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Single-Dose And Multiple-Dose Safety And Tolerability Study Of PF-04856883 In Type 2 Diabetic Adult Females

A Phase 1, Double-blind, Placebo-controlled, Randomized, Parallel Group Study To Assess The Safety, Tolerability, Pharmacokinetics, And Pharmacodynamics Of Pf-04856883 In Adult Female Subjects With Type 2 Diabetes Mellitus

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01301456
Enrollment
84
Registered
2011-02-23
Start date
2011-03-31
Completion date
2012-04-30
Last updated
2018-02-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus, Diabetes Mellitus, Type 2, Endocrine System Diseases, Glucose Metabolism Disorders, Metabolic Diseases

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

BIOLOGICALPlacebo

Single subcutaneous injection of placebo

BIOLOGICALPF-04856883

Single subcutaneous injection of PF-04856883

Sponsors

Pfizer
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 70 Years
Healthy volunteers
No

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

MeasureTime frameDescription
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 50An 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 FindingsStage 1: Baseline up to Day 29; Stage 2: Baseline up to Day 50Physical 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 50ECG 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 AbnormalitiesStage 1: Baseline up to Day 29; Stage 2 : Baseline up to Day 50Criteria 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 MeasurementsStage 1: Baseline up to Day 29; Stage 2: Baseline up to Day 50Following 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

MeasureTime frameDescription
Area Under the Concentration Time Curve From Time Zero to Time Tau (AUCtau) of PF-04856883: Stage 2predose (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 22Area 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 1predose (0 hour), 1, 6, 12, 24, 48, 72, 120, 168, 336, 504, 672 hours postdose on Day 1It 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 2predose (0 hour), 1, 2, 6, 24, 48, 72, 120, 168, 336, 504, 672 hours postdose on Day 22It 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 1predose (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 2predose (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 1predose (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 2predose (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 1Baseline, Day 3 and 8Change 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 2Baseline, Day 3, 15, 24, 29 and 50Change 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 1Baseline, Day 3 and 8Change 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 2Baseline, Day 3, 15, 24, 29 and 50Change 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 1predose (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 2Baseline, Day 3, 15, 24, 29 and 50Change 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 1Baseline, 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 2Baseline, 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 2Baseline, Day 30A 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 2Baseline, Day 29 and 50HbA1c 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 1Baseline, Day 8, 15 and 29
Change From Baseline in Fructosamine Levels at Day 8, 15, 22, 29 and 50: Stage 2Baseline, Day 8, 15, 22, 29 and 50
Change From Baseline in 1, 5 Anhydroglucitol at Day 8, 15 and 29: Stage 1Baseline, Day 8, 15 and 29
Change From Baseline in 1, 5 Anhydroglucitol at Day 8, 15, 22, 29 and 50: Stage 2Baseline, Day 8, 15, 22, 29 and 50
Number of Participants With Anti-Drug Antibodies (ADA): Stage 1Day 1 and 29
Number of Participant With Anti-Drug Antibodies (ADA): Stage 2Day 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 1Baseline, Day 3 and 8Change 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 2predose (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 1predose (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 2predose (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 1predose (0 hour), 1, 6, 12, 24, 48, 72, 120, 168, 336, 504, 672 hours postdose on Day 1AUC (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

ArmCount
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
Total84

Withdrawals & dropouts

PeriodReasonFG000FG001FG002FG003FG004FG005FG006FG007FG008FG009FG010FG011
Stage 1Randomized but not treated000000100000
Stage 1Withdrawal by Subject001010000000
Stage 2Adverse Event000000000010

Baseline characteristics

CharacteristicTotalStage 1: PF-04856883 4 mgStage 1: PF-04856883 8 mgStage 1: PF-04856883 12 mgStage 1: PF-04856883 18 mgStage 1: PF-04856883 24 mgStage 1: PF-04856883 36 mgStage 2: PlaceboStage 2: PF-04856883 12 mgStage 2: PF-04856883 12 mg + 12 mg + 24 mg + 24 mgStage 2: PF-04856883 8 mg + 8 mg + 16 mg + 24 mgStage 2: PF-04856883 12 mg + 20 mg + 28 mg + 36 mgStage 1: PF-04856883 Placebo
Age, Customized
<18 years
0 participants0 participants0 participants0 participants0 participants0 participants0 participants0 participants0 participants0 participants0 participants0 participants0 participants
Age, Customized
>=65 years
13 participants2 participants1 participants2 participants1 participants1 participants2 participants1 participants0 participants3 participants0 participants0 participants0 participants
Age, Customized
Between 18 and 64 years
71 participants3 participants5 participants4 participants6 participants4 participants6 participants6 participants5 participants4 participants7 participants6 participants15 participants
Sex: Female, Male
Female
84 Participants5 Participants6 Participants6 Participants7 Participants5 Participants8 Participants7 Participants5 Participants7 Participants7 Participants6 Participants15 Participants
Sex: Female, Male
Male
0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants

Adverse events

Event typeEG000
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 / 151 / 50 / 62 / 64 / 73 / 54 / 74 / 75 / 55 / 75 / 75 / 6
serious
Total, serious adverse events
0 / 150 / 50 / 60 / 60 / 70 / 50 / 70 / 70 / 50 / 70 / 70 / 6

Outcome results

Primary

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.

ArmMeasureValue (NUMBER)
Stage 1: PF-04856883 PlaceboNumber of Participants With Clinically Significant Abnormalities in Laboratory Measurements15 participants
Stage 1: PF-04856883 4 mgNumber of Participants With Clinically Significant Abnormalities in Laboratory Measurements5 participants
Stage 1: PF-04856883 8 mgNumber of Participants With Clinically Significant Abnormalities in Laboratory Measurements6 participants
Stage 1: PF-04856883 12 mgNumber of Participants With Clinically Significant Abnormalities in Laboratory Measurements6 participants
Stage 1: PF-04856883 18 mgNumber of Participants With Clinically Significant Abnormalities in Laboratory Measurements7 participants
Stage 1: PF-04856883 24 mgNumber of Participants With Clinically Significant Abnormalities in Laboratory Measurements4 participants
Stage 1: PF-04856883 36 mgNumber of Participants With Clinically Significant Abnormalities in Laboratory Measurements6 participants
Stage 2: PlaceboNumber of Participants With Clinically Significant Abnormalities in Laboratory Measurements7 participants
Stage 2: PF-04856883 12 mgNumber of Participants With Clinically Significant Abnormalities in Laboratory Measurements5 participants
Stage 2: PF-04856883 12 mg + 12 mg + 24 mg + 24 mgNumber of Participants With Clinically Significant Abnormalities in Laboratory Measurements7 participants
Stage 2: PF-04856883 8 mg + 8 mg + 16 mg + 24 mgNumber of Participants With Clinically Significant Abnormalities in Laboratory Measurements7 participants
Stage 2: PF-04856883 12 mg + 20 mg + 28 mg + 36 mgNumber of Participants With Clinically Significant Abnormalities in Laboratory Measurements6 participants
Primary

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.

ArmMeasureGroupValue (NUMBER)
Stage 1: PF-04856883 PlaceboNumber of Participants With Clinically Significant Change From Baseline in 12-lead Electrocardiograms (ECG)Maximum QTcB Interval IFB: 30-<60 msec0 participants
Stage 1: PF-04856883 PlaceboNumber 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 PlaceboNumber of Participants With Clinically Significant Change From Baseline in 12-lead Electrocardiograms (ECG)Maximum QTcF Interval IFB: 30-<60 msec0 participants
Stage 1: PF-04856883 4 mgNumber of Participants With Clinically Significant Change From Baseline in 12-lead Electrocardiograms (ECG)Maximum QTcF Interval IFB: 30-<60 msec0 participants
Stage 1: PF-04856883 4 mgNumber of Participants With Clinically Significant Change From Baseline in 12-lead Electrocardiograms (ECG)Maximum QTcB Interval IFB: 30-<60 msec0 participants
Stage 1: PF-04856883 4 mgNumber 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 mgNumber of Participants With Clinically Significant Change From Baseline in 12-lead Electrocardiograms (ECG)Maximum QTcF Interval IFB: 30-<60 msec0 participants
Stage 1: PF-04856883 8 mgNumber 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 mgNumber of Participants With Clinically Significant Change From Baseline in 12-lead Electrocardiograms (ECG)Maximum QTcB Interval IFB: 30-<60 msec0 participants
Stage 1: PF-04856883 12 mgNumber of Participants With Clinically Significant Change From Baseline in 12-lead Electrocardiograms (ECG)Maximum QTcB Interval IFB: 30-<60 msec0 participants
Stage 1: PF-04856883 12 mgNumber of Participants With Clinically Significant Change From Baseline in 12-lead Electrocardiograms (ECG)Maximum QTcF Interval IFB: 30-<60 msec0 participants
Stage 1: PF-04856883 12 mgNumber 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 mgNumber of Participants With Clinically Significant Change From Baseline in 12-lead Electrocardiograms (ECG)Maximum QTcB Interval IFB: 30-<60 msec0 participants
Stage 1: PF-04856883 18 mgNumber 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 mgNumber of Participants With Clinically Significant Change From Baseline in 12-lead Electrocardiograms (ECG)Maximum QTcF Interval IFB: 30-<60 msec0 participants
Stage 1: PF-04856883 24 mgNumber 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 mgNumber of Participants With Clinically Significant Change From Baseline in 12-lead Electrocardiograms (ECG)Maximum QTcF Interval IFB: 30-<60 msec1 participants
Stage 1: PF-04856883 24 mgNumber of Participants With Clinically Significant Change From Baseline in 12-lead Electrocardiograms (ECG)Maximum QTcB Interval IFB: 30-<60 msec1 participants
Stage 1: PF-04856883 36 mgNumber 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 mgNumber of Participants With Clinically Significant Change From Baseline in 12-lead Electrocardiograms (ECG)Maximum QTcB Interval IFB: 30-<60 msec1 participants
Stage 1: PF-04856883 36 mgNumber of Participants With Clinically Significant Change From Baseline in 12-lead Electrocardiograms (ECG)Maximum QTcF Interval IFB: 30-<60 msec0 participants
Stage 2: PlaceboNumber of Participants With Clinically Significant Change From Baseline in 12-lead Electrocardiograms (ECG)Maximum PR Interval IFB: >=25 or 50%1 participants
Stage 2: PlaceboNumber of Participants With Clinically Significant Change From Baseline in 12-lead Electrocardiograms (ECG)Maximum QTcB Interval IFB: 30-<60 msec0 participants
Stage 2: PlaceboNumber of Participants With Clinically Significant Change From Baseline in 12-lead Electrocardiograms (ECG)Maximum QTcF Interval IFB: 30-<60 msec0 participants
Stage 2: PF-04856883 12 mgNumber 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 mgNumber of Participants With Clinically Significant Change From Baseline in 12-lead Electrocardiograms (ECG)Maximum QTcB Interval IFB: 30-<60 msec1 participants
Stage 2: PF-04856883 12 mgNumber of Participants With Clinically Significant Change From Baseline in 12-lead Electrocardiograms (ECG)Maximum QTcF Interval IFB: 30-<60 msec1 participants
Stage 2: PF-04856883 12 mg + 12 mg + 24 mg + 24 mgNumber of Participants With Clinically Significant Change From Baseline in 12-lead Electrocardiograms (ECG)Maximum QTcF Interval IFB: 30-<60 msec0 participants
Stage 2: PF-04856883 12 mg + 12 mg + 24 mg + 24 mgNumber of Participants With Clinically Significant Change From Baseline in 12-lead Electrocardiograms (ECG)Maximum QTcB Interval IFB: 30-<60 msec0 participants
Stage 2: PF-04856883 12 mg + 12 mg + 24 mg + 24 mgNumber 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 mgNumber 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 mgNumber of Participants With Clinically Significant Change From Baseline in 12-lead Electrocardiograms (ECG)Maximum QTcF Interval IFB: 30-<60 msec0 participants
Stage 2: PF-04856883 8 mg + 8 mg + 16 mg + 24 mgNumber of Participants With Clinically Significant Change From Baseline in 12-lead Electrocardiograms (ECG)Maximum QTcB Interval IFB: 30-<60 msec0 participants
Stage 2: PF-04856883 12 mg + 20 mg + 28 mg + 36 mgNumber of Participants With Clinically Significant Change From Baseline in 12-lead Electrocardiograms (ECG)Maximum QTcF Interval IFB: 30-<60 msec0 participants
Stage 2: PF-04856883 12 mg + 20 mg + 28 mg + 36 mgNumber 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 mgNumber of Participants With Clinically Significant Change From Baseline in 12-lead Electrocardiograms (ECG)Maximum QTcB Interval IFB: 30-<60 msec1 participants
Primary

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.

ArmMeasureValue (NUMBER)
Stage 1: PF-04856883 PlaceboNumber of Participants With Clinically Significant Physical Examination Findings0 participants
Stage 1: PF-04856883 4 mgNumber of Participants With Clinically Significant Physical Examination Findings0 participants
Stage 1: PF-04856883 8 mgNumber of Participants With Clinically Significant Physical Examination Findings0 participants
Stage 1: PF-04856883 12 mgNumber of Participants With Clinically Significant Physical Examination Findings0 participants
Stage 1: PF-04856883 18 mgNumber of Participants With Clinically Significant Physical Examination Findings0 participants
Stage 1: PF-04856883 24 mgNumber of Participants With Clinically Significant Physical Examination Findings0 participants
Stage 1: PF-04856883 36 mgNumber of Participants With Clinically Significant Physical Examination Findings0 participants
Stage 2: PlaceboNumber of Participants With Clinically Significant Physical Examination Findings0 participants
Stage 2: PF-04856883 12 mgNumber of Participants With Clinically Significant Physical Examination Findings0 participants
Stage 2: PF-04856883 12 mg + 12 mg + 24 mg + 24 mgNumber of Participants With Clinically Significant Physical Examination Findings0 participants
Stage 2: PF-04856883 8 mg + 8 mg + 16 mg + 24 mgNumber of Participants With Clinically Significant Physical Examination Findings0 participants
Stage 2: PF-04856883 12 mg + 20 mg + 28 mg + 36 mgNumber of Participants With Clinically Significant Physical Examination Findings0 participants
Primary

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.

ArmMeasureGroupValue (NUMBER)
Stage 1: PF-04856883 PlaceboNumber of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)SAE0 participants
Stage 1: PF-04856883 PlaceboNumber of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)AE8 participants
Stage 1: PF-04856883 4 mgNumber of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)AE1 participants
Stage 1: PF-04856883 4 mgNumber of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)SAE0 participants
Stage 1: PF-04856883 8 mgNumber of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)AE0 participants
Stage 1: PF-04856883 8 mgNumber of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)SAE0 participants
Stage 1: PF-04856883 12 mgNumber of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)SAE0 participants
Stage 1: PF-04856883 12 mgNumber of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)AE2 participants
Stage 1: PF-04856883 18 mgNumber of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)SAE0 participants
Stage 1: PF-04856883 18 mgNumber of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)AE4 participants
Stage 1: PF-04856883 24 mgNumber of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)SAE0 participants
Stage 1: PF-04856883 24 mgNumber of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)AE3 participants
Stage 1: PF-04856883 36 mgNumber of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)SAE0 participants
Stage 1: PF-04856883 36 mgNumber of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)AE4 participants
Stage 2: PlaceboNumber of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)AE4 participants
Stage 2: PlaceboNumber of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)SAE0 participants
Stage 2: PF-04856883 12 mgNumber of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)AE5 participants
Stage 2: PF-04856883 12 mgNumber of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)SAE0 participants
Stage 2: PF-04856883 12 mg + 12 mg + 24 mg + 24 mgNumber of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)SAE0 participants
Stage 2: PF-04856883 12 mg + 12 mg + 24 mg + 24 mgNumber of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)AE5 participants
Stage 2: PF-04856883 8 mg + 8 mg + 16 mg + 24 mgNumber of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)SAE0 participants
Stage 2: PF-04856883 8 mg + 8 mg + 16 mg + 24 mgNumber of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)AE5 participants
Stage 2: PF-04856883 12 mg + 20 mg + 28 mg + 36 mgNumber of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)SAE0 participants
Stage 2: PF-04856883 12 mg + 20 mg + 28 mg + 36 mgNumber of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)AE5 participants
Primary

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.

ArmMeasureValue (NUMBER)
Stage 1: PF-04856883 PlaceboNumber of Participants With Vital Sign Abnormalities15 participants
Stage 1: PF-04856883 4 mgNumber of Participants With Vital Sign Abnormalities5 participants
Stage 1: PF-04856883 8 mgNumber of Participants With Vital Sign Abnormalities6 participants
Stage 1: PF-04856883 12 mgNumber of Participants With Vital Sign Abnormalities6 participants
Stage 1: PF-04856883 18 mgNumber of Participants With Vital Sign Abnormalities7 participants
Stage 1: PF-04856883 24 mgNumber of Participants With Vital Sign Abnormalities5 participants
Stage 1: PF-04856883 36 mgNumber of Participants With Vital Sign Abnormalities7 participants
Stage 2: PlaceboNumber of Participants With Vital Sign Abnormalities7 participants
Stage 2: PF-04856883 12 mgNumber of Participants With Vital Sign Abnormalities5 participants
Stage 2: PF-04856883 12 mg + 12 mg + 24 mg + 24 mgNumber of Participants With Vital Sign Abnormalities7 participants
Stage 2: PF-04856883 8 mg + 8 mg + 16 mg + 24 mgNumber of Participants With Vital Sign Abnormalities7 participants
Stage 2: PF-04856883 12 mg + 20 mg + 28 mg + 36 mgNumber of Participants With Vital Sign Abnormalities6 participants
Secondary

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.

ArmMeasureValue (GEOMETRIC_MEAN)Dispersion
Stage 1: PF-04856883 PlaceboApparent Clearance (CL/F) of PF-04856883: Stage 189.14 milliliter per hour (mL/hr)Geometric Coefficient of Variation 84
Stage 1: PF-04856883 4 mgApparent Clearance (CL/F) of PF-04856883: Stage 184.08 milliliter per hour (mL/hr)Geometric Coefficient of Variation 59
Stage 1: PF-04856883 8 mgApparent Clearance (CL/F) of PF-04856883: Stage 140.60 milliliter per hour (mL/hr)Geometric Coefficient of Variation 68
Stage 1: PF-04856883 12 mgApparent Clearance (CL/F) of PF-04856883: Stage 134.13 milliliter per hour (mL/hr)Geometric Coefficient of Variation 35
Stage 1: PF-04856883 18 mgApparent Clearance (CL/F) of PF-04856883: Stage 133.73 milliliter per hour (mL/hr)Geometric Coefficient of Variation 14
Stage 1: PF-04856883 24 mgApparent Clearance (CL/F) of PF-04856883: Stage 155.32 milliliter per hour (mL/hr)Geometric Coefficient of Variation 42
Secondary

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.

ArmMeasureValue (GEOMETRIC_MEAN)Dispersion
Stage 1: PF-04856883 PlaceboApparent Clearance (CL/F) of PF-04856883: Stage 244.67 mL/hrGeometric Coefficient of Variation 28
Stage 1: PF-04856883 4 mgApparent Clearance (CL/F) of PF-04856883: Stage 2NA mL/hr
Stage 1: PF-04856883 8 mgApparent Clearance (CL/F) of PF-04856883: Stage 2NA mL/hr
Stage 1: PF-04856883 12 mgApparent Clearance (CL/F) of PF-04856883: Stage 2NA mL/hr
Secondary

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.

ArmMeasureValue (GEOMETRIC_MEAN)Dispersion
Stage 1: PF-04856883 PlaceboApparent Volume of Distribution (Vz/F) of PF-04856883: Stage 118760 milliliter (mL)Geometric Coefficient of Variation 90
Stage 1: PF-04856883 4 mgApparent Volume of Distribution (Vz/F) of PF-04856883: Stage 121710 milliliter (mL)Geometric Coefficient of Variation 59
Stage 1: PF-04856883 8 mgApparent Volume of Distribution (Vz/F) of PF-04856883: Stage 19191 milliliter (mL)Geometric Coefficient of Variation 51
Stage 1: PF-04856883 12 mgApparent Volume of Distribution (Vz/F) of PF-04856883: Stage 17127 milliliter (mL)Geometric Coefficient of Variation 40
Stage 1: PF-04856883 18 mgApparent Volume of Distribution (Vz/F) of PF-04856883: Stage 18437 milliliter (mL)Geometric Coefficient of Variation 17
Stage 1: PF-04856883 24 mgApparent Volume of Distribution (Vz/F) of PF-04856883: Stage 110010 milliliter (mL)Geometric Coefficient of Variation 67
Secondary

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.

ArmMeasureValue (GEOMETRIC_MEAN)Dispersion
Stage 1: PF-04856883 PlaceboApparent Volume of Distribution (Vz/F) of PF-04856883: Stage 29550 mLGeometric Coefficient of Variation 29
Stage 1: PF-04856883 4 mgApparent Volume of Distribution (Vz/F) of PF-04856883: Stage 2NA mL
Stage 1: PF-04856883 8 mgApparent Volume of Distribution (Vz/F) of PF-04856883: Stage 2NA mL
Stage 1: PF-04856883 12 mgApparent Volume of Distribution (Vz/F) of PF-04856883: Stage 2NA mL
Secondary

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.

ArmMeasureGroupValue (GEOMETRIC_MEAN)Dispersion
Stage 1: PF-04856883 PlaceboArea Under the Concentration Time Curve From Time Zero to Time Tau (AUCtau) of PF-04856883: Stage 2Day 1 (n =5, 7, 7, 6)85370 ng*hr/mLGeometric Coefficient of Variation 38
Stage 1: PF-04856883 PlaceboArea Under the Concentration Time Curve From Time Zero to Time Tau (AUCtau) of PF-04856883: Stage 2Day 22 (n =5, 7, 5, 6)269000 ng*hr/mLGeometric Coefficient of Variation 32
Stage 1: PF-04856883 4 mgArea Under the Concentration Time Curve From Time Zero to Time Tau (AUCtau) of PF-04856883: Stage 2Day 22 (n =5, 7, 5, 6)377400 ng*hr/mLGeometric Coefficient of Variation 28
Stage 1: PF-04856883 4 mgArea Under the Concentration Time Curve From Time Zero to Time Tau (AUCtau) of PF-04856883: Stage 2Day 1 (n =5, 7, 7, 6)99780 ng*hr/mLGeometric Coefficient of Variation 41
Stage 1: PF-04856883 8 mgArea Under the Concentration Time Curve From Time Zero to Time Tau (AUCtau) of PF-04856883: Stage 2Day 1 (n =5, 7, 7, 6)89390 ng*hr/mLGeometric Coefficient of Variation 35
Stage 1: PF-04856883 8 mgArea Under the Concentration Time Curve From Time Zero to Time Tau (AUCtau) of PF-04856883: Stage 2Day 22 (n =5, 7, 5, 6)396300 ng*hr/mLGeometric Coefficient of Variation 28
Stage 1: PF-04856883 12 mgArea Under the Concentration Time Curve From Time Zero to Time Tau (AUCtau) of PF-04856883: Stage 2Day 1 (n =5, 7, 7, 6)91130 ng*hr/mLGeometric Coefficient of Variation 27
Stage 1: PF-04856883 12 mgArea Under the Concentration Time Curve From Time Zero to Time Tau (AUCtau) of PF-04856883: Stage 2Day 22 (n =5, 7, 5, 6)430500 ng*hr/mLGeometric Coefficient of Variation 23
Secondary

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.

ArmMeasureValue (GEOMETRIC_MEAN)Dispersion
Stage 1: PF-04856883 PlaceboArea Under the Curve From Time Zero to Extrapolated Infinite Time (AUC [0 - ∞]) of PF-04856883: Stage 144920 nanogram*hour per milliliter (ng*hr/mL)Geometric Coefficient of Variation 112
Stage 1: PF-04856883 4 mgArea Under the Curve From Time Zero to Extrapolated Infinite Time (AUC [0 - ∞]) of PF-04856883: Stage 195190 nanogram*hour per milliliter (ng*hr/mL)Geometric Coefficient of Variation 76
Stage 1: PF-04856883 8 mgArea Under the Curve From Time Zero to Extrapolated Infinite Time (AUC [0 - ∞]) of PF-04856883: Stage 1295200 nanogram*hour per milliliter (ng*hr/mL)Geometric Coefficient of Variation 46
Stage 1: PF-04856883 12 mgArea Under the Curve From Time Zero to Extrapolated Infinite Time (AUC [0 - ∞]) of PF-04856883: Stage 1527100 nanogram*hour per milliliter (ng*hr/mL)Geometric Coefficient of Variation 53
Stage 1: PF-04856883 18 mgArea Under the Curve From Time Zero to Extrapolated Infinite Time (AUC [0 - ∞]) of PF-04856883: Stage 1711300 nanogram*hour per milliliter (ng*hr/mL)Geometric Coefficient of Variation 13
Stage 1: PF-04856883 24 mgArea Under the Curve From Time Zero to Extrapolated Infinite Time (AUC [0 - ∞]) of PF-04856883: Stage 1652000 nanogram*hour per milliliter (ng*hr/mL)Geometric Coefficient of Variation 50
Secondary

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.

ArmMeasureGroupValue (MEAN)Dispersion
Stage 1: PF-04856883 PlaceboChange From Baseline in 1, 5 Anhydroglucitol at Day 8, 15, 22, 29 and 50: Stage 2Change at Day 8 (n =7, 5, 7, 6, 6)-0.10 mcg/mLStandard Deviation 0.663
Stage 1: PF-04856883 PlaceboChange From Baseline in 1, 5 Anhydroglucitol at Day 8, 15, 22, 29 and 50: Stage 2Baseline (n =7, 5, 7, 7, 6)7.66 mcg/mLStandard Deviation 4.351
Stage 1: PF-04856883 PlaceboChange From Baseline in 1, 5 Anhydroglucitol at Day 8, 15, 22, 29 and 50: Stage 2Change at Day 50 (n =7, 5, 7, 7, 6)0.40 mcg/mLStandard Deviation 2.106
Stage 1: PF-04856883 PlaceboChange From Baseline in 1, 5 Anhydroglucitol at Day 8, 15, 22, 29 and 50: Stage 2Change at Day 29 (n =7, 5, 7, 6, 5)0.36 mcg/mLStandard Deviation 1.765
Stage 1: PF-04856883 PlaceboChange From Baseline in 1, 5 Anhydroglucitol at Day 8, 15, 22, 29 and 50: Stage 2Change at Day 22 (n =7, 5, 7, 6, 6)0.13 mcg/mLStandard Deviation 1.289
Stage 1: PF-04856883 PlaceboChange From Baseline in 1, 5 Anhydroglucitol at Day 8, 15, 22, 29 and 50: Stage 2Change at Day 15 (n =7, 5, 7, 6, 6)-0.03 mcg/mLStandard Deviation 1.376
Stage 1: PF-04856883 4 mgChange From Baseline in 1, 5 Anhydroglucitol at Day 8, 15, 22, 29 and 50: Stage 2Change at Day 22 (n =7, 5, 7, 6, 6)1.14 mcg/mLStandard Deviation 0.518
Stage 1: PF-04856883 4 mgChange From Baseline in 1, 5 Anhydroglucitol at Day 8, 15, 22, 29 and 50: Stage 2Change at Day 8 (n =7, 5, 7, 6, 6)0.40 mcg/mLStandard Deviation 0.962
Stage 1: PF-04856883 4 mgChange From Baseline in 1, 5 Anhydroglucitol at Day 8, 15, 22, 29 and 50: Stage 2Change at Day 15 (n =7, 5, 7, 6, 6)0.72 mcg/mLStandard Deviation 1.512
Stage 1: PF-04856883 4 mgChange From Baseline in 1, 5 Anhydroglucitol at Day 8, 15, 22, 29 and 50: Stage 2Baseline (n =7, 5, 7, 7, 6)6.32 mcg/mLStandard Deviation 3.517
Stage 1: PF-04856883 4 mgChange From Baseline in 1, 5 Anhydroglucitol at Day 8, 15, 22, 29 and 50: Stage 2Change at Day 29 (n =7, 5, 7, 6, 5)1.46 mcg/mLStandard Deviation 0.73
Stage 1: PF-04856883 4 mgChange From Baseline in 1, 5 Anhydroglucitol at Day 8, 15, 22, 29 and 50: Stage 2Change at Day 50 (n =7, 5, 7, 7, 6)0.38 mcg/mLStandard Deviation 2.381
Stage 1: PF-04856883 8 mgChange From Baseline in 1, 5 Anhydroglucitol at Day 8, 15, 22, 29 and 50: Stage 2Baseline (n =7, 5, 7, 7, 6)8.09 mcg/mLStandard Deviation 6.24
Stage 1: PF-04856883 8 mgChange From Baseline in 1, 5 Anhydroglucitol at Day 8, 15, 22, 29 and 50: Stage 2Change at Day 8 (n =7, 5, 7, 6, 6)0.41 mcg/mLStandard Deviation 0.57
Stage 1: PF-04856883 8 mgChange From Baseline in 1, 5 Anhydroglucitol at Day 8, 15, 22, 29 and 50: Stage 2Change at Day 15 (n =7, 5, 7, 6, 6)1.21 mcg/mLStandard Deviation 0.641
Stage 1: PF-04856883 8 mgChange From Baseline in 1, 5 Anhydroglucitol at Day 8, 15, 22, 29 and 50: Stage 2Change at Day 22 (n =7, 5, 7, 6, 6)1.73 mcg/mLStandard Deviation 1.034
Stage 1: PF-04856883 8 mgChange From Baseline in 1, 5 Anhydroglucitol at Day 8, 15, 22, 29 and 50: Stage 2Change at Day 29 (n =7, 5, 7, 6, 5)1.83 mcg/mLStandard Deviation 1.241
Stage 1: PF-04856883 8 mgChange From Baseline in 1, 5 Anhydroglucitol at Day 8, 15, 22, 29 and 50: Stage 2Change at Day 50 (n =7, 5, 7, 7, 6)-0.30 mcg/mLStandard Deviation 1.294
Stage 1: PF-04856883 12 mgChange From Baseline in 1, 5 Anhydroglucitol at Day 8, 15, 22, 29 and 50: Stage 2Change at Day 22 (n =7, 5, 7, 6, 6)0.95 mcg/mLStandard Deviation 3.086
Stage 1: PF-04856883 12 mgChange From Baseline in 1, 5 Anhydroglucitol at Day 8, 15, 22, 29 and 50: Stage 2Change at Day 15 (n =7, 5, 7, 6, 6)0.32 mcg/mLStandard Deviation 2.483
Stage 1: PF-04856883 12 mgChange From Baseline in 1, 5 Anhydroglucitol at Day 8, 15, 22, 29 and 50: Stage 2Change at Day 8 (n =7, 5, 7, 6, 6)-0.08 mcg/mLStandard Deviation 1.599
Stage 1: PF-04856883 12 mgChange From Baseline in 1, 5 Anhydroglucitol at Day 8, 15, 22, 29 and 50: Stage 2Change at Day 50 (n =7, 5, 7, 7, 6)1.64 mcg/mLStandard Deviation 2.985
Stage 1: PF-04856883 12 mgChange From Baseline in 1, 5 Anhydroglucitol at Day 8, 15, 22, 29 and 50: Stage 2Baseline (n =7, 5, 7, 7, 6)7.59 mcg/mLStandard Deviation 5.538
Stage 1: PF-04856883 12 mgChange From Baseline in 1, 5 Anhydroglucitol at Day 8, 15, 22, 29 and 50: Stage 2Change at Day 29 (n =7, 5, 7, 6, 5)1.50 mcg/mLStandard Deviation 2.9
Stage 1: PF-04856883 18 mgChange From Baseline in 1, 5 Anhydroglucitol at Day 8, 15, 22, 29 and 50: Stage 2Baseline (n =7, 5, 7, 7, 6)3.95 mcg/mLStandard Deviation 1.291
Stage 1: PF-04856883 18 mgChange From Baseline in 1, 5 Anhydroglucitol at Day 8, 15, 22, 29 and 50: Stage 2Change at Day 15 (n =7, 5, 7, 6, 6)0.63 mcg/mLStandard Deviation 1.481
Stage 1: PF-04856883 18 mgChange From Baseline in 1, 5 Anhydroglucitol at Day 8, 15, 22, 29 and 50: Stage 2Change at Day 29 (n =7, 5, 7, 6, 5)1.60 mcg/mLStandard Deviation 2.827
Stage 1: PF-04856883 18 mgChange From Baseline in 1, 5 Anhydroglucitol at Day 8, 15, 22, 29 and 50: Stage 2Change at Day 8 (n =7, 5, 7, 6, 6)0.90 mcg/mLStandard Deviation 0.502
Stage 1: PF-04856883 18 mgChange From Baseline in 1, 5 Anhydroglucitol at Day 8, 15, 22, 29 and 50: Stage 2Change at Day 50 (n =7, 5, 7, 7, 6)0.92 mcg/mLStandard Deviation 2.076
Stage 1: PF-04856883 18 mgChange From Baseline in 1, 5 Anhydroglucitol at Day 8, 15, 22, 29 and 50: Stage 2Change at Day 22 (n =7, 5, 7, 6, 6)1.28 mcg/mLStandard Deviation 2.046
Comparison: Day 8: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.p-value: 0.38780% CI: [-0.24, 1.21]Mixed meal tolerance test
Comparison: Day 8: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.p-value: 0.30980% CI: [-0.14, 1.18]Mixed meal tolerance test
Comparison: Day 8: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.p-value: 0.95680% CI: [-0.71, 0.65]Mixed meal tolerance test
Comparison: Day 8: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.p-value: 0.08980% CI: [0.24, 1.67]Mixed meal tolerance test
Comparison: Day 15: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.p-value: 0.43480% CI: [-0.48, 1.95]Mixed meal tolerance test
Comparison: Day 15: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.p-value: 0.1580% CI: [0.14, 2.35]Mixed meal tolerance test
Comparison: Day 15: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.p-value: 0.75280% CI: [-0.86, 1.41]Mixed meal tolerance test
Comparison: Day 15: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.p-value: 0.49280% CI: [-0.55, 1.79]Mixed meal tolerance test
Comparison: Day 22: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.p-value: 0.35880% CI: [-0.4, 2.4]Mixed meal tolerance test
Comparison: Day 22: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.p-value: 0.1180% CI: [0.33, 2.88]Mixed meal tolerance test
Comparison: Day 22: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.p-value: 0.46180% CI: [-0.56, 2.05]Mixed meal tolerance test
Comparison: Day 22: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.p-value: 0.28680% CI: [-0.23, 2.45]Mixed meal tolerance test
Comparison: Day 29: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.p-value: 0.36280% CI: [-0.45, 2.63]Mixed meal tolerance test
Comparison: Day 29: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.p-value: 0.17980% CI: [0.07, 2.88]Mixed meal tolerance test
Comparison: Day 29: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.p-value: 0.34280% CI: [-0.38, 2.49]Mixed meal tolerance test
Comparison: Day 29: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.p-value: 0.27280% CI: [-0.22, 2.75]Mixed meal tolerance test
Comparison: Day 50: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.p-value: 0.97980% CI: [-1.77, 1.7]Mixed meal tolerance test
Comparison: Day 50: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.p-value: 0.56880% CI: [-2.27, 0.88]Mixed meal tolerance test
Comparison: Day 50: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.p-value: 0.31180% CI: [-0.34, 2.82]Mixed meal tolerance test
Comparison: Day 50: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.p-value: 0.7180% CI: [-1.18, 2.13]Mixed meal tolerance test
Secondary

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.

ArmMeasureGroupValue (MEAN)Dispersion
Stage 1: PF-04856883 PlaceboChange From Baseline in 1, 5 Anhydroglucitol at Day 8, 15 and 29: Stage 1Baseline (n =15, 5, 6, 6, 7, 5, 7)8.17 microgram per milliliter (mcg/mL)Standard Deviation 5.021
Stage 1: PF-04856883 PlaceboChange From Baseline in 1, 5 Anhydroglucitol at Day 8, 15 and 29: Stage 1Change 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 PlaceboChange From Baseline in 1, 5 Anhydroglucitol at Day 8, 15 and 29: Stage 1Change 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 PlaceboChange From Baseline in 1, 5 Anhydroglucitol at Day 8, 15 and 29: Stage 1Change 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 mgChange From Baseline in 1, 5 Anhydroglucitol at Day 8, 15 and 29: Stage 1Change 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 mgChange From Baseline in 1, 5 Anhydroglucitol at Day 8, 15 and 29: Stage 1Change 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 mgChange From Baseline in 1, 5 Anhydroglucitol at Day 8, 15 and 29: Stage 1Change 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 mgChange From Baseline in 1, 5 Anhydroglucitol at Day 8, 15 and 29: Stage 1Baseline (n =15, 5, 6, 6, 7, 5, 7)5.02 microgram per milliliter (mcg/mL)Standard Deviation 2.831
Stage 1: PF-04856883 8 mgChange From Baseline in 1, 5 Anhydroglucitol at Day 8, 15 and 29: Stage 1Baseline (n =15, 5, 6, 6, 7, 5, 7)5.77 microgram per milliliter (mcg/mL)Standard Deviation 1.306
Stage 1: PF-04856883 8 mgChange From Baseline in 1, 5 Anhydroglucitol at Day 8, 15 and 29: Stage 1Change 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 mgChange From Baseline in 1, 5 Anhydroglucitol at Day 8, 15 and 29: Stage 1Change 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 mgChange From Baseline in 1, 5 Anhydroglucitol at Day 8, 15 and 29: Stage 1Change 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 mgChange From Baseline in 1, 5 Anhydroglucitol at Day 8, 15 and 29: Stage 1Change 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 mgChange From Baseline in 1, 5 Anhydroglucitol at Day 8, 15 and 29: Stage 1Change 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 mgChange From Baseline in 1, 5 Anhydroglucitol at Day 8, 15 and 29: Stage 1Baseline (n =15, 5, 6, 6, 7, 5, 7)5.35 microgram per milliliter (mcg/mL)Standard Deviation 3.683
Stage 1: PF-04856883 12 mgChange From Baseline in 1, 5 Anhydroglucitol at Day 8, 15 and 29: Stage 1Change 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 mgChange From Baseline in 1, 5 Anhydroglucitol at Day 8, 15 and 29: Stage 1Change 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 mgChange From Baseline in 1, 5 Anhydroglucitol at Day 8, 15 and 29: Stage 1Change 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 mgChange From Baseline in 1, 5 Anhydroglucitol at Day 8, 15 and 29: Stage 1Baseline (n =15, 5, 6, 6, 7, 5, 7)6.20 microgram per milliliter (mcg/mL)Standard Deviation 5.44
Stage 1: PF-04856883 18 mgChange From Baseline in 1, 5 Anhydroglucitol at Day 8, 15 and 29: Stage 1Change 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 mgChange From Baseline in 1, 5 Anhydroglucitol at Day 8, 15 and 29: Stage 1Change 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 mgChange From Baseline in 1, 5 Anhydroglucitol at Day 8, 15 and 29: Stage 1Baseline (n =15, 5, 6, 6, 7, 5, 7)12.04 microgram per milliliter (mcg/mL)Standard Deviation 5.133
Stage 1: PF-04856883 24 mgChange From Baseline in 1, 5 Anhydroglucitol at Day 8, 15 and 29: Stage 1Change 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 mgChange From Baseline in 1, 5 Anhydroglucitol at Day 8, 15 and 29: Stage 1Change 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 mgChange From Baseline in 1, 5 Anhydroglucitol at Day 8, 15 and 29: Stage 1Change 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 mgChange From Baseline in 1, 5 Anhydroglucitol at Day 8, 15 and 29: Stage 1Change 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 mgChange From Baseline in 1, 5 Anhydroglucitol at Day 8, 15 and 29: Stage 1Change 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 mgChange From Baseline in 1, 5 Anhydroglucitol at Day 8, 15 and 29: Stage 1Baseline (n =15, 5, 6, 6, 7, 5, 7)11.84 microgram per milliliter (mcg/mL)Standard Deviation 8.122
Secondary

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.

ArmMeasureGroupValue (MEAN)Dispersion
Stage 1: PF-04856883 PlaceboChange From Baseline in 24 Hours Glucose Normalized Area Under the Curve (NAUC) Profile at Day 30: Stage 2Baseline (n =7, 5, 7, 7 ,6)166.19 mg/dLStandard Deviation 35.437
Stage 1: PF-04856883 PlaceboChange From Baseline in 24 Hours Glucose Normalized Area Under the Curve (NAUC) Profile at Day 30: Stage 2Change at Day 30 (n =7, 5, 7, 6 ,5)172.36 mg/dLStandard Deviation 38.825
Stage 1: PF-04856883 4 mgChange From Baseline in 24 Hours Glucose Normalized Area Under the Curve (NAUC) Profile at Day 30: Stage 2Baseline (n =7, 5, 7, 7 ,6)212.43 mg/dLStandard Deviation 52.764
Stage 1: PF-04856883 4 mgChange From Baseline in 24 Hours Glucose Normalized Area Under the Curve (NAUC) Profile at Day 30: Stage 2Change at Day 30 (n =7, 5, 7, 6 ,5)191.20 mg/dLStandard Deviation 43.953
Stage 1: PF-04856883 8 mgChange From Baseline in 24 Hours Glucose Normalized Area Under the Curve (NAUC) Profile at Day 30: Stage 2Baseline (n =7, 5, 7, 7 ,6)205.56 mg/dLStandard Deviation 51.907
Stage 1: PF-04856883 8 mgChange From Baseline in 24 Hours Glucose Normalized Area Under the Curve (NAUC) Profile at Day 30: Stage 2Change at Day 30 (n =7, 5, 7, 6 ,5)172.24 mg/dLStandard Deviation 48.067
Stage 1: PF-04856883 12 mgChange From Baseline in 24 Hours Glucose Normalized Area Under the Curve (NAUC) Profile at Day 30: Stage 2Change at Day 30 (n =7, 5, 7, 6 ,5)174.08 mg/dLStandard Deviation 41.437
Stage 1: PF-04856883 12 mgChange From Baseline in 24 Hours Glucose Normalized Area Under the Curve (NAUC) Profile at Day 30: Stage 2Baseline (n =7, 5, 7, 7 ,6)202.43 mg/dLStandard Deviation 38.9
Stage 1: PF-04856883 18 mgChange From Baseline in 24 Hours Glucose Normalized Area Under the Curve (NAUC) Profile at Day 30: Stage 2Baseline (n =7, 5, 7, 7 ,6)186.13 mg/dLStandard Deviation 33.839
Stage 1: PF-04856883 18 mgChange From Baseline in 24 Hours Glucose Normalized Area Under the Curve (NAUC) Profile at Day 30: Stage 2Change at Day 30 (n =7, 5, 7, 6 ,5)192.87 mg/dLStandard Deviation 58.037
Comparison: Day 30p-value: 0.03480% CI: [-54.2, -14.16]Mixed meal tolerance test
Comparison: Day 30p-value: 0.04480% CI: [-54.5, -12.84]Mixed meal tolerance test
Comparison: Day 30p-value: 0.85780% CI: [-24.16, 18.31]Mixed meal tolerance test
Comparison: Day 30p-value: 0.21980% CI: [-43.26, 0.93]Mixed meal tolerance test
Secondary

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.

ArmMeasureGroupValue (MEAN)Dispersion
Stage 1: PF-04856883 PlaceboChange 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 2Change at Day 50 (n =7, 5, 7, 6, 5)-0.17 ng*hr/mLStandard Deviation 1.978
Stage 1: PF-04856883 PlaceboChange 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 2Change at Day 29 (n =7, 5, 7, 6, 5)0.10 ng*hr/mLStandard Deviation 3.864
Stage 1: PF-04856883 PlaceboChange 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 2Change at Day 24 (n =7, 4, 7, 6, 6)0.55 ng*hr/mLStandard Deviation 3.518
Stage 1: PF-04856883 PlaceboChange 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 2Change at Day 3 (n =7, 5, 7, 7, 6)1.68 ng*hr/mLStandard Deviation 2.182
Stage 1: PF-04856883 PlaceboChange 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 2Change at Day 15 (n =7, 5, 7, 6, 6)-1.65 ng*hr/mLStandard Deviation 1.493
Stage 1: PF-04856883 PlaceboChange 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 2Baseline (n =7, 5, 7, 7, 6)13.47 ng*hr/mLStandard Deviation 4.315
Stage 1: PF-04856883 4 mgChange 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 2Baseline (n =7, 5, 7, 7, 6)14.59 ng*hr/mLStandard Deviation 4.205
Stage 1: PF-04856883 4 mgChange 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 2Change at Day 24 (n =7, 4, 7, 6, 6)0.71 ng*hr/mLStandard Deviation 4.312
Stage 1: PF-04856883 4 mgChange 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 2Change at Day 15 (n =7, 5, 7, 6, 6)-1.55 ng*hr/mLStandard Deviation 2.821
Stage 1: PF-04856883 4 mgChange 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 2Change at Day 50 (n =7, 5, 7, 6, 5)-1.83 ng*hr/mLStandard Deviation 2.015
Stage 1: PF-04856883 4 mgChange 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 2Change at Day 29 (n =7, 5, 7, 6, 5)-0.07 ng*hr/mLStandard Deviation 2.545
Stage 1: PF-04856883 4 mgChange 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 2Change at Day 3 (n =7, 5, 7, 7, 6)1.89 ng*hr/mLStandard Deviation 4.705
Stage 1: PF-04856883 8 mgChange 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 2Change at Day 29 (n =7, 5, 7, 6, 5)-0.59 ng*hr/mLStandard Deviation 4.144
Stage 1: PF-04856883 8 mgChange 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 2Baseline (n =7, 5, 7, 7, 6)15.63 ng*hr/mLStandard Deviation 4.293
Stage 1: PF-04856883 8 mgChange 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 2Change at Day 3 (n =7, 5, 7, 7, 6)0.50 ng*hr/mLStandard Deviation 4.757
Stage 1: PF-04856883 8 mgChange 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 2Change at Day 24 (n =7, 4, 7, 6, 6)-0.99 ng*hr/mLStandard Deviation 6.22
Stage 1: PF-04856883 8 mgChange 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 2Change at Day 50 (n =7, 5, 7, 6, 5)-4.10 ng*hr/mLStandard Deviation 5.265
Stage 1: PF-04856883 8 mgChange 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 2Change at Day 15 (n =7, 5, 7, 6, 6)-1.92 ng*hr/mLStandard Deviation 6.93
Stage 1: PF-04856883 12 mgChange 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 2Change at Day 50 (n =7, 5, 7, 6, 5)1.06 ng*hr/mLStandard Deviation 1.474
Stage 1: PF-04856883 12 mgChange 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 2Change at Day 15 (n =7, 5, 7, 6, 6)-0.17 ng*hr/mLStandard Deviation 4.135
Stage 1: PF-04856883 12 mgChange 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 2Change at Day 29 (n =7, 5, 7, 6, 5)0.59 ng*hr/mLStandard Deviation 2.733
Stage 1: PF-04856883 12 mgChange 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 2Baseline (n =7, 5, 7, 7, 6)11.74 ng*hr/mLStandard Deviation 5.21
Stage 1: PF-04856883 12 mgChange 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 2Change at Day 3 (n =7, 5, 7, 7, 6)3.16 ng*hr/mLStandard Deviation 1.613
Stage 1: PF-04856883 12 mgChange 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 2Change at Day 24 (n =7, 4, 7, 6, 6)1.63 ng*hr/mLStandard Deviation 2.994
Stage 1: PF-04856883 18 mgChange 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 2Change at Day 50 (n =7, 5, 7, 6, 5)-2.90 ng*hr/mLStandard Deviation 3.711
Stage 1: PF-04856883 18 mgChange 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 2Change at Day 3 (n =7, 5, 7, 7, 6)3.49 ng*hr/mLStandard Deviation 4.452
Stage 1: PF-04856883 18 mgChange 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 2Change at Day 29 (n =7, 5, 7, 6, 5)0.41 ng*hr/mLStandard Deviation 2.09
Stage 1: PF-04856883 18 mgChange 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 2Change at Day 24 (n =7, 4, 7, 6, 6)1.21 ng*hr/mLStandard Deviation 5.784
Stage 1: PF-04856883 18 mgChange 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 2Change at Day 15 (n =7, 5, 7, 6, 6)-0.50 ng*hr/mLStandard Deviation 4.871
Stage 1: PF-04856883 18 mgChange 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 2Baseline (n =7, 5, 7, 7, 6)14.14 ng*hr/mLStandard Deviation 5.211
Secondary

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.

ArmMeasureGroupValue (MEAN)Dispersion
Stage 1: PF-04856883 PlaceboChange From Baseline in C-Peptide Area Under the Curve (AUC) After Mixed Meal Tolerance Test (MMTT) at Day 3 and 8: Stage 1Change at Day 8 (n =15, 4, 5, 6, 7, 5, 6)0.79 ng*hr/mLStandard Deviation 2.864
Stage 1: PF-04856883 PlaceboChange From Baseline in C-Peptide Area Under the Curve (AUC) After Mixed Meal Tolerance Test (MMTT) at Day 3 and 8: Stage 1Change at Day 3 (n =15, 5, 5, 6, 7, 5, 6)2.15 ng*hr/mLStandard Deviation 3.653
Stage 1: PF-04856883 PlaceboChange From Baseline in C-Peptide Area Under the Curve (AUC) After Mixed Meal Tolerance Test (MMTT) at Day 3 and 8: Stage 1Baseline (n =15, 5, 6, 6, 7,5, 7)15.53 ng*hr/mLStandard Deviation 5.332
Stage 1: PF-04856883 4 mgChange From Baseline in C-Peptide Area Under the Curve (AUC) After Mixed Meal Tolerance Test (MMTT) at Day 3 and 8: Stage 1Change at Day 3 (n =15, 5, 5, 6, 7, 5, 6)0.69 ng*hr/mLStandard Deviation 1.465
Stage 1: PF-04856883 4 mgChange From Baseline in C-Peptide Area Under the Curve (AUC) After Mixed Meal Tolerance Test (MMTT) at Day 3 and 8: Stage 1Change at Day 8 (n =15, 4, 5, 6, 7, 5, 6)1.06 ng*hr/mLStandard Deviation 1.806
Stage 1: PF-04856883 4 mgChange From Baseline in C-Peptide Area Under the Curve (AUC) After Mixed Meal Tolerance Test (MMTT) at Day 3 and 8: Stage 1Baseline (n =15, 5, 6, 6, 7,5, 7)16.63 ng*hr/mLStandard Deviation 7.743
Stage 1: PF-04856883 8 mgChange From Baseline in C-Peptide Area Under the Curve (AUC) After Mixed Meal Tolerance Test (MMTT) at Day 3 and 8: Stage 1Baseline (n =15, 5, 6, 6, 7,5, 7)16.43 ng*hr/mLStandard Deviation 4.306
Stage 1: PF-04856883 8 mgChange From Baseline in C-Peptide Area Under the Curve (AUC) After Mixed Meal Tolerance Test (MMTT) at Day 3 and 8: Stage 1Change at Day 8 (n =15, 4, 5, 6, 7, 5, 6)0.83 ng*hr/mLStandard Deviation 1.651
Stage 1: PF-04856883 8 mgChange From Baseline in C-Peptide Area Under the Curve (AUC) After Mixed Meal Tolerance Test (MMTT) at Day 3 and 8: Stage 1Change at Day 3 (n =15, 5, 5, 6, 7, 5, 6)1.65 ng*hr/mLStandard Deviation 4.958
Stage 1: PF-04856883 12 mgChange From Baseline in C-Peptide Area Under the Curve (AUC) After Mixed Meal Tolerance Test (MMTT) at Day 3 and 8: Stage 1Baseline (n =15, 5, 6, 6, 7,5, 7)16.80 ng*hr/mLStandard Deviation 5.711
Stage 1: PF-04856883 12 mgChange From Baseline in C-Peptide Area Under the Curve (AUC) After Mixed Meal Tolerance Test (MMTT) at Day 3 and 8: Stage 1Change at Day 8 (n =15, 4, 5, 6, 7, 5, 6)-2.74 ng*hr/mLStandard Deviation 1.38
Stage 1: PF-04856883 12 mgChange From Baseline in C-Peptide Area Under the Curve (AUC) After Mixed Meal Tolerance Test (MMTT) at Day 3 and 8: Stage 1Change at Day 3 (n =15, 5, 5, 6, 7, 5, 6)1.05 ng*hr/mLStandard Deviation 1.885
Stage 1: PF-04856883 18 mgChange From Baseline in C-Peptide Area Under the Curve (AUC) After Mixed Meal Tolerance Test (MMTT) at Day 3 and 8: Stage 1Change at Day 8 (n =15, 4, 5, 6, 7, 5, 6)1.70 ng*hr/mLStandard Deviation 1.544
Stage 1: PF-04856883 18 mgChange From Baseline in C-Peptide Area Under the Curve (AUC) After Mixed Meal Tolerance Test (MMTT) at Day 3 and 8: Stage 1Change at Day 3 (n =15, 5, 5, 6, 7, 5, 6)4.30 ng*hr/mLStandard Deviation 4.102
Stage 1: PF-04856883 18 mgChange From Baseline in C-Peptide Area Under the Curve (AUC) After Mixed Meal Tolerance Test (MMTT) at Day 3 and 8: Stage 1Baseline (n =15, 5, 6, 6, 7,5, 7)10.64 ng*hr/mLStandard Deviation 1.156
Stage 1: PF-04856883 24 mgChange From Baseline in C-Peptide Area Under the Curve (AUC) After Mixed Meal Tolerance Test (MMTT) at Day 3 and 8: Stage 1Baseline (n =15, 5, 6, 6, 7,5, 7)16.17 ng*hr/mLStandard Deviation 4.531
Stage 1: PF-04856883 24 mgChange From Baseline in C-Peptide Area Under the Curve (AUC) After Mixed Meal Tolerance Test (MMTT) at Day 3 and 8: Stage 1Change at Day 8 (n =15, 4, 5, 6, 7, 5, 6)-0.45 ng*hr/mLStandard Deviation 2.883
Stage 1: PF-04856883 24 mgChange From Baseline in C-Peptide Area Under the Curve (AUC) After Mixed Meal Tolerance Test (MMTT) at Day 3 and 8: Stage 1Change at Day 3 (n =15, 5, 5, 6, 7, 5, 6)5.34 ng*hr/mLStandard Deviation 2.584
Stage 1: PF-04856883 36 mgChange From Baseline in C-Peptide Area Under the Curve (AUC) After Mixed Meal Tolerance Test (MMTT) at Day 3 and 8: Stage 1Baseline (n =15, 5, 6, 6, 7,5, 7)18.37 ng*hr/mLStandard Deviation 7.395
Stage 1: PF-04856883 36 mgChange From Baseline in C-Peptide Area Under the Curve (AUC) After Mixed Meal Tolerance Test (MMTT) at Day 3 and 8: Stage 1Change at Day 3 (n =15, 5, 5, 6, 7, 5, 6)2.34 ng*hr/mLStandard Deviation 4.333
Stage 1: PF-04856883 36 mgChange From Baseline in C-Peptide Area Under the Curve (AUC) After Mixed Meal Tolerance Test (MMTT) at Day 3 and 8: Stage 1Change at Day 8 (n =15, 4, 5, 6, 7, 5, 6)-0.38 ng*hr/mLStandard Deviation 1.565
Secondary

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.

ArmMeasureGroupValue (MEAN)Dispersion
Stage 1: PF-04856883 PlaceboChange From Baseline in Fasting Plasma Glucose (FPG) at Day 2, 4, 6, 15, 22 and 29: Stage 1Change 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 PlaceboChange From Baseline in Fasting Plasma Glucose (FPG) at Day 2, 4, 6, 15, 22 and 29: Stage 1Baseline (n =15, 5, 6, 6, 7, 5, 7)161.67 milligram per deciliter (mg/dL)Standard Deviation 27.102
Stage 1: PF-04856883 PlaceboChange From Baseline in Fasting Plasma Glucose (FPG) at Day 2, 4, 6, 15, 22 and 29: Stage 1Change 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 PlaceboChange From Baseline in Fasting Plasma Glucose (FPG) at Day 2, 4, 6, 15, 22 and 29: Stage 1Change 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 PlaceboChange From Baseline in Fasting Plasma Glucose (FPG) at Day 2, 4, 6, 15, 22 and 29: Stage 1Change 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 PlaceboChange From Baseline in Fasting Plasma Glucose (FPG) at Day 2, 4, 6, 15, 22 and 29: Stage 1Change 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 PlaceboChange From Baseline in Fasting Plasma Glucose (FPG) at Day 2, 4, 6, 15, 22 and 29: Stage 1Change 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 mgChange From Baseline in Fasting Plasma Glucose (FPG) at Day 2, 4, 6, 15, 22 and 29: Stage 1Baseline (n =15, 5, 6, 6, 7, 5, 7)219.60 milligram per deciliter (mg/dL)Standard Deviation 44.557
Stage 1: PF-04856883 4 mgChange From Baseline in Fasting Plasma Glucose (FPG) at Day 2, 4, 6, 15, 22 and 29: Stage 1Change 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 mgChange From Baseline in Fasting Plasma Glucose (FPG) at Day 2, 4, 6, 15, 22 and 29: Stage 1Change 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 mgChange From Baseline in Fasting Plasma Glucose (FPG) at Day 2, 4, 6, 15, 22 and 29: Stage 1Change 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 mgChange From Baseline in Fasting Plasma Glucose (FPG) at Day 2, 4, 6, 15, 22 and 29: Stage 1Change 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 mgChange From Baseline in Fasting Plasma Glucose (FPG) at Day 2, 4, 6, 15, 22 and 29: Stage 1Change 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 mgChange From Baseline in Fasting Plasma Glucose (FPG) at Day 2, 4, 6, 15, 22 and 29: Stage 1Change 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 mgChange From Baseline in Fasting Plasma Glucose (FPG) at Day 2, 4, 6, 15, 22 and 29: Stage 1Change 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 mgChange From Baseline in Fasting Plasma Glucose (FPG) at Day 2, 4, 6, 15, 22 and 29: Stage 1Change 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 mgChange From Baseline in Fasting Plasma Glucose (FPG) at Day 2, 4, 6, 15, 22 and 29: Stage 1Change 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 mgChange From Baseline in Fasting Plasma Glucose (FPG) at Day 2, 4, 6, 15, 22 and 29: Stage 1Baseline (n =15, 5, 6, 6, 7, 5, 7)171.17 milligram per deciliter (mg/dL)Standard Deviation 23.752
Stage 1: PF-04856883 8 mgChange From Baseline in Fasting Plasma Glucose (FPG) at Day 2, 4, 6, 15, 22 and 29: Stage 1Change 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 mgChange From Baseline in Fasting Plasma Glucose (FPG) at Day 2, 4, 6, 15, 22 and 29: Stage 1Change 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 mgChange From Baseline in Fasting Plasma Glucose (FPG) at Day 2, 4, 6, 15, 22 and 29: Stage 1Change 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 mgChange From Baseline in Fasting Plasma Glucose (FPG) at Day 2, 4, 6, 15, 22 and 29: Stage 1Change 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 mgChange From Baseline in Fasting Plasma Glucose (FPG) at Day 2, 4, 6, 15, 22 and 29: Stage 1Baseline (n =15, 5, 6, 6, 7, 5, 7)174.00 milligram per deciliter (mg/dL)Standard Deviation 48.949
Stage 1: PF-04856883 12 mgChange From Baseline in Fasting Plasma Glucose (FPG) at Day 2, 4, 6, 15, 22 and 29: Stage 1Change 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 mgChange From Baseline in Fasting Plasma Glucose (FPG) at Day 2, 4, 6, 15, 22 and 29: Stage 1Change 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 mgChange From Baseline in Fasting Plasma Glucose (FPG) at Day 2, 4, 6, 15, 22 and 29: Stage 1Change 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 mgChange From Baseline in Fasting Plasma Glucose (FPG) at Day 2, 4, 6, 15, 22 and 29: Stage 1Change 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 mgChange From Baseline in Fasting Plasma Glucose (FPG) at Day 2, 4, 6, 15, 22 and 29: Stage 1Change 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 mgChange From Baseline in Fasting Plasma Glucose (FPG) at Day 2, 4, 6, 15, 22 and 29: Stage 1Change 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 mgChange From Baseline in Fasting Plasma Glucose (FPG) at Day 2, 4, 6, 15, 22 and 29: Stage 1Baseline (n =15, 5, 6, 6, 7, 5, 7)168.57 milligram per deciliter (mg/dL)Standard Deviation 38.336
Stage 1: PF-04856883 18 mgChange From Baseline in Fasting Plasma Glucose (FPG) at Day 2, 4, 6, 15, 22 and 29: Stage 1Change 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 mgChange From Baseline in Fasting Plasma Glucose (FPG) at Day 2, 4, 6, 15, 22 and 29: Stage 1Change 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 mgChange From Baseline in Fasting Plasma Glucose (FPG) at Day 2, 4, 6, 15, 22 and 29: Stage 1Change 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 mgChange From Baseline in Fasting Plasma Glucose (FPG) at Day 2, 4, 6, 15, 22 and 29: Stage 1Change 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 mgChange From Baseline in Fasting Plasma Glucose (FPG) at Day 2, 4, 6, 15, 22 and 29: Stage 1Change 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 mgChange From Baseline in Fasting Plasma Glucose (FPG) at Day 2, 4, 6, 15, 22 and 29: Stage 1Change 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 mgChange From Baseline in Fasting Plasma Glucose (FPG) at Day 2, 4, 6, 15, 22 and 29: Stage 1Baseline (n =15, 5, 6, 6, 7, 5, 7)145.60 milligram per deciliter (mg/dL)Standard Deviation 21.606
Stage 1: PF-04856883 24 mgChange From Baseline in Fasting Plasma Glucose (FPG) at Day 2, 4, 6, 15, 22 and 29: Stage 1Change 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 mgChange From Baseline in Fasting Plasma Glucose (FPG) at Day 2, 4, 6, 15, 22 and 29: Stage 1Change 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 mgChange From Baseline in Fasting Plasma Glucose (FPG) at Day 2, 4, 6, 15, 22 and 29: Stage 1Change 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 mgChange From Baseline in Fasting Plasma Glucose (FPG) at Day 2, 4, 6, 15, 22 and 29: Stage 1Change 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 mgChange From Baseline in Fasting Plasma Glucose (FPG) at Day 2, 4, 6, 15, 22 and 29: Stage 1Change 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 mgChange From Baseline in Fasting Plasma Glucose (FPG) at Day 2, 4, 6, 15, 22 and 29: Stage 1Change 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 mgChange From Baseline in Fasting Plasma Glucose (FPG) at Day 2, 4, 6, 15, 22 and 29: Stage 1Change 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 mgChange From Baseline in Fasting Plasma Glucose (FPG) at Day 2, 4, 6, 15, 22 and 29: Stage 1Change 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 mgChange From Baseline in Fasting Plasma Glucose (FPG) at Day 2, 4, 6, 15, 22 and 29: Stage 1Change 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 mgChange From Baseline in Fasting Plasma Glucose (FPG) at Day 2, 4, 6, 15, 22 and 29: Stage 1Baseline (n =15, 5, 6, 6, 7, 5, 7)158.14 milligram per deciliter (mg/dL)Standard Deviation 35.362
Stage 1: PF-04856883 36 mgChange From Baseline in Fasting Plasma Glucose (FPG) at Day 2, 4, 6, 15, 22 and 29: Stage 1Change 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 mgChange From Baseline in Fasting Plasma Glucose (FPG) at Day 2, 4, 6, 15, 22 and 29: Stage 1Change at Day 15 (n =15, 5, 5, 6, 6, 5, 7)-2.71 milligram per deciliter (mg/dL)Standard Deviation 16.53
Secondary

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.

ArmMeasureGroupValue (MEAN)Dispersion
Stage 1: PF-04856883 PlaceboChange From Baseline in Fasting Plasma Glucose (FPG) at Day 2, 4, 6, 8, 22, 23, 25, 27, 30, 36 and 43: Stage 2Change at Day 25 (n =7, 5, 6, 6, 5)13.43 mg/dLStandard Deviation 13.113
Stage 1: PF-04856883 PlaceboChange From Baseline in Fasting Plasma Glucose (FPG) at Day 2, 4, 6, 8, 22, 23, 25, 27, 30, 36 and 43: Stage 2Change at Day 22 (n =7, 4, 7, 6, 6)13.29 mg/dLStandard Deviation 15.294
Stage 1: PF-04856883 PlaceboChange From Baseline in Fasting Plasma Glucose (FPG) at Day 2, 4, 6, 8, 22, 23, 25, 27, 30, 36 and 43: Stage 2Baseline (n =7, 5, 7, 7, 6)148.00 mg/dLStandard Deviation 33.317
Stage 1: PF-04856883 PlaceboChange From Baseline in Fasting Plasma Glucose (FPG) at Day 2, 4, 6, 8, 22, 23, 25, 27, 30, 36 and 43: Stage 2Change at Day 23 (n =7, 4, 6, 6, 5)7.71 mg/dLStandard Deviation 23.894
Stage 1: PF-04856883 PlaceboChange From Baseline in Fasting Plasma Glucose (FPG) at Day 2, 4, 6, 8, 22, 23, 25, 27, 30, 36 and 43: Stage 2Change at Day 8 (n =6, 5, 7, 5, 6)2.50 mg/dLStandard Deviation 17.627
Stage 1: PF-04856883 PlaceboChange From Baseline in Fasting Plasma Glucose (FPG) at Day 2, 4, 6, 8, 22, 23, 25, 27, 30, 36 and 43: Stage 2Change at Day 2 (n =5, 4, 7, 7, 5)3.00 mg/dLStandard Deviation 15.281
Stage 1: PF-04856883 PlaceboChange From Baseline in Fasting Plasma Glucose (FPG) at Day 2, 4, 6, 8, 22, 23, 25, 27, 30, 36 and 43: Stage 2Change at Day 43 (n =7, 5, 5, 6, 6)18.71 mg/dLStandard Deviation 22.552
Stage 1: PF-04856883 PlaceboChange From Baseline in Fasting Plasma Glucose (FPG) at Day 2, 4, 6, 8, 22, 23, 25, 27, 30, 36 and 43: Stage 2Change at Day 6 (n =7, 4, 7, 7, 6)-1.71 mg/dLStandard Deviation 40.24
Stage 1: PF-04856883 PlaceboChange From Baseline in Fasting Plasma Glucose (FPG) at Day 2, 4, 6, 8, 22, 23, 25, 27, 30, 36 and 43: Stage 2Change at Day 4 (n =5, 5, 7, 6, 6)7.60 mg/dLStandard Deviation 6.427
Stage 1: PF-04856883 PlaceboChange From Baseline in Fasting Plasma Glucose (FPG) at Day 2, 4, 6, 8, 22, 23, 25, 27, 30, 36 and 43: Stage 2Change at Day 36 (n =6, 5, 7, 6, 6)-10.50 mg/dLStandard Deviation 32.415
Stage 1: PF-04856883 PlaceboChange From Baseline in Fasting Plasma Glucose (FPG) at Day 2, 4, 6, 8, 22, 23, 25, 27, 30, 36 and 43: Stage 2Change at Day 30 (n =7, 5, 7, 6, 5)2.43 mg/dLStandard Deviation 12.739
Stage 1: PF-04856883 PlaceboChange From Baseline in Fasting Plasma Glucose (FPG) at Day 2, 4, 6, 8, 22, 23, 25, 27, 30, 36 and 43: Stage 2Change at Day 27 (n =7, 5, 6, 6, 5)8.57 mg/dLStandard Deviation 21.11
Stage 1: PF-04856883 4 mgChange From Baseline in Fasting Plasma Glucose (FPG) at Day 2, 4, 6, 8, 22, 23, 25, 27, 30, 36 and 43: Stage 2Change at Day 22 (n =7, 4, 7, 6, 6)-4.25 mg/dLStandard Deviation 13.817
Stage 1: PF-04856883 4 mgChange From Baseline in Fasting Plasma Glucose (FPG) at Day 2, 4, 6, 8, 22, 23, 25, 27, 30, 36 and 43: Stage 2Baseline (n =7, 5, 7, 7, 6)186.80 mg/dLStandard Deviation 23.059
Stage 1: PF-04856883 4 mgChange From Baseline in Fasting Plasma Glucose (FPG) at Day 2, 4, 6, 8, 22, 23, 25, 27, 30, 36 and 43: Stage 2Change at Day 2 (n =5, 4, 7, 7, 5)-26.75 mg/dLStandard Deviation 15.108
Stage 1: PF-04856883 4 mgChange From Baseline in Fasting Plasma Glucose (FPG) at Day 2, 4, 6, 8, 22, 23, 25, 27, 30, 36 and 43: Stage 2Change at Day 25 (n =7, 5, 6, 6, 5)-16.60 mg/dLStandard Deviation 43.443
Stage 1: PF-04856883 4 mgChange From Baseline in Fasting Plasma Glucose (FPG) at Day 2, 4, 6, 8, 22, 23, 25, 27, 30, 36 and 43: Stage 2Change at Day 30 (n =7, 5, 7, 6, 5)-14.20 mg/dLStandard Deviation 17.908
Stage 1: PF-04856883 4 mgChange From Baseline in Fasting Plasma Glucose (FPG) at Day 2, 4, 6, 8, 22, 23, 25, 27, 30, 36 and 43: Stage 2Change at Day 36 (n =6, 5, 7, 6, 6)0.40 mg/dLStandard Deviation 37.846
Stage 1: PF-04856883 4 mgChange From Baseline in Fasting Plasma Glucose (FPG) at Day 2, 4, 6, 8, 22, 23, 25, 27, 30, 36 and 43: Stage 2Change at Day 4 (n =5, 5, 7, 6, 6)-14.80 mg/dLStandard Deviation 24.284
Stage 1: PF-04856883 4 mgChange From Baseline in Fasting Plasma Glucose (FPG) at Day 2, 4, 6, 8, 22, 23, 25, 27, 30, 36 and 43: Stage 2Change at Day 6 (n =7, 4, 7, 7, 6)5.75 mg/dLStandard Deviation 14.08
Stage 1: PF-04856883 4 mgChange From Baseline in Fasting Plasma Glucose (FPG) at Day 2, 4, 6, 8, 22, 23, 25, 27, 30, 36 and 43: Stage 2Change at Day 8 (n =6, 5, 7, 5, 6)4.20 mg/dLStandard Deviation 19.967
Stage 1: PF-04856883 4 mgChange From Baseline in Fasting Plasma Glucose (FPG) at Day 2, 4, 6, 8, 22, 23, 25, 27, 30, 36 and 43: Stage 2Change at Day 23 (n =7, 4, 6, 6, 5)-27.25 mg/dLStandard Deviation 27.293
Stage 1: PF-04856883 4 mgChange From Baseline in Fasting Plasma Glucose (FPG) at Day 2, 4, 6, 8, 22, 23, 25, 27, 30, 36 and 43: Stage 2Change at Day 27 (n =7, 5, 6, 6, 5)-21.60 mg/dLStandard Deviation 15.821
Stage 1: PF-04856883 4 mgChange From Baseline in Fasting Plasma Glucose (FPG) at Day 2, 4, 6, 8, 22, 23, 25, 27, 30, 36 and 43: Stage 2Change at Day 43 (n =7, 5, 5, 6, 6)12.80 mg/dLStandard Deviation 29.064
Stage 1: PF-04856883 8 mgChange From Baseline in Fasting Plasma Glucose (FPG) at Day 2, 4, 6, 8, 22, 23, 25, 27, 30, 36 and 43: Stage 2Change at Day 27 (n =7, 5, 6, 6, 5)-37.33 mg/dLStandard Deviation 17.963
Stage 1: PF-04856883 8 mgChange From Baseline in Fasting Plasma Glucose (FPG) at Day 2, 4, 6, 8, 22, 23, 25, 27, 30, 36 and 43: Stage 2Change at Day 8 (n =6, 5, 7, 5, 6)-37.43 mg/dLStandard Deviation 42.383
Stage 1: PF-04856883 8 mgChange From Baseline in Fasting Plasma Glucose (FPG) at Day 2, 4, 6, 8, 22, 23, 25, 27, 30, 36 and 43: Stage 2Change at Day 30 (n =7, 5, 7, 6, 5)-22.29 mg/dLStandard Deviation 26.171
Stage 1: PF-04856883 8 mgChange From Baseline in Fasting Plasma Glucose (FPG) at Day 2, 4, 6, 8, 22, 23, 25, 27, 30, 36 and 43: Stage 2Change at Day 36 (n =6, 5, 7, 6, 6)1.86 mg/dLStandard Deviation 25.373
Stage 1: PF-04856883 8 mgChange From Baseline in Fasting Plasma Glucose (FPG) at Day 2, 4, 6, 8, 22, 23, 25, 27, 30, 36 and 43: Stage 2Change at Day 43 (n =7, 5, 5, 6, 6)13.20 mg/dLStandard Deviation 17.254
Stage 1: PF-04856883 8 mgChange From Baseline in Fasting Plasma Glucose (FPG) at Day 2, 4, 6, 8, 22, 23, 25, 27, 30, 36 and 43: Stage 2Baseline (n =7, 5, 7, 7, 6)191.14 mg/dLStandard Deviation 56.153
Stage 1: PF-04856883 8 mgChange From Baseline in Fasting Plasma Glucose (FPG) at Day 2, 4, 6, 8, 22, 23, 25, 27, 30, 36 and 43: Stage 2Change at Day 4 (n =5, 5, 7, 6, 6)-14.86 mg/dLStandard Deviation 48.657
Stage 1: PF-04856883 8 mgChange From Baseline in Fasting Plasma Glucose (FPG) at Day 2, 4, 6, 8, 22, 23, 25, 27, 30, 36 and 43: Stage 2Change at Day 2 (n =5, 4, 7, 7, 5)-15.14 mg/dLStandard Deviation 21.217
Stage 1: PF-04856883 8 mgChange From Baseline in Fasting Plasma Glucose (FPG) at Day 2, 4, 6, 8, 22, 23, 25, 27, 30, 36 and 43: Stage 2Change at Day 23 (n =7, 4, 6, 6, 5)-40.33 mg/dLStandard Deviation 18.327
Stage 1: PF-04856883 8 mgChange From Baseline in Fasting Plasma Glucose (FPG) at Day 2, 4, 6, 8, 22, 23, 25, 27, 30, 36 and 43: Stage 2Change at Day 6 (n =7, 4, 7, 7, 6)-44.86 mg/dLStandard Deviation 38.451
Stage 1: PF-04856883 8 mgChange From Baseline in Fasting Plasma Glucose (FPG) at Day 2, 4, 6, 8, 22, 23, 25, 27, 30, 36 and 43: Stage 2Change at Day 22 (n =7, 4, 7, 6, 6)-39.57 mg/dLStandard Deviation 25.468
Stage 1: PF-04856883 8 mgChange From Baseline in Fasting Plasma Glucose (FPG) at Day 2, 4, 6, 8, 22, 23, 25, 27, 30, 36 and 43: Stage 2Change at Day 25 (n =7, 5, 6, 6, 5)-44.67 mg/dLStandard Deviation 27.667
Stage 1: PF-04856883 12 mgChange From Baseline in Fasting Plasma Glucose (FPG) at Day 2, 4, 6, 8, 22, 23, 25, 27, 30, 36 and 43: Stage 2Change at Day 36 (n =6, 5, 7, 6, 6)-5.83 mg/dLStandard Deviation 32.009
Stage 1: PF-04856883 12 mgChange From Baseline in Fasting Plasma Glucose (FPG) at Day 2, 4, 6, 8, 22, 23, 25, 27, 30, 36 and 43: Stage 2Change at Day 22 (n =7, 4, 7, 6, 6)-14.17 mg/dLStandard Deviation 38.27
Stage 1: PF-04856883 12 mgChange From Baseline in Fasting Plasma Glucose (FPG) at Day 2, 4, 6, 8, 22, 23, 25, 27, 30, 36 and 43: Stage 2Change at Day 43 (n =7, 5, 5, 6, 6)-1.17 mg/dLStandard Deviation 41.787
Stage 1: PF-04856883 12 mgChange From Baseline in Fasting Plasma Glucose (FPG) at Day 2, 4, 6, 8, 22, 23, 25, 27, 30, 36 and 43: Stage 2Change at Day 2 (n =5, 4, 7, 7, 5)-23.43 mg/dLStandard Deviation 35.142
Stage 1: PF-04856883 12 mgChange From Baseline in Fasting Plasma Glucose (FPG) at Day 2, 4, 6, 8, 22, 23, 25, 27, 30, 36 and 43: Stage 2Change at Day 4 (n =5, 5, 7, 6, 6)-20.33 mg/dLStandard Deviation 22.818
Stage 1: PF-04856883 12 mgChange From Baseline in Fasting Plasma Glucose (FPG) at Day 2, 4, 6, 8, 22, 23, 25, 27, 30, 36 and 43: Stage 2Change at Day 23 (n =7, 4, 6, 6, 5)-17.50 mg/dLStandard Deviation 73.519
Stage 1: PF-04856883 12 mgChange From Baseline in Fasting Plasma Glucose (FPG) at Day 2, 4, 6, 8, 22, 23, 25, 27, 30, 36 and 43: Stage 2Change at Day 8 (n =6, 5, 7, 5, 6)2.60 mg/dLStandard Deviation 73.449
Stage 1: PF-04856883 12 mgChange From Baseline in Fasting Plasma Glucose (FPG) at Day 2, 4, 6, 8, 22, 23, 25, 27, 30, 36 and 43: Stage 2Change at Day 25 (n =7, 5, 6, 6, 5)-23.33 mg/dLStandard Deviation 52.936
Stage 1: PF-04856883 12 mgChange From Baseline in Fasting Plasma Glucose (FPG) at Day 2, 4, 6, 8, 22, 23, 25, 27, 30, 36 and 43: Stage 2Change at Day 6 (n =7, 4, 7, 7, 6)-8.00 mg/dLStandard Deviation 42.942
Stage 1: PF-04856883 12 mgChange From Baseline in Fasting Plasma Glucose (FPG) at Day 2, 4, 6, 8, 22, 23, 25, 27, 30, 36 and 43: Stage 2Change at Day 27 (n =7, 5, 6, 6, 5)-34.67 mg/dLStandard Deviation 35.803
Stage 1: PF-04856883 12 mgChange From Baseline in Fasting Plasma Glucose (FPG) at Day 2, 4, 6, 8, 22, 23, 25, 27, 30, 36 and 43: Stage 2Change at Day 30 (n =7, 5, 7, 6, 5)-9.33 mg/dLStandard Deviation 32.898
Stage 1: PF-04856883 12 mgChange From Baseline in Fasting Plasma Glucose (FPG) at Day 2, 4, 6, 8, 22, 23, 25, 27, 30, 36 and 43: Stage 2Baseline (n =7, 5, 7, 7, 6)187.29 mg/dLStandard Deviation 45.756
Stage 1: PF-04856883 18 mgChange From Baseline in Fasting Plasma Glucose (FPG) at Day 2, 4, 6, 8, 22, 23, 25, 27, 30, 36 and 43: Stage 2Change at Day 2 (n =5, 4, 7, 7, 5)-10.40 mg/dLStandard Deviation 18.461
Stage 1: PF-04856883 18 mgChange From Baseline in Fasting Plasma Glucose (FPG) at Day 2, 4, 6, 8, 22, 23, 25, 27, 30, 36 and 43: Stage 2Change at Day 36 (n =6, 5, 7, 6, 6)27.67 mg/dLStandard Deviation 59.594
Stage 1: PF-04856883 18 mgChange From Baseline in Fasting Plasma Glucose (FPG) at Day 2, 4, 6, 8, 22, 23, 25, 27, 30, 36 and 43: Stage 2Change at Day 27 (n =7, 5, 6, 6, 5)12.00 mg/dLStandard Deviation 71.039
Stage 1: PF-04856883 18 mgChange From Baseline in Fasting Plasma Glucose (FPG) at Day 2, 4, 6, 8, 22, 23, 25, 27, 30, 36 and 43: Stage 2Change at Day 43 (n =7, 5, 5, 6, 6)8.33 mg/dLStandard Deviation 18.991
Stage 1: PF-04856883 18 mgChange From Baseline in Fasting Plasma Glucose (FPG) at Day 2, 4, 6, 8, 22, 23, 25, 27, 30, 36 and 43: Stage 2Change at Day 6 (n =7, 4, 7, 7, 6)-15.83 mg/dLStandard Deviation 8.909
Stage 1: PF-04856883 18 mgChange From Baseline in Fasting Plasma Glucose (FPG) at Day 2, 4, 6, 8, 22, 23, 25, 27, 30, 36 and 43: Stage 2Change at Day 23 (n =7, 4, 6, 6, 5)-24.00 mg/dLStandard Deviation 29.967
Stage 1: PF-04856883 18 mgChange From Baseline in Fasting Plasma Glucose (FPG) at Day 2, 4, 6, 8, 22, 23, 25, 27, 30, 36 and 43: Stage 2Change at Day 8 (n =6, 5, 7, 5, 6)24.50 mg/dLStandard Deviation 47.618
Stage 1: PF-04856883 18 mgChange From Baseline in Fasting Plasma Glucose (FPG) at Day 2, 4, 6, 8, 22, 23, 25, 27, 30, 36 and 43: Stage 2Change at Day 22 (n =7, 4, 7, 6, 6)-0.33 mg/dLStandard Deviation 51.181
Stage 1: PF-04856883 18 mgChange From Baseline in Fasting Plasma Glucose (FPG) at Day 2, 4, 6, 8, 22, 23, 25, 27, 30, 36 and 43: Stage 2Change at Day 4 (n =5, 5, 7, 6, 6)-1.50 mg/dLStandard Deviation 27.384
Stage 1: PF-04856883 18 mgChange From Baseline in Fasting Plasma Glucose (FPG) at Day 2, 4, 6, 8, 22, 23, 25, 27, 30, 36 and 43: Stage 2Baseline (n =7, 5, 7, 7, 6)158.50 mg/dLStandard Deviation 18.447
Stage 1: PF-04856883 18 mgChange From Baseline in Fasting Plasma Glucose (FPG) at Day 2, 4, 6, 8, 22, 23, 25, 27, 30, 36 and 43: Stage 2Change at Day 25 (n =7, 5, 6, 6, 5)-16.20 mg/dLStandard Deviation 36.513
Stage 1: PF-04856883 18 mgChange From Baseline in Fasting Plasma Glucose (FPG) at Day 2, 4, 6, 8, 22, 23, 25, 27, 30, 36 and 43: Stage 2Change at Day 30 (n =7, 5, 7, 6, 5)15.40 mg/dLStandard Deviation 37.964
Secondary

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.

ArmMeasureGroupValue (MEAN)Dispersion
Stage 1: PF-04856883 PlaceboChange From Baseline in Fructosamine Levels at Day 8, 15, 22, 29 and 50: Stage 2Baseline (n =7, 5, 7, 7, 6)281.14 mcmol/LStandard Deviation 57.875
Stage 1: PF-04856883 PlaceboChange From Baseline in Fructosamine Levels at Day 8, 15, 22, 29 and 50: Stage 2Change at Day 15 (n =7, 5, 7, 6, 6)-1.86 mcmol/LStandard Deviation 21.146
Stage 1: PF-04856883 PlaceboChange From Baseline in Fructosamine Levels at Day 8, 15, 22, 29 and 50: Stage 2Change at Day 22 (n =7, 5, 7, 6, 6)-7.43 mcmol/LStandard Deviation 13.176
Stage 1: PF-04856883 PlaceboChange From Baseline in Fructosamine Levels at Day 8, 15, 22, 29 and 50: Stage 2Change at Day 29 (n =7, 5, 7, 6, 4)-4.43 mcmol/LStandard Deviation 27.098
Stage 1: PF-04856883 PlaceboChange From Baseline in Fructosamine Levels at Day 8, 15, 22, 29 and 50: Stage 2Change at Day 50 (n =7, 5, 7, 7, 6)-6.86 mcmol/LStandard Deviation 20.732
Stage 1: PF-04856883 PlaceboChange From Baseline in Fructosamine Levels at Day 8, 15, 22, 29 and 50: Stage 2Change at Day 8 (n =7, 5, 7, 6, 6)-5.29 mcmol/LStandard Deviation 19.678
Stage 1: PF-04856883 4 mgChange From Baseline in Fructosamine Levels at Day 8, 15, 22, 29 and 50: Stage 2Change at Day 29 (n =7, 5, 7, 6, 4)-26.60 mcmol/LStandard Deviation 22.612
Stage 1: PF-04856883 4 mgChange From Baseline in Fructosamine Levels at Day 8, 15, 22, 29 and 50: Stage 2Change at Day 22 (n =7, 5, 7, 6, 6)-18.20 mcmol/LStandard Deviation 20.462
Stage 1: PF-04856883 4 mgChange From Baseline in Fructosamine Levels at Day 8, 15, 22, 29 and 50: Stage 2Baseline (n =7, 5, 7, 7, 6)309.40 mcmol/LStandard Deviation 47.6
Stage 1: PF-04856883 4 mgChange From Baseline in Fructosamine Levels at Day 8, 15, 22, 29 and 50: Stage 2Change at Day 50 (n =7, 5, 7, 7, 6)-8.80 mcmol/LStandard Deviation 14.446
Stage 1: PF-04856883 4 mgChange From Baseline in Fructosamine Levels at Day 8, 15, 22, 29 and 50: Stage 2Change at Day 15 (n =7, 5, 7, 6, 6)-8.20 mcmol/LStandard Deviation 15.707
Stage 1: PF-04856883 4 mgChange From Baseline in Fructosamine Levels at Day 8, 15, 22, 29 and 50: Stage 2Change at Day 8 (n =7, 5, 7, 6, 6)-8.20 mcmol/LStandard Deviation 11.1
Stage 1: PF-04856883 8 mgChange From Baseline in Fructosamine Levels at Day 8, 15, 22, 29 and 50: Stage 2Change at Day 8 (n =7, 5, 7, 6, 6)-12.14 mcmol/LStandard Deviation 12.668
Stage 1: PF-04856883 8 mgChange From Baseline in Fructosamine Levels at Day 8, 15, 22, 29 and 50: Stage 2Change at Day 15 (n =7, 5, 7, 6, 6)-39.29 mcmol/LStandard Deviation 21.077
Stage 1: PF-04856883 8 mgChange From Baseline in Fructosamine Levels at Day 8, 15, 22, 29 and 50: Stage 2Change at Day 50 (n =7, 5, 7, 7, 6)-6.43 mcmol/LStandard Deviation 20.871
Stage 1: PF-04856883 8 mgChange From Baseline in Fructosamine Levels at Day 8, 15, 22, 29 and 50: Stage 2Change at Day 22 (n =7, 5, 7, 6, 6)-37.86 mcmol/LStandard Deviation 19.945
Stage 1: PF-04856883 8 mgChange From Baseline in Fructosamine Levels at Day 8, 15, 22, 29 and 50: Stage 2Change at Day 29 (n =7, 5, 7, 6, 4)-37.57 mcmol/LStandard Deviation 14.976
Stage 1: PF-04856883 8 mgChange From Baseline in Fructosamine Levels at Day 8, 15, 22, 29 and 50: Stage 2Baseline (n =7, 5, 7, 7, 6)301.14 mcmol/LStandard Deviation 43.69
Stage 1: PF-04856883 12 mgChange From Baseline in Fructosamine Levels at Day 8, 15, 22, 29 and 50: Stage 2Change at Day 50 (n =7, 5, 7, 7, 6)-12.43 mcmol/LStandard Deviation 26.732
Stage 1: PF-04856883 12 mgChange From Baseline in Fructosamine Levels at Day 8, 15, 22, 29 and 50: Stage 2Change at Day 29 (n =7, 5, 7, 6, 4)-32.67 mcmol/LStandard Deviation 28.507
Stage 1: PF-04856883 12 mgChange From Baseline in Fructosamine Levels at Day 8, 15, 22, 29 and 50: Stage 2Change at Day 8 (n =7, 5, 7, 6, 6)-9.17 mcmol/LStandard Deviation 23.043
Stage 1: PF-04856883 12 mgChange From Baseline in Fructosamine Levels at Day 8, 15, 22, 29 and 50: Stage 2Change at Day 15 (n =7, 5, 7, 6, 6)-11.67 mcmol/LStandard Deviation 24.047
Stage 1: PF-04856883 12 mgChange From Baseline in Fructosamine Levels at Day 8, 15, 22, 29 and 50: Stage 2Baseline (n =7, 5, 7, 7, 6)291.29 mcmol/LStandard Deviation 37.911
Stage 1: PF-04856883 12 mgChange From Baseline in Fructosamine Levels at Day 8, 15, 22, 29 and 50: Stage 2Change at Day 22 (n =7, 5, 7, 6, 6)-24.67 mcmol/LStandard Deviation 20.925
Stage 1: PF-04856883 18 mgChange From Baseline in Fructosamine Levels at Day 8, 15, 22, 29 and 50: Stage 2Change at Day 50 (n =7, 5, 7, 7, 6)-5.67 mcmol/LStandard Deviation 31.258
Stage 1: PF-04856883 18 mgChange From Baseline in Fructosamine Levels at Day 8, 15, 22, 29 and 50: Stage 2Baseline (n =7, 5, 7, 7, 6)303.67 mcmol/LStandard Deviation 47.272
Stage 1: PF-04856883 18 mgChange From Baseline in Fructosamine Levels at Day 8, 15, 22, 29 and 50: Stage 2Change at Day 29 (n =7, 5, 7, 6, 4)-41.00 mcmol/LStandard Deviation 29.855
Stage 1: PF-04856883 18 mgChange From Baseline in Fructosamine Levels at Day 8, 15, 22, 29 and 50: Stage 2Change at Day 22 (n =7, 5, 7, 6, 6)-27.50 mcmol/LStandard Deviation 25.399
Stage 1: PF-04856883 18 mgChange From Baseline in Fructosamine Levels at Day 8, 15, 22, 29 and 50: Stage 2Change at Day 8 (n =7, 5, 7, 6, 6)-10.17 mcmol/LStandard Deviation 21.72
Stage 1: PF-04856883 18 mgChange From Baseline in Fructosamine Levels at Day 8, 15, 22, 29 and 50: Stage 2Change at Day 15 (n =7, 5, 7, 6, 6)-14.67 mcmol/LStandard Deviation 33.037
Comparison: Day 8: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.p-value: 0.66380% CI: [-8.16, 16.37]Mixed meal tolerance test
Comparison: Day 8: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.p-value: 0.82580% CI: [-13.03, 9.25]mixed meal tolerance test
Comparison: Day 8: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.p-value: 0.87880% CI: [-10.2, 12.92]Mixed meal tolerance test
Comparison: Day 8: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.p-value: 0.93680% CI: [-10.89, 12.33]Mixed meal tolerance test
Comparison: Day 15: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.p-value: 0.95980% CI: [-16.46, 17.82]Mixed meal tolerance test
Comparison: Day 15: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.p-value: 0.01180% CI: [-48.07, -16.85]Mixed meal tolerance test
Comparison: Day 15: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.p-value: 0.83380% CI: [-18.67, 13.45]Mixed meal tolerance test
Comparison: Day 15: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.p-value: 0.56580% CI: [-23.47, 9.05]Mixed meal tolerance test
Comparison: Day 22: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.p-value: 0.70380% CI: [-16.52, 9.02]Mixed meal tolerance test
Comparison: Day 22: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.p-value: 0.00880% CI: [-37.07, -13.85]Mixed meal tolerance test
Comparison: Day 22: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.p-value: 0.25380% CI: [-22.51, 1.32]Mixed meal tolerance test
Comparison: Day 22: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.p-value: 0.12880% CI: [-26.57, -2.38]Mixed meal tolerance test
Comparison: Day 29: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.p-value: 0.19680% CI: [-30.17, -0.13]Mixed meal tolerance test
Comparison: Day 29: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.p-value: 0.01280% CI: [-41.84, -14.51]Mixed meal tolerance test
Comparison: Day 29: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.p-value: 0.04780% CI: [-36.65, -8.32]Mixed meal tolerance test
Comparison: Day 29: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.p-value: 0.02380% CI: [-44.19, -13.06]Mixed meal tolerance test
Comparison: Day 50: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.p-value: 0.71180% CI: [-12.77, 22.93]Mixed meal tolerance test
Comparison: Day 50: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.p-value: 0.66680% CI: [-10.86, 21.66]Mixed meal tolerance test
Comparison: Day 50: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.p-value: 0.80780% CI: [-19.27, 13.17]Mixed meal tolerance test
Comparison: Day 50: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.p-value: 0.60380% CI: [-10.15, 23.72]Mixed meal tolerance test
Secondary

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.

ArmMeasureGroupValue (MEAN)Dispersion
Stage 1: PF-04856883 PlaceboChange From Baseline in Fructosamine Levels at Day 8, 15 and 29: Stage 1Change 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 PlaceboChange From Baseline in Fructosamine Levels at Day 8, 15 and 29: Stage 1Baseline (n =15, 5, 6, 6, 7, 5, 7)270.60 micromole per liter (mcmol/L)Standard Deviation 34.618
Stage 1: PF-04856883 PlaceboChange From Baseline in Fructosamine Levels at Day 8, 15 and 29: Stage 1Change 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 PlaceboChange From Baseline in Fructosamine Levels at Day 8, 15 and 29: Stage 1Change 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 mgChange From Baseline in Fructosamine Levels at Day 8, 15 and 29: Stage 1Change 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 mgChange From Baseline in Fructosamine Levels at Day 8, 15 and 29: Stage 1Change 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 mgChange From Baseline in Fructosamine Levels at Day 8, 15 and 29: Stage 1Change 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 mgChange From Baseline in Fructosamine Levels at Day 8, 15 and 29: Stage 1Baseline (n =15, 5, 6, 6, 7, 5, 7)289.20 micromole per liter (mcmol/L)Standard Deviation 48.329
Stage 1: PF-04856883 8 mgChange From Baseline in Fructosamine Levels at Day 8, 15 and 29: Stage 1Change 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 mgChange From Baseline in Fructosamine Levels at Day 8, 15 and 29: Stage 1Change 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 mgChange From Baseline in Fructosamine Levels at Day 8, 15 and 29: Stage 1Baseline (n =15, 5, 6, 6, 7, 5, 7)279.67 micromole per liter (mcmol/L)Standard Deviation 30.507
Stage 1: PF-04856883 8 mgChange From Baseline in Fructosamine Levels at Day 8, 15 and 29: Stage 1Change 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 mgChange From Baseline in Fructosamine Levels at Day 8, 15 and 29: Stage 1Baseline (n =15, 5, 6, 6, 7, 5, 7)304.83 micromole per liter (mcmol/L)Standard Deviation 45.155
Stage 1: PF-04856883 12 mgChange From Baseline in Fructosamine Levels at Day 8, 15 and 29: Stage 1Change 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 mgChange From Baseline in Fructosamine Levels at Day 8, 15 and 29: Stage 1Change 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 mgChange From Baseline in Fructosamine Levels at Day 8, 15 and 29: Stage 1Change 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 mgChange From Baseline in Fructosamine Levels at Day 8, 15 and 29: Stage 1Baseline (n =15, 5, 6, 6, 7, 5, 7)263.43 micromole per liter (mcmol/L)Standard Deviation 34.942
Stage 1: PF-04856883 18 mgChange From Baseline in Fructosamine Levels at Day 8, 15 and 29: Stage 1Change 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 mgChange From Baseline in Fructosamine Levels at Day 8, 15 and 29: Stage 1Change 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 mgChange From Baseline in Fructosamine Levels at Day 8, 15 and 29: Stage 1Change 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 mgChange From Baseline in Fructosamine Levels at Day 8, 15 and 29: Stage 1Baseline (n =15, 5, 6, 6, 7, 5, 7)259.80 micromole per liter (mcmol/L)Standard Deviation 53.644
Stage 1: PF-04856883 24 mgChange From Baseline in Fructosamine Levels at Day 8, 15 and 29: Stage 1Change 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 mgChange From Baseline in Fructosamine Levels at Day 8, 15 and 29: Stage 1Change 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 mgChange From Baseline in Fructosamine Levels at Day 8, 15 and 29: Stage 1Change 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 mgChange From Baseline in Fructosamine Levels at Day 8, 15 and 29: Stage 1Change 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 mgChange From Baseline in Fructosamine Levels at Day 8, 15 and 29: Stage 1Baseline (n =15, 5, 6, 6, 7, 5, 7)273.71 micromole per liter (mcmol/L)Standard Deviation 36.036
Stage 1: PF-04856883 36 mgChange From Baseline in Fructosamine Levels at Day 8, 15 and 29: Stage 1Change 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 mgChange From Baseline in Fructosamine Levels at Day 8, 15 and 29: Stage 1Change at Day 15 (n =15, 5, 5, 6, 6, 5, 7)-3.00 micromole per liter (mcmol/L)Standard Deviation 11.165
Secondary

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.

ArmMeasureGroupValue (MEAN)Dispersion
Stage 1: PF-04856883 PlaceboChange From Baseline in Insulin Area Under the Curve (AUC) After Mixed Meal Tolerance Test (MMTT) at Day 3, 15, 24, 29 and 50: Stage 2Change at Day 29 (n =7, 5, 7, 6, 5)8.25 mU*hr/LStandard Deviation 55.799
Stage 1: PF-04856883 PlaceboChange From Baseline in Insulin Area Under the Curve (AUC) After Mixed Meal Tolerance Test (MMTT) at Day 3, 15, 24, 29 and 50: Stage 2Change at Day 15 (n =7, 5, 7, 6, 6)-16.77 mU*hr/LStandard Deviation 20.53
Stage 1: PF-04856883 PlaceboChange From Baseline in Insulin Area Under the Curve (AUC) After Mixed Meal Tolerance Test (MMTT) at Day 3, 15, 24, 29 and 50: Stage 2Baseline (n =7, 5, 7, 7, 6)175.26 mU*hr/LStandard Deviation 62.218
Stage 1: PF-04856883 PlaceboChange From Baseline in Insulin Area Under the Curve (AUC) After Mixed Meal Tolerance Test (MMTT) at Day 3, 15, 24, 29 and 50: Stage 2Change at Day 3 (n =7, 5, 7, 7, 6)38.32 mU*hr/LStandard Deviation 62.135
Stage 1: PF-04856883 PlaceboChange From Baseline in Insulin Area Under the Curve (AUC) After Mixed Meal Tolerance Test (MMTT) at Day 3, 15, 24, 29 and 50: Stage 2Change at Day 24 (n =7, 4, 7, 6, 6)0.23 mU*hr/LStandard Deviation 55.174
Stage 1: PF-04856883 PlaceboChange From Baseline in Insulin Area Under the Curve (AUC) After Mixed Meal Tolerance Test (MMTT) at Day 3, 15, 24, 29 and 50: Stage 2Change at Day 50 (n =7, 5, 7, 6, 5)8.14 mU*hr/LStandard Deviation 29.909
Stage 1: PF-04856883 4 mgChange From Baseline in Insulin Area Under the Curve (AUC) After Mixed Meal Tolerance Test (MMTT) at Day 3, 15, 24, 29 and 50: Stage 2Change at Day 50 (n =7, 5, 7, 6, 5)-16.64 mU*hr/LStandard Deviation 33.133
Stage 1: PF-04856883 4 mgChange From Baseline in Insulin Area Under the Curve (AUC) After Mixed Meal Tolerance Test (MMTT) at Day 3, 15, 24, 29 and 50: Stage 2Change at Day 3 (n =7, 5, 7, 7, 6)13.29 mU*hr/LStandard Deviation 55.764
Stage 1: PF-04856883 4 mgChange From Baseline in Insulin Area Under the Curve (AUC) After Mixed Meal Tolerance Test (MMTT) at Day 3, 15, 24, 29 and 50: Stage 2Change at Day 15 (n =7, 5, 7, 6, 6)-39.16 mU*hr/LStandard Deviation 42.93
Stage 1: PF-04856883 4 mgChange From Baseline in Insulin Area Under the Curve (AUC) After Mixed Meal Tolerance Test (MMTT) at Day 3, 15, 24, 29 and 50: Stage 2Baseline (n =7, 5, 7, 7, 6)176.65 mU*hr/LStandard Deviation 76.04
Stage 1: PF-04856883 4 mgChange From Baseline in Insulin Area Under the Curve (AUC) After Mixed Meal Tolerance Test (MMTT) at Day 3, 15, 24, 29 and 50: Stage 2Change at Day 24 (n =7, 4, 7, 6, 6)-15.19 mU*hr/LStandard Deviation 38.9
Stage 1: PF-04856883 4 mgChange From Baseline in Insulin Area Under the Curve (AUC) After Mixed Meal Tolerance Test (MMTT) at Day 3, 15, 24, 29 and 50: Stage 2Change at Day 29 (n =7, 5, 7, 6, 5)3.98 mU*hr/LStandard Deviation 11.218
Stage 1: PF-04856883 8 mgChange From Baseline in Insulin Area Under the Curve (AUC) After Mixed Meal Tolerance Test (MMTT) at Day 3, 15, 24, 29 and 50: Stage 2Change at Day 29 (n =7, 5, 7, 6, 5)12.71 mU*hr/LStandard Deviation 115.095
Stage 1: PF-04856883 8 mgChange From Baseline in Insulin Area Under the Curve (AUC) After Mixed Meal Tolerance Test (MMTT) at Day 3, 15, 24, 29 and 50: Stage 2Change at Day 24 (n =7, 4, 7, 6, 6)6.87 mU*hr/LStandard Deviation 184.83
Stage 1: PF-04856883 8 mgChange From Baseline in Insulin Area Under the Curve (AUC) After Mixed Meal Tolerance Test (MMTT) at Day 3, 15, 24, 29 and 50: Stage 2Change at Day 15 (n =7, 5, 7, 6, 6)-10.07 mU*hr/LStandard Deviation 172.044
Stage 1: PF-04856883 8 mgChange From Baseline in Insulin Area Under the Curve (AUC) After Mixed Meal Tolerance Test (MMTT) at Day 3, 15, 24, 29 and 50: Stage 2Change at Day 3 (n =7, 5, 7, 7, 6)19.50 mU*hr/LStandard Deviation 134.651
Stage 1: PF-04856883 8 mgChange From Baseline in Insulin Area Under the Curve (AUC) After Mixed Meal Tolerance Test (MMTT) at Day 3, 15, 24, 29 and 50: Stage 2Baseline (n =7, 5, 7, 7, 6)267.29 mU*hr/LStandard Deviation 111.497
Stage 1: PF-04856883 8 mgChange From Baseline in Insulin Area Under the Curve (AUC) After Mixed Meal Tolerance Test (MMTT) at Day 3, 15, 24, 29 and 50: Stage 2Change at Day 50 (n =7, 5, 7, 6, 5)-57.14 mU*hr/LStandard Deviation 116.193
Stage 1: PF-04856883 12 mgChange From Baseline in Insulin Area Under the Curve (AUC) After Mixed Meal Tolerance Test (MMTT) at Day 3, 15, 24, 29 and 50: Stage 2Change at Day 3 (n =7, 5, 7, 7, 6)27.99 mU*hr/LStandard Deviation 32.655
Stage 1: PF-04856883 12 mgChange From Baseline in Insulin Area Under the Curve (AUC) After Mixed Meal Tolerance Test (MMTT) at Day 3, 15, 24, 29 and 50: Stage 2Change at Day 29 (n =7, 5, 7, 6, 5)-1.61 mU*hr/LStandard Deviation 85.866
Stage 1: PF-04856883 12 mgChange From Baseline in Insulin Area Under the Curve (AUC) After Mixed Meal Tolerance Test (MMTT) at Day 3, 15, 24, 29 and 50: Stage 2Change at Day 24 (n =7, 4, 7, 6, 6)4.18 mU*hr/LStandard Deviation 51.903
Stage 1: PF-04856883 12 mgChange From Baseline in Insulin Area Under the Curve (AUC) After Mixed Meal Tolerance Test (MMTT) at Day 3, 15, 24, 29 and 50: Stage 2Baseline (n =7, 5, 7, 7, 6)162.96 mU*hr/LStandard Deviation 111.688
Stage 1: PF-04856883 12 mgChange From Baseline in Insulin Area Under the Curve (AUC) After Mixed Meal Tolerance Test (MMTT) at Day 3, 15, 24, 29 and 50: Stage 2Change at Day 15 (n =7, 5, 7, 6, 6)-51.69 mU*hr/LStandard Deviation 77.925
Stage 1: PF-04856883 12 mgChange From Baseline in Insulin Area Under the Curve (AUC) After Mixed Meal Tolerance Test (MMTT) at Day 3, 15, 24, 29 and 50: Stage 2Change at Day 50 (n =7, 5, 7, 6, 5)49.27 mU*hr/LStandard Deviation 81.874
Stage 1: PF-04856883 18 mgChange From Baseline in Insulin Area Under the Curve (AUC) After Mixed Meal Tolerance Test (MMTT) at Day 3, 15, 24, 29 and 50: Stage 2Change at Day 24 (n =7, 4, 7, 6, 6)60.11 mU*hr/LStandard Deviation 189.287
Stage 1: PF-04856883 18 mgChange From Baseline in Insulin Area Under the Curve (AUC) After Mixed Meal Tolerance Test (MMTT) at Day 3, 15, 24, 29 and 50: Stage 2Change at Day 29 (n =7, 5, 7, 6, 5)15.70 mU*hr/LStandard Deviation 38.476
Stage 1: PF-04856883 18 mgChange From Baseline in Insulin Area Under the Curve (AUC) After Mixed Meal Tolerance Test (MMTT) at Day 3, 15, 24, 29 and 50: Stage 2Baseline (n =7, 5, 7, 7, 6)190.64 mU*hr/LStandard Deviation 83.945
Stage 1: PF-04856883 18 mgChange From Baseline in Insulin Area Under the Curve (AUC) After Mixed Meal Tolerance Test (MMTT) at Day 3, 15, 24, 29 and 50: Stage 2Change at Day 50 (n =7, 5, 7, 6, 5)-26.78 mU*hr/LStandard Deviation 81.518
Stage 1: PF-04856883 18 mgChange From Baseline in Insulin Area Under the Curve (AUC) After Mixed Meal Tolerance Test (MMTT) at Day 3, 15, 24, 29 and 50: Stage 2Change at Day 15 (n =7, 5, 7, 6, 6)-24.36 mU*hr/LStandard Deviation 85.633
Stage 1: PF-04856883 18 mgChange From Baseline in Insulin Area Under the Curve (AUC) After Mixed Meal Tolerance Test (MMTT) at Day 3, 15, 24, 29 and 50: Stage 2Change at Day 3 (n =7, 5, 7, 7, 6)87.67 mU*hr/LStandard Deviation 124.052
Secondary

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.

ArmMeasureGroupValue (MEAN)Dispersion
Stage 1: PF-04856883 PlaceboChange From Baseline in Insulin Area Under the Curve (AUC) After Mixed Meal Tolerance Test (MMTT) at Day 3 and 8: Stage 1Change 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 PlaceboChange From Baseline in Insulin Area Under the Curve (AUC) After Mixed Meal Tolerance Test (MMTT) at Day 3 and 8: Stage 1Change 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 PlaceboChange From Baseline in Insulin Area Under the Curve (AUC) After Mixed Meal Tolerance Test (MMTT) at Day 3 and 8: Stage 1Baseline (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 mgChange From Baseline in Insulin Area Under the Curve (AUC) After Mixed Meal Tolerance Test (MMTT) at Day 3 and 8: Stage 1Change 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 mgChange From Baseline in Insulin Area Under the Curve (AUC) After Mixed Meal Tolerance Test (MMTT) at Day 3 and 8: Stage 1Baseline (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 mgChange From Baseline in Insulin Area Under the Curve (AUC) After Mixed Meal Tolerance Test (MMTT) at Day 3 and 8: Stage 1Change 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 mgChange From Baseline in Insulin Area Under the Curve (AUC) After Mixed Meal Tolerance Test (MMTT) at Day 3 and 8: Stage 1Change 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 mgChange From Baseline in Insulin Area Under the Curve (AUC) After Mixed Meal Tolerance Test (MMTT) at Day 3 and 8: Stage 1Change 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 mgChange From Baseline in Insulin Area Under the Curve (AUC) After Mixed Meal Tolerance Test (MMTT) at Day 3 and 8: Stage 1Baseline (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 mgChange From Baseline in Insulin Area Under the Curve (AUC) After Mixed Meal Tolerance Test (MMTT) at Day 3 and 8: Stage 1Change 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 mgChange From Baseline in Insulin Area Under the Curve (AUC) After Mixed Meal Tolerance Test (MMTT) at Day 3 and 8: Stage 1Baseline (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 mgChange From Baseline in Insulin Area Under the Curve (AUC) After Mixed Meal Tolerance Test (MMTT) at Day 3 and 8: Stage 1Change 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 mgChange From Baseline in Insulin Area Under the Curve (AUC) After Mixed Meal Tolerance Test (MMTT) at Day 3 and 8: Stage 1Baseline (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 mgChange From Baseline in Insulin Area Under the Curve (AUC) After Mixed Meal Tolerance Test (MMTT) at Day 3 and 8: Stage 1Change 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 mgChange From Baseline in Insulin Area Under the Curve (AUC) After Mixed Meal Tolerance Test (MMTT) at Day 3 and 8: Stage 1Change 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 mgChange From Baseline in Insulin Area Under the Curve (AUC) After Mixed Meal Tolerance Test (MMTT) at Day 3 and 8: Stage 1Baseline (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 mgChange From Baseline in Insulin Area Under the Curve (AUC) After Mixed Meal Tolerance Test (MMTT) at Day 3 and 8: Stage 1Change 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 mgChange From Baseline in Insulin Area Under the Curve (AUC) After Mixed Meal Tolerance Test (MMTT) at Day 3 and 8: Stage 1Change 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 mgChange From Baseline in Insulin Area Under the Curve (AUC) After Mixed Meal Tolerance Test (MMTT) at Day 3 and 8: Stage 1Change 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 mgChange From Baseline in Insulin Area Under the Curve (AUC) After Mixed Meal Tolerance Test (MMTT) at Day 3 and 8: Stage 1Change 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 mgChange From Baseline in Insulin Area Under the Curve (AUC) After Mixed Meal Tolerance Test (MMTT) at Day 3 and 8: Stage 1Baseline (n =15, 5, 6, 6, 7, 5, 7)283.59 milliUnit*hour per liter (mU*hr/L)Standard Deviation 156.831
Secondary

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.

ArmMeasureGroupValue (MEAN)Dispersion
Stage 1: PF-04856883 PlaceboChange 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 2Baseline (n =7, 4, 7, 7, 6)606.49 mg*hr/dLStandard Deviation 158.249
Stage 1: PF-04856883 PlaceboChange 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 2Change at Day 29 (n =7, 4, 7, 6, 5)30.08 mg*hr/dLStandard Deviation 59.49
Stage 1: PF-04856883 PlaceboChange 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 2Change at Day 15 (n =7, 4, 6, 6, 6)-18.48 mg*hr/dLStandard Deviation 50.874
Stage 1: PF-04856883 PlaceboChange 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 2Change at Day 24 (n =7, 4, 7, 6, 5)-6.20 mg*hr/dLStandard Deviation 46.238
Stage 1: PF-04856883 PlaceboChange 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 2Change at Day 3 (n =7, 4, 5, 6, 5)44.41 mg*hr/dLStandard Deviation 74.405
Stage 1: PF-04856883 PlaceboChange 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 2Change at Day 50 (n =7, 3, 6, 6, 6)50.26 mg*hr/dLStandard Deviation 81.717
Stage 1: PF-04856883 4 mgChange 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 2Change at Day 24 (n =7, 4, 7, 6, 5)-146.61 mg*hr/dLStandard Deviation 78.863
Stage 1: PF-04856883 4 mgChange 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 2Change at Day 50 (n =7, 3, 6, 6, 6)-48.82 mg*hr/dLStandard Deviation 80.733
Stage 1: PF-04856883 4 mgChange 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 2Change at Day 3 (n =7, 4, 5, 6, 5)-97.03 mg*hr/dLStandard Deviation 55.692
Stage 1: PF-04856883 4 mgChange 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 2Baseline (n =7, 4, 7, 7, 6)811.36 mg*hr/dLStandard Deviation 131.145
Stage 1: PF-04856883 4 mgChange 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 2Change at Day 15 (n =7, 4, 6, 6, 6)-265.64 mg*hr/dLStandard Deviation 89.889
Stage 1: PF-04856883 4 mgChange 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 2Change at Day 29 (n =7, 4, 7, 6, 5)-55.43 mg*hr/dLStandard Deviation 74.973
Stage 1: PF-04856883 8 mgChange 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 2Change at Day 29 (n =7, 4, 7, 6, 5)-157.54 mg*hr/dLStandard Deviation 88.652
Stage 1: PF-04856883 8 mgChange 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 2Change at Day 3 (n =7, 4, 5, 6, 5)-103.00 mg*hr/dLStandard Deviation 118.759
Stage 1: PF-04856883 8 mgChange 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 2Change at Day 24 (n =7, 4, 7, 6, 5)-207.12 mg*hr/dLStandard Deviation 89.687
Stage 1: PF-04856883 8 mgChange 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 2Baseline (n =7, 4, 7, 7, 6)756.17 mg*hr/dLStandard Deviation 240.43
Stage 1: PF-04856883 8 mgChange 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 2Change at Day 50 (n =7, 3, 6, 6, 6)-33.77 mg*hr/dLStandard Deviation 250.859
Stage 1: PF-04856883 8 mgChange 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 2Change at Day 15 (n =7, 4, 6, 6, 6)-293.04 mg*hr/dLStandard Deviation 163.074
Stage 1: PF-04856883 12 mgChange 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 2Change at Day 50 (n =7, 3, 6, 6, 6)-125.06 mg*hr/dLStandard Deviation 217.403
Stage 1: PF-04856883 12 mgChange 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 2Change at Day 15 (n =7, 4, 6, 6, 6)-254.54 mg*hr/dLStandard Deviation 144.897
Stage 1: PF-04856883 12 mgChange 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 2Change at Day 24 (n =7, 4, 7, 6, 5)-242.35 mg*hr/dLStandard Deviation 231.302
Stage 1: PF-04856883 12 mgChange 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 2Change at Day 29 (n =7, 4, 7, 6, 5)-192.97 mg*hr/dLStandard Deviation 185.056
Stage 1: PF-04856883 12 mgChange 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 2Baseline (n =7, 4, 7, 7, 6)800.66 mg*hr/dLStandard Deviation 206.776
Stage 1: PF-04856883 12 mgChange 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 2Change at Day 3 (n =7, 4, 5, 6, 5)-98.38 mg*hr/dLStandard Deviation 114.644
Stage 1: PF-04856883 18 mgChange 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 2Change at Day 3 (n =7, 4, 5, 6, 5)-68.52 mg*hr/dLStandard Deviation 153.127
Stage 1: PF-04856883 18 mgChange 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 2Baseline (n =7, 4, 7, 7, 6)723.57 mg*hr/dLStandard Deviation 220.872
Stage 1: PF-04856883 18 mgChange 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 2Change at Day 50 (n =7, 3, 6, 6, 6)-23.99 mg*hr/dLStandard Deviation 123.611
Stage 1: PF-04856883 18 mgChange 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 2Change at Day 29 (n =7, 4, 7, 6, 5)-106.58 mg*hr/dLStandard Deviation 171.297
Stage 1: PF-04856883 18 mgChange 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 2Change at Day 24 (n =7, 4, 7, 6, 5)-121.13 mg*hr/dLStandard Deviation 258.528
Stage 1: PF-04856883 18 mgChange 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 2Change at Day 15 (n =7, 4, 6, 6, 6)-240.65 mg*hr/dLStandard Deviation 252.349
Secondary

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.

ArmMeasureGroupValue (MEAN)Dispersion
Stage 1: PF-04856883 PlaceboChange From Baseline in Post-prandial Glucose Area Under the Curve (AUC) After Mixed Meal Tolerance Test (MMTT) at Day 3 and 8: Stage 1Change 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 PlaceboChange From Baseline in Post-prandial Glucose Area Under the Curve (AUC) After Mixed Meal Tolerance Test (MMTT) at Day 3 and 8: Stage 1Change 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 PlaceboChange From Baseline in Post-prandial Glucose Area Under the Curve (AUC) After Mixed Meal Tolerance Test (MMTT) at Day 3 and 8: Stage 1Baseline (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 mgChange From Baseline in Post-prandial Glucose Area Under the Curve (AUC) After Mixed Meal Tolerance Test (MMTT) at Day 3 and 8: Stage 1Change 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 mgChange From Baseline in Post-prandial Glucose Area Under the Curve (AUC) After Mixed Meal Tolerance Test (MMTT) at Day 3 and 8: Stage 1Baseline (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 mgChange From Baseline in Post-prandial Glucose Area Under the Curve (AUC) After Mixed Meal Tolerance Test (MMTT) at Day 3 and 8: Stage 1Change 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 mgChange From Baseline in Post-prandial Glucose Area Under the Curve (AUC) After Mixed Meal Tolerance Test (MMTT) at Day 3 and 8: Stage 1Baseline (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 mgChange From Baseline in Post-prandial Glucose Area Under the Curve (AUC) After Mixed Meal Tolerance Test (MMTT) at Day 3 and 8: Stage 1Change 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 mgChange From Baseline in Post-prandial Glucose Area Under the Curve (AUC) After Mixed Meal Tolerance Test (MMTT) at Day 3 and 8: Stage 1Change 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 mgChange From Baseline in Post-prandial Glucose Area Under the Curve (AUC) After Mixed Meal Tolerance Test (MMTT) at Day 3 and 8: Stage 1Change 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 mgChange From Baseline in Post-prandial Glucose Area Under the Curve (AUC) After Mixed Meal Tolerance Test (MMTT) at Day 3 and 8: Stage 1Baseline (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 mgChange From Baseline in Post-prandial Glucose Area Under the Curve (AUC) After Mixed Meal Tolerance Test (MMTT) at Day 3 and 8: Stage 1Change 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 mgChange From Baseline in Post-prandial Glucose Area Under the Curve (AUC) After Mixed Meal Tolerance Test (MMTT) at Day 3 and 8: Stage 1Baseline (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 mgChange From Baseline in Post-prandial Glucose Area Under the Curve (AUC) After Mixed Meal Tolerance Test (MMTT) at Day 3 and 8: Stage 1Change 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 mgChange From Baseline in Post-prandial Glucose Area Under the Curve (AUC) After Mixed Meal Tolerance Test (MMTT) at Day 3 and 8: Stage 1Change 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 mgChange From Baseline in Post-prandial Glucose Area Under the Curve (AUC) After Mixed Meal Tolerance Test (MMTT) at Day 3 and 8: Stage 1Change 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 mgChange From Baseline in Post-prandial Glucose Area Under the Curve (AUC) After Mixed Meal Tolerance Test (MMTT) at Day 3 and 8: Stage 1Change 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 mgChange From Baseline in Post-prandial Glucose Area Under the Curve (AUC) After Mixed Meal Tolerance Test (MMTT) at Day 3 and 8: Stage 1Baseline (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 mgChange From Baseline in Post-prandial Glucose Area Under the Curve (AUC) After Mixed Meal Tolerance Test (MMTT) at Day 3 and 8: Stage 1Change 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 mgChange From Baseline in Post-prandial Glucose Area Under the Curve (AUC) After Mixed Meal Tolerance Test (MMTT) at Day 3 and 8: Stage 1Baseline (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 mgChange From Baseline in Post-prandial Glucose Area Under the Curve (AUC) After Mixed Meal Tolerance Test (MMTT) at Day 3 and 8: Stage 1Change at Day 3 (n =15, 5, 5, 6, 7, 5, 6)-153.04 milligram*hour per deciliter (mg*hr/dL)Standard Deviation 41.501
Secondary

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.

ArmMeasureValue (GEOMETRIC_MEAN)Dispersion
Stage 1: PF-04856883 PlaceboMaximum Observed Plasma Concentration (Cmax) of PF-04856883: Stage 1181.2 nanogram per milliliter (ng/mL)Geometric Coefficient of Variation 85
Stage 1: PF-04856883 4 mgMaximum Observed Plasma Concentration (Cmax) of PF-04856883: Stage 1324.7 nanogram per milliliter (ng/mL)Geometric Coefficient of Variation 61
Stage 1: PF-04856883 8 mgMaximum Observed Plasma Concentration (Cmax) of PF-04856883: Stage 1793.7 nanogram per milliliter (ng/mL)Geometric Coefficient of Variation 65
Stage 1: PF-04856883 12 mgMaximum Observed Plasma Concentration (Cmax) of PF-04856883: Stage 11855 nanogram per milliliter (ng/mL)Geometric Coefficient of Variation 66
Stage 1: PF-04856883 18 mgMaximum Observed Plasma Concentration (Cmax) of PF-04856883: Stage 11776 nanogram per milliliter (ng/mL)Geometric Coefficient of Variation 21
Stage 1: PF-04856883 24 mgMaximum Observed Plasma Concentration (Cmax) of PF-04856883: Stage 12006 nanogram per milliliter (ng/mL)Geometric Coefficient of Variation 52
Secondary

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.

ArmMeasureGroupValue (GEOMETRIC_MEAN)Dispersion
Stage 1: PF-04856883 PlaceboMaximum Observed Plasma Concentration (Cmax) of PF-04856883: Stage 2Day 1 (n =5, 7, 7, 6)1369 ng/mLGeometric Coefficient of Variation 17
Stage 1: PF-04856883 PlaceboMaximum Observed Plasma Concentration (Cmax) of PF-04856883: Stage 2Day 22 (n =5, 7, 5, 6)1802 ng/mLGeometric Coefficient of Variation 33
Stage 1: PF-04856883 4 mgMaximum Observed Plasma Concentration (Cmax) of PF-04856883: Stage 2Day 22 (n =5, 7, 5, 6)2757 ng/mLGeometric Coefficient of Variation 26
Stage 1: PF-04856883 4 mgMaximum Observed Plasma Concentration (Cmax) of PF-04856883: Stage 2Day 1 (n =5, 7, 7, 6)1203 ng/mLGeometric Coefficient of Variation 20
Stage 1: PF-04856883 8 mgMaximum Observed Plasma Concentration (Cmax) of PF-04856883: Stage 2Day 1 (n =5, 7, 7, 6)1027 ng/mLGeometric Coefficient of Variation 29
Stage 1: PF-04856883 8 mgMaximum Observed Plasma Concentration (Cmax) of PF-04856883: Stage 2Day 22 (n =5, 7, 5, 6)3030 ng/mLGeometric Coefficient of Variation 42
Stage 1: PF-04856883 12 mgMaximum Observed Plasma Concentration (Cmax) of PF-04856883: Stage 2Day 1 (n =5, 7, 7, 6)1407 ng/mLGeometric Coefficient of Variation 29
Stage 1: PF-04856883 12 mgMaximum Observed Plasma Concentration (Cmax) of PF-04856883: Stage 2Day 22 (n =5, 7, 5, 6)3046 ng/mLGeometric Coefficient of Variation 24
Secondary

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.

ArmMeasureGroupValue (NUMBER)
Stage 1: PF-04856883 PlaceboNumber of Participants With Anti-Drug Antibodies (ADA): Stage 1Day 1 (n =5, 6, 6, 7, 5, 7)1 participants
Stage 1: PF-04856883 PlaceboNumber of Participants With Anti-Drug Antibodies (ADA): Stage 1Day 29 (n =5, 5, 6, 6, 5, 7)1 participants
Stage 1: PF-04856883 4 mgNumber of Participants With Anti-Drug Antibodies (ADA): Stage 1Day 1 (n =5, 6, 6, 7, 5, 7)1 participants
Stage 1: PF-04856883 4 mgNumber of Participants With Anti-Drug Antibodies (ADA): Stage 1Day 29 (n =5, 5, 6, 6, 5, 7)2 participants
Stage 1: PF-04856883 8 mgNumber of Participants With Anti-Drug Antibodies (ADA): Stage 1Day 1 (n =5, 6, 6, 7, 5, 7)0 participants
Stage 1: PF-04856883 8 mgNumber of Participants With Anti-Drug Antibodies (ADA): Stage 1Day 29 (n =5, 5, 6, 6, 5, 7)1 participants
Stage 1: PF-04856883 12 mgNumber of Participants With Anti-Drug Antibodies (ADA): Stage 1Day 1 (n =5, 6, 6, 7, 5, 7)0 participants
Stage 1: PF-04856883 12 mgNumber of Participants With Anti-Drug Antibodies (ADA): Stage 1Day 29 (n =5, 5, 6, 6, 5, 7)0 participants
Stage 1: PF-04856883 18 mgNumber of Participants With Anti-Drug Antibodies (ADA): Stage 1Day 1 (n =5, 6, 6, 7, 5, 7)0 participants
Stage 1: PF-04856883 18 mgNumber of Participants With Anti-Drug Antibodies (ADA): Stage 1Day 29 (n =5, 5, 6, 6, 5, 7)0 participants
Stage 1: PF-04856883 24 mgNumber of Participants With Anti-Drug Antibodies (ADA): Stage 1Day 1 (n =5, 6, 6, 7, 5, 7)2 participants
Stage 1: PF-04856883 24 mgNumber of Participants With Anti-Drug Antibodies (ADA): Stage 1Day 29 (n =5, 5, 6, 6, 5, 7)2 participants
Secondary

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.

ArmMeasureGroupValue (NUMBER)
Stage 1: PF-04856883 PlaceboNumber of Participant With Anti-Drug Antibodies (ADA): Stage 2Day 1 (n =5, 7, 7, 6)0 participants
Stage 1: PF-04856883 PlaceboNumber of Participant With Anti-Drug Antibodies (ADA): Stage 2Day 50 (n =5, 7, 6, 6)0 participants
Stage 1: PF-04856883 PlaceboNumber of Participant With Anti-Drug Antibodies (ADA): Stage 2Day 29 (n =5, 7, 6, 5)0 participants
Stage 1: PF-04856883 4 mgNumber of Participant With Anti-Drug Antibodies (ADA): Stage 2Day 1 (n =5, 7, 7, 6)1 participants
Stage 1: PF-04856883 4 mgNumber of Participant With Anti-Drug Antibodies (ADA): Stage 2Day 29 (n =5, 7, 6, 5)2 participants
Stage 1: PF-04856883 4 mgNumber of Participant With Anti-Drug Antibodies (ADA): Stage 2Day 50 (n =5, 7, 6, 6)3 participants
Stage 1: PF-04856883 8 mgNumber of Participant With Anti-Drug Antibodies (ADA): Stage 2Day 29 (n =5, 7, 6, 5)2 participants
Stage 1: PF-04856883 8 mgNumber of Participant With Anti-Drug Antibodies (ADA): Stage 2Day 1 (n =5, 7, 7, 6)1 participants
Stage 1: PF-04856883 8 mgNumber of Participant With Anti-Drug Antibodies (ADA): Stage 2Day 50 (n =5, 7, 6, 6)2 participants
Stage 1: PF-04856883 12 mgNumber of Participant With Anti-Drug Antibodies (ADA): Stage 2Day 50 (n =5, 7, 6, 6)3 participants
Stage 1: PF-04856883 12 mgNumber of Participant With Anti-Drug Antibodies (ADA): Stage 2Day 1 (n =5, 7, 7, 6)0 participants
Stage 1: PF-04856883 12 mgNumber of Participant With Anti-Drug Antibodies (ADA): Stage 2Day 29 (n =5, 7, 6, 5)1 participants
Secondary

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.

ArmMeasureGroupValue (MEAN)Dispersion
Stage 1: PF-04856883 PlaceboPercent Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Day 29 and 50: Stage 2Day 50 (n =6, 5, 7, 7, 6)0.15 percentStandard Deviation 0.769
Stage 1: PF-04856883 PlaceboPercent Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Day 29 and 50: Stage 2Day 29 (n =7, 5, 7, 6, 5)0.06 percentStandard Deviation 0.547
Stage 1: PF-04856883 4 mgPercent Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Day 29 and 50: Stage 2Day 50 (n =6, 5, 7, 7, 6)-0.08 percentStandard Deviation 0.335
Stage 1: PF-04856883 4 mgPercent Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Day 29 and 50: Stage 2Day 29 (n =7, 5, 7, 6, 5)-0.24 percentStandard Deviation 0.288
Stage 1: PF-04856883 8 mgPercent Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Day 29 and 50: Stage 2Day 50 (n =6, 5, 7, 7, 6)-0.24 percentStandard Deviation 0.326
Stage 1: PF-04856883 8 mgPercent Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Day 29 and 50: Stage 2Day 29 (n =7, 5, 7, 6, 5)-0.41 percentStandard Deviation 0.212
Stage 1: PF-04856883 12 mgPercent Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Day 29 and 50: Stage 2Day 29 (n =7, 5, 7, 6, 5)-0.42 percentStandard Deviation 0.44
Stage 1: PF-04856883 12 mgPercent Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Day 29 and 50: Stage 2Day 50 (n =6, 5, 7, 7, 6)-0.33 percentStandard Deviation 0.754
Stage 1: PF-04856883 18 mgPercent Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Day 29 and 50: Stage 2Day 29 (n =7, 5, 7, 6, 5)-0.40 percentStandard Deviation 0.43
Stage 1: PF-04856883 18 mgPercent Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Day 29 and 50: Stage 2Day 50 (n =6, 5, 7, 7, 6)-0.40 percentStandard Deviation 0.58
Comparison: Day 29: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.p-value: 0.41980% CI: [-0.54, 0.12]Mixed meal tolerance test
Comparison: Day 29: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.p-value: 0.07780% CI: [-0.71, -0.12]Mixed meal tolerance test
Comparison: Day 29: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.p-value: 0.14780% CI: [-0.65, -0.04]Mixed meal tolerance test
Comparison: Day 29: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.p-value: 0.08680% CI: [-0.76, -0.11]Mixed meal tolerance test
Secondary

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.

ArmMeasureValue (MEAN)Dispersion
Stage 1: PF-04856883 PlaceboTerminal Elimination Half- Life (t1/2) of PF-04856883: Stage 1146.3 hourStandard Deviation 13.614
Stage 1: PF-04856883 4 mgTerminal Elimination Half- Life (t1/2) of PF-04856883: Stage 1179.7 hourStandard Deviation 14.572
Stage 1: PF-04856883 8 mgTerminal Elimination Half- Life (t1/2) of PF-04856883: Stage 1147.0 hourStandard Deviation 18.52
Stage 1: PF-04856883 12 mgTerminal Elimination Half- Life (t1/2) of PF-04856883: Stage 1133.8 hourStandard Deviation 23.936
Stage 1: PF-04856883 18 mgTerminal Elimination Half- Life (t1/2) of PF-04856883: Stage 1173.7 hourStandard Deviation 7.0238
Stage 1: PF-04856883 24 mgTerminal Elimination Half- Life (t1/2) of PF-04856883: Stage 1131.6 hourStandard Deviation 45.883
Secondary

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.

ArmMeasureValue (MEAN)Dispersion
Stage 1: PF-04856883 PlaceboTerminal Elimination Half-life (t1/2) of PF-04856883: Stage 2149.4 hourStandard Deviation 21.87
Stage 1: PF-04856883 4 mgTerminal Elimination Half-life (t1/2) of PF-04856883: Stage 2135.0 hourStandard Deviation 43.98
Stage 1: PF-04856883 8 mgTerminal Elimination Half-life (t1/2) of PF-04856883: Stage 2143.8 hourStandard Deviation 20.565
Stage 1: PF-04856883 12 mgTerminal Elimination Half-life (t1/2) of PF-04856883: Stage 2145.0 hourStandard Deviation 37
Secondary

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.

ArmMeasureValue (MEDIAN)
Stage 1: PF-04856883 PlaceboTime to Reach Maximum Observed Plasma Concentration (Tmax) of PF-04856883: Stage 1168 hour
Stage 1: PF-04856883 4 mgTime to Reach Maximum Observed Plasma Concentration (Tmax) of PF-04856883: Stage 1120 hour
Stage 1: PF-04856883 8 mgTime to Reach Maximum Observed Plasma Concentration (Tmax) of PF-04856883: Stage 1120 hour
Stage 1: PF-04856883 12 mgTime to Reach Maximum Observed Plasma Concentration (Tmax) of PF-04856883: Stage 1120 hour
Stage 1: PF-04856883 18 mgTime to Reach Maximum Observed Plasma Concentration (Tmax) of PF-04856883: Stage 1120 hour
Stage 1: PF-04856883 24 mgTime to Reach Maximum Observed Plasma Concentration (Tmax) of PF-04856883: Stage 1122 hour
Secondary

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.

ArmMeasureGroupValue (MEDIAN)
Stage 1: PF-04856883 PlaceboTime to Reach Maximum Observed Plasma Concentration (Tmax) of PF-04856883: Stage 2Day 1 (n =5, 7, 7, 6)336 hour
Stage 1: PF-04856883 PlaceboTime to Reach Maximum Observed Plasma Concentration (Tmax) of PF-04856883: Stage 2Day 22 (n =5, 7, 5, 6)48.0 hour
Stage 1: PF-04856883 4 mgTime to Reach Maximum Observed Plasma Concentration (Tmax) of PF-04856883: Stage 2Day 22 (n =5, 7, 5, 6)72.0 hour
Stage 1: PF-04856883 4 mgTime to Reach Maximum Observed Plasma Concentration (Tmax) of PF-04856883: Stage 2Day 1 (n =5, 7, 7, 6)336 hour
Stage 1: PF-04856883 8 mgTime to Reach Maximum Observed Plasma Concentration (Tmax) of PF-04856883: Stage 2Day 1 (n =5, 7, 7, 6)335 hour
Stage 1: PF-04856883 8 mgTime to Reach Maximum Observed Plasma Concentration (Tmax) of PF-04856883: Stage 2Day 22 (n =5, 7, 5, 6)72.0 hour
Stage 1: PF-04856883 12 mgTime to Reach Maximum Observed Plasma Concentration (Tmax) of PF-04856883: Stage 2Day 1 (n =5, 7, 7, 6)336 hour
Stage 1: PF-04856883 12 mgTime to Reach Maximum Observed Plasma Concentration (Tmax) of PF-04856883: Stage 2Day 22 (n =5, 7, 5, 6)60.0 hour

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026