Diabetes Mellitus, Diabetes Mellitus, Type 2, Endocrine System Diseases, Glucose Metabolism Disorders, Metabolic Diseases
Conditions
Keywords
Phase 1, Type 2 Diabetes, CVX-096
Brief summary
The primary objective of this study is to evaluate the safety and tolerability of PF-04856883 (CVX-096) in adult female subjects with Type 2 diabetes mellitus on high dose of metformin.
Interventions
Single subcutaneous injection of placebo
Single subcutaneous injection of PF-04856883
Sponsors
Study design
Eligibility
Inclusion criteria
* History of Type 2 diabetes and currently being treated with high dose metformin * BMI between 22.0 and 40.0 kg/m2 * HbA1c between 7.0-10.0% * Fasting C-peptide \>1.21 ng/mL
Exclusion criteria
* History of clinically significant chronic conditions other than Type 2 diabetes not well controlled by either diet or medications * Treatment with anti-diabetic therapies other than metformin * History of allergic or anaphylactic reaction to any therapeutic or diagnostic monoclonal antibody * Males or women of childbearing potential
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) | Stage 1: Baseline up to Day 29; Stage 2: Baseline up to Day 50 | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose (Day 50) that were absent before treatment or that worsened relative to pretreatment state. |
| Number of Participants With Clinically Significant Physical Examination Findings | Stage 1: Baseline up to Day 29; Stage 2: Baseline up to Day 50 | Physical examination included examination of general appearance, head, ears, eyes (including fundoscopy), nose, mouth, throat, neck (including thyroid), skin, breast (optional), cardiac, respiratory, gastrointestinal, musculoskeletal and neurological systems. |
| Number of Participants With Clinically Significant Change From Baseline in 12-lead Electrocardiograms (ECG) | Stage 1: Baseline up to Day 29; Stage 2: Baseline up to Day 50 | ECG parameters included pulse rate (PR) interval, QRS interval, corrected QT interval using Bazett's formula (QTcB) and corrected QT interval using Fridericia's formula (QTcF). ECG criteria of clinically significant concern were 1) PR interval: greater than equal to (\>=) 25 percent (%) increase when baseline greater than (\>)200 milliseconds (msec); or increase \>=50% when baseline less than or equal to (\<=200) msec; 2) QRS interval: \>=25% increase when baseline \>100 msec; \>=50% increase when baseline \<= 100 msec; 3) QTCF interval: QTc interval using Fridericia's formula (QTcF interval) and Bazett's formula (QTcB interval): absolute value 450 - \<480 msec, 480 - \<500 msec \>=500; absolute change 30 - \<60, \>=60 msec. The number of participants with potentially clinically significant ECG findings at any visit were reported. IFB = increase from baseline. |
| Number of Participants With Vital Sign Abnormalities | Stage 1: Baseline up to Day 29; Stage 2 : Baseline up to Day 50 | Criteria for vital signs abnormalities: sitting/supine systolic pulse rate less than (\<) 40 beats per minute (bpm) or greater than (\>) 120 bpm, standing/supine systolic pulse \< 40 bpm or \> 140 bpm, systolic blood pressure of \>=30 millimeters of mercury (mmHg) change from baseline and systolic blood pressure \<90 mmHg, diastolic blood pressure \>=20 mmHg change from baseline and diastolic blood pressure \<50 mm Hg. |
| Number of Participants With Clinically Significant Abnormalities in Laboratory Measurements | Stage 1: Baseline up to Day 29; Stage 2: Baseline up to Day 50 | Following parameters were analyzed for laboratory examination: Hematology: hemoglobin, hematocrit, red blood cell (RBC) \<0.8\*lower limit of the reference range (LLRR); leukocytes \<0.6\*LLRR or \>1.5\*ULRR; platelet count \<0.5\*LLRR or \>1.75\*upper limit of the reference range (ULRR); total neutrophils (absolute \[abs\]), lymphocytes (abs) \<0.8\*LLRR or \>1.2\*ULRR; eosinophils (abs), basophils (abs), monocytes (abs) \>1.2\*ULRR; chemistry (total bilirubin, direct bilirubin, indirect bilirubin \>1.5\*ULRR; aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase \>3\*ULRR, albumin, total protein \<0.8\*LLRR or \>1.2\*ULRR; blood urea nitrogen (BUN), creatinine \>1.3\*ULRR; glucose (fasting) \<0.6\*LLRR or \>1.5\*ULRR; uric acid \>1.2\* ULRR; sodium \<0.95\*LLRR or \>1.05\*ULRR; potassium, chloride, bicarbonate, calcium \<0.9\*LLRR or \>1.1\*ULRR. Urinalysis: Urine white blood cell (WBC), Urine RBC =\>20/ high-power field (HPF). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Area Under the Concentration Time Curve From Time Zero to Time Tau (AUCtau) of PF-04856883: Stage 2 | predose (0 hour), 1, 6, 12, 24, 48, 72, 120, 168 hours postdose Day 1; predose (0 hour), 1, 2, 6, 24, 48, 72, 120, 168 hours postdose Day 22 | Area under the serum concentration-time curve from time 0 to tau (AUCtau), where tau was the dosing interval of 168 hours. |
| Apparent Clearance (CL/F) of PF-04856883: Stage 1 | predose (0 hour), 1, 6, 12, 24, 48, 72, 120, 168, 336, 504, 672 hours postdose on Day 1 | It was calculated by dividing dose with AUC (0 - ∞) where AUC (0 - ∞) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞). Outcome measure was planned to be analyzed in Stage 1 only. |
| Apparent Clearance (CL/F) of PF-04856883: Stage 2 | predose (0 hour), 1, 2, 6, 24, 48, 72, 120, 168, 336, 504, 672 hours postdose on Day 22 | It was calculated by dividing dose with AUC (0 - ∞) where AUC (0 - ∞) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞). Outcome measure was planned to be analyzed in Stage 2 only. Data was not estimable if values were below the limit of quantification. |
| Apparent Volume of Distribution (Vz/F) of PF-04856883: Stage 1 | predose (0 hour), 1, 6, 12, 24, 48, 72, 120, 168, 336, 504, 672 hours postdose on Day 1 | — |
| Apparent Volume of Distribution (Vz/F) of PF-04856883: Stage 2 | predose (0 hour), 1, 2, 6, 24, 48, 72, 120, 168, 336, 504, 672 hours postdose on Day 22 | — |
| Terminal Elimination Half- Life (t1/2) of PF-04856883: Stage 1 | predose (0 hour), 1, 6, 12, 24, 48, 72, 120, 168, 336, 504, 672 hours postdose on Day 1 | — |
| Terminal Elimination Half-life (t1/2) of PF-04856883: Stage 2 | predose (0 hour), 1, 2, 6, 24, 48, 72, 120, 168, 336, 504, 672 hours postdose on Day 22 | — |
| Change From Baseline in Post-prandial Glucose Area Under the Curve (AUC) After Mixed Meal Tolerance Test (MMTT) at Day 3 and 8: Stage 1 | Baseline, Day 3 and 8 | Change from baseline in post-prandial area under the plasma glucose concentration time curve as determined by standardized MMTT. Linear trapezoidal method was used to compute AUC |
| Change From Baseline in Post-prandial Glucose Area Under the Curve (AUC) After Mixed Meal Tolerance Test (MMTT) at Day 3, 15, 24, 29 and 50: Stage 2 | Baseline, Day 3, 15, 24, 29 and 50 | Change from baseline in post-prandial area under the plasma glucose concentration time curve as determined by standardized MMTT. Linear trapezoidal method was used to compute AUC. |
| Change From Baseline in Insulin Area Under the Curve (AUC) After Mixed Meal Tolerance Test (MMTT) at Day 3 and 8: Stage 1 | Baseline, Day 3 and 8 | Change from baseline in post-prandial plasma insulin AUC under the plasma insulin concentration versus time curve as determined by standardized MMTT. Linear trapezoidal method was used to compute AUC. |
| Change From Baseline in Insulin Area Under the Curve (AUC) After Mixed Meal Tolerance Test (MMTT) at Day 3, 15, 24, 29 and 50: Stage 2 | Baseline, Day 3, 15, 24, 29 and 50 | Change from baseline in post-prandial plasma insulin AUC under the plasma insulin concentration versus time curve as determined by standardized MMTT. Linear trapezoidal method was used to compute AUC. |
| Maximum Observed Plasma Concentration (Cmax) of PF-04856883: Stage 1 | predose (0 hour), 1, 6, 12, 24, 48, 72, 120, 168, 336, 504, 672 hours postdose on Day 1 | — |
| Change From Baseline in C-Peptide Area Under the Curve (AUC) After Mixed Meal Tolerance Test (MMTT) at Day 3, 15, 24, 29 and 50: Stage 2 | Baseline, Day 3, 15, 24, 29 and 50 | Change from baseline in post-prandial area under the plasma C-peptide concentration time curve as determined by standardized MMTT. Linear trapezoidal method was used to compute AUC. |
| Change From Baseline in Fasting Plasma Glucose (FPG) at Day 2, 4, 6, 15, 22 and 29: Stage 1 | Baseline, Day 2, 4, 6, 15, 22 and 29 | — |
| Change From Baseline in Fasting Plasma Glucose (FPG) at Day 2, 4, 6, 8, 22, 23, 25, 27, 30, 36 and 43: Stage 2 | Baseline, Day 2, 4, 6, 8, 22, 23, 25, 27, 30, 36 and 43 | — |
| Change From Baseline in 24 Hours Glucose Normalized Area Under the Curve (NAUC) Profile at Day 30: Stage 2 | Baseline, Day 30 | A normalized area under the curve (NAUC) were computed by dividing the AUC by the amount of time between the last time point captured and the first time point captured. |
| Percent Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Day 29 and 50: Stage 2 | Baseline, Day 29 and 50 | HbA1c is a measure of the glycosylated hemoglobin. Change (measured as percent): HbA1c at observation minus HbA1c at baseline. Outcome measure was planned to analyzed only for Stage 2. |
| Change From Baseline in Fructosamine Levels at Day 8, 15 and 29: Stage 1 | Baseline, Day 8, 15 and 29 | — |
| Change From Baseline in Fructosamine Levels at Day 8, 15, 22, 29 and 50: Stage 2 | Baseline, Day 8, 15, 22, 29 and 50 | — |
| Change From Baseline in 1, 5 Anhydroglucitol at Day 8, 15 and 29: Stage 1 | Baseline, Day 8, 15 and 29 | — |
| Change From Baseline in 1, 5 Anhydroglucitol at Day 8, 15, 22, 29 and 50: Stage 2 | Baseline, Day 8, 15, 22, 29 and 50 | — |
| Number of Participants With Anti-Drug Antibodies (ADA): Stage 1 | Day 1 and 29 | — |
| Number of Participant With Anti-Drug Antibodies (ADA): Stage 2 | Day 1, 29 and 50 | — |
| Change From Baseline in C-Peptide Area Under the Curve (AUC) After Mixed Meal Tolerance Test (MMTT) at Day 3 and 8: Stage 1 | Baseline, Day 3 and 8 | Change from baseline in post-prandial area under the plasma C-peptide concentration time curve as determined by standardized MMTT. Linear trapezoidal method was used to compute AUC. |
| Maximum Observed Plasma Concentration (Cmax) of PF-04856883: Stage 2 | predose (0 hour), 1, 6, 12, 24, 48, 72, 120, 168, 336 hours postdose on Day 1; predose (0 hour), 1, 2, 6, 24, 48, 72, 120, 168, 336, 504, 672 hours postdose on Day 22 | — |
| Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-04856883: Stage 1 | predose (0 hour), 1, 6, 12, 24, 48, 72, 120, 168, 336, 504, 672 hours postdose on Day 1 | — |
| Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-04856883: Stage 2 | predose (0 hour), 1, 6, 12, 24, 48, 72, 120, 168, 336 hours postdose on Day 1; predose (0 hour), 1, 2, 6, 24, 48, 72, 120, 168, 336, 504, 672 hours postdose on Day 22 | — |
| Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUC [0 - ∞]) of PF-04856883: Stage 1 | predose (0 hour), 1, 6, 12, 24, 48, 72, 120, 168, 336, 504, 672 hours postdose on Day 1 | AUC (0 - ∞) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞). |
Countries
United States
Participant flow
Pre-assignment details
Data for reporting arm Placebo 1a and 1b in stage 1 was planned to be pooled during analysis, as per protocol. Study consisted of two stages: stage 1 and stage 2. Participants were enrolled and randomized for stage 1 and stage 2 separately.
Participants by arm
| Arm | Count |
|---|---|
| Stage 1: PF-04856883 Placebo Participants received placebo matched to PF-04856883 subcutaneously injection once on Day 1 in Stage 1. | 15 |
| Stage 1: PF-04856883 4 mg Participants received PF-04856883 4 mg subcutaneous injection once on Day 1 in Stage 1. | 5 |
| Stage 1: PF-04856883 8 mg Participants received PF-04856883 8 mg subcutaneous injection once on Day 1 in Stage 1. | 6 |
| Stage 1: PF-04856883 12 mg Participants received PF-04856883 12 mg subcutaneous injection once on Day 1 in Stage 1. | 6 |
| Stage 1: PF-04856883 18 mg Participants received PF-04856883 18 mg subcutaneous injection once on Day 1 in Stage 1. | 7 |
| Stage 1: PF-04856883 24 mg Participants received PF-04856883 24 mg subcutaneous injection once on Day 1 in Stage 1. | 5 |
| Stage 1: PF-04856883 36 mg Participants received PF-04856883 36 mg subcutaneous injection once on Day 1 in Stage 1. | 8 |
| Stage 2: Placebo Participants received placebo matched to PF-04856883 subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2. | 7 |
| Stage 2: PF-04856883 12 mg Participants received single dose of PF-04856883 12 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2. | 5 |
| Stage 2: PF-04856883 12 mg + 12 mg + 24 mg + 24 mg Participants received single dose of PF-04856883 12 mg, 12 mg, 24 mg, 24 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2. | 7 |
| Stage 2: PF-04856883 8 mg + 8 mg + 16 mg + 24 mg Participants received single dose of PF-04856883 8 mg, 8 mg, 16 mg, 24 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2. | 7 |
| Stage 2: PF-04856883 12 mg + 20 mg + 28 mg + 36 mg Participants received single dose of PF-04856883 12 mg, 20 mg, 28 mg, 36 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2. | 6 |
| Total | 84 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 | FG007 | FG008 | FG009 | FG010 | FG011 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Stage 1 | Randomized but not treated | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 |
| Stage 1 | Withdrawal by Subject | 0 | 0 | 1 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Stage 2 | Adverse Event | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 |
Baseline characteristics
| Characteristic | Total | Stage 1: PF-04856883 4 mg | Stage 1: PF-04856883 8 mg | Stage 1: PF-04856883 12 mg | Stage 1: PF-04856883 18 mg | Stage 1: PF-04856883 24 mg | Stage 1: PF-04856883 36 mg | Stage 2: Placebo | Stage 2: PF-04856883 12 mg | Stage 2: PF-04856883 12 mg + 12 mg + 24 mg + 24 mg | Stage 2: PF-04856883 8 mg + 8 mg + 16 mg + 24 mg | Stage 2: PF-04856883 12 mg + 20 mg + 28 mg + 36 mg | Stage 1: PF-04856883 Placebo |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized <18 years | 0 participants | 0 participants | 0 participants | 0 participants | 0 participants | 0 participants | 0 participants | 0 participants | 0 participants | 0 participants | 0 participants | 0 participants | 0 participants |
| Age, Customized >=65 years | 13 participants | 2 participants | 1 participants | 2 participants | 1 participants | 1 participants | 2 participants | 1 participants | 0 participants | 3 participants | 0 participants | 0 participants | 0 participants |
| Age, Customized Between 18 and 64 years | 71 participants | 3 participants | 5 participants | 4 participants | 6 participants | 4 participants | 6 participants | 6 participants | 5 participants | 4 participants | 7 participants | 6 participants | 15 participants |
| Sex: Female, Male Female | 84 Participants | 5 Participants | 6 Participants | 6 Participants | 7 Participants | 5 Participants | 8 Participants | 7 Participants | 5 Participants | 7 Participants | 7 Participants | 6 Participants | 15 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 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 | EG006 affected / at risk | EG007 affected / at risk | EG008 affected / at risk | EG009 affected / at risk | EG010 affected / at risk | EG011 affected / at risk |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 8 / 15 | 1 / 5 | 0 / 6 | 2 / 6 | 4 / 7 | 3 / 5 | 4 / 7 | 4 / 7 | 5 / 5 | 5 / 7 | 5 / 7 | 5 / 6 |
| serious Total, serious adverse events | 0 / 15 | 0 / 5 | 0 / 6 | 0 / 6 | 0 / 7 | 0 / 5 | 0 / 7 | 0 / 7 | 0 / 5 | 0 / 7 | 0 / 7 | 0 / 6 |
Outcome results
Number of Participants With Clinically Significant Abnormalities in Laboratory Measurements
Following parameters were analyzed for laboratory examination: Hematology: hemoglobin, hematocrit, red blood cell (RBC) \<0.8\*lower limit of the reference range (LLRR); leukocytes \<0.6\*LLRR or \>1.5\*ULRR; platelet count \<0.5\*LLRR or \>1.75\*upper limit of the reference range (ULRR); total neutrophils (absolute \[abs\]), lymphocytes (abs) \<0.8\*LLRR or \>1.2\*ULRR; eosinophils (abs), basophils (abs), monocytes (abs) \>1.2\*ULRR; chemistry (total bilirubin, direct bilirubin, indirect bilirubin \>1.5\*ULRR; aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase \>3\*ULRR, albumin, total protein \<0.8\*LLRR or \>1.2\*ULRR; blood urea nitrogen (BUN), creatinine \>1.3\*ULRR; glucose (fasting) \<0.6\*LLRR or \>1.5\*ULRR; uric acid \>1.2\* ULRR; sodium \<0.95\*LLRR or \>1.05\*ULRR; potassium, chloride, bicarbonate, calcium \<0.9\*LLRR or \>1.1\*ULRR. Urinalysis: Urine white blood cell (WBC), Urine RBC =\>20/ high-power field (HPF).
Time frame: Stage 1: Baseline up to Day 29; Stage 2: Baseline up to Day 50
Population: The safety population included all randomized participants who received at least 1 dose of study treatment.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Stage 1: PF-04856883 Placebo | Number of Participants With Clinically Significant Abnormalities in Laboratory Measurements | 15 participants |
| Stage 1: PF-04856883 4 mg | Number of Participants With Clinically Significant Abnormalities in Laboratory Measurements | 5 participants |
| Stage 1: PF-04856883 8 mg | Number of Participants With Clinically Significant Abnormalities in Laboratory Measurements | 6 participants |
| Stage 1: PF-04856883 12 mg | Number of Participants With Clinically Significant Abnormalities in Laboratory Measurements | 6 participants |
| Stage 1: PF-04856883 18 mg | Number of Participants With Clinically Significant Abnormalities in Laboratory Measurements | 7 participants |
| Stage 1: PF-04856883 24 mg | Number of Participants With Clinically Significant Abnormalities in Laboratory Measurements | 4 participants |
| Stage 1: PF-04856883 36 mg | Number of Participants With Clinically Significant Abnormalities in Laboratory Measurements | 6 participants |
| Stage 2: Placebo | Number of Participants With Clinically Significant Abnormalities in Laboratory Measurements | 7 participants |
| Stage 2: PF-04856883 12 mg | Number of Participants With Clinically Significant Abnormalities in Laboratory Measurements | 5 participants |
| Stage 2: PF-04856883 12 mg + 12 mg + 24 mg + 24 mg | Number of Participants With Clinically Significant Abnormalities in Laboratory Measurements | 7 participants |
| Stage 2: PF-04856883 8 mg + 8 mg + 16 mg + 24 mg | Number of Participants With Clinically Significant Abnormalities in Laboratory Measurements | 7 participants |
| Stage 2: PF-04856883 12 mg + 20 mg + 28 mg + 36 mg | Number of Participants With Clinically Significant Abnormalities in Laboratory Measurements | 6 participants |
Number of Participants With Clinically Significant Change From Baseline in 12-lead Electrocardiograms (ECG)
ECG parameters included pulse rate (PR) interval, QRS interval, corrected QT interval using Bazett's formula (QTcB) and corrected QT interval using Fridericia's formula (QTcF). ECG criteria of clinically significant concern were 1) PR interval: greater than equal to (\>=) 25 percent (%) increase when baseline greater than (\>)200 milliseconds (msec); or increase \>=50% when baseline less than or equal to (\<=200) msec; 2) QRS interval: \>=25% increase when baseline \>100 msec; \>=50% increase when baseline \<= 100 msec; 3) QTCF interval: QTc interval using Fridericia's formula (QTcF interval) and Bazett's formula (QTcB interval): absolute value 450 - \<480 msec, 480 - \<500 msec \>=500; absolute change 30 - \<60, \>=60 msec. The number of participants with potentially clinically significant ECG findings at any visit were reported. IFB = increase from baseline.
Time frame: Stage 1: Baseline up to Day 29; Stage 2: Baseline up to Day 50
Population: The safety population included all randomized participants who received at least 1 dose of study treatment.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Stage 1: PF-04856883 Placebo | Number of Participants With Clinically Significant Change From Baseline in 12-lead Electrocardiograms (ECG) | Maximum QTcB Interval IFB: 30-<60 msec | 0 participants |
| Stage 1: PF-04856883 Placebo | Number of Participants With Clinically Significant Change From Baseline in 12-lead Electrocardiograms (ECG) | Maximum PR Interval IFB: >=25 or 50% | 0 participants |
| Stage 1: PF-04856883 Placebo | Number of Participants With Clinically Significant Change From Baseline in 12-lead Electrocardiograms (ECG) | Maximum QTcF Interval IFB: 30-<60 msec | 0 participants |
| Stage 1: PF-04856883 4 mg | Number of Participants With Clinically Significant Change From Baseline in 12-lead Electrocardiograms (ECG) | Maximum QTcF Interval IFB: 30-<60 msec | 0 participants |
| Stage 1: PF-04856883 4 mg | Number of Participants With Clinically Significant Change From Baseline in 12-lead Electrocardiograms (ECG) | Maximum QTcB Interval IFB: 30-<60 msec | 0 participants |
| Stage 1: PF-04856883 4 mg | Number of Participants With Clinically Significant Change From Baseline in 12-lead Electrocardiograms (ECG) | Maximum PR Interval IFB: >=25 or 50% | 0 participants |
| Stage 1: PF-04856883 8 mg | Number of Participants With Clinically Significant Change From Baseline in 12-lead Electrocardiograms (ECG) | Maximum QTcF Interval IFB: 30-<60 msec | 0 participants |
| Stage 1: PF-04856883 8 mg | Number of Participants With Clinically Significant Change From Baseline in 12-lead Electrocardiograms (ECG) | Maximum PR Interval IFB: >=25 or 50% | 0 participants |
| Stage 1: PF-04856883 8 mg | Number of Participants With Clinically Significant Change From Baseline in 12-lead Electrocardiograms (ECG) | Maximum QTcB Interval IFB: 30-<60 msec | 0 participants |
| Stage 1: PF-04856883 12 mg | Number of Participants With Clinically Significant Change From Baseline in 12-lead Electrocardiograms (ECG) | Maximum QTcB Interval IFB: 30-<60 msec | 0 participants |
| Stage 1: PF-04856883 12 mg | Number of Participants With Clinically Significant Change From Baseline in 12-lead Electrocardiograms (ECG) | Maximum QTcF Interval IFB: 30-<60 msec | 0 participants |
| Stage 1: PF-04856883 12 mg | Number of Participants With Clinically Significant Change From Baseline in 12-lead Electrocardiograms (ECG) | Maximum PR Interval IFB: >=25 or 50% | 0 participants |
| Stage 1: PF-04856883 18 mg | Number of Participants With Clinically Significant Change From Baseline in 12-lead Electrocardiograms (ECG) | Maximum QTcB Interval IFB: 30-<60 msec | 0 participants |
| Stage 1: PF-04856883 18 mg | Number of Participants With Clinically Significant Change From Baseline in 12-lead Electrocardiograms (ECG) | Maximum PR Interval IFB: >=25 or 50% | 0 participants |
| Stage 1: PF-04856883 18 mg | Number of Participants With Clinically Significant Change From Baseline in 12-lead Electrocardiograms (ECG) | Maximum QTcF Interval IFB: 30-<60 msec | 0 participants |
| Stage 1: PF-04856883 24 mg | Number of Participants With Clinically Significant Change From Baseline in 12-lead Electrocardiograms (ECG) | Maximum PR Interval IFB: >=25 or 50% | 0 participants |
| Stage 1: PF-04856883 24 mg | Number of Participants With Clinically Significant Change From Baseline in 12-lead Electrocardiograms (ECG) | Maximum QTcF Interval IFB: 30-<60 msec | 1 participants |
| Stage 1: PF-04856883 24 mg | Number of Participants With Clinically Significant Change From Baseline in 12-lead Electrocardiograms (ECG) | Maximum QTcB Interval IFB: 30-<60 msec | 1 participants |
| Stage 1: PF-04856883 36 mg | Number of Participants With Clinically Significant Change From Baseline in 12-lead Electrocardiograms (ECG) | Maximum PR Interval IFB: >=25 or 50% | 0 participants |
| Stage 1: PF-04856883 36 mg | Number of Participants With Clinically Significant Change From Baseline in 12-lead Electrocardiograms (ECG) | Maximum QTcB Interval IFB: 30-<60 msec | 1 participants |
| Stage 1: PF-04856883 36 mg | Number of Participants With Clinically Significant Change From Baseline in 12-lead Electrocardiograms (ECG) | Maximum QTcF Interval IFB: 30-<60 msec | 0 participants |
| Stage 2: Placebo | Number of Participants With Clinically Significant Change From Baseline in 12-lead Electrocardiograms (ECG) | Maximum PR Interval IFB: >=25 or 50% | 1 participants |
| Stage 2: Placebo | Number of Participants With Clinically Significant Change From Baseline in 12-lead Electrocardiograms (ECG) | Maximum QTcB Interval IFB: 30-<60 msec | 0 participants |
| Stage 2: Placebo | Number of Participants With Clinically Significant Change From Baseline in 12-lead Electrocardiograms (ECG) | Maximum QTcF Interval IFB: 30-<60 msec | 0 participants |
| Stage 2: PF-04856883 12 mg | Number of Participants With Clinically Significant Change From Baseline in 12-lead Electrocardiograms (ECG) | Maximum PR Interval IFB: >=25 or 50% | 0 participants |
| Stage 2: PF-04856883 12 mg | Number of Participants With Clinically Significant Change From Baseline in 12-lead Electrocardiograms (ECG) | Maximum QTcB Interval IFB: 30-<60 msec | 1 participants |
| Stage 2: PF-04856883 12 mg | Number of Participants With Clinically Significant Change From Baseline in 12-lead Electrocardiograms (ECG) | Maximum QTcF Interval IFB: 30-<60 msec | 1 participants |
| Stage 2: PF-04856883 12 mg + 12 mg + 24 mg + 24 mg | Number of Participants With Clinically Significant Change From Baseline in 12-lead Electrocardiograms (ECG) | Maximum QTcF Interval IFB: 30-<60 msec | 0 participants |
| Stage 2: PF-04856883 12 mg + 12 mg + 24 mg + 24 mg | Number of Participants With Clinically Significant Change From Baseline in 12-lead Electrocardiograms (ECG) | Maximum QTcB Interval IFB: 30-<60 msec | 0 participants |
| Stage 2: PF-04856883 12 mg + 12 mg + 24 mg + 24 mg | Number of Participants With Clinically Significant Change From Baseline in 12-lead Electrocardiograms (ECG) | Maximum PR Interval IFB: >=25 or 50% | 0 participants |
| Stage 2: PF-04856883 8 mg + 8 mg + 16 mg + 24 mg | Number of Participants With Clinically Significant Change From Baseline in 12-lead Electrocardiograms (ECG) | Maximum PR Interval IFB: >=25 or 50% | 1 participants |
| Stage 2: PF-04856883 8 mg + 8 mg + 16 mg + 24 mg | Number of Participants With Clinically Significant Change From Baseline in 12-lead Electrocardiograms (ECG) | Maximum QTcF Interval IFB: 30-<60 msec | 0 participants |
| Stage 2: PF-04856883 8 mg + 8 mg + 16 mg + 24 mg | Number of Participants With Clinically Significant Change From Baseline in 12-lead Electrocardiograms (ECG) | Maximum QTcB Interval IFB: 30-<60 msec | 0 participants |
| Stage 2: PF-04856883 12 mg + 20 mg + 28 mg + 36 mg | Number of Participants With Clinically Significant Change From Baseline in 12-lead Electrocardiograms (ECG) | Maximum QTcF Interval IFB: 30-<60 msec | 0 participants |
| Stage 2: PF-04856883 12 mg + 20 mg + 28 mg + 36 mg | Number of Participants With Clinically Significant Change From Baseline in 12-lead Electrocardiograms (ECG) | Maximum PR Interval IFB: >=25 or 50% | 0 participants |
| Stage 2: PF-04856883 12 mg + 20 mg + 28 mg + 36 mg | Number of Participants With Clinically Significant Change From Baseline in 12-lead Electrocardiograms (ECG) | Maximum QTcB Interval IFB: 30-<60 msec | 1 participants |
Number of Participants With Clinically Significant Physical Examination Findings
Physical examination included examination of general appearance, head, ears, eyes (including fundoscopy), nose, mouth, throat, neck (including thyroid), skin, breast (optional), cardiac, respiratory, gastrointestinal, musculoskeletal and neurological systems.
Time frame: Stage 1: Baseline up to Day 29; Stage 2: Baseline up to Day 50
Population: The safety population included all randomized participants who received at least 1 dose of study treatment.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Stage 1: PF-04856883 Placebo | Number of Participants With Clinically Significant Physical Examination Findings | 0 participants |
| Stage 1: PF-04856883 4 mg | Number of Participants With Clinically Significant Physical Examination Findings | 0 participants |
| Stage 1: PF-04856883 8 mg | Number of Participants With Clinically Significant Physical Examination Findings | 0 participants |
| Stage 1: PF-04856883 12 mg | Number of Participants With Clinically Significant Physical Examination Findings | 0 participants |
| Stage 1: PF-04856883 18 mg | Number of Participants With Clinically Significant Physical Examination Findings | 0 participants |
| Stage 1: PF-04856883 24 mg | Number of Participants With Clinically Significant Physical Examination Findings | 0 participants |
| Stage 1: PF-04856883 36 mg | Number of Participants With Clinically Significant Physical Examination Findings | 0 participants |
| Stage 2: Placebo | Number of Participants With Clinically Significant Physical Examination Findings | 0 participants |
| Stage 2: PF-04856883 12 mg | Number of Participants With Clinically Significant Physical Examination Findings | 0 participants |
| Stage 2: PF-04856883 12 mg + 12 mg + 24 mg + 24 mg | Number of Participants With Clinically Significant Physical Examination Findings | 0 participants |
| Stage 2: PF-04856883 8 mg + 8 mg + 16 mg + 24 mg | Number of Participants With Clinically Significant Physical Examination Findings | 0 participants |
| Stage 2: PF-04856883 12 mg + 20 mg + 28 mg + 36 mg | Number of Participants With Clinically Significant Physical Examination Findings | 0 participants |
Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose (Day 50) that were absent before treatment or that worsened relative to pretreatment state.
Time frame: Stage 1: Baseline up to Day 29; Stage 2: Baseline up to Day 50
Population: The safety population included all randomized participants who received at least 1 dose of study treatment.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Stage 1: PF-04856883 Placebo | Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) | SAE | 0 participants |
| Stage 1: PF-04856883 Placebo | Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) | AE | 8 participants |
| Stage 1: PF-04856883 4 mg | Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) | AE | 1 participants |
| Stage 1: PF-04856883 4 mg | Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) | SAE | 0 participants |
| Stage 1: PF-04856883 8 mg | Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) | AE | 0 participants |
| Stage 1: PF-04856883 8 mg | Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) | SAE | 0 participants |
| Stage 1: PF-04856883 12 mg | Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) | SAE | 0 participants |
| Stage 1: PF-04856883 12 mg | Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) | AE | 2 participants |
| Stage 1: PF-04856883 18 mg | Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) | SAE | 0 participants |
| Stage 1: PF-04856883 18 mg | Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) | AE | 4 participants |
| Stage 1: PF-04856883 24 mg | Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) | SAE | 0 participants |
| Stage 1: PF-04856883 24 mg | Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) | AE | 3 participants |
| Stage 1: PF-04856883 36 mg | Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) | SAE | 0 participants |
| Stage 1: PF-04856883 36 mg | Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) | AE | 4 participants |
| Stage 2: Placebo | Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) | AE | 4 participants |
| Stage 2: Placebo | Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) | SAE | 0 participants |
| Stage 2: PF-04856883 12 mg | Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) | AE | 5 participants |
| Stage 2: PF-04856883 12 mg | Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) | SAE | 0 participants |
| Stage 2: PF-04856883 12 mg + 12 mg + 24 mg + 24 mg | Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) | SAE | 0 participants |
| Stage 2: PF-04856883 12 mg + 12 mg + 24 mg + 24 mg | Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) | AE | 5 participants |
| Stage 2: PF-04856883 8 mg + 8 mg + 16 mg + 24 mg | Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) | SAE | 0 participants |
| Stage 2: PF-04856883 8 mg + 8 mg + 16 mg + 24 mg | Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) | AE | 5 participants |
| Stage 2: PF-04856883 12 mg + 20 mg + 28 mg + 36 mg | Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) | SAE | 0 participants |
| Stage 2: PF-04856883 12 mg + 20 mg + 28 mg + 36 mg | Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) | AE | 5 participants |
Number of Participants With Vital Sign Abnormalities
Criteria for vital signs abnormalities: sitting/supine systolic pulse rate less than (\<) 40 beats per minute (bpm) or greater than (\>) 120 bpm, standing/supine systolic pulse \< 40 bpm or \> 140 bpm, systolic blood pressure of \>=30 millimeters of mercury (mmHg) change from baseline and systolic blood pressure \<90 mmHg, diastolic blood pressure \>=20 mmHg change from baseline and diastolic blood pressure \<50 mm Hg.
Time frame: Stage 1: Baseline up to Day 29; Stage 2 : Baseline up to Day 50
Population: The safety population included all randomized participants who received at least 1 dose of study treatment.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Stage 1: PF-04856883 Placebo | Number of Participants With Vital Sign Abnormalities | 15 participants |
| Stage 1: PF-04856883 4 mg | Number of Participants With Vital Sign Abnormalities | 5 participants |
| Stage 1: PF-04856883 8 mg | Number of Participants With Vital Sign Abnormalities | 6 participants |
| Stage 1: PF-04856883 12 mg | Number of Participants With Vital Sign Abnormalities | 6 participants |
| Stage 1: PF-04856883 18 mg | Number of Participants With Vital Sign Abnormalities | 7 participants |
| Stage 1: PF-04856883 24 mg | Number of Participants With Vital Sign Abnormalities | 5 participants |
| Stage 1: PF-04856883 36 mg | Number of Participants With Vital Sign Abnormalities | 7 participants |
| Stage 2: Placebo | Number of Participants With Vital Sign Abnormalities | 7 participants |
| Stage 2: PF-04856883 12 mg | Number of Participants With Vital Sign Abnormalities | 5 participants |
| Stage 2: PF-04856883 12 mg + 12 mg + 24 mg + 24 mg | Number of Participants With Vital Sign Abnormalities | 7 participants |
| Stage 2: PF-04856883 8 mg + 8 mg + 16 mg + 24 mg | Number of Participants With Vital Sign Abnormalities | 7 participants |
| Stage 2: PF-04856883 12 mg + 20 mg + 28 mg + 36 mg | Number of Participants With Vital Sign Abnormalities | 6 participants |
Apparent Clearance (CL/F) of PF-04856883: Stage 1
It was calculated by dividing dose with AUC (0 - ∞) where AUC (0 - ∞) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞). Outcome measure was planned to be analyzed in Stage 1 only.
Time frame: predose (0 hour), 1, 6, 12, 24, 48, 72, 120, 168, 336, 504, 672 hours postdose on Day 1
Population: PK parameter analysis population included all randomized participants who had received at least one dose of study treatment and had at least 1 of the PK parameters of interest. Here, 'N' signifies those participants who were evaluable for this outcome measure.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Stage 1: PF-04856883 Placebo | Apparent Clearance (CL/F) of PF-04856883: Stage 1 | 89.14 milliliter per hour (mL/hr) | Geometric Coefficient of Variation 84 |
| Stage 1: PF-04856883 4 mg | Apparent Clearance (CL/F) of PF-04856883: Stage 1 | 84.08 milliliter per hour (mL/hr) | Geometric Coefficient of Variation 59 |
| Stage 1: PF-04856883 8 mg | Apparent Clearance (CL/F) of PF-04856883: Stage 1 | 40.60 milliliter per hour (mL/hr) | Geometric Coefficient of Variation 68 |
| Stage 1: PF-04856883 12 mg | Apparent Clearance (CL/F) of PF-04856883: Stage 1 | 34.13 milliliter per hour (mL/hr) | Geometric Coefficient of Variation 35 |
| Stage 1: PF-04856883 18 mg | Apparent Clearance (CL/F) of PF-04856883: Stage 1 | 33.73 milliliter per hour (mL/hr) | Geometric Coefficient of Variation 14 |
| Stage 1: PF-04856883 24 mg | Apparent Clearance (CL/F) of PF-04856883: Stage 1 | 55.32 milliliter per hour (mL/hr) | Geometric Coefficient of Variation 42 |
Apparent Clearance (CL/F) of PF-04856883: Stage 2
It was calculated by dividing dose with AUC (0 - ∞) where AUC (0 - ∞) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞). Outcome measure was planned to be analyzed in Stage 2 only. Data was not estimable if values were below the limit of quantification.
Time frame: predose (0 hour), 1, 2, 6, 24, 48, 72, 120, 168, 336, 504, 672 hours postdose on Day 22
Population: PK parameter analysis population included all randomized participants who had received at least one dose of study treatment and had at least 1 of the PK parameters of interest. Here, 'N' signifies those participants who were evaluable for this outcome measure.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Stage 1: PF-04856883 Placebo | Apparent Clearance (CL/F) of PF-04856883: Stage 2 | 44.67 mL/hr | Geometric Coefficient of Variation 28 |
| Stage 1: PF-04856883 4 mg | Apparent Clearance (CL/F) of PF-04856883: Stage 2 | NA mL/hr | — |
| Stage 1: PF-04856883 8 mg | Apparent Clearance (CL/F) of PF-04856883: Stage 2 | NA mL/hr | — |
| Stage 1: PF-04856883 12 mg | Apparent Clearance (CL/F) of PF-04856883: Stage 2 | NA mL/hr | — |
Apparent Volume of Distribution (Vz/F) of PF-04856883: Stage 1
Time frame: predose (0 hour), 1, 6, 12, 24, 48, 72, 120, 168, 336, 504, 672 hours postdose on Day 1
Population: PK parameter analysis population included all randomized participants who had received at least one dose of study treatment and had at least 1 of the PK parameters of interest. Here, 'N' signifies those participants who were evaluable for this outcome measure.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Stage 1: PF-04856883 Placebo | Apparent Volume of Distribution (Vz/F) of PF-04856883: Stage 1 | 18760 milliliter (mL) | Geometric Coefficient of Variation 90 |
| Stage 1: PF-04856883 4 mg | Apparent Volume of Distribution (Vz/F) of PF-04856883: Stage 1 | 21710 milliliter (mL) | Geometric Coefficient of Variation 59 |
| Stage 1: PF-04856883 8 mg | Apparent Volume of Distribution (Vz/F) of PF-04856883: Stage 1 | 9191 milliliter (mL) | Geometric Coefficient of Variation 51 |
| Stage 1: PF-04856883 12 mg | Apparent Volume of Distribution (Vz/F) of PF-04856883: Stage 1 | 7127 milliliter (mL) | Geometric Coefficient of Variation 40 |
| Stage 1: PF-04856883 18 mg | Apparent Volume of Distribution (Vz/F) of PF-04856883: Stage 1 | 8437 milliliter (mL) | Geometric Coefficient of Variation 17 |
| Stage 1: PF-04856883 24 mg | Apparent Volume of Distribution (Vz/F) of PF-04856883: Stage 1 | 10010 milliliter (mL) | Geometric Coefficient of Variation 67 |
Apparent Volume of Distribution (Vz/F) of PF-04856883: Stage 2
Time frame: predose (0 hour), 1, 2, 6, 24, 48, 72, 120, 168, 336, 504, 672 hours postdose on Day 22
Population: PK parameter analysis population included all randomized participants who had received at least one dose of study treatment and had at least 1 of the PK parameters of interest. Here, 'N' signifies those participants who were evaluable for this outcome measure.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Stage 1: PF-04856883 Placebo | Apparent Volume of Distribution (Vz/F) of PF-04856883: Stage 2 | 9550 mL | Geometric Coefficient of Variation 29 |
| Stage 1: PF-04856883 4 mg | Apparent Volume of Distribution (Vz/F) of PF-04856883: Stage 2 | NA mL | — |
| Stage 1: PF-04856883 8 mg | Apparent Volume of Distribution (Vz/F) of PF-04856883: Stage 2 | NA mL | — |
| Stage 1: PF-04856883 12 mg | Apparent Volume of Distribution (Vz/F) of PF-04856883: Stage 2 | NA mL | — |
Area Under the Concentration Time Curve From Time Zero to Time Tau (AUCtau) of PF-04856883: Stage 2
Area under the serum concentration-time curve from time 0 to tau (AUCtau), where tau was the dosing interval of 168 hours.
Time frame: predose (0 hour), 1, 6, 12, 24, 48, 72, 120, 168 hours postdose Day 1; predose (0 hour), 1, 2, 6, 24, 48, 72, 120, 168 hours postdose Day 22
Population: PK parameter analysis population included all randomized participants who had received at least one dose of study treatment and had at least 1 of the PK parameters of interest. Here, 'n' signifies those participants who were evaluable at specified time point for each arm, respectively.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Stage 1: PF-04856883 Placebo | Area Under the Concentration Time Curve From Time Zero to Time Tau (AUCtau) of PF-04856883: Stage 2 | Day 1 (n =5, 7, 7, 6) | 85370 ng*hr/mL | Geometric Coefficient of Variation 38 |
| Stage 1: PF-04856883 Placebo | Area Under the Concentration Time Curve From Time Zero to Time Tau (AUCtau) of PF-04856883: Stage 2 | Day 22 (n =5, 7, 5, 6) | 269000 ng*hr/mL | Geometric Coefficient of Variation 32 |
| Stage 1: PF-04856883 4 mg | Area Under the Concentration Time Curve From Time Zero to Time Tau (AUCtau) of PF-04856883: Stage 2 | Day 22 (n =5, 7, 5, 6) | 377400 ng*hr/mL | Geometric Coefficient of Variation 28 |
| Stage 1: PF-04856883 4 mg | Area Under the Concentration Time Curve From Time Zero to Time Tau (AUCtau) of PF-04856883: Stage 2 | Day 1 (n =5, 7, 7, 6) | 99780 ng*hr/mL | Geometric Coefficient of Variation 41 |
| Stage 1: PF-04856883 8 mg | Area Under the Concentration Time Curve From Time Zero to Time Tau (AUCtau) of PF-04856883: Stage 2 | Day 1 (n =5, 7, 7, 6) | 89390 ng*hr/mL | Geometric Coefficient of Variation 35 |
| Stage 1: PF-04856883 8 mg | Area Under the Concentration Time Curve From Time Zero to Time Tau (AUCtau) of PF-04856883: Stage 2 | Day 22 (n =5, 7, 5, 6) | 396300 ng*hr/mL | Geometric Coefficient of Variation 28 |
| Stage 1: PF-04856883 12 mg | Area Under the Concentration Time Curve From Time Zero to Time Tau (AUCtau) of PF-04856883: Stage 2 | Day 1 (n =5, 7, 7, 6) | 91130 ng*hr/mL | Geometric Coefficient of Variation 27 |
| Stage 1: PF-04856883 12 mg | Area Under the Concentration Time Curve From Time Zero to Time Tau (AUCtau) of PF-04856883: Stage 2 | Day 22 (n =5, 7, 5, 6) | 430500 ng*hr/mL | Geometric Coefficient of Variation 23 |
Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUC [0 - ∞]) of PF-04856883: Stage 1
AUC (0 - ∞) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞).
Time frame: predose (0 hour), 1, 6, 12, 24, 48, 72, 120, 168, 336, 504, 672 hours postdose on Day 1
Population: PK parameter analysis population included all randomized participants who had received at least one dose of study treatment and had at least 1 of the PK parameters of interest. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Stage 1: PF-04856883 Placebo | Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUC [0 - ∞]) of PF-04856883: Stage 1 | 44920 nanogram*hour per milliliter (ng*hr/mL) | Geometric Coefficient of Variation 112 |
| Stage 1: PF-04856883 4 mg | Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUC [0 - ∞]) of PF-04856883: Stage 1 | 95190 nanogram*hour per milliliter (ng*hr/mL) | Geometric Coefficient of Variation 76 |
| Stage 1: PF-04856883 8 mg | Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUC [0 - ∞]) of PF-04856883: Stage 1 | 295200 nanogram*hour per milliliter (ng*hr/mL) | Geometric Coefficient of Variation 46 |
| Stage 1: PF-04856883 12 mg | Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUC [0 - ∞]) of PF-04856883: Stage 1 | 527100 nanogram*hour per milliliter (ng*hr/mL) | Geometric Coefficient of Variation 53 |
| Stage 1: PF-04856883 18 mg | Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUC [0 - ∞]) of PF-04856883: Stage 1 | 711300 nanogram*hour per milliliter (ng*hr/mL) | Geometric Coefficient of Variation 13 |
| Stage 1: PF-04856883 24 mg | Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUC [0 - ∞]) of PF-04856883: Stage 1 | 652000 nanogram*hour per milliliter (ng*hr/mL) | Geometric Coefficient of Variation 50 |
Change From Baseline in 1, 5 Anhydroglucitol at Day 8, 15, 22, 29 and 50: Stage 2
Time frame: Baseline, Day 8, 15, 22, 29 and 50
Population: Pharmacodynamic analysis population included all enrolled participants who had received at least 1 dose of study treatment and have at least 1 pharmacodynamic parameter. Here, 'n' signifies those participants who were evaluable at specified time point for each arm, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Stage 1: PF-04856883 Placebo | Change From Baseline in 1, 5 Anhydroglucitol at Day 8, 15, 22, 29 and 50: Stage 2 | Change at Day 8 (n =7, 5, 7, 6, 6) | -0.10 mcg/mL | Standard Deviation 0.663 |
| Stage 1: PF-04856883 Placebo | Change From Baseline in 1, 5 Anhydroglucitol at Day 8, 15, 22, 29 and 50: Stage 2 | Baseline (n =7, 5, 7, 7, 6) | 7.66 mcg/mL | Standard Deviation 4.351 |
| Stage 1: PF-04856883 Placebo | Change From Baseline in 1, 5 Anhydroglucitol at Day 8, 15, 22, 29 and 50: Stage 2 | Change at Day 50 (n =7, 5, 7, 7, 6) | 0.40 mcg/mL | Standard Deviation 2.106 |
| Stage 1: PF-04856883 Placebo | Change From Baseline in 1, 5 Anhydroglucitol at Day 8, 15, 22, 29 and 50: Stage 2 | Change at Day 29 (n =7, 5, 7, 6, 5) | 0.36 mcg/mL | Standard Deviation 1.765 |
| Stage 1: PF-04856883 Placebo | Change From Baseline in 1, 5 Anhydroglucitol at Day 8, 15, 22, 29 and 50: Stage 2 | Change at Day 22 (n =7, 5, 7, 6, 6) | 0.13 mcg/mL | Standard Deviation 1.289 |
| Stage 1: PF-04856883 Placebo | Change From Baseline in 1, 5 Anhydroglucitol at Day 8, 15, 22, 29 and 50: Stage 2 | Change at Day 15 (n =7, 5, 7, 6, 6) | -0.03 mcg/mL | Standard Deviation 1.376 |
| Stage 1: PF-04856883 4 mg | Change From Baseline in 1, 5 Anhydroglucitol at Day 8, 15, 22, 29 and 50: Stage 2 | Change at Day 22 (n =7, 5, 7, 6, 6) | 1.14 mcg/mL | Standard Deviation 0.518 |
| Stage 1: PF-04856883 4 mg | Change From Baseline in 1, 5 Anhydroglucitol at Day 8, 15, 22, 29 and 50: Stage 2 | Change at Day 8 (n =7, 5, 7, 6, 6) | 0.40 mcg/mL | Standard Deviation 0.962 |
| Stage 1: PF-04856883 4 mg | Change From Baseline in 1, 5 Anhydroglucitol at Day 8, 15, 22, 29 and 50: Stage 2 | Change at Day 15 (n =7, 5, 7, 6, 6) | 0.72 mcg/mL | Standard Deviation 1.512 |
| Stage 1: PF-04856883 4 mg | Change From Baseline in 1, 5 Anhydroglucitol at Day 8, 15, 22, 29 and 50: Stage 2 | Baseline (n =7, 5, 7, 7, 6) | 6.32 mcg/mL | Standard Deviation 3.517 |
| Stage 1: PF-04856883 4 mg | Change From Baseline in 1, 5 Anhydroglucitol at Day 8, 15, 22, 29 and 50: Stage 2 | Change at Day 29 (n =7, 5, 7, 6, 5) | 1.46 mcg/mL | Standard Deviation 0.73 |
| Stage 1: PF-04856883 4 mg | Change From Baseline in 1, 5 Anhydroglucitol at Day 8, 15, 22, 29 and 50: Stage 2 | Change at Day 50 (n =7, 5, 7, 7, 6) | 0.38 mcg/mL | Standard Deviation 2.381 |
| Stage 1: PF-04856883 8 mg | Change From Baseline in 1, 5 Anhydroglucitol at Day 8, 15, 22, 29 and 50: Stage 2 | Baseline (n =7, 5, 7, 7, 6) | 8.09 mcg/mL | Standard Deviation 6.24 |
| Stage 1: PF-04856883 8 mg | Change From Baseline in 1, 5 Anhydroglucitol at Day 8, 15, 22, 29 and 50: Stage 2 | Change at Day 8 (n =7, 5, 7, 6, 6) | 0.41 mcg/mL | Standard Deviation 0.57 |
| Stage 1: PF-04856883 8 mg | Change From Baseline in 1, 5 Anhydroglucitol at Day 8, 15, 22, 29 and 50: Stage 2 | Change at Day 15 (n =7, 5, 7, 6, 6) | 1.21 mcg/mL | Standard Deviation 0.641 |
| Stage 1: PF-04856883 8 mg | Change From Baseline in 1, 5 Anhydroglucitol at Day 8, 15, 22, 29 and 50: Stage 2 | Change at Day 22 (n =7, 5, 7, 6, 6) | 1.73 mcg/mL | Standard Deviation 1.034 |
| Stage 1: PF-04856883 8 mg | Change From Baseline in 1, 5 Anhydroglucitol at Day 8, 15, 22, 29 and 50: Stage 2 | Change at Day 29 (n =7, 5, 7, 6, 5) | 1.83 mcg/mL | Standard Deviation 1.241 |
| Stage 1: PF-04856883 8 mg | Change From Baseline in 1, 5 Anhydroglucitol at Day 8, 15, 22, 29 and 50: Stage 2 | Change at Day 50 (n =7, 5, 7, 7, 6) | -0.30 mcg/mL | Standard Deviation 1.294 |
| Stage 1: PF-04856883 12 mg | Change From Baseline in 1, 5 Anhydroglucitol at Day 8, 15, 22, 29 and 50: Stage 2 | Change at Day 22 (n =7, 5, 7, 6, 6) | 0.95 mcg/mL | Standard Deviation 3.086 |
| Stage 1: PF-04856883 12 mg | Change From Baseline in 1, 5 Anhydroglucitol at Day 8, 15, 22, 29 and 50: Stage 2 | Change at Day 15 (n =7, 5, 7, 6, 6) | 0.32 mcg/mL | Standard Deviation 2.483 |
| Stage 1: PF-04856883 12 mg | Change From Baseline in 1, 5 Anhydroglucitol at Day 8, 15, 22, 29 and 50: Stage 2 | Change at Day 8 (n =7, 5, 7, 6, 6) | -0.08 mcg/mL | Standard Deviation 1.599 |
| Stage 1: PF-04856883 12 mg | Change From Baseline in 1, 5 Anhydroglucitol at Day 8, 15, 22, 29 and 50: Stage 2 | Change at Day 50 (n =7, 5, 7, 7, 6) | 1.64 mcg/mL | Standard Deviation 2.985 |
| Stage 1: PF-04856883 12 mg | Change From Baseline in 1, 5 Anhydroglucitol at Day 8, 15, 22, 29 and 50: Stage 2 | Baseline (n =7, 5, 7, 7, 6) | 7.59 mcg/mL | Standard Deviation 5.538 |
| Stage 1: PF-04856883 12 mg | Change From Baseline in 1, 5 Anhydroglucitol at Day 8, 15, 22, 29 and 50: Stage 2 | Change at Day 29 (n =7, 5, 7, 6, 5) | 1.50 mcg/mL | Standard Deviation 2.9 |
| Stage 1: PF-04856883 18 mg | Change From Baseline in 1, 5 Anhydroglucitol at Day 8, 15, 22, 29 and 50: Stage 2 | Baseline (n =7, 5, 7, 7, 6) | 3.95 mcg/mL | Standard Deviation 1.291 |
| Stage 1: PF-04856883 18 mg | Change From Baseline in 1, 5 Anhydroglucitol at Day 8, 15, 22, 29 and 50: Stage 2 | Change at Day 15 (n =7, 5, 7, 6, 6) | 0.63 mcg/mL | Standard Deviation 1.481 |
| Stage 1: PF-04856883 18 mg | Change From Baseline in 1, 5 Anhydroglucitol at Day 8, 15, 22, 29 and 50: Stage 2 | Change at Day 29 (n =7, 5, 7, 6, 5) | 1.60 mcg/mL | Standard Deviation 2.827 |
| Stage 1: PF-04856883 18 mg | Change From Baseline in 1, 5 Anhydroglucitol at Day 8, 15, 22, 29 and 50: Stage 2 | Change at Day 8 (n =7, 5, 7, 6, 6) | 0.90 mcg/mL | Standard Deviation 0.502 |
| Stage 1: PF-04856883 18 mg | Change From Baseline in 1, 5 Anhydroglucitol at Day 8, 15, 22, 29 and 50: Stage 2 | Change at Day 50 (n =7, 5, 7, 7, 6) | 0.92 mcg/mL | Standard Deviation 2.076 |
| Stage 1: PF-04856883 18 mg | Change From Baseline in 1, 5 Anhydroglucitol at Day 8, 15, 22, 29 and 50: Stage 2 | Change at Day 22 (n =7, 5, 7, 6, 6) | 1.28 mcg/mL | Standard Deviation 2.046 |
Change From Baseline in 1, 5 Anhydroglucitol at Day 8, 15 and 29: Stage 1
Time frame: Baseline, Day 8, 15 and 29
Population: Pharmacodynamic analysis population included all enrolled participants who had received at least 1 dose of study treatment and have at least 1 pharmacodynamic parameter. Here, 'n' signifies those participants who were evaluable at specified time point for each arm, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Stage 1: PF-04856883 Placebo | Change From Baseline in 1, 5 Anhydroglucitol at Day 8, 15 and 29: Stage 1 | Baseline (n =15, 5, 6, 6, 7, 5, 7) | 8.17 microgram per milliliter (mcg/mL) | Standard Deviation 5.021 |
| Stage 1: PF-04856883 Placebo | Change From Baseline in 1, 5 Anhydroglucitol at Day 8, 15 and 29: Stage 1 | Change at Day 29 (n =15, 5, 5, 6, 7, 5, 7) | 0.46 microgram per milliliter (mcg/mL) | Standard Deviation 1.608 |
| Stage 1: PF-04856883 Placebo | Change From Baseline in 1, 5 Anhydroglucitol at Day 8, 15 and 29: Stage 1 | Change at Day 8 (n =15, 5, 5, 6, 7, 5, 7) | 0.39 microgram per milliliter (mcg/mL) | Standard Deviation 0.895 |
| Stage 1: PF-04856883 Placebo | Change From Baseline in 1, 5 Anhydroglucitol at Day 8, 15 and 29: Stage 1 | Change at Day 15 (n =15, 5, 5, 6, 6, 5, 7) | 0.38 microgram per milliliter (mcg/mL) | Standard Deviation 1.047 |
| Stage 1: PF-04856883 4 mg | Change From Baseline in 1, 5 Anhydroglucitol at Day 8, 15 and 29: Stage 1 | Change at Day 15 (n =15, 5, 5, 6, 6, 5, 7) | 0.42 microgram per milliliter (mcg/mL) | Standard Deviation 1.711 |
| Stage 1: PF-04856883 4 mg | Change From Baseline in 1, 5 Anhydroglucitol at Day 8, 15 and 29: Stage 1 | Change at Day 8 (n =15, 5, 5, 6, 7, 5, 7) | -0.36 microgram per milliliter (mcg/mL) | Standard Deviation 0.727 |
| Stage 1: PF-04856883 4 mg | Change From Baseline in 1, 5 Anhydroglucitol at Day 8, 15 and 29: Stage 1 | Change at Day 29 (n =15, 5, 5, 6, 7, 5, 7) | -0.36 microgram per milliliter (mcg/mL) | Standard Deviation 0.82 |
| Stage 1: PF-04856883 4 mg | Change From Baseline in 1, 5 Anhydroglucitol at Day 8, 15 and 29: Stage 1 | Baseline (n =15, 5, 6, 6, 7, 5, 7) | 5.02 microgram per milliliter (mcg/mL) | Standard Deviation 2.831 |
| Stage 1: PF-04856883 8 mg | Change From Baseline in 1, 5 Anhydroglucitol at Day 8, 15 and 29: Stage 1 | Baseline (n =15, 5, 6, 6, 7, 5, 7) | 5.77 microgram per milliliter (mcg/mL) | Standard Deviation 1.306 |
| Stage 1: PF-04856883 8 mg | Change From Baseline in 1, 5 Anhydroglucitol at Day 8, 15 and 29: Stage 1 | Change at Day 15 (n =15, 5, 5, 6, 6, 5, 7) | 1.50 microgram per milliliter (mcg/mL) | Standard Deviation 1.321 |
| Stage 1: PF-04856883 8 mg | Change From Baseline in 1, 5 Anhydroglucitol at Day 8, 15 and 29: Stage 1 | Change at Day 29 (n =15, 5, 5, 6, 7, 5, 7) | -0.52 microgram per milliliter (mcg/mL) | Standard Deviation 3.192 |
| Stage 1: PF-04856883 8 mg | Change From Baseline in 1, 5 Anhydroglucitol at Day 8, 15 and 29: Stage 1 | Change at Day 8 (n =15, 5, 5, 6, 7, 5, 7) | 0.64 microgram per milliliter (mcg/mL) | Standard Deviation 0.639 |
| Stage 1: PF-04856883 12 mg | Change From Baseline in 1, 5 Anhydroglucitol at Day 8, 15 and 29: Stage 1 | Change at Day 29 (n =15, 5, 5, 6, 7, 5, 7) | -0.62 microgram per milliliter (mcg/mL) | Standard Deviation 1.492 |
| Stage 1: PF-04856883 12 mg | Change From Baseline in 1, 5 Anhydroglucitol at Day 8, 15 and 29: Stage 1 | Change at Day 15 (n =15, 5, 5, 6, 6, 5, 7) | -0.32 microgram per milliliter (mcg/mL) | Standard Deviation 1.143 |
| Stage 1: PF-04856883 12 mg | Change From Baseline in 1, 5 Anhydroglucitol at Day 8, 15 and 29: Stage 1 | Baseline (n =15, 5, 6, 6, 7, 5, 7) | 5.35 microgram per milliliter (mcg/mL) | Standard Deviation 3.683 |
| Stage 1: PF-04856883 12 mg | Change From Baseline in 1, 5 Anhydroglucitol at Day 8, 15 and 29: Stage 1 | Change at Day 8 (n =15, 5, 5, 6, 7, 5, 7) | 0.15 microgram per milliliter (mcg/mL) | Standard Deviation 0.596 |
| Stage 1: PF-04856883 18 mg | Change From Baseline in 1, 5 Anhydroglucitol at Day 8, 15 and 29: Stage 1 | Change at Day 29 (n =15, 5, 5, 6, 7, 5, 7) | 0.97 microgram per milliliter (mcg/mL) | Standard Deviation 1.467 |
| Stage 1: PF-04856883 18 mg | Change From Baseline in 1, 5 Anhydroglucitol at Day 8, 15 and 29: Stage 1 | Change at Day 8 (n =15, 5, 5, 6, 7, 5, 7) | 0.73 microgram per milliliter (mcg/mL) | Standard Deviation 0.632 |
| Stage 1: PF-04856883 18 mg | Change From Baseline in 1, 5 Anhydroglucitol at Day 8, 15 and 29: Stage 1 | Baseline (n =15, 5, 6, 6, 7, 5, 7) | 6.20 microgram per milliliter (mcg/mL) | Standard Deviation 5.44 |
| Stage 1: PF-04856883 18 mg | Change From Baseline in 1, 5 Anhydroglucitol at Day 8, 15 and 29: Stage 1 | Change at Day 15 (n =15, 5, 5, 6, 6, 5, 7) | 1.07 microgram per milliliter (mcg/mL) | Standard Deviation 1.111 |
| Stage 1: PF-04856883 24 mg | Change From Baseline in 1, 5 Anhydroglucitol at Day 8, 15 and 29: Stage 1 | Change at Day 8 (n =15, 5, 5, 6, 7, 5, 7) | 0.00 microgram per milliliter (mcg/mL) | Standard Deviation 1.584 |
| Stage 1: PF-04856883 24 mg | Change From Baseline in 1, 5 Anhydroglucitol at Day 8, 15 and 29: Stage 1 | Baseline (n =15, 5, 6, 6, 7, 5, 7) | 12.04 microgram per milliliter (mcg/mL) | Standard Deviation 5.133 |
| Stage 1: PF-04856883 24 mg | Change From Baseline in 1, 5 Anhydroglucitol at Day 8, 15 and 29: Stage 1 | Change at Day 15 (n =15, 5, 5, 6, 6, 5, 7) | 0.32 microgram per milliliter (mcg/mL) | Standard Deviation 1.608 |
| Stage 1: PF-04856883 24 mg | Change From Baseline in 1, 5 Anhydroglucitol at Day 8, 15 and 29: Stage 1 | Change at Day 29 (n =15, 5, 5, 6, 7, 5, 7) | 0.36 microgram per milliliter (mcg/mL) | Standard Deviation 1.499 |
| Stage 1: PF-04856883 36 mg | Change From Baseline in 1, 5 Anhydroglucitol at Day 8, 15 and 29: Stage 1 | Change at Day 8 (n =15, 5, 5, 6, 7, 5, 7) | 0.97 microgram per milliliter (mcg/mL) | Standard Deviation 0.629 |
| Stage 1: PF-04856883 36 mg | Change From Baseline in 1, 5 Anhydroglucitol at Day 8, 15 and 29: Stage 1 | Change at Day 29 (n =15, 5, 5, 6, 7, 5, 7) | 0.66 microgram per milliliter (mcg/mL) | Standard Deviation 1.11 |
| Stage 1: PF-04856883 36 mg | Change From Baseline in 1, 5 Anhydroglucitol at Day 8, 15 and 29: Stage 1 | Change at Day 15 (n =15, 5, 5, 6, 6, 5, 7) | 1.17 microgram per milliliter (mcg/mL) | Standard Deviation 0.78 |
| Stage 1: PF-04856883 36 mg | Change From Baseline in 1, 5 Anhydroglucitol at Day 8, 15 and 29: Stage 1 | Baseline (n =15, 5, 6, 6, 7, 5, 7) | 11.84 microgram per milliliter (mcg/mL) | Standard Deviation 8.122 |
Change From Baseline in 24 Hours Glucose Normalized Area Under the Curve (NAUC) Profile at Day 30: Stage 2
A normalized area under the curve (NAUC) were computed by dividing the AUC by the amount of time between the last time point captured and the first time point captured.
Time frame: Baseline, Day 30
Population: Pharmacodynamic analysis population included all enrolled participants who had received at least 1 dose of study treatment and have at least 1 pharmacodynamic parameter. Here, 'n' signifies those participants who were evaluable at specified time point for each arm, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Stage 1: PF-04856883 Placebo | Change From Baseline in 24 Hours Glucose Normalized Area Under the Curve (NAUC) Profile at Day 30: Stage 2 | Baseline (n =7, 5, 7, 7 ,6) | 166.19 mg/dL | Standard Deviation 35.437 |
| Stage 1: PF-04856883 Placebo | Change From Baseline in 24 Hours Glucose Normalized Area Under the Curve (NAUC) Profile at Day 30: Stage 2 | Change at Day 30 (n =7, 5, 7, 6 ,5) | 172.36 mg/dL | Standard Deviation 38.825 |
| Stage 1: PF-04856883 4 mg | Change From Baseline in 24 Hours Glucose Normalized Area Under the Curve (NAUC) Profile at Day 30: Stage 2 | Baseline (n =7, 5, 7, 7 ,6) | 212.43 mg/dL | Standard Deviation 52.764 |
| Stage 1: PF-04856883 4 mg | Change From Baseline in 24 Hours Glucose Normalized Area Under the Curve (NAUC) Profile at Day 30: Stage 2 | Change at Day 30 (n =7, 5, 7, 6 ,5) | 191.20 mg/dL | Standard Deviation 43.953 |
| Stage 1: PF-04856883 8 mg | Change From Baseline in 24 Hours Glucose Normalized Area Under the Curve (NAUC) Profile at Day 30: Stage 2 | Baseline (n =7, 5, 7, 7 ,6) | 205.56 mg/dL | Standard Deviation 51.907 |
| Stage 1: PF-04856883 8 mg | Change From Baseline in 24 Hours Glucose Normalized Area Under the Curve (NAUC) Profile at Day 30: Stage 2 | Change at Day 30 (n =7, 5, 7, 6 ,5) | 172.24 mg/dL | Standard Deviation 48.067 |
| Stage 1: PF-04856883 12 mg | Change From Baseline in 24 Hours Glucose Normalized Area Under the Curve (NAUC) Profile at Day 30: Stage 2 | Change at Day 30 (n =7, 5, 7, 6 ,5) | 174.08 mg/dL | Standard Deviation 41.437 |
| Stage 1: PF-04856883 12 mg | Change From Baseline in 24 Hours Glucose Normalized Area Under the Curve (NAUC) Profile at Day 30: Stage 2 | Baseline (n =7, 5, 7, 7 ,6) | 202.43 mg/dL | Standard Deviation 38.9 |
| Stage 1: PF-04856883 18 mg | Change From Baseline in 24 Hours Glucose Normalized Area Under the Curve (NAUC) Profile at Day 30: Stage 2 | Baseline (n =7, 5, 7, 7 ,6) | 186.13 mg/dL | Standard Deviation 33.839 |
| Stage 1: PF-04856883 18 mg | Change From Baseline in 24 Hours Glucose Normalized Area Under the Curve (NAUC) Profile at Day 30: Stage 2 | Change at Day 30 (n =7, 5, 7, 6 ,5) | 192.87 mg/dL | Standard Deviation 58.037 |
Change From Baseline in C-Peptide Area Under the Curve (AUC) After Mixed Meal Tolerance Test (MMTT) at Day 3, 15, 24, 29 and 50: Stage 2
Change from baseline in post-prandial area under the plasma C-peptide concentration time curve as determined by standardized MMTT. Linear trapezoidal method was used to compute AUC.
Time frame: Baseline, Day 3, 15, 24, 29 and 50
Population: Pharmacodynamic analysis population included all enrolled participants who had received at least 1 dose of study treatment and have at least 1 pharmacodynamic parameter. Here, 'n' signifies those participants who were evaluable at specified time point for each arm, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Stage 1: PF-04856883 Placebo | Change From Baseline in C-Peptide Area Under the Curve (AUC) After Mixed Meal Tolerance Test (MMTT) at Day 3, 15, 24, 29 and 50: Stage 2 | Change at Day 50 (n =7, 5, 7, 6, 5) | -0.17 ng*hr/mL | Standard Deviation 1.978 |
| Stage 1: PF-04856883 Placebo | Change From Baseline in C-Peptide Area Under the Curve (AUC) After Mixed Meal Tolerance Test (MMTT) at Day 3, 15, 24, 29 and 50: Stage 2 | Change at Day 29 (n =7, 5, 7, 6, 5) | 0.10 ng*hr/mL | Standard Deviation 3.864 |
| Stage 1: PF-04856883 Placebo | Change From Baseline in C-Peptide Area Under the Curve (AUC) After Mixed Meal Tolerance Test (MMTT) at Day 3, 15, 24, 29 and 50: Stage 2 | Change at Day 24 (n =7, 4, 7, 6, 6) | 0.55 ng*hr/mL | Standard Deviation 3.518 |
| Stage 1: PF-04856883 Placebo | Change From Baseline in C-Peptide Area Under the Curve (AUC) After Mixed Meal Tolerance Test (MMTT) at Day 3, 15, 24, 29 and 50: Stage 2 | Change at Day 3 (n =7, 5, 7, 7, 6) | 1.68 ng*hr/mL | Standard Deviation 2.182 |
| Stage 1: PF-04856883 Placebo | Change From Baseline in C-Peptide Area Under the Curve (AUC) After Mixed Meal Tolerance Test (MMTT) at Day 3, 15, 24, 29 and 50: Stage 2 | Change at Day 15 (n =7, 5, 7, 6, 6) | -1.65 ng*hr/mL | Standard Deviation 1.493 |
| Stage 1: PF-04856883 Placebo | Change From Baseline in C-Peptide Area Under the Curve (AUC) After Mixed Meal Tolerance Test (MMTT) at Day 3, 15, 24, 29 and 50: Stage 2 | Baseline (n =7, 5, 7, 7, 6) | 13.47 ng*hr/mL | Standard Deviation 4.315 |
| Stage 1: PF-04856883 4 mg | Change From Baseline in C-Peptide Area Under the Curve (AUC) After Mixed Meal Tolerance Test (MMTT) at Day 3, 15, 24, 29 and 50: Stage 2 | Baseline (n =7, 5, 7, 7, 6) | 14.59 ng*hr/mL | Standard Deviation 4.205 |
| Stage 1: PF-04856883 4 mg | Change From Baseline in C-Peptide Area Under the Curve (AUC) After Mixed Meal Tolerance Test (MMTT) at Day 3, 15, 24, 29 and 50: Stage 2 | Change at Day 24 (n =7, 4, 7, 6, 6) | 0.71 ng*hr/mL | Standard Deviation 4.312 |
| Stage 1: PF-04856883 4 mg | Change From Baseline in C-Peptide Area Under the Curve (AUC) After Mixed Meal Tolerance Test (MMTT) at Day 3, 15, 24, 29 and 50: Stage 2 | Change at Day 15 (n =7, 5, 7, 6, 6) | -1.55 ng*hr/mL | Standard Deviation 2.821 |
| Stage 1: PF-04856883 4 mg | Change From Baseline in C-Peptide Area Under the Curve (AUC) After Mixed Meal Tolerance Test (MMTT) at Day 3, 15, 24, 29 and 50: Stage 2 | Change at Day 50 (n =7, 5, 7, 6, 5) | -1.83 ng*hr/mL | Standard Deviation 2.015 |
| Stage 1: PF-04856883 4 mg | Change From Baseline in C-Peptide Area Under the Curve (AUC) After Mixed Meal Tolerance Test (MMTT) at Day 3, 15, 24, 29 and 50: Stage 2 | Change at Day 29 (n =7, 5, 7, 6, 5) | -0.07 ng*hr/mL | Standard Deviation 2.545 |
| Stage 1: PF-04856883 4 mg | Change From Baseline in C-Peptide Area Under the Curve (AUC) After Mixed Meal Tolerance Test (MMTT) at Day 3, 15, 24, 29 and 50: Stage 2 | Change at Day 3 (n =7, 5, 7, 7, 6) | 1.89 ng*hr/mL | Standard Deviation 4.705 |
| Stage 1: PF-04856883 8 mg | Change From Baseline in C-Peptide Area Under the Curve (AUC) After Mixed Meal Tolerance Test (MMTT) at Day 3, 15, 24, 29 and 50: Stage 2 | Change at Day 29 (n =7, 5, 7, 6, 5) | -0.59 ng*hr/mL | Standard Deviation 4.144 |
| Stage 1: PF-04856883 8 mg | Change From Baseline in C-Peptide Area Under the Curve (AUC) After Mixed Meal Tolerance Test (MMTT) at Day 3, 15, 24, 29 and 50: Stage 2 | Baseline (n =7, 5, 7, 7, 6) | 15.63 ng*hr/mL | Standard Deviation 4.293 |
| Stage 1: PF-04856883 8 mg | Change From Baseline in C-Peptide Area Under the Curve (AUC) After Mixed Meal Tolerance Test (MMTT) at Day 3, 15, 24, 29 and 50: Stage 2 | Change at Day 3 (n =7, 5, 7, 7, 6) | 0.50 ng*hr/mL | Standard Deviation 4.757 |
| Stage 1: PF-04856883 8 mg | Change From Baseline in C-Peptide Area Under the Curve (AUC) After Mixed Meal Tolerance Test (MMTT) at Day 3, 15, 24, 29 and 50: Stage 2 | Change at Day 24 (n =7, 4, 7, 6, 6) | -0.99 ng*hr/mL | Standard Deviation 6.22 |
| Stage 1: PF-04856883 8 mg | Change From Baseline in C-Peptide Area Under the Curve (AUC) After Mixed Meal Tolerance Test (MMTT) at Day 3, 15, 24, 29 and 50: Stage 2 | Change at Day 50 (n =7, 5, 7, 6, 5) | -4.10 ng*hr/mL | Standard Deviation 5.265 |
| Stage 1: PF-04856883 8 mg | Change From Baseline in C-Peptide Area Under the Curve (AUC) After Mixed Meal Tolerance Test (MMTT) at Day 3, 15, 24, 29 and 50: Stage 2 | Change at Day 15 (n =7, 5, 7, 6, 6) | -1.92 ng*hr/mL | Standard Deviation 6.93 |
| Stage 1: PF-04856883 12 mg | Change From Baseline in C-Peptide Area Under the Curve (AUC) After Mixed Meal Tolerance Test (MMTT) at Day 3, 15, 24, 29 and 50: Stage 2 | Change at Day 50 (n =7, 5, 7, 6, 5) | 1.06 ng*hr/mL | Standard Deviation 1.474 |
| Stage 1: PF-04856883 12 mg | Change From Baseline in C-Peptide Area Under the Curve (AUC) After Mixed Meal Tolerance Test (MMTT) at Day 3, 15, 24, 29 and 50: Stage 2 | Change at Day 15 (n =7, 5, 7, 6, 6) | -0.17 ng*hr/mL | Standard Deviation 4.135 |
| Stage 1: PF-04856883 12 mg | Change From Baseline in C-Peptide Area Under the Curve (AUC) After Mixed Meal Tolerance Test (MMTT) at Day 3, 15, 24, 29 and 50: Stage 2 | Change at Day 29 (n =7, 5, 7, 6, 5) | 0.59 ng*hr/mL | Standard Deviation 2.733 |
| Stage 1: PF-04856883 12 mg | Change From Baseline in C-Peptide Area Under the Curve (AUC) After Mixed Meal Tolerance Test (MMTT) at Day 3, 15, 24, 29 and 50: Stage 2 | Baseline (n =7, 5, 7, 7, 6) | 11.74 ng*hr/mL | Standard Deviation 5.21 |
| Stage 1: PF-04856883 12 mg | Change From Baseline in C-Peptide Area Under the Curve (AUC) After Mixed Meal Tolerance Test (MMTT) at Day 3, 15, 24, 29 and 50: Stage 2 | Change at Day 3 (n =7, 5, 7, 7, 6) | 3.16 ng*hr/mL | Standard Deviation 1.613 |
| Stage 1: PF-04856883 12 mg | Change From Baseline in C-Peptide Area Under the Curve (AUC) After Mixed Meal Tolerance Test (MMTT) at Day 3, 15, 24, 29 and 50: Stage 2 | Change at Day 24 (n =7, 4, 7, 6, 6) | 1.63 ng*hr/mL | Standard Deviation 2.994 |
| Stage 1: PF-04856883 18 mg | Change From Baseline in C-Peptide Area Under the Curve (AUC) After Mixed Meal Tolerance Test (MMTT) at Day 3, 15, 24, 29 and 50: Stage 2 | Change at Day 50 (n =7, 5, 7, 6, 5) | -2.90 ng*hr/mL | Standard Deviation 3.711 |
| Stage 1: PF-04856883 18 mg | Change From Baseline in C-Peptide Area Under the Curve (AUC) After Mixed Meal Tolerance Test (MMTT) at Day 3, 15, 24, 29 and 50: Stage 2 | Change at Day 3 (n =7, 5, 7, 7, 6) | 3.49 ng*hr/mL | Standard Deviation 4.452 |
| Stage 1: PF-04856883 18 mg | Change From Baseline in C-Peptide Area Under the Curve (AUC) After Mixed Meal Tolerance Test (MMTT) at Day 3, 15, 24, 29 and 50: Stage 2 | Change at Day 29 (n =7, 5, 7, 6, 5) | 0.41 ng*hr/mL | Standard Deviation 2.09 |
| Stage 1: PF-04856883 18 mg | Change From Baseline in C-Peptide Area Under the Curve (AUC) After Mixed Meal Tolerance Test (MMTT) at Day 3, 15, 24, 29 and 50: Stage 2 | Change at Day 24 (n =7, 4, 7, 6, 6) | 1.21 ng*hr/mL | Standard Deviation 5.784 |
| Stage 1: PF-04856883 18 mg | Change From Baseline in C-Peptide Area Under the Curve (AUC) After Mixed Meal Tolerance Test (MMTT) at Day 3, 15, 24, 29 and 50: Stage 2 | Change at Day 15 (n =7, 5, 7, 6, 6) | -0.50 ng*hr/mL | Standard Deviation 4.871 |
| Stage 1: PF-04856883 18 mg | Change From Baseline in C-Peptide Area Under the Curve (AUC) After Mixed Meal Tolerance Test (MMTT) at Day 3, 15, 24, 29 and 50: Stage 2 | Baseline (n =7, 5, 7, 7, 6) | 14.14 ng*hr/mL | Standard Deviation 5.211 |
Change From Baseline in C-Peptide Area Under the Curve (AUC) After Mixed Meal Tolerance Test (MMTT) at Day 3 and 8: Stage 1
Change from baseline in post-prandial area under the plasma C-peptide concentration time curve as determined by standardized MMTT. Linear trapezoidal method was used to compute AUC.
Time frame: Baseline, Day 3 and 8
Population: Pharmacodynamic analysis population included all enrolled participants who had received at least 1 dose of study treatment and have at least 1 pharmacodynamic parameter. Here, 'n' signifies those participants who were evaluable at specified time point for each arm, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Stage 1: PF-04856883 Placebo | Change From Baseline in C-Peptide Area Under the Curve (AUC) After Mixed Meal Tolerance Test (MMTT) at Day 3 and 8: Stage 1 | Change at Day 8 (n =15, 4, 5, 6, 7, 5, 6) | 0.79 ng*hr/mL | Standard Deviation 2.864 |
| Stage 1: PF-04856883 Placebo | Change From Baseline in C-Peptide Area Under the Curve (AUC) After Mixed Meal Tolerance Test (MMTT) at Day 3 and 8: Stage 1 | Change at Day 3 (n =15, 5, 5, 6, 7, 5, 6) | 2.15 ng*hr/mL | Standard Deviation 3.653 |
| Stage 1: PF-04856883 Placebo | Change From Baseline in C-Peptide Area Under the Curve (AUC) After Mixed Meal Tolerance Test (MMTT) at Day 3 and 8: Stage 1 | Baseline (n =15, 5, 6, 6, 7,5, 7) | 15.53 ng*hr/mL | Standard Deviation 5.332 |
| Stage 1: PF-04856883 4 mg | Change From Baseline in C-Peptide Area Under the Curve (AUC) After Mixed Meal Tolerance Test (MMTT) at Day 3 and 8: Stage 1 | Change at Day 3 (n =15, 5, 5, 6, 7, 5, 6) | 0.69 ng*hr/mL | Standard Deviation 1.465 |
| Stage 1: PF-04856883 4 mg | Change From Baseline in C-Peptide Area Under the Curve (AUC) After Mixed Meal Tolerance Test (MMTT) at Day 3 and 8: Stage 1 | Change at Day 8 (n =15, 4, 5, 6, 7, 5, 6) | 1.06 ng*hr/mL | Standard Deviation 1.806 |
| Stage 1: PF-04856883 4 mg | Change From Baseline in C-Peptide Area Under the Curve (AUC) After Mixed Meal Tolerance Test (MMTT) at Day 3 and 8: Stage 1 | Baseline (n =15, 5, 6, 6, 7,5, 7) | 16.63 ng*hr/mL | Standard Deviation 7.743 |
| Stage 1: PF-04856883 8 mg | Change From Baseline in C-Peptide Area Under the Curve (AUC) After Mixed Meal Tolerance Test (MMTT) at Day 3 and 8: Stage 1 | Baseline (n =15, 5, 6, 6, 7,5, 7) | 16.43 ng*hr/mL | Standard Deviation 4.306 |
| Stage 1: PF-04856883 8 mg | Change From Baseline in C-Peptide Area Under the Curve (AUC) After Mixed Meal Tolerance Test (MMTT) at Day 3 and 8: Stage 1 | Change at Day 8 (n =15, 4, 5, 6, 7, 5, 6) | 0.83 ng*hr/mL | Standard Deviation 1.651 |
| Stage 1: PF-04856883 8 mg | Change From Baseline in C-Peptide Area Under the Curve (AUC) After Mixed Meal Tolerance Test (MMTT) at Day 3 and 8: Stage 1 | Change at Day 3 (n =15, 5, 5, 6, 7, 5, 6) | 1.65 ng*hr/mL | Standard Deviation 4.958 |
| Stage 1: PF-04856883 12 mg | Change From Baseline in C-Peptide Area Under the Curve (AUC) After Mixed Meal Tolerance Test (MMTT) at Day 3 and 8: Stage 1 | Baseline (n =15, 5, 6, 6, 7,5, 7) | 16.80 ng*hr/mL | Standard Deviation 5.711 |
| Stage 1: PF-04856883 12 mg | Change From Baseline in C-Peptide Area Under the Curve (AUC) After Mixed Meal Tolerance Test (MMTT) at Day 3 and 8: Stage 1 | Change at Day 8 (n =15, 4, 5, 6, 7, 5, 6) | -2.74 ng*hr/mL | Standard Deviation 1.38 |
| Stage 1: PF-04856883 12 mg | Change From Baseline in C-Peptide Area Under the Curve (AUC) After Mixed Meal Tolerance Test (MMTT) at Day 3 and 8: Stage 1 | Change at Day 3 (n =15, 5, 5, 6, 7, 5, 6) | 1.05 ng*hr/mL | Standard Deviation 1.885 |
| Stage 1: PF-04856883 18 mg | Change From Baseline in C-Peptide Area Under the Curve (AUC) After Mixed Meal Tolerance Test (MMTT) at Day 3 and 8: Stage 1 | Change at Day 8 (n =15, 4, 5, 6, 7, 5, 6) | 1.70 ng*hr/mL | Standard Deviation 1.544 |
| Stage 1: PF-04856883 18 mg | Change From Baseline in C-Peptide Area Under the Curve (AUC) After Mixed Meal Tolerance Test (MMTT) at Day 3 and 8: Stage 1 | Change at Day 3 (n =15, 5, 5, 6, 7, 5, 6) | 4.30 ng*hr/mL | Standard Deviation 4.102 |
| Stage 1: PF-04856883 18 mg | Change From Baseline in C-Peptide Area Under the Curve (AUC) After Mixed Meal Tolerance Test (MMTT) at Day 3 and 8: Stage 1 | Baseline (n =15, 5, 6, 6, 7,5, 7) | 10.64 ng*hr/mL | Standard Deviation 1.156 |
| Stage 1: PF-04856883 24 mg | Change From Baseline in C-Peptide Area Under the Curve (AUC) After Mixed Meal Tolerance Test (MMTT) at Day 3 and 8: Stage 1 | Baseline (n =15, 5, 6, 6, 7,5, 7) | 16.17 ng*hr/mL | Standard Deviation 4.531 |
| Stage 1: PF-04856883 24 mg | Change From Baseline in C-Peptide Area Under the Curve (AUC) After Mixed Meal Tolerance Test (MMTT) at Day 3 and 8: Stage 1 | Change at Day 8 (n =15, 4, 5, 6, 7, 5, 6) | -0.45 ng*hr/mL | Standard Deviation 2.883 |
| Stage 1: PF-04856883 24 mg | Change From Baseline in C-Peptide Area Under the Curve (AUC) After Mixed Meal Tolerance Test (MMTT) at Day 3 and 8: Stage 1 | Change at Day 3 (n =15, 5, 5, 6, 7, 5, 6) | 5.34 ng*hr/mL | Standard Deviation 2.584 |
| Stage 1: PF-04856883 36 mg | Change From Baseline in C-Peptide Area Under the Curve (AUC) After Mixed Meal Tolerance Test (MMTT) at Day 3 and 8: Stage 1 | Baseline (n =15, 5, 6, 6, 7,5, 7) | 18.37 ng*hr/mL | Standard Deviation 7.395 |
| Stage 1: PF-04856883 36 mg | Change From Baseline in C-Peptide Area Under the Curve (AUC) After Mixed Meal Tolerance Test (MMTT) at Day 3 and 8: Stage 1 | Change at Day 3 (n =15, 5, 5, 6, 7, 5, 6) | 2.34 ng*hr/mL | Standard Deviation 4.333 |
| Stage 1: PF-04856883 36 mg | Change From Baseline in C-Peptide Area Under the Curve (AUC) After Mixed Meal Tolerance Test (MMTT) at Day 3 and 8: Stage 1 | Change at Day 8 (n =15, 4, 5, 6, 7, 5, 6) | -0.38 ng*hr/mL | Standard Deviation 1.565 |
Change From Baseline in Fasting Plasma Glucose (FPG) at Day 2, 4, 6, 15, 22 and 29: Stage 1
Time frame: Baseline, Day 2, 4, 6, 15, 22 and 29
Population: Pharmacodynamic analysis population included all enrolled participants who had received at least 1 dose of study treatment and have at least 1 pharmacodynamic parameter. Here, 'n' signifies those participants who were evaluable at specified time point for each arm, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Stage 1: PF-04856883 Placebo | Change From Baseline in Fasting Plasma Glucose (FPG) at Day 2, 4, 6, 15, 22 and 29: Stage 1 | Change at Day 22 (n =14, 4, 5, 6, 6, 5, 7) | 11.00 milligram per deciliter (mg/dL) | Standard Deviation 28.205 |
| Stage 1: PF-04856883 Placebo | Change From Baseline in Fasting Plasma Glucose (FPG) at Day 2, 4, 6, 15, 22 and 29: Stage 1 | Baseline (n =15, 5, 6, 6, 7, 5, 7) | 161.67 milligram per deciliter (mg/dL) | Standard Deviation 27.102 |
| Stage 1: PF-04856883 Placebo | Change From Baseline in Fasting Plasma Glucose (FPG) at Day 2, 4, 6, 15, 22 and 29: Stage 1 | Change at Day 6 (n =15, 5, 4, 6, 7, 5, 7) | 18.80 milligram per deciliter (mg/dL) | Standard Deviation 29.547 |
| Stage 1: PF-04856883 Placebo | Change From Baseline in Fasting Plasma Glucose (FPG) at Day 2, 4, 6, 15, 22 and 29: Stage 1 | Change at Day 2 (n =15, 5, 6, 6, 7, 5, 7) | 3.13 milligram per deciliter (mg/dL) | Standard Deviation 11.807 |
| Stage 1: PF-04856883 Placebo | Change From Baseline in Fasting Plasma Glucose (FPG) at Day 2, 4, 6, 15, 22 and 29: Stage 1 | Change at Day 4 (n =15, 5, 5, 6, 7, 5, 6) | 2.73 milligram per deciliter (mg/dL) | Standard Deviation 17.161 |
| Stage 1: PF-04856883 Placebo | Change From Baseline in Fasting Plasma Glucose (FPG) at Day 2, 4, 6, 15, 22 and 29: Stage 1 | Change at Day 15 (n =15, 5, 5, 6, 6, 5, 7) | 12.13 milligram per deciliter (mg/dL) | Standard Deviation 32.822 |
| Stage 1: PF-04856883 Placebo | Change From Baseline in Fasting Plasma Glucose (FPG) at Day 2, 4, 6, 15, 22 and 29: Stage 1 | Change at Day 29 (n =14, 5, 5, 6, 7, 5, 7) | 22.00 milligram per deciliter (mg/dL) | Standard Deviation 33.439 |
| Stage 1: PF-04856883 4 mg | Change From Baseline in Fasting Plasma Glucose (FPG) at Day 2, 4, 6, 15, 22 and 29: Stage 1 | Baseline (n =15, 5, 6, 6, 7, 5, 7) | 219.60 milligram per deciliter (mg/dL) | Standard Deviation 44.557 |
| Stage 1: PF-04856883 4 mg | Change From Baseline in Fasting Plasma Glucose (FPG) at Day 2, 4, 6, 15, 22 and 29: Stage 1 | Change at Day 2 (n =15, 5, 6, 6, 7, 5, 7) | 13.60 milligram per deciliter (mg/dL) | Standard Deviation 32.393 |
| Stage 1: PF-04856883 4 mg | Change From Baseline in Fasting Plasma Glucose (FPG) at Day 2, 4, 6, 15, 22 and 29: Stage 1 | Change at Day 4 (n =15, 5, 5, 6, 7, 5, 6) | 19.60 milligram per deciliter (mg/dL) | Standard Deviation 35.683 |
| Stage 1: PF-04856883 4 mg | Change From Baseline in Fasting Plasma Glucose (FPG) at Day 2, 4, 6, 15, 22 and 29: Stage 1 | Change at Day 29 (n =14, 5, 5, 6, 7, 5, 7) | 1.60 milligram per deciliter (mg/dL) | Standard Deviation 27.763 |
| Stage 1: PF-04856883 4 mg | Change From Baseline in Fasting Plasma Glucose (FPG) at Day 2, 4, 6, 15, 22 and 29: Stage 1 | Change at Day 22 (n =14, 4, 5, 6, 6, 5, 7) | 23.75 milligram per deciliter (mg/dL) | Standard Deviation 61.163 |
| Stage 1: PF-04856883 4 mg | Change From Baseline in Fasting Plasma Glucose (FPG) at Day 2, 4, 6, 15, 22 and 29: Stage 1 | Change at Day 15 (n =15, 5, 5, 6, 6, 5, 7) | -13.80 milligram per deciliter (mg/dL) | Standard Deviation 46.949 |
| Stage 1: PF-04856883 4 mg | Change From Baseline in Fasting Plasma Glucose (FPG) at Day 2, 4, 6, 15, 22 and 29: Stage 1 | Change at Day 6 (n =15, 5, 4, 6, 7, 5, 7) | 26.40 milligram per deciliter (mg/dL) | Standard Deviation 32.377 |
| Stage 1: PF-04856883 8 mg | Change From Baseline in Fasting Plasma Glucose (FPG) at Day 2, 4, 6, 15, 22 and 29: Stage 1 | Change at Day 15 (n =15, 5, 5, 6, 6, 5, 7) | 23.80 milligram per deciliter (mg/dL) | Standard Deviation 56.857 |
| Stage 1: PF-04856883 8 mg | Change From Baseline in Fasting Plasma Glucose (FPG) at Day 2, 4, 6, 15, 22 and 29: Stage 1 | Change at Day 6 (n =15, 5, 4, 6, 7, 5, 7) | 10.25 milligram per deciliter (mg/dL) | Standard Deviation 29.056 |
| Stage 1: PF-04856883 8 mg | Change From Baseline in Fasting Plasma Glucose (FPG) at Day 2, 4, 6, 15, 22 and 29: Stage 1 | Change at Day 2 (n =15, 5, 6, 6, 7, 5, 7) | -18.67 milligram per deciliter (mg/dL) | Standard Deviation 21.011 |
| Stage 1: PF-04856883 8 mg | Change From Baseline in Fasting Plasma Glucose (FPG) at Day 2, 4, 6, 15, 22 and 29: Stage 1 | Baseline (n =15, 5, 6, 6, 7, 5, 7) | 171.17 milligram per deciliter (mg/dL) | Standard Deviation 23.752 |
| Stage 1: PF-04856883 8 mg | Change From Baseline in Fasting Plasma Glucose (FPG) at Day 2, 4, 6, 15, 22 and 29: Stage 1 | Change at Day 4 (n =15, 5, 5, 6, 7, 5, 6) | -12.40 milligram per deciliter (mg/dL) | Standard Deviation 17.358 |
| Stage 1: PF-04856883 8 mg | Change From Baseline in Fasting Plasma Glucose (FPG) at Day 2, 4, 6, 15, 22 and 29: Stage 1 | Change at Day 22 (n =14, 4, 5, 6, 6, 5, 7) | 33.40 milligram per deciliter (mg/dL) | Standard Deviation 76.064 |
| Stage 1: PF-04856883 8 mg | Change From Baseline in Fasting Plasma Glucose (FPG) at Day 2, 4, 6, 15, 22 and 29: Stage 1 | Change at Day 29 (n =14, 5, 5, 6, 7, 5, 7) | 27.80 milligram per deciliter (mg/dL) | Standard Deviation 29.575 |
| Stage 1: PF-04856883 12 mg | Change From Baseline in Fasting Plasma Glucose (FPG) at Day 2, 4, 6, 15, 22 and 29: Stage 1 | Change at Day 22 (n =14, 4, 5, 6, 6, 5, 7) | 11.17 milligram per deciliter (mg/dL) | Standard Deviation 26.446 |
| Stage 1: PF-04856883 12 mg | Change From Baseline in Fasting Plasma Glucose (FPG) at Day 2, 4, 6, 15, 22 and 29: Stage 1 | Baseline (n =15, 5, 6, 6, 7, 5, 7) | 174.00 milligram per deciliter (mg/dL) | Standard Deviation 48.949 |
| Stage 1: PF-04856883 12 mg | Change From Baseline in Fasting Plasma Glucose (FPG) at Day 2, 4, 6, 15, 22 and 29: Stage 1 | Change at Day 2 (n =15, 5, 6, 6, 7, 5, 7) | -20.50 milligram per deciliter (mg/dL) | Standard Deviation 20.433 |
| Stage 1: PF-04856883 12 mg | Change From Baseline in Fasting Plasma Glucose (FPG) at Day 2, 4, 6, 15, 22 and 29: Stage 1 | Change at Day 15 (n =15, 5, 5, 6, 6, 5, 7) | 19.33 milligram per deciliter (mg/dL) | Standard Deviation 16.476 |
| Stage 1: PF-04856883 12 mg | Change From Baseline in Fasting Plasma Glucose (FPG) at Day 2, 4, 6, 15, 22 and 29: Stage 1 | Change at Day 29 (n =14, 5, 5, 6, 7, 5, 7) | 0.33 milligram per deciliter (mg/dL) | Standard Deviation 16.978 |
| Stage 1: PF-04856883 12 mg | Change From Baseline in Fasting Plasma Glucose (FPG) at Day 2, 4, 6, 15, 22 and 29: Stage 1 | Change at Day 4 (n =15, 5, 5, 6, 7, 5, 6) | -10.33 milligram per deciliter (mg/dL) | Standard Deviation 15.744 |
| Stage 1: PF-04856883 12 mg | Change From Baseline in Fasting Plasma Glucose (FPG) at Day 2, 4, 6, 15, 22 and 29: Stage 1 | Change at Day 6 (n =15, 5, 4, 6, 7, 5, 7) | -8.33 milligram per deciliter (mg/dL) | Standard Deviation 27.156 |
| Stage 1: PF-04856883 18 mg | Change From Baseline in Fasting Plasma Glucose (FPG) at Day 2, 4, 6, 15, 22 and 29: Stage 1 | Change at Day 6 (n =15, 5, 4, 6, 7, 5, 7) | -6.29 milligram per deciliter (mg/dL) | Standard Deviation 15.85 |
| Stage 1: PF-04856883 18 mg | Change From Baseline in Fasting Plasma Glucose (FPG) at Day 2, 4, 6, 15, 22 and 29: Stage 1 | Baseline (n =15, 5, 6, 6, 7, 5, 7) | 168.57 milligram per deciliter (mg/dL) | Standard Deviation 38.336 |
| Stage 1: PF-04856883 18 mg | Change From Baseline in Fasting Plasma Glucose (FPG) at Day 2, 4, 6, 15, 22 and 29: Stage 1 | Change at Day 22 (n =14, 4, 5, 6, 6, 5, 7) | 2.17 milligram per deciliter (mg/dL) | Standard Deviation 15.065 |
| Stage 1: PF-04856883 18 mg | Change From Baseline in Fasting Plasma Glucose (FPG) at Day 2, 4, 6, 15, 22 and 29: Stage 1 | Change at Day 15 (n =15, 5, 5, 6, 6, 5, 7) | 8.00 milligram per deciliter (mg/dL) | Standard Deviation 21.223 |
| Stage 1: PF-04856883 18 mg | Change From Baseline in Fasting Plasma Glucose (FPG) at Day 2, 4, 6, 15, 22 and 29: Stage 1 | Change at Day 2 (n =15, 5, 6, 6, 7, 5, 7) | -22.14 milligram per deciliter (mg/dL) | Standard Deviation 34.09 |
| Stage 1: PF-04856883 18 mg | Change From Baseline in Fasting Plasma Glucose (FPG) at Day 2, 4, 6, 15, 22 and 29: Stage 1 | Change at Day 4 (n =15, 5, 5, 6, 7, 5, 6) | -30.71 milligram per deciliter (mg/dL) | Standard Deviation 13.841 |
| Stage 1: PF-04856883 18 mg | Change From Baseline in Fasting Plasma Glucose (FPG) at Day 2, 4, 6, 15, 22 and 29: Stage 1 | Change at Day 29 (n =14, 5, 5, 6, 7, 5, 7) | 1.57 milligram per deciliter (mg/dL) | Standard Deviation 21.22 |
| Stage 1: PF-04856883 24 mg | Change From Baseline in Fasting Plasma Glucose (FPG) at Day 2, 4, 6, 15, 22 and 29: Stage 1 | Change at Day 6 (n =15, 5, 4, 6, 7, 5, 7) | -16.80 milligram per deciliter (mg/dL) | Standard Deviation 19.176 |
| Stage 1: PF-04856883 24 mg | Change From Baseline in Fasting Plasma Glucose (FPG) at Day 2, 4, 6, 15, 22 and 29: Stage 1 | Baseline (n =15, 5, 6, 6, 7, 5, 7) | 145.60 milligram per deciliter (mg/dL) | Standard Deviation 21.606 |
| Stage 1: PF-04856883 24 mg | Change From Baseline in Fasting Plasma Glucose (FPG) at Day 2, 4, 6, 15, 22 and 29: Stage 1 | Change at Day 2 (n =15, 5, 6, 6, 7, 5, 7) | -35.00 milligram per deciliter (mg/dL) | Standard Deviation 12.369 |
| Stage 1: PF-04856883 24 mg | Change From Baseline in Fasting Plasma Glucose (FPG) at Day 2, 4, 6, 15, 22 and 29: Stage 1 | Change at Day 29 (n =14, 5, 5, 6, 7, 5, 7) | -3.80 milligram per deciliter (mg/dL) | Standard Deviation 22.643 |
| Stage 1: PF-04856883 24 mg | Change From Baseline in Fasting Plasma Glucose (FPG) at Day 2, 4, 6, 15, 22 and 29: Stage 1 | Change at Day 4 (n =15, 5, 5, 6, 7, 5, 6) | -27.00 milligram per deciliter (mg/dL) | Standard Deviation 8.803 |
| Stage 1: PF-04856883 24 mg | Change From Baseline in Fasting Plasma Glucose (FPG) at Day 2, 4, 6, 15, 22 and 29: Stage 1 | Change at Day 22 (n =14, 4, 5, 6, 6, 5, 7) | 1.20 milligram per deciliter (mg/dL) | Standard Deviation 18.847 |
| Stage 1: PF-04856883 24 mg | Change From Baseline in Fasting Plasma Glucose (FPG) at Day 2, 4, 6, 15, 22 and 29: Stage 1 | Change at Day 15 (n =15, 5, 5, 6, 6, 5, 7) | 3.40 milligram per deciliter (mg/dL) | Standard Deviation 27.309 |
| Stage 1: PF-04856883 36 mg | Change From Baseline in Fasting Plasma Glucose (FPG) at Day 2, 4, 6, 15, 22 and 29: Stage 1 | Change at Day 22 (n =14, 4, 5, 6, 6, 5, 7) | -0.57 milligram per deciliter (mg/dL) | Standard Deviation 13.377 |
| Stage 1: PF-04856883 36 mg | Change From Baseline in Fasting Plasma Glucose (FPG) at Day 2, 4, 6, 15, 22 and 29: Stage 1 | Change at Day 29 (n =14, 5, 5, 6, 7, 5, 7) | -2.29 milligram per deciliter (mg/dL) | Standard Deviation 19.551 |
| Stage 1: PF-04856883 36 mg | Change From Baseline in Fasting Plasma Glucose (FPG) at Day 2, 4, 6, 15, 22 and 29: Stage 1 | Change at Day 2 (n =15, 5, 6, 6, 7, 5, 7) | -29.71 milligram per deciliter (mg/dL) | Standard Deviation 30.804 |
| Stage 1: PF-04856883 36 mg | Change From Baseline in Fasting Plasma Glucose (FPG) at Day 2, 4, 6, 15, 22 and 29: Stage 1 | Change at Day 4 (n =15, 5, 5, 6, 7, 5, 6) | -28.33 milligram per deciliter (mg/dL) | Standard Deviation 21.942 |
| Stage 1: PF-04856883 36 mg | Change From Baseline in Fasting Plasma Glucose (FPG) at Day 2, 4, 6, 15, 22 and 29: Stage 1 | Baseline (n =15, 5, 6, 6, 7, 5, 7) | 158.14 milligram per deciliter (mg/dL) | Standard Deviation 35.362 |
| Stage 1: PF-04856883 36 mg | Change From Baseline in Fasting Plasma Glucose (FPG) at Day 2, 4, 6, 15, 22 and 29: Stage 1 | Change at Day 6 (n =15, 5, 4, 6, 7, 5, 7) | -16.14 milligram per deciliter (mg/dL) | Standard Deviation 22.319 |
| Stage 1: PF-04856883 36 mg | Change From Baseline in Fasting Plasma Glucose (FPG) at Day 2, 4, 6, 15, 22 and 29: Stage 1 | Change at Day 15 (n =15, 5, 5, 6, 6, 5, 7) | -2.71 milligram per deciliter (mg/dL) | Standard Deviation 16.53 |
Change From Baseline in Fasting Plasma Glucose (FPG) at Day 2, 4, 6, 8, 22, 23, 25, 27, 30, 36 and 43: Stage 2
Time frame: Baseline, Day 2, 4, 6, 8, 22, 23, 25, 27, 30, 36 and 43
Population: Pharmacodynamic analysis population included all enrolled participants who had received at least 1 dose of study treatment and have at least 1 pharmacodynamic parameter. Here, 'n' signifies those participants who were evaluable at specified time point for each arm, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Stage 1: PF-04856883 Placebo | Change From Baseline in Fasting Plasma Glucose (FPG) at Day 2, 4, 6, 8, 22, 23, 25, 27, 30, 36 and 43: Stage 2 | Change at Day 25 (n =7, 5, 6, 6, 5) | 13.43 mg/dL | Standard Deviation 13.113 |
| Stage 1: PF-04856883 Placebo | Change From Baseline in Fasting Plasma Glucose (FPG) at Day 2, 4, 6, 8, 22, 23, 25, 27, 30, 36 and 43: Stage 2 | Change at Day 22 (n =7, 4, 7, 6, 6) | 13.29 mg/dL | Standard Deviation 15.294 |
| Stage 1: PF-04856883 Placebo | Change From Baseline in Fasting Plasma Glucose (FPG) at Day 2, 4, 6, 8, 22, 23, 25, 27, 30, 36 and 43: Stage 2 | Baseline (n =7, 5, 7, 7, 6) | 148.00 mg/dL | Standard Deviation 33.317 |
| Stage 1: PF-04856883 Placebo | Change From Baseline in Fasting Plasma Glucose (FPG) at Day 2, 4, 6, 8, 22, 23, 25, 27, 30, 36 and 43: Stage 2 | Change at Day 23 (n =7, 4, 6, 6, 5) | 7.71 mg/dL | Standard Deviation 23.894 |
| Stage 1: PF-04856883 Placebo | Change From Baseline in Fasting Plasma Glucose (FPG) at Day 2, 4, 6, 8, 22, 23, 25, 27, 30, 36 and 43: Stage 2 | Change at Day 8 (n =6, 5, 7, 5, 6) | 2.50 mg/dL | Standard Deviation 17.627 |
| Stage 1: PF-04856883 Placebo | Change From Baseline in Fasting Plasma Glucose (FPG) at Day 2, 4, 6, 8, 22, 23, 25, 27, 30, 36 and 43: Stage 2 | Change at Day 2 (n =5, 4, 7, 7, 5) | 3.00 mg/dL | Standard Deviation 15.281 |
| Stage 1: PF-04856883 Placebo | Change From Baseline in Fasting Plasma Glucose (FPG) at Day 2, 4, 6, 8, 22, 23, 25, 27, 30, 36 and 43: Stage 2 | Change at Day 43 (n =7, 5, 5, 6, 6) | 18.71 mg/dL | Standard Deviation 22.552 |
| Stage 1: PF-04856883 Placebo | Change From Baseline in Fasting Plasma Glucose (FPG) at Day 2, 4, 6, 8, 22, 23, 25, 27, 30, 36 and 43: Stage 2 | Change at Day 6 (n =7, 4, 7, 7, 6) | -1.71 mg/dL | Standard Deviation 40.24 |
| Stage 1: PF-04856883 Placebo | Change From Baseline in Fasting Plasma Glucose (FPG) at Day 2, 4, 6, 8, 22, 23, 25, 27, 30, 36 and 43: Stage 2 | Change at Day 4 (n =5, 5, 7, 6, 6) | 7.60 mg/dL | Standard Deviation 6.427 |
| Stage 1: PF-04856883 Placebo | Change From Baseline in Fasting Plasma Glucose (FPG) at Day 2, 4, 6, 8, 22, 23, 25, 27, 30, 36 and 43: Stage 2 | Change at Day 36 (n =6, 5, 7, 6, 6) | -10.50 mg/dL | Standard Deviation 32.415 |
| Stage 1: PF-04856883 Placebo | Change From Baseline in Fasting Plasma Glucose (FPG) at Day 2, 4, 6, 8, 22, 23, 25, 27, 30, 36 and 43: Stage 2 | Change at Day 30 (n =7, 5, 7, 6, 5) | 2.43 mg/dL | Standard Deviation 12.739 |
| Stage 1: PF-04856883 Placebo | Change From Baseline in Fasting Plasma Glucose (FPG) at Day 2, 4, 6, 8, 22, 23, 25, 27, 30, 36 and 43: Stage 2 | Change at Day 27 (n =7, 5, 6, 6, 5) | 8.57 mg/dL | Standard Deviation 21.11 |
| Stage 1: PF-04856883 4 mg | Change From Baseline in Fasting Plasma Glucose (FPG) at Day 2, 4, 6, 8, 22, 23, 25, 27, 30, 36 and 43: Stage 2 | Change at Day 22 (n =7, 4, 7, 6, 6) | -4.25 mg/dL | Standard Deviation 13.817 |
| Stage 1: PF-04856883 4 mg | Change From Baseline in Fasting Plasma Glucose (FPG) at Day 2, 4, 6, 8, 22, 23, 25, 27, 30, 36 and 43: Stage 2 | Baseline (n =7, 5, 7, 7, 6) | 186.80 mg/dL | Standard Deviation 23.059 |
| Stage 1: PF-04856883 4 mg | Change From Baseline in Fasting Plasma Glucose (FPG) at Day 2, 4, 6, 8, 22, 23, 25, 27, 30, 36 and 43: Stage 2 | Change at Day 2 (n =5, 4, 7, 7, 5) | -26.75 mg/dL | Standard Deviation 15.108 |
| Stage 1: PF-04856883 4 mg | Change From Baseline in Fasting Plasma Glucose (FPG) at Day 2, 4, 6, 8, 22, 23, 25, 27, 30, 36 and 43: Stage 2 | Change at Day 25 (n =7, 5, 6, 6, 5) | -16.60 mg/dL | Standard Deviation 43.443 |
| Stage 1: PF-04856883 4 mg | Change From Baseline in Fasting Plasma Glucose (FPG) at Day 2, 4, 6, 8, 22, 23, 25, 27, 30, 36 and 43: Stage 2 | Change at Day 30 (n =7, 5, 7, 6, 5) | -14.20 mg/dL | Standard Deviation 17.908 |
| Stage 1: PF-04856883 4 mg | Change From Baseline in Fasting Plasma Glucose (FPG) at Day 2, 4, 6, 8, 22, 23, 25, 27, 30, 36 and 43: Stage 2 | Change at Day 36 (n =6, 5, 7, 6, 6) | 0.40 mg/dL | Standard Deviation 37.846 |
| Stage 1: PF-04856883 4 mg | Change From Baseline in Fasting Plasma Glucose (FPG) at Day 2, 4, 6, 8, 22, 23, 25, 27, 30, 36 and 43: Stage 2 | Change at Day 4 (n =5, 5, 7, 6, 6) | -14.80 mg/dL | Standard Deviation 24.284 |
| Stage 1: PF-04856883 4 mg | Change From Baseline in Fasting Plasma Glucose (FPG) at Day 2, 4, 6, 8, 22, 23, 25, 27, 30, 36 and 43: Stage 2 | Change at Day 6 (n =7, 4, 7, 7, 6) | 5.75 mg/dL | Standard Deviation 14.08 |
| Stage 1: PF-04856883 4 mg | Change From Baseline in Fasting Plasma Glucose (FPG) at Day 2, 4, 6, 8, 22, 23, 25, 27, 30, 36 and 43: Stage 2 | Change at Day 8 (n =6, 5, 7, 5, 6) | 4.20 mg/dL | Standard Deviation 19.967 |
| Stage 1: PF-04856883 4 mg | Change From Baseline in Fasting Plasma Glucose (FPG) at Day 2, 4, 6, 8, 22, 23, 25, 27, 30, 36 and 43: Stage 2 | Change at Day 23 (n =7, 4, 6, 6, 5) | -27.25 mg/dL | Standard Deviation 27.293 |
| Stage 1: PF-04856883 4 mg | Change From Baseline in Fasting Plasma Glucose (FPG) at Day 2, 4, 6, 8, 22, 23, 25, 27, 30, 36 and 43: Stage 2 | Change at Day 27 (n =7, 5, 6, 6, 5) | -21.60 mg/dL | Standard Deviation 15.821 |
| Stage 1: PF-04856883 4 mg | Change From Baseline in Fasting Plasma Glucose (FPG) at Day 2, 4, 6, 8, 22, 23, 25, 27, 30, 36 and 43: Stage 2 | Change at Day 43 (n =7, 5, 5, 6, 6) | 12.80 mg/dL | Standard Deviation 29.064 |
| Stage 1: PF-04856883 8 mg | Change From Baseline in Fasting Plasma Glucose (FPG) at Day 2, 4, 6, 8, 22, 23, 25, 27, 30, 36 and 43: Stage 2 | Change at Day 27 (n =7, 5, 6, 6, 5) | -37.33 mg/dL | Standard Deviation 17.963 |
| Stage 1: PF-04856883 8 mg | Change From Baseline in Fasting Plasma Glucose (FPG) at Day 2, 4, 6, 8, 22, 23, 25, 27, 30, 36 and 43: Stage 2 | Change at Day 8 (n =6, 5, 7, 5, 6) | -37.43 mg/dL | Standard Deviation 42.383 |
| Stage 1: PF-04856883 8 mg | Change From Baseline in Fasting Plasma Glucose (FPG) at Day 2, 4, 6, 8, 22, 23, 25, 27, 30, 36 and 43: Stage 2 | Change at Day 30 (n =7, 5, 7, 6, 5) | -22.29 mg/dL | Standard Deviation 26.171 |
| Stage 1: PF-04856883 8 mg | Change From Baseline in Fasting Plasma Glucose (FPG) at Day 2, 4, 6, 8, 22, 23, 25, 27, 30, 36 and 43: Stage 2 | Change at Day 36 (n =6, 5, 7, 6, 6) | 1.86 mg/dL | Standard Deviation 25.373 |
| Stage 1: PF-04856883 8 mg | Change From Baseline in Fasting Plasma Glucose (FPG) at Day 2, 4, 6, 8, 22, 23, 25, 27, 30, 36 and 43: Stage 2 | Change at Day 43 (n =7, 5, 5, 6, 6) | 13.20 mg/dL | Standard Deviation 17.254 |
| Stage 1: PF-04856883 8 mg | Change From Baseline in Fasting Plasma Glucose (FPG) at Day 2, 4, 6, 8, 22, 23, 25, 27, 30, 36 and 43: Stage 2 | Baseline (n =7, 5, 7, 7, 6) | 191.14 mg/dL | Standard Deviation 56.153 |
| Stage 1: PF-04856883 8 mg | Change From Baseline in Fasting Plasma Glucose (FPG) at Day 2, 4, 6, 8, 22, 23, 25, 27, 30, 36 and 43: Stage 2 | Change at Day 4 (n =5, 5, 7, 6, 6) | -14.86 mg/dL | Standard Deviation 48.657 |
| Stage 1: PF-04856883 8 mg | Change From Baseline in Fasting Plasma Glucose (FPG) at Day 2, 4, 6, 8, 22, 23, 25, 27, 30, 36 and 43: Stage 2 | Change at Day 2 (n =5, 4, 7, 7, 5) | -15.14 mg/dL | Standard Deviation 21.217 |
| Stage 1: PF-04856883 8 mg | Change From Baseline in Fasting Plasma Glucose (FPG) at Day 2, 4, 6, 8, 22, 23, 25, 27, 30, 36 and 43: Stage 2 | Change at Day 23 (n =7, 4, 6, 6, 5) | -40.33 mg/dL | Standard Deviation 18.327 |
| Stage 1: PF-04856883 8 mg | Change From Baseline in Fasting Plasma Glucose (FPG) at Day 2, 4, 6, 8, 22, 23, 25, 27, 30, 36 and 43: Stage 2 | Change at Day 6 (n =7, 4, 7, 7, 6) | -44.86 mg/dL | Standard Deviation 38.451 |
| Stage 1: PF-04856883 8 mg | Change From Baseline in Fasting Plasma Glucose (FPG) at Day 2, 4, 6, 8, 22, 23, 25, 27, 30, 36 and 43: Stage 2 | Change at Day 22 (n =7, 4, 7, 6, 6) | -39.57 mg/dL | Standard Deviation 25.468 |
| Stage 1: PF-04856883 8 mg | Change From Baseline in Fasting Plasma Glucose (FPG) at Day 2, 4, 6, 8, 22, 23, 25, 27, 30, 36 and 43: Stage 2 | Change at Day 25 (n =7, 5, 6, 6, 5) | -44.67 mg/dL | Standard Deviation 27.667 |
| Stage 1: PF-04856883 12 mg | Change From Baseline in Fasting Plasma Glucose (FPG) at Day 2, 4, 6, 8, 22, 23, 25, 27, 30, 36 and 43: Stage 2 | Change at Day 36 (n =6, 5, 7, 6, 6) | -5.83 mg/dL | Standard Deviation 32.009 |
| Stage 1: PF-04856883 12 mg | Change From Baseline in Fasting Plasma Glucose (FPG) at Day 2, 4, 6, 8, 22, 23, 25, 27, 30, 36 and 43: Stage 2 | Change at Day 22 (n =7, 4, 7, 6, 6) | -14.17 mg/dL | Standard Deviation 38.27 |
| Stage 1: PF-04856883 12 mg | Change From Baseline in Fasting Plasma Glucose (FPG) at Day 2, 4, 6, 8, 22, 23, 25, 27, 30, 36 and 43: Stage 2 | Change at Day 43 (n =7, 5, 5, 6, 6) | -1.17 mg/dL | Standard Deviation 41.787 |
| Stage 1: PF-04856883 12 mg | Change From Baseline in Fasting Plasma Glucose (FPG) at Day 2, 4, 6, 8, 22, 23, 25, 27, 30, 36 and 43: Stage 2 | Change at Day 2 (n =5, 4, 7, 7, 5) | -23.43 mg/dL | Standard Deviation 35.142 |
| Stage 1: PF-04856883 12 mg | Change From Baseline in Fasting Plasma Glucose (FPG) at Day 2, 4, 6, 8, 22, 23, 25, 27, 30, 36 and 43: Stage 2 | Change at Day 4 (n =5, 5, 7, 6, 6) | -20.33 mg/dL | Standard Deviation 22.818 |
| Stage 1: PF-04856883 12 mg | Change From Baseline in Fasting Plasma Glucose (FPG) at Day 2, 4, 6, 8, 22, 23, 25, 27, 30, 36 and 43: Stage 2 | Change at Day 23 (n =7, 4, 6, 6, 5) | -17.50 mg/dL | Standard Deviation 73.519 |
| Stage 1: PF-04856883 12 mg | Change From Baseline in Fasting Plasma Glucose (FPG) at Day 2, 4, 6, 8, 22, 23, 25, 27, 30, 36 and 43: Stage 2 | Change at Day 8 (n =6, 5, 7, 5, 6) | 2.60 mg/dL | Standard Deviation 73.449 |
| Stage 1: PF-04856883 12 mg | Change From Baseline in Fasting Plasma Glucose (FPG) at Day 2, 4, 6, 8, 22, 23, 25, 27, 30, 36 and 43: Stage 2 | Change at Day 25 (n =7, 5, 6, 6, 5) | -23.33 mg/dL | Standard Deviation 52.936 |
| Stage 1: PF-04856883 12 mg | Change From Baseline in Fasting Plasma Glucose (FPG) at Day 2, 4, 6, 8, 22, 23, 25, 27, 30, 36 and 43: Stage 2 | Change at Day 6 (n =7, 4, 7, 7, 6) | -8.00 mg/dL | Standard Deviation 42.942 |
| Stage 1: PF-04856883 12 mg | Change From Baseline in Fasting Plasma Glucose (FPG) at Day 2, 4, 6, 8, 22, 23, 25, 27, 30, 36 and 43: Stage 2 | Change at Day 27 (n =7, 5, 6, 6, 5) | -34.67 mg/dL | Standard Deviation 35.803 |
| Stage 1: PF-04856883 12 mg | Change From Baseline in Fasting Plasma Glucose (FPG) at Day 2, 4, 6, 8, 22, 23, 25, 27, 30, 36 and 43: Stage 2 | Change at Day 30 (n =7, 5, 7, 6, 5) | -9.33 mg/dL | Standard Deviation 32.898 |
| Stage 1: PF-04856883 12 mg | Change From Baseline in Fasting Plasma Glucose (FPG) at Day 2, 4, 6, 8, 22, 23, 25, 27, 30, 36 and 43: Stage 2 | Baseline (n =7, 5, 7, 7, 6) | 187.29 mg/dL | Standard Deviation 45.756 |
| Stage 1: PF-04856883 18 mg | Change From Baseline in Fasting Plasma Glucose (FPG) at Day 2, 4, 6, 8, 22, 23, 25, 27, 30, 36 and 43: Stage 2 | Change at Day 2 (n =5, 4, 7, 7, 5) | -10.40 mg/dL | Standard Deviation 18.461 |
| Stage 1: PF-04856883 18 mg | Change From Baseline in Fasting Plasma Glucose (FPG) at Day 2, 4, 6, 8, 22, 23, 25, 27, 30, 36 and 43: Stage 2 | Change at Day 36 (n =6, 5, 7, 6, 6) | 27.67 mg/dL | Standard Deviation 59.594 |
| Stage 1: PF-04856883 18 mg | Change From Baseline in Fasting Plasma Glucose (FPG) at Day 2, 4, 6, 8, 22, 23, 25, 27, 30, 36 and 43: Stage 2 | Change at Day 27 (n =7, 5, 6, 6, 5) | 12.00 mg/dL | Standard Deviation 71.039 |
| Stage 1: PF-04856883 18 mg | Change From Baseline in Fasting Plasma Glucose (FPG) at Day 2, 4, 6, 8, 22, 23, 25, 27, 30, 36 and 43: Stage 2 | Change at Day 43 (n =7, 5, 5, 6, 6) | 8.33 mg/dL | Standard Deviation 18.991 |
| Stage 1: PF-04856883 18 mg | Change From Baseline in Fasting Plasma Glucose (FPG) at Day 2, 4, 6, 8, 22, 23, 25, 27, 30, 36 and 43: Stage 2 | Change at Day 6 (n =7, 4, 7, 7, 6) | -15.83 mg/dL | Standard Deviation 8.909 |
| Stage 1: PF-04856883 18 mg | Change From Baseline in Fasting Plasma Glucose (FPG) at Day 2, 4, 6, 8, 22, 23, 25, 27, 30, 36 and 43: Stage 2 | Change at Day 23 (n =7, 4, 6, 6, 5) | -24.00 mg/dL | Standard Deviation 29.967 |
| Stage 1: PF-04856883 18 mg | Change From Baseline in Fasting Plasma Glucose (FPG) at Day 2, 4, 6, 8, 22, 23, 25, 27, 30, 36 and 43: Stage 2 | Change at Day 8 (n =6, 5, 7, 5, 6) | 24.50 mg/dL | Standard Deviation 47.618 |
| Stage 1: PF-04856883 18 mg | Change From Baseline in Fasting Plasma Glucose (FPG) at Day 2, 4, 6, 8, 22, 23, 25, 27, 30, 36 and 43: Stage 2 | Change at Day 22 (n =7, 4, 7, 6, 6) | -0.33 mg/dL | Standard Deviation 51.181 |
| Stage 1: PF-04856883 18 mg | Change From Baseline in Fasting Plasma Glucose (FPG) at Day 2, 4, 6, 8, 22, 23, 25, 27, 30, 36 and 43: Stage 2 | Change at Day 4 (n =5, 5, 7, 6, 6) | -1.50 mg/dL | Standard Deviation 27.384 |
| Stage 1: PF-04856883 18 mg | Change From Baseline in Fasting Plasma Glucose (FPG) at Day 2, 4, 6, 8, 22, 23, 25, 27, 30, 36 and 43: Stage 2 | Baseline (n =7, 5, 7, 7, 6) | 158.50 mg/dL | Standard Deviation 18.447 |
| Stage 1: PF-04856883 18 mg | Change From Baseline in Fasting Plasma Glucose (FPG) at Day 2, 4, 6, 8, 22, 23, 25, 27, 30, 36 and 43: Stage 2 | Change at Day 25 (n =7, 5, 6, 6, 5) | -16.20 mg/dL | Standard Deviation 36.513 |
| Stage 1: PF-04856883 18 mg | Change From Baseline in Fasting Plasma Glucose (FPG) at Day 2, 4, 6, 8, 22, 23, 25, 27, 30, 36 and 43: Stage 2 | Change at Day 30 (n =7, 5, 7, 6, 5) | 15.40 mg/dL | Standard Deviation 37.964 |
Change From Baseline in Fructosamine Levels at Day 8, 15, 22, 29 and 50: Stage 2
Time frame: Baseline, Day 8, 15, 22, 29 and 50
Population: Pharmacodynamic analysis population included all enrolled participants who had received at least 1 dose of study treatment and have at least 1 pharmacodynamic parameter. Here, 'n' signifies those participants who were evaluable at specified time point for each arm, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Stage 1: PF-04856883 Placebo | Change From Baseline in Fructosamine Levels at Day 8, 15, 22, 29 and 50: Stage 2 | Baseline (n =7, 5, 7, 7, 6) | 281.14 mcmol/L | Standard Deviation 57.875 |
| Stage 1: PF-04856883 Placebo | Change From Baseline in Fructosamine Levels at Day 8, 15, 22, 29 and 50: Stage 2 | Change at Day 15 (n =7, 5, 7, 6, 6) | -1.86 mcmol/L | Standard Deviation 21.146 |
| Stage 1: PF-04856883 Placebo | Change From Baseline in Fructosamine Levels at Day 8, 15, 22, 29 and 50: Stage 2 | Change at Day 22 (n =7, 5, 7, 6, 6) | -7.43 mcmol/L | Standard Deviation 13.176 |
| Stage 1: PF-04856883 Placebo | Change From Baseline in Fructosamine Levels at Day 8, 15, 22, 29 and 50: Stage 2 | Change at Day 29 (n =7, 5, 7, 6, 4) | -4.43 mcmol/L | Standard Deviation 27.098 |
| Stage 1: PF-04856883 Placebo | Change From Baseline in Fructosamine Levels at Day 8, 15, 22, 29 and 50: Stage 2 | Change at Day 50 (n =7, 5, 7, 7, 6) | -6.86 mcmol/L | Standard Deviation 20.732 |
| Stage 1: PF-04856883 Placebo | Change From Baseline in Fructosamine Levels at Day 8, 15, 22, 29 and 50: Stage 2 | Change at Day 8 (n =7, 5, 7, 6, 6) | -5.29 mcmol/L | Standard Deviation 19.678 |
| Stage 1: PF-04856883 4 mg | Change From Baseline in Fructosamine Levels at Day 8, 15, 22, 29 and 50: Stage 2 | Change at Day 29 (n =7, 5, 7, 6, 4) | -26.60 mcmol/L | Standard Deviation 22.612 |
| Stage 1: PF-04856883 4 mg | Change From Baseline in Fructosamine Levels at Day 8, 15, 22, 29 and 50: Stage 2 | Change at Day 22 (n =7, 5, 7, 6, 6) | -18.20 mcmol/L | Standard Deviation 20.462 |
| Stage 1: PF-04856883 4 mg | Change From Baseline in Fructosamine Levels at Day 8, 15, 22, 29 and 50: Stage 2 | Baseline (n =7, 5, 7, 7, 6) | 309.40 mcmol/L | Standard Deviation 47.6 |
| Stage 1: PF-04856883 4 mg | Change From Baseline in Fructosamine Levels at Day 8, 15, 22, 29 and 50: Stage 2 | Change at Day 50 (n =7, 5, 7, 7, 6) | -8.80 mcmol/L | Standard Deviation 14.446 |
| Stage 1: PF-04856883 4 mg | Change From Baseline in Fructosamine Levels at Day 8, 15, 22, 29 and 50: Stage 2 | Change at Day 15 (n =7, 5, 7, 6, 6) | -8.20 mcmol/L | Standard Deviation 15.707 |
| Stage 1: PF-04856883 4 mg | Change From Baseline in Fructosamine Levels at Day 8, 15, 22, 29 and 50: Stage 2 | Change at Day 8 (n =7, 5, 7, 6, 6) | -8.20 mcmol/L | Standard Deviation 11.1 |
| Stage 1: PF-04856883 8 mg | Change From Baseline in Fructosamine Levels at Day 8, 15, 22, 29 and 50: Stage 2 | Change at Day 8 (n =7, 5, 7, 6, 6) | -12.14 mcmol/L | Standard Deviation 12.668 |
| Stage 1: PF-04856883 8 mg | Change From Baseline in Fructosamine Levels at Day 8, 15, 22, 29 and 50: Stage 2 | Change at Day 15 (n =7, 5, 7, 6, 6) | -39.29 mcmol/L | Standard Deviation 21.077 |
| Stage 1: PF-04856883 8 mg | Change From Baseline in Fructosamine Levels at Day 8, 15, 22, 29 and 50: Stage 2 | Change at Day 50 (n =7, 5, 7, 7, 6) | -6.43 mcmol/L | Standard Deviation 20.871 |
| Stage 1: PF-04856883 8 mg | Change From Baseline in Fructosamine Levels at Day 8, 15, 22, 29 and 50: Stage 2 | Change at Day 22 (n =7, 5, 7, 6, 6) | -37.86 mcmol/L | Standard Deviation 19.945 |
| Stage 1: PF-04856883 8 mg | Change From Baseline in Fructosamine Levels at Day 8, 15, 22, 29 and 50: Stage 2 | Change at Day 29 (n =7, 5, 7, 6, 4) | -37.57 mcmol/L | Standard Deviation 14.976 |
| Stage 1: PF-04856883 8 mg | Change From Baseline in Fructosamine Levels at Day 8, 15, 22, 29 and 50: Stage 2 | Baseline (n =7, 5, 7, 7, 6) | 301.14 mcmol/L | Standard Deviation 43.69 |
| Stage 1: PF-04856883 12 mg | Change From Baseline in Fructosamine Levels at Day 8, 15, 22, 29 and 50: Stage 2 | Change at Day 50 (n =7, 5, 7, 7, 6) | -12.43 mcmol/L | Standard Deviation 26.732 |
| Stage 1: PF-04856883 12 mg | Change From Baseline in Fructosamine Levels at Day 8, 15, 22, 29 and 50: Stage 2 | Change at Day 29 (n =7, 5, 7, 6, 4) | -32.67 mcmol/L | Standard Deviation 28.507 |
| Stage 1: PF-04856883 12 mg | Change From Baseline in Fructosamine Levels at Day 8, 15, 22, 29 and 50: Stage 2 | Change at Day 8 (n =7, 5, 7, 6, 6) | -9.17 mcmol/L | Standard Deviation 23.043 |
| Stage 1: PF-04856883 12 mg | Change From Baseline in Fructosamine Levels at Day 8, 15, 22, 29 and 50: Stage 2 | Change at Day 15 (n =7, 5, 7, 6, 6) | -11.67 mcmol/L | Standard Deviation 24.047 |
| Stage 1: PF-04856883 12 mg | Change From Baseline in Fructosamine Levels at Day 8, 15, 22, 29 and 50: Stage 2 | Baseline (n =7, 5, 7, 7, 6) | 291.29 mcmol/L | Standard Deviation 37.911 |
| Stage 1: PF-04856883 12 mg | Change From Baseline in Fructosamine Levels at Day 8, 15, 22, 29 and 50: Stage 2 | Change at Day 22 (n =7, 5, 7, 6, 6) | -24.67 mcmol/L | Standard Deviation 20.925 |
| Stage 1: PF-04856883 18 mg | Change From Baseline in Fructosamine Levels at Day 8, 15, 22, 29 and 50: Stage 2 | Change at Day 50 (n =7, 5, 7, 7, 6) | -5.67 mcmol/L | Standard Deviation 31.258 |
| Stage 1: PF-04856883 18 mg | Change From Baseline in Fructosamine Levels at Day 8, 15, 22, 29 and 50: Stage 2 | Baseline (n =7, 5, 7, 7, 6) | 303.67 mcmol/L | Standard Deviation 47.272 |
| Stage 1: PF-04856883 18 mg | Change From Baseline in Fructosamine Levels at Day 8, 15, 22, 29 and 50: Stage 2 | Change at Day 29 (n =7, 5, 7, 6, 4) | -41.00 mcmol/L | Standard Deviation 29.855 |
| Stage 1: PF-04856883 18 mg | Change From Baseline in Fructosamine Levels at Day 8, 15, 22, 29 and 50: Stage 2 | Change at Day 22 (n =7, 5, 7, 6, 6) | -27.50 mcmol/L | Standard Deviation 25.399 |
| Stage 1: PF-04856883 18 mg | Change From Baseline in Fructosamine Levels at Day 8, 15, 22, 29 and 50: Stage 2 | Change at Day 8 (n =7, 5, 7, 6, 6) | -10.17 mcmol/L | Standard Deviation 21.72 |
| Stage 1: PF-04856883 18 mg | Change From Baseline in Fructosamine Levels at Day 8, 15, 22, 29 and 50: Stage 2 | Change at Day 15 (n =7, 5, 7, 6, 6) | -14.67 mcmol/L | Standard Deviation 33.037 |
Change From Baseline in Fructosamine Levels at Day 8, 15 and 29: Stage 1
Time frame: Baseline, Day 8, 15 and 29
Population: Pharmacodynamic analysis population included all enrolled participants who had received at least 1 dose of study treatment and have at least 1 pharmacodynamic parameter. Here, 'n' signifies those participants who were evaluable at specified time point for each arm, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Stage 1: PF-04856883 Placebo | Change From Baseline in Fructosamine Levels at Day 8, 15 and 29: Stage 1 | Change at Day 8 (n =15, 5, 5, 6, 7, 5, 7) | 1.13 micromole per liter (mcmol/L) | Standard Deviation 14.461 |
| Stage 1: PF-04856883 Placebo | Change From Baseline in Fructosamine Levels at Day 8, 15 and 29: Stage 1 | Baseline (n =15, 5, 6, 6, 7, 5, 7) | 270.60 micromole per liter (mcmol/L) | Standard Deviation 34.618 |
| Stage 1: PF-04856883 Placebo | Change From Baseline in Fructosamine Levels at Day 8, 15 and 29: Stage 1 | Change at Day 29 (n =15, 5, 5, 6, 7, 5, 7) | 0.93 micromole per liter (mcmol/L) | Standard Deviation 19.627 |
| Stage 1: PF-04856883 Placebo | Change From Baseline in Fructosamine Levels at Day 8, 15 and 29: Stage 1 | Change at Day 15 (n =15, 5, 5, 6, 6, 5, 7) | -5.67 micromole per liter (mcmol/L) | Standard Deviation 17.839 |
| Stage 1: PF-04856883 4 mg | Change From Baseline in Fructosamine Levels at Day 8, 15 and 29: Stage 1 | Change at Day 15 (n =15, 5, 5, 6, 6, 5, 7) | -20.40 micromole per liter (mcmol/L) | Standard Deviation 25.393 |
| Stage 1: PF-04856883 4 mg | Change From Baseline in Fructosamine Levels at Day 8, 15 and 29: Stage 1 | Change at Day 8 (n =15, 5, 5, 6, 7, 5, 7) | 20.20 micromole per liter (mcmol/L) | Standard Deviation 10.986 |
| Stage 1: PF-04856883 4 mg | Change From Baseline in Fructosamine Levels at Day 8, 15 and 29: Stage 1 | Change at Day 29 (n =15, 5, 5, 6, 7, 5, 7) | 8.40 micromole per liter (mcmol/L) | Standard Deviation 30.876 |
| Stage 1: PF-04856883 4 mg | Change From Baseline in Fructosamine Levels at Day 8, 15 and 29: Stage 1 | Baseline (n =15, 5, 6, 6, 7, 5, 7) | 289.20 micromole per liter (mcmol/L) | Standard Deviation 48.329 |
| Stage 1: PF-04856883 8 mg | Change From Baseline in Fructosamine Levels at Day 8, 15 and 29: Stage 1 | Change at Day 15 (n =15, 5, 5, 6, 6, 5, 7) | -16.40 micromole per liter (mcmol/L) | Standard Deviation 13.502 |
| Stage 1: PF-04856883 8 mg | Change From Baseline in Fructosamine Levels at Day 8, 15 and 29: Stage 1 | Change at Day 8 (n =15, 5, 5, 6, 7, 5, 7) | 4.20 micromole per liter (mcmol/L) | Standard Deviation 18.295 |
| Stage 1: PF-04856883 8 mg | Change From Baseline in Fructosamine Levels at Day 8, 15 and 29: Stage 1 | Baseline (n =15, 5, 6, 6, 7, 5, 7) | 279.67 micromole per liter (mcmol/L) | Standard Deviation 30.507 |
| Stage 1: PF-04856883 8 mg | Change From Baseline in Fructosamine Levels at Day 8, 15 and 29: Stage 1 | Change at Day 29 (n =15, 5, 5, 6, 7, 5, 7) | 7.20 micromole per liter (mcmol/L) | Standard Deviation 29.66 |
| Stage 1: PF-04856883 12 mg | Change From Baseline in Fructosamine Levels at Day 8, 15 and 29: Stage 1 | Baseline (n =15, 5, 6, 6, 7, 5, 7) | 304.83 micromole per liter (mcmol/L) | Standard Deviation 45.155 |
| Stage 1: PF-04856883 12 mg | Change From Baseline in Fructosamine Levels at Day 8, 15 and 29: Stage 1 | Change at Day 15 (n =15, 5, 5, 6, 6, 5, 7) | -9.17 micromole per liter (mcmol/L) | Standard Deviation 25.135 |
| Stage 1: PF-04856883 12 mg | Change From Baseline in Fructosamine Levels at Day 8, 15 and 29: Stage 1 | Change at Day 8 (n =15, 5, 5, 6, 7, 5, 7) | 5.67 micromole per liter (mcmol/L) | Standard Deviation 13.095 |
| Stage 1: PF-04856883 12 mg | Change From Baseline in Fructosamine Levels at Day 8, 15 and 29: Stage 1 | Change at Day 29 (n =15, 5, 5, 6, 7, 5, 7) | -4.50 micromole per liter (mcmol/L) | Standard Deviation 16.109 |
| Stage 1: PF-04856883 18 mg | Change From Baseline in Fructosamine Levels at Day 8, 15 and 29: Stage 1 | Baseline (n =15, 5, 6, 6, 7, 5, 7) | 263.43 micromole per liter (mcmol/L) | Standard Deviation 34.942 |
| Stage 1: PF-04856883 18 mg | Change From Baseline in Fructosamine Levels at Day 8, 15 and 29: Stage 1 | Change at Day 15 (n =15, 5, 5, 6, 6, 5, 7) | 13.33 micromole per liter (mcmol/L) | Standard Deviation 24.188 |
| Stage 1: PF-04856883 18 mg | Change From Baseline in Fructosamine Levels at Day 8, 15 and 29: Stage 1 | Change at Day 29 (n =15, 5, 5, 6, 7, 5, 7) | 15.86 micromole per liter (mcmol/L) | Standard Deviation 24.024 |
| Stage 1: PF-04856883 18 mg | Change From Baseline in Fructosamine Levels at Day 8, 15 and 29: Stage 1 | Change at Day 8 (n =15, 5, 5, 6, 7, 5, 7) | 4.29 micromole per liter (mcmol/L) | Standard Deviation 16.72 |
| Stage 1: PF-04856883 24 mg | Change From Baseline in Fructosamine Levels at Day 8, 15 and 29: Stage 1 | Baseline (n =15, 5, 6, 6, 7, 5, 7) | 259.80 micromole per liter (mcmol/L) | Standard Deviation 53.644 |
| Stage 1: PF-04856883 24 mg | Change From Baseline in Fructosamine Levels at Day 8, 15 and 29: Stage 1 | Change at Day 29 (n =15, 5, 5, 6, 7, 5, 7) | 1.40 micromole per liter (mcmol/L) | Standard Deviation 17.344 |
| Stage 1: PF-04856883 24 mg | Change From Baseline in Fructosamine Levels at Day 8, 15 and 29: Stage 1 | Change at Day 8 (n =15, 5, 5, 6, 7, 5, 7) | -13.60 micromole per liter (mcmol/L) | Standard Deviation 23.554 |
| Stage 1: PF-04856883 24 mg | Change From Baseline in Fructosamine Levels at Day 8, 15 and 29: Stage 1 | Change at Day 15 (n =15, 5, 5, 6, 6, 5, 7) | -9.60 micromole per liter (mcmol/L) | Standard Deviation 22.267 |
| Stage 1: PF-04856883 36 mg | Change From Baseline in Fructosamine Levels at Day 8, 15 and 29: Stage 1 | Change at Day 29 (n =15, 5, 5, 6, 7, 5, 7) | -4.43 micromole per liter (mcmol/L) | Standard Deviation 18.867 |
| Stage 1: PF-04856883 36 mg | Change From Baseline in Fructosamine Levels at Day 8, 15 and 29: Stage 1 | Baseline (n =15, 5, 6, 6, 7, 5, 7) | 273.71 micromole per liter (mcmol/L) | Standard Deviation 36.036 |
| Stage 1: PF-04856883 36 mg | Change From Baseline in Fructosamine Levels at Day 8, 15 and 29: Stage 1 | Change at Day 8 (n =15, 5, 5, 6, 7, 5, 7) | -12.29 micromole per liter (mcmol/L) | Standard Deviation 10.579 |
| Stage 1: PF-04856883 36 mg | Change From Baseline in Fructosamine Levels at Day 8, 15 and 29: Stage 1 | Change at Day 15 (n =15, 5, 5, 6, 6, 5, 7) | -3.00 micromole per liter (mcmol/L) | Standard Deviation 11.165 |
Change From Baseline in Insulin Area Under the Curve (AUC) After Mixed Meal Tolerance Test (MMTT) at Day 3, 15, 24, 29 and 50: Stage 2
Change from baseline in post-prandial plasma insulin AUC under the plasma insulin concentration versus time curve as determined by standardized MMTT. Linear trapezoidal method was used to compute AUC.
Time frame: Baseline, Day 3, 15, 24, 29 and 50
Population: Pharmacodynamic analysis population included all enrolled participants who had received at least 1 dose of study treatment and have at least 1 pharmacodynamic parameter. Here, 'n' signifies those participants who were evaluable at specified time point for each arm, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Stage 1: PF-04856883 Placebo | Change From Baseline in Insulin Area Under the Curve (AUC) After Mixed Meal Tolerance Test (MMTT) at Day 3, 15, 24, 29 and 50: Stage 2 | Change at Day 29 (n =7, 5, 7, 6, 5) | 8.25 mU*hr/L | Standard Deviation 55.799 |
| Stage 1: PF-04856883 Placebo | Change From Baseline in Insulin Area Under the Curve (AUC) After Mixed Meal Tolerance Test (MMTT) at Day 3, 15, 24, 29 and 50: Stage 2 | Change at Day 15 (n =7, 5, 7, 6, 6) | -16.77 mU*hr/L | Standard Deviation 20.53 |
| Stage 1: PF-04856883 Placebo | Change From Baseline in Insulin Area Under the Curve (AUC) After Mixed Meal Tolerance Test (MMTT) at Day 3, 15, 24, 29 and 50: Stage 2 | Baseline (n =7, 5, 7, 7, 6) | 175.26 mU*hr/L | Standard Deviation 62.218 |
| Stage 1: PF-04856883 Placebo | Change From Baseline in Insulin Area Under the Curve (AUC) After Mixed Meal Tolerance Test (MMTT) at Day 3, 15, 24, 29 and 50: Stage 2 | Change at Day 3 (n =7, 5, 7, 7, 6) | 38.32 mU*hr/L | Standard Deviation 62.135 |
| Stage 1: PF-04856883 Placebo | Change From Baseline in Insulin Area Under the Curve (AUC) After Mixed Meal Tolerance Test (MMTT) at Day 3, 15, 24, 29 and 50: Stage 2 | Change at Day 24 (n =7, 4, 7, 6, 6) | 0.23 mU*hr/L | Standard Deviation 55.174 |
| Stage 1: PF-04856883 Placebo | Change From Baseline in Insulin Area Under the Curve (AUC) After Mixed Meal Tolerance Test (MMTT) at Day 3, 15, 24, 29 and 50: Stage 2 | Change at Day 50 (n =7, 5, 7, 6, 5) | 8.14 mU*hr/L | Standard Deviation 29.909 |
| Stage 1: PF-04856883 4 mg | Change From Baseline in Insulin Area Under the Curve (AUC) After Mixed Meal Tolerance Test (MMTT) at Day 3, 15, 24, 29 and 50: Stage 2 | Change at Day 50 (n =7, 5, 7, 6, 5) | -16.64 mU*hr/L | Standard Deviation 33.133 |
| Stage 1: PF-04856883 4 mg | Change From Baseline in Insulin Area Under the Curve (AUC) After Mixed Meal Tolerance Test (MMTT) at Day 3, 15, 24, 29 and 50: Stage 2 | Change at Day 3 (n =7, 5, 7, 7, 6) | 13.29 mU*hr/L | Standard Deviation 55.764 |
| Stage 1: PF-04856883 4 mg | Change From Baseline in Insulin Area Under the Curve (AUC) After Mixed Meal Tolerance Test (MMTT) at Day 3, 15, 24, 29 and 50: Stage 2 | Change at Day 15 (n =7, 5, 7, 6, 6) | -39.16 mU*hr/L | Standard Deviation 42.93 |
| Stage 1: PF-04856883 4 mg | Change From Baseline in Insulin Area Under the Curve (AUC) After Mixed Meal Tolerance Test (MMTT) at Day 3, 15, 24, 29 and 50: Stage 2 | Baseline (n =7, 5, 7, 7, 6) | 176.65 mU*hr/L | Standard Deviation 76.04 |
| Stage 1: PF-04856883 4 mg | Change From Baseline in Insulin Area Under the Curve (AUC) After Mixed Meal Tolerance Test (MMTT) at Day 3, 15, 24, 29 and 50: Stage 2 | Change at Day 24 (n =7, 4, 7, 6, 6) | -15.19 mU*hr/L | Standard Deviation 38.9 |
| Stage 1: PF-04856883 4 mg | Change From Baseline in Insulin Area Under the Curve (AUC) After Mixed Meal Tolerance Test (MMTT) at Day 3, 15, 24, 29 and 50: Stage 2 | Change at Day 29 (n =7, 5, 7, 6, 5) | 3.98 mU*hr/L | Standard Deviation 11.218 |
| Stage 1: PF-04856883 8 mg | Change From Baseline in Insulin Area Under the Curve (AUC) After Mixed Meal Tolerance Test (MMTT) at Day 3, 15, 24, 29 and 50: Stage 2 | Change at Day 29 (n =7, 5, 7, 6, 5) | 12.71 mU*hr/L | Standard Deviation 115.095 |
| Stage 1: PF-04856883 8 mg | Change From Baseline in Insulin Area Under the Curve (AUC) After Mixed Meal Tolerance Test (MMTT) at Day 3, 15, 24, 29 and 50: Stage 2 | Change at Day 24 (n =7, 4, 7, 6, 6) | 6.87 mU*hr/L | Standard Deviation 184.83 |
| Stage 1: PF-04856883 8 mg | Change From Baseline in Insulin Area Under the Curve (AUC) After Mixed Meal Tolerance Test (MMTT) at Day 3, 15, 24, 29 and 50: Stage 2 | Change at Day 15 (n =7, 5, 7, 6, 6) | -10.07 mU*hr/L | Standard Deviation 172.044 |
| Stage 1: PF-04856883 8 mg | Change From Baseline in Insulin Area Under the Curve (AUC) After Mixed Meal Tolerance Test (MMTT) at Day 3, 15, 24, 29 and 50: Stage 2 | Change at Day 3 (n =7, 5, 7, 7, 6) | 19.50 mU*hr/L | Standard Deviation 134.651 |
| Stage 1: PF-04856883 8 mg | Change From Baseline in Insulin Area Under the Curve (AUC) After Mixed Meal Tolerance Test (MMTT) at Day 3, 15, 24, 29 and 50: Stage 2 | Baseline (n =7, 5, 7, 7, 6) | 267.29 mU*hr/L | Standard Deviation 111.497 |
| Stage 1: PF-04856883 8 mg | Change From Baseline in Insulin Area Under the Curve (AUC) After Mixed Meal Tolerance Test (MMTT) at Day 3, 15, 24, 29 and 50: Stage 2 | Change at Day 50 (n =7, 5, 7, 6, 5) | -57.14 mU*hr/L | Standard Deviation 116.193 |
| Stage 1: PF-04856883 12 mg | Change From Baseline in Insulin Area Under the Curve (AUC) After Mixed Meal Tolerance Test (MMTT) at Day 3, 15, 24, 29 and 50: Stage 2 | Change at Day 3 (n =7, 5, 7, 7, 6) | 27.99 mU*hr/L | Standard Deviation 32.655 |
| Stage 1: PF-04856883 12 mg | Change From Baseline in Insulin Area Under the Curve (AUC) After Mixed Meal Tolerance Test (MMTT) at Day 3, 15, 24, 29 and 50: Stage 2 | Change at Day 29 (n =7, 5, 7, 6, 5) | -1.61 mU*hr/L | Standard Deviation 85.866 |
| Stage 1: PF-04856883 12 mg | Change From Baseline in Insulin Area Under the Curve (AUC) After Mixed Meal Tolerance Test (MMTT) at Day 3, 15, 24, 29 and 50: Stage 2 | Change at Day 24 (n =7, 4, 7, 6, 6) | 4.18 mU*hr/L | Standard Deviation 51.903 |
| Stage 1: PF-04856883 12 mg | Change From Baseline in Insulin Area Under the Curve (AUC) After Mixed Meal Tolerance Test (MMTT) at Day 3, 15, 24, 29 and 50: Stage 2 | Baseline (n =7, 5, 7, 7, 6) | 162.96 mU*hr/L | Standard Deviation 111.688 |
| Stage 1: PF-04856883 12 mg | Change From Baseline in Insulin Area Under the Curve (AUC) After Mixed Meal Tolerance Test (MMTT) at Day 3, 15, 24, 29 and 50: Stage 2 | Change at Day 15 (n =7, 5, 7, 6, 6) | -51.69 mU*hr/L | Standard Deviation 77.925 |
| Stage 1: PF-04856883 12 mg | Change From Baseline in Insulin Area Under the Curve (AUC) After Mixed Meal Tolerance Test (MMTT) at Day 3, 15, 24, 29 and 50: Stage 2 | Change at Day 50 (n =7, 5, 7, 6, 5) | 49.27 mU*hr/L | Standard Deviation 81.874 |
| Stage 1: PF-04856883 18 mg | Change From Baseline in Insulin Area Under the Curve (AUC) After Mixed Meal Tolerance Test (MMTT) at Day 3, 15, 24, 29 and 50: Stage 2 | Change at Day 24 (n =7, 4, 7, 6, 6) | 60.11 mU*hr/L | Standard Deviation 189.287 |
| Stage 1: PF-04856883 18 mg | Change From Baseline in Insulin Area Under the Curve (AUC) After Mixed Meal Tolerance Test (MMTT) at Day 3, 15, 24, 29 and 50: Stage 2 | Change at Day 29 (n =7, 5, 7, 6, 5) | 15.70 mU*hr/L | Standard Deviation 38.476 |
| Stage 1: PF-04856883 18 mg | Change From Baseline in Insulin Area Under the Curve (AUC) After Mixed Meal Tolerance Test (MMTT) at Day 3, 15, 24, 29 and 50: Stage 2 | Baseline (n =7, 5, 7, 7, 6) | 190.64 mU*hr/L | Standard Deviation 83.945 |
| Stage 1: PF-04856883 18 mg | Change From Baseline in Insulin Area Under the Curve (AUC) After Mixed Meal Tolerance Test (MMTT) at Day 3, 15, 24, 29 and 50: Stage 2 | Change at Day 50 (n =7, 5, 7, 6, 5) | -26.78 mU*hr/L | Standard Deviation 81.518 |
| Stage 1: PF-04856883 18 mg | Change From Baseline in Insulin Area Under the Curve (AUC) After Mixed Meal Tolerance Test (MMTT) at Day 3, 15, 24, 29 and 50: Stage 2 | Change at Day 15 (n =7, 5, 7, 6, 6) | -24.36 mU*hr/L | Standard Deviation 85.633 |
| Stage 1: PF-04856883 18 mg | Change From Baseline in Insulin Area Under the Curve (AUC) After Mixed Meal Tolerance Test (MMTT) at Day 3, 15, 24, 29 and 50: Stage 2 | Change at Day 3 (n =7, 5, 7, 7, 6) | 87.67 mU*hr/L | Standard Deviation 124.052 |
Change From Baseline in Insulin Area Under the Curve (AUC) After Mixed Meal Tolerance Test (MMTT) at Day 3 and 8: Stage 1
Change from baseline in post-prandial plasma insulin AUC under the plasma insulin concentration versus time curve as determined by standardized MMTT. Linear trapezoidal method was used to compute AUC.
Time frame: Baseline, Day 3 and 8
Population: Pharmacodynamic analysis population included all enrolled participants who had received at least 1 dose of study treatment and have at least 1 pharmacodynamic parameter. Here, 'n' signifies those participants who were evaluable at specified time point for each arm, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Stage 1: PF-04856883 Placebo | Change From Baseline in Insulin Area Under the Curve (AUC) After Mixed Meal Tolerance Test (MMTT) at Day 3 and 8: Stage 1 | Change at Day 8 (n =15, 4, 5, 6, 7, 5, 6) | 34.23 milliUnit*hour per liter (mU*hr/L) | Standard Deviation 103.279 |
| Stage 1: PF-04856883 Placebo | Change From Baseline in Insulin Area Under the Curve (AUC) After Mixed Meal Tolerance Test (MMTT) at Day 3 and 8: Stage 1 | Change at Day 3 (n =15, 5, 5, 6, 7, 5, 6) | 68.79 milliUnit*hour per liter (mU*hr/L) | Standard Deviation 115.555 |
| Stage 1: PF-04856883 Placebo | Change From Baseline in Insulin Area Under the Curve (AUC) After Mixed Meal Tolerance Test (MMTT) at Day 3 and 8: Stage 1 | Baseline (n =15, 5, 6, 6, 7, 5, 7) | 222.18 milliUnit*hour per liter (mU*hr/L) | Standard Deviation 139.981 |
| Stage 1: PF-04856883 4 mg | Change From Baseline in Insulin Area Under the Curve (AUC) After Mixed Meal Tolerance Test (MMTT) at Day 3 and 8: Stage 1 | Change at Day 8 (n =15, 4, 5, 6, 7, 5, 6) | 22.05 milliUnit*hour per liter (mU*hr/L) | Standard Deviation 89.419 |
| Stage 1: PF-04856883 4 mg | Change From Baseline in Insulin Area Under the Curve (AUC) After Mixed Meal Tolerance Test (MMTT) at Day 3 and 8: Stage 1 | Baseline (n =15, 5, 6, 6, 7, 5, 7) | 227.07 milliUnit*hour per liter (mU*hr/L) | Standard Deviation 142.547 |
| Stage 1: PF-04856883 4 mg | Change From Baseline in Insulin Area Under the Curve (AUC) After Mixed Meal Tolerance Test (MMTT) at Day 3 and 8: Stage 1 | Change at Day 3 (n =15, 5, 5, 6, 7, 5, 6) | 22.99 milliUnit*hour per liter (mU*hr/L) | Standard Deviation 32.706 |
| Stage 1: PF-04856883 8 mg | Change From Baseline in Insulin Area Under the Curve (AUC) After Mixed Meal Tolerance Test (MMTT) at Day 3 and 8: Stage 1 | Change at Day 8 (n =15, 4, 5, 6, 7, 5, 6) | 39.96 milliUnit*hour per liter (mU*hr/L) | Standard Deviation 38.941 |
| Stage 1: PF-04856883 8 mg | Change From Baseline in Insulin Area Under the Curve (AUC) After Mixed Meal Tolerance Test (MMTT) at Day 3 and 8: Stage 1 | Change at Day 3 (n =15, 5, 5, 6, 7, 5, 6) | 35.09 milliUnit*hour per liter (mU*hr/L) | Standard Deviation 57.093 |
| Stage 1: PF-04856883 8 mg | Change From Baseline in Insulin Area Under the Curve (AUC) After Mixed Meal Tolerance Test (MMTT) at Day 3 and 8: Stage 1 | Baseline (n =15, 5, 6, 6, 7, 5, 7) | 210.80 milliUnit*hour per liter (mU*hr/L) | Standard Deviation 95.536 |
| Stage 1: PF-04856883 12 mg | Change From Baseline in Insulin Area Under the Curve (AUC) After Mixed Meal Tolerance Test (MMTT) at Day 3 and 8: Stage 1 | Change at Day 8 (n =15, 4, 5, 6, 7, 5, 6) | -50.51 milliUnit*hour per liter (mU*hr/L) | Standard Deviation 40.624 |
| Stage 1: PF-04856883 12 mg | Change From Baseline in Insulin Area Under the Curve (AUC) After Mixed Meal Tolerance Test (MMTT) at Day 3 and 8: Stage 1 | Baseline (n =15, 5, 6, 6, 7, 5, 7) | 235.84 milliUnit*hour per liter (mU*hr/L) | Standard Deviation 130.071 |
| Stage 1: PF-04856883 12 mg | Change From Baseline in Insulin Area Under the Curve (AUC) After Mixed Meal Tolerance Test (MMTT) at Day 3 and 8: Stage 1 | Change at Day 3 (n =15, 5, 5, 6, 7, 5, 6) | 12.15 milliUnit*hour per liter (mU*hr/L) | Standard Deviation 54.495 |
| Stage 1: PF-04856883 18 mg | Change From Baseline in Insulin Area Under the Curve (AUC) After Mixed Meal Tolerance Test (MMTT) at Day 3 and 8: Stage 1 | Baseline (n =15, 5, 6, 6, 7, 5, 7) | 105.34 milliUnit*hour per liter (mU*hr/L) | Standard Deviation 19.118 |
| Stage 1: PF-04856883 18 mg | Change From Baseline in Insulin Area Under the Curve (AUC) After Mixed Meal Tolerance Test (MMTT) at Day 3 and 8: Stage 1 | Change at Day 8 (n =15, 4, 5, 6, 7, 5, 6) | 38.04 milliUnit*hour per liter (mU*hr/L) | Standard Deviation 15.736 |
| Stage 1: PF-04856883 18 mg | Change From Baseline in Insulin Area Under the Curve (AUC) After Mixed Meal Tolerance Test (MMTT) at Day 3 and 8: Stage 1 | Change at Day 3 (n =15, 5, 5, 6, 7, 5, 6) | 59.06 milliUnit*hour per liter (mU*hr/L) | Standard Deviation 94.643 |
| Stage 1: PF-04856883 24 mg | Change From Baseline in Insulin Area Under the Curve (AUC) After Mixed Meal Tolerance Test (MMTT) at Day 3 and 8: Stage 1 | Baseline (n =15, 5, 6, 6, 7, 5, 7) | 257.73 milliUnit*hour per liter (mU*hr/L) | Standard Deviation 127.358 |
| Stage 1: PF-04856883 24 mg | Change From Baseline in Insulin Area Under the Curve (AUC) After Mixed Meal Tolerance Test (MMTT) at Day 3 and 8: Stage 1 | Change at Day 3 (n =15, 5, 5, 6, 7, 5, 6) | 83.82 milliUnit*hour per liter (mU*hr/L) | Standard Deviation 70.182 |
| Stage 1: PF-04856883 24 mg | Change From Baseline in Insulin Area Under the Curve (AUC) After Mixed Meal Tolerance Test (MMTT) at Day 3 and 8: Stage 1 | Change at Day 8 (n =15, 4, 5, 6, 7, 5, 6) | -0.36 milliUnit*hour per liter (mU*hr/L) | Standard Deviation 50.674 |
| Stage 1: PF-04856883 36 mg | Change From Baseline in Insulin Area Under the Curve (AUC) After Mixed Meal Tolerance Test (MMTT) at Day 3 and 8: Stage 1 | Change at Day 8 (n =15, 4, 5, 6, 7, 5, 6) | 1.08 milliUnit*hour per liter (mU*hr/L) | Standard Deviation 47.135 |
| Stage 1: PF-04856883 36 mg | Change From Baseline in Insulin Area Under the Curve (AUC) After Mixed Meal Tolerance Test (MMTT) at Day 3 and 8: Stage 1 | Change at Day 3 (n =15, 5, 5, 6, 7, 5, 6) | 13.72 milliUnit*hour per liter (mU*hr/L) | Standard Deviation 98.682 |
| Stage 1: PF-04856883 36 mg | Change From Baseline in Insulin Area Under the Curve (AUC) After Mixed Meal Tolerance Test (MMTT) at Day 3 and 8: Stage 1 | Baseline (n =15, 5, 6, 6, 7, 5, 7) | 283.59 milliUnit*hour per liter (mU*hr/L) | Standard Deviation 156.831 |
Change From Baseline in Post-prandial Glucose Area Under the Curve (AUC) After Mixed Meal Tolerance Test (MMTT) at Day 3, 15, 24, 29 and 50: Stage 2
Change from baseline in post-prandial area under the plasma glucose concentration time curve as determined by standardized MMTT. Linear trapezoidal method was used to compute AUC.
Time frame: Baseline, Day 3, 15, 24, 29 and 50
Population: Pharmacodynamic analysis population included all enrolled participants who had received at least 1 dose of study treatment and have at least 1 pharmacodynamic parameter. Here, 'n' signifies those participants who were evaluable at specified time point for each arm, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Stage 1: PF-04856883 Placebo | Change From Baseline in Post-prandial Glucose Area Under the Curve (AUC) After Mixed Meal Tolerance Test (MMTT) at Day 3, 15, 24, 29 and 50: Stage 2 | Baseline (n =7, 4, 7, 7, 6) | 606.49 mg*hr/dL | Standard Deviation 158.249 |
| Stage 1: PF-04856883 Placebo | Change From Baseline in Post-prandial Glucose Area Under the Curve (AUC) After Mixed Meal Tolerance Test (MMTT) at Day 3, 15, 24, 29 and 50: Stage 2 | Change at Day 29 (n =7, 4, 7, 6, 5) | 30.08 mg*hr/dL | Standard Deviation 59.49 |
| Stage 1: PF-04856883 Placebo | Change From Baseline in Post-prandial Glucose Area Under the Curve (AUC) After Mixed Meal Tolerance Test (MMTT) at Day 3, 15, 24, 29 and 50: Stage 2 | Change at Day 15 (n =7, 4, 6, 6, 6) | -18.48 mg*hr/dL | Standard Deviation 50.874 |
| Stage 1: PF-04856883 Placebo | Change From Baseline in Post-prandial Glucose Area Under the Curve (AUC) After Mixed Meal Tolerance Test (MMTT) at Day 3, 15, 24, 29 and 50: Stage 2 | Change at Day 24 (n =7, 4, 7, 6, 5) | -6.20 mg*hr/dL | Standard Deviation 46.238 |
| Stage 1: PF-04856883 Placebo | Change From Baseline in Post-prandial Glucose Area Under the Curve (AUC) After Mixed Meal Tolerance Test (MMTT) at Day 3, 15, 24, 29 and 50: Stage 2 | Change at Day 3 (n =7, 4, 5, 6, 5) | 44.41 mg*hr/dL | Standard Deviation 74.405 |
| Stage 1: PF-04856883 Placebo | Change From Baseline in Post-prandial Glucose Area Under the Curve (AUC) After Mixed Meal Tolerance Test (MMTT) at Day 3, 15, 24, 29 and 50: Stage 2 | Change at Day 50 (n =7, 3, 6, 6, 6) | 50.26 mg*hr/dL | Standard Deviation 81.717 |
| Stage 1: PF-04856883 4 mg | Change From Baseline in Post-prandial Glucose Area Under the Curve (AUC) After Mixed Meal Tolerance Test (MMTT) at Day 3, 15, 24, 29 and 50: Stage 2 | Change at Day 24 (n =7, 4, 7, 6, 5) | -146.61 mg*hr/dL | Standard Deviation 78.863 |
| Stage 1: PF-04856883 4 mg | Change From Baseline in Post-prandial Glucose Area Under the Curve (AUC) After Mixed Meal Tolerance Test (MMTT) at Day 3, 15, 24, 29 and 50: Stage 2 | Change at Day 50 (n =7, 3, 6, 6, 6) | -48.82 mg*hr/dL | Standard Deviation 80.733 |
| Stage 1: PF-04856883 4 mg | Change From Baseline in Post-prandial Glucose Area Under the Curve (AUC) After Mixed Meal Tolerance Test (MMTT) at Day 3, 15, 24, 29 and 50: Stage 2 | Change at Day 3 (n =7, 4, 5, 6, 5) | -97.03 mg*hr/dL | Standard Deviation 55.692 |
| Stage 1: PF-04856883 4 mg | Change From Baseline in Post-prandial Glucose Area Under the Curve (AUC) After Mixed Meal Tolerance Test (MMTT) at Day 3, 15, 24, 29 and 50: Stage 2 | Baseline (n =7, 4, 7, 7, 6) | 811.36 mg*hr/dL | Standard Deviation 131.145 |
| Stage 1: PF-04856883 4 mg | Change From Baseline in Post-prandial Glucose Area Under the Curve (AUC) After Mixed Meal Tolerance Test (MMTT) at Day 3, 15, 24, 29 and 50: Stage 2 | Change at Day 15 (n =7, 4, 6, 6, 6) | -265.64 mg*hr/dL | Standard Deviation 89.889 |
| Stage 1: PF-04856883 4 mg | Change From Baseline in Post-prandial Glucose Area Under the Curve (AUC) After Mixed Meal Tolerance Test (MMTT) at Day 3, 15, 24, 29 and 50: Stage 2 | Change at Day 29 (n =7, 4, 7, 6, 5) | -55.43 mg*hr/dL | Standard Deviation 74.973 |
| Stage 1: PF-04856883 8 mg | Change From Baseline in Post-prandial Glucose Area Under the Curve (AUC) After Mixed Meal Tolerance Test (MMTT) at Day 3, 15, 24, 29 and 50: Stage 2 | Change at Day 29 (n =7, 4, 7, 6, 5) | -157.54 mg*hr/dL | Standard Deviation 88.652 |
| Stage 1: PF-04856883 8 mg | Change From Baseline in Post-prandial Glucose Area Under the Curve (AUC) After Mixed Meal Tolerance Test (MMTT) at Day 3, 15, 24, 29 and 50: Stage 2 | Change at Day 3 (n =7, 4, 5, 6, 5) | -103.00 mg*hr/dL | Standard Deviation 118.759 |
| Stage 1: PF-04856883 8 mg | Change From Baseline in Post-prandial Glucose Area Under the Curve (AUC) After Mixed Meal Tolerance Test (MMTT) at Day 3, 15, 24, 29 and 50: Stage 2 | Change at Day 24 (n =7, 4, 7, 6, 5) | -207.12 mg*hr/dL | Standard Deviation 89.687 |
| Stage 1: PF-04856883 8 mg | Change From Baseline in Post-prandial Glucose Area Under the Curve (AUC) After Mixed Meal Tolerance Test (MMTT) at Day 3, 15, 24, 29 and 50: Stage 2 | Baseline (n =7, 4, 7, 7, 6) | 756.17 mg*hr/dL | Standard Deviation 240.43 |
| Stage 1: PF-04856883 8 mg | Change From Baseline in Post-prandial Glucose Area Under the Curve (AUC) After Mixed Meal Tolerance Test (MMTT) at Day 3, 15, 24, 29 and 50: Stage 2 | Change at Day 50 (n =7, 3, 6, 6, 6) | -33.77 mg*hr/dL | Standard Deviation 250.859 |
| Stage 1: PF-04856883 8 mg | Change From Baseline in Post-prandial Glucose Area Under the Curve (AUC) After Mixed Meal Tolerance Test (MMTT) at Day 3, 15, 24, 29 and 50: Stage 2 | Change at Day 15 (n =7, 4, 6, 6, 6) | -293.04 mg*hr/dL | Standard Deviation 163.074 |
| Stage 1: PF-04856883 12 mg | Change From Baseline in Post-prandial Glucose Area Under the Curve (AUC) After Mixed Meal Tolerance Test (MMTT) at Day 3, 15, 24, 29 and 50: Stage 2 | Change at Day 50 (n =7, 3, 6, 6, 6) | -125.06 mg*hr/dL | Standard Deviation 217.403 |
| Stage 1: PF-04856883 12 mg | Change From Baseline in Post-prandial Glucose Area Under the Curve (AUC) After Mixed Meal Tolerance Test (MMTT) at Day 3, 15, 24, 29 and 50: Stage 2 | Change at Day 15 (n =7, 4, 6, 6, 6) | -254.54 mg*hr/dL | Standard Deviation 144.897 |
| Stage 1: PF-04856883 12 mg | Change From Baseline in Post-prandial Glucose Area Under the Curve (AUC) After Mixed Meal Tolerance Test (MMTT) at Day 3, 15, 24, 29 and 50: Stage 2 | Change at Day 24 (n =7, 4, 7, 6, 5) | -242.35 mg*hr/dL | Standard Deviation 231.302 |
| Stage 1: PF-04856883 12 mg | Change From Baseline in Post-prandial Glucose Area Under the Curve (AUC) After Mixed Meal Tolerance Test (MMTT) at Day 3, 15, 24, 29 and 50: Stage 2 | Change at Day 29 (n =7, 4, 7, 6, 5) | -192.97 mg*hr/dL | Standard Deviation 185.056 |
| Stage 1: PF-04856883 12 mg | Change From Baseline in Post-prandial Glucose Area Under the Curve (AUC) After Mixed Meal Tolerance Test (MMTT) at Day 3, 15, 24, 29 and 50: Stage 2 | Baseline (n =7, 4, 7, 7, 6) | 800.66 mg*hr/dL | Standard Deviation 206.776 |
| Stage 1: PF-04856883 12 mg | Change From Baseline in Post-prandial Glucose Area Under the Curve (AUC) After Mixed Meal Tolerance Test (MMTT) at Day 3, 15, 24, 29 and 50: Stage 2 | Change at Day 3 (n =7, 4, 5, 6, 5) | -98.38 mg*hr/dL | Standard Deviation 114.644 |
| Stage 1: PF-04856883 18 mg | Change From Baseline in Post-prandial Glucose Area Under the Curve (AUC) After Mixed Meal Tolerance Test (MMTT) at Day 3, 15, 24, 29 and 50: Stage 2 | Change at Day 3 (n =7, 4, 5, 6, 5) | -68.52 mg*hr/dL | Standard Deviation 153.127 |
| Stage 1: PF-04856883 18 mg | Change From Baseline in Post-prandial Glucose Area Under the Curve (AUC) After Mixed Meal Tolerance Test (MMTT) at Day 3, 15, 24, 29 and 50: Stage 2 | Baseline (n =7, 4, 7, 7, 6) | 723.57 mg*hr/dL | Standard Deviation 220.872 |
| Stage 1: PF-04856883 18 mg | Change From Baseline in Post-prandial Glucose Area Under the Curve (AUC) After Mixed Meal Tolerance Test (MMTT) at Day 3, 15, 24, 29 and 50: Stage 2 | Change at Day 50 (n =7, 3, 6, 6, 6) | -23.99 mg*hr/dL | Standard Deviation 123.611 |
| Stage 1: PF-04856883 18 mg | Change From Baseline in Post-prandial Glucose Area Under the Curve (AUC) After Mixed Meal Tolerance Test (MMTT) at Day 3, 15, 24, 29 and 50: Stage 2 | Change at Day 29 (n =7, 4, 7, 6, 5) | -106.58 mg*hr/dL | Standard Deviation 171.297 |
| Stage 1: PF-04856883 18 mg | Change From Baseline in Post-prandial Glucose Area Under the Curve (AUC) After Mixed Meal Tolerance Test (MMTT) at Day 3, 15, 24, 29 and 50: Stage 2 | Change at Day 24 (n =7, 4, 7, 6, 5) | -121.13 mg*hr/dL | Standard Deviation 258.528 |
| Stage 1: PF-04856883 18 mg | Change From Baseline in Post-prandial Glucose Area Under the Curve (AUC) After Mixed Meal Tolerance Test (MMTT) at Day 3, 15, 24, 29 and 50: Stage 2 | Change at Day 15 (n =7, 4, 6, 6, 6) | -240.65 mg*hr/dL | Standard Deviation 252.349 |
Change From Baseline in Post-prandial Glucose Area Under the Curve (AUC) After Mixed Meal Tolerance Test (MMTT) at Day 3 and 8: Stage 1
Change from baseline in post-prandial area under the plasma glucose concentration time curve as determined by standardized MMTT. Linear trapezoidal method was used to compute AUC
Time frame: Baseline, Day 3 and 8
Population: Pharmacodynamic analysis population included all enrolled participants who had received at least 1 dose of study treatment and have at least 1 pharmacodynamic parameter. Here, 'n' signifies those participants who were evaluable at specified time point for each arm, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Stage 1: PF-04856883 Placebo | Change From Baseline in Post-prandial Glucose Area Under the Curve (AUC) After Mixed Meal Tolerance Test (MMTT) at Day 3 and 8: Stage 1 | Change at Day 3 (n =15, 5, 5, 6, 7, 5, 6) | 7.72 milligram*hour per deciliter (mg*hr/dL) | Standard Deviation 89.366 |
| Stage 1: PF-04856883 Placebo | Change From Baseline in Post-prandial Glucose Area Under the Curve (AUC) After Mixed Meal Tolerance Test (MMTT) at Day 3 and 8: Stage 1 | Change at Day 8 (n =15, 5, 5, 6, 7, 5, 6) | -4.82 milligram*hour per deciliter (mg*hr/dL) | Standard Deviation 75.396 |
| Stage 1: PF-04856883 Placebo | Change From Baseline in Post-prandial Glucose Area Under the Curve (AUC) After Mixed Meal Tolerance Test (MMTT) at Day 3 and 8: Stage 1 | Baseline (n =15, 5, 6, 6, 7, 5, 7) | 656.35 milligram*hour per deciliter (mg*hr/dL) | Standard Deviation 114.496 |
| Stage 1: PF-04856883 4 mg | Change From Baseline in Post-prandial Glucose Area Under the Curve (AUC) After Mixed Meal Tolerance Test (MMTT) at Day 3 and 8: Stage 1 | Change at Day 8 (n =15, 5, 5, 6, 7, 5, 6) | 10.37 milligram*hour per deciliter (mg*hr/dL) | Standard Deviation 158.368 |
| Stage 1: PF-04856883 4 mg | Change From Baseline in Post-prandial Glucose Area Under the Curve (AUC) After Mixed Meal Tolerance Test (MMTT) at Day 3 and 8: Stage 1 | Baseline (n =15, 5, 6, 6, 7, 5, 7) | 834.03 milligram*hour per deciliter (mg*hr/dL) | Standard Deviation 158.952 |
| Stage 1: PF-04856883 4 mg | Change From Baseline in Post-prandial Glucose Area Under the Curve (AUC) After Mixed Meal Tolerance Test (MMTT) at Day 3 and 8: Stage 1 | Change at Day 3 (n =15, 5, 5, 6, 7, 5, 6) | 77.82 milligram*hour per deciliter (mg*hr/dL) | Standard Deviation 125.011 |
| Stage 1: PF-04856883 8 mg | Change From Baseline in Post-prandial Glucose Area Under the Curve (AUC) After Mixed Meal Tolerance Test (MMTT) at Day 3 and 8: Stage 1 | Baseline (n =15, 5, 6, 6, 7, 5, 7) | 712.11 milligram*hour per deciliter (mg*hr/dL) | Standard Deviation 88.942 |
| Stage 1: PF-04856883 8 mg | Change From Baseline in Post-prandial Glucose Area Under the Curve (AUC) After Mixed Meal Tolerance Test (MMTT) at Day 3 and 8: Stage 1 | Change at Day 3 (n =15, 5, 5, 6, 7, 5, 6) | -89.38 milligram*hour per deciliter (mg*hr/dL) | Standard Deviation 58.909 |
| Stage 1: PF-04856883 8 mg | Change From Baseline in Post-prandial Glucose Area Under the Curve (AUC) After Mixed Meal Tolerance Test (MMTT) at Day 3 and 8: Stage 1 | Change at Day 8 (n =15, 5, 5, 6, 7, 5, 6) | 0.85 milligram*hour per deciliter (mg*hr/dL) | Standard Deviation 125.384 |
| Stage 1: PF-04856883 12 mg | Change From Baseline in Post-prandial Glucose Area Under the Curve (AUC) After Mixed Meal Tolerance Test (MMTT) at Day 3 and 8: Stage 1 | Change at Day 8 (n =15, 5, 5, 6, 7, 5, 6) | -82.51 milligram*hour per deciliter (mg*hr/dL) | Standard Deviation 48.898 |
| Stage 1: PF-04856883 12 mg | Change From Baseline in Post-prandial Glucose Area Under the Curve (AUC) After Mixed Meal Tolerance Test (MMTT) at Day 3 and 8: Stage 1 | Baseline (n =15, 5, 6, 6, 7, 5, 7) | 796.14 milligram*hour per deciliter (mg*hr/dL) | Standard Deviation 208.733 |
| Stage 1: PF-04856883 12 mg | Change From Baseline in Post-prandial Glucose Area Under the Curve (AUC) After Mixed Meal Tolerance Test (MMTT) at Day 3 and 8: Stage 1 | Change at Day 3 (n =15, 5, 5, 6, 7, 5, 6) | -101.47 milligram*hour per deciliter (mg*hr/dL) | Standard Deviation 31.725 |
| Stage 1: PF-04856883 18 mg | Change From Baseline in Post-prandial Glucose Area Under the Curve (AUC) After Mixed Meal Tolerance Test (MMTT) at Day 3 and 8: Stage 1 | Baseline (n =15, 5, 6, 6, 7, 5, 7) | 660.64 milligram*hour per deciliter (mg*hr/dL) | Standard Deviation 110.833 |
| Stage 1: PF-04856883 18 mg | Change From Baseline in Post-prandial Glucose Area Under the Curve (AUC) After Mixed Meal Tolerance Test (MMTT) at Day 3 and 8: Stage 1 | Change at Day 3 (n =15, 5, 5, 6, 7, 5, 6) | -68.05 milligram*hour per deciliter (mg*hr/dL) | Standard Deviation 111.431 |
| Stage 1: PF-04856883 18 mg | Change From Baseline in Post-prandial Glucose Area Under the Curve (AUC) After Mixed Meal Tolerance Test (MMTT) at Day 3 and 8: Stage 1 | Change at Day 8 (n =15, 5, 5, 6, 7, 5, 6) | -28.36 milligram*hour per deciliter (mg*hr/dL) | Standard Deviation 61.456 |
| Stage 1: PF-04856883 24 mg | Change From Baseline in Post-prandial Glucose Area Under the Curve (AUC) After Mixed Meal Tolerance Test (MMTT) at Day 3 and 8: Stage 1 | Change at Day 3 (n =15, 5, 5, 6, 7, 5, 6) | -141.27 milligram*hour per deciliter (mg*hr/dL) | Standard Deviation 15.975 |
| Stage 1: PF-04856883 24 mg | Change From Baseline in Post-prandial Glucose Area Under the Curve (AUC) After Mixed Meal Tolerance Test (MMTT) at Day 3 and 8: Stage 1 | Change at Day 8 (n =15, 5, 5, 6, 7, 5, 6) | -123.43 milligram*hour per deciliter (mg*hr/dL) | Standard Deviation 68.219 |
| Stage 1: PF-04856883 24 mg | Change From Baseline in Post-prandial Glucose Area Under the Curve (AUC) After Mixed Meal Tolerance Test (MMTT) at Day 3 and 8: Stage 1 | Baseline (n =15, 5, 6, 6, 7, 5, 7) | 652.20 milligram*hour per deciliter (mg*hr/dL) | Standard Deviation 48.707 |
| Stage 1: PF-04856883 36 mg | Change From Baseline in Post-prandial Glucose Area Under the Curve (AUC) After Mixed Meal Tolerance Test (MMTT) at Day 3 and 8: Stage 1 | Change at Day 8 (n =15, 5, 5, 6, 7, 5, 6) | -39.60 milligram*hour per deciliter (mg*hr/dL) | Standard Deviation 85.256 |
| Stage 1: PF-04856883 36 mg | Change From Baseline in Post-prandial Glucose Area Under the Curve (AUC) After Mixed Meal Tolerance Test (MMTT) at Day 3 and 8: Stage 1 | Baseline (n =15, 5, 6, 6, 7, 5, 7) | 636.57 milligram*hour per deciliter (mg*hr/dL) | Standard Deviation 119.662 |
| Stage 1: PF-04856883 36 mg | Change From Baseline in Post-prandial Glucose Area Under the Curve (AUC) After Mixed Meal Tolerance Test (MMTT) at Day 3 and 8: Stage 1 | Change at Day 3 (n =15, 5, 5, 6, 7, 5, 6) | -153.04 milligram*hour per deciliter (mg*hr/dL) | Standard Deviation 41.501 |
Maximum Observed Plasma Concentration (Cmax) of PF-04856883: Stage 1
Time frame: predose (0 hour), 1, 6, 12, 24, 48, 72, 120, 168, 336, 504, 672 hours postdose on Day 1
Population: Pharmacokinetic (PK) parameter analysis population included all randomized participants who had received at least one dose of study treatment and had at least 1 of the PK parameters of interest.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Stage 1: PF-04856883 Placebo | Maximum Observed Plasma Concentration (Cmax) of PF-04856883: Stage 1 | 181.2 nanogram per milliliter (ng/mL) | Geometric Coefficient of Variation 85 |
| Stage 1: PF-04856883 4 mg | Maximum Observed Plasma Concentration (Cmax) of PF-04856883: Stage 1 | 324.7 nanogram per milliliter (ng/mL) | Geometric Coefficient of Variation 61 |
| Stage 1: PF-04856883 8 mg | Maximum Observed Plasma Concentration (Cmax) of PF-04856883: Stage 1 | 793.7 nanogram per milliliter (ng/mL) | Geometric Coefficient of Variation 65 |
| Stage 1: PF-04856883 12 mg | Maximum Observed Plasma Concentration (Cmax) of PF-04856883: Stage 1 | 1855 nanogram per milliliter (ng/mL) | Geometric Coefficient of Variation 66 |
| Stage 1: PF-04856883 18 mg | Maximum Observed Plasma Concentration (Cmax) of PF-04856883: Stage 1 | 1776 nanogram per milliliter (ng/mL) | Geometric Coefficient of Variation 21 |
| Stage 1: PF-04856883 24 mg | Maximum Observed Plasma Concentration (Cmax) of PF-04856883: Stage 1 | 2006 nanogram per milliliter (ng/mL) | Geometric Coefficient of Variation 52 |
Maximum Observed Plasma Concentration (Cmax) of PF-04856883: Stage 2
Time frame: predose (0 hour), 1, 6, 12, 24, 48, 72, 120, 168, 336 hours postdose on Day 1; predose (0 hour), 1, 2, 6, 24, 48, 72, 120, 168, 336, 504, 672 hours postdose on Day 22
Population: PK parameter analysis population included all randomized participants who had received at least one dose of study treatment and had at least 1 of the PK parameters of interest. Here, 'n' signifies those participants who were evaluable at specified time point for each arm, respectively.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Stage 1: PF-04856883 Placebo | Maximum Observed Plasma Concentration (Cmax) of PF-04856883: Stage 2 | Day 1 (n =5, 7, 7, 6) | 1369 ng/mL | Geometric Coefficient of Variation 17 |
| Stage 1: PF-04856883 Placebo | Maximum Observed Plasma Concentration (Cmax) of PF-04856883: Stage 2 | Day 22 (n =5, 7, 5, 6) | 1802 ng/mL | Geometric Coefficient of Variation 33 |
| Stage 1: PF-04856883 4 mg | Maximum Observed Plasma Concentration (Cmax) of PF-04856883: Stage 2 | Day 22 (n =5, 7, 5, 6) | 2757 ng/mL | Geometric Coefficient of Variation 26 |
| Stage 1: PF-04856883 4 mg | Maximum Observed Plasma Concentration (Cmax) of PF-04856883: Stage 2 | Day 1 (n =5, 7, 7, 6) | 1203 ng/mL | Geometric Coefficient of Variation 20 |
| Stage 1: PF-04856883 8 mg | Maximum Observed Plasma Concentration (Cmax) of PF-04856883: Stage 2 | Day 1 (n =5, 7, 7, 6) | 1027 ng/mL | Geometric Coefficient of Variation 29 |
| Stage 1: PF-04856883 8 mg | Maximum Observed Plasma Concentration (Cmax) of PF-04856883: Stage 2 | Day 22 (n =5, 7, 5, 6) | 3030 ng/mL | Geometric Coefficient of Variation 42 |
| Stage 1: PF-04856883 12 mg | Maximum Observed Plasma Concentration (Cmax) of PF-04856883: Stage 2 | Day 1 (n =5, 7, 7, 6) | 1407 ng/mL | Geometric Coefficient of Variation 29 |
| Stage 1: PF-04856883 12 mg | Maximum Observed Plasma Concentration (Cmax) of PF-04856883: Stage 2 | Day 22 (n =5, 7, 5, 6) | 3046 ng/mL | Geometric Coefficient of Variation 24 |
Number of Participants With Anti-Drug Antibodies (ADA): Stage 1
Time frame: Day 1 and 29
Population: Safety population included all participants who received at least 1 dose of study medication. Here, 'n' signifies those participants who were evaluable at specified time point for each arm, respectively.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Stage 1: PF-04856883 Placebo | Number of Participants With Anti-Drug Antibodies (ADA): Stage 1 | Day 1 (n =5, 6, 6, 7, 5, 7) | 1 participants |
| Stage 1: PF-04856883 Placebo | Number of Participants With Anti-Drug Antibodies (ADA): Stage 1 | Day 29 (n =5, 5, 6, 6, 5, 7) | 1 participants |
| Stage 1: PF-04856883 4 mg | Number of Participants With Anti-Drug Antibodies (ADA): Stage 1 | Day 1 (n =5, 6, 6, 7, 5, 7) | 1 participants |
| Stage 1: PF-04856883 4 mg | Number of Participants With Anti-Drug Antibodies (ADA): Stage 1 | Day 29 (n =5, 5, 6, 6, 5, 7) | 2 participants |
| Stage 1: PF-04856883 8 mg | Number of Participants With Anti-Drug Antibodies (ADA): Stage 1 | Day 1 (n =5, 6, 6, 7, 5, 7) | 0 participants |
| Stage 1: PF-04856883 8 mg | Number of Participants With Anti-Drug Antibodies (ADA): Stage 1 | Day 29 (n =5, 5, 6, 6, 5, 7) | 1 participants |
| Stage 1: PF-04856883 12 mg | Number of Participants With Anti-Drug Antibodies (ADA): Stage 1 | Day 1 (n =5, 6, 6, 7, 5, 7) | 0 participants |
| Stage 1: PF-04856883 12 mg | Number of Participants With Anti-Drug Antibodies (ADA): Stage 1 | Day 29 (n =5, 5, 6, 6, 5, 7) | 0 participants |
| Stage 1: PF-04856883 18 mg | Number of Participants With Anti-Drug Antibodies (ADA): Stage 1 | Day 1 (n =5, 6, 6, 7, 5, 7) | 0 participants |
| Stage 1: PF-04856883 18 mg | Number of Participants With Anti-Drug Antibodies (ADA): Stage 1 | Day 29 (n =5, 5, 6, 6, 5, 7) | 0 participants |
| Stage 1: PF-04856883 24 mg | Number of Participants With Anti-Drug Antibodies (ADA): Stage 1 | Day 1 (n =5, 6, 6, 7, 5, 7) | 2 participants |
| Stage 1: PF-04856883 24 mg | Number of Participants With Anti-Drug Antibodies (ADA): Stage 1 | Day 29 (n =5, 5, 6, 6, 5, 7) | 2 participants |
Number of Participant With Anti-Drug Antibodies (ADA): Stage 2
Time frame: Day 1, 29 and 50
Population: Safety population included all participants who received at least 1 dose of study medication. Here, 'n' signifies those participants who were evaluable at specified time point for each arm, respectively.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Stage 1: PF-04856883 Placebo | Number of Participant With Anti-Drug Antibodies (ADA): Stage 2 | Day 1 (n =5, 7, 7, 6) | 0 participants |
| Stage 1: PF-04856883 Placebo | Number of Participant With Anti-Drug Antibodies (ADA): Stage 2 | Day 50 (n =5, 7, 6, 6) | 0 participants |
| Stage 1: PF-04856883 Placebo | Number of Participant With Anti-Drug Antibodies (ADA): Stage 2 | Day 29 (n =5, 7, 6, 5) | 0 participants |
| Stage 1: PF-04856883 4 mg | Number of Participant With Anti-Drug Antibodies (ADA): Stage 2 | Day 1 (n =5, 7, 7, 6) | 1 participants |
| Stage 1: PF-04856883 4 mg | Number of Participant With Anti-Drug Antibodies (ADA): Stage 2 | Day 29 (n =5, 7, 6, 5) | 2 participants |
| Stage 1: PF-04856883 4 mg | Number of Participant With Anti-Drug Antibodies (ADA): Stage 2 | Day 50 (n =5, 7, 6, 6) | 3 participants |
| Stage 1: PF-04856883 8 mg | Number of Participant With Anti-Drug Antibodies (ADA): Stage 2 | Day 29 (n =5, 7, 6, 5) | 2 participants |
| Stage 1: PF-04856883 8 mg | Number of Participant With Anti-Drug Antibodies (ADA): Stage 2 | Day 1 (n =5, 7, 7, 6) | 1 participants |
| Stage 1: PF-04856883 8 mg | Number of Participant With Anti-Drug Antibodies (ADA): Stage 2 | Day 50 (n =5, 7, 6, 6) | 2 participants |
| Stage 1: PF-04856883 12 mg | Number of Participant With Anti-Drug Antibodies (ADA): Stage 2 | Day 50 (n =5, 7, 6, 6) | 3 participants |
| Stage 1: PF-04856883 12 mg | Number of Participant With Anti-Drug Antibodies (ADA): Stage 2 | Day 1 (n =5, 7, 7, 6) | 0 participants |
| Stage 1: PF-04856883 12 mg | Number of Participant With Anti-Drug Antibodies (ADA): Stage 2 | Day 29 (n =5, 7, 6, 5) | 1 participants |
Percent Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Day 29 and 50: Stage 2
HbA1c is a measure of the glycosylated hemoglobin. Change (measured as percent): HbA1c at observation minus HbA1c at baseline. Outcome measure was planned to analyzed only for Stage 2.
Time frame: Baseline, Day 29 and 50
Population: Pharmacodynamic analysis population included all enrolled participants who had received at least 1 dose of study treatment and have at least 1 pharmacodynamic parameter. Here, 'n' signifies those participants who were evaluable at specified time point for each arm, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Stage 1: PF-04856883 Placebo | Percent Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Day 29 and 50: Stage 2 | Day 50 (n =6, 5, 7, 7, 6) | 0.15 percent | Standard Deviation 0.769 |
| Stage 1: PF-04856883 Placebo | Percent Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Day 29 and 50: Stage 2 | Day 29 (n =7, 5, 7, 6, 5) | 0.06 percent | Standard Deviation 0.547 |
| Stage 1: PF-04856883 4 mg | Percent Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Day 29 and 50: Stage 2 | Day 50 (n =6, 5, 7, 7, 6) | -0.08 percent | Standard Deviation 0.335 |
| Stage 1: PF-04856883 4 mg | Percent Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Day 29 and 50: Stage 2 | Day 29 (n =7, 5, 7, 6, 5) | -0.24 percent | Standard Deviation 0.288 |
| Stage 1: PF-04856883 8 mg | Percent Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Day 29 and 50: Stage 2 | Day 50 (n =6, 5, 7, 7, 6) | -0.24 percent | Standard Deviation 0.326 |
| Stage 1: PF-04856883 8 mg | Percent Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Day 29 and 50: Stage 2 | Day 29 (n =7, 5, 7, 6, 5) | -0.41 percent | Standard Deviation 0.212 |
| Stage 1: PF-04856883 12 mg | Percent Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Day 29 and 50: Stage 2 | Day 29 (n =7, 5, 7, 6, 5) | -0.42 percent | Standard Deviation 0.44 |
| Stage 1: PF-04856883 12 mg | Percent Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Day 29 and 50: Stage 2 | Day 50 (n =6, 5, 7, 7, 6) | -0.33 percent | Standard Deviation 0.754 |
| Stage 1: PF-04856883 18 mg | Percent Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Day 29 and 50: Stage 2 | Day 29 (n =7, 5, 7, 6, 5) | -0.40 percent | Standard Deviation 0.43 |
| Stage 1: PF-04856883 18 mg | Percent Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Day 29 and 50: Stage 2 | Day 50 (n =6, 5, 7, 7, 6) | -0.40 percent | Standard Deviation 0.58 |
Terminal Elimination Half- Life (t1/2) of PF-04856883: Stage 1
Time frame: predose (0 hour), 1, 6, 12, 24, 48, 72, 120, 168, 336, 504, 672 hours postdose on Day 1
Population: PK parameter analysis population included all randomized participants who had received at least one dose of study treatment and had at least 1 of the PK parameters of interest. Here, 'N' signifies those participants who were evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Stage 1: PF-04856883 Placebo | Terminal Elimination Half- Life (t1/2) of PF-04856883: Stage 1 | 146.3 hour | Standard Deviation 13.614 |
| Stage 1: PF-04856883 4 mg | Terminal Elimination Half- Life (t1/2) of PF-04856883: Stage 1 | 179.7 hour | Standard Deviation 14.572 |
| Stage 1: PF-04856883 8 mg | Terminal Elimination Half- Life (t1/2) of PF-04856883: Stage 1 | 147.0 hour | Standard Deviation 18.52 |
| Stage 1: PF-04856883 12 mg | Terminal Elimination Half- Life (t1/2) of PF-04856883: Stage 1 | 133.8 hour | Standard Deviation 23.936 |
| Stage 1: PF-04856883 18 mg | Terminal Elimination Half- Life (t1/2) of PF-04856883: Stage 1 | 173.7 hour | Standard Deviation 7.0238 |
| Stage 1: PF-04856883 24 mg | Terminal Elimination Half- Life (t1/2) of PF-04856883: Stage 1 | 131.6 hour | Standard Deviation 45.883 |
Terminal Elimination Half-life (t1/2) of PF-04856883: Stage 2
Time frame: predose (0 hour), 1, 2, 6, 24, 48, 72, 120, 168, 336, 504, 672 hours postdose on Day 22
Population: PK parameter analysis population included all randomized participants who had received at least one dose of study treatment and had at least 1 of the PK parameters of interest. Here, 'N' signifies those participants who were evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Stage 1: PF-04856883 Placebo | Terminal Elimination Half-life (t1/2) of PF-04856883: Stage 2 | 149.4 hour | Standard Deviation 21.87 |
| Stage 1: PF-04856883 4 mg | Terminal Elimination Half-life (t1/2) of PF-04856883: Stage 2 | 135.0 hour | Standard Deviation 43.98 |
| Stage 1: PF-04856883 8 mg | Terminal Elimination Half-life (t1/2) of PF-04856883: Stage 2 | 143.8 hour | Standard Deviation 20.565 |
| Stage 1: PF-04856883 12 mg | Terminal Elimination Half-life (t1/2) of PF-04856883: Stage 2 | 145.0 hour | Standard Deviation 37 |
Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-04856883: Stage 1
Time frame: predose (0 hour), 1, 6, 12, 24, 48, 72, 120, 168, 336, 504, 672 hours postdose on Day 1
Population: PK parameter analysis population included all randomized participants who had received at least one dose of study treatment and had at least 1 of the PK parameters of interest.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Stage 1: PF-04856883 Placebo | Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-04856883: Stage 1 | 168 hour |
| Stage 1: PF-04856883 4 mg | Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-04856883: Stage 1 | 120 hour |
| Stage 1: PF-04856883 8 mg | Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-04856883: Stage 1 | 120 hour |
| Stage 1: PF-04856883 12 mg | Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-04856883: Stage 1 | 120 hour |
| Stage 1: PF-04856883 18 mg | Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-04856883: Stage 1 | 120 hour |
| Stage 1: PF-04856883 24 mg | Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-04856883: Stage 1 | 122 hour |
Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-04856883: Stage 2
Time frame: predose (0 hour), 1, 6, 12, 24, 48, 72, 120, 168, 336 hours postdose on Day 1; predose (0 hour), 1, 2, 6, 24, 48, 72, 120, 168, 336, 504, 672 hours postdose on Day 22
Population: PK parameter analysis population included all randomized participants who had received at least one dose of study treatment and had at least 1 of the PK parameters of interest. Here, 'n' signifies those participants who were evaluable at specified time point for each arm, respectively.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Stage 1: PF-04856883 Placebo | Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-04856883: Stage 2 | Day 1 (n =5, 7, 7, 6) | 336 hour |
| Stage 1: PF-04856883 Placebo | Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-04856883: Stage 2 | Day 22 (n =5, 7, 5, 6) | 48.0 hour |
| Stage 1: PF-04856883 4 mg | Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-04856883: Stage 2 | Day 22 (n =5, 7, 5, 6) | 72.0 hour |
| Stage 1: PF-04856883 4 mg | Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-04856883: Stage 2 | Day 1 (n =5, 7, 7, 6) | 336 hour |
| Stage 1: PF-04856883 8 mg | Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-04856883: Stage 2 | Day 1 (n =5, 7, 7, 6) | 335 hour |
| Stage 1: PF-04856883 8 mg | Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-04856883: Stage 2 | Day 22 (n =5, 7, 5, 6) | 72.0 hour |
| Stage 1: PF-04856883 12 mg | Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-04856883: Stage 2 | Day 1 (n =5, 7, 7, 6) | 336 hour |
| Stage 1: PF-04856883 12 mg | Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-04856883: Stage 2 | Day 22 (n =5, 7, 5, 6) | 60.0 hour |