estimation Comments
Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection PF-04991532 450 mg, Placebo
Comments 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.
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesis p-Value 0.8031
Comments Two-sided p-value was calculated.
Method Mixed Models Analysis
Comments
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 1.32
Confidence Interval (2-Sided) 95%
-9.11 to 11.75
Parameter Dispersion Type: Standard Error of the Mean
Value: 5.296
Estimation Comments
Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection PF-04991532 750 mg, Placebo
Comments 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.
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesis p-Value 0.5490
Comments Two-sided p-value was calculated.
Method Mixed Models Analysis
Comments
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -3.22
Confidence Interval (2-Sided) 95%
-13.78 to 7.34
Parameter Dispersion Type: Standard Error of the Mean
Value: 5.364
Estimation Comments
Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Sitagliptin 100 mg, Placebo
Comments 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.
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesis p-Value 0.0051
Comments Two-sided p-value was calculated.
Method Mixed Models Analysis
Comments
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -15.07
Confidence Interval (2-Sided) 95%
-25.58 to -4.55
Parameter Dispersion Type: Standard Error of the Mean
Value: 5.340
Estimation Comments
Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection PF-04991532 150 mg, Placebo
Comments 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.
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesis p-Value 0.6291
Comments Two-sided p-value was calculated.
Method Mixed Models Analysis
Comments
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -2.43
Confidence Interval (2-Sided) 95%
-12.31 to 7.46
Parameter Dispersion Type: Standard Error of the Mean
Value: 5.020
Estimation Comments
Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection PF-04991532 450 mg, Placebo
Comments 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.
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesis p-Value 0.4396
Comments Two-sided p-value was calculated.
Method Mixed Models Analysis
Comments
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 3.87
Confidence Interval (2-Sided) 95%
-5.98 to 13.72
Parameter Dispersion Type: Standard Error of the Mean
Value: 5.001
Estimation Comments
Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection PF-04991532 750 mg, Placebo
Comments 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.
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesis p-Value 0.1934
Comments Two-sided p-value was calculated.
Method Mixed Models Analysis
Comments
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -6.56
Confidence Interval (2-Sided) 95%
-16.46 to 3.34
Parameter Dispersion Type: Standard Error of the Mean
Value: 5.030
Estimation Comments
Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Sitagliptin 100 mg, Placebo
Comments 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.
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesis p-Value 0.0007
Comments Two-sided p-value was calculated.
Method Mixed Models Analysis
Comments
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -17.32
Confidence Interval (2-Sided) 95%
-27.24 to -7.40
Parameter Dispersion Type: Standard Error of the Mean
Value: 5.039
Estimation Comments
Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection PF-04991532 150 mg, Placebo
Comments 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.
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesis p-Value 0.5479
Comments Two-sided p-value was calculated.
Method Mixed Models Analysis
Comments
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 3.13
Confidence Interval (2-Sided) 95%
-7.11 to 13.37
Parameter Dispersion Type: Standard Error of the Mean
Value: 5.201
Estimation Comments
Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection PF-04991532 450 mg, Placebo
Comments 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.
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesis p-Value 0.4276
Comments Two-sided p-value was calculated.
Method Mixed Models Analysis
Comments
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -4.14
Confidence Interval (2-Sided) 95%
-14.39 to 6.12
Parameter Dispersion Type: Standard Error of the Mean
Value: 5.209
Estimation Comments
Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection PF-04991532 750 mg, Placebo
Comments 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.
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesis p-Value 0.1596
Comments Two-sided p-value was calculated.
Method Mixed Models Analysis
Comments
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -7.38
Confidence Interval (2-Sided) 95%
-17.69 to 2.92
Parameter Dispersion Type: Standard Error of the Mean
Value: 5.235
Estimation Comments
Statistical Analysis 12
Statistical Analysis Overview Comparison Group Selection Sitagliptin 100 mg, Placebo
Comments 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.
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesis p-Value <0.0001
Comments Two-sided p-value was calculated.
Method Mixed Models Analysis
Comments
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -22.83
Confidence Interval (2-Sided) 95%
-33.06 to -12.60
Parameter Dispersion Type: Standard Error of the Mean
Value: 5.198
Estimation Comments
Statistical Analysis 13
Statistical Analysis Overview Comparison Group Selection PF-04991532 150 mg, Placebo
Comments 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.
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesis p-Value 0.8509
Comments Two-sided p-value was calculated.
Method Mixed Models Analysis
Comments
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -1.10
Confidence Interval (2-Sided) 95%
-12.63 to 10.43
Parameter Dispersion Type: Standard Error of the Mean
Value: 5.855
Estimation Comments
Statistical Analysis 14
Statistical Analysis Overview Comparison Group Selection PF-04991532 450 mg, Placebo
Comments 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.
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesis p-Value 0.1505
Comments Two-sided p-value was calculated.
Method Mixed Models Analysis
Comments
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -8.53
Confidence Interval (2-Sided) 95%
-20.17 to 3.12
Parameter Dispersion Type: Standard Error of the Mean
Value: 5.913
Estimation Comments
Statistical Analysis 15
Statistical Analysis Overview Comparison Group Selection PF-04991532 750 mg, Placebo
Comments 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.
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesis p-Value 0.2662
Comments Two-sided p-value was calculated.
Method Mixed Models Analysis
Comments
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -6.62
Confidence Interval (2-Sided) 95%
-18.31 to 5.08
Parameter Dispersion Type: Standard Error of the Mean
Value: 5.940
Estimation Comments
Statistical Analysis 16
Statistical Analysis Overview Comparison Group Selection Sitagliptin 100 mg, Placebo
Comments 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.
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesis p-Value 0.0003
Comments Two-sided p-value was calculated.
Method Mixed Models Analysis
Comments
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -21.52
Confidence Interval (2-Sided) 95%
-32.97 to -10.07
Parameter Dispersion Type: Standard Error of the Mean
Value: 5.818
Estimation Comments
Statistical Analysis 17
Statistical Analysis Overview Comparison Group Selection PF-04991532 150 mg, Placebo
Comments 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.
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesis p-Value 0.7724
Comments Two-sided p-value was calculated.
Method Mixed Models Analysis
Comments
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -2.01
Confidence Interval (2-Sided) 95%
-15.68 to 11.66
Parameter Dispersion Type: Standard Error of the Mean
Value: 6.940
Estimation Comments
Statistical Analysis 18
Statistical Analysis Overview Comparison Group Selection PF-04991532 450 mg, Placebo
Comments 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.
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesis p-Value 0.9202
Comments Two-sided p-value was calculated.
Method Mixed Models Analysis
Comments
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.70
Confidence Interval (2-Sided) 95%
-14.47 to 13.07
Parameter Dispersion Type: Standard Error of the Mean
Value: 6.986
Estimation Comments
Statistical Analysis 19
Statistical Analysis Overview Comparison Group Selection PF-04991532 750 mg, Placebo
Comments 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.
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesis p-Value 0.8183
Comments Two-sided p-value was calculated.
Method Mixed Models Analysis
Comments
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -1.61
Confidence Interval (2-Sided) 95%
-15.40 to 12.18
Parameter Dispersion Type: Standard Error of the Mean
Value: 6.998
Estimation Comments
Statistical Analysis 20
Statistical Analysis Overview Comparison Group Selection Sitagliptin 100 mg, Placebo
Comments 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.
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesis p-Value 0.0003
Comments Two-sided p-value was calculated.
Method Mixed Models Analysis
Comments
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -24.96
Confidence Interval (2-Sided) 95%
-38.40 to -11.53
Parameter Dispersion Type: Standard Error of the Mean
Value: 6.821
Estimation Comments
3. Secondary Outcome
Title Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 1, 2, 4 and 8
Description 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.
Time Frame Baseline, Week 1, 2, 4, 8

Outcome Measure Data

Analysis Population Description
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.
Arm/Group Title PF-04991532 150 mg PF-04991532 450 mg PF-04991532 750 mg Sitagliptin 100 mg Placebo
Arm/Group Description 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. 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. 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. 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. 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.
Measure Participants 52 53 52 54 53
Change at Week 1 (n=50, 51, 49, 49, 48)
-0.04
(0.227)
-0.03
(0.210)
-0.13
(0.217)
-0.07
(0.200)
-0.02
(0.287)
Change at Week 2 (n=50, 52, 49, 49, 47)
-0.04
(0.349)
-0.14
(0.288)
-0.18
(0.271)
-0.23
(0.311)
-0.07
(0.372)
Change at Week 4 (n=48, 49, 48, 50, 46)
-0.22
(0.475)
-0.34
(0.392)
-0.40
(0.421)
-0.42
(0.483)
-0.16
(0.591)
Change at Week 8 (n=45, 44, 45, 47, 45)
-0.21
(0.728)
-0.50
(0.562)
-0.66
(0.772)
-0.71
(0.713)
-0.22
(0.762)
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection PF-04991532 150 mg, Placebo
Comments Week 1: Treatment difference and 80% CI were based on LS mean. A 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.
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesis p-Value 0.2327
Comments One-sided p-value was calculated.
Method Mixed Models Analysis
Comments
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.04
Confidence Interval (2-Sided) 80%
-0.10 to 0.03
Parameter Dispersion Type: Standard Error of the Mean
Value: 0.048
Estimation Comments
Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection PF-04991532 450 mg, Placebo
Comments Week 1: Treatment difference and 80% CI were based on LS mean. A 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.
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesis p-Value 0.3580
Comments One-sided p-value was calculated.
Method Mixed Models Analysis
Comments
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.02
Confidence Interval (2-Sided) 80%
-0.08 to 0.04
Parameter Dispersion Type: Standard Error of the Mean
Value: 0.048
Estimation Comments
Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection PF-04991532 750 mg, Placebo
Comments Week 1: Treatment difference and 80% CI were based on LS mean. A 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.
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesis p-Value 0.0036
Comments One-sided p-value was calculated.
Method Mixed Models Analysis
Comments
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.13
Confidence Interval (2-Sided) 80%
-0.20 to -0.07
Parameter Dispersion Type: Standard Error of the Mean
Value: 0.049
Estimation Comments
Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Sitagliptin 100 mg, Placebo
Comments Week 1: Treatment difference and 80% CI were based on LS mean. A 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.
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesis p-Value 0.1251
Comments One-sided p-value was calculated.
Method Mixed Models Analysis
Comments
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.06
Confidence Interval (2-Sided) 80%
-0.12 to 0.01
Parameter Dispersion Type: Standard Error of the Mean
Value: 0.049
Estimation Comments
Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection PF-04991532 150 mg, Placebo
Comments Week 2: Treatment difference and 80% CI were based on LS mean. A 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.
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesis p-Value 0.3466
Comments One-sided p-value was calculated.
Method Mixed Models Analysis
Comments
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.03
Confidence Interval (2-Sided) 80%
-0.11 to 0.06
Parameter Dispersion Type: Standard Error of the Mean
Value: 0.066
Estimation Comments
Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection PF-04991532 450 mg, Placebo
Comments Week 2: Treatment difference and 80% CI were based on LS mean. A 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.
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesis p-Value 0.0439
Comments One-sided p-value was calculated.
Method Mixed Models Analysis
Comments
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.11
Confidence Interval (2-Sided) 80%
-0.20 to -0.03
Parameter Dispersion Type: Standard Error of the Mean
Value: 0.066
Estimation Comments
Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection PF-04991532 750 mg, Placebo
Comments Week 2: Treatment difference and 80% CI were based on LS mean. A 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.
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesis p-Value 0.0040
Comments One-sided p-value was calculated.
Method Mixed Models Analysis
Comments
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.18
Confidence Interval (2-Sided) 80%
-0.27 to -0.09
Parameter Dispersion Type: Standard Error of the Mean
Value: 0.067
Estimation Comments
Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Sitagliptin 100 mg, Placebo
Comments Week 2: Treatment difference and 80% CI were based on LS mean. A 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.
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesis p-Value 0.0009
Comments One-sided p-value was calculated.
Method Mixed Models Analysis
Comments
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.20
Confidence Interval (2-Sided) 80%
-0.29 to -0.12
Parameter Dispersion Type: Standard Error of the Mean
Value: 0.065
Estimation Comments
Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection PF-04991532 150 mg, Placebo
Comments Week 4: Treatment difference and 80% CI were based on LS mean. A 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.
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesis p-Value 0.1405
Comments One-sided p-value was calculated.
Method Mixed Models Analysis
Comments
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.10
Confidence Interval (2-Sided) 80%
-0.23 to 0.02
Parameter Dispersion Type: Standard Error of the Mean
Value: 0.096
Estimation Comments
Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection PF-04991532 450 mg, Placebo
Comments Week 4: Treatment difference and 80% CI were based on LS mean. A 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.
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesis p-Value 0.0067
Comments One-sided p-value was calculated.
Method Mixed Models Analysis
Comments
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.24
Confidence Interval (2-Sided) 80%
-0.36 to -0.12
Parameter Dispersion Type: Standard Error of the Mean
Value: 0.097
Estimation Comments
Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection PF-04991532 750 mg, Placebo
Comments Week 4: Treatment difference and 80% CI were based on LS mean. A 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.
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesis p-Value 0.0001
Comments One-sided p-value was calculated.
Method Mixed Models Analysis
Comments
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.37
Confidence Interval (2-Sided) 80%
-0.50 to -0.24
Parameter Dispersion Type: Standard Error of the Mean
Value: 0.098
Estimation Comments
Statistical Analysis 12
Statistical Analysis Overview Comparison Group Selection Sitagliptin 100 mg, Placebo
Comments Week 4: Treatment difference and 80% CI were based on LS mean. A 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.
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesis p-Value 0.0002
Comments One-sided p-value was calculated.
Method Mixed Models Analysis
Comments
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.34
Confidence Interval (2-Sided) 80%
-0.46 to -0.22
Parameter Dispersion Type: Standard Error of the Mean
Value: 0.094
Estimation Comments
Statistical Analysis 13
Statistical Analysis Overview Comparison Group Selection PF-04991532 150 mg, Placebo
Comments Week 8: Treatment difference and 80% CI were based on LS mean. A 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.
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesis p-Value 0.4887
Comments One-sided p-value was calculated.
Method Mixed Models Analysis
Comments
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.00
Confidence Interval (2-Sided) 80%
-0.18 to 0.17
Parameter Dispersion Type: Standard Error of the Mean
Value: 0.135
Estimation Comments
Statistical Analysis 14
Statistical Analysis Overview Comparison Group Selection PF-04991532 450 mg, Placebo
Comments Week 8: Treatment difference and 80% CI were based on LS mean. A 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.
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesis p-Value 0.0020
Comments One-sided p-value was calculated.
Method Mixed Models Analysis
Comments
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.40
Confidence Interval (2-Sided) 80%
-0.57 to -0.22
Parameter Dispersion Type: Standard Error of the Mean
Value: 0.137
Estimation Comments
Statistical Analysis 15
Statistical Analysis Overview Comparison Group Selection PF-04991532 750 mg, Placebo
Comments Week 8: Treatment difference and 80% CI were based on LS mean. A 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.
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesis p-Value <0.0001
Comments One-sided p-value was calculated.
Method Mixed Models Analysis
Comments
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.58
Confidence Interval (2-Sided) 80%
-0.76 to -0.41
Parameter Dispersion Type: Standard Error of the Mean
Value: 0.138
Estimation Comments
Statistical Analysis 16
Statistical Analysis Overview Comparison Group Selection Sitagliptin 100 mg, Placebo
Comments Week 8: Treatment difference and 80% CI were based on LS mean. A 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.
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesis p-Value <0.0001
Comments One-sided p-value was calculated.
Method Mixed Models Analysis
Comments
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.59
Confidence Interval (2-Sided) 80%
-0.76 to -0.42
Parameter Dispersion Type: Standard Error of the Mean
Value: 0.133
Estimation Comments
4. Secondary Outcome
Title Percentage of Participants Achieving Less Than (<) 6.5% or <7% Glycosylated Hemoglobin (HbA1c) Levels
Description 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.
Time Frame Week 12

Outcome Measure Data

Analysis Population Description
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.
Arm/Group Title PF-04991532 150 mg PF-04991532 450 mg PF-04991532 750 mg Sitagliptin 100 mg Placebo
Arm/Group Description 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. 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. 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. 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. 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.
Measure Participants 44 44 43 48 43
< 6.5%
4.5
8.7%
9.1
16.9%
23.3
44%
14.6
27%
11.6
21.9%
< 7%
13.6
26.2%
36.4
67.4%
60.5
114.2%
39.6
73.3%
16.3
30.8%
5. Secondary Outcome
Title Change From Baseline in Body Weight at Week 1, 2, 4, 8 and 12
Description 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.
Time Frame Baseline, Week 1, 2, 4, 8, 12

Outcome Measure Data

Analysis Population Description
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.
Arm/Group Title PF-04991532 150 mg PF-04991532 450 mg PF-04991532 750 mg Sitagliptin 100 mg Placebo
Arm/Group Description 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. 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. 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. 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. 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.
Measure Participants 52 53 52 54 53
Baseline (n=52, 53, 52, 54, 53)
92.57
(19.957)
88.91
(22.781)
86.08
(17.787)
87.48
(19.883)
87.43
(19.351)
Change at Week 1 (n=50, 51, 49, 51, 51)
-0.10
(1.176)
-0.31
(1.091)
-0.34
(1.100)
0.14
(0.982)
-0.33
(1.050)
Change at Week 2 (n=50, 52, 51, 50, 48)
-0.12
(1.189)
-0.33
(1.175)
-0.38
(1.115)
-0.00
(1.364)
-0.37
(0.885)
Change at Week 4 (n=49, 49, 49, 50, 46)
-0.18
(1.357)
-0.72
(1.499)
-0.34
(1.486)
0.15
(1.170)
-0.52
(1.139)
Change at Week 8 (n=46, 44, 45, 48, 45)
-0.27
(1.865)
-0.66
(2.047)
-0.45
(2.026)
-0.21
(2.059)
-0.60
(1.444)
Change at Week 12 (n=45, 44, 45, 48, 43)
-0.91
(1.880)
-0.82
(2.126)
-0.90
(2.421)
-0.22
(1.993)
-0.95
(2.058)
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection PF-04991532 150 mg, Placebo
Comments 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.
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesis p-Value 0.2067
Comments Two-sided p-value was calculated.
Method Mixed Models Analysis
Comments
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.28
Confidence Interval (2-Sided) 95%
-0.16 to 0.73
Parameter Dispersion Type: Standard Error of the Mean
Value: 0.225
Estimation Comments
Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection PF-04991532 450 mg, Placebo
Comments 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.
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesis p-Value 0.8602
Comments Two-sided p-value was calculated.
Method Mixed Models Analysis
Comments
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.04
Confidence Interval (2-Sided) 95%
-0.40 to 0.48
Parameter Dispersion Type: Standard Error of the Mean
Value: 0.224
Estimation Comments
Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection PF-04991532 750 mg, Placebo
Comments 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.
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesis p-Value 0.9200
Comments Two-sided p-value was calculated.
Method Mixed Models Analysis
Comments
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.02
Confidence Interval (2-Sided) 95%
-0.47 to 0.42
Parameter Dispersion Type: Standard Error of the Mean
Value: 0.225
Estimation Comments
Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Sitagliptin 100 mg, Placebo
Comments 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.
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesis p-Value 0.0399
Comments Two-sided p-value was calculated.
Method Mixed Models Analysis
Comments
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.46
Confidence Interval (2-Sided) 95%
0.02 to 0.90
Parameter Dispersion Type: Standard Error of the Mean
Value: 0.223
Estimation Comments
Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection PF-04991532 150 mg, Placebo
Comments 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.
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesis p-Value 0.2266
Comments Two-sided p-value was calculated.
Method Mixed Models Analysis
Comments
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.29
Confidence Interval (2-Sided) 95%
-0.18 to 0.77
Parameter Dispersion Type: Standard Error of the Mean
Value: 0.242
Estimation Comments
Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection PF-04991532 450 mg, Placebo
Comments 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.
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesis p-Value 0.8493
Comments Two-sided p-value was calculated.
Method Mixed Models Analysis
Comments
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.05
Confidence Interval (2-Sided) 95%
-0.43 to 0.52
Parameter Dispersion Type: Standard Error of the Mean
Value: 0.241
Estimation Comments
Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection PF-04991532 750 mg, Placebo
Comments 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.
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesis p-Value 0.9511
Comments Two-sided p-value was calculated.
Method Mixed Models Analysis
Comments
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.01
Confidence Interval (2-Sided) 95%
-0.49 to 0.46
Parameter Dispersion Type: Standard Error of the Mean
Value: 0.242
Estimation Comments
Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Sitagliptin 100 mg, Placebo
Comments 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.
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesis p-Value 0.1369
Comments Two-sided p-value was calculated.
Method Mixed Models Analysis
Comments
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.36
Confidence Interval (2-Sided) 95%
-0.11 to 0.83
Parameter Dispersion Type: Standard Error of the Mean
Value: 0.241
Estimation Comments
Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection PF-04991532 150 mg, Placebo
Comments 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.
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesis p-Value 0.1562
Comments Two-sided p-value was calculated.
Method Mixed Models Analysis
Comments
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.39
Confidence Interval (2-Sided) 95%
-0.15 to 0.92
Parameter Dispersion Type: Standard Error of the Mean
Value: 0.272
Estimation Comments
Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection PF-04991532 450 mg, Placebo
Comments 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.
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesis p-Value 0.4913
Comments Two-sided p-value was calculated.
Method Mixed Models Analysis
Comments
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.19
Confidence Interval (2-Sided) 95%
-0.72 to 0.35
Parameter Dispersion Type: Standard Error of the Mean
Value: 0.272
Estimation Comments
Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection PF-04991532 750 mg, Placebo
Comments 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.
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesis p-Value 0.5130
Comments Two-sided p-value was calculated.
Method Mixed Models Analysis
Comments
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.18
Confidence Interval (2-Sided) 95%
-0.36 to 0.71
Parameter Dispersion Type: Standard Error of the Mean
Value: 0.272
Estimation Comments
Statistical Analysis 12
Statistical Analysis Overview Comparison Group Selection Sitagliptin 100 mg, Placebo
Comments 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.
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesis p-Value 0.0298
Comments Two-sided p-value was calculated.
Method Mixed Models Analysis
Comments
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.59
Confidence Interval (2-Sided) 95%
0.06 to 1.12
Parameter Dispersion Type: Standard Error of the Mean
Value: 0.269
Estimation Comments
Statistical Analysis 13
Statistical Analysis Overview Comparison Group Selection PF-04991532 150 mg, Placebo
Comments 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.
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesis p-Value 0.3196
Comments Two-sided p-value was calculated.
Method Mixed Models Analysis
Comments
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.36
Confidence Interval (2-Sided) 95%
-0.35 to 1.08
Parameter Dispersion Type: Standard Error of the Mean
Value: 0.363
Estimation Comments
Statistical Analysis 14
Statistical Analysis Overview Comparison Group Selection PF-04991532 450 mg, Placebo
Comments 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.
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesis p-Value 0.8884
Comments Two-sided p-value was calculated.
Method Mixed Models Analysis
Comments
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.05
Confidence Interval (2-Sided) 95%
-0.77 to 0.67
Parameter Dispersion Type: Standard Error of the Mean
Value: 0.367
Estimation Comments
Statistical Analysis 15
Statistical Analysis Overview Comparison Group Selection PF-04991532 750 mg, Placebo
Comments 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.
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesis p-Value 0.7325
Comments Two-sided p-value was calculated.
Method Mixed Models Analysis
Comments
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.12
Confidence Interval (2-Sided) 95%
-0.59 to 0.84
Parameter Dispersion Type: Standard Error of the Mean
Value: 0.365
Estimation Comments
Statistical Analysis 16
Statistical Analysis Overview Comparison Group Selection Sitagliptin 100 mg, Placebo
Comments 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.
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesis p-Value 0.3395
Comments Two-sided p-value was calculated.
Method Mixed Models Analysis
Comments
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.34
Confidence Interval (2-Sided) 95%
-0.36 to 1.04
Parameter Dispersion Type: Standard Error of the Mean
Value: 0.357
Estimation Comments
Statistical Analysis 17
Statistical Analysis Overview Comparison Group Selection PF-04991532 150 mg, Placebo
Comments 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.
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesis p-Value 0.7514
Comments Two-sided p-value was calculated.
Method Mixed Models Analysis
Comments
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.13
Confidence Interval (2-Sided) 95%
-0.68 to 0.94
Parameter Dispersion Type: Standard Error of the Mean
Value: 0.410
Estimation Comments
Statistical Analysis 18
Statistical Analysis Overview Comparison Group Selection PF-04991532 450 mg, Placebo
Comments 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.
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesis p-Value 0.7529
Comments Two-sided p-value was calculated.
Method Mixed Models Analysis
Comments
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.13
Confidence Interval (2-Sided) 95%
-0.68 to 0.94
Parameter Dispersion Type: Standard Error of the Mean
Value: 0.413
Estimation Comments
Statistical Analysis 19
Statistical Analysis Overview Comparison Group Selection PF-04991532 750 mg, Placebo
Comments 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.
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesis p-Value 0.9638
Comments Two-sided p-value was calculated.
Method Mixed Models Analysis
Comments
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.02
Confidence Interval (2-Sided) 95%
-0.79 to 0.83
Parameter Dispersion Type: Standard Error of the Mean
Value: 0.411
Estimation Comments
Statistical Analysis 20
Statistical Analysis Overview Comparison Group Selection Sitagliptin 100 mg, Placebo
Comments 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.
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesis p-Value 0.0962
Comments Two-sided p-value was calculated.
Method Mixed Models Analysis
Comments
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.67
Confidence Interval (2-Sided) 95%
-0.12 to 1.47
Parameter Dispersion Type: Standard Error of the Mean
Value: 0.404
Estimation Comments
6. Secondary Outcome
Title Percentage of Participants With Greater Than or Equal to (>=) 1% or >= 2% Body Weight Gain From Baseline
Description 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.
Time Frame Week 12

Outcome Measure Data

Analysis Population Description
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.
Arm/Group Title PF-04991532 150 mg PF-04991532 450 mg PF-04991532 750 mg Sitagliptin 100 mg Placebo
Arm/Group Description 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. 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. 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. 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. 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.
Measure Participants 45 44 45 48 43
>= 1%
17.78
34.2%
18.18
33.7%
15.56
29.4%
29.17
54%
23.26
43.9%
>= 2%
6.67
12.8%
11.36
21%
11.11
21%
14.58
27%
6.98
13.2%
7. Secondary Outcome
Title Percentage of Participants With Greater Than or Equal to (>=) 1% or >= 2% Body Weight Loss From Baseline
Description 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.
Time Frame Week 12

Outcome Measure Data

Analysis Population Description
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.
Arm/Group Title PF-04991532 150 mg PF-04991532 450 mg PF-04991532 750 mg Sitagliptin 100 mg Placebo
Arm/Group Description 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. 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. 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. 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. 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.
Measure Participants 45 44 45 48 43
>= 1%
55.56
106.8%
47.73
88.4%
46.67
88.1%
29.17
54%
41.86
79%
>= 2%
26.67
51.3%
34.09
63.1%
31.11
58.7%
18.75
34.7%
34.88
65.8%

Adverse Events

Time Frame
Adverse Event Reporting Description The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Arm/Group Title PF-04991532 150 mg PF-04991532 450 mg PF-04991532 750 mg Sitagliptin 100 mg Placebo
Arm/Group Description 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. 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. 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. 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. 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.
All Cause Mortality
PF-04991532 150 mg PF-04991532 450 mg PF-04991532 750 mg Sitagliptin 100 mg Placebo
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)
Serious Adverse Events
PF-04991532 150 mg PF-04991532 450 mg PF-04991532 750 mg Sitagliptin 100 mg Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 0/52 (0%) 0/54 (0%) 0/53 (0%) 0/54 (0%) 0/53 (0%)
Other (Not Including Serious) Adverse Events
PF-04991532 150 mg PF-04991532 450 mg PF-04991532 750 mg Sitagliptin 100 mg Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 17/52 (32.7%) 20/54 (37%) 23/53 (43.4%) 14/54 (25.9%) 16/53 (30.2%)
Gastrointestinal disorders
Diarrhoea 1/52 (1.9%) 1/54 (1.9%) 7/53 (13.2%) 2/54 (3.7%) 0/53 (0%)
Dyspepsia 2/52 (3.8%) 0/54 (0%) 1/53 (1.9%) 1/54 (1.9%) 0/53 (0%)
Nausea 2/52 (3.8%) 4/54 (7.4%) 4/53 (7.5%) 2/54 (3.7%) 0/53 (0%)
Toothache 1/52 (1.9%) 0/54 (0%) 2/53 (3.8%) 0/54 (0%) 0/53 (0%)
Vomiting 1/52 (1.9%) 2/54 (3.7%) 1/53 (1.9%) 0/54 (0%) 1/53 (1.9%)
Infections and infestations
Influenza 2/52 (3.8%) 1/54 (1.9%) 0/53 (0%) 0/54 (0%) 1/53 (1.9%)
Nasopharyngitis 2/52 (3.8%) 2/54 (3.7%) 3/53 (5.7%) 0/54 (0%) 2/53 (3.8%)
Pharyngitis 0/52 (0%) 0/54 (0%) 2/53 (3.8%) 1/54 (1.9%) 0/53 (0%)
Sinusitis 1/52 (1.9%) 0/54 (0%) 1/53 (1.9%) 2/54 (3.7%) 2/53 (3.8%)
Upper respiratory tract infection 0/52 (0%) 5/54 (9.3%) 1/53 (1.9%) 1/54 (1.9%) 2/53 (3.8%)
Urinary tract infection 2/52 (3.8%) 0/54 (0%) 1/53 (1.9%) 1/54 (1.9%) 2/53 (3.8%)
Injury, poisoning and procedural complications
Contusion 0/52 (0%) 2/54 (3.7%) 0/53 (0%) 0/54 (0%) 0/53 (0%)
Investigations
Blood glucose increased 0/52 (0%) 0/54 (0%) 0/53 (0%) 0/54 (0%) 2/53 (3.8%)
Metabolism and nutrition disorders
Dyslipidaemia 2/52 (3.8%) 2/54 (3.7%) 1/53 (1.9%) 0/54 (0%) 0/53 (0%)
Hyperglycaemia 3/52 (5.8%) 1/54 (1.9%) 3/53 (5.7%) 0/54 (0%) 2/53 (3.8%)
Hypoglycaemia 1/52 (1.9%) 2/54 (3.7%) 0/53 (0%) 2/54 (3.7%) 1/53 (1.9%)
Musculoskeletal and connective tissue disorders
Pain in extremity 0/52 (0%) 0/54 (0%) 0/53 (0%) 2/54 (3.7%) 1/53 (1.9%)
Nervous system disorders
Headache 1/52 (1.9%) 1/54 (1.9%) 3/53 (5.7%) 1/54 (1.9%) 1/53 (1.9%)
Psychiatric disorders
Insomnia 0/52 (0%) 0/54 (0%) 0/53 (0%) 3/54 (5.6%) 0/53 (0%)
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain 0/52 (0%) 1/54 (1.9%) 1/53 (1.9%) 1/54 (1.9%) 2/53 (3.8%)
Vascular disorders
Hypertension 0/52 (0%) 3/54 (5.6%) 0/53 (0%) 0/54 (0%) 1/53 (1.9%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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.

Results Point of Contact

Name/Title Pfizer ClinicalTrials.gov Call Center
Organization Pfizer, Inc.
Phone 1-800-718-1021
Email ClinicalTrials.gov_Inquiries@pfizer.com
Responsible Party:
Pfizer
ClinicalTrials.gov Identifier:
NCT01336738
Other Study ID Numbers:
  • B2611002
First Posted:
Apr 18, 2011
Last Update Posted:
Aug 6, 2013
Last Verified:
Jun 1, 2013