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

Sponsor
Pfizer (Industry)
Overall Status
Completed
CT.gov ID
NCT01301456
Collaborator
(none)
84
7
13
13
12
0.9

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Biological: Placebo
  • Biological: PF-04856883
  • Biological: PF-04856883
  • Biological: PF-04856883
  • Biological: Placebo
  • Biological: PF-04856883
  • Biological: PF-04856883
  • Biological: PF-04856883
  • Biological: Placebo
  • Biological: PF-04856883
  • Biological: PF-04856883
  • Biological: PF-04856883
  • Biological: PF-04856883
Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
84 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
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
Actual Study Start Date :
Mar 1, 2011
Actual Primary Completion Date :
Dec 1, 2011
Actual Study Completion Date :
Apr 1, 2012

Arms and Interventions

Arm Intervention/Treatment
Placebo Comparator: Treatment Arm 1 (Stage 1A)

Biological: Placebo
Single subcutaneous injection of placebo

Experimental: Treatment Arm 2 (Stage 1A)

Biological: PF-04856883
Single subcutaneous injection of PF-04856883
Other Names:
  • CVX-096
  • Experimental: Treatment Arm 3 (Stage 1A)

    Biological: PF-04856883
    Single subcutaneous injection of PF-04856883
    Other Names:
  • CVX-096
  • Experimental: Treatment Arm 4 (Stage 1A)

    Biological: PF-04856883
    Single subcutaneous injection of PF-04856883
    Other Names:
  • CVX-096
  • Placebo Comparator: Treatment Arm 5 (Stage 1B)

    Biological: Placebo
    Single subcutaneous injection of placebo

    Experimental: Treatment Arm 6 (Stage 1B)

    Biological: PF-04856883
    Single subcutaneous injection of PF-04856883
    Other Names:
  • CVX-096
  • Experimental: Treatment Arm 7 (Stage 1B)

    Biological: PF-04856883
    Single subcutaneous injection of PF-04856883
    Other Names:
  • CVX-096
  • Experimental: Treatment Arm 8 (Stage 1B)

    Biological: PF-04856883
    Single subcutaneous injection of PF-04856883
    Other Names:
  • CVX-096
  • Placebo Comparator: Treatment Arm 9 (Stage 2)

    Biological: Placebo
    Multiple weekly subcutaneous injections of placebo for 3 weeks
    Other Names:
  • CVX-096
  • Experimental: Treatment Arm 10 (Stage 2)

    Biological: PF-04856883
    Multiple weekly subcutaneous injections of PF-04856883 for 3 weeks
    Other Names:
  • CVX-096
  • Experimental: Treatment Arm 11 (Stage 2)

    Biological: PF-04856883
    Multiple weekly subcutaneous injections of PF-04856883 for 3 weeks
    Other Names:
  • CVX-096
  • Experimental: Treatment Arm 12 (Stage 2)

    Biological: PF-04856883
    Multiple weekly subcutaneous injections of PF-04856883 for 3 weeks
    Other Names:
  • CVX-096
  • Experimental: Treatment Arm 13 (Stage 2)

    Biological: PF-04856883
    Multiple weekly subcutaneous injections of PF-04856883 for 3 weeks
    Other Names:
  • CVX-096
  • Outcome Measures

    Primary Outcome Measures

    1. Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) [Stage 1: Baseline up to Day 29; Stage 2: Baseline up to Day 50]

      An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose (Day 50) that were absent before treatment or that worsened relative to pretreatment state.

    2. Number of Participants With Clinically Significant Physical Examination Findings [Stage 1: Baseline up to Day 29; Stage 2: Baseline up to Day 50]

      Physical examination included examination of general appearance, head, ears, eyes (including fundoscopy), nose, mouth, throat, neck (including thyroid), skin, breast (optional), cardiac, respiratory, gastrointestinal, musculoskeletal and neurological systems.

    3. Number of Participants With Clinically Significant Change From Baseline in 12-lead Electrocardiograms (ECG) [Stage 1: Baseline up to Day 29; Stage 2: Baseline up to Day 50]

      ECG parameters included pulse rate (PR) interval, QRS interval, corrected QT interval using Bazett's formula (QTcB) and corrected QT interval using Fridericia's formula (QTcF). ECG criteria of clinically significant concern were 1) PR interval: greater than equal to (>=) 25 percent (%) increase when baseline greater than (>)200 milliseconds (msec); or increase >=50% when baseline less than or equal to (<=200) msec; 2) QRS interval: >=25% increase when baseline >100 msec; >=50% increase when baseline <= 100 msec; 3) QTCF interval: QTc interval using Fridericia's formula (QTcF interval) and Bazett's formula (QTcB interval): absolute value 450 - <480 msec, 480 - <500 msec >=500; absolute change 30 - <60, >=60 msec. The number of participants with potentially clinically significant ECG findings at any visit were reported. IFB = increase from baseline.

    4. Number of Participants With Vital Sign Abnormalities [Stage 1: Baseline up to Day 29; Stage 2 : Baseline up to Day 50]

      Criteria for vital signs abnormalities: sitting/supine systolic pulse rate less than (<) 40 beats per minute (bpm) or greater than (>) 120 bpm, standing/supine systolic pulse < 40 bpm or > 140 bpm, systolic blood pressure of >=30 millimeters of mercury (mmHg) change from baseline and systolic blood pressure <90 mmHg, diastolic blood pressure >=20 mmHg change from baseline and diastolic blood pressure <50 mm Hg.

    5. Number of Participants With Clinically Significant Abnormalities in Laboratory Measurements [Stage 1: Baseline up to Day 29; Stage 2: Baseline up to Day 50]

      Following parameters were analyzed for laboratory examination: Hematology: hemoglobin, hematocrit, red blood cell (RBC) <0.8*lower limit of the reference range (LLRR); leukocytes <0.6*LLRR or >1.5*ULRR; platelet count <0.5*LLRR or >1.75*upper limit of the reference range (ULRR); total neutrophils (absolute [abs]), lymphocytes (abs) <0.8*LLRR or >1.2*ULRR; eosinophils (abs), basophils (abs), monocytes (abs) >1.2*ULRR; chemistry (total bilirubin, direct bilirubin, indirect bilirubin >1.5*ULRR; aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase >3*ULRR, albumin, total protein <0.8*LLRR or >1.2*ULRR; blood urea nitrogen (BUN), creatinine >1.3*ULRR; glucose (fasting) <0.6*LLRR or >1.5*ULRR; uric acid >1.2* ULRR; sodium <0.95*LLRR or >1.05*ULRR; potassium, chloride, bicarbonate, calcium <0.9*LLRR or >1.1*ULRR. Urinalysis: Urine white blood cell (WBC), Urine RBC =>20/ high-power field (HPF).

    Secondary Outcome Measures

    1. Maximum Observed Plasma Concentration (Cmax) of PF-04856883: Stage 1 [predose (0 hour), 1, 6, 12, 24, 48, 72, 120, 168, 336, 504, 672 hours postdose on Day 1]

    2. Maximum Observed Plasma Concentration (Cmax) of PF-04856883: Stage 2 [predose (0 hour), 1, 6, 12, 24, 48, 72, 120, 168, 336 hours postdose on Day 1; predose (0 hour), 1, 2, 6, 24, 48, 72, 120, 168, 336, 504, 672 hours postdose on Day 22]

    3. Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-04856883: Stage 1 [predose (0 hour), 1, 6, 12, 24, 48, 72, 120, 168, 336, 504, 672 hours postdose on Day 1]

    4. Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-04856883: Stage 2 [predose (0 hour), 1, 6, 12, 24, 48, 72, 120, 168, 336 hours postdose on Day 1; predose (0 hour), 1, 2, 6, 24, 48, 72, 120, 168, 336, 504, 672 hours postdose on Day 22]

    5. Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUC [0 - ∞]) of PF-04856883: Stage 1 [predose (0 hour), 1, 6, 12, 24, 48, 72, 120, 168, 336, 504, 672 hours postdose on Day 1]

      AUC (0 - ∞) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞).

    6. Area Under the Concentration Time Curve From Time Zero to Time Tau (AUCtau) of PF-04856883: Stage 2 [predose (0 hour), 1, 6, 12, 24, 48, 72, 120, 168 hours postdose Day 1; predose (0 hour), 1, 2, 6, 24, 48, 72, 120, 168 hours postdose Day 22]

      Area under the serum concentration-time curve from time 0 to tau (AUCtau), where tau was the dosing interval of 168 hours.

    7. Apparent Clearance (CL/F) of PF-04856883: Stage 1 [predose (0 hour), 1, 6, 12, 24, 48, 72, 120, 168, 336, 504, 672 hours postdose on Day 1]

      It was calculated by dividing dose with AUC (0 - ∞) where AUC (0 - ∞) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞). Outcome measure was planned to be analyzed in Stage 1 only.

    8. Apparent Clearance (CL/F) of PF-04856883: Stage 2 [predose (0 hour), 1, 2, 6, 24, 48, 72, 120, 168, 336, 504, 672 hours postdose on Day 22]

      It was calculated by dividing dose with AUC (0 - ∞) where AUC (0 - ∞) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞). Outcome measure was planned to be analyzed in Stage 2 only. Data was not estimable if values were below the limit of quantification.

    9. Apparent Volume of Distribution (Vz/F) of PF-04856883: Stage 1 [predose (0 hour), 1, 6, 12, 24, 48, 72, 120, 168, 336, 504, 672 hours postdose on Day 1]

    10. Apparent Volume of Distribution (Vz/F) of PF-04856883: Stage 2 [predose (0 hour), 1, 2, 6, 24, 48, 72, 120, 168, 336, 504, 672 hours postdose on Day 22]

    11. Terminal Elimination Half- Life (t1/2) of PF-04856883: Stage 1 [predose (0 hour), 1, 6, 12, 24, 48, 72, 120, 168, 336, 504, 672 hours postdose on Day 1]

    12. Terminal Elimination Half-life (t1/2) of PF-04856883: Stage 2 [predose (0 hour), 1, 2, 6, 24, 48, 72, 120, 168, 336, 504, 672 hours postdose on Day 22]

    13. Change From Baseline in Post-prandial Glucose Area Under the Curve (AUC) After Mixed Meal Tolerance Test (MMTT) at Day 3 and 8: Stage 1 [Baseline, Day 3 and 8]

      Change from baseline in post-prandial area under the plasma glucose concentration time curve as determined by standardized MMTT. Linear trapezoidal method was used to compute AUC

    14. Change From Baseline in Post-prandial Glucose Area Under the Curve (AUC) After Mixed Meal Tolerance Test (MMTT) at Day 3, 15, 24, 29 and 50: Stage 2 [Baseline, Day 3, 15, 24, 29 and 50]

      Change from baseline in post-prandial area under the plasma glucose concentration time curve as determined by standardized MMTT. Linear trapezoidal method was used to compute AUC.

    15. Change From Baseline in Insulin Area Under the Curve (AUC) After Mixed Meal Tolerance Test (MMTT) at Day 3 and 8: Stage 1 [Baseline, Day 3 and 8]

      Change from baseline in post-prandial plasma insulin AUC under the plasma insulin concentration versus time curve as determined by standardized MMTT. Linear trapezoidal method was used to compute AUC.

    16. Change From Baseline in Insulin Area Under the Curve (AUC) After Mixed Meal Tolerance Test (MMTT) at Day 3, 15, 24, 29 and 50: Stage 2 [Baseline, Day 3, 15, 24, 29 and 50]

      Change from baseline in post-prandial plasma insulin AUC under the plasma insulin concentration versus time curve as determined by standardized MMTT. Linear trapezoidal method was used to compute AUC.

    17. Change From Baseline in C-Peptide Area Under the Curve (AUC) After Mixed Meal Tolerance Test (MMTT) at Day 3 and 8: Stage 1 [Baseline, Day 3 and 8]

      Change from baseline in post-prandial area under the plasma C-peptide concentration time curve as determined by standardized MMTT. Linear trapezoidal method was used to compute AUC.

    18. Change From Baseline in C-Peptide Area Under the Curve (AUC) After Mixed Meal Tolerance Test (MMTT) at Day 3, 15, 24, 29 and 50: Stage 2 [Baseline, Day 3, 15, 24, 29 and 50]

      Change from baseline in post-prandial area under the plasma C-peptide concentration time curve as determined by standardized MMTT. Linear trapezoidal method was used to compute AUC.

    19. Change From Baseline in Fasting Plasma Glucose (FPG) at Day 2, 4, 6, 15, 22 and 29: Stage 1 [Baseline, Day 2, 4, 6, 15, 22 and 29]

    20. Change From Baseline in Fasting Plasma Glucose (FPG) at Day 2, 4, 6, 8, 22, 23, 25, 27, 30, 36 and 43: Stage 2 [Baseline, Day 2, 4, 6, 8, 22, 23, 25, 27, 30, 36 and 43]

    21. Change From Baseline in 24 Hours Glucose Normalized Area Under the Curve (NAUC) Profile at Day 30: Stage 2 [Baseline, Day 30]

      A normalized area under the curve (NAUC) were computed by dividing the AUC by the amount of time between the last time point captured and the first time point captured.

    22. Percent Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Day 29 and 50: Stage 2 [Baseline, Day 29 and 50]

      HbA1c is a measure of the glycosylated hemoglobin. Change (measured as percent): HbA1c at observation minus HbA1c at baseline. Outcome measure was planned to analyzed only for Stage 2.

    23. Change From Baseline in Fructosamine Levels at Day 8, 15 and 29: Stage 1 [Baseline, Day 8, 15 and 29]

    24. Change From Baseline in Fructosamine Levels at Day 8, 15, 22, 29 and 50: Stage 2 [Baseline, Day 8, 15, 22, 29 and 50]

    25. Change From Baseline in 1, 5 Anhydroglucitol at Day 8, 15 and 29: Stage 1 [Baseline, Day 8, 15 and 29]

    26. Change From Baseline in 1, 5 Anhydroglucitol at Day 8, 15, 22, 29 and 50: Stage 2 [Baseline, Day 8, 15, 22, 29 and 50]

    27. Number of Participants With Anti-Drug Antibodies (ADA): Stage 1 [Day 1 and 29]

    28. Number of Participant With Anti-Drug Antibodies (ADA): Stage 2 [Day 1, 29 and 50]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 70 Years
    Sexes Eligible for Study:
    Female
    Accepts 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Profil Institute for Clinical Research, Inc. Chula Vista California United States 91911
    2 Elite Research Institute Miami Florida United States 33169
    3 Comprehensive Phase One (A Division of Comprehensive NeuroScience, Inc.) Miramar Florida United States 33025
    4 Atlanta Center for Medical Research Atlanta Georgia United States 30308
    5 ICON Clinical Pharmacology, LLC Omaha Nebraska United States 68154
    6 CRI Worldwide, LLC Philadelphia Pennsylvania United States 19139
    7 Healthcare Discoveries LLC d/b/a ICON Development Solutions San Antonio Texas United States 78209

    Sponsors and Collaborators

    • Pfizer

    Investigators

    • Study Director: Pfizer CT.gov Call Center, Pfizer

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Pfizer
    ClinicalTrials.gov Identifier:
    NCT01301456
    Other Study ID Numbers:
    • B1111002
    First Posted:
    Feb 23, 2011
    Last Update Posted:
    Feb 9, 2018
    Last Verified:
    Jul 1, 2017

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment Detail 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.
    Arm/Group Title Stage 1: PF-04856883 Placebo Stage 1: PF-04856883 4 mg Stage 1: PF-04856883 8 mg Stage 1: PF-04856883 12 mg Stage 1: PF-04856883 18 mg Stage 1: PF-04856883 24 mg Stage 1: PF-04856883 36 mg Stage 2: Placebo Stage 2: PF-04856883 12 mg Stage 2: PF-04856883 12 mg + 12 mg + 24 mg + 24 mg Stage 2: PF-04856883 8 mg + 8 mg + 16 mg + 24 mg Stage 2: PF-04856883 12 mg + 20 mg + 28 mg + 36 mg
    Arm/Group Description Participants received placebo matched to PF-04856883 subcutaneously injection once on Day 1 in Stage 1. Participants received PF-04856883 4 milligram (mg) subcutaneous injection once on Day 1 in Stage 1. Participants received PF-04856883 8 mg subcutaneous injection once on Day 1 in Stage 1. Participants received PF-04856883 12 mg subcutaneous injection once on Day 1 in Stage 1. Participants received PF-04856883 18 mg subcutaneous injection once on Day 1 in Stage 1. Participants received PF-04856883 24 mg subcutaneous injection once on Day 1 in Stage 1. Participants received PF-04856883 36 mg subcutaneous injection once on Day 1 in Stage 1. Participants received placebo matched to PF-04856883 subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2. Participants received single dose of PF-04856883 12 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2. 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. 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. 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.
    Period Title: Stage 1
    STARTED 15 5 6 6 7 5 8 0 0 0 0 0
    Received Treatment 15 5 6 6 7 5 7 0 0 0 0 0
    COMPLETED 15 5 5 6 6 5 7 0 0 0 0 0
    NOT COMPLETED 0 0 1 0 1 0 1 0 0 0 0 0
    Period Title: Stage 1
    STARTED 0 0 0 0 0 0 0 7 5 7 7 6
    Received Treatment 0 0 0 0 0 0 0 7 5 7 7 6
    COMPLETED 0 0 0 0 0 0 0 7 5 7 6 6
    NOT COMPLETED 0 0 0 0 0 0 0 0 0 0 1 0

    Baseline Characteristics

    Arm/Group Title Stage 1: PF-04856883 Placebo Stage 1: PF-04856883 4 mg Stage 1: PF-04856883 8 mg Stage 1: PF-04856883 12 mg Stage 1: PF-04856883 18 mg Stage 1: PF-04856883 24 mg Stage 1: PF-04856883 36 mg Stage 2: Placebo Stage 2: PF-04856883 12 mg Stage 2: PF-04856883 12 mg + 12 mg + 24 mg + 24 mg Stage 2: PF-04856883 8 mg + 8 mg + 16 mg + 24 mg Stage 2: PF-04856883 12 mg + 20 mg + 28 mg + 36 mg Total
    Arm/Group Description Participants received placebo matched to PF-04856883 subcutaneously injection once on Day 1 in Stage 1. Participants received PF-04856883 4 mg subcutaneous injection once on Day 1 in Stage 1. Participants received PF-04856883 8 mg subcutaneous injection once on Day 1 in Stage 1. Participants received PF-04856883 12 mg subcutaneous injection once on Day 1 in Stage 1. Participants received PF-04856883 18 mg subcutaneous injection once on Day 1 in Stage 1. Participants received PF-04856883 24 mg subcutaneous injection once on Day 1 in Stage 1. Participants received PF-04856883 36 mg subcutaneous injection once on Day 1 in Stage 1. Participants received placebo matched to PF-04856883 subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2. Participants received single dose of PF-04856883 12 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2. 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. 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. 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. Total of all reporting groups
    Overall Participants 15 5 6 6 7 5 8 7 5 7 7 6 84
    Age, Customized (participants) [Number]
    <18 years
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Between 18 and 64 years
    15
    100%
    3
    60%
    5
    83.3%
    4
    66.7%
    6
    85.7%
    4
    80%
    6
    75%
    6
    85.7%
    5
    100%
    4
    57.1%
    7
    100%
    6
    100%
    71
    84.5%
    >=65 years
    0
    0%
    2
    40%
    1
    16.7%
    2
    33.3%
    1
    14.3%
    1
    20%
    2
    25%
    1
    14.3%
    0
    0%
    3
    42.9%
    0
    0%
    0
    0%
    13
    15.5%
    Sex: Female, Male (Count of Participants)
    Female
    15
    100%
    5
    100%
    6
    100%
    6
    100%
    7
    100%
    5
    100%
    8
    100%
    7
    100%
    5
    100%
    7
    100%
    7
    100%
    6
    100%
    84
    100%
    Male
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%

    Outcome Measures

    1. Primary Outcome
    Title Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)
    Description 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

    Outcome Measure Data

    Analysis Population Description
    The safety population included all randomized participants who received at least 1 dose of study treatment.
    Arm/Group Title Stage 1: PF-04856883 Placebo Stage 1: PF-04856883 4 mg Stage 1: PF-04856883 8 mg Stage 1: PF-04856883 12 mg Stage 1: PF-04856883 18 mg Stage 1: PF-04856883 24 mg Stage 1: PF-04856883 36 mg Stage 2: Placebo Stage 2: PF-04856883 12 mg Stage 2: PF-04856883 12 mg + 12 mg + 24 mg + 24 mg Stage 2: PF-04856883 8 mg + 8 mg + 16 mg + 24 mg Stage 2: PF-04856883 12 mg + 20 mg + 28 mg + 36 mg
    Arm/Group Description Participants received placebo matched to PF-04856883 subcutaneously injection once on Day 1 in Stage 1. Participants received PF-04856883 4 mg subcutaneous injection once on Day 1 in Stage 1. Participants received PF-04856883 8 mg subcutaneous injection once on Day 1 in Stage 1. Participants received PF-04856883 12 mg subcutaneous injection once on Day 1 in Stage 1. Participants received PF-04856883 18 mg subcutaneous injection once on Day 1 in Stage 1. Participants received PF-04856883 24 mg subcutaneous injection once on Day 1 in Stage 1. Participants received PF-04856883 36 mg subcutaneous injection once on Day 1 in Stage 1. Participants received placebo matched to PF-04856883 subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2. Participants received single dose of PF-04856883 12 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2. 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. 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. 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.
    Measure Participants 15 5 6 6 7 5 7 7 5 7 7 6
    SAE
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    AE
    8
    53.3%
    1
    20%
    0
    0%
    2
    33.3%
    4
    57.1%
    3
    60%
    4
    50%
    4
    57.1%
    5
    100%
    5
    71.4%
    5
    71.4%
    5
    83.3%
    2. Primary Outcome
    Title Number of Participants With Clinically Significant Physical Examination Findings
    Description 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

    Outcome Measure Data

    Analysis Population Description
    The safety population included all randomized participants who received at least 1 dose of study treatment.
    Arm/Group Title Stage 1: PF-04856883 Placebo Stage 1: PF-04856883 4 mg Stage 1: PF-04856883 8 mg Stage 1: PF-04856883 12 mg Stage 1: PF-04856883 18 mg Stage 1: PF-04856883 24 mg Stage 1: PF-04856883 36mg Single Dose Stage 2: Placebo Stage 2: PF-04856883 12 mg Stage 2: PF-04856883 12 mg + 12 mg + 24 mg + 24 mg Stage 2: PF-04856883 8 mg + 8 mg + 16 mg + 24 mg Stage 2: PF-04856883 12 mg + 20 mg + 28 mg + 36 mg
    Arm/Group Description Participants received placebo matched to PF-04856883 subcutaneously injection once on Day 1 in Stage 1. Participants received PF-04856883 4 mg subcutaneous injection once on Day 1 in Stage 1. Participants received PF-04856883 8 mg subcutaneous injection once on Day 1 in Stage 1. Participants received PF-04856883 12 mg subcutaneous injection once on Day 1 in Stage 1. Participants received PF-04856883 18 mg subcutaneous injection once on Day 1 in Stage 1. Participants received PF-04856883 24 mg subcutaneous injection once on Day 1 in Stage 1. Participants received subcutaneous injection of PF-04856883 4 mg by a 4-week follow up period in Stage 1 Participants received placebo matched to PF-04856883 subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2. Participants received single dose of PF-04856883 12 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2. 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. 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. 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.
    Measure Participants 15 5 6 6 7 5 7 7 5 7 7 6
    Number [participants]
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    3. Primary Outcome
    Title Number of Participants With Clinically Significant Change From Baseline in 12-lead Electrocardiograms (ECG)
    Description 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

    Outcome Measure Data

    Analysis Population Description
    The safety population included all randomized participants who received at least 1 dose of study treatment.
    Arm/Group Title Stage 1: PF-04856883 Placebo Stage 1: PF-04856883 4 mg Stage 1: PF-04856883 8 mg Stage 1: PF-04856883 12 mg Stage 1: PF-04856883 18 mg Stage 1: PF-04856883 24 mg Stage 1: PF-04856883 36 mg Stage 2: Placebo Stage 2: PF-04856883 12 mg Stage 2: PF-04856883 12 mg + 12 mg + 24 mg + 24 mg Stage 2: PF-04856883 8 mg + 8 mg + 16 mg + 24 mg Stage 2: PF-04856883 12 mg + 20 mg + 28 mg + 36 mg
    Arm/Group Description Participants received placebo matched to PF-04856883 subcutaneously injection once on Day 1 in Stage 1. Participants received PF-04856883 4 mg subcutaneous injection once on Day 1 in Stage 1. Participants received PF-04856883 8 mg subcutaneous injection once on Day 1 in Stage 1. Participants received PF-04856883 12 mg subcutaneous injection once on Day 1 in Stage 1. Participants received PF-04856883 18 mg subcutaneous injection once on Day 1 in Stage 1. Participants received PF-04856883 24 mg subcutaneous injection once on Day 1 in Stage 1. Participants received PF-04856883 36 mg subcutaneous injection once on Day 1 in Stage 1. Participants received placebo matched to PF-04856883 subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2. Participants received single dose of PF-04856883 12 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2. 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. 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. 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.
    Measure Participants 15 5 6 6 7 5 7 7 5 7 7 6
    Maximum PR Interval IFB: >=25 or 50%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    1
    14.3%
    0
    0%
    0
    0%
    1
    14.3%
    0
    0%
    Maximum QTcB Interval IFB: 30-<60 msec
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    1
    20%
    1
    12.5%
    0
    0%
    1
    20%
    0
    0%
    0
    0%
    1
    16.7%
    Maximum QTcF Interval IFB: 30-<60 msec
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    1
    20%
    0
    0%
    0
    0%
    1
    20%
    0
    0%
    0
    0%
    0
    0%
    4. Primary Outcome
    Title Number of Participants With Vital Sign Abnormalities
    Description 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

    Outcome Measure Data

    Analysis Population Description
    The safety population included all randomized participants who received at least 1 dose of study treatment.
    Arm/Group Title Stage 1: PF-04856883 Placebo Stage 1: PF-04856883 4 mg Stage 1: PF-04856883 8 mg Stage 1: PF-04856883 12 mg Stage 1: PF-04856883 18 mg Stage 1: PF-04856883 24 mg Stage 1: PF-04856883 36 mg Stage 2: Placebo Stage 2: PF-04856883 12 mg Stage 2: PF-04856883 12 mg + 12 mg + 24 mg + 24 mg Stage 2: PF-04856883 8 mg + 8 mg + 16 mg + 24 mg Stage 2: PF-04856883 12 mg + 20 mg + 28 mg + 36 mg
    Arm/Group Description Participants received placebo matched to PF-04856883 subcutaneously injection once on Day 1 in Stage 1. Participants received PF-04856883 4 mg subcutaneous injection once on Day 1 in Stage 1. Participants received PF-04856883 8 mg subcutaneous injection once on Day 1 in Stage 1. Participants received PF-04856883 12 mg subcutaneous injection once on Day 1 in Stage 1. Participants received PF-04856883 18 mg subcutaneous injection once on Day 1 in Stage 1. Participants received PF-04856883 24 mg subcutaneous injection once on Day 1 in Stage 1. Participants received PF-04856883 36 mg subcutaneous injection once on Day 1 in Stage 1. Participants received placebo matched to PF-04856883 subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2. Participants received single dose of PF-04856883 12 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2. 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. 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. 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.
    Measure Participants 15 5 6 6 7 5 7 7 5 7 7 6
    Number [participants]
    15
    100%
    5
    100%
    6
    100%
    6
    100%
    7
    100%
    5
    100%
    7
    87.5%
    7
    100%
    5
    100%
    7
    100%
    7
    100%
    6
    100%
    5. Primary Outcome
    Title Number of Participants With Clinically Significant Abnormalities in Laboratory Measurements
    Description 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

    Outcome Measure Data

    Analysis Population Description
    The safety population included all randomized participants who received at least 1 dose of study treatment.
    Arm/Group Title Stage 1: PF-04856883 Placebo Stage 1: PF-04856883 4 mg Stage 1: PF-04856883 8 mg Stage 1: PF-04856883 12 mg Stage 1: PF-04856883 18 mg Stage 1: PF-04856883 24 mg Stage 1: PF-04856883 36 mg Stage 2: Placebo Stage 2: PF-04856883 12 mg Stage 2: PF-04856883 12 mg + 12 mg + 24 mg + 24 mg Stage 2: PF-04856883 8 mg + 8 mg + 16 mg + 24 mg Stage 2: PF-04856883 12 mg + 20 mg + 28 mg + 36 mg
    Arm/Group Description Participants received placebo matched to PF-04856883 subcutaneously injection once on Day 1 in Stage 1. Participants received PF-04856883 4 mg subcutaneous injection once on Day 1 in Stage 1. Participants received PF-04856883 8 mg subcutaneous injection once on Day 1 in Stage 1. Participants received PF-04856883 12 mg subcutaneous injection once on Day 1 in Stage 1. Participants received PF-04856883 18 mg subcutaneous injection once on Day 1 in Stage 1. Participants received PF-04856883 24 mg subcutaneous injection once on Day 1 in Stage 1. Participants received PF-04856883 36 mg subcutaneous injection once on Day 1 in Stage 1. Participants received placebo matched to PF-04856883 subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2. Participants received single dose of PF-04856883 12 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2. 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. 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. 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.
    Measure Participants 15 5 6 6 7 5 7 7 5 7 7 6
    Number [participants]
    15
    100%
    5
    100%
    6
    100%
    6
    100%
    7
    100%
    4
    80%
    6
    75%
    7
    100%
    5
    100%
    7
    100%
    7
    100%
    6
    100%
    6. Secondary Outcome
    Title Maximum Observed Plasma Concentration (Cmax) of PF-04856883: Stage 1
    Description
    Time Frame predose (0 hour), 1, 6, 12, 24, 48, 72, 120, 168, 336, 504, 672 hours postdose on Day 1

    Outcome Measure Data

    Analysis Population Description
    Pharmacokinetic (PK) parameter analysis population included all randomized participants who had received at least one dose of study treatment and had at least 1 of the PK parameters of interest.
    Arm/Group Title Stage 1: PF-04856883 4 mg Stage 1: PF-04856883 8 mg Stage 1: PF-04856883 12 mg Stage 1: PF-04856883 18 mg Stage 1: PF-04856883 24 mg Stage 1: PF-04856883 36 mg
    Arm/Group Description Participants received PF-04856883 4 mg subcutaneous injection once on Day 1 in Stage 1. Participants received PF-04856883 8 mg subcutaneous injection once on Day 1 in Stage 1. Participants received PF-04856883 12 mg subcutaneous injection once on Day 1 in Stage 1. Participants received PF-04856883 18 mg subcutaneous injection once on Day 1 in Stage 1. Participants received PF-04856883 24 mg subcutaneous injection once on Day 1 in Stage 1. Participants received PF-04856883 36 mg subcutaneous injection once on Day 1 in Stage 1.
    Measure Participants 5 6 6 7 5 7
    Geometric Mean (Geometric Coefficient of Variation) [nanogram per milliliter (ng/mL)]
    181.2
    (85)
    324.7
    (61)
    793.7
    (65)
    1855
    (66)
    1776
    (21)
    2006
    (52)
    7. Secondary Outcome
    Title Maximum Observed Plasma Concentration (Cmax) of PF-04856883: Stage 2
    Description
    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

    Outcome Measure Data

    Analysis Population Description
    PK parameter analysis population included all randomized participants who had received at least one dose of study treatment and had at least 1 of the PK parameters of interest. Here, 'n' signifies those participants who were evaluable at specified time point for each arm, respectively.
    Arm/Group Title Stage 2: PF-04856883 12 mg Stage 2: PF-04856883 12 mg + 12 mg + 24 mg + 24 mg Stage 2: PF-04856883 8 mg + 8 mg + 16 mg + 24 mg Stage 2: PF-04856883 12 mg + 20 mg + 28 mg + 36 mg
    Arm/Group Description Participants received single dose of PF-04856883 12 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2. 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. 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. 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.
    Measure Participants 5 7 7 6
    Day 1 (n =5, 7, 7, 6)
    1369
    (17)
    1203
    (20)
    1027
    (29)
    1407
    (29)
    Day 22 (n =5, 7, 5, 6)
    1802
    (33)
    2757
    (26)
    3030
    (42)
    3046
    (24)
    8. Secondary Outcome
    Title Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-04856883: Stage 1
    Description
    Time Frame predose (0 hour), 1, 6, 12, 24, 48, 72, 120, 168, 336, 504, 672 hours postdose on Day 1

    Outcome Measure Data

    Analysis Population Description
    PK parameter analysis population included all randomized participants who had received at least one dose of study treatment and had at least 1 of the PK parameters of interest.
    Arm/Group Title Stage 1: PF-04856883 4 mg Stage 1: PF-04856883 8 mg Stage 1: PF-04856883 12 mg Stage 1: PF-04856883 18 mg Stage 1: PF-04856883 24 mg Stage 1: PF-04856883 36 mg
    Arm/Group Description Participants received PF-04856883 4 mg subcutaneous injection once on Day 1 in Stage 1. Participants received PF-04856883 8 mg subcutaneous injection once on Day 1 in Stage 1. Participants received PF-04856883 12 mg subcutaneous injection once on Day 1 in Stage 1. Participants received PF-04856883 18 mg subcutaneous injection once on Day 1 in Stage 1. Participants received PF-04856883 24 mg subcutaneous injection once on Day 1 in Stage 1. Participants received PF-04856883 36 mg subcutaneous injection once on Day 1 in Stage 1.
    Measure Participants 5 6 6 7 5 7
    Median (Full Range) [hour]
    168
    120
    120
    120
    120
    122
    9. Secondary Outcome
    Title Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-04856883: Stage 2
    Description
    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

    Outcome Measure Data

    Analysis Population Description
    PK parameter analysis population included all randomized participants who had received at least one dose of study treatment and had at least 1 of the PK parameters of interest. Here, 'n' signifies those participants who were evaluable at specified time point for each arm, respectively.
    Arm/Group Title Stage 2: PF-04856883 12 mg Stage 2: PF-04856883 12 mg + 12 mg + 24 mg + 24 mg Stage 2: PF-04856883 8 mg + 8 mg + 16 mg + 24 mg Stage 2: PF-04856883 12 mg + 20 mg + 28 mg + 36 mg
    Arm/Group Description Participants received single dose of PF-04856883 12 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2. 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. 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. 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.
    Measure Participants 5 7 7 6
    Day 1 (n =5, 7, 7, 6)
    336
    336
    335
    336
    Day 22 (n =5, 7, 5, 6)
    48.0
    72.0
    72.0
    60.0
    10. Secondary Outcome
    Title Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUC [0 - ∞]) of PF-04856883: Stage 1
    Description 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

    Outcome Measure Data

    Analysis Population Description
    PK parameter analysis population included all randomized participants who had received at least one dose of study treatment and had at least 1 of the PK parameters of interest. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.
    Arm/Group Title Stage 1: PF-04856883 4 mg Stage 1: PF-04856883 8 mg Stage 1: PF-04856883 12 mg Stage 1: PF-04856883 18 mg Stage 1: PF-04856883 24 mg Stage 1: PF-04856883 36 mg
    Arm/Group Description Participants received PF-04856883 4 mg subcutaneous injection once on Day 1 in Stage 1. Participants received PF-04856883 8 mg subcutaneous injection once on Day 1 in Stage 1. Participants received PF-04856883 12 mg subcutaneous injection once on Day 1 in Stage 1. Participants received PF-04856883 18 mg subcutaneous injection once on Day 1 in Stage 1. Participants received PF-04856883 24 mg subcutaneous injection once on Day 1 in Stage 1. Participants received PF-04856883 36 mg subcutaneous injection once on Day 1 in Stage 1.
    Measure Participants 3 3 4 5 3 3
    Geometric Mean (Geometric Coefficient of Variation) [nanogram*hour per milliliter (ng*hr/mL)]
    44920
    (112)
    95190
    (76)
    295200
    (46)
    527100
    (53)
    711300
    (13)
    652000
    (50)
    11. Secondary Outcome
    Title Area Under the Concentration Time Curve From Time Zero to Time Tau (AUCtau) of PF-04856883: Stage 2
    Description 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

    Outcome Measure Data

    Analysis Population Description
    PK parameter analysis population included all randomized participants who had received at least one dose of study treatment and had at least 1 of the PK parameters of interest. Here, 'n' signifies those participants who were evaluable at specified time point for each arm, respectively.
    Arm/Group Title Stage 2: PF-04856883 12 mg Stage 2: PF-04856883 12 mg + 12 mg + 24 mg + 24 mg Stage 2: PF-04856883 8 mg + 8 mg + 16 mg + 24 mg Stage 2: PF-04856883 12 mg + 20 mg + 28 mg + 36 mg
    Arm/Group Description Participants received single dose of PF-04856883 12 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2. 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. 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. 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.
    Measure Participants 5 7 7 6
    Day 1 (n =5, 7, 7, 6)
    85370
    (38)
    99780
    (41)
    89390
    (35)
    91130
    (27)
    Day 22 (n =5, 7, 5, 6)
    269000
    (32)
    377400
    (28)
    396300
    (28)
    430500
    (23)
    12. Secondary Outcome
    Title Apparent Clearance (CL/F) of PF-04856883: Stage 1
    Description 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

    Outcome Measure Data

    Analysis Population Description
    PK parameter analysis population included all randomized participants who had received at least one dose of study treatment and had at least 1 of the PK parameters of interest. Here, 'N' signifies those participants who were evaluable for this outcome measure.
    Arm/Group Title Stage 1: PF-04856883 4 mg Stage 1: PF-04856883 8 mg Stage 1: PF-04856883 12 mg Stage 1: PF-04856883 18 mg Stage 1: PF-04856883 24 mg Stage 1: PF-04856883 36 mg
    Arm/Group Description Participants received PF-04856883 4 mg subcutaneous injection once on Day 1 in Stage 1. Participants received PF-04856883 8 mg subcutaneous injection once on Day 1 in Stage 1. Participants received PF-04856883 12 mg subcutaneous injection once on Day 1 in Stage 1. Participants received PF-04856883 18 mg subcutaneous injection once on Day 1 in Stage 1. Participants received PF-04856883 24 mg subcutaneous injection once on Day 1 in Stage 1. Participants received PF-04856883 36 mg subcutaneous injection once on Day 1 in Stage 1.
    Measure Participants 3 3 4 5 3 3
    Geometric Mean (Geometric Coefficient of Variation) [milliliter per hour (mL/hr)]
    89.14
    (84)
    84.08
    (59)
    40.60
    (68)
    34.13
    (35)
    33.73
    (14)
    55.32
    (42)
    13. Secondary Outcome
    Title Apparent Clearance (CL/F) of PF-04856883: Stage 2
    Description 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

    Outcome Measure Data

    Analysis Population Description
    PK parameter analysis population included all randomized participants who had received at least one dose of study treatment and had at least 1 of the PK parameters of interest. Here, 'N' signifies those participants who were evaluable for this outcome measure.
    Arm/Group Title Stage 2: PF-04856883 12 mg Stage 2: PF-04856883 12 mg + 12 mg + 24 mg + 24 mg Stage 2: PF-04856883 8 mg + 8 mg + 16 mg + 24 mg Stage 2: PF-04856883 12 mg + 20 mg + 28 mg + 36 mg
    Arm/Group Description Participants received single dose of PF-04856883 12 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2. 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. 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. 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.
    Measure Participants 5 7 7 6
    Geometric Mean (Geometric Coefficient of Variation) [mL/hr]
    44.67
    (28)
    NA
    (NA)
    NA
    (NA)
    NA
    (NA)
    14. Secondary Outcome
    Title Apparent Volume of Distribution (Vz/F) of PF-04856883: Stage 1
    Description
    Time Frame predose (0 hour), 1, 6, 12, 24, 48, 72, 120, 168, 336, 504, 672 hours postdose on Day 1

    Outcome Measure Data

    Analysis Population Description
    PK parameter analysis population included all randomized participants who had received at least one dose of study treatment and had at least 1 of the PK parameters of interest. Here, 'N' signifies those participants who were evaluable for this outcome measure.
    Arm/Group Title Stage 1: PF-04856883 4 mg Stage 1: PF-04856883 8 mg Stage 1: PF-04856883 12 mg Stage 1: PF-04856883 18 mg Stage 1: PF-04856883 24 mg Stage 1: PF-04856883 36 mg
    Arm/Group Description Participants received PF-04856883 4 mg subcutaneous injection once on Day 1 in Stage 1. Participants received PF-04856883 8 mg subcutaneous injection once on Day 1 in Stage 1. Participants received PF-04856883 12 mg subcutaneous injection once on Day 1 in Stage 1. Participants received PF-04856883 18 mg subcutaneous injection once on Day 1 in Stage 1. Participants received PF-04856883 24 mg subcutaneous injection once on Day 1 in Stage 1. Participants received PF-04856883 36 mg subcutaneous injection once on Day 1 in Stage 1.
    Measure Participants 3 3 4 5 3 3
    Geometric Mean (Geometric Coefficient of Variation) [milliliter (mL)]
    18760
    (90)
    21710
    (59)
    9191
    (51)
    7127
    (40)
    8437
    (17)
    10010
    (67)
    15. Secondary Outcome
    Title Apparent Volume of Distribution (Vz/F) of PF-04856883: Stage 2
    Description
    Time Frame predose (0 hour), 1, 2, 6, 24, 48, 72, 120, 168, 336, 504, 672 hours postdose on Day 22

    Outcome Measure Data

    Analysis Population Description
    PK parameter analysis population included all randomized participants who had received at least one dose of study treatment and had at least 1 of the PK parameters of interest. Here, 'N' signifies those participants who were evaluable for this outcome measure.
    Arm/Group Title Stage 2: PF-04856883 12 mg Stage 2: PF-04856883 12 mg + 12 mg + 24 mg + 24 mg Stage 2: PF-04856883 8 mg + 8 mg + 16 mg + 24 mg Stage 2: PF-04856883 12 mg + 20 mg + 28 mg + 36 mg
    Arm/Group Description Participants received single dose of PF-04856883 12 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2. 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. 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. 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.
    Measure Participants 5 7 7 6
    Geometric Mean (Geometric Coefficient of Variation) [mL]
    9550
    (29)
    NA
    (NA)
    NA
    (NA)
    NA
    (NA)
    16. Secondary Outcome
    Title Terminal Elimination Half- Life (t1/2) of PF-04856883: Stage 1
    Description
    Time Frame predose (0 hour), 1, 6, 12, 24, 48, 72, 120, 168, 336, 504, 672 hours postdose on Day 1

    Outcome Measure Data

    Analysis Population Description
    PK parameter analysis population included all randomized participants who had received at least one dose of study treatment and had at least 1 of the PK parameters of interest. Here, 'N' signifies those participants who were evaluable for this outcome measure.
    Arm/Group Title Stage 1: PF-04856883 4 mg Stage 1: PF-04856883 8 mg Stage 1: PF-04856883 12 mg Stage 1: PF-04856883 18 mg Stage 1: PF-04856883 24 mg Stage 1: PF-04856883 36 mg
    Arm/Group Description Participants received PF-04856883 4 mg subcutaneous injection once on Day 1 in Stage 1. Participants received PF-04856883 8 mg subcutaneous injection once on Day 1 in Stage 1. Participants received PF-04856883 12 mg subcutaneous injection once on Day 1 in Stage 1. Participants received PF-04856883 18 mg subcutaneous injection once on Day 1 in Stage 1. Participants received PF-04856883 24 mg subcutaneous injection once on Day 1 in Stage 1. Participants received PF-04856883 36 mg subcutaneous injection once on Day 1 in Stage 1.
    Measure Participants 3 3 3 4 3 3
    Mean (Standard Deviation) [hour]
    146.3
    (13.614)
    179.7
    (14.572)
    147.0
    (18.520)
    133.8
    (23.936)
    173.7
    (7.0238)
    131.6
    (45.883)
    17. Secondary Outcome
    Title Terminal Elimination Half-life (t1/2) of PF-04856883: Stage 2
    Description
    Time Frame predose (0 hour), 1, 2, 6, 24, 48, 72, 120, 168, 336, 504, 672 hours postdose on Day 22

    Outcome Measure Data

    Analysis Population Description
    PK parameter analysis population included all randomized participants who had received at least one dose of study treatment and had at least 1 of the PK parameters of interest. Here, 'N' signifies those participants who were evaluable for this outcome measure.
    Arm/Group Title Stage 2: PF-04856883 12 mg Stage 2: PF-04856883 12 mg + 12 mg + 24 mg + 24 mg Stage 2: PF-04856883 8 mg + 8 mg + 16 mg + 24 mg Stage 2: PF-04856883 12 mg + 20 mg + 28 mg + 36 mg
    Arm/Group Description Participants received single dose of PF-04856883 12 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2. 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. 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. 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.
    Measure Participants 5 5 4 5
    Mean (Standard Deviation) [hour]
    149.4
    (21.870)
    135.0
    (43.980)
    143.8
    (20.565)
    145.0
    (37.000)
    18. Secondary Outcome
    Title 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
    Description 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

    Outcome Measure Data

    Analysis Population Description
    Pharmacodynamic analysis population included all enrolled participants who had received at least 1 dose of study treatment and have at least 1 pharmacodynamic parameter. Here, 'n' signifies those participants who were evaluable at specified time point for each arm, respectively.
    Arm/Group Title Stage 1: PF-04856883 Placebo Stage 1: PF-04856883 4 mg Stage 1: PF-04856883 8 mg Stage 1: PF-04856883 12 mg Stage 1: PF-04856883 18 mg Stage 1: PF-04856883 24 mg Stage 1: PF-04856883 36 mg
    Arm/Group Description Participants received placebo matched to PF-04856883 subcutaneously injection once on Day 1 in Stage 1. Participants received PF-04856883 4 mg subcutaneous injection once on Day 1 in Stage 1. Participants received PF-04856883 8 mg subcutaneous injection once on Day 1 in Stage 1. Participants received PF-04856883 12 mg subcutaneous injection once on Day 1 in Stage 1. Participants received PF-04856883 18 mg subcutaneous injection once on Day 1 in Stage 1. Participants received PF-04856883 24 mg subcutaneous injection once on Day 1 in Stage 1. Participants received PF-04856883 36 mg subcutaneous injection once on Day 1 in Stage 1.
    Measure Participants 15 5 6 6 7 5 7
    Baseline (n =15, 5, 6, 6, 7, 5, 7)
    656.35
    (114.496)
    834.03
    (158.952)
    712.11
    (88.942)
    796.14
    (208.733)
    660.64
    (110.833)
    652.20
    (48.707)
    636.57
    (119.662)
    Change at Day 3 (n =15, 5, 5, 6, 7, 5, 6)
    7.72
    (89.366)
    77.82
    (125.011)
    -89.38
    (58.909)
    -101.47
    (31.725)
    -68.05
    (111.431)
    -141.27
    (15.975)
    -153.04
    (41.501)
    Change at Day 8 (n =15, 5, 5, 6, 7, 5, 6)
    -4.82
    (75.396)
    10.37
    (158.368)
    0.85
    (125.384)
    -82.51
    (48.898)
    -28.36
    (61.456)
    -123.43
    (68.219)
    -39.60
    (85.256)
    19. Secondary Outcome
    Title 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
    Description 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

    Outcome Measure Data

    Analysis Population Description
    Pharmacodynamic analysis population included all enrolled participants who had received at least 1 dose of study treatment and have at least 1 pharmacodynamic parameter. Here, 'n' signifies those participants who were evaluable at specified time point for each arm, respectively.
    Arm/Group Title Stage 2: Placebo Stage 2: PF-04856883 12 mg Stage 2: PF-04856883 12 mg + 12 mg + 24 mg + 24 mg Stage 2: PF-04856883 8 mg + 8 mg + 16 mg + 24 mg Stage 2: PF-04856883 12 mg + 20 mg + 28 mg + 36 mg
    Arm/Group Description Participants received placebo matched to PF-04856883 subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2. Participants received single dose of PF-04856883 12 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2. 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. 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. 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.
    Measure Participants 7 5 7 7 6
    Baseline (n =7, 4, 7, 7, 6)
    606.49
    (158.249)
    811.36
    (131.145)
    756.17
    (240.430)
    800.66
    (206.776)
    723.57
    (220.872)
    Change at Day 3 (n =7, 4, 5, 6, 5)
    44.41
    (74.405)
    -97.03
    (55.692)
    -103.00
    (118.759)
    -98.38
    (114.644)
    -68.52
    (153.127)
    Change at Day 15 (n =7, 4, 6, 6, 6)
    -18.48
    (50.874)
    -265.64
    (89.889)
    -293.04
    (163.074)
    -254.54
    (144.897)
    -240.65
    (252.349)
    Change at Day 24 (n =7, 4, 7, 6, 5)
    -6.20
    (46.238)
    -146.61
    (78.863)
    -207.12
    (89.687)
    -242.35
    (231.302)
    -121.13
    (258.528)
    Change at Day 29 (n =7, 4, 7, 6, 5)
    30.08
    (59.490)
    -55.43
    (74.973)
    -157.54
    (88.652)
    -192.97
    (185.056)
    -106.58
    (171.297)
    Change at Day 50 (n =7, 3, 6, 6, 6)
    50.26
    (81.717)
    -48.82
    (80.733)
    -33.77
    (250.859)
    -125.06
    (217.403)
    -23.99
    (123.611)
    20. Secondary Outcome
    Title Change From Baseline in Insulin Area Under the Curve (AUC) After Mixed Meal Tolerance Test (MMTT) at Day 3 and 8: Stage 1
    Description 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

    Outcome Measure Data

    Analysis Population Description
    Pharmacodynamic analysis population included all enrolled participants who had received at least 1 dose of study treatment and have at least 1 pharmacodynamic parameter. Here, 'n' signifies those participants who were evaluable at specified time point for each arm, respectively.
    Arm/Group Title Stage 1: PF-04856883 Placebo Stage 1: PF-04856883 4 mg Stage 1: PF-04856883 8 mg Stage 1: PF-04856883 12 mg Stage 1: PF-04856883 18 mg Stage 1: PF-04856883 24 mg Stage 1: PF-04856883 36 mg
    Arm/Group Description Participants received placebo matched to PF-04856883 subcutaneously injection once on Day 1 in Stage 1. Participants received PF-04856883 4 mg subcutaneous injection once on Day 1 in Stage 1. Participants received PF-04856883 8 mg subcutaneous injection once on Day 1 in Stage 1. Participants received PF-04856883 12 mg subcutaneous injection once on Day 1 in Stage 1. Participants received PF-04856883 18 mg subcutaneous injection once on Day 1 in Stage 1. Participants received PF-04856883 24 mg subcutaneous injection once on Day 1 in Stage 1. Participants received PF-04856883 36 mg subcutaneous injection once on Day 1 in Stage 1.
    Measure Participants 15 5 6 6 7 5 7
    Baseline (n =15, 5, 6, 6, 7, 5, 7)
    222.18
    (139.981)
    227.07
    (142.547)
    210.80
    (95.536)
    235.84
    (130.071)
    105.34
    (19.118)
    257.73
    (127.358)
    283.59
    (156.831)
    Change at Day 3 (n =15, 5, 5, 6, 7, 5, 6)
    68.79
    (115.555)
    22.99
    (32.706)
    35.09
    (57.093)
    12.15
    (54.495)
    59.06
    (94.643)
    83.82
    (70.182)
    13.72
    (98.682)
    Change at Day 8 (n =15, 4, 5, 6, 7, 5, 6)
    34.23
    (103.279)
    22.05
    (89.419)
    39.96
    (38.941)
    -50.51
    (40.624)
    38.04
    (15.736)
    -0.36
    (50.674)
    1.08
    (47.135)
    21. Secondary Outcome
    Title 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
    Description 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

    Outcome Measure Data

    Analysis Population Description
    Pharmacodynamic analysis population included all enrolled participants who had received at least 1 dose of study treatment and have at least 1 pharmacodynamic parameter. Here, 'n' signifies those participants who were evaluable at specified time point for each arm, respectively.
    Arm/Group Title Stage 2: Placebo Stage 2: PF-04856883 12 mg Stage 2: PF-04856883 12 mg + 12 mg + 24 mg + 24 mg Stage 2: PF-04856883 8 mg + 8 mg + 16 mg + 24 mg Stage 2: PF-04856883 12 mg + 20 mg + 28 mg + 36 mg
    Arm/Group Description Participants received placebo matched to PF-04856883 subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2. Participants received single dose of PF-04856883 12 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2. 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. 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. 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.
    Measure Participants 7 5 7 7 6
    Baseline (n =7, 5, 7, 7, 6)
    175.26
    (62.218)
    176.65
    (76.040)
    267.29
    (111.497)
    162.96
    (111.688)
    190.64
    (83.945)
    Change at Day 3 (n =7, 5, 7, 7, 6)
    38.32
    (62.135)
    13.29
    (55.764)
    19.50
    (134.651)
    27.99
    (32.655)
    87.67
    (124.052)
    Change at Day 15 (n =7, 5, 7, 6, 6)
    -16.77
    (20.530)
    -39.16
    (42.930)
    -10.07
    (172.044)
    -51.69
    (77.925)
    -24.36
    (85.633)
    Change at Day 24 (n =7, 4, 7, 6, 6)
    0.23
    (55.174)
    -15.19
    (38.900)
    6.87
    (184.830)
    4.18
    (51.903)
    60.11
    (189.287)
    Change at Day 29 (n =7, 5, 7, 6, 5)
    8.25
    (55.799)
    3.98
    (11.218)
    12.71
    (115.095)
    -1.61
    (85.866)
    15.70
    (38.476)
    Change at Day 50 (n =7, 5, 7, 6, 5)
    8.14
    (29.909)
    -16.64
    (33.133)
    -57.14
    (116.193)
    49.27
    (81.874)
    -26.78
    (81.518)
    22. Secondary Outcome
    Title Change From Baseline in C-Peptide Area Under the Curve (AUC) After Mixed Meal Tolerance Test (MMTT) at Day 3 and 8: Stage 1
    Description 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

    Outcome Measure Data

    Analysis Population Description
    Pharmacodynamic analysis population included all enrolled participants who had received at least 1 dose of study treatment and have at least 1 pharmacodynamic parameter. Here, 'n' signifies those participants who were evaluable at specified time point for each arm, respectively.
    Arm/Group Title Stage 1: PF-04856883 Placebo Stage 1: PF-04856883 4 mg Stage 1: PF-04856883 8 mg Stage 1: PF-04856883 12 mg Stage 1: PF-04856883 18 mg Stage 1: PF-04856883 24 mg Stage 1: PF-04856883 36 mg
    Arm/Group Description Participants received placebo matched to PF-04856883 subcutaneously injection once on Day 1 in Stage 1. Participants received PF-04856883 4 mg subcutaneous injection once on Day 1 in Stage 1. Participants received PF-04856883 8 mg subcutaneous injection once on Day 1 in Stage 1. Participants received PF-04856883 12 mg subcutaneous injection once on Day 1 in Stage 1. Participants received PF-04856883 18 mg subcutaneous injection once on Day 1 in Stage 1. Participants received PF-04856883 24 mg subcutaneous injection once on Day 1 in Stage 1. Participants received PF-04856883 36 mg subcutaneous injection once on Day 1 in Stage 1.
    Measure Participants 15 5 6 6 7 5 7
    Baseline (n =15, 5, 6, 6, 7,5, 7)
    15.53
    (5.332)
    16.63
    (7.743)
    16.43
    (4.306)
    16.80
    (5.711)
    10.64
    (1.156)
    16.17
    (4.531)
    18.37
    (7.395)
    Change at Day 3 (n =15, 5, 5, 6, 7, 5, 6)
    2.15
    (3.653)
    0.69
    (1.465)
    1.65
    (4.958)
    1.05
    (1.885)
    4.30
    (4.102)
    5.34
    (2.584)
    2.34
    (4.333)
    Change at Day 8 (n =15, 4, 5, 6, 7, 5, 6)
    0.79
    (2.864)
    1.06
    (1.806)
    0.83
    (1.651)
    -2.74
    (1.380)
    1.70
    (1.544)
    -0.45
    (2.883)
    -0.38
    (1.565)
    23. Secondary Outcome
    Title 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
    Description 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

    Outcome Measure Data

    Analysis Population Description
    Pharmacodynamic analysis population included all enrolled participants who had received at least 1 dose of study treatment and have at least 1 pharmacodynamic parameter. Here, 'n' signifies those participants who were evaluable at specified time point for each arm, respectively.
    Arm/Group Title Stage 2: Placebo Stage 2: PF-04856883 12 mg Stage 2: PF-04856883 12 mg + 12 mg + 24 mg + 24 mg Stage 2: PF-04856883 8 mg + 8 mg + 16 mg + 24 mg Stage 2: PF-04856883 12 mg + 20 mg + 28 mg + 36 mg
    Arm/Group Description Participants received placebo matched to PF-04856883 subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2. Participants received single dose of PF-04856883 12 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2. 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. 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. 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.
    Measure Participants 7 5 7 7 6
    Baseline (n =7, 5, 7, 7, 6)
    13.47
    (4.315)
    14.59
    (4.205)
    15.63
    (4.293)
    11.74
    (5.210)
    14.14
    (5.211)
    Change at Day 3 (n =7, 5, 7, 7, 6)
    1.68
    (2.182)
    1.89
    (4.705)
    0.50
    (4.757)
    3.16
    (1.613)
    3.49
    (4.452)
    Change at Day 15 (n =7, 5, 7, 6, 6)
    -1.65
    (1.493)
    -1.55
    (2.821)
    -1.92
    (6.930)
    -0.17
    (4.135)
    -0.50
    (4.871)
    Change at Day 24 (n =7, 4, 7, 6, 6)
    0.55
    (3.518)
    0.71
    (4.312)
    -0.99
    (6.220)
    1.63
    (2.994)
    1.21
    (5.784)
    Change at Day 29 (n =7, 5, 7, 6, 5)
    0.10
    (3.864)
    -0.07
    (2.545)
    -0.59
    (4.144)
    0.59
    (2.733)
    0.41
    (2.090)
    Change at Day 50 (n =7, 5, 7, 6, 5)
    -0.17
    (1.978)
    -1.83
    (2.015)
    -4.10
    (5.265)
    1.06
    (1.474)
    -2.90
    (3.711)
    24. Secondary Outcome
    Title Change From Baseline in Fasting Plasma Glucose (FPG) at Day 2, 4, 6, 15, 22 and 29: Stage 1
    Description
    Time Frame Baseline, Day 2, 4, 6, 15, 22 and 29

    Outcome Measure Data

    Analysis Population Description
    Pharmacodynamic analysis population included all enrolled participants who had received at least 1 dose of study treatment and have at least 1 pharmacodynamic parameter. Here, 'n' signifies those participants who were evaluable at specified time point for each arm, respectively.
    Arm/Group Title Stage 1: PF-04856883 Placebo Stage 1: PF-04856883 4 mg Stage 1: PF-04856883 8 mg Stage 1: PF-04856883 12 mg Stage 1: PF-04856883 18 mg Stage 1: PF-04856883 24 mg Stage 2: PF-04856883 36 mg
    Arm/Group Description Participants received placebo matched to PF-04856883 subcutaneously injection once on Day 1 in Stage 1. Participants received PF-04856883 4 mg subcutaneous injection once on Day 1 in Stage 1. Participants received PF-04856883 8 mg subcutaneous injection once on Day 1 in Stage 1. Participants received PF-04856883 12 mg subcutaneous injection once on Day 1 in Stage 1. Participants received PF-04856883 18 mg subcutaneous injection once on Day 1 in Stage 1. Participants received PF-04856883 24 mg subcutaneous injection once on Day 1 in Stage 1. Participants received PF-04856883 36 mg subcutaneous injection once on Day 1 in Stage 1.
    Measure Participants 15 5 6 6 7 5 7
    Baseline (n =15, 5, 6, 6, 7, 5, 7)
    161.67
    (27.102)
    219.60
    (44.557)
    171.17
    (23.752)
    174.00
    (48.949)
    168.57
    (38.336)
    145.60
    (21.606)
    158.14
    (35.362)
    Change at Day 2 (n =15, 5, 6, 6, 7, 5, 7)
    3.13
    (11.807)
    13.60
    (32.393)
    -18.67
    (21.011)
    -20.50
    (20.433)
    -22.14
    (34.090)
    -35.00
    (12.369)
    -29.71
    (30.804)
    Change at Day 4 (n =15, 5, 5, 6, 7, 5, 6)
    2.73
    (17.161)
    19.60
    (35.683)
    -12.40
    (17.358)
    -10.33
    (15.744)
    -30.71
    (13.841)
    -27.00
    (8.803)
    -28.33
    (21.942)
    Change at Day 6 (n =15, 5, 4, 6, 7, 5, 7)
    18.80
    (29.547)
    26.40
    (32.377)
    10.25
    (29.056)
    -8.33
    (27.156)
    -6.29
    (15.850)
    -16.80
    (19.176)
    -16.14
    (22.319)
    Change at Day 15 (n =15, 5, 5, 6, 6, 5, 7)
    12.13
    (32.822)
    -13.80
    (46.949)
    23.80
    (56.857)
    19.33
    (16.476)
    8.00
    (21.223)
    3.40
    (27.309)
    -2.71
    (16.530)
    Change at Day 22 (n =14, 4, 5, 6, 6, 5, 7)
    11.00
    (28.205)
    23.75
    (61.163)
    33.40
    (76.064)
    11.17
    (26.446)
    2.17
    (15.065)
    1.20
    (18.847)
    -0.57
    (13.377)
    Change at Day 29 (n =14, 5, 5, 6, 7, 5, 7)
    22.00
    (33.439)
    1.60
    (27.763)
    27.80
    (29.575)
    0.33
    (16.978)
    1.57
    (21.220)
    -3.80
    (22.643)
    -2.29
    (19.551)
    25. Secondary Outcome
    Title Change From Baseline in Fasting Plasma Glucose (FPG) at Day 2, 4, 6, 8, 22, 23, 25, 27, 30, 36 and 43: Stage 2
    Description
    Time Frame Baseline, Day 2, 4, 6, 8, 22, 23, 25, 27, 30, 36 and 43

    Outcome Measure Data

    Analysis Population Description
    Pharmacodynamic analysis population included all enrolled participants who had received at least 1 dose of study treatment and have at least 1 pharmacodynamic parameter. Here, 'n' signifies those participants who were evaluable at specified time point for each arm, respectively.
    Arm/Group Title Stage 2: Placebo Stage 2: PF-04856883 12 mg Stage 2: PF-04856883 12 mg + 12 mg + 24 mg + 24 mg Stage 2: PF-04856883 8 mg + 8 mg + 16 mg + 24 mg Stage 2: PF-04856883 12 mg + 20 mg + 28 mg + 36 mg
    Arm/Group Description Participants received placebo matched to PF-04856883 subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2. Participants received single dose of PF-04856883 12 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2. 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. 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. 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.
    Measure Participants 7 5 7 7 6
    Baseline (n =7, 5, 7, 7, 6)
    148.00
    (33.317)
    186.80
    (23.059)
    191.14
    (56.153)
    187.29
    (45.756)
    158.50
    (18.447)
    Change at Day 2 (n =5, 4, 7, 7, 5)
    3.00
    (15.281)
    -26.75
    (15.108)
    -15.14
    (21.217)
    -23.43
    (35.142)
    -10.40
    (18.461)
    Change at Day 4 (n =5, 5, 7, 6, 6)
    7.60
    (6.427)
    -14.80
    (24.284)
    -14.86
    (48.657)
    -20.33
    (22.818)
    -1.50
    (27.384)
    Change at Day 6 (n =7, 4, 7, 7, 6)
    -1.71
    (40.240)
    5.75
    (14.080)
    -44.86
    (38.451)
    -8.00
    (42.942)
    -15.83
    (8.909)
    Change at Day 8 (n =6, 5, 7, 5, 6)
    2.50
    (17.627)
    4.20
    (19.967)
    -37.43
    (42.383)
    2.60
    (73.449)
    24.50
    (47.618)
    Change at Day 22 (n =7, 4, 7, 6, 6)
    13.29
    (15.294)
    -4.25
    (13.817)
    -39.57
    (25.468)
    -14.17
    (38.270)
    -0.33
    (51.181)
    Change at Day 23 (n =7, 4, 6, 6, 5)
    7.71
    (23.894)
    -27.25
    (27.293)
    -40.33
    (18.327)
    -17.50
    (73.519)
    -24.00
    (29.967)
    Change at Day 25 (n =7, 5, 6, 6, 5)
    13.43
    (13.113)
    -16.60
    (43.443)
    -44.67
    (27.667)
    -23.33
    (52.936)
    -16.20
    (36.513)
    Change at Day 27 (n =7, 5, 6, 6, 5)
    8.57
    (21.110)
    -21.60
    (15.821)
    -37.33
    (17.963)
    -34.67
    (35.803)
    12.00
    (71.039)
    Change at Day 30 (n =7, 5, 7, 6, 5)
    2.43
    (12.739)
    -14.20
    (17.908)
    -22.29
    (26.171)
    -9.33
    (32.898)
    15.40
    (37.964)
    Change at Day 36 (n =6, 5, 7, 6, 6)
    -10.50
    (32.415)
    0.40
    (37.846)
    1.86
    (25.373)
    -5.83
    (32.009)
    27.67
    (59.594)
    Change at Day 43 (n =7, 5, 5, 6, 6)
    18.71
    (22.552)
    12.80
    (29.064)
    13.20
    (17.254)
    -1.17
    (41.787)
    8.33
    (18.991)
    26. Secondary Outcome
    Title Change From Baseline in 24 Hours Glucose Normalized Area Under the Curve (NAUC) Profile at Day 30: Stage 2
    Description 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

    Outcome Measure Data

    Analysis Population Description
    Pharmacodynamic analysis population included all enrolled participants who had received at least 1 dose of study treatment and have at least 1 pharmacodynamic parameter. Here, 'n' signifies those participants who were evaluable at specified time point for each arm, respectively.
    Arm/Group Title Stage 2: Placebo Stage 2: PF-04856883 12 mg Stage 2: PF-04856883 12 mg + 12 mg + 24 mg + 24 mg Stage 2: PF-04856883 8 mg + 8 mg + 16 mg + 24 mg Stage 2: PF-04856883 12 mg + 20 mg + 28 mg + 36 mg
    Arm/Group Description Participants received placebo matched to PF-04856883 subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2. Participants received single dose of PF-04856883 12 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2. 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. 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. 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.
    Measure Participants 7 5 7 7 6
    Baseline (n =7, 5, 7, 7 ,6)
    166.19
    (35.437)
    212.43
    (52.764)
    205.56
    (51.907)
    202.43
    (38.900)
    186.13
    (33.839)
    Change at Day 30 (n =7, 5, 7, 6 ,5)
    172.36
    (38.825)
    191.20
    (43.953)
    172.24
    (48.067)
    174.08
    (41.437)
    192.87
    (58.037)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Stage 1: PF-04856883 Placebo, Stage 1: PF-04856883 4 mg
    Comments Day 30
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.219
    Comments
    Method Mixed meal tolerance test
    Comments
    Method of Estimation Estimation Parameter Least square (LS) mean
    Estimated Value -21.16
    Confidence Interval (2-Sided) 80%
    -43.26 to 0.93
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 16.766
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Stage 1: PF-04856883 Placebo, Stage 1: PF-04856883 8 mg
    Comments Day 30
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.034
    Comments
    Method Mixed meal tolerance test
    Comments
    Method of Estimation Estimation Parameter LS mean
    Estimated Value -34.18
    Confidence Interval (2-Sided) 80%
    -54.20 to -14.16
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 15.189
    Estimation Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Stage 1: PF-04856883 Placebo, Stage 1: PF-04856883 12 mg
    Comments Day 30
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.044
    Comments
    Method Mixed meal tolerance test
    Comments
    Method of Estimation Estimation Parameter LS mean
    Estimated Value -33.67
    Confidence Interval (2-Sided) 80%
    -54.50 to -12.84
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 15.806
    Estimation Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Stage 1: PF-04856883 Placebo, Stage 1: PF-04856883 18 mg
    Comments Day 30
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.857
    Comments
    Method Mixed meal tolerance test
    Comments
    Method of Estimation Estimation Parameter LS mean
    Estimated Value -2.93
    Confidence Interval (2-Sided) 80%
    -24.16 to 18.31
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 16.111
    Estimation Comments
    27. Secondary Outcome
    Title Percent Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Day 29 and 50: Stage 2
    Description 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

    Outcome Measure Data

    Analysis Population Description
    Pharmacodynamic analysis population included all enrolled participants who had received at least 1 dose of study treatment and have at least 1 pharmacodynamic parameter. Here, 'n' signifies those participants who were evaluable at specified time point for each arm, respectively.
    Arm/Group Title Stage 2: Placebo Stage 2: PF-04856883 12 mg Stage 2: PF-04856883 12 mg + 12 mg + 24 mg + 24 mg Stage 2: PF-04856883 8 mg + 8 mg + 16 mg + 24 mg Stage 2: PF-04856883 12 mg + 20 mg + 28 mg + 36 mg
    Arm/Group Description Participants received placebo matched to PF-04856883 subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2. Participants received single dose of PF-04856883 12 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2. 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. 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. 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.
    Measure Participants 7 5 7 7 6
    Day 29 (n =7, 5, 7, 6, 5)
    0.06
    (0.547)
    -0.24
    (0.288)
    -0.41
    (0.212)
    -0.42
    (0.440)
    -0.40
    (0.430)
    Day 50 (n =6, 5, 7, 7, 6)
    0.15
    (0.769)
    -0.08
    (0.335)
    -0.24
    (0.326)
    -0.33
    (0.754)
    -0.40
    (0.580)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Stage 1: PF-04856883 Placebo, Stage 1: PF-04856883 4 mg
    Comments Day 29: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.419
    Comments
    Method Mixed meal tolerance test
    Comments
    Method of Estimation Estimation Parameter LS Mean Difference
    Estimated Value -0.21
    Confidence Interval (2-Sided) 80%
    -0.54 to 0.12
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.251
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Stage 1: PF-04856883 Placebo, Stage 1: PF-04856883 8 mg
    Comments Day 29: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.077
    Comments
    Method Mixed meal tolerance test
    Comments
    Method of Estimation Estimation Parameter LS Mean Difference
    Estimated Value -0.41
    Confidence Interval (2-Sided) 80%
    -0.71 to -0.12
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.224
    Estimation Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Stage 1: PF-04856883 Placebo, Stage 1: PF-04856883 12 mg
    Comments Day 29: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.147
    Comments
    Method Mixed meal tolerance test
    Comments
    Method of Estimation Estimation Parameter LS Mean Difference
    Estimated Value -0.34
    Confidence Interval (2-Sided) 80%
    -0.65 to -0.04
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.230
    Estimation Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Stage 1: PF-04856883 Placebo, Stage 1: PF-04856883 18 mg
    Comments Day 29: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.086
    Comments
    Method Mixed meal tolerance test
    Comments
    Method of Estimation Estimation Parameter LS Mean Difference
    Estimated Value -0.43
    Confidence Interval (2-Sided) 80%
    -0.76 to -0.11
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.244
    Estimation Comments
    28. Secondary Outcome
    Title Change From Baseline in Fructosamine Levels at Day 8, 15 and 29: Stage 1
    Description
    Time Frame Baseline, Day 8, 15 and 29

    Outcome Measure Data

    Analysis Population Description
    Pharmacodynamic analysis population included all enrolled participants who had received at least 1 dose of study treatment and have at least 1 pharmacodynamic parameter. Here, 'n' signifies those participants who were evaluable at specified time point for each arm, respectively.
    Arm/Group Title Stage 1: PF-04856883 Placebo Stage 1: PF-04856883 4 mg Stage 1: PF-04856883 8 mg Stage 1: PF-04856883 12 mg Stage 1: PF-04856883 18 mg Stage 1: PF-04856883 24mg Stage 1: PF-04856883 36 mg
    Arm/Group Description Participants received placebo matched to PF-04856883 subcutaneously injection once on Day 1 in Stage 1. Participants received PF-04856883 4 mg subcutaneous injection once on Day 1 in Stage 1. Participants received PF-04856883 8 mg subcutaneous injection once on Day 1 in Stage 1. Participants received PF-04856883 12 mg subcutaneous injection once on Day 1 in Stage 1. Participants received PF-04856883 18 mg subcutaneous injection once on Day 1 in Stage 1. Participants received PF-04856883 24 mg subcutaneous injection once on Day 1 in Stage 1. Participants received PF-04856883 36 mg subcutaneous injection once on Day 1 in Stage 1.
    Measure Participants 15 5 6 6 7 5 7
    Baseline (n =15, 5, 6, 6, 7, 5, 7)
    270.60
    (34.618)
    289.20
    (48.329)
    279.67
    (30.507)
    304.83
    (45.155)
    263.43
    (34.942)
    259.80
    (53.644)
    273.71
    (36.036)
    Change at Day 8 (n =15, 5, 5, 6, 7, 5, 7)
    1.13
    (14.461)
    20.20
    (10.986)
    4.20
    (18.295)
    5.67
    (13.095)
    4.29
    (16.720)
    -13.60
    (23.554)
    -12.29
    (10.579)
    Change at Day 15 (n =15, 5, 5, 6, 6, 5, 7)
    -5.67
    (17.839)
    -20.40
    (25.393)
    -16.40
    (13.502)
    -9.17
    (25.135)
    13.33
    (24.188)
    -9.60
    (22.267)
    -3.00
    (11.165)
    Change at Day 29 (n =15, 5, 5, 6, 7, 5, 7)
    0.93
    (19.627)
    8.40
    (30.876)
    7.20
    (29.660)
    -4.50
    (16.109)
    15.86
    (24.024)
    1.40
    (17.344)
    -4.43
    (18.867)
    29. Secondary Outcome
    Title Change From Baseline in Fructosamine Levels at Day 8, 15, 22, 29 and 50: Stage 2
    Description
    Time Frame Baseline, Day 8, 15, 22, 29 and 50

    Outcome Measure Data

    Analysis Population Description
    Pharmacodynamic analysis population included all enrolled participants who had received at least 1 dose of study treatment and have at least 1 pharmacodynamic parameter. Here, 'n' signifies those participants who were evaluable at specified time point for each arm, respectively.
    Arm/Group Title Stage 2: Placebo Stage 2: PF-04856883 12 mg Stage 2: PF-04856883 12 mg + 12 mg + 24 mg + 24 mg Stage 2: PF-04856883 8 mg + 8 mg + 16 mg + 24 mg Stage 2: PF-04856883 12 mg + 20 mg + 28 mg + 36 mg
    Arm/Group Description Participants received placebo matched to PF-04856883 subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2. Participants received single dose of PF-04856883 12 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2. 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. 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. 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.
    Measure Participants 7 5 7 7 6
    Baseline (n =7, 5, 7, 7, 6)
    281.14
    (57.875)
    309.40
    (47.600)
    301.14
    (43.690)
    291.29
    (37.911)
    303.67
    (47.272)
    Change at Day 8 (n =7, 5, 7, 6, 6)
    -5.29
    (19.678)
    -8.20
    (11.100)
    -12.14
    (12.668)
    -9.17
    (23.043)
    -10.17
    (21.720)
    Change at Day 15 (n =7, 5, 7, 6, 6)
    -1.86
    (21.146)
    -8.20
    (15.707)
    -39.29
    (21.077)
    -11.67
    (24.047)
    -14.67
    (33.037)
    Change at Day 22 (n =7, 5, 7, 6, 6)
    -7.43
    (13.176)
    -18.20
    (20.462)
    -37.86
    (19.945)
    -24.67
    (20.925)
    -27.50
    (25.399)
    Change at Day 29 (n =7, 5, 7, 6, 4)
    -4.43
    (27.098)
    -26.60
    (22.612)
    -37.57
    (14.976)
    -32.67
    (28.507)
    -41.00
    (29.855)
    Change at Day 50 (n =7, 5, 7, 7, 6)
    -6.86
    (20.732)
    -8.80
    (14.446)
    -6.43
    (20.871)
    -12.43
    (26.732)
    -5.67
    (31.258)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Stage 1: PF-04856883 Placebo, Stage 1: PF-04856883 4 mg
    Comments Day 8: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.663
    Comments
    Method Mixed meal tolerance test
    Comments
    Method of Estimation Estimation Parameter LS Mean Difference
    Estimated Value 4.11
    Confidence Interval (2-Sided) 80%
    -8.16 to 16.37
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 9.326
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Stage 1: PF-04856883 Placebo, Stage 1: PF-04856883 8 mg
    Comments Day 8: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.825
    Comments
    Method mixed meal tolerance test
    Comments
    Method of Estimation Estimation Parameter LS Mean Difference
    Estimated Value -1.89
    Confidence Interval (2-Sided) 80%
    -13.03 to 9.25
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 8.472
    Estimation Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Stage 1: PF-04856883 Placebo, Stage 1: PF-04856883 12 mg
    Comments Day 8: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.878
    Comments
    Method Mixed meal tolerance test
    Comments
    Method of Estimation Estimation Parameter LS Mean Difference
    Estimated Value 1.36
    Confidence Interval (2-Sided) 80%
    -10.20 to 12.92
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 8.791
    Estimation Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Stage 1: PF-04856883 Placebo, Stage 1: PF-04856883 18 mg
    Comments Day 8: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.936
    Comments
    Method Mixed meal tolerance test
    Comments
    Method of Estimation Estimation Parameter LS Mean Difference
    Estimated Value 0.72
    Confidence Interval (2-Sided) 80%
    -10.89 to 12.33
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 8.829
    Estimation Comments
    Statistical Analysis 5
    Statistical Analysis Overview Comparison Group Selection Stage 1: PF-04856883 Placebo, Stage 1: PF-04856883 4 mg
    Comments Day 15: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.959
    Comments
    Method Mixed meal tolerance test
    Comments
    Method of Estimation Estimation Parameter LS Mean Difference
    Estimated Value 0.68
    Confidence Interval (2-Sided) 80%
    -16.46 to 17.82
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 13.037
    Estimation Comments
    Statistical Analysis 6
    Statistical Analysis Overview Comparison Group Selection Stage 1: PF-04856883 Placebo, Stage 1: PF-04856883 8 mg
    Comments Day 15: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.011
    Comments
    Method Mixed meal tolerance test
    Comments
    Method of Estimation Estimation Parameter LS Mean Difference
    Estimated Value -32.46
    Confidence Interval (2-Sided) 80%
    -48.07 to -16.85
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 11.872
    Estimation Comments
    Statistical Analysis 7
    Statistical Analysis Overview Comparison Group Selection Stage 1: PF-04856883 Placebo, Stage 1: PF-04856883 12 mg
    Comments Day 15: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.833
    Comments
    Method Mixed meal tolerance test
    Comments
    Method of Estimation Estimation Parameter LS Mean Difference
    Estimated Value -2.61
    Confidence Interval (2-Sided) 80%
    -18.67 to 13.45
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 12.212
    Estimation Comments
    Statistical Analysis 8
    Statistical Analysis Overview Comparison Group Selection Stage 1: PF-04856883 Placebo, Stage 1: PF-04856883 18 mg
    Comments Day 15: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.565
    Comments
    Method Mixed meal tolerance test
    Comments
    Method of Estimation Estimation Parameter LS Mean Difference
    Estimated Value -7.21
    Confidence Interval (2-Sided) 80%
    -23.47 to 9.05
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 12.365
    Estimation Comments
    Statistical Analysis 9
    Statistical Analysis Overview Comparison Group Selection Stage 1: PF-04856883 Placebo, Stage 1: PF-04856883 4 mg
    Comments Day 22: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.703
    Comments
    Method Mixed meal tolerance test
    Comments
    Method of Estimation Estimation Parameter LS Mean Difference
    Estimated Value -3.75
    Confidence Interval (2-Sided) 80%
    -16.52 to 9.02
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 9.713
    Estimation Comments
    Statistical Analysis 10
    Statistical Analysis Overview Comparison Group Selection Stage 1: PF-04856883 Placebo, Stage 1: PF-04856883 8 mg
    Comments Day 22: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.008
    Comments
    Method Mixed meal tolerance test
    Comments
    Method of Estimation Estimation Parameter LS Mean Difference
    Estimated Value -25.46
    Confidence Interval (2-Sided) 80%
    -37.07 to -13.85
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 8.827
    Estimation Comments
    Statistical Analysis 11
    Statistical Analysis Overview Comparison Group Selection Stage 1: PF-04856883 Placebo, Stage 1: PF-04856883 12 mg
    Comments Day 22: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.253
    Comments
    Method Mixed meal tolerance test
    Comments
    Method of Estimation Estimation Parameter LS Mean Difference
    Estimated Value -10.60
    Confidence Interval (2-Sided) 80%
    -22.51 to 1.32
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 9.061
    Estimation Comments
    Statistical Analysis 12
    Statistical Analysis Overview Comparison Group Selection Stage 1: PF-04856883 Placebo, Stage 1: PF-04856883 18 mg
    Comments Day 22: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.128
    Comments
    Method Mixed meal tolerance test
    Comments
    Method of Estimation Estimation Parameter LS Mean Difference
    Estimated Value -14.47
    Confidence Interval (2-Sided) 80%
    -26.57 to -2.38
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 9.198
    Estimation Comments
    Statistical Analysis 13
    Statistical Analysis Overview Comparison Group Selection Stage 1: PF-04856883 Placebo, Stage 1: PF-04856883 4 mg
    Comments Day 29: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.196
    Comments
    Method Mixed meal tolerance test
    Comments
    Method of Estimation Estimation Parameter LS Mean Difference
    Estimated Value -15.15
    Confidence Interval (2-Sided) 80%
    -30.17 to -0.13
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 11.421
    Estimation Comments
    Statistical Analysis 14
    Statistical Analysis Overview Comparison Group Selection Stage 1: PF-04856883 Placebo, Stage 1: PF-04856883 8 mg
    Comments Day 29: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.012
    Comments
    Method Mixed meal tolerance test
    Comments
    Method of Estimation Estimation Parameter LS Mean Difference
    Estimated Value -28.17
    Confidence Interval (2-Sided) 80%
    -41.84 to -14.51
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 10.393
    Estimation Comments
    Statistical Analysis 15
    Statistical Analysis Overview Comparison Group Selection Stage 1: PF-04856883 Placebo, Stage 1: PF-04856883 12 mg
    Comments Day 29: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.047
    Comments
    Method Mixed meal tolerance test
    Comments
    Method of Estimation Estimation Parameter LS Mean Difference
    Estimated Value -22.48
    Confidence Interval (2-Sided) 80%
    -36.65 to -8.32
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 10.773
    Estimation Comments
    Statistical Analysis 16
    Statistical Analysis Overview Comparison Group Selection Stage 1: PF-04856883 Placebo, Stage 1: PF-04856883 18 mg
    Comments Day 29: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.023
    Comments
    Method Mixed meal tolerance test
    Comments
    Method of Estimation Estimation Parameter LS Mean Difference
    Estimated Value -28.63
    Confidence Interval (2-Sided) 80%
    -44.19 to -13.06
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 11.837
    Estimation Comments
    Statistical Analysis 17
    Statistical Analysis Overview Comparison Group Selection Stage 1: PF-04856883 Placebo, Stage 1: PF-04856883 4 mg
    Comments Day 50: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.711
    Comments
    Method Mixed meal tolerance test
    Comments
    Method of Estimation Estimation Parameter LS Mean Difference
    Estimated Value 5.08
    Confidence Interval (2-Sided) 80%
    -12.77 to 22.93
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 13.576
    Estimation Comments
    Statistical Analysis 18
    Statistical Analysis Overview Comparison Group Selection Stage 1: PF-04856883 Placebo, Stage 1: PF-04856883 8 mg
    Comments Day 50: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.666
    Comments
    Method Mixed meal tolerance test
    Comments
    Method of Estimation Estimation Parameter LS Mean Difference
    Estimated Value 5.40
    Confidence Interval (2-Sided) 80%
    -10.86 to 21.66
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 12.365
    Estimation Comments
    Statistical Analysis 19
    Statistical Analysis Overview Comparison Group Selection Stage 1: PF-04856883 Placebo, Stage 1: PF-04856883 12 mg
    Comments Day 50: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.807
    Comments
    Method Mixed meal tolerance test
    Comments
    Method of Estimation Estimation Parameter LS Mean Difference
    Estimated Value -3.05
    Confidence Interval (2-Sided) 80%
    -19.27 to 13.17
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 12.333
    Estimation Comments
    Statistical Analysis 20
    Statistical Analysis Overview Comparison Group Selection Stage 1: PF-04856883 Placebo, Stage 1: PF-04856883 18 mg
    Comments Day 50: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.603
    Comments
    Method Mixed meal tolerance test
    Comments
    Method of Estimation Estimation Parameter LS Mean Difference
    Estimated Value 6.79
    Confidence Interval (2-Sided) 80%
    -10.15 to 23.72
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 12.877
    Estimation Comments
    30. Secondary Outcome
    Title Change From Baseline in 1, 5 Anhydroglucitol at Day 8, 15 and 29: Stage 1
    Description
    Time Frame Baseline, Day 8, 15 and 29

    Outcome Measure Data

    Analysis Population Description
    Pharmacodynamic analysis population included all enrolled participants who had received at least 1 dose of study treatment and have at least 1 pharmacodynamic parameter. Here, 'n' signifies those participants who were evaluable at specified time point for each arm, respectively.
    Arm/Group Title Stage 1: PF-04856883 Placebo Stage 1: PF-04856883 4 mg Stage 1: PF-04856883 8 mg Stage 1: PF-04856883 12 mg Stage 1: PF-04856883 18 mg Stage 1: PF-04856883 24 mg Stage 1: PF-04856883 36 mg
    Arm/Group Description Participants received placebo matched to PF-04856883 subcutaneously injection once on Day 1 in Stage 1. Participants received PF-04856883 4 mg subcutaneous injection once on Day 1 in Stage 1. Participants received PF-04856883 8 mg subcutaneous injection once on Day 1 in Stage 1. Participants received PF-04856883 12 mg subcutaneous injection once on Day 1 in Stage 1. Participants received PF-04856883 18 mg subcutaneous injection once on Day 1 in Stage 1. Participants received PF-04856883 24 mg subcutaneous injection once on Day 1 in Stage 1. Participants received PF-04856883 36 mg subcutaneous injection once on Day 1 in Stage 1.
    Measure Participants 15 5 6 6 7 5 7
    Baseline (n =15, 5, 6, 6, 7, 5, 7)
    8.17
    (5.021)
    5.02
    (2.831)
    5.77
    (1.306)
    5.35
    (3.683)
    6.20
    (5.440)
    12.04
    (5.133)
    11.84
    (8.122)
    Change at Day 8 (n =15, 5, 5, 6, 7, 5, 7)
    0.39
    (0.895)
    -0.36
    (0.727)
    0.64
    (0.639)
    0.15
    (0.596)
    0.73
    (0.632)
    0.00
    (1.584)
    0.97
    (0.629)
    Change at Day 15 (n =15, 5, 5, 6, 6, 5, 7)
    0.38
    (1.047)
    0.42
    (1.711)
    1.50
    (1.321)
    -0.32
    (1.143)
    1.07
    (1.111)
    0.32
    (1.608)
    1.17
    (0.780)
    Change at Day 29 (n =15, 5, 5, 6, 7, 5, 7)
    0.46
    (1.608)
    -0.36
    (0.820)
    -0.52
    (3.192)
    -0.62
    (1.492)
    0.97
    (1.467)
    0.36
    (1.499)
    0.66
    (1.110)
    31. Secondary Outcome
    Title Change From Baseline in 1, 5 Anhydroglucitol at Day 8, 15, 22, 29 and 50: Stage 2
    Description
    Time Frame Baseline, Day 8, 15, 22, 29 and 50

    Outcome Measure Data

    Analysis Population Description
    Pharmacodynamic analysis population included all enrolled participants who had received at least 1 dose of study treatment and have at least 1 pharmacodynamic parameter. Here, 'n' signifies those participants who were evaluable at specified time point for each arm, respectively.
    Arm/Group Title Stage 2: Placebo Stage 2: PF-04856883 12 mg Stage 2: PF-04856883 12 mg + 12 mg + 24 mg + 24 mg Stage 2: PF-04856883 8 mg + 8 mg + 16 mg + 24 mg Stage 2: PF-04856883 12 mg + 20 mg + 28 mg + 36 mg
    Arm/Group Description Participants received placebo matched to PF-04856883 subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2. Participants received single dose of PF-04856883 12 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2. 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. 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. 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.
    Measure Participants 7 5 7 7 6
    Baseline (n =7, 5, 7, 7, 6)
    7.66
    (4.351)
    6.32
    (3.517)
    8.09
    (6.240)
    7.59
    (5.538)
    3.95
    (1.291)
    Change at Day 8 (n =7, 5, 7, 6, 6)
    -0.10
    (0.663)
    0.40
    (0.962)
    0.41
    (0.570)
    -0.08
    (1.599)
    0.90
    (0.502)
    Change at Day 15 (n =7, 5, 7, 6, 6)
    -0.03
    (1.376)
    0.72
    (1.512)
    1.21
    (0.641)
    0.32
    (2.483)
    0.63
    (1.481)
    Change at Day 22 (n =7, 5, 7, 6, 6)
    0.13
    (1.289)
    1.14
    (0.518)
    1.73
    (1.034)
    0.95
    (3.086)
    1.28
    (2.046)
    Change at Day 29 (n =7, 5, 7, 6, 5)
    0.36
    (1.765)
    1.46
    (0.730)
    1.83
    (1.241)
    1.50
    (2.900)
    1.60
    (2.827)
    Change at Day 50 (n =7, 5, 7, 7, 6)
    0.40
    (2.106)
    0.38
    (2.381)
    -0.30
    (1.294)
    1.64
    (2.985)
    0.92
    (2.076)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Stage 1: PF-04856883 Placebo, Stage 1: PF-04856883 4 mg
    Comments Day 8: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.387
    Comments
    Method Mixed meal tolerance test
    Comments
    Method of Estimation Estimation Parameter LS Mean Difference
    Estimated Value 0.48
    Confidence Interval (2-Sided) 80%
    -0.24 to 1.21
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.551
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Stage 1: PF-04856883 Placebo, Stage 1: PF-04856883 8 mg
    Comments Day 8: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.309
    Comments
    Method Mixed meal tolerance test
    Comments
    Method of Estimation Estimation Parameter LS Mean Difference
    Estimated Value 0.52
    Confidence Interval (2-Sided) 80%
    -0.14 to 1.18
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.501
    Estimation Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Stage 1: PF-04856883 Placebo, Stage 1: PF-04856883 12 mg
    Comments Day 8: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.956
    Comments
    Method Mixed meal tolerance test
    Comments
    Method of Estimation Estimation Parameter LS Mean Difference
    Estimated Value -0.03
    Confidence Interval (2-Sided) 80%
    -0.71 to 0.65
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.518
    Estimation Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Stage 1: PF-04856883 Placebo, Stage 1: PF-04856883 18 mg
    Comments Day 8: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.089
    Comments
    Method Mixed meal tolerance test
    Comments
    Method of Estimation Estimation Parameter LS Mean Difference
    Estimated Value 0.96
    Confidence Interval (2-Sided) 80%
    0.24 to 1.67
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.542
    Estimation Comments
    Statistical Analysis 5
    Statistical Analysis Overview Comparison Group Selection Stage 1: PF-04856883 Placebo, Stage 1: PF-04856883 4 mg
    Comments Day 15: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.434
    Comments
    Method Mixed meal tolerance test
    Comments
    Method of Estimation Estimation Parameter LS Mean Difference
    Estimated Value 0.73
    Confidence Interval (2-Sided) 80%
    -0.48 to 1.95
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.923
    Estimation Comments
    Statistical Analysis 6
    Statistical Analysis Overview Comparison Group Selection Stage 1: PF-04856883 Placebo, Stage 1: PF-04856883 8 mg
    Comments Day 15: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.150
    Comments
    Method Mixed meal tolerance test
    Comments
    Method of Estimation Estimation Parameter LS Mean Difference
    Estimated Value 1.25
    Confidence Interval (2-Sided) 80%
    0.14 to 2.35
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.841
    Estimation Comments
    Statistical Analysis 7
    Statistical Analysis Overview Comparison Group Selection Stage 1: PF-04856883 Placebo, Stage 1: PF-04856883 12 mg
    Comments Day 15: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.752
    Comments
    Method Mixed meal tolerance test
    Comments
    Method of Estimation Estimation Parameter LS Mean Difference
    Estimated Value 0.27
    Confidence Interval (2-Sided) 80%
    -0.86 to 1.41
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.861
    Estimation Comments
    Statistical Analysis 8
    Statistical Analysis Overview Comparison Group Selection Stage 1: PF-04856883 Placebo, Stage 1: PF-04856883 18 mg
    Comments Day 15: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.492
    Comments
    Method Mixed meal tolerance test
    Comments
    Method of Estimation Estimation Parameter LS Mean Difference
    Estimated Value 0.62
    Confidence Interval (2-Sided) 80%
    -0.55 to 1.79
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.888
    Estimation Comments
    Statistical Analysis 9
    Statistical Analysis Overview Comparison Group Selection Stage 1: PF-04856883 Placebo, Stage 1: PF-04856883 4 mg
    Comments Day 22: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.358
    Comments
    Method Mixed meal tolerance test
    Comments
    Method of Estimation Estimation Parameter LS Mean Difference
    Estimated Value 1.00
    Confidence Interval (2-Sided) 80%
    -0.40 to 2.40
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 1.064
    Estimation Comments
    Statistical Analysis 10
    Statistical Analysis Overview Comparison Group Selection Stage 1: PF-04856883 Placebo, Stage 1: PF-04856883 8 mg
    Comments Day 22: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.110
    Comments
    Method Mixed meal tolerance test
    Comments
    Method of Estimation Estimation Parameter LS mean Difference
    Estimated Value 1.60
    Confidence Interval (2-Sided) 80%
    0.33 to 2.88
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.970
    Estimation Comments
    Statistical Analysis 11
    Statistical Analysis Overview Comparison Group Selection Stage 1: PF-04856883 Placebo, Stage 1: PF-04856883 12 mg
    Comments Day 22: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.461
    Comments
    Method Mixed meal tolerance test
    Comments
    Method of Estimation Estimation Parameter LS mean Difference
    Estimated Value 0.74
    Confidence Interval (2-Sided) 80%
    -0.56 to 2.05
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.993
    Estimation Comments
    Statistical Analysis 12
    Statistical Analysis Overview Comparison Group Selection Stage 1: PF-04856883 Placebo, Stage 1: PF-04856883 18 mg
    Comments Day 22: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.286
    Comments
    Method Mixed meal tolerance test
    Comments
    Method of Estimation Estimation Parameter LS mean Difference
    Estimated Value 1.11
    Confidence Interval (2-Sided) 80%
    -0.23 to 2.45
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 1.021
    Estimation Comments
    Statistical Analysis 13
    Statistical Analysis Overview Comparison Group Selection Stage 1: PF-04856883 Placebo, Stage 1: PF-04856883 4 mg
    Comments Day 29: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.362
    Comments
    Method Mixed meal tolerance test
    Comments
    Method of Estimation Estimation Parameter LS Mean Difference
    Estimated Value 1.09
    Confidence Interval (2-Sided) 80%
    -0.45 to 2.63
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 1.172
    Estimation Comments
    Statistical Analysis 14
    Statistical Analysis Overview Comparison Group Selection Stage 1: PF-04856883 Placebo, Stage 1: PF-04856883 8 mg
    Comments Day 29: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.179
    Comments
    Method Mixed meal tolerance test
    Comments
    Method of Estimation Estimation Parameter LS Mean Difference
    Estimated Value 1.48
    Confidence Interval (2-Sided) 80%
    0.07 to 2.88
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 1.069
    Estimation Comments
    Statistical Analysis 15
    Statistical Analysis Overview Comparison Group Selection Stage 1: PF-04856883 Placebo, Stage 1: PF-04856883 12 mg
    Comments Day 29: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.342
    Comments
    Method Mixed meal tolerance test
    Comments
    Method of Estimation Estimation Parameter LS Mean Difference
    Estimated Value 1.06
    Confidence Interval (2-Sided) 80%
    -0.38 to 2.49
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 1.092
    Estimation Comments
    Statistical Analysis 16
    Statistical Analysis Overview Comparison Group Selection Stage 1: PF-04856883 Placebo, Stage 1: PF-04856883 18 mg
    Comments Day 29: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.272
    Comments
    Method Mixed meal tolerance test
    Comments
    Method of Estimation Estimation Parameter LS Mean Difference
    Estimated Value 1.27
    Confidence Interval (2-Sided) 80%
    -0.22 to 2.75
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 1.129
    Estimation Comments
    Statistical Analysis 17
    Statistical Analysis Overview Comparison Group Selection Stage 1: PF-04856883 Placebo, Stage 1: PF-04856883 4 mg
    Comments Day 50: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.979
    Comments
    Method Mixed meal tolerance test
    Comments
    Method of Estimation Estimation Parameter LS Mean Difference
    Estimated Value -0.04
    Confidence Interval (2-Sided) 80%
    -1.77 to 1.70
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 1.317
    Estimation Comments
    Statistical Analysis 18
    Statistical Analysis Overview Comparison Group Selection Stage 1: PF-04856883 Placebo, Stage 1: PF-04856883 8 mg
    Comments Day 50: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.568
    Comments
    Method Mixed meal tolerance test
    Comments
    Method of Estimation Estimation Parameter LS Mean Difference
    Estimated Value -0.70
    Confidence Interval (2-Sided) 80%
    -2.27 to 0.88
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 1.201
    Estimation Comments
    Statistical Analysis 19
    Statistical Analysis Overview Comparison Group Selection Stage 1: PF-04856883 Placebo, Stage 1: PF-04856883 12 mg
    Comments Day 50: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.311
    Comments
    Method Mixed meal tolerance test
    Comments
    Method of Estimation Estimation Parameter LS Mean Difference
    Estimated Value 1.24
    Confidence Interval (2-Sided) 80%
    -0.34 to 2.82
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 1.201
    Estimation Comments
    Statistical Analysis 20
    Statistical Analysis Overview Comparison Group Selection Stage 1: PF-04856883 Placebo, Stage 1: PF-04856883 18 mg
    Comments Day 50: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.710
    Comments
    Method Mixed meal tolerance test
    Comments
    Method of Estimation Estimation Parameter LS Mean Difference
    Estimated Value 0.47
    Confidence Interval (2-Sided) 80%
    -1.18 to 2.13
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 1.260
    Estimation Comments
    32. Secondary Outcome
    Title Number of Participants With Anti-Drug Antibodies (ADA): Stage 1
    Description
    Time Frame Day 1 and 29

    Outcome Measure Data

    Analysis Population Description
    Safety population included all participants who received at least 1 dose of study medication. Here, 'n' signifies those participants who were evaluable at specified time point for each arm, respectively.
    Arm/Group Title Stage 1: PF-04856883 4 mg Stage 1: PF-04856883 8 mg Stage 1: PF-04856883 12 mg Stage 1: PF-04856883 18 mg Stage 1: PF-04856883 24 mg Stage 1: PF-04856883 36 mg
    Arm/Group Description Participants received PF-04856883 4 mg subcutaneous injection once on Day 1 in Stage 1. Participants received PF-04856883 8 mg subcutaneous injection once on Day 1 in Stage 1. Participants received PF-04856883 12 mg subcutaneous injection once on Day 1 in Stage 1. Participants received PF-04856883 18 mg subcutaneous injection once on Day 1 in Stage 1. Participants received PF-04856883 24 mg subcutaneous injection once on Day 1 in Stage 1. Participants received PF-04856883 36 mg subcutaneous injection once on Day 1 in Stage 1.
    Measure Participants 5 6 6 7 5 7
    Day 1 (n =5, 6, 6, 7, 5, 7)
    1
    6.7%
    1
    20%
    0
    0%
    0
    0%
    0
    0%
    2
    40%
    Day 29 (n =5, 5, 6, 6, 5, 7)
    1
    6.7%
    2
    40%
    1
    16.7%
    0
    0%
    0
    0%
    2
    40%
    33. Secondary Outcome
    Title Number of Participant With Anti-Drug Antibodies (ADA): Stage 2
    Description
    Time Frame Day 1, 29 and 50

    Outcome Measure Data

    Analysis Population Description
    Safety population included all participants who received at least 1 dose of study medication. Here, 'n' signifies those participants who were evaluable at specified time point for each arm, respectively.
    Arm/Group Title Stage 2: PF-04856883 12 mg Stage 2: PF-04856883 12 mg + 12 mg + 24 mg + 24 mg Stage 2: PF-04856883 8 mg + 8 mg + 16 mg + 24 mg Stage 2: PF-04856883 12 mg + 20 mg + 28 mg + 36 mg
    Arm/Group Description Participants received single dose of PF-04856883 12 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2. 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. 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. 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.
    Measure Participants 5 7 7 6
    Day 1 (n =5, 7, 7, 6)
    0
    0%
    1
    20%
    1
    16.7%
    0
    0%
    Day 29 (n =5, 7, 6, 5)
    0
    0%
    2
    40%
    2
    33.3%
    1
    16.7%
    Day 50 (n =5, 7, 6, 6)
    0
    0%
    3
    60%
    2
    33.3%
    3
    50%

    Adverse Events

    Time Frame
    Adverse Event Reporting Description
    Arm/Group Title Stage 1: PF-04856883 Placebo Stage 1: PF-04856883 4 mg Stage 1: PF-04856883 8 mg Stage 1: PF-04856883 12 mg Stage 1: PF-04856883 18 mg Stage 1: PF-04856883 24 mg Stage 1: PF-04856883 36 mg Stage 2: Placebo Stage 2: PF-04856883 12.0 mg Stage 2: PF-04856883 12 mg + 12 mg + 24 mg + 24 mg Stage 2: PF-04856883 8 mg + 8 mg + 16 mg + 24 mg Stage 2: PF-04856883 12 mg + 20 mg + 28 mg + 36 mg
    Arm/Group Description Participants received placebo matched to PF-04856883 subcutaneously injection once on Day 1 in Stage 1. Participants received PF-04856883 4 milligram (mg) subcutaneous injection once on Day 1 in Stage 1. Participants received PF-04856883 8 mg subcutaneous injection once on Day 1 in Stage 1. Participants received PF-04856883 12 mg subcutaneous injection once on Day 1 in Stage 1. Participants received PF-04856883 18 mg subcutaneous injection once on Day 1 in Stage 1. Participants received PF-04856883 24 mg subcutaneous injection once on Day 1 in Stage 1. Participants received PF-04856883 36 mg subcutaneous injection once on Day 1 in Stage 1. Participants received placebo matched to PF-04856883 subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2. Participants received single dose of PF-04856883 12.0 mg subcutaneous injection on Day 1, 8, 15 and 22 in Stage 2. 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. 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. 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.
    All Cause Mortality
    Stage 1: PF-04856883 Placebo Stage 1: PF-04856883 4 mg Stage 1: PF-04856883 8 mg Stage 1: PF-04856883 12 mg Stage 1: PF-04856883 18 mg Stage 1: PF-04856883 24 mg Stage 1: PF-04856883 36 mg Stage 2: Placebo Stage 2: PF-04856883 12.0 mg Stage 2: PF-04856883 12 mg + 12 mg + 24 mg + 24 mg Stage 2: PF-04856883 8 mg + 8 mg + 16 mg + 24 mg Stage 2: PF-04856883 12 mg + 20 mg + 28 mg + 36 mg
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total / (NaN) / (NaN) / (NaN) / (NaN) / (NaN) / (NaN) / (NaN) / (NaN) / (NaN) / (NaN) / (NaN) / (NaN)
    Serious Adverse Events
    Stage 1: PF-04856883 Placebo Stage 1: PF-04856883 4 mg Stage 1: PF-04856883 8 mg Stage 1: PF-04856883 12 mg Stage 1: PF-04856883 18 mg Stage 1: PF-04856883 24 mg Stage 1: PF-04856883 36 mg Stage 2: Placebo Stage 2: PF-04856883 12.0 mg Stage 2: PF-04856883 12 mg + 12 mg + 24 mg + 24 mg Stage 2: PF-04856883 8 mg + 8 mg + 16 mg + 24 mg Stage 2: PF-04856883 12 mg + 20 mg + 28 mg + 36 mg
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/15 (0%) 0/5 (0%) 0/6 (0%) 0/6 (0%) 0/7 (0%) 0/5 (0%) 0/7 (0%) 0/7 (0%) 0/5 (0%) 0/7 (0%) 0/7 (0%) 0/6 (0%)
    Other (Not Including Serious) Adverse Events
    Stage 1: PF-04856883 Placebo Stage 1: PF-04856883 4 mg Stage 1: PF-04856883 8 mg Stage 1: PF-04856883 12 mg Stage 1: PF-04856883 18 mg Stage 1: PF-04856883 24 mg Stage 1: PF-04856883 36 mg Stage 2: Placebo Stage 2: PF-04856883 12.0 mg Stage 2: PF-04856883 12 mg + 12 mg + 24 mg + 24 mg Stage 2: PF-04856883 8 mg + 8 mg + 16 mg + 24 mg Stage 2: PF-04856883 12 mg + 20 mg + 28 mg + 36 mg
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 8/15 (53.3%) 1/5 (20%) 0/6 (0%) 2/6 (33.3%) 4/7 (57.1%) 3/5 (60%) 4/7 (57.1%) 4/7 (57.1%) 5/5 (100%) 5/7 (71.4%) 5/7 (71.4%) 5/6 (83.3%)
    Blood and lymphatic system disorders
    Anaemia 0/15 (0%) 0/5 (0%) 0/6 (0%) 1/6 (16.7%) 0/7 (0%) 0/5 (0%) 0/7 (0%) 1/7 (14.3%) 1/5 (20%) 1/7 (14.3%) 0/7 (0%) 0/6 (0%)
    Cardiac disorders
    Palpitations 0/15 (0%) 0/5 (0%) 0/6 (0%) 0/6 (0%) 0/7 (0%) 0/5 (0%) 0/7 (0%) 0/7 (0%) 0/5 (0%) 0/7 (0%) 1/7 (14.3%) 0/6 (0%)
    Ear and labyrinth disorders
    Ear pain 1/15 (6.7%) 0/5 (0%) 0/6 (0%) 0/6 (0%) 0/7 (0%) 0/5 (0%) 0/7 (0%) 0/7 (0%) 0/5 (0%) 0/7 (0%) 0/7 (0%) 0/6 (0%)
    Eye disorders
    Conjunctival hyperaemia 0/15 (0%) 0/5 (0%) 0/6 (0%) 0/6 (0%) 0/7 (0%) 0/5 (0%) 0/7 (0%) 0/7 (0%) 0/5 (0%) 0/7 (0%) 0/7 (0%) 1/6 (16.7%)
    Gastrointestinal disorders
    Abdominal distension 0/15 (0%) 0/5 (0%) 0/6 (0%) 0/6 (0%) 0/7 (0%) 0/5 (0%) 1/7 (14.3%) 0/7 (0%) 1/5 (20%) 2/7 (28.6%) 0/7 (0%) 0/6 (0%)
    Abdominal pain 0/15 (0%) 0/5 (0%) 0/6 (0%) 0/6 (0%) 0/7 (0%) 0/5 (0%) 1/7 (14.3%) 0/7 (0%) 0/5 (0%) 1/7 (14.3%) 0/7 (0%) 0/6 (0%)
    Abdominal pain upper 0/15 (0%) 0/5 (0%) 0/6 (0%) 0/6 (0%) 1/7 (14.3%) 0/5 (0%) 0/7 (0%) 1/7 (14.3%) 0/5 (0%) 0/7 (0%) 0/7 (0%) 0/6 (0%)
    Diarrhoea 2/15 (13.3%) 0/5 (0%) 0/6 (0%) 1/6 (16.7%) 0/7 (0%) 0/5 (0%) 1/7 (14.3%) 2/7 (28.6%) 1/5 (20%) 2/7 (28.6%) 2/7 (28.6%) 3/6 (50%)
    Nausea 2/15 (13.3%) 0/5 (0%) 0/6 (0%) 1/6 (16.7%) 3/7 (42.9%) 2/5 (40%) 2/7 (28.6%) 3/7 (42.9%) 2/5 (40%) 3/7 (42.9%) 4/7 (57.1%) 3/6 (50%)
    Vomiting 0/15 (0%) 0/5 (0%) 0/6 (0%) 0/6 (0%) 3/7 (42.9%) 3/5 (60%) 3/7 (42.9%) 2/7 (28.6%) 2/5 (40%) 2/7 (28.6%) 3/7 (42.9%) 3/6 (50%)
    Abdominal discomfort 0/15 (0%) 0/5 (0%) 0/6 (0%) 0/6 (0%) 0/7 (0%) 0/5 (0%) 0/7 (0%) 0/7 (0%) 1/5 (20%) 0/7 (0%) 0/7 (0%) 0/6 (0%)
    Constipation 0/15 (0%) 0/5 (0%) 0/6 (0%) 0/6 (0%) 0/7 (0%) 0/5 (0%) 0/7 (0%) 0/7 (0%) 0/5 (0%) 3/7 (42.9%) 0/7 (0%) 0/6 (0%)
    Dyspepsia 0/15 (0%) 0/5 (0%) 0/6 (0%) 0/6 (0%) 0/7 (0%) 0/5 (0%) 0/7 (0%) 0/7 (0%) 0/5 (0%) 0/7 (0%) 0/7 (0%) 1/6 (16.7%)
    Faecal volume increased 0/15 (0%) 0/5 (0%) 0/6 (0%) 0/6 (0%) 0/7 (0%) 0/5 (0%) 0/7 (0%) 0/7 (0%) 0/5 (0%) 0/7 (0%) 1/7 (14.3%) 0/6 (0%)
    Faeces discoloured 0/15 (0%) 0/5 (0%) 0/6 (0%) 1/6 (16.7%) 0/7 (0%) 0/5 (0%) 0/7 (0%) 0/7 (0%) 0/5 (0%) 0/7 (0%) 1/7 (14.3%) 0/6 (0%)
    Gastritis 0/15 (0%) 0/5 (0%) 0/6 (0%) 0/6 (0%) 0/7 (0%) 0/5 (0%) 0/7 (0%) 0/7 (0%) 1/5 (20%) 0/7 (0%) 0/7 (0%) 0/6 (0%)
    Gastrooesophageal reflux disease 0/15 (0%) 0/5 (0%) 0/6 (0%) 0/6 (0%) 0/7 (0%) 0/5 (0%) 0/7 (0%) 1/7 (14.3%) 0/5 (0%) 0/7 (0%) 0/7 (0%) 0/6 (0%)
    Haematemesis 0/15 (0%) 0/5 (0%) 0/6 (0%) 0/6 (0%) 0/7 (0%) 0/5 (0%) 1/7 (14.3%) 0/7 (0%) 0/5 (0%) 0/7 (0%) 0/7 (0%) 0/6 (0%)
    Lip swelling 0/15 (0%) 0/5 (0%) 0/6 (0%) 0/6 (0%) 0/7 (0%) 0/5 (0%) 0/7 (0%) 0/7 (0%) 0/5 (0%) 0/7 (0%) 0/7 (0%) 1/6 (16.7%)
    Toothache 0/15 (0%) 0/5 (0%) 0/6 (0%) 0/6 (0%) 0/7 (0%) 0/5 (0%) 1/7 (14.3%) 0/7 (0%) 0/5 (0%) 0/7 (0%) 0/7 (0%) 0/6 (0%)
    General disorders
    Asthenia 0/15 (0%) 0/5 (0%) 0/6 (0%) 0/6 (0%) 0/7 (0%) 0/5 (0%) 1/7 (14.3%) 1/7 (14.3%) 0/5 (0%) 0/7 (0%) 0/7 (0%) 0/6 (0%)
    Injection site reaction 1/15 (6.7%) 0/5 (0%) 0/6 (0%) 0/6 (0%) 0/7 (0%) 0/5 (0%) 0/7 (0%) 0/7 (0%) 1/5 (20%) 0/7 (0%) 0/7 (0%) 1/6 (16.7%)
    Chest pain 0/15 (0%) 0/5 (0%) 0/6 (0%) 0/6 (0%) 0/7 (0%) 0/5 (0%) 0/7 (0%) 0/7 (0%) 1/5 (20%) 0/7 (0%) 0/7 (0%) 0/6 (0%)
    Fatigue 0/15 (0%) 0/5 (0%) 0/6 (0%) 0/6 (0%) 0/7 (0%) 1/5 (20%) 0/7 (0%) 0/7 (0%) 0/5 (0%) 0/7 (0%) 0/7 (0%) 0/6 (0%)
    Oedema peripheral 0/15 (0%) 0/5 (0%) 0/6 (0%) 0/6 (0%) 0/7 (0%) 0/5 (0%) 0/7 (0%) 1/7 (14.3%) 0/5 (0%) 0/7 (0%) 0/7 (0%) 0/6 (0%)
    Local swelling 0/15 (0%) 0/5 (0%) 0/6 (0%) 0/6 (0%) 0/7 (0%) 0/5 (0%) 1/7 (14.3%) 0/7 (0%) 0/5 (0%) 0/7 (0%) 0/7 (0%) 0/6 (0%)
    Infections and infestations
    Urinary tract infection 0/15 (0%) 1/5 (20%) 0/6 (0%) 0/6 (0%) 0/7 (0%) 0/5 (0%) 0/7 (0%) 1/7 (14.3%) 0/5 (0%) 0/7 (0%) 0/7 (0%) 0/6 (0%)
    Gastroenteritis 1/15 (6.7%) 0/5 (0%) 0/6 (0%) 0/6 (0%) 0/7 (0%) 0/5 (0%) 0/7 (0%) 0/7 (0%) 0/5 (0%) 0/7 (0%) 0/7 (0%) 0/6 (0%)
    Subcutaneous abscess 1/15 (6.7%) 0/5 (0%) 0/6 (0%) 0/6 (0%) 0/7 (0%) 0/5 (0%) 0/7 (0%) 0/7 (0%) 0/5 (0%) 0/7 (0%) 0/7 (0%) 0/6 (0%)
    Tinea cruris 0/15 (0%) 0/5 (0%) 0/6 (0%) 0/6 (0%) 0/7 (0%) 0/5 (0%) 1/7 (14.3%) 0/7 (0%) 0/5 (0%) 0/7 (0%) 0/7 (0%) 0/6 (0%)
    Upper respiratory tract infection 0/15 (0%) 0/5 (0%) 0/6 (0%) 0/6 (0%) 0/7 (0%) 0/5 (0%) 0/7 (0%) 0/7 (0%) 0/5 (0%) 0/7 (0%) 1/7 (14.3%) 1/6 (16.7%)
    Injury, poisoning and procedural complications
    Arthropod bite 1/15 (6.7%) 0/5 (0%) 0/6 (0%) 0/6 (0%) 0/7 (0%) 0/5 (0%) 0/7 (0%) 0/7 (0%) 0/5 (0%) 0/7 (0%) 0/7 (0%) 0/6 (0%)
    Ligament sprain 1/15 (6.7%) 0/5 (0%) 0/6 (0%) 0/6 (0%) 0/7 (0%) 0/5 (0%) 0/7 (0%) 0/7 (0%) 0/5 (0%) 0/7 (0%) 0/7 (0%) 0/6 (0%)
    Periorbital haematoma 1/15 (6.7%) 0/5 (0%) 0/6 (0%) 0/6 (0%) 0/7 (0%) 0/5 (0%) 0/7 (0%) 0/7 (0%) 0/5 (0%) 0/7 (0%) 0/7 (0%) 0/6 (0%)
    Investigations
    Blood uric acid increased 0/15 (0%) 0/5 (0%) 0/6 (0%) 0/6 (0%) 0/7 (0%) 0/5 (0%) 0/7 (0%) 1/7 (14.3%) 0/5 (0%) 0/7 (0%) 0/7 (0%) 0/6 (0%)
    Heart rate increased 0/15 (0%) 0/5 (0%) 0/6 (0%) 0/6 (0%) 0/7 (0%) 0/5 (0%) 1/7 (14.3%) 0/7 (0%) 0/5 (0%) 0/7 (0%) 0/7 (0%) 0/6 (0%)
    Metabolism and nutrition disorders
    Decreased appetite 0/15 (0%) 0/5 (0%) 0/6 (0%) 0/6 (0%) 0/7 (0%) 0/5 (0%) 0/7 (0%) 1/7 (14.3%) 4/5 (80%) 1/7 (14.3%) 0/7 (0%) 1/6 (16.7%)
    Musculoskeletal and connective tissue disorders
    Arthralgia 0/15 (0%) 0/5 (0%) 0/6 (0%) 0/6 (0%) 0/7 (0%) 0/5 (0%) 0/7 (0%) 1/7 (14.3%) 0/5 (0%) 0/7 (0%) 0/7 (0%) 0/6 (0%)
    Bone pain 0/15 (0%) 0/5 (0%) 0/6 (0%) 0/6 (0%) 0/7 (0%) 0/5 (0%) 0/7 (0%) 1/7 (14.3%) 0/5 (0%) 0/7 (0%) 0/7 (0%) 0/6 (0%)
    Musculoskeletal pain 0/15 (0%) 0/5 (0%) 0/6 (0%) 0/6 (0%) 0/7 (0%) 0/5 (0%) 0/7 (0%) 0/7 (0%) 1/5 (20%) 1/7 (14.3%) 0/7 (0%) 0/6 (0%)
    Myalgia 0/15 (0%) 0/5 (0%) 0/6 (0%) 0/6 (0%) 0/7 (0%) 0/5 (0%) 0/7 (0%) 1/7 (14.3%) 0/5 (0%) 0/7 (0%) 0/7 (0%) 0/6 (0%)
    Neck pain 0/15 (0%) 0/5 (0%) 0/6 (0%) 0/6 (0%) 0/7 (0%) 0/5 (0%) 0/7 (0%) 0/7 (0%) 0/5 (0%) 1/7 (14.3%) 0/7 (0%) 0/6 (0%)
    Pain in jaw 1/15 (6.7%) 0/5 (0%) 0/6 (0%) 0/6 (0%) 0/7 (0%) 0/5 (0%) 0/7 (0%) 0/7 (0%) 0/5 (0%) 0/7 (0%) 0/7 (0%) 0/6 (0%)
    Nervous system disorders
    Dizziness 0/15 (0%) 0/5 (0%) 0/6 (0%) 0/6 (0%) 0/7 (0%) 0/5 (0%) 1/7 (14.3%) 0/7 (0%) 1/5 (20%) 0/7 (0%) 0/7 (0%) 0/6 (0%)
    Headache 0/15 (0%) 0/5 (0%) 0/6 (0%) 0/6 (0%) 0/7 (0%) 0/5 (0%) 2/7 (28.6%) 3/7 (42.9%) 2/5 (40%) 4/7 (57.1%) 3/7 (42.9%) 3/6 (50%)
    Psychiatric disorders
    Depressed mood 0/15 (0%) 0/5 (0%) 0/6 (0%) 0/6 (0%) 0/7 (0%) 0/5 (0%) 0/7 (0%) 1/7 (14.3%) 0/5 (0%) 0/7 (0%) 0/7 (0%) 0/6 (0%)
    Insomnia 0/15 (0%) 0/5 (0%) 0/6 (0%) 0/6 (0%) 0/7 (0%) 0/5 (0%) 0/7 (0%) 0/7 (0%) 1/5 (20%) 0/7 (0%) 0/7 (0%) 0/6 (0%)
    Renal and urinary disorders
    Chromaturia 0/15 (0%) 0/5 (0%) 0/6 (0%) 0/6 (0%) 1/7 (14.3%) 0/5 (0%) 0/7 (0%) 0/7 (0%) 0/5 (0%) 0/7 (0%) 0/7 (0%) 0/6 (0%)
    Micturition urgency 0/15 (0%) 0/5 (0%) 0/6 (0%) 0/6 (0%) 0/7 (0%) 0/5 (0%) 0/7 (0%) 0/7 (0%) 0/5 (0%) 0/7 (0%) 1/7 (14.3%) 0/6 (0%)
    Reproductive system and breast disorders
    Pruritus genital 0/15 (0%) 0/5 (0%) 0/6 (0%) 0/6 (0%) 0/7 (0%) 0/5 (0%) 0/7 (0%) 0/7 (0%) 0/5 (0%) 1/7 (14.3%) 0/7 (0%) 0/6 (0%)
    Respiratory, thoracic and mediastinal disorders
    Oropharyngeal pain 1/15 (6.7%) 0/5 (0%) 0/6 (0%) 0/6 (0%) 0/7 (0%) 0/5 (0%) 0/7 (0%) 0/7 (0%) 0/5 (0%) 1/7 (14.3%) 0/7 (0%) 0/6 (0%)
    Cough 1/15 (6.7%) 0/5 (0%) 0/6 (0%) 0/6 (0%) 0/7 (0%) 0/5 (0%) 0/7 (0%) 0/7 (0%) 0/5 (0%) 0/7 (0%) 0/7 (0%) 0/6 (0%)
    Respiratory tract congestion 1/15 (6.7%) 0/5 (0%) 0/6 (0%) 0/6 (0%) 0/7 (0%) 0/5 (0%) 0/7 (0%) 0/7 (0%) 0/5 (0%) 0/7 (0%) 0/7 (0%) 0/6 (0%)
    Skin and subcutaneous tissue disorders
    Cold sweat 0/15 (0%) 0/5 (0%) 0/6 (0%) 0/6 (0%) 0/7 (0%) 0/5 (0%) 0/7 (0%) 0/7 (0%) 0/5 (0%) 0/7 (0%) 1/7 (14.3%) 0/6 (0%)
    Dermatitis 0/15 (0%) 0/5 (0%) 0/6 (0%) 1/6 (16.7%) 0/7 (0%) 0/5 (0%) 0/7 (0%) 0/7 (0%) 0/5 (0%) 0/7 (0%) 0/7 (0%) 0/6 (0%)
    Hyperhidrosis 0/15 (0%) 0/5 (0%) 0/6 (0%) 0/6 (0%) 0/7 (0%) 0/5 (0%) 0/7 (0%) 1/7 (14.3%) 0/5 (0%) 0/7 (0%) 0/7 (0%) 0/6 (0%)
    Petechiae 0/15 (0%) 0/5 (0%) 0/6 (0%) 1/6 (16.7%) 0/7 (0%) 0/5 (0%) 0/7 (0%) 0/7 (0%) 0/5 (0%) 0/7 (0%) 0/7 (0%) 0/6 (0%)
    Pruritus generalised 0/15 (0%) 0/5 (0%) 0/6 (0%) 0/6 (0%) 0/7 (0%) 0/5 (0%) 0/7 (0%) 0/7 (0%) 0/5 (0%) 0/7 (0%) 1/7 (14.3%) 0/6 (0%)
    Rash papular 1/15 (6.7%) 0/5 (0%) 0/6 (0%) 0/6 (0%) 0/7 (0%) 0/5 (0%) 0/7 (0%) 0/7 (0%) 0/5 (0%) 0/7 (0%) 0/7 (0%) 0/6 (0%)
    Vascular disorders
    Hypertension 0/15 (0%) 0/5 (0%) 0/6 (0%) 0/6 (0%) 0/7 (0%) 0/5 (0%) 1/7 (14.3%) 0/7 (0%) 0/5 (0%) 0/7 (0%) 1/7 (14.3%) 0/6 (0%)

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    Principal Investigators are NOT employed by the organization sponsoring the study.

    Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.

    Results Point of Contact

    Name/Title Pfizer ClinicalTrials.gov
    Organization Pfizer, Inc.
    Phone 1-800-718-1021
    Email ClinicalTrials.gov_Inquiries@pfizer.com
    Responsible Party:
    Pfizer
    ClinicalTrials.gov Identifier:
    NCT01301456
    Other Study ID Numbers:
    • B1111002
    First Posted:
    Feb 23, 2011
    Last Update Posted:
    Feb 9, 2018
    Last Verified:
    Jul 1, 2017