Diabetes Mellitus, Type 2
Conditions
Keywords
Phase 2, safety and efficacy study with PF-04991532, Type 2 diabetes
Brief summary
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.
Interventions
DRUGPlacebo
Tablets (n=4), 0 mg twice daily for 84 days
DRUG25 mg PF-04991532
Tablets (n=1), 25 mg strength + tablets (n=3) 0 mg twice daily for 84 days
DRUG75 mg PF-04991532
Tablets (n=3), 25 mg strength + tablets (n=1) 0 mg twice daily for 84 days
Tablets (n=1), 150 mg strength + tablets (n=3) 0 mg twice daily for 84 days
DRUG300 mg PF-04991532
Tablets (n=2), 150 mg strength + tablets (n=2) 0 mg twice daily for 84 days
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.
Sponsors
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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. |
| Percentage of Participants With Greater Than or Equal to (>=) 1% or >= 2% Gain in Body Weight From Baseline | Week 12 | 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. |
| 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. |
| Percentage of Participants With Greater Than or Equal to (>=) 1% or >= 2% Loss in Body Weight 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% loss in body weight from baseline signifies an improvement of glycemia. |
| 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. |
Countries
Canada, Hungary, Mexico, Slovakia, Taiwan, United States
Participant flow
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 50 |
| 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. | 49 |
| 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. | 50 |
| 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. | 50 |
| 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. | 52 |
| 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. | 50 |
| Total | 301 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 |
|---|---|---|---|---|---|---|---|
| Overall Study | Adverse Event | 4 | 4 | 1 | 5 | 4 | 1 |
| Overall Study | Lost to Follow-up | 0 | 0 | 1 | 0 | 1 | 0 |
| Overall Study | Other | 3 | 3 | 3 | 2 | 0 | 2 |
| Overall Study | Protocol Violation | 0 | 2 | 2 | 2 | 1 | 1 |
| Overall Study | Withdrawal by Subject | 2 | 3 | 4 | 0 | 0 | 2 |
Baseline characteristics
| Characteristic | Placebo | PF-04991532 25 mg | PF-04991532 75 mg | PF-04991532 150 mg | PF-04991532 300 mg | Sitagliptin 100 mg | Total |
|---|---|---|---|---|---|---|---|
| Age Continuous | 55.7 years STANDARD_DEVIATION 8.8 | 59.2 years STANDARD_DEVIATION 6.8 | 56.1 years STANDARD_DEVIATION 8.6 | 57.2 years STANDARD_DEVIATION 8.7 | 56.0 years STANDARD_DEVIATION 7.7 | 55.6 years STANDARD_DEVIATION 9 | 56.6 years STANDARD_DEVIATION 8.3 |
| Sex: Female, Male Female | 16 Participants | 30 Participants | 21 Participants | 20 Participants | 30 Participants | 15 Participants | 132 Participants |
| Sex: Female, Male Male | 34 Participants | 19 Participants | 29 Participants | 30 Participants | 22 Participants | 35 Participants | 169 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 14 / 50 | 16 / 49 | 14 / 50 | 11 / 50 | 15 / 52 | 11 / 50 |
| serious Total, serious adverse events | 0 / 50 | 0 / 49 | 0 / 50 | 0 / 50 | 0 / 52 | 0 / 50 |
Outcome results
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.
Time frame: Baseline, Week 12
Population: 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 | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 12 | Baseline (n= 50, 49, 50, 50, 52, 50) | 8.11 percentage of hemoglobin | Standard Deviation 1.255 |
| Placebo | Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 12 | Change at Week 12 (n= 42, 37, 39, 40, 46, 44) | -0.30 percentage of hemoglobin | Standard Deviation 0.681 |
| PF-04991532 25 mg | Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 12 | Baseline (n= 50, 49, 50, 50, 52, 50) | 7.90 percentage of hemoglobin | Standard Deviation 0.939 |
| PF-04991532 25 mg | Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 12 | Change at Week 12 (n= 42, 37, 39, 40, 46, 44) | -0.15 percentage of hemoglobin | Standard Deviation 0.593 |
| PF-04991532 75 mg | Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 12 | Baseline (n= 50, 49, 50, 50, 52, 50) | 7.86 percentage of hemoglobin | Standard Deviation 0.998 |
| PF-04991532 75 mg | Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 12 | Change at Week 12 (n= 42, 37, 39, 40, 46, 44) | -0.51 percentage of hemoglobin | Standard Deviation 0.847 |
| PF-04991532 150 mg | Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 12 | Baseline (n= 50, 49, 50, 50, 52, 50) | 7.93 percentage of hemoglobin | Standard Deviation 1.018 |
| PF-04991532 150 mg | Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 12 | Change at Week 12 (n= 42, 37, 39, 40, 46, 44) | -0.36 percentage of hemoglobin | Standard Deviation 0.828 |
| PF-04991532 300 mg | Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 12 | Baseline (n= 50, 49, 50, 50, 52, 50) | 8.01 percentage of hemoglobin | Standard Deviation 1.064 |
| PF-04991532 300 mg | Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 12 | Change at Week 12 (n= 42, 37, 39, 40, 46, 44) | -0.79 percentage of hemoglobin | Standard Deviation 0.743 |
| Sitagliptin 100 mg | Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 12 | Baseline (n= 50, 49, 50, 50, 52, 50) | 8.05 percentage of hemoglobin | Standard Deviation 0.958 |
| Sitagliptin 100 mg | Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 12 | Change at Week 12 (n= 42, 37, 39, 40, 46, 44) | -0.65 percentage of hemoglobin | Standard Deviation 0.754 |
Comparison: Treatment difference and 80% confidence interval (CI) were based on least squares (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, baseline-by-treatment interaction, baseline-by-treatment-by-time interaction as the covariates, time was repeated for participant.p-value: 0.760680% CI: [-0.08, 0.29]Mixed Models Analysis
Comparison: 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.p-value: 0.026680% CI: [-0.46, -0.09]Mixed Models Analysis
Comparison: 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.p-value: 0.04480% CI: [-0.42, -0.06]Mixed Models Analysis
Comparison: 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.p-value: 0.000180% CI: [-0.71, -0.36]Mixed Models Analysis
Comparison: 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.p-value: 0.001380% CI: [-0.6, -0.25]Mixed Models Analysis
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.
Time frame: Baseline, Week 1, 2, 4, 8, 12
Population: 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 | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Body Weight at Week 1, 2, 4, 8 and 12 | Baseline (n= 50, 49, 50, 50, 52, 50) | 89.69 kilogram (kg) | Standard Deviation 17.571 |
| Placebo | Change From Baseline in Body Weight at Week 1, 2, 4, 8 and 12 | Change at Week 1 (n= 48, 47, 47, 46, 47, 47) | 0.01 kilogram (kg) | Standard Deviation 0.792 |
| Placebo | Change From Baseline in Body Weight at Week 1, 2, 4, 8 and 12 | Change at Week 2 (n= 45, 44, 45, 45, 47, 48) | 0.31 kilogram (kg) | Standard Deviation 2.041 |
| Placebo | Change From Baseline in Body Weight at Week 1, 2, 4, 8 and 12 | Change at Week 4 (n= 46, 42, 44, 45, 48, 49) | -0.10 kilogram (kg) | Standard Deviation 1.255 |
| Placebo | Change From Baseline in Body Weight at Week 1, 2, 4, 8 and 12 | Change at Week 8 (n= 43, 40, 41, 42, 46, 45) | -0.21 kilogram (kg) | Standard Deviation 1.848 |
| Placebo | Change From Baseline in Body Weight at Week 1, 2, 4, 8 and 12 | Change at Week 12 (n= 42, 37, 39, 41, 46, 44) | -0.30 kilogram (kg) | Standard Deviation 1.869 |
| PF-04991532 25 mg | Change From Baseline in Body Weight at Week 1, 2, 4, 8 and 12 | Change at Week 1 (n= 48, 47, 47, 46, 47, 47) | -0.20 kilogram (kg) | Standard Deviation 1.17 |
| PF-04991532 25 mg | Change From Baseline in Body Weight at Week 1, 2, 4, 8 and 12 | Change at Week 4 (n= 46, 42, 44, 45, 48, 49) | -0.55 kilogram (kg) | Standard Deviation 1.576 |
| PF-04991532 25 mg | Change From Baseline in Body Weight at Week 1, 2, 4, 8 and 12 | Change at Week 12 (n= 42, 37, 39, 41, 46, 44) | -0.71 kilogram (kg) | Standard Deviation 1.98 |
| PF-04991532 25 mg | Change From Baseline in Body Weight at Week 1, 2, 4, 8 and 12 | Baseline (n= 50, 49, 50, 50, 52, 50) | 87.24 kilogram (kg) | Standard Deviation 19.805 |
| PF-04991532 25 mg | Change From Baseline in Body Weight at Week 1, 2, 4, 8 and 12 | Change at Week 2 (n= 45, 44, 45, 45, 47, 48) | -0.49 kilogram (kg) | Standard Deviation 1.462 |
| PF-04991532 25 mg | Change From Baseline in Body Weight at Week 1, 2, 4, 8 and 12 | Change at Week 8 (n= 43, 40, 41, 42, 46, 45) | -0.57 kilogram (kg) | Standard Deviation 1.488 |
| PF-04991532 75 mg | Change From Baseline in Body Weight at Week 1, 2, 4, 8 and 12 | Change at Week 12 (n= 42, 37, 39, 41, 46, 44) | -0.15 kilogram (kg) | Standard Deviation 2.757 |
| PF-04991532 75 mg | Change From Baseline in Body Weight at Week 1, 2, 4, 8 and 12 | Change at Week 8 (n= 43, 40, 41, 42, 46, 45) | -0.04 kilogram (kg) | Standard Deviation 2.318 |
| PF-04991532 75 mg | Change From Baseline in Body Weight at Week 1, 2, 4, 8 and 12 | Change at Week 4 (n= 46, 42, 44, 45, 48, 49) | 0.20 kilogram (kg) | Standard Deviation 1.594 |
| PF-04991532 75 mg | Change From Baseline in Body Weight at Week 1, 2, 4, 8 and 12 | Change at Week 2 (n= 45, 44, 45, 45, 47, 48) | 0.07 kilogram (kg) | Standard Deviation 1.51 |
| PF-04991532 75 mg | Change From Baseline in Body Weight at Week 1, 2, 4, 8 and 12 | Baseline (n= 50, 49, 50, 50, 52, 50) | 85.69 kilogram (kg) | Standard Deviation 19.805 |
| PF-04991532 75 mg | Change From Baseline in Body Weight at Week 1, 2, 4, 8 and 12 | Change at Week 1 (n= 48, 47, 47, 46, 47, 47) | 0.14 kilogram (kg) | Standard Deviation 1.6 |
| PF-04991532 150 mg | Change From Baseline in Body Weight at Week 1, 2, 4, 8 and 12 | Change at Week 4 (n= 46, 42, 44, 45, 48, 49) | -0.27 kilogram (kg) | Standard Deviation 1.381 |
| PF-04991532 150 mg | Change From Baseline in Body Weight at Week 1, 2, 4, 8 and 12 | Change at Week 1 (n= 48, 47, 47, 46, 47, 47) | -0.20 kilogram (kg) | Standard Deviation 0.861 |
| PF-04991532 150 mg | Change From Baseline in Body Weight at Week 1, 2, 4, 8 and 12 | Change at Week 2 (n= 45, 44, 45, 45, 47, 48) | -0.25 kilogram (kg) | Standard Deviation 1.086 |
| PF-04991532 150 mg | Change From Baseline in Body Weight at Week 1, 2, 4, 8 and 12 | Change at Week 12 (n= 42, 37, 39, 41, 46, 44) | -0.83 kilogram (kg) | Standard Deviation 2.099 |
| PF-04991532 150 mg | Change From Baseline in Body Weight at Week 1, 2, 4, 8 and 12 | Change at Week 8 (n= 43, 40, 41, 42, 46, 45) | -0.64 kilogram (kg) | Standard Deviation 1.538 |
| PF-04991532 150 mg | Change From Baseline in Body Weight at Week 1, 2, 4, 8 and 12 | Baseline (n= 50, 49, 50, 50, 52, 50) | 85.44 kilogram (kg) | Standard Deviation 18.305 |
| PF-04991532 300 mg | Change From Baseline in Body Weight at Week 1, 2, 4, 8 and 12 | Baseline (n= 50, 49, 50, 50, 52, 50) | 91.61 kilogram (kg) | Standard Deviation 21.822 |
| PF-04991532 300 mg | Change From Baseline in Body Weight at Week 1, 2, 4, 8 and 12 | Change at Week 8 (n= 43, 40, 41, 42, 46, 45) | -0.67 kilogram (kg) | Standard Deviation 1.649 |
| PF-04991532 300 mg | Change From Baseline in Body Weight at Week 1, 2, 4, 8 and 12 | Change at Week 1 (n= 48, 47, 47, 46, 47, 47) | -0.20 kilogram (kg) | Standard Deviation 1.168 |
| PF-04991532 300 mg | Change From Baseline in Body Weight at Week 1, 2, 4, 8 and 12 | Change at Week 2 (n= 45, 44, 45, 45, 47, 48) | -0.03 kilogram (kg) | Standard Deviation 1.414 |
| PF-04991532 300 mg | Change From Baseline in Body Weight at Week 1, 2, 4, 8 and 12 | Change at Week 4 (n= 46, 42, 44, 45, 48, 49) | -0.58 kilogram (kg) | Standard Deviation 1.401 |
| PF-04991532 300 mg | Change From Baseline in Body Weight at Week 1, 2, 4, 8 and 12 | Change at Week 12 (n= 42, 37, 39, 41, 46, 44) | -0.75 kilogram (kg) | Standard Deviation 2.087 |
| Sitagliptin 100 mg | Change From Baseline in Body Weight at Week 1, 2, 4, 8 and 12 | Change at Week 4 (n= 46, 42, 44, 45, 48, 49) | -0.30 kilogram (kg) | Standard Deviation 2.276 |
| Sitagliptin 100 mg | Change From Baseline in Body Weight at Week 1, 2, 4, 8 and 12 | Change at Week 2 (n= 45, 44, 45, 45, 47, 48) | -0.32 kilogram (kg) | Standard Deviation 2.488 |
| Sitagliptin 100 mg | Change From Baseline in Body Weight at Week 1, 2, 4, 8 and 12 | Change at Week 8 (n= 43, 40, 41, 42, 46, 45) | -0.61 kilogram (kg) | Standard Deviation 2.648 |
| Sitagliptin 100 mg | Change From Baseline in Body Weight at Week 1, 2, 4, 8 and 12 | Change at Week 12 (n= 42, 37, 39, 41, 46, 44) | -0.83 kilogram (kg) | Standard Deviation 3.026 |
| Sitagliptin 100 mg | Change From Baseline in Body Weight at Week 1, 2, 4, 8 and 12 | Change at Week 1 (n= 48, 47, 47, 46, 47, 47) | -0.33 kilogram (kg) | Standard Deviation 2.089 |
| Sitagliptin 100 mg | Change From Baseline in Body Weight at Week 1, 2, 4, 8 and 12 | Baseline (n= 50, 49, 50, 50, 52, 50) | 91.00 kilogram (kg) | Standard Deviation 21.013 |
Comparison: Week 1: Treatment difference and 95% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.p-value: 0.563695% CI: [-0.69, 0.38]Mixed Models Analysis
Comparison: Week 1: Treatment difference and 95% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.p-value: 0.488995% CI: [-0.35, 0.72]Mixed Models Analysis
Comparison: Week 1: Treatment difference and 95% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.p-value: 0.584995% CI: [-0.68, 0.39]Mixed Models Analysis
Comparison: Week 1: Treatment difference and 95% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.p-value: 0.510495% CI: [-0.7, 0.35]Mixed Models Analysis
Comparison: Week 1: Treatment difference and 95% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.p-value: 0.26495% CI: [-0.83, 0.23]Mixed Models Analysis
Comparison: Week 2: Treatment difference and 95% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.p-value: 0.046495% CI: [-1.42, -0.01]Mixed Models Analysis
Comparison: Week 2: Treatment difference and 95% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.p-value: 0.710795% CI: [-0.83, 0.56]Mixed Models Analysis
Comparison: Week 2: Treatment difference and 95% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.p-value: 0.156495% CI: [-1.19, 0.19]Mixed Models Analysis
Comparison: Week 2: Treatment difference and 95% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.p-value: 0.383495% CI: [-0.98, 0.38]Mixed Models Analysis
Comparison: Week 2: Treatment difference and 95% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.p-value: 0.127995% CI: [-1.21, 0.15]Mixed Models Analysis
Comparison: Week 4: Treatment difference and 95% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.p-value: 0.25295% CI: [-1.06, 0.28]Mixed Models Analysis
Comparison: Week 4: Treatment difference and 95% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.p-value: 0.277295% CI: [-0.3, 1.03]Mixed Models Analysis
Comparison: Week 4: Treatment difference and 95% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.p-value: 0.703895% CI: [-0.79, 0.53]Mixed Models Analysis
Comparison: Week 4: Treatment difference and 95% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.p-value: 0.203195% CI: [-1.07, 0.23]Mixed Models Analysis
Comparison: Week 4: Treatment difference and 95% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.p-value: 0.694895% CI: [-0.78, 0.52]Mixed Models Analysis
Comparison: Week 8: Treatment difference and 95% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.p-value: 0.569195% CI: [-1.07, 0.59]Mixed Models Analysis
Comparison: Week 8: Treatment difference and 95% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.p-value: 0.344795% CI: [-0.42, 1.21]Mixed Models Analysis
Comparison: Week 8: Treatment difference and 95% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.p-value: 0.576995% CI: [-1.04, 0.58]Mixed Models Analysis
Comparison: Week 8: Treatment difference and 95% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.p-value: 0.359995% CI: [-1.16, 0.42]Mixed Models Analysis
Comparison: Week 8: Treatment difference and 95% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.p-value: 0.4695% CI: [-1.1, 0.5]Mixed Models Analysis
Comparison: Week 12: Treatment difference and 95% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.p-value: 0.425395% CI: [-1.39, 0.59]Mixed Models Analysis
Comparison: Week 12: Treatment difference and 95% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.p-value: 0.434995% CI: [-0.59, 1.37]Mixed Models Analysis
Comparison: Week 12: Treatment difference and 95% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.p-value: 0.669795% CI: [-1.18, 0.76]Mixed Models Analysis
Comparison: Week 12: Treatment difference and 95% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.p-value: 0.550195% CI: [-1.22, 0.65]Mixed Models Analysis
Comparison: Week 12: Treatment difference and 95% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.p-value: 0.408195% CI: [-1.35, 0.55]Mixed Models Analysis
Secondary
Change From Baseline in Fasting Plasma Glucose at Week 1, 2, 4, 8 and 12
Time frame: Baseline, Week 1, 2, 4, 8, 12
Population: 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 | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Fasting Plasma Glucose at Week 1, 2, 4, 8 and 12 | Change at Week 12 (n= 42, 37, 38, 40, 46, 44) | 3.41 milligram/deciliter (mg/dL) | Standard Deviation 34.43 |
| Placebo | Change From Baseline in Fasting Plasma Glucose at Week 1, 2, 4, 8 and 12 | Change at Week 2 (n= 44, 44, 45, 45, 47, 48) | -1.31 milligram/deciliter (mg/dL) | Standard Deviation 21.746 |
| Placebo | Change From Baseline in Fasting Plasma Glucose at Week 1, 2, 4, 8 and 12 | Change at Week 8 (n= 43, 40, 41, 42, 46, 45) | 5.63 milligram/deciliter (mg/dL) | Standard Deviation 26.183 |
| Placebo | Change From Baseline in Fasting Plasma Glucose at Week 1, 2, 4, 8 and 12 | Baseline (n= 50, 49, 50, 50 ,52, 50) | 168.41 milligram/deciliter (mg/dL) | Standard Deviation 51.859 |
| Placebo | Change From Baseline in Fasting Plasma Glucose at Week 1, 2, 4, 8 and 12 | Change at Week 1 (n= 48, 47, 47, 46, 46, 45) | 3.69 milligram/deciliter (mg/dL) | Standard Deviation 24.632 |
| Placebo | Change From Baseline in Fasting Plasma Glucose at Week 1, 2, 4, 8 and 12 | Change at Week 4 (n= 46, 42, 44, 45, 48, 49) | 2.00 milligram/deciliter (mg/dL) | Standard Deviation 36.067 |
| PF-04991532 25 mg | Change From Baseline in Fasting Plasma Glucose at Week 1, 2, 4, 8 and 12 | Change at Week 12 (n= 42, 37, 38, 40, 46, 44) | 8.06 milligram/deciliter (mg/dL) | Standard Deviation 23.298 |
| PF-04991532 25 mg | Change From Baseline in Fasting Plasma Glucose at Week 1, 2, 4, 8 and 12 | Baseline (n= 50, 49, 50, 50 ,52, 50) | 167.71 milligram/deciliter (mg/dL) | Standard Deviation 52.401 |
| PF-04991532 25 mg | Change From Baseline in Fasting Plasma Glucose at Week 1, 2, 4, 8 and 12 | Change at Week 2 (n= 44, 44, 45, 45, 47, 48) | 1.05 milligram/deciliter (mg/dL) | Standard Deviation 22.186 |
| PF-04991532 25 mg | Change From Baseline in Fasting Plasma Glucose at Week 1, 2, 4, 8 and 12 | Change at Week 8 (n= 43, 40, 41, 42, 46, 45) | 9.42 milligram/deciliter (mg/dL) | Standard Deviation 28.172 |
| PF-04991532 25 mg | Change From Baseline in Fasting Plasma Glucose at Week 1, 2, 4, 8 and 12 | Change at Week 1 (n= 48, 47, 47, 46, 46, 45) | -0.70 milligram/deciliter (mg/dL) | Standard Deviation 26.644 |
| PF-04991532 25 mg | Change From Baseline in Fasting Plasma Glucose at Week 1, 2, 4, 8 and 12 | Change at Week 4 (n= 46, 42, 44, 45, 48, 49) | 6.08 milligram/deciliter (mg/dL) | Standard Deviation 24.687 |
| PF-04991532 75 mg | Change From Baseline in Fasting Plasma Glucose at Week 1, 2, 4, 8 and 12 | Change at Week 2 (n= 44, 44, 45, 45, 47, 48) | -3.84 milligram/deciliter (mg/dL) | Standard Deviation 24.007 |
| PF-04991532 75 mg | Change From Baseline in Fasting Plasma Glucose at Week 1, 2, 4, 8 and 12 | Change at Week 12 (n= 42, 37, 38, 40, 46, 44) | -6.55 milligram/deciliter (mg/dL) | Standard Deviation 31.919 |
| PF-04991532 75 mg | Change From Baseline in Fasting Plasma Glucose at Week 1, 2, 4, 8 and 12 | Change at Week 1 (n= 48, 47, 47, 46, 46, 45) | -3.29 milligram/deciliter (mg/dL) | Standard Deviation 20.131 |
| PF-04991532 75 mg | Change From Baseline in Fasting Plasma Glucose at Week 1, 2, 4, 8 and 12 | Baseline (n= 50, 49, 50, 50 ,52, 50) | 161.43 milligram/deciliter (mg/dL) | Standard Deviation 43.009 |
| PF-04991532 75 mg | Change From Baseline in Fasting Plasma Glucose at Week 1, 2, 4, 8 and 12 | Change at Week 4 (n= 46, 42, 44, 45, 48, 49) | -6.56 milligram/deciliter (mg/dL) | Standard Deviation 32.88 |
| PF-04991532 75 mg | Change From Baseline in Fasting Plasma Glucose at Week 1, 2, 4, 8 and 12 | Change at Week 8 (n= 43, 40, 41, 42, 46, 45) | -4.98 milligram/deciliter (mg/dL) | Standard Deviation 30.696 |
| PF-04991532 150 mg | Change From Baseline in Fasting Plasma Glucose at Week 1, 2, 4, 8 and 12 | Change at Week 4 (n= 46, 42, 44, 45, 48, 49) | 3.61 milligram/deciliter (mg/dL) | Standard Deviation 36.385 |
| PF-04991532 150 mg | Change From Baseline in Fasting Plasma Glucose at Week 1, 2, 4, 8 and 12 | Change at Week 12 (n= 42, 37, 38, 40, 46, 44) | 6.20 milligram/deciliter (mg/dL) | Standard Deviation 38.122 |
| PF-04991532 150 mg | Change From Baseline in Fasting Plasma Glucose at Week 1, 2, 4, 8 and 12 | Baseline (n= 50, 49, 50, 50 ,52, 50) | 163.38 milligram/deciliter (mg/dL) | Standard Deviation 44.976 |
| PF-04991532 150 mg | Change From Baseline in Fasting Plasma Glucose at Week 1, 2, 4, 8 and 12 | Change at Week 1 (n= 48, 47, 47, 46, 46, 45) | -3.75 milligram/deciliter (mg/dL) | Standard Deviation 19.486 |
| PF-04991532 150 mg | Change From Baseline in Fasting Plasma Glucose at Week 1, 2, 4, 8 and 12 | Change at Week 2 (n= 44, 44, 45, 45, 47, 48) | -1.68 milligram/deciliter (mg/dL) | Standard Deviation 26.966 |
| PF-04991532 150 mg | Change From Baseline in Fasting Plasma Glucose at Week 1, 2, 4, 8 and 12 | Change at Week 8 (n= 43, 40, 41, 42, 46, 45) | 4.43 milligram/deciliter (mg/dL) | Standard Deviation 28.491 |
| PF-04991532 300 mg | Change From Baseline in Fasting Plasma Glucose at Week 1, 2, 4, 8 and 12 | Change at Week 2 (n= 44, 44, 45, 45, 47, 48) | -16.68 milligram/deciliter (mg/dL) | Standard Deviation 43.62 |
| PF-04991532 300 mg | Change From Baseline in Fasting Plasma Glucose at Week 1, 2, 4, 8 and 12 | Baseline (n= 50, 49, 50, 50 ,52, 50) | 168.87 milligram/deciliter (mg/dL) | Standard Deviation 47.63 |
| PF-04991532 300 mg | Change From Baseline in Fasting Plasma Glucose at Week 1, 2, 4, 8 and 12 | Change at Week 8 (n= 43, 40, 41, 42, 46, 45) | -14.24 milligram/deciliter (mg/dL) | Standard Deviation 42.128 |
| PF-04991532 300 mg | Change From Baseline in Fasting Plasma Glucose at Week 1, 2, 4, 8 and 12 | Change at Week 4 (n= 46, 42, 44, 45, 48, 49) | -19.84 milligram/deciliter (mg/dL) | Standard Deviation 31.334 |
| PF-04991532 300 mg | Change From Baseline in Fasting Plasma Glucose at Week 1, 2, 4, 8 and 12 | Change at Week 12 (n= 42, 37, 38, 40, 46, 44) | -16.80 milligram/deciliter (mg/dL) | Standard Deviation 35.765 |
| PF-04991532 300 mg | Change From Baseline in Fasting Plasma Glucose at Week 1, 2, 4, 8 and 12 | Change at Week 1 (n= 48, 47, 47, 46, 46, 45) | -15.35 milligram/deciliter (mg/dL) | Standard Deviation 35.673 |
| Sitagliptin 100 mg | Change From Baseline in Fasting Plasma Glucose at Week 1, 2, 4, 8 and 12 | Change at Week 12 (n= 42, 37, 38, 40, 46, 44) | -16.07 milligram/deciliter (mg/dL) | Standard Deviation 31.298 |
| Sitagliptin 100 mg | Change From Baseline in Fasting Plasma Glucose at Week 1, 2, 4, 8 and 12 | Baseline (n= 50, 49, 50, 50 ,52, 50) | 170.42 milligram/deciliter (mg/dL) | Standard Deviation 41.366 |
| Sitagliptin 100 mg | Change From Baseline in Fasting Plasma Glucose at Week 1, 2, 4, 8 and 12 | Change at Week 1 (n= 48, 47, 47, 46, 46, 45) | -18.59 milligram/deciliter (mg/dL) | Standard Deviation 30.637 |
| Sitagliptin 100 mg | Change From Baseline in Fasting Plasma Glucose at Week 1, 2, 4, 8 and 12 | Change at Week 2 (n= 44, 44, 45, 45, 47, 48) | -20.13 milligram/deciliter (mg/dL) | Standard Deviation 32.632 |
| Sitagliptin 100 mg | Change From Baseline in Fasting Plasma Glucose at Week 1, 2, 4, 8 and 12 | Change at Week 8 (n= 43, 40, 41, 42, 46, 45) | -17.84 milligram/deciliter (mg/dL) | Standard Deviation 28.715 |
| Sitagliptin 100 mg | Change From Baseline in Fasting Plasma Glucose at Week 1, 2, 4, 8 and 12 | Change at Week 4 (n= 46, 42, 44, 45, 48, 49) | -18.90 milligram/deciliter (mg/dL) | Standard Deviation 28.434 |
Comparison: Week 8: Treatment difference and 95% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.p-value: 0.009195% CI: [-26.79, -3.81]Mixed Models Analysis
Comparison: Week 1: Treatment difference and 95% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.p-value: 0.361195% CI: [-16.4, 5.98]Mixed Models Analysis
Comparison: Week 1: Treatment difference and 95% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.p-value: 0.096995% CI: [-20.61, 1.71]Mixed Models Analysis
Comparison: Week 1: Treatment difference and 95% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.p-value: 0.156695% CI: [-19.3, 3.11]Mixed Models Analysis
Comparison: Week 1: Treatment difference and 95% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.p-value: 0.005295% CI: [-27.06, -4.77]Mixed Models Analysis
Comparison: Week 1: Treatment difference and 95% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.p-value: 0.000295% CI: [-32.3, -9.88]Mixed Models Analysis
Comparison: Week 2: Treatment difference and 95% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.p-value: 0.989395% CI: [-11.41, 11.56]Mixed Models Analysis
Comparison: Week 2: Treatment difference and 95% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.p-value: 0.476795% CI: [-15.55, 7.27]Mixed Models Analysis
Comparison: Week 2: Treatment difference and 95% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.p-value: 0.622295% CI: [-14.28, 8.55]Mixed Models Analysis
Comparison: Week 2: Treatment difference and 95% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.p-value: 0.015995% CI: [-25.16, -2.61]Mixed Models Analysis
Comparison: Week 2: Treatment difference and 95% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.p-value: 0.001295% CI: [-29.95, -7.44]Mixed Models Analysis
Comparison: Week 4: Treatment difference and 95% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.p-value: 0.512595% CI: [-7.71, 15.43]Mixed Models Analysis
Comparison: Week 4: Treatment difference and 95% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.p-value: 0.145595% CI: [-19.89, 2.94]Mixed Models Analysis
Comparison: Week 4: Treatment difference and 95% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.p-value: 0.871295% CI: [-10.43, 12.31]Mixed Models Analysis
Comparison: Week 4: Treatment difference and 95% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.p-value: 0.000695% CI: [-30.77, -8.36]Mixed Models Analysis
Comparison: Week 4: Treatment difference and 95% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.p-value: 0.000895% CI: [-30.26, -7.9]Mixed Models Analysis
Comparison: Week 8: Treatment difference and 95% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.p-value: 0.248895% CI: [-4.9, 18.87]Mixed Models Analysis
Comparison: Week 8: Treatment difference and 95% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.p-value: 0.208495% CI: [-19.34, 4.23]Mixed Models Analysis
Comparison: Week 8: Treatment difference and 95% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.p-value: 0.905395% CI: [-11.01, 12.43]Mixed Models Analysis
Comparison: Week 8: Treatment difference and 95% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.p-value: 0.001695% CI: [-30.15, -7.09]Mixed Models Analysis
Comparison: Week 12: Treatment difference and 95% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.p-value: 0.296395% CI: [-5.71, 18.7]Mixed Models Analysis
Comparison: Week 12: Treatment difference and 95% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.p-value: 0.115995% CI: [-21.82, 2.4]Mixed Models Analysis
Comparison: Week 12: Treatment difference and 95% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.p-value: 0.441395% CI: [-7.28, 16.68]Mixed Models Analysis
Comparison: Week 12: Treatment difference and 95% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.p-value: 0.009995% CI: [-26.91, -3.68]Mixed Models Analysis
Comparison: Week 12: Treatment difference and 95% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.p-value: 0.012695% CI: [-26.69, -3.21]Mixed Models Analysis
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.
Time frame: Baseline, Week 1, 2, 4, 8
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 1, 2, 4 and 8 | Change at Week 1 (n= 48, 47, 47, 46, 46, 47) | 0.03 percentage of hemoglobin | Standard Deviation 0.496 |
| Placebo | Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 1, 2, 4 and 8 | Change at Week 2 (n= 45, 44, 45, 45, 47, 48) | -0.02 percentage of hemoglobin | Standard Deviation 0.481 |
| Placebo | Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 1, 2, 4 and 8 | Change at Week 4 (n= 46, 42, 44, 45, 48, 49) | -0.14 percentage of hemoglobin | Standard Deviation 0.558 |
| Placebo | Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 1, 2, 4 and 8 | Change at Week 8 (n= 43, 40, 41, 42, 45, 45) | -0.26 percentage of hemoglobin | Standard Deviation 0.615 |
| PF-04991532 25 mg | Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 1, 2, 4 and 8 | Change at Week 4 (n= 46, 42, 44, 45, 48, 49) | -0.15 percentage of hemoglobin | Standard Deviation 0.326 |
| PF-04991532 25 mg | Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 1, 2, 4 and 8 | Change at Week 2 (n= 45, 44, 45, 45, 47, 48) | -0.10 percentage of hemoglobin | Standard Deviation 0.236 |
| PF-04991532 25 mg | Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 1, 2, 4 and 8 | Change at Week 1 (n= 48, 47, 47, 46, 46, 47) | -0.01 percentage of hemoglobin | Standard Deviation 0.19 |
| PF-04991532 25 mg | Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 1, 2, 4 and 8 | Change at Week 8 (n= 43, 40, 41, 42, 45, 45) | -0.14 percentage of hemoglobin | Standard Deviation 0.492 |
| PF-04991532 75 mg | Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 1, 2, 4 and 8 | Change at Week 8 (n= 43, 40, 41, 42, 45, 45) | -0.40 percentage of hemoglobin | Standard Deviation 0.697 |
| PF-04991532 75 mg | Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 1, 2, 4 and 8 | Change at Week 4 (n= 46, 42, 44, 45, 48, 49) | -0.26 percentage of hemoglobin | Standard Deviation 0.436 |
| PF-04991532 75 mg | Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 1, 2, 4 and 8 | Change at Week 2 (n= 45, 44, 45, 45, 47, 48) | -0.08 percentage of hemoglobin | Standard Deviation 0.23 |
| PF-04991532 75 mg | Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 1, 2, 4 and 8 | Change at Week 1 (n= 48, 47, 47, 46, 46, 47) | -0.07 percentage of hemoglobin | Standard Deviation 0.182 |
| PF-04991532 150 mg | Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 1, 2, 4 and 8 | Change at Week 1 (n= 48, 47, 47, 46, 46, 47) | -0.06 percentage of hemoglobin | Standard Deviation 0.227 |
| PF-04991532 150 mg | Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 1, 2, 4 and 8 | Change at Week 8 (n= 43, 40, 41, 42, 45, 45) | -0.42 percentage of hemoglobin | Standard Deviation 0.708 |
| PF-04991532 150 mg | Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 1, 2, 4 and 8 | Change at Week 2 (n= 45, 44, 45, 45, 47, 48) | -0.06 percentage of hemoglobin | Standard Deviation 0.342 |
| PF-04991532 150 mg | Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 1, 2, 4 and 8 | Change at Week 4 (n= 46, 42, 44, 45, 48, 49) | -0.32 percentage of hemoglobin | Standard Deviation 0.525 |
| PF-04991532 300 mg | Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 1, 2, 4 and 8 | Change at Week 4 (n= 46, 42, 44, 45, 48, 49) | -0.37 percentage of hemoglobin | Standard Deviation 0.395 |
| PF-04991532 300 mg | Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 1, 2, 4 and 8 | Change at Week 8 (n= 43, 40, 41, 42, 45, 45) | -0.58 percentage of hemoglobin | Standard Deviation 0.607 |
| PF-04991532 300 mg | Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 1, 2, 4 and 8 | Change at Week 2 (n= 45, 44, 45, 45, 47, 48) | -0.17 percentage of hemoglobin | Standard Deviation 0.275 |
| PF-04991532 300 mg | Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 1, 2, 4 and 8 | Change at Week 1 (n= 48, 47, 47, 46, 46, 47) | -0.02 percentage of hemoglobin | Standard Deviation 0.21 |
| Sitagliptin 100 mg | Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 1, 2, 4 and 8 | Change at Week 2 (n= 45, 44, 45, 45, 47, 48) | -0.21 percentage of hemoglobin | Standard Deviation 0.357 |
| Sitagliptin 100 mg | Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 1, 2, 4 and 8 | Change at Week 4 (n= 46, 42, 44, 45, 48, 49) | -0.40 percentage of hemoglobin | Standard Deviation 0.463 |
| Sitagliptin 100 mg | Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 1, 2, 4 and 8 | Change at Week 8 (n= 43, 40, 41, 42, 45, 45) | -0.54 percentage of hemoglobin | Standard Deviation 0.696 |
| Sitagliptin 100 mg | Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 1, 2, 4 and 8 | Change at Week 1 (n= 48, 47, 47, 46, 46, 47) | -0.14 percentage of hemoglobin | Standard Deviation 0.223 |
Comparison: Week 1: Treatment difference and 80% CI were based on LS mean. 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.p-value: 0.179780% CI: [-0.13, 0.02]Mixed Models Analysis
Comparison: Week 1: Treatment difference and 80% CI were based on LS mean. 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.p-value: 0.023495% CI: [-0.19, -0.04]Mixed Models Analysis
Comparison: Week 1: Treatment difference and 80% CI were based on LS mean. 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.p-value: 0.0480% CI: [-0.18, -0.03]Mixed Models Analysis
Comparison: Week 1: Treatment difference and 80% CI were based on LS mean. 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.p-value: 0.156880% CI: [-0.13, 0.02]Mixed Models Analysis
Comparison: Week 1: Treatment difference and 80% CI were based on LS mean. 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.p-value: 0.00180% CI: [-0.25, -0.11]Mixed Models Analysis
Comparison: Week 2: Treatment difference and 80% CI were based on LS mean. 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.p-value: 0.069580% CI: [-0.19, -0.01]Mixed Models Analysis
Comparison: Week 2: Treatment difference and 80% CI were based on LS mean. 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.p-value: 0.063680% CI: [-0.2, -0.02]Mixed Models Analysis
Comparison: Week 2: Treatment difference and 80% CI were based on LS mean. 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.p-value: 0.051280% CI: [-0.2, -0.02]Mixed Models Analysis
Comparison: Week 2: Treatment difference and 80% CI were based on LS mean. 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.p-value: 0.005180% CI: [-0.26, -0.09]Mixed Models Analysis
Comparison: Week 2: Treatment difference and 80% CI were based on LS mean. 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.p-value: 0.000980% CI: [-0.3, -0.13]Mixed Models Analysis
Comparison: Week 4: Treatment difference and 80% CI were based on LS mean. 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.p-value: 0.239280% CI: [-0.19, 0.05]Mixed Models Analysis
Comparison: Week 4: Treatment difference and 80% CI were based on LS mean. 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.p-value: 0.030880% CI: [-0.29, -0.05]Mixed Models Analysis
Comparison: Week 4: Treatment difference and 80% CI were based on LS mean. 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.p-value: 0.001980% CI: [-0.38, -0.15]Mixed Models Analysis
Comparison: Week 4: Treatment difference and 80% CI were based on LS mean. 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.p-value: 0.003480% CI: [-0.36, -0.13]Mixed Models Analysis
Comparison: Week 4: Treatment difference and 80% CI were based on LS mean. 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.p-value: 0.000280% CI: [-0.44, -0.21]Mixed Models Analysis
Comparison: Week 8: Treatment difference and 80% CI were based on LS mean. 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.p-value: 0.785480% CI: [-0.06, 0.26]Mixed Models Analysis
Comparison: Week 8: Treatment difference and 80% CI were based on LS mean. 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.p-value: 0.077880% CI: [-0.33, -0.02]Mixed Models Analysis
Comparison: Week 8: Treatment difference and 80% CI were based on LS mean. 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.p-value: 0.006580% CI: [-0.46, -0.15]Mixed Models Analysis
Comparison: Week 8: Treatment difference and 80% CI were based on LS mean. 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.p-value: 0.001180% CI: [-0.52, -0.21]Mixed Models Analysis
Comparison: Week 8: Treatment difference and 80% CI were based on LS mean. 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.p-value: 0.001380% CI: [-0.52, -0.21]Mixed Models Analysis
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.
Time frame: Week 12
Population: 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 | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Percentage of Participants Achieving Less Than (<) 6.5% or <7% Glycosylated Hemoglobin (HbA1c) Levels | < 6.5% | 11.9 percentage of participants |
| Placebo | Percentage of Participants Achieving Less Than (<) 6.5% or <7% Glycosylated Hemoglobin (HbA1c) Levels | < 7% | 23.8 percentage of participants |
| PF-04991532 25 mg | Percentage of Participants Achieving Less Than (<) 6.5% or <7% Glycosylated Hemoglobin (HbA1c) Levels | < 6.5% | 8.1 percentage of participants |
| PF-04991532 25 mg | Percentage of Participants Achieving Less Than (<) 6.5% or <7% Glycosylated Hemoglobin (HbA1c) Levels | < 7% | 29.7 percentage of participants |
| PF-04991532 75 mg | Percentage of Participants Achieving Less Than (<) 6.5% or <7% Glycosylated Hemoglobin (HbA1c) Levels | < 6.5% | 15.4 percentage of participants |
| PF-04991532 75 mg | Percentage of Participants Achieving Less Than (<) 6.5% or <7% Glycosylated Hemoglobin (HbA1c) Levels | < 7% | 38.5 percentage of participants |
| PF-04991532 150 mg | Percentage of Participants Achieving Less Than (<) 6.5% or <7% Glycosylated Hemoglobin (HbA1c) Levels | < 6.5% | 17.5 percentage of participants |
| PF-04991532 150 mg | Percentage of Participants Achieving Less Than (<) 6.5% or <7% Glycosylated Hemoglobin (HbA1c) Levels | < 7% | 35.0 percentage of participants |
| PF-04991532 300 mg | Percentage of Participants Achieving Less Than (<) 6.5% or <7% Glycosylated Hemoglobin (HbA1c) Levels | < 6.5% | 17.4 percentage of participants |
| PF-04991532 300 mg | Percentage of Participants Achieving Less Than (<) 6.5% or <7% Glycosylated Hemoglobin (HbA1c) Levels | < 7% | 43.5 percentage of participants |
| Sitagliptin 100 mg | Percentage of Participants Achieving Less Than (<) 6.5% or <7% Glycosylated Hemoglobin (HbA1c) Levels | < 6.5% | 15.9 percentage of participants |
| Sitagliptin 100 mg | Percentage of Participants Achieving Less Than (<) 6.5% or <7% Glycosylated Hemoglobin (HbA1c) Levels | < 7% | 36.4 percentage of participants |
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.
Time frame: Week 12
Population: 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 | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Percentage of Participants With Greater Than or Equal to (>=) 1% or >= 2% Gain in Body Weight From Baseline | >= 1% | 23.81 percentage of participants |
| Placebo | Percentage of Participants With Greater Than or Equal to (>=) 1% or >= 2% Gain in Body Weight From Baseline | >= 2% | 2.38 percentage of participants |
| PF-04991532 25 mg | Percentage of Participants With Greater Than or Equal to (>=) 1% or >= 2% Gain in Body Weight From Baseline | >= 1% | 27.03 percentage of participants |
| PF-04991532 25 mg | Percentage of Participants With Greater Than or Equal to (>=) 1% or >= 2% Gain in Body Weight From Baseline | >= 2% | 2.70 percentage of participants |
| PF-04991532 75 mg | Percentage of Participants With Greater Than or Equal to (>=) 1% or >= 2% Gain in Body Weight From Baseline | >= 1% | 38.46 percentage of participants |
| PF-04991532 75 mg | Percentage of Participants With Greater Than or Equal to (>=) 1% or >= 2% Gain in Body Weight From Baseline | >= 2% | 15.38 percentage of participants |
| PF-04991532 150 mg | Percentage of Participants With Greater Than or Equal to (>=) 1% or >= 2% Gain in Body Weight From Baseline | >= 1% | 21.95 percentage of participants |
| PF-04991532 150 mg | Percentage of Participants With Greater Than or Equal to (>=) 1% or >= 2% Gain in Body Weight From Baseline | >= 2% | 7.32 percentage of participants |
| PF-04991532 300 mg | Percentage of Participants With Greater Than or Equal to (>=) 1% or >= 2% Gain in Body Weight From Baseline | >= 1% | 15.22 percentage of participants |
| PF-04991532 300 mg | Percentage of Participants With Greater Than or Equal to (>=) 1% or >= 2% Gain in Body Weight From Baseline | >= 2% | 6.52 percentage of participants |
| Sitagliptin 100 mg | Percentage of Participants With Greater Than or Equal to (>=) 1% or >= 2% Gain in Body Weight From Baseline | >= 1% | 31.82 percentage of participants |
| Sitagliptin 100 mg | Percentage of Participants With Greater Than or Equal to (>=) 1% or >= 2% Gain in Body Weight From Baseline | >= 2% | 15.91 percentage of participants |
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.
Time frame: Week 12
Population: 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 | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Percentage of Participants With Greater Than or Equal to (>=) 1% or >= 2% Loss in Body Weight From Baseline | >= 1% | 38.10 percentage of participants |
| Placebo | Percentage of Participants With Greater Than or Equal to (>=) 1% or >= 2% Loss in Body Weight From Baseline | >= 2% | 23.81 percentage of participants |
| PF-04991532 25 mg | Percentage of Participants With Greater Than or Equal to (>=) 1% or >= 2% Loss in Body Weight From Baseline | >= 1% | 35.14 percentage of participants |
| PF-04991532 25 mg | Percentage of Participants With Greater Than or Equal to (>=) 1% or >= 2% Loss in Body Weight From Baseline | >= 2% | 27.03 percentage of participants |
| PF-04991532 75 mg | Percentage of Participants With Greater Than or Equal to (>=) 1% or >= 2% Loss in Body Weight From Baseline | >= 1% | 30.77 percentage of participants |
| PF-04991532 75 mg | Percentage of Participants With Greater Than or Equal to (>=) 1% or >= 2% Loss in Body Weight From Baseline | >= 2% | 17.95 percentage of participants |
| PF-04991532 150 mg | Percentage of Participants With Greater Than or Equal to (>=) 1% or >= 2% Loss in Body Weight From Baseline | >= 1% | 48.78 percentage of participants |
| PF-04991532 150 mg | Percentage of Participants With Greater Than or Equal to (>=) 1% or >= 2% Loss in Body Weight From Baseline | >= 2% | 26.83 percentage of participants |
| PF-04991532 300 mg | Percentage of Participants With Greater Than or Equal to (>=) 1% or >= 2% Loss in Body Weight From Baseline | >= 1% | 41.30 percentage of participants |
| PF-04991532 300 mg | Percentage of Participants With Greater Than or Equal to (>=) 1% or >= 2% Loss in Body Weight From Baseline | >= 2% | 30.43 percentage of participants |
| Sitagliptin 100 mg | Percentage of Participants With Greater Than or Equal to (>=) 1% or >= 2% Loss in Body Weight From Baseline | >= 1% | 40.91 percentage of participants |
| Sitagliptin 100 mg | Percentage of Participants With Greater Than or Equal to (>=) 1% or >= 2% Loss in Body Weight From Baseline | >= 2% | 29.55 percentage of participants |