| Primary | Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose (Day 50) that were absent before treatment or that worsened relative to pretreatment state. | The safety population included all randomized participants who received at least 1 dose of study treatment. | Posted | | Number | | participants | | Stage 1: Baseline up to Day 29; Stage 2: Baseline up to Day 50 | | | | ID | Title | Description |
|---|
| OG000 | Stage 1: PF-04856883 Placebo | Participants received placebo matched to PF-04856883 subcutaneously injection once on Day 1 in Stage 1. | | OG001 | Stage 1: PF-04856883 4 mg | Participants received PF-04856883 4 mg subcutaneous injection once on Day 1 in Stage 1. | | OG002 | Stage 1: PF-04856883 8 mg | Participants received PF-04856883 8 mg subcutaneous injection once on Day 1 in Stage 1. | | OG003 | Stage 1: PF-04856883 12 mg | Participants received PF-04856883 12 mg subcutaneous injection once on Day 1 in Stage 1. | | OG004 | Stage 1: PF-04856883 18 mg | Participants received PF-04856883 18 mg subcutaneous injection once on Day 1 in Stage 1. | | OG005 | Stage 1: PF-04856883 24 mg | Participants received PF-04856883 24 mg subcutaneous injection once on Day 1 in Stage 1. | | OG006 | Stage 1: PF-04856883 36 mg | Participants received PF-04856883 36 mg subcutaneous injection once on Day 1 in Stage 1. | | OG007 | Stage 2: Placebo | Participants received placebo matched to PF-04856883 subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2. | | OG008 | Stage 2: PF-04856883 12 mg | Participants received single dose of PF-04856883 12 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2. | | OG009 | Stage 2: PF-04856883 12 mg + 12 mg + 24 mg + 24 mg | Participants received single dose of PF-04856883 12 mg, 12 mg, 24 mg, 24 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2. | | OG010 | Stage 2: PF-04856883 8 mg + 8 mg + 16 mg + 24 mg | Participants received single dose of PF-04856883 8 mg, 8 mg, 16 mg, 24 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2. | | OG011 | Stage 2: PF-04856883 12 mg + 20 mg + 28 mg + 36 mg | Participants received single dose of PF-04856883 12 mg, 20 mg, 28 mg, 36 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2. |
| | | Title | Denominators | Categories |
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| SAE | | |
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| Primary | Number of Participants With Clinically Significant Physical Examination Findings | Physical examination included examination of general appearance, head, ears, eyes (including fundoscopy), nose, mouth, throat, neck (including thyroid), skin, breast (optional), cardiac, respiratory, gastrointestinal, musculoskeletal and neurological systems. | The safety population included all randomized participants who received at least 1 dose of study treatment. | Posted | | Number | | participants | | Stage 1: Baseline up to Day 29; Stage 2: Baseline up to Day 50 | | | | ID | Title | Description |
|---|
| OG000 | Stage 1: PF-04856883 Placebo | Participants received placebo matched to PF-04856883 subcutaneously injection once on Day 1 in Stage 1. | | OG001 | Stage 1: PF-04856883 4 mg | Participants received PF-04856883 4 mg subcutaneous injection once on Day 1 in Stage 1. | | OG002 | Stage 1: PF-04856883 8 mg | Participants received PF-04856883 8 mg subcutaneous injection once on Day 1 in Stage 1. | | OG003 | Stage 1: PF-04856883 12 mg | |
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| Primary | Number of Participants With Clinically Significant Change From Baseline in 12-lead Electrocardiograms (ECG) | ECG parameters included pulse rate (PR) interval, QRS interval, corrected QT interval using Bazett's formula (QTcB) and corrected QT interval using Fridericia's formula (QTcF). ECG criteria of clinically significant concern were 1) PR interval: greater than equal to (>=) 25 percent (%) increase when baseline greater than (>)200 milliseconds (msec); or increase >=50% when baseline less than or equal to (<=200) msec; 2) QRS interval: >=25% increase when baseline >100 msec; >=50% increase when baseline <= 100 msec; 3) QTCF interval: QTc interval using Fridericia's formula (QTcF interval) and Bazett's formula (QTcB interval): absolute value 450 - <480 msec, 480 - <500 msec >=500; absolute change 30 - <60, >=60 msec. The number of participants with potentially clinically significant ECG findings at any visit were reported. IFB = increase from baseline. | The safety population included all randomized participants who received at least 1 dose of study treatment. | Posted | | Number | | participants | | Stage 1: Baseline up to Day 29; Stage 2: Baseline up to Day 50 | | | | ID | Title | Description |
|---|
| OG000 | Stage 1: PF-04856883 Placebo | Participants received placebo matched to PF-04856883 subcutaneously injection once on Day 1 in Stage 1. | | OG001 | Stage 1: PF-04856883 4 mg | Participants received PF-04856883 4 mg subcutaneous injection once on Day 1 in Stage 1. |
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| Primary | Number of Participants With Vital Sign Abnormalities | Criteria for vital signs abnormalities: sitting/supine systolic pulse rate less than (<) 40 beats per minute (bpm) or greater than (>) 120 bpm, standing/supine systolic pulse < 40 bpm or > 140 bpm, systolic blood pressure of >=30 millimeters of mercury (mmHg) change from baseline and systolic blood pressure <90 mmHg, diastolic blood pressure >=20 mmHg change from baseline and diastolic blood pressure <50 mm Hg. | The safety population included all randomized participants who received at least 1 dose of study treatment. | Posted | | Number | | participants | | Stage 1: Baseline up to Day 29; Stage 2 : Baseline up to Day 50 | | | | ID | Title | Description |
|---|
| OG000 | Stage 1: PF-04856883 Placebo | Participants received placebo matched to PF-04856883 subcutaneously injection once on Day 1 in Stage 1. | | OG001 | Stage 1: PF-04856883 4 mg | Participants received PF-04856883 4 mg subcutaneous injection once on Day 1 in Stage 1. | | OG002 | Stage 1: PF-04856883 8 mg | Participants received PF-04856883 8 mg subcutaneous injection once on Day 1 in Stage 1. | | OG003 |
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| Primary | Number of Participants With Clinically Significant Abnormalities in Laboratory Measurements | Following parameters were analyzed for laboratory examination: Hematology: hemoglobin, hematocrit, red blood cell (RBC) <0.8*lower limit of the reference range (LLRR); leukocytes <0.6*LLRR or >1.5*ULRR; platelet count <0.5*LLRR or >1.75*upper limit of the reference range (ULRR); total neutrophils (absolute [abs]), lymphocytes (abs) <0.8*LLRR or >1.2*ULRR; eosinophils (abs), basophils (abs), monocytes (abs) >1.2*ULRR; chemistry (total bilirubin, direct bilirubin, indirect bilirubin >1.5*ULRR; aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase >3*ULRR, albumin, total protein <0.8*LLRR or >1.2*ULRR; blood urea nitrogen (BUN), creatinine >1.3*ULRR; glucose (fasting) <0.6*LLRR or >1.5*ULRR; uric acid >1.2* ULRR; sodium <0.95*LLRR or >1.05*ULRR; potassium, chloride, bicarbonate, calcium <0.9*LLRR or >1.1*ULRR. Urinalysis: Urine white blood cell (WBC), Urine RBC =>20/ high-power field (HPF). | The safety population included all randomized participants who received at least 1 dose of study treatment. | Posted | | Number | | participants | | Stage 1: Baseline up to Day 29; Stage 2: Baseline up to Day 50 | | | | ID | Title | Description |
|---|
| OG000 | Stage 1: PF-04856883 Placebo | Participants received placebo matched to PF-04856883 subcutaneously injection once on Day 1 in Stage 1. | | OG001 | Stage 1: PF-04856883 4 mg | Participants received PF-04856883 4 mg subcutaneous injection once on Day 1 in Stage 1. |
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| Secondary | Maximum Observed Plasma Concentration (Cmax) of PF-04856883: Stage 1 | | 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. | Posted | | Geometric Mean | Geometric Coefficient of Variation | nanogram per milliliter (ng/mL) | | predose (0 hour), 1, 6, 12, 24, 48, 72, 120, 168, 336, 504, 672 hours postdose on Day 1 | | | | ID | Title | Description |
|---|
| OG000 | Stage 1: PF-04856883 4 mg | Participants received PF-04856883 4 mg subcutaneous injection once on Day 1 in Stage 1. | | OG001 | Stage 1: PF-04856883 8 mg | Participants received PF-04856883 8 mg subcutaneous injection once on Day 1 in Stage 1. | | OG002 | Stage 1: PF-04856883 12 mg | Participants received PF-04856883 12 mg subcutaneous injection once on Day 1 in Stage 1. | | OG003 | Stage 1: PF-04856883 18 mg | Participants received PF-04856883 18 mg subcutaneous injection once on Day 1 in Stage 1. |
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| Secondary | Maximum Observed Plasma Concentration (Cmax) of PF-04856883: Stage 2 | | 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. | Posted | | Geometric Mean | Geometric Coefficient of Variation | ng/mL | | 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 | | | | ID | Title | Description |
|---|
| OG000 | Stage 2: PF-04856883 12 mg | Participants received single dose of PF-04856883 12 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2. | | OG001 | Stage 2: PF-04856883 12 mg + 12 mg + 24 mg + 24 mg | Participants received single dose of PF-04856883 12 mg, 12 mg, 24 mg, 24 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2. | | OG002 | Stage 2: PF-04856883 8 mg + 8 mg + 16 mg + 24 mg | Participants received single dose of PF-04856883 8 mg, 8 mg, 16 mg, 24 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2. | |
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| Secondary | Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-04856883: Stage 1 | | 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. | Posted | | Median | Full Range | hour | | predose (0 hour), 1, 6, 12, 24, 48, 72, 120, 168, 336, 504, 672 hours postdose on Day 1 | | | | ID | Title | Description |
|---|
| OG000 | Stage 1: PF-04856883 4 mg | Participants received PF-04856883 4 mg subcutaneous injection once on Day 1 in Stage 1. | | OG001 | Stage 1: PF-04856883 8 mg | Participants received PF-04856883 8 mg subcutaneous injection once on Day 1 in Stage 1. | | OG002 | Stage 1: PF-04856883 12 mg | Participants received PF-04856883 12 mg subcutaneous injection once on Day 1 in Stage 1. | | OG003 | Stage 1: PF-04856883 18 mg | Participants received PF-04856883 18 mg subcutaneous injection once on Day 1 in Stage 1. | | OG004 |
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| Secondary | Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-04856883: Stage 2 | | 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. | Posted | | Median | Full Range | hour | | 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 | | | | ID | Title | Description |
|---|
| OG000 | Stage 2: PF-04856883 12 mg | Participants received single dose of PF-04856883 12 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2. | | OG001 | Stage 2: PF-04856883 12 mg + 12 mg + 24 mg + 24 mg | Participants received single dose of PF-04856883 12 mg, 12 mg, 24 mg, 24 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2. | | OG002 | Stage 2: PF-04856883 8 mg + 8 mg + 16 mg + 24 mg | Participants received single dose of PF-04856883 8 mg, 8 mg, 16 mg, 24 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2. | |
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| Secondary | Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUC [0 - ∞]) of PF-04856883: Stage 1 | AUC (0 - ∞) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞). | 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. | Posted | | Geometric Mean | Geometric Coefficient of Variation | nanogram*hour per milliliter (ng*hr/mL) | | predose (0 hour), 1, 6, 12, 24, 48, 72, 120, 168, 336, 504, 672 hours postdose on Day 1 | | | | ID | Title | Description |
|---|
| OG000 | Stage 1: PF-04856883 4 mg | Participants received PF-04856883 4 mg subcutaneous injection once on Day 1 in Stage 1. | | OG001 | Stage 1: PF-04856883 8 mg | Participants received PF-04856883 8 mg subcutaneous injection once on Day 1 in Stage 1. | | OG002 | Stage 1: PF-04856883 12 mg | Participants received PF-04856883 12 mg subcutaneous injection once on Day 1 in Stage 1. |
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| Secondary | Area Under the Concentration Time Curve From Time Zero to Time Tau (AUCtau) of PF-04856883: Stage 2 | Area under the serum concentration-time curve from time 0 to tau (AUCtau), where tau was the dosing interval of 168 hours. | 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. | Posted | | Geometric Mean | Geometric Coefficient of Variation | ng*hr/mL | | 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 | | | | ID | Title | Description |
|---|
| OG000 | Stage 2: PF-04856883 12 mg | Participants received single dose of PF-04856883 12 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2. | | OG001 | Stage 2: PF-04856883 12 mg + 12 mg + 24 mg + 24 mg | Participants received single dose of PF-04856883 12 mg, 12 mg, 24 mg, 24 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2. | | OG002 | Stage 2: PF-04856883 8 mg + 8 mg + 16 mg + 24 mg | Participants received single dose of PF-04856883 8 mg, 8 mg, 16 mg, 24 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2. |
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| Secondary | Apparent Clearance (CL/F) of PF-04856883: Stage 1 | It was calculated by dividing dose with AUC (0 - ∞) where AUC (0 - ∞) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞). Outcome measure was planned to be analyzed in Stage 1 only. | 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. | Posted | | Geometric Mean | Geometric Coefficient of Variation | milliliter per hour (mL/hr) | | predose (0 hour), 1, 6, 12, 24, 48, 72, 120, 168, 336, 504, 672 hours postdose on Day 1 | | | | ID | Title | Description |
|---|
| OG000 | Stage 1: PF-04856883 4 mg | Participants received PF-04856883 4 mg subcutaneous injection once on Day 1 in Stage 1. | | OG001 | Stage 1: PF-04856883 8 mg | Participants received PF-04856883 8 mg subcutaneous injection once on Day 1 in Stage 1. | | OG002 | Stage 1: PF-04856883 12 mg | Participants received PF-04856883 12 mg subcutaneous injection once on Day 1 in Stage 1. |
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| Secondary | Apparent Clearance (CL/F) of PF-04856883: Stage 2 | It was calculated by dividing dose with AUC (0 - ∞) where AUC (0 - ∞) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞). Outcome measure was planned to be analyzed in Stage 2 only. Data was not estimable if values were below the limit of quantification. | 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. | Posted | | Geometric Mean | Geometric Coefficient of Variation | mL/hr | | predose (0 hour), 1, 2, 6, 24, 48, 72, 120, 168, 336, 504, 672 hours postdose on Day 22 | | | | ID | Title | Description |
|---|
| OG000 | Stage 2: PF-04856883 12 mg | Participants received single dose of PF-04856883 12 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2. | | OG001 | Stage 2: PF-04856883 12 mg + 12 mg + 24 mg + 24 mg | Participants received single dose of PF-04856883 12 mg, 12 mg, 24 mg, 24 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2. | | OG002 | Stage 2: PF-04856883 8 mg + 8 mg + 16 mg + 24 mg | |
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| Secondary | Apparent Volume of Distribution (Vz/F) of PF-04856883: Stage 1 | | 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. | Posted | | Geometric Mean | Geometric Coefficient of Variation | milliliter (mL) | | predose (0 hour), 1, 6, 12, 24, 48, 72, 120, 168, 336, 504, 672 hours postdose on Day 1 | | | | ID | Title | Description |
|---|
| OG000 | Stage 1: PF-04856883 4 mg | Participants received PF-04856883 4 mg subcutaneous injection once on Day 1 in Stage 1. | | OG001 | Stage 1: PF-04856883 8 mg | Participants received PF-04856883 8 mg subcutaneous injection once on Day 1 in Stage 1. | | OG002 | Stage 1: PF-04856883 12 mg | Participants received PF-04856883 12 mg subcutaneous injection once on Day 1 in Stage 1. | | OG003 | Stage 1: PF-04856883 18 mg | Participants received PF-04856883 18 mg subcutaneous injection once on Day 1 in Stage 1. |
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| Secondary | Apparent Volume of Distribution (Vz/F) of PF-04856883: Stage 2 | | 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. | Posted | | Geometric Mean | Geometric Coefficient of Variation | mL | | predose (0 hour), 1, 2, 6, 24, 48, 72, 120, 168, 336, 504, 672 hours postdose on Day 22 | | | | ID | Title | Description |
|---|
| OG000 | Stage 2: PF-04856883 12 mg | Participants received single dose of PF-04856883 12 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2. | | OG001 | Stage 2: PF-04856883 12 mg + 12 mg + 24 mg + 24 mg | Participants received single dose of PF-04856883 12 mg, 12 mg, 24 mg, 24 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2. | | OG002 | Stage 2: PF-04856883 8 mg + 8 mg + 16 mg + 24 mg | Participants received single dose of PF-04856883 8 mg, 8 mg, 16 mg, 24 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2. | | OG003 | Stage 2: PF-04856883 12 mg + 20 mg + 28 mg + 36 mg |
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| Secondary | Terminal Elimination Half- Life (t1/2) of PF-04856883: Stage 1 | | 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. | Posted | | Mean | Standard Deviation | hour | | predose (0 hour), 1, 6, 12, 24, 48, 72, 120, 168, 336, 504, 672 hours postdose on Day 1 | | | | ID | Title | Description |
|---|
| OG000 | Stage 1: PF-04856883 4 mg | Participants received PF-04856883 4 mg subcutaneous injection once on Day 1 in Stage 1. | | OG001 | Stage 1: PF-04856883 8 mg | Participants received PF-04856883 8 mg subcutaneous injection once on Day 1 in Stage 1. | | OG002 | Stage 1: PF-04856883 12 mg | Participants received PF-04856883 12 mg subcutaneous injection once on Day 1 in Stage 1. | | OG003 | Stage 1: PF-04856883 18 mg | Participants received PF-04856883 18 mg subcutaneous injection once on Day 1 in Stage 1. |
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| Secondary | Terminal Elimination Half-life (t1/2) of PF-04856883: Stage 2 | | 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. | Posted | | Mean | Standard Deviation | hour | | predose (0 hour), 1, 2, 6, 24, 48, 72, 120, 168, 336, 504, 672 hours postdose on Day 22 | | | | ID | Title | Description |
|---|
| OG000 | Stage 2: PF-04856883 12 mg | Participants received single dose of PF-04856883 12 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2. | | OG001 | Stage 2: PF-04856883 12 mg + 12 mg + 24 mg + 24 mg | Participants received single dose of PF-04856883 12 mg, 12 mg, 24 mg, 24 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2. | | OG002 | Stage 2: PF-04856883 8 mg + 8 mg + 16 mg + 24 mg | Participants received single dose of PF-04856883 8 mg, 8 mg, 16 mg, 24 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2. | | OG003 | Stage 2: PF-04856883 12 mg + 20 mg + 28 mg + 36 mg |
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| Secondary | Change From Baseline in Post-prandial Glucose Area Under the Curve (AUC) After Mixed Meal Tolerance Test (MMTT) at Day 3 and 8: Stage 1 | Change from baseline in post-prandial area under the plasma glucose concentration time curve as determined by standardized MMTT. Linear trapezoidal method was used to compute AUC | 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. | Posted | | Mean | Standard Deviation | milligram*hour per deciliter (mg*hr/dL) | | Baseline, Day 3 and 8 | | | | ID | Title | Description |
|---|
| OG000 | Stage 1: PF-04856883 Placebo | Participants received placebo matched to PF-04856883 subcutaneously injection once on Day 1 in Stage 1. | | OG001 | Stage 1: PF-04856883 4 mg | Participants received PF-04856883 4 mg subcutaneous injection once on Day 1 in Stage 1. | | OG002 | Stage 1: PF-04856883 8 mg | Participants received PF-04856883 8 mg subcutaneous injection once on Day 1 in Stage 1. | |
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| Secondary | Change From Baseline in Post-prandial Glucose Area Under the Curve (AUC) After Mixed Meal Tolerance Test (MMTT) at Day 3, 15, 24, 29 and 50: Stage 2 | Change from baseline in post-prandial area under the plasma glucose concentration time curve as determined by standardized MMTT. Linear trapezoidal method was used to compute AUC. | 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. | Posted | | Mean | Standard Deviation | mg*hr/dL | | Baseline, Day 3, 15, 24, 29 and 50 | | | | ID | Title | Description |
|---|
| OG000 | Stage 2: Placebo | Participants received placebo matched to PF-04856883 subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2. | | OG001 | Stage 2: PF-04856883 12 mg | Participants received single dose of PF-04856883 12 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2. | | OG002 | Stage 2: PF-04856883 12 mg + 12 mg + 24 mg + 24 mg | Participants received single dose of PF-04856883 12 mg, 12 mg, 24 mg, 24 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2. |
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| Secondary | Change From Baseline in Insulin Area Under the Curve (AUC) After Mixed Meal Tolerance Test (MMTT) at Day 3 and 8: Stage 1 | Change from baseline in post-prandial plasma insulin AUC under the plasma insulin concentration versus time curve as determined by standardized MMTT. Linear trapezoidal method was used to compute AUC. | 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. | Posted | | Mean | Standard Deviation | milliUnit*hour per liter (mU*hr/L) | | Baseline, Day 3 and 8 | | | | ID | Title | Description |
|---|
| OG000 | Stage 1: PF-04856883 Placebo | Participants received placebo matched to PF-04856883 subcutaneously injection once on Day 1 in Stage 1. | | OG001 | Stage 1: PF-04856883 4 mg | Participants received PF-04856883 4 mg subcutaneous injection once on Day 1 in Stage 1. | | OG002 | Stage 1: PF-04856883 8 mg | Participants received PF-04856883 8 mg subcutaneous injection once on Day 1 in Stage 1. | |
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| Secondary | Change From Baseline in Insulin Area Under the Curve (AUC) After Mixed Meal Tolerance Test (MMTT) at Day 3, 15, 24, 29 and 50: Stage 2 | Change from baseline in post-prandial plasma insulin AUC under the plasma insulin concentration versus time curve as determined by standardized MMTT. Linear trapezoidal method was used to compute AUC. | 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. | Posted | | Mean | Standard Deviation | mU*hr/L | | Baseline, Day 3, 15, 24, 29 and 50 | | | | ID | Title | Description |
|---|
| OG000 | Stage 2: Placebo | Participants received placebo matched to PF-04856883 subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2. | | OG001 | Stage 2: PF-04856883 12 mg | Participants received single dose of PF-04856883 12 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2. | | OG002 | Stage 2: PF-04856883 12 mg + 12 mg + 24 mg + 24 mg | Participants received single dose of PF-04856883 12 mg, 12 mg, 24 mg, 24 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2. |
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| Secondary | Change From Baseline in C-Peptide Area Under the Curve (AUC) After Mixed Meal Tolerance Test (MMTT) at Day 3 and 8: Stage 1 | Change from baseline in post-prandial area under the plasma C-peptide concentration time curve as determined by standardized MMTT. Linear trapezoidal method was used to compute AUC. | 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. | Posted | | Mean | Standard Deviation | ng*hr/mL | | Baseline, Day 3 and 8 | | | | ID | Title | Description |
|---|
| OG000 | Stage 1: PF-04856883 Placebo | Participants received placebo matched to PF-04856883 subcutaneously injection once on Day 1 in Stage 1. | | OG001 | Stage 1: PF-04856883 4 mg | Participants received PF-04856883 4 mg subcutaneous injection once on Day 1 in Stage 1. | | OG002 | Stage 1: PF-04856883 8 mg | Participants received PF-04856883 8 mg subcutaneous injection once on Day 1 in Stage 1. | | OG003 |
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| Secondary | Change From Baseline in C-Peptide Area Under the Curve (AUC) After Mixed Meal Tolerance Test (MMTT) at Day 3, 15, 24, 29 and 50: Stage 2 | Change from baseline in post-prandial area under the plasma C-peptide concentration time curve as determined by standardized MMTT. Linear trapezoidal method was used to compute AUC. | 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. | Posted | | Mean | Standard Deviation | ng*hr/mL | | Baseline, Day 3, 15, 24, 29 and 50 | | | | ID | Title | Description |
|---|
| OG000 | Stage 2: Placebo | Participants received placebo matched to PF-04856883 subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2. | | OG001 | Stage 2: PF-04856883 12 mg | Participants received single dose of PF-04856883 12 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2. | | OG002 | Stage 2: PF-04856883 12 mg + 12 mg + 24 mg + 24 mg | Participants received single dose of PF-04856883 12 mg, 12 mg, 24 mg, 24 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2. |
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| Secondary | Change From Baseline in Fasting Plasma Glucose (FPG) at Day 2, 4, 6, 15, 22 and 29: Stage 1 | | 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. | Posted | | Mean | Standard Deviation | milligram per deciliter (mg/dL) | | Baseline, Day 2, 4, 6, 15, 22 and 29 | | | | ID | Title | Description |
|---|
| OG000 | Stage 1: PF-04856883 Placebo | Participants received placebo matched to PF-04856883 subcutaneously injection once on Day 1 in Stage 1. | | OG001 | Stage 1: PF-04856883 4 mg | Participants received PF-04856883 4 mg subcutaneous injection once on Day 1 in Stage 1. | | OG002 | Stage 1: PF-04856883 8 mg | Participants received PF-04856883 8 mg subcutaneous injection once on Day 1 in Stage 1. | | OG003 | Stage 1: PF-04856883 12 mg | Participants received PF-04856883 12 mg subcutaneous injection once on Day 1 in Stage 1. |
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| Secondary | Change From Baseline in Fasting Plasma Glucose (FPG) at Day 2, 4, 6, 8, 22, 23, 25, 27, 30, 36 and 43: Stage 2 | | 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. | Posted | | Mean | Standard Deviation | mg/dL | | Baseline, Day 2, 4, 6, 8, 22, 23, 25, 27, 30, 36 and 43 | | | | ID | Title | Description |
|---|
| OG000 | Stage 2: Placebo | Participants received placebo matched to PF-04856883 subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2. | | OG001 | Stage 2: PF-04856883 12 mg | Participants received single dose of PF-04856883 12 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2. | | OG002 | Stage 2: PF-04856883 12 mg + 12 mg + 24 mg + 24 mg | Participants received single dose of PF-04856883 12 mg, 12 mg, 24 mg, 24 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2. | | OG003 | Stage 2: PF-04856883 8 mg + 8 mg + 16 mg + 24 mg |
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| Secondary | Change From Baseline in 24 Hours Glucose Normalized Area Under the Curve (NAUC) Profile at Day 30: Stage 2 | A normalized area under the curve (NAUC) were computed by dividing the AUC by the amount of time between the last time point captured and the first time point captured. | 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. | Posted | | Mean | Standard Deviation | mg/dL | | Baseline, Day 30 | | | | ID | Title | Description |
|---|
| OG000 | Stage 2: Placebo | Participants received placebo matched to PF-04856883 subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2. | | OG001 | Stage 2: PF-04856883 12 mg | Participants received single dose of PF-04856883 12 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2. | | OG002 | Stage 2: PF-04856883 12 mg + 12 mg + 24 mg + 24 mg | Participants received single dose of PF-04856883 12 mg, 12 mg, 24 mg, 24 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2. |
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| Secondary | Percent Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Day 29 and 50: Stage 2 | HbA1c is a measure of the glycosylated hemoglobin. Change (measured as percent): HbA1c at observation minus HbA1c at baseline. Outcome measure was planned to analyzed only for Stage 2. | 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. | Posted | | Mean | Standard Deviation | percent | | Baseline, Day 29 and 50 | | | | ID | Title | Description |
|---|
| OG000 | Stage 2: Placebo | Participants received placebo matched to PF-04856883 subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2. | | OG001 | Stage 2: PF-04856883 12 mg | Participants received single dose of PF-04856883 12 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2. | | OG002 | Stage 2: PF-04856883 12 mg + 12 mg + 24 mg + 24 mg | Participants received single dose of PF-04856883 12 mg, 12 mg, 24 mg, 24 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2. |
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| Secondary | Change From Baseline in Fructosamine Levels at Day 8, 15 and 29: Stage 1 | | 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. | Posted | | Mean | Standard Deviation | micromole per liter (mcmol/L) | | Baseline, Day 8, 15 and 29 | | | | ID | Title | Description |
|---|
| OG000 | Stage 1: PF-04856883 Placebo | Participants received placebo matched to PF-04856883 subcutaneously injection once on Day 1 in Stage 1. | | OG001 | Stage 1: PF-04856883 4 mg | Participants received PF-04856883 4 mg subcutaneous injection once on Day 1 in Stage 1. | | OG002 | Stage 1: PF-04856883 8 mg | Participants received PF-04856883 8 mg subcutaneous injection once on Day 1 in Stage 1. | | OG003 | Stage 1: PF-04856883 12 mg | Participants received PF-04856883 12 mg subcutaneous injection once on Day 1 in Stage 1. |
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| Secondary | Change From Baseline in Fructosamine Levels at Day 8, 15, 22, 29 and 50: Stage 2 | | 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. | Posted | | Mean | Standard Deviation | mcmol/L | | Baseline, Day 8, 15, 22, 29 and 50 | | | | ID | Title | Description |
|---|
| OG000 | Stage 2: Placebo | Participants received placebo matched to PF-04856883 subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2. | | OG001 | Stage 2: PF-04856883 12 mg | Participants received single dose of PF-04856883 12 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2. | | OG002 | Stage 2: PF-04856883 12 mg + 12 mg + 24 mg + 24 mg | Participants received single dose of PF-04856883 12 mg, 12 mg, 24 mg, 24 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2. | | OG003 | Stage 2: PF-04856883 8 mg + 8 mg + 16 mg + 24 mg | |
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| Secondary | Change From Baseline in 1, 5 Anhydroglucitol at Day 8, 15 and 29: Stage 1 | | 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. | Posted | | Mean | Standard Deviation | microgram per milliliter (mcg/mL) | | Baseline, Day 8, 15 and 29 | | | | ID | Title | Description |
|---|
| OG000 | Stage 1: PF-04856883 Placebo | Participants received placebo matched to PF-04856883 subcutaneously injection once on Day 1 in Stage 1. | | OG001 | Stage 1: PF-04856883 4 mg | Participants received PF-04856883 4 mg subcutaneous injection once on Day 1 in Stage 1. | | OG002 | Stage 1: PF-04856883 8 mg | Participants received PF-04856883 8 mg subcutaneous injection once on Day 1 in Stage 1. | | OG003 | Stage 1: PF-04856883 12 mg | Participants received PF-04856883 12 mg subcutaneous injection once on Day 1 in Stage 1. |
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| Secondary | Change From Baseline in 1, 5 Anhydroglucitol at Day 8, 15, 22, 29 and 50: Stage 2 | | 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. | Posted | | Mean | Standard Deviation | mcg/mL | | Baseline, Day 8, 15, 22, 29 and 50 | | | | ID | Title | Description |
|---|
| OG000 | Stage 2: Placebo | Participants received placebo matched to PF-04856883 subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2. | | OG001 | Stage 2: PF-04856883 12 mg | Participants received single dose of PF-04856883 12 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2. | | OG002 | Stage 2: PF-04856883 12 mg + 12 mg + 24 mg + 24 mg | Participants received single dose of PF-04856883 12 mg, 12 mg, 24 mg, 24 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2. | | OG003 | Stage 2: PF-04856883 8 mg + 8 mg + 16 mg + 24 mg | |
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| Secondary | Number of Participants With Anti-Drug Antibodies (ADA): Stage 1 | | 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. | Posted | | Number | | participants | | Day 1 and 29 | | | | ID | Title | Description |
|---|
| OG000 | Stage 1: PF-04856883 4 mg | Participants received PF-04856883 4 mg subcutaneous injection once on Day 1 in Stage 1. | | OG001 | Stage 1: PF-04856883 8 mg | Participants received PF-04856883 8 mg subcutaneous injection once on Day 1 in Stage 1. | | OG002 | Stage 1: PF-04856883 12 mg | Participants received PF-04856883 12 mg subcutaneous injection once on Day 1 in Stage 1. | | OG003 | Stage 1: PF-04856883 18 mg | Participants received PF-04856883 18 mg subcutaneous injection once on Day 1 in Stage 1. | | OG004 | Stage 1: PF-04856883 24 mg |
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| Secondary | Number of Participant With Anti-Drug Antibodies (ADA): Stage 2 | | 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. | Posted | | Number | | participants | | Day 1, 29 and 50 | | | | ID | Title | Description |
|---|
| OG000 | Stage 2: PF-04856883 12 mg | Participants received single dose of PF-04856883 12 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2. | | OG001 | Stage 2: PF-04856883 12 mg + 12 mg + 24 mg + 24 mg | Participants received single dose of PF-04856883 12 mg, 12 mg, 24 mg, 24 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2. | | OG002 | Stage 2: PF-04856883 8 mg + 8 mg + 16 mg + 24 mg | Participants received single dose of PF-04856883 8 mg, 8 mg, 16 mg, 24 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2. | | OG003 | Stage 2: PF-04856883 12 mg + 20 mg + 28 mg + 36 mg | Participants received single dose of PF-04856883 12 mg, 20 mg, 28 mg, 36 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2. |
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