Diabetes Mellitus, Type 2
Conditions
Brief summary
This multicenter, randomized, double-blind, placebo controlled, parallel group study is being conducted to provide data on efficacy, safety, tolerability and pharmacokinetics (PK) of multiple dose levels of PF-06882961 in adults with type 2 diabetes mellitus (T2DM) inadequately controlled on metformin and/or diet and exercise. In addition, the study is intended to enable selection of efficacious doses for future clinical development of PF-06882961.
Interventions
DRUGPlacebo
4 matching placebo tablets taken twice a day (BID)
DRUGPF-06882961
Participants will be randomized to one of 5 active doses (2.5, 10, 40, 80, or 120 mg), taking 4 tablets twice daily for 16 weeks.
Sponsors
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Patients with T2DM who are treated with metformin and/or diet and exercise * HbA1c greater than or equal to 7% and less than or equal to 10.5% * Total body weight \>50 kg (110 lb) with BMI 24.5 to 45.4 kg/m\^2
Exclusion criteria
* Any condition possibly affecting drug absorption * Diagnosis of Type 1 diabetes * History of myocardial infarction, unstable angina, arterial revascularization, stroke, heart failure, or transient ischemic attack within 6 months of screening * Any malignancy not considered cured * Personal or family history of MTC or MEN2, or participants with suspected MTC * Acute pancreatitis or history of chronic pancreatitis * Symptomatic gallbladder disease * Known medical history of active proliferative retinopathy and/or macular edema * Known medical history of active liver disease, including chronic active hepatitis B or C, or primary biliary cirrhosis * Known history of HIV * Supine blood pressure greater than or equal to 160 mmHg (systolic) or greater than or equal to 100 mmHg (diastolic) * Clinically relevant ECG abnormalities * Positive urine drug test
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Glycated Hemoglobin (HbA1c) at Week 16 | Baseline, Week 16 | HbA1c can be used as a diagnostic test for diabetes. The target HbA1c level for people with diabetes is usually less than 7%. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Glycated Hemoglobin (HbA1c) at Week 2 | Baseline, Week 2 | HbA1c can be used as a diagnostic test for diabetes. The target HbA1c level for people with diabetes is usually less than 7%. |
| Change From Baseline in Glycated Hemoglobin (HbA1c) at Week 4 | Baseline, Week 4 | HbA1c can be used as a diagnostic test for diabetes. The target HbA1c level for people with diabetes is usually less than 7%. |
| Change From Baseline in Glycated Hemoglobin (HbA1c) at Week 6 | Baseline, Week 6 | HbA1c can be used as a diagnostic test for diabetes. The target HbA1c level for people with diabetes is usually less than 7%. |
| Change From Baseline in Glycated Hemoglobin (HbA1c) at Week 8 | Baseline, Week 8 | HbA1c can be used as a diagnostic test for diabetes. The target HbA1c level for people with diabetes is usually less than 7%. |
| Change From Baseline in Glycated Hemoglobin (HbA1c) at Week 12 | Baseline, Week 12 | HbA1c can be used as a diagnostic test for diabetes. The target HbA1c level for people with diabetes is usually less than 7%. |
| Change From Baseline in Fasting Plasma Glucose at Week 2 | Baseline, Week 2 | The fasting plasma glucose test measures the levels of glucose (sugar) in the blood, with a normal range of 70 milligram per deciliter (mg/dL) to 99 mg/dL. |
| Change From Baseline in Fasting Plasma Glucose at Week 4 | Baseline, Week 4 | The fasting plasma glucose test measures the levels of glucose (sugar) in the blood, with a normal range of 70 mg/dL to 99 mg/dL. |
| Change From Baseline in Fasting Plasma Glucose at Week 6 | Baseline, Week 6 | The fasting plasma glucose test measures the levels of glucose (sugar) in the blood, with a normal range of 70 mg/dL to 99 mg/dL. |
| Change From Baseline in Fasting Plasma Glucose at Week 8 | Baseline, Week 8 | The fasting plasma glucose test measures the levels of glucose (sugar) in the blood, with a normal range of 70 mg/dL to 99 mg/dL. |
| Change From Baseline in Fasting Plasma Glucose at Week 12 | Baseline, Week 12 | The fasting plasma glucose test measures the levels of glucose (sugar) in the blood, with a normal range of 70 mg/dL to 99 mg/dL. |
| Percentage of Participants Achieving Less Than (<) 7% Glycated Hemoglobin (HbA1c) Levels | Baseline, Week 16 | HbA1c can be used as a diagnostic test for diabetes. The target HbA1c level for people with diabetes is usually less than 7%. |
| Change From Baseline in Body Weight at Week 2 | Baseline, Week 2 | Weight was recorded using a calibrated scale (with the same scale used if possible for the duration of the study) reporting weight in kilograms (kg), and accuracy to the nearest 0.1 kg. |
| Change From Baseline in Body Weight at Week 4 | Baseline, Week 4 | Weight was recorded using a calibrated scale (with the same scale used if possible for the duration of the study) reporting weight in kilograms (kg), and accuracy to the nearest 0.1 kg. |
| Change From Baseline in Body Weight at Week 6 | Baseline, Week 6 | Weight was recorded using a calibrated scale (with the same scale used if possible for the duration of the study) reporting weight in kilograms (kg), and accuracy to the nearest 0.1 kg. |
| Change From Baseline in Body Weight at Week 8 | Baseline, Week 8 | Weight was recorded using a calibrated scale (with the same scale used if possible for the duration of the study) reporting weight in kilograms (kg), and accuracy to the nearest 0.1 kg. |
| Change From Baseline in Body Weight at Week 12 | Baseline, Week 12 | Weight was recorded using a calibrated scale (with the same scale used if possible for the duration of the study) reporting weight in kilograms (kg), and accuracy to the nearest 0.1 kg. |
| Change From Baseline in Body Weight at Week 16 | Baseline, Week 16 | Weight was recorded using a calibrated scale (with the same scale used if possible for the duration of the study) reporting weight in kilograms (kg), and accuracy to the nearest 0.1 kg. |
| Number of Participants With Treatment Emergent Adverse Events (Adverse Events [AEs] and Serious Adverse Events [SAEs]) | Baseline up to Week 21 | An adverse event (AE) was any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. A serious AE (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; life-threatening; initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect. Any such events with initial onset or increasing in severity after the first dose of study treatment were counted as treatment-emergent. |
| Number of Participants With Treatment Emergent Clinical Laboratory Abnormalities Without Regard to Baseline Abnormality | Baseline Through Week 21 | Following laboratory parameters were assessed against pre-defined abnormality criteria: hematology (hemoglobin, hematocrit, erythrocytes, reticulocytes, platelets, leukocytes, lymphocytes, neutrophils, basophils, eosinophils, monocytes, activated partial thromboplastin time, prothrombin time, PT/INR, reticulocytes); chemistry (indirect bilirubin, direct bilirubin, protein, albumin, blood urea nitrogen, creatinine, creatine kinase, urate, calcium, sodium, potassium, chloride, bicarbonate, urine urobilinogen); urinalysis (pH, urine glucose, urine ketones, urine protein, urine hemoglobin, nitrites, leukocyte esterase, urine erythrocytes, urine leukocytes, urine hyaline casts, urine bilirubin); lipid panel (low density lipoprotein cholesterol, high density lipoprotein cholesterol). |
| Number of Participants With Treatment Emergent Vital Signs Abnormalities | Baseline through Week 21 | Vital signs abnormality criteria: 1) supine systolic blood pressure (SBP) \<90 millimeters of mercury (mmHg); 2) supine diastolic blood pressure (DBP) \<50 mmHg; 3) supine pulse rate \<40 or \>120 beats per minute (bpm); 4) change from baseline (increase or decrease) in supine SBP greater than or equal to (\>=) 30 mmHg; 5) change from baseline (increase or decrease) in supine DBP \>= 20 mmHg. |
| Number of Participants With Treatment Emergent ECG Abnormalities | Baseline Through Week 21 | ECG categorical abnormality criteria: 1. PR interval (the interval between the start of the P wave and the start of the QRS complex, corresponding to the time between the onset of the atrial depolarization and onset of ventricular depolarization): a) greater than or equal to (\>=) 300 millisecond (msec), b) \>=25% increase when baseline is \> 200 msec or \>=50% increase when baseline is less than or equal to (\<=) 200 msec. 2\. QRS interval (time from ECG Q wave to the end of the S wave corresponding to ventricle depolarization): a) \>=140 msec, b) \>=50% increase from baseline. 3\. QTcF interval (QT corrected using the Fridericia formula): a) \>450 msec and \<=480 msec, b) \>480 msec and \<=500 msec, c) \>500 msec, d) \>30 msec and \<=60 msec increase from baseline, e) \>60 msec increase from baseline. |
| Change From Baseline in Fasting Plasma Glucose at Week 16 | Baseline, Week 16 | The fasting plasma glucose test measures the levels of glucose (sugar) in the blood, with a normal range of 70 mg/dL to 99 mg/dL. |
Countries
Bulgaria, Canada, Hungary, Poland, Slovakia, South Korea, Taiwan, United States
Participant flow
Pre-assignment details
A total of 859 participants were screened in the study, among whom, 412 participants were randomized, and 411 participants were treated with PF-06882961 (Danuglipron)/placebo; 1 participant randomized to the PF-06882961 120 mg BID group was not treated.
Participants by arm
| Arm | Count |
|---|---|
| Placebo Placebo matched to PF-06882961 was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up. | 66 |
| PF-06882961 2.5mg BID PF-06882961 2.5 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up. | 68 |
| PF-06882961 10mg BID PF-06882961 10 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up. | 68 |
| PF-06882961 40mg BID PF-06882961 40 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up. Titration was implemented. | 71 |
| PF-06882961 80mg BID PF-06882961 80 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up. Titration was implemented. | 67 |
| PF-06882961 120mg BID PF-06882961 120 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up. Titration was implemented. | 71 |
| Total | 411 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 |
|---|---|---|---|---|---|---|---|
| DOUBLE-BLIND TREATMENT | Adverse Event | 5 | 2 | 3 | 8 | 15 | 24 |
| DOUBLE-BLIND TREATMENT | Lost to Follow-up | 1 | 3 | 0 | 3 | 3 | 1 |
| DOUBLE-BLIND TREATMENT | No Longer Meets Eligibility Criteria | 1 | 1 | 0 | 1 | 0 | 0 |
| DOUBLE-BLIND TREATMENT | Other | 1 | 2 | 0 | 2 | 1 | 0 |
| DOUBLE-BLIND TREATMENT | Protocol Violation | 1 | 2 | 0 | 0 | 0 | 1 |
| DOUBLE-BLIND TREATMENT | Withdrawal by Subject | 0 | 4 | 2 | 0 | 1 | 7 |
| FOLLOW-UP | Lost to Follow-up | 0 | 0 | 1 | 0 | 0 | 0 |
Baseline characteristics
| Characteristic | Placebo | PF-06882961 2.5mg BID | PF-06882961 10mg BID | PF-06882961 40mg BID | PF-06882961 80mg BID | PF-06882961 120mg BID | Total |
|---|---|---|---|---|---|---|---|
| Age, Continuous Mean (SD) | 57.9 Years STANDARD_DEVIATION 10.27 | 58.9 Years STANDARD_DEVIATION 9.3 | 58.1 Years STANDARD_DEVIATION 9.43 | 59.6 Years STANDARD_DEVIATION 8.58 | 58.4 Years STANDARD_DEVIATION 9.18 | 58.8 Years STANDARD_DEVIATION 9.43 | 58.6 Years STANDARD_DEVIATION 9.33 |
| Age, Customized 18-44 Years | 6 Participants | 4 Participants | 7 Participants | 2 Participants | 5 Participants | 8 Participants | 32 Participants |
| Age, Customized 45-64 Years | 44 Participants | 43 Participants | 41 Participants | 45 Participants | 42 Participants | 44 Participants | 259 Participants |
| Age, Customized >=65 Years | 16 Participants | 21 Participants | 20 Participants | 24 Participants | 20 Participants | 19 Participants | 120 Participants |
| Age Range | 59.0 Years | 59.0 Years | 60.0 Years | 61.0 Years | 58.0 Years | 60.0 Years | 59.0 Years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 24 Participants | 22 Participants | 17 Participants | 24 Participants | 23 Participants | 18 Participants | 128 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 42 Participants | 46 Participants | 50 Participants | 47 Participants | 44 Participants | 52 Participants | 281 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants | 2 Participants |
| Race/Ethnicity, Customized Asian | 5 Participants | 7 Participants | 4 Participants | 6 Participants | 6 Participants | 7 Participants | 35 Participants |
| Race/Ethnicity, Customized Black or African American | 2 Participants | 4 Participants | 10 Participants | 6 Participants | 1 Participants | 4 Participants | 27 Participants |
| Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 2 Participants |
| Race/Ethnicity, Customized Not reported | 1 Participants | 0 Participants | 1 Participants | 1 Participants | 1 Participants | 0 Participants | 4 Participants |
| Race/Ethnicity, Customized White | 57 Participants | 57 Participants | 53 Participants | 58 Participants | 59 Participants | 59 Participants | 343 Participants |
| Sex: Female, Male Female | 33 Participants | 30 Participants | 33 Participants | 37 Participants | 32 Participants | 37 Participants | 202 Participants |
| Sex: Female, Male Male | 33 Participants | 38 Participants | 35 Participants | 34 Participants | 35 Participants | 34 Participants | 209 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 | 0 / 66 | 1 / 68 | 0 / 68 | 2 / 71 | 0 / 67 | 0 / 71 |
| other Total, other adverse events | 15 / 66 | 21 / 68 | 17 / 68 | 33 / 71 | 40 / 67 | 35 / 71 |
| serious Total, serious adverse events | 1 / 66 | 1 / 68 | 2 / 68 | 6 / 71 | 2 / 67 | 1 / 71 |
Outcome results
Primary
Change From Baseline in Glycated Hemoglobin (HbA1c) at Week 16
HbA1c can be used as a diagnostic test for diabetes. The target HbA1c level for people with diabetes is usually less than 7%.
Time frame: Baseline, Week 16
Population: Overall number of participants analyzed included all participants randomly assigned to study treatment and who took at least 1 dose of study treatment.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Placebo | Change From Baseline in Glycated Hemoglobin (HbA1c) at Week 16 | -0.02 Percent |
| PF-06882961 2.5 BID | Change From Baseline in Glycated Hemoglobin (HbA1c) at Week 16 | -0.49 Percent |
| PF-06882961 10 mg BID | Change From Baseline in Glycated Hemoglobin (HbA1c) at Week 16 | -0.91 Percent |
| PF-06882961 40 mg BID | Change From Baseline in Glycated Hemoglobin (HbA1c) at Week 16 | -1.03 Percent |
| PF-06882961 80 mg BID | Change From Baseline in Glycated Hemoglobin (HbA1c) at Week 16 | -0.96 Percent |
| PF-06882961 120 mg BID | Change From Baseline in Glycated Hemoglobin (HbA1c) at Week 16 | -1.18 Percent |
p-value: 0.007190% CI: [-0.76, -0.18]Mixed Models Analysis
p-value: <0.000190% CI: [-1.18, -0.62]Mixed Models Analysis
p-value: <0.000190% CI: [-1.3, -0.73]Mixed Models Analysis
p-value: <0.000190% CI: [-1.24, -0.65]Mixed Models Analysis
p-value: <0.000190% CI: [-1.47, -0.86]Mixed Models Analysis
Secondary
Change From Baseline in Body Weight at Week 12
Weight was recorded using a calibrated scale (with the same scale used if possible for the duration of the study) reporting weight in kilograms (kg), and accuracy to the nearest 0.1 kg.
Time frame: Baseline, Week 12
Population: Overall number of participants analyzed included all participants randomly assigned to study treatment and who took at least 1 dose of study treatment.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Placebo | Change From Baseline in Body Weight at Week 12 | -0.24 Kilogram |
| PF-06882961 2.5 BID | Change From Baseline in Body Weight at Week 12 | -0.09 Kilogram |
| PF-06882961 10 mg BID | Change From Baseline in Body Weight at Week 12 | -0.00 Kilogram |
| PF-06882961 40 mg BID | Change From Baseline in Body Weight at Week 12 | -1.05 Kilogram |
| PF-06882961 80 mg BID | Change From Baseline in Body Weight at Week 12 | -2.52 Kilogram |
| PF-06882961 120 mg BID | Change From Baseline in Body Weight at Week 12 | -3.81 Kilogram |
p-value: 0.775890% CI: [-0.7, 0.99]Mixed Models Analysis
p-value: 0.636790% CI: [-0.58, 1.05]Mixed Models Analysis
p-value: 0.108290% CI: [-1.63, 0.02]Mixed Models Analysis
p-value: <0.000190% CI: [-3.14, -1.42]Mixed Models Analysis
p-value: <0.000190% CI: [-4.44, -2.7]Mixed Models Analysis
Secondary
Change From Baseline in Body Weight at Week 16
Weight was recorded using a calibrated scale (with the same scale used if possible for the duration of the study) reporting weight in kilograms (kg), and accuracy to the nearest 0.1 kg.
Time frame: Baseline, Week 16
Population: Overall number of participants analyzed included all participants randomly assigned to study treatment and who took at least 1 dose of study treatment.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Placebo | Change From Baseline in Body Weight at Week 16 | -0.43 Kilogram |
| PF-06882961 2.5 BID | Change From Baseline in Body Weight at Week 16 | 0.02 Kilogram |
| PF-06882961 10 mg BID | Change From Baseline in Body Weight at Week 16 | -0.06 Kilogram |
| PF-06882961 40 mg BID | Change From Baseline in Body Weight at Week 16 | -1.16 Kilogram |
| PF-06882961 80 mg BID | Change From Baseline in Body Weight at Week 16 | -2.48 Kilogram |
| PF-06882961 120 mg BID | Change From Baseline in Body Weight at Week 16 | -4.60 Kilogram |
p-value: 0.432590% CI: [-0.5, 1.41]Mixed Models Analysis
p-value: 0.497890% CI: [-0.54, 1.3]Mixed Models Analysis
p-value: 0.19790% CI: [-1.66, 0.2]Mixed Models Analysis
p-value: 0.000690% CI: [-3.01, -1.07]Mixed Models Analysis
p-value: <0.000190% CI: [-5.15, -3.18]Mixed Models Analysis
Secondary
Change From Baseline in Body Weight at Week 2
Weight was recorded using a calibrated scale (with the same scale used if possible for the duration of the study) reporting weight in kilograms (kg), and accuracy to the nearest 0.1 kg.
Time frame: Baseline, Week 2
Population: Overall number of participants analyzed included all participants randomly assigned to study treatment and who took at least 1 dose of study treatment.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Placebo | Change From Baseline in Body Weight at Week 2 | -0.15 Kilogram |
| PF-06882961 2.5 BID | Change From Baseline in Body Weight at Week 2 | -0.09 Kilogram |
| PF-06882961 10 mg BID | Change From Baseline in Body Weight at Week 2 | -0.12 Kilogram |
| PF-06882961 40 mg BID | Change From Baseline in Body Weight at Week 2 | -0.23 Kilogram |
| PF-06882961 80 mg BID | Change From Baseline in Body Weight at Week 2 | -0.57 Kilogram |
| PF-06882961 120 mg BID | Change From Baseline in Body Weight at Week 2 | -0.54 Kilogram |
p-value: 0.801190% CI: [-0.33, 0.44]Mixed Models Analysis
p-value: 0.914990% CI: [-0.35, 0.4]Mixed Models Analysis
p-value: 0.721690% CI: [-0.46, 0.3]Mixed Models Analysis
p-value: 0.075890% CI: [-0.8, -0.03]Mixed Models Analysis
p-value: 0.08690% CI: [-0.77, -0.02]Mixed Models Analysis
Secondary
Change From Baseline in Body Weight at Week 4
Weight was recorded using a calibrated scale (with the same scale used if possible for the duration of the study) reporting weight in kilograms (kg), and accuracy to the nearest 0.1 kg.
Time frame: Baseline, Week 4
Population: Overall number of participants analyzed included all participants randomly assigned to study treatment and who took at least 1 dose of study treatment.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Placebo | Change From Baseline in Body Weight at Week 4 | -0.25 Kilogram |
| PF-06882961 2.5 BID | Change From Baseline in Body Weight at Week 4 | -0.33 Kilogram |
| PF-06882961 10 mg BID | Change From Baseline in Body Weight at Week 4 | -0.08 Kilogram |
| PF-06882961 40 mg BID | Change From Baseline in Body Weight at Week 4 | -0.77 Kilogram |
| PF-06882961 80 mg BID | Change From Baseline in Body Weight at Week 4 | -1.05 Kilogram |
| PF-06882961 120 mg BID | Change From Baseline in Body Weight at Week 4 | -1.33 Kilogram |
p-value: 0.789890% CI: [-0.59, 0.42]Mixed Models Analysis
p-value: 0.582990% CI: [-0.33, 0.66]Mixed Models Analysis
p-value: 0.082790% CI: [-1.02, -0.03]Mixed Models Analysis
p-value: 0.010190% CI: [-1.31, -0.29]Mixed Models Analysis
p-value: 0.000490% CI: [-1.59, -0.59]Mixed Models Analysis
Secondary
Change From Baseline in Body Weight at Week 6
Weight was recorded using a calibrated scale (with the same scale used if possible for the duration of the study) reporting weight in kilograms (kg), and accuracy to the nearest 0.1 kg.
Time frame: Baseline, Week 6
Population: Overall number of participants analyzed included all participants randomly assigned to study treatment and who took at least 1 dose of study treatment.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Placebo | Change From Baseline in Body Weight at Week 6 | -0.09 Kilogram |
| PF-06882961 2.5 BID | Change From Baseline in Body Weight at Week 6 | -0.19 Kilogram |
| PF-06882961 10 mg BID | Change From Baseline in Body Weight at Week 6 | -0.32 Kilogram |
| PF-06882961 40 mg BID | Change From Baseline in Body Weight at Week 6 | -0.83 Kilogram |
| PF-06882961 80 mg BID | Change From Baseline in Body Weight at Week 6 | -1.69 Kilogram |
| PF-06882961 120 mg BID | Change From Baseline in Body Weight at Week 6 | -2.34 Kilogram |
p-value: 0.798590% CI: [-0.75, 0.55]Mixed Models Analysis
p-value: 0.548490% CI: [-0.86, 0.4]Mixed Models Analysis
p-value: 0.054190% CI: [-1.38, -0.11]Mixed Models Analysis
p-value: <0.000190% CI: [-2.26, -0.95]Mixed Models Analysis
p-value: <0.000190% CI: [-2.9, -1.6]Mixed Models Analysis
Secondary
Change From Baseline in Body Weight at Week 8
Weight was recorded using a calibrated scale (with the same scale used if possible for the duration of the study) reporting weight in kilograms (kg), and accuracy to the nearest 0.1 kg.
Time frame: Baseline, Week 8
Population: Overall number of participants analyzed included all participants randomly assigned to study treatment and who took at least 1 dose of study treatment.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Placebo | Change From Baseline in Body Weight at Week 8 | -0.36 Kilogram |
| PF-06882961 2.5 BID | Change From Baseline in Body Weight at Week 8 | -0.05 Kilogram |
| PF-06882961 10 mg BID | Change From Baseline in Body Weight at Week 8 | -0.27 Kilogram |
| PF-06882961 40 mg BID | Change From Baseline in Body Weight at Week 8 | -1.09 Kilogram |
| PF-06882961 80 mg BID | Change From Baseline in Body Weight at Week 8 | -1.97 Kilogram |
| PF-06882961 120 mg BID | Change From Baseline in Body Weight at Week 8 | -3.31 Kilogram |
p-value: 0.469290% CI: [-0.4, 1.03]Mixed Models Analysis
p-value: 0.827490% CI: [-0.6, 0.78]Mixed Models Analysis
p-value: 0.088790% CI: [-1.42, -0.02]Mixed Models Analysis
p-value: 0.000390% CI: [-2.33, -0.88]Mixed Models Analysis
p-value: <0.000190% CI: [-3.67, -2.22]Mixed Models Analysis
Secondary
Change From Baseline in Fasting Plasma Glucose at Week 12
The fasting plasma glucose test measures the levels of glucose (sugar) in the blood, with a normal range of 70 mg/dL to 99 mg/dL.
Time frame: Baseline, Week 12
Population: Overall number of participants analyzed included all participants randomly assigned to study treatment and who took at least 1 dose of study treatment.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Placebo | Change From Baseline in Fasting Plasma Glucose at Week 12 | 1.21 mg/dL |
| PF-06882961 2.5 BID | Change From Baseline in Fasting Plasma Glucose at Week 12 | -6.49 mg/dL |
| PF-06882961 10 mg BID | Change From Baseline in Fasting Plasma Glucose at Week 12 | -22.56 mg/dL |
| PF-06882961 40 mg BID | Change From Baseline in Fasting Plasma Glucose at Week 12 | -32.01 mg/dL |
| PF-06882961 80 mg BID | Change From Baseline in Fasting Plasma Glucose at Week 12 | -30.45 mg/dL |
| PF-06882961 120 mg BID | Change From Baseline in Fasting Plasma Glucose at Week 12 | -32.38 mg/dL |
p-value: 0.29490% CI: [-19.78, 4.38]Mixed Models Analysis
p-value: 0.000890% CI: [-35.37, -12.17]Mixed Models Analysis
p-value: <0.000190% CI: [-45.05, -21.4]Mixed Models Analysis
p-value: <0.000190% CI: [-44.14, -19.19]Mixed Models Analysis
p-value: <0.000190% CI: [-46.67, -20.51]Mixed Models Analysis
Secondary
Change From Baseline in Fasting Plasma Glucose at Week 16
The fasting plasma glucose test measures the levels of glucose (sugar) in the blood, with a normal range of 70 mg/dL to 99 mg/dL.
Time frame: Baseline, Week 16
Population: Overall number of participants analyzed included all participants randomly assigned to study treatment and who took at least 1 dose of study treatment.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Placebo | Change From Baseline in Fasting Plasma Glucose at Week 16 | 1.31 mg/dL |
| PF-06882961 2.5 BID | Change From Baseline in Fasting Plasma Glucose at Week 16 | -12.81 mg/dL |
| PF-06882961 10 mg BID | Change From Baseline in Fasting Plasma Glucose at Week 16 | -24.53 mg/dL |
| PF-06882961 40 mg BID | Change From Baseline in Fasting Plasma Glucose at Week 16 | -30.47 mg/dL |
| PF-06882961 80 mg BID | Change From Baseline in Fasting Plasma Glucose at Week 16 | -25.71 mg/dL |
| PF-06882961 120 mg BID | Change From Baseline in Fasting Plasma Glucose at Week 16 | -31.93 mg/dL |
p-value: 0.046490% CI: [-25.77, -2.47]Mixed Models Analysis
p-value: 0.000290% CI: [-37.05, -14.62]Mixed Models Analysis
p-value: <0.000190% CI: [-43.2, -20.35]Mixed Models Analysis
p-value: 0.000290% CI: [-39.03, -15.01]Mixed Models Analysis
p-value: <0.000190% CI: [-45.63, -20.84]Mixed Models Analysis
Secondary
Change From Baseline in Fasting Plasma Glucose at Week 2
The fasting plasma glucose test measures the levels of glucose (sugar) in the blood, with a normal range of 70 milligram per deciliter (mg/dL) to 99 mg/dL.
Time frame: Baseline, Week 2
Population: Overall number of participants analyzed included all participants randomly assigned to study treatment and who took at least 1 dose of study treatment.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Placebo | Change From Baseline in Fasting Plasma Glucose at Week 2 | -5.58 mg/dL |
| PF-06882961 2.5 BID | Change From Baseline in Fasting Plasma Glucose at Week 2 | -22.72 mg/dL |
| PF-06882961 10 mg BID | Change From Baseline in Fasting Plasma Glucose at Week 2 | -21.96 mg/dL |
| PF-06882961 40 mg BID | Change From Baseline in Fasting Plasma Glucose at Week 2 | -27.79 mg/dL |
| PF-06882961 80 mg BID | Change From Baseline in Fasting Plasma Glucose at Week 2 | -24.18 mg/dL |
| PF-06882961 120 mg BID | Change From Baseline in Fasting Plasma Glucose at Week 2 | -30.92 mg/dL |
p-value: 0.001490% CI: [-25.94, -8.33]Mixed Models Analysis
p-value: 0.002190% CI: [-25.08, -7.67]Mixed Models Analysis
p-value: <0.000190% CI: [-30.88, -13.53]Mixed Models Analysis
p-value: 0.000690% CI: [-27.43, -9.76]Mixed Models Analysis
p-value: <0.000190% CI: [-34, -16.67]Mixed Models Analysis
Secondary
Change From Baseline in Fasting Plasma Glucose at Week 4
The fasting plasma glucose test measures the levels of glucose (sugar) in the blood, with a normal range of 70 mg/dL to 99 mg/dL.
Time frame: Baseline, Week 4
Population: Overall number of participants analyzed included all participants randomly assigned to study treatment and who took at least 1 dose of study treatment.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Placebo | Change From Baseline in Fasting Plasma Glucose at Week 4 | -5.98 mg/dL |
| PF-06882961 2.5 BID | Change From Baseline in Fasting Plasma Glucose at Week 4 | -17.77 mg/dL |
| PF-06882961 10 mg BID | Change From Baseline in Fasting Plasma Glucose at Week 4 | -24.66 mg/dL |
| PF-06882961 40 mg BID | Change From Baseline in Fasting Plasma Glucose at Week 4 | -33.42 mg/dL |
| PF-06882961 80 mg BID | Change From Baseline in Fasting Plasma Glucose at Week 4 | -33.34 mg/dL |
| PF-06882961 120 mg BID | Change From Baseline in Fasting Plasma Glucose at Week 4 | -34.06 mg/dL |
p-value: 0.046890% CI: [-21.55, -2.04]Mixed Models Analysis
p-value: 0.001290% CI: [-28.12, -9.25]Mixed Models Analysis
p-value: <0.000190% CI: [-37.03, -17.85]Mixed Models Analysis
p-value: <0.000190% CI: [-37.22, -17.51]Mixed Models Analysis
p-value: <0.000190% CI: [-37.72, -18.45]Mixed Models Analysis
Secondary
Change From Baseline in Fasting Plasma Glucose at Week 6
The fasting plasma glucose test measures the levels of glucose (sugar) in the blood, with a normal range of 70 mg/dL to 99 mg/dL.
Time frame: Baseline, Week 6
Population: Overall number of participants analyzed included all participants randomly assigned to study treatment and who took at least 1 dose of study treatment.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Placebo | Change From Baseline in Fasting Plasma Glucose at Week 6 | -0.88 mg/dL |
| PF-06882961 2.5 BID | Change From Baseline in Fasting Plasma Glucose at Week 6 | -16.78 mg/dL |
| PF-06882961 10 mg BID | Change From Baseline in Fasting Plasma Glucose at Week 6 | -26.41 mg/dL |
| PF-06882961 40 mg BID | Change From Baseline in Fasting Plasma Glucose at Week 6 | -30.89 mg/dL |
| PF-06882961 80 mg BID | Change From Baseline in Fasting Plasma Glucose at Week 6 | -28.36 mg/dL |
| PF-06882961 120 mg BID | Change From Baseline in Fasting Plasma Glucose at Week 6 | -32.65 mg/dL |
p-value: 0.009190% CI: [-25.9, -5.9]Mixed Models Analysis
p-value: <0.000190% CI: [-35.18, -15.89]Mixed Models Analysis
p-value: <0.000190% CI: [-39.8, -20.21]Mixed Models Analysis
p-value: <0.000190% CI: [-37.63, -17.33]Mixed Models Analysis
p-value: <0.000190% CI: [-41.77, -21.78]Mixed Models Analysis
Secondary
Change From Baseline in Fasting Plasma Glucose at Week 8
The fasting plasma glucose test measures the levels of glucose (sugar) in the blood, with a normal range of 70 mg/dL to 99 mg/dL.
Time frame: Baseline, Week 8
Population: Overall number of participants analyzed included all participants randomly assigned to study treatment and who took at least 1 dose of study treatment.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Placebo | Change From Baseline in Fasting Plasma Glucose at Week 8 | -9.10 mg/dL |
| PF-06882961 2.5 BID | Change From Baseline in Fasting Plasma Glucose at Week 8 | -12.73 mg/dL |
| PF-06882961 10 mg BID | Change From Baseline in Fasting Plasma Glucose at Week 8 | -26.23 mg/dL |
| PF-06882961 40 mg BID | Change From Baseline in Fasting Plasma Glucose at Week 8 | -29.74 mg/dL |
| PF-06882961 80 mg BID | Change From Baseline in Fasting Plasma Glucose at Week 8 | -33.22 mg/dL |
| PF-06882961 120 mg BID | Change From Baseline in Fasting Plasma Glucose at Week 8 | -34.31 mg/dL |
p-value: 0.544990% CI: [-13.51, 6.25]Mixed Models Analysis
p-value: 0.003190% CI: [-26.62, -7.63]Mixed Models Analysis
p-value: 0.000590% CI: [-30.31, -10.96]Mixed Models Analysis
p-value: <0.000190% CI: [-34.2, -14.04]Mixed Models Analysis
p-value: <0.000190% CI: [-35.44, -14.97]Mixed Models Analysis
Secondary
Change From Baseline in Glycated Hemoglobin (HbA1c) at Week 12
HbA1c can be used as a diagnostic test for diabetes. The target HbA1c level for people with diabetes is usually less than 7%.
Time frame: Baseline, Week 12
Population: Overall number of participants analyzed included all participants randomly assigned to study treatment and who took at least 1 dose of study treatment.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Placebo | Change From Baseline in Glycated Hemoglobin (HbA1c) at Week 12 | -0.09 Percent |
| PF-06882961 2.5 BID | Change From Baseline in Glycated Hemoglobin (HbA1c) at Week 12 | -0.53 Percent |
| PF-06882961 10 mg BID | Change From Baseline in Glycated Hemoglobin (HbA1c) at Week 12 | -0.88 Percent |
| PF-06882961 40 mg BID | Change From Baseline in Glycated Hemoglobin (HbA1c) at Week 12 | -1.06 Percent |
| PF-06882961 80 mg BID | Change From Baseline in Glycated Hemoglobin (HbA1c) at Week 12 | -0.91 Percent |
| PF-06882961 120 mg BID | Change From Baseline in Glycated Hemoglobin (HbA1c) at Week 12 | -1.11 Percent |
p-value: 0.006190% CI: [-0.71, -0.18]Mixed Models Analysis
p-value: <0.000190% CI: [-1.05, -0.54]Mixed Models Analysis
p-value: <0.000190% CI: [-1.24, -0.72]Mixed Models Analysis
p-value: <0.000190% CI: [-1.1, -0.56]Mixed Models Analysis
p-value: <0.000190% CI: [-1.3, -0.75]Mixed Models Analysis
Secondary
Change From Baseline in Glycated Hemoglobin (HbA1c) at Week 2
HbA1c can be used as a diagnostic test for diabetes. The target HbA1c level for people with diabetes is usually less than 7%.
Time frame: Baseline, Week 2
Population: Overall number of participants analyzed included all participants randomly assigned to study treatment and who took at least 1 dose of study treatment.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Placebo | Change From Baseline in Glycated Hemoglobin (HbA1c) at Week 2 | -0.09 Percent |
| PF-06882961 2.5 BID | Change From Baseline in Glycated Hemoglobin (HbA1c) at Week 2 | -0.18 Percent |
| PF-06882961 10 mg BID | Change From Baseline in Glycated Hemoglobin (HbA1c) at Week 2 | -0.31 Percent |
| PF-06882961 40 mg BID | Change From Baseline in Glycated Hemoglobin (HbA1c) at Week 2 | -0.29 Percent |
| PF-06882961 80 mg BID | Change From Baseline in Glycated Hemoglobin (HbA1c) at Week 2 | -0.33 Percent |
| PF-06882961 120 mg BID | Change From Baseline in Glycated Hemoglobin (HbA1c) at Week 2 | -0.35 Percent |
p-value: 0.157890% CI: [-0.19, 0.01]Mixed Models Analysis
p-value: 0.000390% CI: [-0.32, -0.12]Mixed Models Analysis
p-value: 0.001390% CI: [-0.3, -0.1]Mixed Models Analysis
p-value: 0.000190% CI: [-0.34, -0.14]Mixed Models Analysis
p-value: <0.000190% CI: [-0.36, -0.16]Mixed Models Analysis
Secondary
Change From Baseline in Glycated Hemoglobin (HbA1c) at Week 4
HbA1c can be used as a diagnostic test for diabetes. The target HbA1c level for people with diabetes is usually less than 7%.
Time frame: Baseline, Week 4
Population: Overall number of participants analyzed included all participants randomly assigned to study treatment and who took at least 1 dose of study treatment.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Placebo | Change From Baseline in Glycated Hemoglobin (HbA1c) at Week 4 | -0.08 Percent |
| PF-06882961 2.5 BID | Change From Baseline in Glycated Hemoglobin (HbA1c) at Week 4 | -0.38 Percent |
| PF-06882961 10 mg BID | Change From Baseline in Glycated Hemoglobin (HbA1c) at Week 4 | -0.51 Percent |
| PF-06882961 40 mg BID | Change From Baseline in Glycated Hemoglobin (HbA1c) at Week 4 | -0.63 Percent |
| PF-06882961 80 mg BID | Change From Baseline in Glycated Hemoglobin (HbA1c) at Week 4 | -0.58 Percent |
| PF-06882961 120 mg BID | Change From Baseline in Glycated Hemoglobin (HbA1c) at Week 4 | -0.64 Percent |
p-value: 0.001390% CI: [-0.46, -0.15]Mixed Models Analysis
p-value: <0.000190% CI: [-0.58, -0.28]Mixed Models Analysis
p-value: <0.000190% CI: [-0.7, -0.4]Mixed Models Analysis
p-value: <0.000190% CI: [-0.66, -0.35]Mixed Models Analysis
p-value: <0.000190% CI: [-0.71, -0.41]Mixed Models Analysis
Secondary
Change From Baseline in Glycated Hemoglobin (HbA1c) at Week 6
HbA1c can be used as a diagnostic test for diabetes. The target HbA1c level for people with diabetes is usually less than 7%.
Time frame: Baseline, Week 6
Population: Overall number of participants analyzed included all participants randomly assigned to study treatment and who took at least 1 dose of study treatment.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Placebo | Change From Baseline in Glycated Hemoglobin (HbA1c) at Week 6 | -0.07 Percent |
| PF-06882961 2.5 BID | Change From Baseline in Glycated Hemoglobin (HbA1c) at Week 6 | -0.47 Percent |
| PF-06882961 10 mg BID | Change From Baseline in Glycated Hemoglobin (HbA1c) at Week 6 | -0.71 Percent |
| PF-06882961 40 mg BID | Change From Baseline in Glycated Hemoglobin (HbA1c) at Week 6 | -0.84 Percent |
| PF-06882961 80 mg BID | Change From Baseline in Glycated Hemoglobin (HbA1c) at Week 6 | -0.79 Percent |
| PF-06882961 120 mg BID | Change From Baseline in Glycated Hemoglobin (HbA1c) at Week 6 | -0.84 Percent |
p-value: 0.000490% CI: [-0.59, -0.22]Mixed Models Analysis
p-value: <0.000190% CI: [-0.81, -0.46]Mixed Models Analysis
p-value: <0.000190% CI: [-0.95, -0.59]Mixed Models Analysis
p-value: <0.000190% CI: [-0.91, -0.53]Mixed Models Analysis
p-value: <0.000190% CI: [-0.95, -0.59]Mixed Models Analysis
Secondary
Change From Baseline in Glycated Hemoglobin (HbA1c) at Week 8
HbA1c can be used as a diagnostic test for diabetes. The target HbA1c level for people with diabetes is usually less than 7%.
Time frame: Baseline, Week 8
Population: Overall number of participants analyzed included all participants randomly assigned to study treatment and who took at least 1 dose of study treatment.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Placebo | Change From Baseline in Glycated Hemoglobin (HbA1c) at Week 8 | -0.13 Percent |
| PF-06882961 2.5 BID | Change From Baseline in Glycated Hemoglobin (HbA1c) at Week 8 | -0.50 Percent |
| PF-06882961 10 mg BID | Change From Baseline in Glycated Hemoglobin (HbA1c) at Week 8 | -0.78 Percent |
| PF-06882961 40 mg BID | Change From Baseline in Glycated Hemoglobin (HbA1c) at Week 8 | -0.97 Percent |
| PF-06882961 80 mg BID | Change From Baseline in Glycated Hemoglobin (HbA1c) at Week 8 | -0.92 Percent |
| PF-06882961 120 mg BID | Change From Baseline in Glycated Hemoglobin (HbA1c) at Week 8 | -1.02 Percent |
p-value: 0.005490% CI: [-0.59, -0.15]Mixed Models Analysis
p-value: <0.000190% CI: [-0.86, -0.44]Mixed Models Analysis
p-value: <0.000190% CI: [-1.06, -0.63]Mixed Models Analysis
p-value: <0.000190% CI: [-1.02, -0.57]Mixed Models Analysis
p-value: <0.000190% CI: [-1.11, -0.67]Mixed Models Analysis
Secondary
Number of Participants With Treatment Emergent Adverse Events (Adverse Events [AEs] and Serious Adverse Events [SAEs])
An adverse event (AE) was any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. A serious AE (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; life-threatening; initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect. Any such events with initial onset or increasing in severity after the first dose of study treatment were counted as treatment-emergent.
Time frame: Baseline up to Week 21
Population: Safety analysis set included all participants randomly assigned to study treatment and who took at least 1 dose of study treatment.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo | Number of Participants With Treatment Emergent Adverse Events (Adverse Events [AEs] and Serious Adverse Events [SAEs]) | Number of Participants With Treatment Emergent SAEs | 1 Participants |
| Placebo | Number of Participants With Treatment Emergent Adverse Events (Adverse Events [AEs] and Serious Adverse Events [SAEs]) | Number of Participants With Treatment Emergent AEs | 32 Participants |
| PF-06882961 2.5 BID | Number of Participants With Treatment Emergent Adverse Events (Adverse Events [AEs] and Serious Adverse Events [SAEs]) | Number of Participants With Treatment Emergent SAEs | 1 Participants |
| PF-06882961 2.5 BID | Number of Participants With Treatment Emergent Adverse Events (Adverse Events [AEs] and Serious Adverse Events [SAEs]) | Number of Participants With Treatment Emergent AEs | 32 Participants |
| PF-06882961 10 mg BID | Number of Participants With Treatment Emergent Adverse Events (Adverse Events [AEs] and Serious Adverse Events [SAEs]) | Number of Participants With Treatment Emergent SAEs | 2 Participants |
| PF-06882961 10 mg BID | Number of Participants With Treatment Emergent Adverse Events (Adverse Events [AEs] and Serious Adverse Events [SAEs]) | Number of Participants With Treatment Emergent AEs | 31 Participants |
| PF-06882961 40 mg BID | Number of Participants With Treatment Emergent Adverse Events (Adverse Events [AEs] and Serious Adverse Events [SAEs]) | Number of Participants With Treatment Emergent AEs | 42 Participants |
| PF-06882961 40 mg BID | Number of Participants With Treatment Emergent Adverse Events (Adverse Events [AEs] and Serious Adverse Events [SAEs]) | Number of Participants With Treatment Emergent SAEs | 6 Participants |
| PF-06882961 80 mg BID | Number of Participants With Treatment Emergent Adverse Events (Adverse Events [AEs] and Serious Adverse Events [SAEs]) | Number of Participants With Treatment Emergent AEs | 43 Participants |
| PF-06882961 80 mg BID | Number of Participants With Treatment Emergent Adverse Events (Adverse Events [AEs] and Serious Adverse Events [SAEs]) | Number of Participants With Treatment Emergent SAEs | 2 Participants |
| PF-06882961 120 mg BID | Number of Participants With Treatment Emergent Adverse Events (Adverse Events [AEs] and Serious Adverse Events [SAEs]) | Number of Participants With Treatment Emergent SAEs | 1 Participants |
| PF-06882961 120 mg BID | Number of Participants With Treatment Emergent Adverse Events (Adverse Events [AEs] and Serious Adverse Events [SAEs]) | Number of Participants With Treatment Emergent AEs | 44 Participants |
Secondary
Number of Participants With Treatment Emergent Clinical Laboratory Abnormalities Without Regard to Baseline Abnormality
Following laboratory parameters were assessed against pre-defined abnormality criteria: hematology (hemoglobin, hematocrit, erythrocytes, reticulocytes, platelets, leukocytes, lymphocytes, neutrophils, basophils, eosinophils, monocytes, activated partial thromboplastin time, prothrombin time, PT/INR, reticulocytes); chemistry (indirect bilirubin, direct bilirubin, protein, albumin, blood urea nitrogen, creatinine, creatine kinase, urate, calcium, sodium, potassium, chloride, bicarbonate, urine urobilinogen); urinalysis (pH, urine glucose, urine ketones, urine protein, urine hemoglobin, nitrites, leukocyte esterase, urine erythrocytes, urine leukocytes, urine hyaline casts, urine bilirubin); lipid panel (low density lipoprotein cholesterol, high density lipoprotein cholesterol).
Time frame: Baseline Through Week 21
Population: Overall number of participants analyzed included all participants randomly assigned to study treatment and who took at least 1 dose of study treatment and had at least 1 measurement available.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Placebo | Number of Participants With Treatment Emergent Clinical Laboratory Abnormalities Without Regard to Baseline Abnormality | 60 Participants |
| PF-06882961 2.5 BID | Number of Participants With Treatment Emergent Clinical Laboratory Abnormalities Without Regard to Baseline Abnormality | 57 Participants |
| PF-06882961 10 mg BID | Number of Participants With Treatment Emergent Clinical Laboratory Abnormalities Without Regard to Baseline Abnormality | 57 Participants |
| PF-06882961 40 mg BID | Number of Participants With Treatment Emergent Clinical Laboratory Abnormalities Without Regard to Baseline Abnormality | 57 Participants |
| PF-06882961 80 mg BID | Number of Participants With Treatment Emergent Clinical Laboratory Abnormalities Without Regard to Baseline Abnormality | 60 Participants |
| PF-06882961 120 mg BID | Number of Participants With Treatment Emergent Clinical Laboratory Abnormalities Without Regard to Baseline Abnormality | 64 Participants |
Secondary
Number of Participants With Treatment Emergent ECG Abnormalities
ECG categorical abnormality criteria: 1. PR interval (the interval between the start of the P wave and the start of the QRS complex, corresponding to the time between the onset of the atrial depolarization and onset of ventricular depolarization): a) greater than or equal to (\>=) 300 millisecond (msec), b) \>=25% increase when baseline is \> 200 msec or \>=50% increase when baseline is less than or equal to (\<=) 200 msec. 2\. QRS interval (time from ECG Q wave to the end of the S wave corresponding to ventricle depolarization): a) \>=140 msec, b) \>=50% increase from baseline. 3\. QTcF interval (QT corrected using the Fridericia formula): a) \>450 msec and \<=480 msec, b) \>480 msec and \<=500 msec, c) \>500 msec, d) \>30 msec and \<=60 msec increase from baseline, e) \>60 msec increase from baseline.
Time frame: Baseline Through Week 21
Population: Overall number of participants analyzed included all participants randomly assigned to study treatment, took at least 1 dose of study treatment and had at least 1 measurement available.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo | Number of Participants With Treatment Emergent ECG Abnormalities | PR interval ≥300 msec | 0 Participants |
| Placebo | Number of Participants With Treatment Emergent ECG Abnormalities | %Change in PR interval ≥25/50% | 3 Participants |
| Placebo | Number of Participants With Treatment Emergent ECG Abnormalities | Change in QTcF interval >30 and ≤60 msec | 2 Participants |
| Placebo | Number of Participants With Treatment Emergent ECG Abnormalities | %Change in QRS interval ≥50% | 1 Participants |
| Placebo | Number of Participants With Treatment Emergent ECG Abnormalities | QRS interval ≥140 msec | 1 Participants |
| Placebo | Number of Participants With Treatment Emergent ECG Abnormalities | QTcF interval >480 and ≤500 msec | 0 Participants |
| Placebo | Number of Participants With Treatment Emergent ECG Abnormalities | Change in QTcF interval >60 msec | 0 Participants |
| Placebo | Number of Participants With Treatment Emergent ECG Abnormalities | QTcF interval >500 msec | 0 Participants |
| Placebo | Number of Participants With Treatment Emergent ECG Abnormalities | QTcF interval >450 and ≤480 msec | 2 Participants |
| PF-06882961 2.5 BID | Number of Participants With Treatment Emergent ECG Abnormalities | QTcF interval >450 and ≤480 msec | 3 Participants |
| PF-06882961 2.5 BID | Number of Participants With Treatment Emergent ECG Abnormalities | QTcF interval >500 msec | 0 Participants |
| PF-06882961 2.5 BID | Number of Participants With Treatment Emergent ECG Abnormalities | QTcF interval >480 and ≤500 msec | 0 Participants |
| PF-06882961 2.5 BID | Number of Participants With Treatment Emergent ECG Abnormalities | Change in QTcF interval >30 and ≤60 msec | 3 Participants |
| PF-06882961 2.5 BID | Number of Participants With Treatment Emergent ECG Abnormalities | %Change in PR interval ≥25/50% | 0 Participants |
| PF-06882961 2.5 BID | Number of Participants With Treatment Emergent ECG Abnormalities | PR interval ≥300 msec | 0 Participants |
| PF-06882961 2.5 BID | Number of Participants With Treatment Emergent ECG Abnormalities | QRS interval ≥140 msec | 1 Participants |
| PF-06882961 2.5 BID | Number of Participants With Treatment Emergent ECG Abnormalities | %Change in QRS interval ≥50% | 1 Participants |
| PF-06882961 2.5 BID | Number of Participants With Treatment Emergent ECG Abnormalities | Change in QTcF interval >60 msec | 0 Participants |
| PF-06882961 10 mg BID | Number of Participants With Treatment Emergent ECG Abnormalities | PR interval ≥300 msec | 0 Participants |
| PF-06882961 10 mg BID | Number of Participants With Treatment Emergent ECG Abnormalities | QTcF interval >480 and ≤500 msec | 0 Participants |
| PF-06882961 10 mg BID | Number of Participants With Treatment Emergent ECG Abnormalities | Change in QTcF interval >30 and ≤60 msec | 2 Participants |
| PF-06882961 10 mg BID | Number of Participants With Treatment Emergent ECG Abnormalities | %Change in QRS interval ≥50% | 0 Participants |
| PF-06882961 10 mg BID | Number of Participants With Treatment Emergent ECG Abnormalities | QTcF interval >450 and ≤480 msec | 2 Participants |
| PF-06882961 10 mg BID | Number of Participants With Treatment Emergent ECG Abnormalities | QTcF interval >500 msec | 0 Participants |
| PF-06882961 10 mg BID | Number of Participants With Treatment Emergent ECG Abnormalities | Change in QTcF interval >60 msec | 1 Participants |
| PF-06882961 10 mg BID | Number of Participants With Treatment Emergent ECG Abnormalities | QRS interval ≥140 msec | 0 Participants |
| PF-06882961 10 mg BID | Number of Participants With Treatment Emergent ECG Abnormalities | %Change in PR interval ≥25/50% | 0 Participants |
| PF-06882961 40 mg BID | Number of Participants With Treatment Emergent ECG Abnormalities | QTcF interval >500 msec | 0 Participants |
| PF-06882961 40 mg BID | Number of Participants With Treatment Emergent ECG Abnormalities | Change in QTcF interval >60 msec | 1 Participants |
| PF-06882961 40 mg BID | Number of Participants With Treatment Emergent ECG Abnormalities | %Change in PR interval ≥25/50% | 0 Participants |
| PF-06882961 40 mg BID | Number of Participants With Treatment Emergent ECG Abnormalities | QRS interval ≥140 msec | 0 Participants |
| PF-06882961 40 mg BID | Number of Participants With Treatment Emergent ECG Abnormalities | %Change in QRS interval ≥50% | 0 Participants |
| PF-06882961 40 mg BID | Number of Participants With Treatment Emergent ECG Abnormalities | PR interval ≥300 msec | 0 Participants |
| PF-06882961 40 mg BID | Number of Participants With Treatment Emergent ECG Abnormalities | QTcF interval >450 and ≤480 msec | 1 Participants |
| PF-06882961 40 mg BID | Number of Participants With Treatment Emergent ECG Abnormalities | QTcF interval >480 and ≤500 msec | 0 Participants |
| PF-06882961 40 mg BID | Number of Participants With Treatment Emergent ECG Abnormalities | Change in QTcF interval >30 and ≤60 msec | 6 Participants |
| PF-06882961 80 mg BID | Number of Participants With Treatment Emergent ECG Abnormalities | QTcF interval >480 and ≤500 msec | 0 Participants |
| PF-06882961 80 mg BID | Number of Participants With Treatment Emergent ECG Abnormalities | QTcF interval >450 and ≤480 msec | 3 Participants |
| PF-06882961 80 mg BID | Number of Participants With Treatment Emergent ECG Abnormalities | %Change in QRS interval ≥50% | 0 Participants |
| PF-06882961 80 mg BID | Number of Participants With Treatment Emergent ECG Abnormalities | Change in QTcF interval >30 and ≤60 msec | 3 Participants |
| PF-06882961 80 mg BID | Number of Participants With Treatment Emergent ECG Abnormalities | QTcF interval >500 msec | 0 Participants |
| PF-06882961 80 mg BID | Number of Participants With Treatment Emergent ECG Abnormalities | QRS interval ≥140 msec | 0 Participants |
| PF-06882961 80 mg BID | Number of Participants With Treatment Emergent ECG Abnormalities | %Change in PR interval ≥25/50% | 1 Participants |
| PF-06882961 80 mg BID | Number of Participants With Treatment Emergent ECG Abnormalities | Change in QTcF interval >60 msec | 0 Participants |
| PF-06882961 80 mg BID | Number of Participants With Treatment Emergent ECG Abnormalities | PR interval ≥300 msec | 0 Participants |
| PF-06882961 120 mg BID | Number of Participants With Treatment Emergent ECG Abnormalities | Change in QTcF interval >60 msec | 3 Participants |
| PF-06882961 120 mg BID | Number of Participants With Treatment Emergent ECG Abnormalities | PR interval ≥300 msec | 1 Participants |
| PF-06882961 120 mg BID | Number of Participants With Treatment Emergent ECG Abnormalities | %Change in PR interval ≥25/50% | 0 Participants |
| PF-06882961 120 mg BID | Number of Participants With Treatment Emergent ECG Abnormalities | QTcF interval >450 and ≤480 msec | 4 Participants |
| PF-06882961 120 mg BID | Number of Participants With Treatment Emergent ECG Abnormalities | %Change in QRS interval ≥50% | 0 Participants |
| PF-06882961 120 mg BID | Number of Participants With Treatment Emergent ECG Abnormalities | QTcF interval >480 and ≤500 msec | 1 Participants |
| PF-06882961 120 mg BID | Number of Participants With Treatment Emergent ECG Abnormalities | QTcF interval >500 msec | 0 Participants |
| PF-06882961 120 mg BID | Number of Participants With Treatment Emergent ECG Abnormalities | Change in QTcF interval >30 and ≤60 msec | 6 Participants |
| PF-06882961 120 mg BID | Number of Participants With Treatment Emergent ECG Abnormalities | QRS interval ≥140 msec | 0 Participants |
Secondary
Number of Participants With Treatment Emergent Vital Signs Abnormalities
Vital signs abnormality criteria: 1) supine systolic blood pressure (SBP) \<90 millimeters of mercury (mmHg); 2) supine diastolic blood pressure (DBP) \<50 mmHg; 3) supine pulse rate \<40 or \>120 beats per minute (bpm); 4) change from baseline (increase or decrease) in supine SBP greater than or equal to (\>=) 30 mmHg; 5) change from baseline (increase or decrease) in supine DBP \>= 20 mmHg.
Time frame: Baseline through Week 21
Population: Overall number of participants analyzed included all participants randomly assigned to study treatment, took at least 1 dose of study treatment and had at least 1 measurement available.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo | Number of Participants With Treatment Emergent Vital Signs Abnormalities | Supine SBP increase >=30 mmHg | 3 Participants |
| Placebo | Number of Participants With Treatment Emergent Vital Signs Abnormalities | Supine DBP increase >=20 mmHg | 1 Participants |
| Placebo | Number of Participants With Treatment Emergent Vital Signs Abnormalities | Supine SBP decrease >=30 mmHg | 4 Participants |
| Placebo | Number of Participants With Treatment Emergent Vital Signs Abnormalities | Supine pulse rate >120 bpm | 0 Participants |
| Placebo | Number of Participants With Treatment Emergent Vital Signs Abnormalities | Supine pulse rate <40 bpm | 0 Participants |
| Placebo | Number of Participants With Treatment Emergent Vital Signs Abnormalities | Supine DBP decrease >=20 mmHg | 3 Participants |
| Placebo | Number of Participants With Treatment Emergent Vital Signs Abnormalities | Supine DBP <50 mmHg | 1 Participants |
| Placebo | Number of Participants With Treatment Emergent Vital Signs Abnormalities | Supine SBP <90 mmHg | 0 Participants |
| PF-06882961 2.5 BID | Number of Participants With Treatment Emergent Vital Signs Abnormalities | Supine DBP decrease >=20 mmHg | 4 Participants |
| PF-06882961 2.5 BID | Number of Participants With Treatment Emergent Vital Signs Abnormalities | Supine pulse rate <40 bpm | 0 Participants |
| PF-06882961 2.5 BID | Number of Participants With Treatment Emergent Vital Signs Abnormalities | Supine SBP increase >=30 mmHg | 4 Participants |
| PF-06882961 2.5 BID | Number of Participants With Treatment Emergent Vital Signs Abnormalities | Supine SBP decrease >=30 mmHg | 4 Participants |
| PF-06882961 2.5 BID | Number of Participants With Treatment Emergent Vital Signs Abnormalities | Supine pulse rate >120 bpm | 0 Participants |
| PF-06882961 2.5 BID | Number of Participants With Treatment Emergent Vital Signs Abnormalities | Supine DBP <50 mmHg | 0 Participants |
| PF-06882961 2.5 BID | Number of Participants With Treatment Emergent Vital Signs Abnormalities | Supine SBP <90 mmHg | 0 Participants |
| PF-06882961 2.5 BID | Number of Participants With Treatment Emergent Vital Signs Abnormalities | Supine DBP increase >=20 mmHg | 1 Participants |
| PF-06882961 10 mg BID | Number of Participants With Treatment Emergent Vital Signs Abnormalities | Supine SBP <90 mmHg | 0 Participants |
| PF-06882961 10 mg BID | Number of Participants With Treatment Emergent Vital Signs Abnormalities | Supine DBP decrease >=20 mmHg | 1 Participants |
| PF-06882961 10 mg BID | Number of Participants With Treatment Emergent Vital Signs Abnormalities | Supine DBP increase >=20 mmHg | 2 Participants |
| PF-06882961 10 mg BID | Number of Participants With Treatment Emergent Vital Signs Abnormalities | Supine DBP <50 mmHg | 0 Participants |
| PF-06882961 10 mg BID | Number of Participants With Treatment Emergent Vital Signs Abnormalities | Supine SBP increase >=30 mmHg | 3 Participants |
| PF-06882961 10 mg BID | Number of Participants With Treatment Emergent Vital Signs Abnormalities | Supine pulse rate <40 bpm | 0 Participants |
| PF-06882961 10 mg BID | Number of Participants With Treatment Emergent Vital Signs Abnormalities | Supine SBP decrease >=30 mmHg | 3 Participants |
| PF-06882961 10 mg BID | Number of Participants With Treatment Emergent Vital Signs Abnormalities | Supine pulse rate >120 bpm | 0 Participants |
| PF-06882961 40 mg BID | Number of Participants With Treatment Emergent Vital Signs Abnormalities | Supine SBP decrease >=30 mmHg | 5 Participants |
| PF-06882961 40 mg BID | Number of Participants With Treatment Emergent Vital Signs Abnormalities | Supine pulse rate >120 bpm | 0 Participants |
| PF-06882961 40 mg BID | Number of Participants With Treatment Emergent Vital Signs Abnormalities | Supine pulse rate <40 bpm | 0 Participants |
| PF-06882961 40 mg BID | Number of Participants With Treatment Emergent Vital Signs Abnormalities | Supine DBP <50 mmHg | 1 Participants |
| PF-06882961 40 mg BID | Number of Participants With Treatment Emergent Vital Signs Abnormalities | Supine DBP decrease >=20 mmHg | 3 Participants |
| PF-06882961 40 mg BID | Number of Participants With Treatment Emergent Vital Signs Abnormalities | Supine SBP <90 mmHg | 0 Participants |
| PF-06882961 40 mg BID | Number of Participants With Treatment Emergent Vital Signs Abnormalities | Supine SBP increase >=30 mmHg | 3 Participants |
| PF-06882961 40 mg BID | Number of Participants With Treatment Emergent Vital Signs Abnormalities | Supine DBP increase >=20 mmHg | 3 Participants |
| PF-06882961 80 mg BID | Number of Participants With Treatment Emergent Vital Signs Abnormalities | Supine SBP <90 mmHg | 0 Participants |
| PF-06882961 80 mg BID | Number of Participants With Treatment Emergent Vital Signs Abnormalities | Supine SBP increase >=30 mmHg | 0 Participants |
| PF-06882961 80 mg BID | Number of Participants With Treatment Emergent Vital Signs Abnormalities | Supine SBP decrease >=30 mmHg | 5 Participants |
| PF-06882961 80 mg BID | Number of Participants With Treatment Emergent Vital Signs Abnormalities | Supine DBP <50 mmHg | 0 Participants |
| PF-06882961 80 mg BID | Number of Participants With Treatment Emergent Vital Signs Abnormalities | Supine DBP increase >=20 mmHg | 3 Participants |
| PF-06882961 80 mg BID | Number of Participants With Treatment Emergent Vital Signs Abnormalities | Supine DBP decrease >=20 mmHg | 2 Participants |
| PF-06882961 80 mg BID | Number of Participants With Treatment Emergent Vital Signs Abnormalities | Supine pulse rate <40 bpm | 0 Participants |
| PF-06882961 80 mg BID | Number of Participants With Treatment Emergent Vital Signs Abnormalities | Supine pulse rate >120 bpm | 0 Participants |
| PF-06882961 120 mg BID | Number of Participants With Treatment Emergent Vital Signs Abnormalities | Supine pulse rate >120 bpm | 0 Participants |
| PF-06882961 120 mg BID | Number of Participants With Treatment Emergent Vital Signs Abnormalities | Supine pulse rate <40 bpm | 0 Participants |
| PF-06882961 120 mg BID | Number of Participants With Treatment Emergent Vital Signs Abnormalities | Supine DBP <50 mmHg | 1 Participants |
| PF-06882961 120 mg BID | Number of Participants With Treatment Emergent Vital Signs Abnormalities | Supine SBP decrease >=30 mmHg | 0 Participants |
| PF-06882961 120 mg BID | Number of Participants With Treatment Emergent Vital Signs Abnormalities | Supine SBP <90 mmHg | 0 Participants |
| PF-06882961 120 mg BID | Number of Participants With Treatment Emergent Vital Signs Abnormalities | Supine SBP increase >=30 mmHg | 5 Participants |
| PF-06882961 120 mg BID | Number of Participants With Treatment Emergent Vital Signs Abnormalities | Supine DBP decrease >=20 mmHg | 1 Participants |
| PF-06882961 120 mg BID | Number of Participants With Treatment Emergent Vital Signs Abnormalities | Supine DBP increase >=20 mmHg | 3 Participants |
Secondary
Percentage of Participants Achieving Less Than (<) 7% Glycated Hemoglobin (HbA1c) Levels
HbA1c can be used as a diagnostic test for diabetes. The target HbA1c level for people with diabetes is usually less than 7%.
Time frame: Baseline, Week 16
Population: Overall number of participants analyzed included all participants randomly assigned to study treatment and who took at least 1 dose of study treatment.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Percentage of Participants Achieving Less Than (<) 7% Glycated Hemoglobin (HbA1c) Levels | 7.7 Percentage of Participants |
| PF-06882961 2.5 BID | Percentage of Participants Achieving Less Than (<) 7% Glycated Hemoglobin (HbA1c) Levels | 30.8 Percentage of Participants |
| PF-06882961 10 mg BID | Percentage of Participants Achieving Less Than (<) 7% Glycated Hemoglobin (HbA1c) Levels | 54.1 Percentage of Participants |
| PF-06882961 40 mg BID | Percentage of Participants Achieving Less Than (<) 7% Glycated Hemoglobin (HbA1c) Levels | 58.2 Percentage of Participants |
| PF-06882961 80 mg BID | Percentage of Participants Achieving Less Than (<) 7% Glycated Hemoglobin (HbA1c) Levels | 65.2 Percentage of Participants |
| PF-06882961 120 mg BID | Percentage of Participants Achieving Less Than (<) 7% Glycated Hemoglobin (HbA1c) Levels | 60.5 Percentage of Participants |
90% CI: [1.84, 14.18]Regression, Logistic
90% CI: [6.18, 45.93]Regression, Logistic
90% CI: [7.03, 50.21]Regression, Logistic
90% CI: [8.66, 66.39]Regression, Logistic
90% CI: [8.72, 68.57]Regression, Logistic