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B2611003 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 6 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Placebo for PF-04991532 and sitagliptin |
|
| 25 mg PF-04991532 | Experimental |
| |
| 75 mg PF-04991532 | Experimental |
| |
| 150 mg PF-04991532 | Experimental |
| |
| 300 mg PF-04991532 | Experimental |
| |
| Sitagliptin 100 mg | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | Tablets (n=4), 0 mg twice daily for 84 days |
| |
| 25 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. |
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Investigational Site | Little Rock | Arkansas | 72205 | United States | ||
| Pfizer Investigational Site |
Not provided
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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All participants received placebo matched to PF-04991532 or placebo matched to sitagliptin tablet orally twice 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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Placebo matched to PF-04991532 tablets orally twice daily or placebo matched to sitagliptin tablet orally twice daily along with background metformin 500 milligram (mg) immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks. |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Drug |
Tablets (n=1), 25 mg strength + tablets (n=3) 0 mg twice daily for 84 days |
|
| 75 mg PF-04991532 | Drug | Tablets (n=3), 25 mg strength + tablets (n=1) 0 mg twice daily for 84 days |
|
| 150 mg PF-04991532 | Drug | Tablets (n=1), 150 mg strength + tablets (n=3) 0 mg twice daily for 84 days |
|
| 300 mg PF-04991532 | Drug | Tablets (n=2), 150 mg strength + tablets (n=2) 0 mg twice daily for 84 days |
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| Sitagliptin 100 mg | Drug | Tablets (n=1), 100 mg strength + tablets (n=3) 0 mg once daily in the morning for 84 days; and tablets (n=4) 0 mg once daily in the evening for 84 days. |
|
| Baseline, Week 1, 2, 4, 8 |
| 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. | Week 12 |
| 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. | Baseline, Week 1, 2, 4, 8, 12 |
| Percentage of Participants With Greater Than or Equal to (>=) 1% or >= 2% Gain in Body Weight From Baseline | Overweight or obesity increases the risk for developing diabetes. Participants with >= 1% or >= 2% gain in body weight from baseline signifies a higher risk of diabetes. | Week 12 |
| Percentage of Participants With Greater Than or Equal to (>=) 1% or >= 2% Loss in Body Weight 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% loss in body weight from baseline signifies an improvement of glycemia. | Week 12 |
| Roseville |
| California |
| 95661 |
| United States |
| Pfizer Investigational Site | Denver | Colorado | 80209 | United States |
| Pfizer Investigational Site | Coral Gables | Florida | 33134 | United States |
| Pfizer Investigational Site | Ocala | Florida | 34471 | United States |
| Pfizer Investigational Site | Honolulu | Hawaii | 96814 | United States |
| Pfizer Investigational Site | Indianapolis | Indiana | 46260 | United States |
| Pfizer Investigational Site | Augusta | Kansas | 67010 | United States |
| Pfizer Investigational Site | Overland Park | Kansas | 66215 | United States |
| Pfizer Investigational Site | Wichita | Kansas | 67207 | United States |
| Pfizer Investigational Site | Lexington | Kentucky | 40504 | United States |
| Pfizer Investigational Site | Lake Charles | Louisiana | 70601 | United States |
| Pfizer Investigational Site | Auburn | Maine | 04210 | United States |
| Pfizer Investigational Site | Brooklyn Center | Minnesota | 55430 | United States |
| Pfizer Investigational Site | Las Vegas | Nevada | 89101 | United States |
| Pfizer Investigational Site | Trenton | New Jersey | 08611 | United States |
| Pfizer Investigational Site | Charlotte | North Carolina | 28277 | United States |
| Pfizer Investigational Site | Fargo | North Dakota | 58103 | United States |
| Pfizer Investigational Site | Cincinnati | Ohio | 45245 | United States |
| Pfizer Investigational Site | Lansdale | Pennsylvania | 19446 | United States |
| Pfizer Investigational Site | Dallas | Texas | 75246 | United States |
| Pfizer Investigational Site | Katy | Texas | 77450 | United States |
| Pfizer Investigational Site | San Antonio | Texas | 78229 | United States |
| Pfizer Investigational Site | Norfolk | Virginia | 23502 | United States |
| Pfizer Investigational Site | Richmond | Virginia | 23294 | United States |
| Pfizer Investigational Site | Surrey | British Columbia | V4A 2H9 | Canada |
| Pfizer Investigational Site | Bay Roberts | Newfoundland and Labrador | A0A 1G0 | Canada |
| Pfizer Investigational Site | Brampton | Ontario | L6T 0G1 | Canada |
| Pfizer Investigational Site | Mississauga | Ontario | L4Y 2N8 | Canada |
| Pfizer Investigational Site | Mirabel | Quebec | J7J 2K8 | Canada |
| Pfizer Investigational Site | Québec | Quebec | G3K 2P8 | Canada |
| Pfizer Investigational Site | Balatonfüred | 8230 | Hungary |
| Pfizer Investigational Site | Kistelek | 6760 | Hungary |
| Pfizer Investigational Site | Aguascalientes | Aguascalientes | 20234 | Mexico |
| Pfizer Investigational Site | Mexico City | Mexico City | 06700 | Mexico |
| Pfizer Investigational Site | Tlalnepantla | State of Mexico | 54055 | Mexico |
| Pfizer Investigational Site | Bratislava | 851 01 | Slovakia |
| Pfizer Investigational Site | Nové Mesto nad Váhom | 915 01 | Slovakia |
| Pfizer Investigational Site | Pezinok | 902 01 | Slovakia |
| Pfizer Investigational Site | Prešov | 080 01 | Slovakia |
| Pfizer Investigational Site | Taichung | 40705 | Taiwan |
| Pfizer Investigational Site | Taoyuan County | 333 | Taiwan |
| PF-04991532 25 mg |
PF-04991532 25 mg tablet orally twice 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. |
| FG002 | PF-04991532 75 mg | PF-04991532 75 mg tablet orally twice daily along background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks. |
| FG003 | PF-04991532 150 mg | PF-04991532 150 mg tablet orally twice 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. |
| FG004 | PF-04991532 300 mg | PF-04991532 300 mg tablet orally twice 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. |
| FG005 | Sitagliptin 100 mg | Sitagliptin 100 mg tablet orally once daily as morning dose and placebo matched to sitagliptin tablet orally once daily as evening dose 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. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Placebo matched to PF-04991532 tablets orally twice daily or placebo matched to sitagliptin tablet orally twice daily along with background metformin 500 milligram (mg) immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks. |
| BG001 | PF-04991532 25 mg | PF-04991532 25 mg tablet orally twice 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 75 mg | PF-04991532 75 mg tablet orally twice daily along background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks. |
| BG003 | PF-04991532 150 mg | PF-04991532 150 mg tablet orally twice 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 | PF-04991532 300 mg | PF-04991532 300 mg tablet orally twice 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 | Sitagliptin 100 mg | Sitagliptin 100 mg tablet orally once daily as morning dose and placebo matched to sitagliptin tablet orally once daily as evening dose 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. |
| BG006 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| 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 |
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| 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 |
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| 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. | 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 and 'n' signifies participants who were evaluable at specific time point for each treatment arm respectively. | Posted | Mean | Standard Deviation | percentage of hemoglobin | Baseline, Week 1, 2, 4, 8 |
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| 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 |
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| 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. | 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 | kilogram (kg) | Baseline, Week 1, 2, 4, 8, 12 |
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| Secondary | Percentage of Participants With Greater Than or Equal to (>=) 1% or >= 2% Gain in Body Weight From Baseline | Overweight or obesity increases the risk for developing diabetes. Participants with >= 1% or >= 2% gain in body weight 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 |
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| Secondary | Percentage of Participants With Greater Than or Equal to (>=) 1% or >= 2% Loss in Body Weight 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% loss in body weight 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 |
|
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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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Placebo matched to PF-04991532 tablets orally twice daily or placebo matched to sitagliptin tablet orally twice daily along with background metformin 500 milligram (mg) immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks. | 0 | 50 | 14 | 50 | ||
| EG001 | PF-04991532 25 mg | PF-04991532 25 mg tablet orally twice 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. | 0 | 49 | 16 | 49 | ||
| EG002 | PF-04991532 75 mg | PF-04991532 75 mg tablet orally twice daily along background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks. | 0 | 50 | 14 | 50 | ||
| EG003 | PF-04991532 150 mg | PF-04991532 150 mg tablet orally twice 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. | 0 | 50 | 11 | 50 | ||
| EG004 | PF-04991532 300 mg | PF-04991532 300 mg tablet orally twice 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. | 0 | 52 | 15 | 52 | ||
| EG005 | Sitagliptin 100 mg | Sitagliptin 100 mg tablet orally once daily as morning dose and placebo matched to sitagliptin tablet orally once daily as evening dose 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. | 0 | 50 | 11 | 50 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA v15.0 | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA v15.0 | Non-systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA v15.0 | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA v15.0 | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA v15.0 | Non-systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA v15.0 | Non-systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA v15.0 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA v15.0 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA v15.0 | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA v15.0 | Non-systematic Assessment |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| 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 |
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| Male |
|
| Change at Week 12 (n= 42, 37, 39, 40, 46, 44) |
|
| 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, baseline-by-treatment interaction, baseline-by-treatment-by-time interaction as the covariates, time was repeated for participant. | Mixed Models Analysis | 0.0266 | LS mean difference | -0.28 | Standard Error of the Mean | 0.142 | 2-Sided | 80 | -0.46 | -0.09 | No | Superiority or Other |
| 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, baseline-by-treatment interaction, baseline-by-treatment-by-time interaction as the covariates, time was repeated for participant. | Mixed Models Analysis | 0.0440 | LS mean difference | -0.24 | Standard Error of the Mean | 0.141 | 2-Sided | 80 | -0.42 | -0.06 | No | Superiority or Other |
| 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, baseline-by-treatment interaction, baseline-by-treatment-by-time interaction as the covariates, time was repeated for participant. | Mixed Models Analysis | 0.0001 | LS mean difference | -0.53 | Standard Error of the Mean | 0.137 | 2-Sided | 80 | -0.71 | -0.36 | No | Superiority or Other |
| 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, baseline-by-treatment interaction, baseline-by-treatment-by-time interaction as the covariates, time was repeated for participant. | Mixed Models Analysis | 0.0013 | LS mean difference | -0.43 | Standard Error of the Mean | 0.139 | 2-Sided | 80 | -0.60 | -0.25 | No | Superiority or Other |
| PF-04991532 150 mg |
PF-04991532 150 mg tablet orally twice 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 | PF-04991532 300 mg | PF-04991532 300 mg tablet orally twice 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. |
| OG005 | Sitagliptin 100 mg | Sitagliptin 100 mg tablet orally once daily as morning dose and placebo matched to sitagliptin tablet orally once daily as evening dose 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 75 mg |
PF-04991532 75 mg tablet orally twice daily along background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks. |
| OG003 | PF-04991532 150 mg | PF-04991532 150 mg tablet orally twice 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 | PF-04991532 300 mg | PF-04991532 300 mg tablet orally twice 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. |
| OG005 | Sitagliptin 100 mg | Sitagliptin 100 mg tablet orally once daily as morning dose and placebo matched to sitagliptin tablet orally once daily as evening dose 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 75 mg tablet orally twice daily along background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
| OG003 | PF-04991532 150 mg | PF-04991532 150 mg tablet orally twice 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 | PF-04991532 300 mg | PF-04991532 300 mg tablet orally twice 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. |
| OG005 | Sitagliptin 100 mg | Sitagliptin 100 mg tablet orally once daily as morning dose and placebo matched to sitagliptin tablet orally once daily as evening dose 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 | PF-04991532 150 mg | PF-04991532 150 mg tablet orally twice 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 | PF-04991532 300 mg | PF-04991532 300 mg tablet orally twice 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. |
| OG005 | Sitagliptin 100 mg | Sitagliptin 100 mg tablet orally once daily as morning dose and placebo matched to sitagliptin tablet orally once daily as evening dose 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 | PF-04991532 150 mg | PF-04991532 150 mg tablet orally twice 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 | PF-04991532 300 mg | PF-04991532 300 mg tablet orally twice 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. |
| OG005 | Sitagliptin 100 mg | Sitagliptin 100 mg tablet orally once daily as morning dose and placebo matched to sitagliptin tablet orally once daily as evening dose 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 75 mg tablet orally twice daily along background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
| OG003 | PF-04991532 150 mg | PF-04991532 150 mg tablet orally twice 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 | PF-04991532 300 mg | PF-04991532 300 mg tablet orally twice 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. |
| OG005 | Sitagliptin 100 mg | Sitagliptin 100 mg tablet orally once daily as morning dose and placebo matched to sitagliptin tablet orally once daily as evening dose 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. |
|
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