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Multiple Dose Study Of PF-04937319 In Patients With Type 2 Diabetes

A Phase 1 Placebo-controlled Trial To Assess The Safety, Tolerability, Pharmacokinetics, And Pharmacodynamics Of Multiple Escalating Oral Doses Of Pf-04937319 In Adult Patients With Type 2 Diabetes Mellitus (t2dm)

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01272804
Enrollment
61
Registered
2011-01-10
Start date
2011-02-28
Completion date
2011-07-31
Last updated
2017-02-01

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

Conditions

Diabetes Mellitus, Type 2, NIDDM

Keywords

Pharmacokinetics PK Pharmacodynamics PD T2DM Phase 1 Type 2 diabetes mellitus safety and tolerability

Brief summary

The purpose of this study is to characterize the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of PF-04937319 following multiple (14 days) escalating oral doses in patients with type 2 diabetes.

Interventions

Subjects will be dosed with PF-04937319 for 14 days. The doses planned are 10, 30, 100 and 300 mg QD. All doses will be administered as tablets (10 and 100 mg strengths). In each Cohort, 9 patients will receive PF 04937319 and 3 will receive placebo. An additional cohort of 12 patients (9 active, 3 placebo) may be performed to explore a QD or BID dose. The dose for this additional cohort could be a dose already studied or a new dose that is within the exposure stopping criteria.

DRUGPlacebo

Placebo to match PF-04937319 will be provided. Subjects will be dosed for 14 days. In each cohort 9 subjects will receive PF-04937319 and 3 will receive placebo.

Sponsors

Pfizer
Lead SponsorINDUSTRY

Study design

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

Eligibility

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

Inclusion criteria

* Patients with type 2 diabetes mellitus who are taking metformin only. * Treatment should be stable, where this is defined as no change in the treatment, including dose, over the past 2 months. Regimens may include once daily and twice daily dosing only. * Male and/or female patients (females will be women of non childbearing potential) * Body Mass Index (BMI) of 18.5 to 45.0 kg/m2; and a total body weight \>50 kg (110 lbs). * HbA1c between 7.0% and 10.0%.

Exclusion criteria

* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing). Patients who have chronic conditions other than T2DM (for example, hypercholesterolemia or hypertension) but are controlled by either diet or stable (for the last 2 months) doses of medications may be included as well (for example, a subject with hypercholesterolemia on appropriate treatment is eligible). * Evidence or history of diabetic complications with significant end organ damage, eg, proliferative retinopathy and/or macular edema, creatinine clearance less than 60 mL/min * Any condition possibly affecting drug absorption (eg, gastrectomy) * History of stroke or transient ischemic attack or myocardial infarction within the past 6 months * History of coronary artery bypass graft or stent implantation. * Clinically significant peripheral vascular disease (eg, manifested by claudication). * Any history or clinical evidence of congestive heart failure, NYHA Classes II to IV. * One or more self reported significant/severe/requiring treatment episodes of hypoglycemia within the last 3 months, or two or more self reported significant/severe/requiring treatment episodes of hypoglycaemia within the last 6 months. * Current history of angina/unstable angina. * Milk or soy allergy

Design outcomes

Primary

MeasureTime frameDescription
Percent Change From Baseline in Glucose Area Under the Curve From Time 2 to 6 Hours (AUC [2-6]) After a Mixed Meal Tolerance Test (MMTT) at Day 14-46, -45.75, -45.5, -45, -44.5, -44, -43, -42 hrs pre-dose on Day -1; 2, 2.25, 2.5, 3, 3.5, 4, 5, 6 hrs post-dose on Day 14 (fasted condition)Percent change from baseline in area under the plasma glucose concentration-time curve as determined by standardized MMTT. Linear trapezoidal method was used to compute AUC. Baseline value was the AUC (2-6) calculated on Day -1.
Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) on Day 10 (pre-dose), 0.5, 1.5, 3, 5, 8, 12, 16, 24 hours post morning dose on Day 1 (fasted condition)AUCtau is the area under the plasma concentration versus time curve from time zero (pre-dose) to the end of the dosing interval (tau), here dosing interval is 24 hours.
Maximum Observed Plasma Concentration at Steady State (Cmax, ss) On Day 140 (pre-dose), 0.5, 1.5, 3, 5, 8, 12, 16, 24 hours post morning dose on Day 14 (fasted condition)
Time to Reach Maximum Observed Plasma Concentration at Steady State (Tmax, ss) on Day 140 (pre-dose), 0.5, 1.5, 3, 5, 8, 12, 16, 24 hours post morning dose on Day 14 (fasted condition)
Percentage of Unchanged Drug Excreted in the Urine Over Dosing Interval (Ae[%]) on Day 140 hour (pre-dose) through 24 hours post-dose on Day 14Percentage of drug excreted unchanged in urine calculated as overall amount of unchanged drug excreted in the urine over the dosing interval (24 hours) divided by total daily dose multiplied by 100.
Apparent Oral Clearance (CL/F) on Day 140 (pre-dose), 0.5, 1.5, 3, 5, 8, 12, 16, 24 hours post morning dose on Day 14 (fasted condition)Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.
Apparent Volume of Distribution (Vz/F) on Day 140 (pre-dose), 0.5, 1.5, 3, 5, 8, 12, 16, 24 hours post morning dose on Day 14 (fasted condition)Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug.
Observed Accumulation Ratio for AUCtau (Rac)0 (pre-dose), 0.5, 1.5, 3, 5, 8, 12, 16, 24 hours post morning dose on Day 1 and Day 14 (fasted condition)Accumulation ratio for AUCtau (Rac) was calculated as area under the curve from time zero to end of dosing interval (AUCtau) on Day 14 divided by area under the curve from time zero to end of dosing interval (AUCtau) on Day 1. Dosing interval = 24 hours.
Observed Accumulation Ratio for Cmax (Rac, Cmax)0 (pre-dose), 0.5, 1.5, 3, 5, 8, 12, 16, 24 hours post morning dose on Day 1 and Day 14 (fasted condition)Accumulation ratio for Cmax (Rac, Cmax) was calculated as maximum observed plasma concentration (Cmax) on Day 14 divided by maximum observed plasma concentration (Cmax) on Day 1.
Percent Change From Baseline in Glucose Area Under the Curve From Time 2 to 6 Hours (AUC [2-6]) After a Mixed Meal Tolerance Test (MMTT) at Day 1-46, -45.75, -45.5, -45, -44.5, -44, -43, -42 hrs pre-dose on Day -1; 2, 2.25, 2.5, 3, 3.5, 4, 5, 6 hrs post-dose on Day 1 (fasted condition)Percent change from baseline in area under the plasma glucose concentration-time curve as determined by standardized MMTT. Linear trapezoidal method was used to compute AUC. Baseline value was the AUC (2-6) calculated on Day -1.
Minimum Observed Plasma Trough Concentration at Steady State (Cmin, ss) on Day 140 (pre-dose), 0.5, 1.5, 3, 5, 8, 12, 16 hours post morning dose on Day 14 (fasted condition)
Plasma Decay Half-Life (t1/2) on Day 140 (pre-dose), 0.5, 1.5, 3, 5, 8, 12, 16, 24, 36, 48 hours post morning dose on Day 14 (fasted condition)Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.
Area Under the Curve From Time Zero to End of Dosing Interval at Steady State (AUCtau, ss) on Day 140 (pre-dose), 0.5, 1.5, 3, 5, 8, 12, 16, 24 hours post morning dose on Day 14 (fasted condition)AUCtau, ss = Area under the plasma concentration versus time curve from time zero (pre-dose) to the end of the dosing interval (tau) at steady state, here dosing interval is 24 hours.
Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)Baseline (Day 1) up to 14 days after last dose of study treatment (up to 28 days)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 14 days after last dose that were absent before treatment or that worsened relative to pre-treatment state.
Maximum Observed Plasma Concentration (Cmax) On Day 10 (pre-dose), 0.5, 1.5, 3, 5, 8, 12, 16, 24 hours (hrs) post morning dose on Day 1 (fasted condition)
Maximum Observed Plasma Concentration (Cmax) On Day 60 (pre-dose), 0.5, 1.5, 3, 5, 8 hours post-dose on Day 6 (fed condition)
Time to Reach Maximum Observed Plasma Concentration (Tmax) on Day 10 (pre-dose), 0.5, 1.5, 3, 5, 8, 12, 16, 24 hours post morning dose on Day 1 (fasted condition)
Time to Reach Maximum Observed Plasma Concentration (Tmax) on Day 60 (pre-dose), 0.5, 1.5, 3, 5, 8 hours post-dose on Day 6 (fed condition)

Secondary

MeasureTime frameDescription
Percent Change From Baseline in Insulin Area Under the Curve From Time 2 to 6 Hours (AUC [2-6]) After a Mixed Meal Tolerance Test (MMTT) at Day 1 and 14-46, -45.75, -45.5, -45, -44.5, -44, -43, -42 hrs pre-dose on Day -1; 2, 2.25, 2.5, 3, 3.5, 4, 5, 6 hrs post-dose on Day 1 and 14 (fasted condition)Percent change from baseline in area under the plasma insulin concentration-time curve as determined by standardized MMTT. Linear trapezoidal method was used to compute AUC. Baseline value was the AUC (2-6) calculated on Day -1.
Percent Change From Baseline in C-peptide Area Under the Curve From Time 2 to 6 Hours (AUC [2-6]) After a Mixed Meal Tolerance Test (MMTT) at Day 1 and 14-46, -45.75, -45.5, -45, -44.5, -44, -43, -42 hrs pre-dose on Day -1; 2, 2.25, 2.5, 3, 3.5, 4, 5, 6 hrs post-dose on Day 1 and 14 (fasted condition)Percent change from baseline in area under the plasma C-peptide concentration-time curve as determined by standardized MMTT. Linear trapezoidal method was used to compute AUC. Baseline value was the AUC (2-6) calculated on Day -1.
Change From Baseline in Average Plasma Glucose at Day 1, 6, 14-46, -44, -42, -40, -38, -36, -30, -27 hrs pre-dose on Day -1; 2, 6, 8, 10, 12,18,21 hrs post-dose on Day 1, 6 and 14; additional 0 hr (pre-dose) on Day 6 and 4 hr post-dose on Day 1 and 14Glucometer testing performed by finger-stick at 8 time points per day to measure glucose levels. Average plasma glucose was calculated as area under the plasma glucose concentration-time curve from 0 to 24 hours (AUC \[0-24\]) divided by 24.
Change From Baseline in Fasting Plasma Glucose at Day 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15Baseline (Pre-dose on Day 1), Day 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15
Change From Baseline in Triglyceride (TG) Level at Day 3, 6, 10, 14, 16 and Follow-upBaseline (Day -2), Day 3, 6, 10, 14, 16 and Follow-up (7 to 14 days after last dose of study medication)Blood sample for lipid biomarker was taken following 12-hours fasting. Baseline value was collected on Day -2 for lipids.
Change From Baseline in Total Cholesterol (TC) Level at Day 3, 6, 10, 14, 16 and Follow-upBaseline (Day -2), Day 3, 6, 10, 14, 16 and Follow-up (7 to 14 days after last dose of study medication)Blood sample for lipid biomarker was taken following 12-hours fasting. Baseline value was collected on Day -2 for lipids.
Change From Baseline in High Density Lipoprotein-Cholesterol (HDL-C) Level at Day 3, 6, 10, 14, 16 and Follow-upBaseline (Day -2), Day 3, 6, 10, 14, 16 and Follow-up (7 to 14 days after last dose of study medication)Blood sample for lipid biomarker was taken following 12-hours fasting. Baseline value was collected on Day -2 for lipids.
Change From Baseline in Lactate Level at Day 6 and 14Baseline (Day 1), Day 6 and 14Baseline value was collected at 0 hour on Day 1 for lactate.
Change From Baseline in Low Density Lipoprotein-Cholesterol (LDL-C) Level at Day 3, 6, 10, 14, 16 and Follow-upBaseline (Day -2), Day 3, 6, 10, 14, 16 and Follow-up (7 to 14 days after last dose of study medication)Blood sample for lipid biomarker was taken following 12-hours fasting. Baseline value was collected on Day -2 for lipids.

Countries

United States

Participant flow

Participants by arm

ArmCount
PF-04937319 10 mg
Participants received PF-04937319 10 milligram (mg) tablet orally once daily for 14 days.
9
PF-04937319 30 mg
Participants received PF-04937319 30 mg (3 tablets of 10 mg) orally once daily for 14 days.
9
PF-04937319 50 mg
Participants received PF-04937319 50 mg (5 tablets of 10 mg) orally once daily for 14 days.
9
PF-04937319 100 mg
Participants received PF-04937319 100 mg tablet orally once daily for 14 days.
9
PF-04937319 300 mg
Participants received PF-04937319 300 mg (3 tablets of 100 mg) orally once daily for 14 days.
9
Placebo
Participants received placebo matched to PF-04937319 tablet orally once daily for 14 days.
16
Total61

Withdrawals & dropouts

PeriodReasonFG000FG001FG002FG003FG004FG005
Overall StudyAdverse Event100021

Baseline characteristics

CharacteristicPF-04937319 50 mgPF-04937319 100 mgPF-04937319 300 mgPlaceboTotalPF-04937319 10 mgPF-04937319 30 mg
Age, Continuous54.2 years
STANDARD_DEVIATION 5.4
51.4 years
STANDARD_DEVIATION 10.6
56.4 years
STANDARD_DEVIATION 5.8
57.3 years
STANDARD_DEVIATION 5.8
54.4 years
STANDARD_DEVIATION 7.7
55.6 years
STANDARD_DEVIATION 9.2
49.4 years
STANDARD_DEVIATION 7.8
Gender
Female
2 Participants3 Participants3 Participants6 Participants18 Participants4 Participants0 Participants
Gender
Male
7 Participants6 Participants6 Participants10 Participants43 Participants5 Participants9 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
EG003
affected / at risk
EG004
affected / at risk
EG005
affected / at risk
deaths
Total, all-cause mortality
— / —— / —— / —— / —— / —— / —
other
Total, other adverse events
6 / 95 / 90 / 93 / 98 / 95 / 16
serious
Total, serious adverse events
0 / 90 / 90 / 90 / 90 / 90 / 16

Outcome results

Primary

Apparent Oral Clearance (CL/F) on Day 14

Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.

Time frame: 0 (pre-dose), 0.5, 1.5, 3, 5, 8, 12, 16, 24 hours post morning dose on Day 14 (fasted condition)

Population: PK parameter analysis population included all enrolled participants treated with PF-04937319 who had at least 1 of the PK parameters of interest. Here 'N' (number of participants analyzed) signifies participants evaluable for this measure.

ArmMeasureValue (GEOMETRIC_MEAN)Dispersion
PF-04937319 10 mgApparent Oral Clearance (CL/F) on Day 1421.86 liter per hourGeometric Coefficient of Variation 25
PF-04937319 30 mgApparent Oral Clearance (CL/F) on Day 1432.32 liter per hourGeometric Coefficient of Variation 23
PF-04937319 50 mgApparent Oral Clearance (CL/F) on Day 1426.48 liter per hourGeometric Coefficient of Variation 34
PF-04937319 100 mgApparent Oral Clearance (CL/F) on Day 1431.56 liter per hourGeometric Coefficient of Variation 37
PF-04937319 300 mgApparent Oral Clearance (CL/F) on Day 1440.29 liter per hourGeometric Coefficient of Variation 43
Primary

Apparent Volume of Distribution (Vz/F) on Day 14

Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug.

Time frame: 0 (pre-dose), 0.5, 1.5, 3, 5, 8, 12, 16, 24 hours post morning dose on Day 14 (fasted condition)

Population: PK parameter analysis population included all enrolled participants treated with PF-04937319 who had at least 1 of the PK parameters of interest. Here 'N' (number of participants analyzed) signifies participants evaluable for this measure.

ArmMeasureValue (GEOMETRIC_MEAN)Dispersion
PF-04937319 10 mgApparent Volume of Distribution (Vz/F) on Day 14205.3 literGeometric Coefficient of Variation 20
PF-04937319 30 mgApparent Volume of Distribution (Vz/F) on Day 14311.6 literGeometric Coefficient of Variation 32
PF-04937319 50 mgApparent Volume of Distribution (Vz/F) on Day 14236.7 literGeometric Coefficient of Variation 27
PF-04937319 100 mgApparent Volume of Distribution (Vz/F) on Day 14314.0 literGeometric Coefficient of Variation 28
PF-04937319 300 mgApparent Volume of Distribution (Vz/F) on Day 14475.2 literGeometric Coefficient of Variation 48
Primary

Area Under the Curve From Time Zero to End of Dosing Interval at Steady State (AUCtau, ss) on Day 14

AUCtau, ss = Area under the plasma concentration versus time curve from time zero (pre-dose) to the end of the dosing interval (tau) at steady state, here dosing interval is 24 hours.

Time frame: 0 (pre-dose), 0.5, 1.5, 3, 5, 8, 12, 16, 24 hours post morning dose on Day 14 (fasted condition)

Population: PK parameter analysis population included all enrolled participants treated with PF-04937319 who had at least 1 of the PK parameters of interest. Here 'N' (number of participants analyzed) signifies participants evaluable for this measure.

ArmMeasureValue (GEOMETRIC_MEAN)Dispersion
PF-04937319 10 mgArea Under the Curve From Time Zero to End of Dosing Interval at Steady State (AUCtau, ss) on Day 14458.0 nanogram*hour per milliliterGeometric Coefficient of Variation 35
PF-04937319 30 mgArea Under the Curve From Time Zero to End of Dosing Interval at Steady State (AUCtau, ss) on Day 14928.7 nanogram*hour per milliliterGeometric Coefficient of Variation 23
PF-04937319 50 mgArea Under the Curve From Time Zero to End of Dosing Interval at Steady State (AUCtau, ss) on Day 141889 nanogram*hour per milliliterGeometric Coefficient of Variation 52
PF-04937319 100 mgArea Under the Curve From Time Zero to End of Dosing Interval at Steady State (AUCtau, ss) on Day 143167 nanogram*hour per milliliterGeometric Coefficient of Variation 40
PF-04937319 300 mgArea Under the Curve From Time Zero to End of Dosing Interval at Steady State (AUCtau, ss) on Day 147446 nanogram*hour per milliliterGeometric Coefficient of Variation 42
Primary

Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) on Day 1

AUCtau is the area under the plasma concentration versus time curve from time zero (pre-dose) to the end of the dosing interval (tau), here dosing interval is 24 hours.

Time frame: 0 (pre-dose), 0.5, 1.5, 3, 5, 8, 12, 16, 24 hours post morning dose on Day 1 (fasted condition)

Population: PK parameter analysis population included all enrolled participants treated with PF-04937319 who had at least 1 of the PK parameters of interest.

ArmMeasureValue (GEOMETRIC_MEAN)Dispersion
PF-04937319 10 mgArea Under the Curve From Time Zero to End of Dosing Interval (AUCtau) on Day 1407.0 nanogram*hour per milliliterGeometric Coefficient of Variation 29
PF-04937319 30 mgArea Under the Curve From Time Zero to End of Dosing Interval (AUCtau) on Day 1867.7 nanogram*hour per milliliterGeometric Coefficient of Variation 21
PF-04937319 50 mgArea Under the Curve From Time Zero to End of Dosing Interval (AUCtau) on Day 11456 nanogram*hour per milliliterGeometric Coefficient of Variation 48
PF-04937319 100 mgArea Under the Curve From Time Zero to End of Dosing Interval (AUCtau) on Day 12749 nanogram*hour per milliliterGeometric Coefficient of Variation 38
PF-04937319 300 mgArea Under the Curve From Time Zero to End of Dosing Interval (AUCtau) on Day 16034 nanogram*hour per milliliterGeometric Coefficient of Variation 40
Primary

Maximum Observed Plasma Concentration at Steady State (Cmax, ss) On Day 14

Time frame: 0 (pre-dose), 0.5, 1.5, 3, 5, 8, 12, 16, 24 hours post morning dose on Day 14 (fasted condition)

Population: PK parameter analysis population included all enrolled participants treated with PF-04937319 who had at least 1 of the PK parameters of interest. Here 'N' (number of participants analyzed) signifies participants evaluable for this measure.

ArmMeasureValue (GEOMETRIC_MEAN)Dispersion
PF-04937319 10 mgMaximum Observed Plasma Concentration at Steady State (Cmax, ss) On Day 1451.09 ng/mLGeometric Coefficient of Variation 27
PF-04937319 30 mgMaximum Observed Plasma Concentration at Steady State (Cmax, ss) On Day 1479.30 ng/mLGeometric Coefficient of Variation 31
PF-04937319 50 mgMaximum Observed Plasma Concentration at Steady State (Cmax, ss) On Day 14171.3 ng/mLGeometric Coefficient of Variation 36
PF-04937319 100 mgMaximum Observed Plasma Concentration at Steady State (Cmax, ss) On Day 14251.5 ng/mLGeometric Coefficient of Variation 44
PF-04937319 300 mgMaximum Observed Plasma Concentration at Steady State (Cmax, ss) On Day 14555.9 ng/mLGeometric Coefficient of Variation 44
Primary

Maximum Observed Plasma Concentration (Cmax) On Day 1

Time frame: 0 (pre-dose), 0.5, 1.5, 3, 5, 8, 12, 16, 24 hours (hrs) post morning dose on Day 1 (fasted condition)

Population: Pharmacokinetic (PK) parameter analysis population included all enrolled participants treated with PF-04937319 who had at least 1 of the PK parameters of interest.

ArmMeasureValue (GEOMETRIC_MEAN)Dispersion
PF-04937319 10 mgMaximum Observed Plasma Concentration (Cmax) On Day 138.22 nanogram per milliliter (ng/mL)Geometric Coefficient of Variation 25
PF-04937319 30 mgMaximum Observed Plasma Concentration (Cmax) On Day 169.49 nanogram per milliliter (ng/mL)Geometric Coefficient of Variation 32
PF-04937319 50 mgMaximum Observed Plasma Concentration (Cmax) On Day 1119.4 nanogram per milliliter (ng/mL)Geometric Coefficient of Variation 38
PF-04937319 100 mgMaximum Observed Plasma Concentration (Cmax) On Day 1245.4 nanogram per milliliter (ng/mL)Geometric Coefficient of Variation 42
PF-04937319 300 mgMaximum Observed Plasma Concentration (Cmax) On Day 1449.3 nanogram per milliliter (ng/mL)Geometric Coefficient of Variation 39
Primary

Maximum Observed Plasma Concentration (Cmax) On Day 6

Time frame: 0 (pre-dose), 0.5, 1.5, 3, 5, 8 hours post-dose on Day 6 (fed condition)

Population: PK parameter analysis population included all enrolled participants treated with PF-04937319 who had at least 1 of the PK parameters of interest. Here 'N' (number of participants analyzed) signifies participants evaluable for this measure.

ArmMeasureValue (GEOMETRIC_MEAN)Dispersion
PF-04937319 10 mgMaximum Observed Plasma Concentration (Cmax) On Day 657.73 ng/mLGeometric Coefficient of Variation 17
PF-04937319 30 mgMaximum Observed Plasma Concentration (Cmax) On Day 6122.3 ng/mLGeometric Coefficient of Variation 17
PF-04937319 50 mgMaximum Observed Plasma Concentration (Cmax) On Day 6234.1 ng/mLGeometric Coefficient of Variation 24
PF-04937319 100 mgMaximum Observed Plasma Concentration (Cmax) On Day 6421.5 ng/mLGeometric Coefficient of Variation 31
PF-04937319 300 mgMaximum Observed Plasma Concentration (Cmax) On Day 6970.6 ng/mLGeometric Coefficient of Variation 35
Primary

Minimum Observed Plasma Trough Concentration at Steady State (Cmin, ss) on Day 14

Time frame: 0 (pre-dose), 0.5, 1.5, 3, 5, 8, 12, 16 hours post morning dose on Day 14 (fasted condition)

Population: PK parameter analysis population included all enrolled participants treated with PF-04937319 who had at least 1 of the PK parameters of interest. Here 'N' (number of participants analyzed) signifies participants evaluable for this measure.

ArmMeasureValue (GEOMETRIC_MEAN)Dispersion
PF-04937319 10 mgMinimum Observed Plasma Trough Concentration at Steady State (Cmin, ss) on Day 141.380 ng/mLGeometric Coefficient of Variation 83
PF-04937319 30 mgMinimum Observed Plasma Trough Concentration at Steady State (Cmin, ss) on Day 1410.56 ng/mLGeometric Coefficient of Variation 43
PF-04937319 50 mgMinimum Observed Plasma Trough Concentration at Steady State (Cmin, ss) on Day 1422.73 ng/mLGeometric Coefficient of Variation 103
PF-04937319 100 mgMinimum Observed Plasma Trough Concentration at Steady State (Cmin, ss) on Day 1441.68 ng/mLGeometric Coefficient of Variation 64
PF-04937319 300 mgMinimum Observed Plasma Trough Concentration at Steady State (Cmin, ss) on Day 14129.8 ng/mLGeometric Coefficient of Variation 62
Primary

Number of Participants With Treatment-Emergent Adverse Events (AEs) and 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 14 days after last dose that were absent before treatment or that worsened relative to pre-treatment state.

Time frame: Baseline (Day 1) up to 14 days after last dose of study treatment (up to 28 days)

Population: Safety analysis set included all participants who received at least 1 dose of study medication.

ArmMeasureGroupValue (NUMBER)
PF-04937319 10 mgNumber of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)SAEs0 participants
PF-04937319 10 mgNumber of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)AEs6 participants
PF-04937319 30 mgNumber of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)SAEs0 participants
PF-04937319 30 mgNumber of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)AEs5 participants
PF-04937319 50 mgNumber of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)AEs0 participants
PF-04937319 50 mgNumber of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)SAEs0 participants
PF-04937319 100 mgNumber of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)SAEs0 participants
PF-04937319 100 mgNumber of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)AEs3 participants
PF-04937319 300 mgNumber of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)AEs8 participants
PF-04937319 300 mgNumber of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)SAEs0 participants
PlaceboNumber of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)SAEs0 participants
PlaceboNumber of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)AEs5 participants
Primary

Observed Accumulation Ratio for AUCtau (Rac)

Accumulation ratio for AUCtau (Rac) was calculated as area under the curve from time zero to end of dosing interval (AUCtau) on Day 14 divided by area under the curve from time zero to end of dosing interval (AUCtau) on Day 1. Dosing interval = 24 hours.

Time frame: 0 (pre-dose), 0.5, 1.5, 3, 5, 8, 12, 16, 24 hours post morning dose on Day 1 and Day 14 (fasted condition)

Population: PK parameter analysis population included all enrolled participants treated with PF-04937319 who had at least 1 of the PK parameters of interest. Here 'N' (number of participants analyzed) signifies participants evaluable for this measure.

ArmMeasureValue (GEOMETRIC_MEAN)Dispersion
PF-04937319 10 mgObserved Accumulation Ratio for AUCtau (Rac)1.204 ratioGeometric Coefficient of Variation 22
PF-04937319 30 mgObserved Accumulation Ratio for AUCtau (Rac)1.069 ratioGeometric Coefficient of Variation 15
PF-04937319 50 mgObserved Accumulation Ratio for AUCtau (Rac)1.296 ratioGeometric Coefficient of Variation 24
PF-04937319 100 mgObserved Accumulation Ratio for AUCtau (Rac)1.152 ratioGeometric Coefficient of Variation 22
PF-04937319 300 mgObserved Accumulation Ratio for AUCtau (Rac)1.118 ratioGeometric Coefficient of Variation 40
Primary

Observed Accumulation Ratio for Cmax (Rac, Cmax)

Accumulation ratio for Cmax (Rac, Cmax) was calculated as maximum observed plasma concentration (Cmax) on Day 14 divided by maximum observed plasma concentration (Cmax) on Day 1.

Time frame: 0 (pre-dose), 0.5, 1.5, 3, 5, 8, 12, 16, 24 hours post morning dose on Day 1 and Day 14 (fasted condition)

Population: PK parameter analysis population included all enrolled participants treated with PF-04937319 who had at least 1 of the PK parameters of interest. Here 'N' (number of participants analyzed) signifies participants evaluable for this measure.

ArmMeasureValue (GEOMETRIC_MEAN)Dispersion
PF-04937319 10 mgObserved Accumulation Ratio for Cmax (Rac, Cmax)1.414 ratioGeometric Coefficient of Variation 41
PF-04937319 30 mgObserved Accumulation Ratio for Cmax (Rac, Cmax)1.141 ratioGeometric Coefficient of Variation 28
PF-04937319 50 mgObserved Accumulation Ratio for Cmax (Rac, Cmax)1.437 ratioGeometric Coefficient of Variation 17
PF-04937319 100 mgObserved Accumulation Ratio for Cmax (Rac, Cmax)1.026 ratioGeometric Coefficient of Variation 25
PF-04937319 300 mgObserved Accumulation Ratio for Cmax (Rac, Cmax)1.080 ratioGeometric Coefficient of Variation 40
Primary

Percentage of Unchanged Drug Excreted in the Urine Over Dosing Interval (Ae[%]) on Day 14

Percentage of drug excreted unchanged in urine calculated as overall amount of unchanged drug excreted in the urine over the dosing interval (24 hours) divided by total daily dose multiplied by 100.

Time frame: 0 hour (pre-dose) through 24 hours post-dose on Day 14

Population: PK parameter analysis population included all enrolled participants treated with PF-04937319 who had at least 1 of the PK parameters of interest. Here 'N' (number of participants analyzed) signifies participants evaluable for this measure.

ArmMeasureValue (MEAN)Dispersion
PF-04937319 10 mgPercentage of Unchanged Drug Excreted in the Urine Over Dosing Interval (Ae[%]) on Day 140.3904 percentage of doseStandard Deviation 0.11901
PF-04937319 30 mgPercentage of Unchanged Drug Excreted in the Urine Over Dosing Interval (Ae[%]) on Day 140.3533 percentage of doseStandard Deviation 0.20183
PF-04937319 50 mgPercentage of Unchanged Drug Excreted in the Urine Over Dosing Interval (Ae[%]) on Day 140.6463 percentage of doseStandard Deviation 0.56717
PF-04937319 100 mgPercentage of Unchanged Drug Excreted in the Urine Over Dosing Interval (Ae[%]) on Day 140.5380 percentage of doseStandard Deviation 0.34593
PF-04937319 300 mgPercentage of Unchanged Drug Excreted in the Urine Over Dosing Interval (Ae[%]) on Day 140.4294 percentage of doseStandard Deviation 0.44676
Primary

Percent Change From Baseline in Glucose Area Under the Curve From Time 2 to 6 Hours (AUC [2-6]) After a Mixed Meal Tolerance Test (MMTT) at Day 1

Percent change from baseline in area under the plasma glucose concentration-time curve as determined by standardized MMTT. Linear trapezoidal method was used to compute AUC. Baseline value was the AUC (2-6) calculated on Day -1.

Time frame: -46, -45.75, -45.5, -45, -44.5, -44, -43, -42 hrs pre-dose on Day -1; 2, 2.25, 2.5, 3, 3.5, 4, 5, 6 hrs post-dose on Day 1 (fasted condition)

Population: Pharmacodynamic (PD) analysis population included all enrolled participants who received at least 1 dose of study medication and had at least 1 PD parameter.

ArmMeasureValue (MEAN)Dispersion
PF-04937319 10 mgPercent Change From Baseline in Glucose Area Under the Curve From Time 2 to 6 Hours (AUC [2-6]) After a Mixed Meal Tolerance Test (MMTT) at Day 1-0.46 percent changeStandard Deviation 8.881
PF-04937319 30 mgPercent Change From Baseline in Glucose Area Under the Curve From Time 2 to 6 Hours (AUC [2-6]) After a Mixed Meal Tolerance Test (MMTT) at Day 1-2.67 percent changeStandard Deviation 6.67
PF-04937319 50 mgPercent Change From Baseline in Glucose Area Under the Curve From Time 2 to 6 Hours (AUC [2-6]) After a Mixed Meal Tolerance Test (MMTT) at Day 16.41 percent changeStandard Deviation 14.532
PF-04937319 100 mgPercent Change From Baseline in Glucose Area Under the Curve From Time 2 to 6 Hours (AUC [2-6]) After a Mixed Meal Tolerance Test (MMTT) at Day 1-12.11 percent changeStandard Deviation 14.225
PF-04937319 300 mgPercent Change From Baseline in Glucose Area Under the Curve From Time 2 to 6 Hours (AUC [2-6]) After a Mixed Meal Tolerance Test (MMTT) at Day 1-12.29 percent changeStandard Deviation 13.711
PlaceboPercent Change From Baseline in Glucose Area Under the Curve From Time 2 to 6 Hours (AUC [2-6]) After a Mixed Meal Tolerance Test (MMTT) at Day 1-3.71 percent changeStandard Deviation 10.848
Primary

Percent Change From Baseline in Glucose Area Under the Curve From Time 2 to 6 Hours (AUC [2-6]) After a Mixed Meal Tolerance Test (MMTT) at Day 14

Percent change from baseline in area under the plasma glucose concentration-time curve as determined by standardized MMTT. Linear trapezoidal method was used to compute AUC. Baseline value was the AUC (2-6) calculated on Day -1.

Time frame: -46, -45.75, -45.5, -45, -44.5, -44, -43, -42 hrs pre-dose on Day -1; 2, 2.25, 2.5, 3, 3.5, 4, 5, 6 hrs post-dose on Day 14 (fasted condition)

Population: PD analysis population included all enrolled participants who received at least 1 dose of study medication and had at least 1 PD parameter. Here 'N' (number of participants analyzed) signifies participants evaluable for this measure.

ArmMeasureValue (MEAN)Dispersion
PF-04937319 10 mgPercent Change From Baseline in Glucose Area Under the Curve From Time 2 to 6 Hours (AUC [2-6]) After a Mixed Meal Tolerance Test (MMTT) at Day 14-11.94 percent changeStandard Deviation 15.477
PF-04937319 30 mgPercent Change From Baseline in Glucose Area Under the Curve From Time 2 to 6 Hours (AUC [2-6]) After a Mixed Meal Tolerance Test (MMTT) at Day 14-4.91 percent changeStandard Deviation 16.601
PF-04937319 50 mgPercent Change From Baseline in Glucose Area Under the Curve From Time 2 to 6 Hours (AUC [2-6]) After a Mixed Meal Tolerance Test (MMTT) at Day 14-4.11 percent changeStandard Deviation 17.321
PF-04937319 100 mgPercent Change From Baseline in Glucose Area Under the Curve From Time 2 to 6 Hours (AUC [2-6]) After a Mixed Meal Tolerance Test (MMTT) at Day 14-26.83 percent changeStandard Deviation 21.054
PF-04937319 300 mgPercent Change From Baseline in Glucose Area Under the Curve From Time 2 to 6 Hours (AUC [2-6]) After a Mixed Meal Tolerance Test (MMTT) at Day 14-11.37 percent changeStandard Deviation 15.205
PlaceboPercent Change From Baseline in Glucose Area Under the Curve From Time 2 to 6 Hours (AUC [2-6]) After a Mixed Meal Tolerance Test (MMTT) at Day 14-2.86 percent changeStandard Deviation 12.103
Primary

Plasma Decay Half-Life (t1/2) on Day 14

Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.

Time frame: 0 (pre-dose), 0.5, 1.5, 3, 5, 8, 12, 16, 24, 36, 48 hours post morning dose on Day 14 (fasted condition)

Population: PK parameter analysis population included all enrolled participants treated with PF-04937319 who had at least 1 of the PK parameters of interest. Here 'N' (number of participants analyzed) signifies participants evaluable for this measure.

ArmMeasureValue (MEAN)Dispersion
PF-04937319 10 mgPlasma Decay Half-Life (t1/2) on Day 146.563 hourStandard Deviation 0.77897
PF-04937319 30 mgPlasma Decay Half-Life (t1/2) on Day 146.884 hourStandard Deviation 1.9264
PF-04937319 50 mgPlasma Decay Half-Life (t1/2) on Day 146.348 hourStandard Deviation 1.4271
PF-04937319 100 mgPlasma Decay Half-Life (t1/2) on Day 146.960 hourStandard Deviation 1.0358
PF-04937319 300 mgPlasma Decay Half-Life (t1/2) on Day 148.479 hourStandard Deviation 2.4173
Primary

Time to Reach Maximum Observed Plasma Concentration at Steady State (Tmax, ss) on Day 14

Time frame: 0 (pre-dose), 0.5, 1.5, 3, 5, 8, 12, 16, 24 hours post morning dose on Day 14 (fasted condition)

Population: PK parameter analysis population included all enrolled participants treated with PF-04937319 who had at least 1 of the PK parameters of interest. Here 'N' (number of participants analyzed) signifies participants evaluable for this measure.

ArmMeasureValue (MEDIAN)
PF-04937319 10 mgTime to Reach Maximum Observed Plasma Concentration at Steady State (Tmax, ss) on Day 143.00 hour
PF-04937319 30 mgTime to Reach Maximum Observed Plasma Concentration at Steady State (Tmax, ss) on Day 143.00 hour
PF-04937319 50 mgTime to Reach Maximum Observed Plasma Concentration at Steady State (Tmax, ss) on Day 143.00 hour
PF-04937319 100 mgTime to Reach Maximum Observed Plasma Concentration at Steady State (Tmax, ss) on Day 143.00 hour
PF-04937319 300 mgTime to Reach Maximum Observed Plasma Concentration at Steady State (Tmax, ss) on Day 143.00 hour
Primary

Time to Reach Maximum Observed Plasma Concentration (Tmax) on Day 1

Time frame: 0 (pre-dose), 0.5, 1.5, 3, 5, 8, 12, 16, 24 hours post morning dose on Day 1 (fasted condition)

Population: PK parameter analysis population included all enrolled participants treated with PF-04937319 who had at least 1 of the PK parameters of interest.

ArmMeasureValue (MEDIAN)
PF-04937319 10 mgTime to Reach Maximum Observed Plasma Concentration (Tmax) on Day 13.00 hour
PF-04937319 30 mgTime to Reach Maximum Observed Plasma Concentration (Tmax) on Day 13.00 hour
PF-04937319 50 mgTime to Reach Maximum Observed Plasma Concentration (Tmax) on Day 13.00 hour
PF-04937319 100 mgTime to Reach Maximum Observed Plasma Concentration (Tmax) on Day 13.00 hour
PF-04937319 300 mgTime to Reach Maximum Observed Plasma Concentration (Tmax) on Day 13.00 hour
Primary

Time to Reach Maximum Observed Plasma Concentration (Tmax) on Day 6

Time frame: 0 (pre-dose), 0.5, 1.5, 3, 5, 8 hours post-dose on Day 6 (fed condition)

Population: PK parameter analysis population included all enrolled participants treated with PF-04937319 who had at least 1 of the PK parameters of interest. Here 'N' (number of participants analyzed) signifies participants evaluable for this measure.

ArmMeasureValue (MEDIAN)
PF-04937319 10 mgTime to Reach Maximum Observed Plasma Concentration (Tmax) on Day 61.50 hour
PF-04937319 30 mgTime to Reach Maximum Observed Plasma Concentration (Tmax) on Day 61.50 hour
PF-04937319 50 mgTime to Reach Maximum Observed Plasma Concentration (Tmax) on Day 61.50 hour
PF-04937319 100 mgTime to Reach Maximum Observed Plasma Concentration (Tmax) on Day 61.50 hour
PF-04937319 300 mgTime to Reach Maximum Observed Plasma Concentration (Tmax) on Day 61.50 hour
Secondary

Change From Baseline in Average Plasma Glucose at Day 1, 6, 14

Glucometer testing performed by finger-stick at 8 time points per day to measure glucose levels. Average plasma glucose was calculated as area under the plasma glucose concentration-time curve from 0 to 24 hours (AUC \[0-24\]) divided by 24.

Time frame: -46, -44, -42, -40, -38, -36, -30, -27 hrs pre-dose on Day -1; 2, 6, 8, 10, 12,18,21 hrs post-dose on Day 1, 6 and 14; additional 0 hr (pre-dose) on Day 6 and 4 hr post-dose on Day 1 and 14

Population: PD analysis population included all enrolled participants who received at least 1 dose of study medication and had at least 1 PD parameter. Here 'n' signifies participants evaluable for this measure at specified time point for each arm group, respectively.

ArmMeasureGroupValue (MEAN)Dispersion
PF-04937319 10 mgChange From Baseline in Average Plasma Glucose at Day 1, 6, 14Change at Day 6 (n=8,9,9,9,7,15)-19.62 mg/dLStandard Deviation 16.247
PF-04937319 10 mgChange From Baseline in Average Plasma Glucose at Day 1, 6, 14Change at Day 1 (n=9,9,9,9,9,16)-7.18 mg/dLStandard Deviation 9.851
PF-04937319 10 mgChange From Baseline in Average Plasma Glucose at Day 1, 6, 14Baseline (n=9,9,9,9,9,16)192.10 mg/dLStandard Deviation 22.913
PF-04937319 10 mgChange From Baseline in Average Plasma Glucose at Day 1, 6, 14Change at Day 14 (n=8,9,9,9,7,15)-12.65 mg/dLStandard Deviation 25.918
PF-04937319 30 mgChange From Baseline in Average Plasma Glucose at Day 1, 6, 14Change at Day 1 (n=9,9,9,9,9,16)-5.24 mg/dLStandard Deviation 6.421
PF-04937319 30 mgChange From Baseline in Average Plasma Glucose at Day 1, 6, 14Baseline (n=9,9,9,9,9,16)188.83 mg/dLStandard Deviation 48.992
PF-04937319 30 mgChange From Baseline in Average Plasma Glucose at Day 1, 6, 14Change at Day 6 (n=8,9,9,9,7,15)-6.35 mg/dLStandard Deviation 22.496
PF-04937319 30 mgChange From Baseline in Average Plasma Glucose at Day 1, 6, 14Change at Day 14 (n=8,9,9,9,7,15)-16.45 mg/dLStandard Deviation 27.709
PF-04937319 50 mgChange From Baseline in Average Plasma Glucose at Day 1, 6, 14Baseline (n=9,9,9,9,9,16)195.78 mg/dLStandard Deviation 37.871
PF-04937319 50 mgChange From Baseline in Average Plasma Glucose at Day 1, 6, 14Change at Day 14 (n=8,9,9,9,7,15)-14.79 mg/dLStandard Deviation 33.687
PF-04937319 50 mgChange From Baseline in Average Plasma Glucose at Day 1, 6, 14Change at Day 6 (n=8,9,9,9,7,15)9.80 mg/dLStandard Deviation 30.359
PF-04937319 50 mgChange From Baseline in Average Plasma Glucose at Day 1, 6, 14Change at Day 1 (n=9,9,9,9,9,16)8.72 mg/dLStandard Deviation 15.071
PF-04937319 100 mgChange From Baseline in Average Plasma Glucose at Day 1, 6, 14Change at Day 14 (n=8,9,9,9,7,15)-48.87 mg/dLStandard Deviation 27.216
PF-04937319 100 mgChange From Baseline in Average Plasma Glucose at Day 1, 6, 14Change at Day 6 (n=8,9,9,9,7,15)-32.36 mg/dLStandard Deviation 24.121
PF-04937319 100 mgChange From Baseline in Average Plasma Glucose at Day 1, 6, 14Baseline (n=9,9,9,9,9,16)205.38 mg/dLStandard Deviation 44.632
PF-04937319 100 mgChange From Baseline in Average Plasma Glucose at Day 1, 6, 14Change at Day 1 (n=9,9,9,9,9,16)-1.90 mg/dLStandard Deviation 21.784
PF-04937319 300 mgChange From Baseline in Average Plasma Glucose at Day 1, 6, 14Baseline (n=9,9,9,9,9,16)170.95 mg/dLStandard Deviation 51.465
PF-04937319 300 mgChange From Baseline in Average Plasma Glucose at Day 1, 6, 14Change at Day 6 (n=8,9,9,9,7,15)-47.19 mg/dLStandard Deviation 25.752
PF-04937319 300 mgChange From Baseline in Average Plasma Glucose at Day 1, 6, 14Change at Day 14 (n=8,9,9,9,7,15)-34.15 mg/dLStandard Deviation 24.596
PF-04937319 300 mgChange From Baseline in Average Plasma Glucose at Day 1, 6, 14Change at Day 1 (n=9,9,9,9,9,16)-23.26 mg/dLStandard Deviation 19.189
PlaceboChange From Baseline in Average Plasma Glucose at Day 1, 6, 14Change at Day 14 (n=8,9,9,9,7,15)-7.48 mg/dLStandard Deviation 21.703
PlaceboChange From Baseline in Average Plasma Glucose at Day 1, 6, 14Change at Day 1 (n=9,9,9,9,9,16)3.04 mg/dLStandard Deviation 17.611
PlaceboChange From Baseline in Average Plasma Glucose at Day 1, 6, 14Change at Day 6 (n=8,9,9,9,7,15)3.92 mg/dLStandard Deviation 17.068
PlaceboChange From Baseline in Average Plasma Glucose at Day 1, 6, 14Baseline (n=9,9,9,9,9,16)189.07 mg/dLStandard Deviation 39.131
Secondary

Change From Baseline in Fasting Plasma Glucose at Day 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15

Time frame: Baseline (Pre-dose on Day 1), Day 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15

Population: PD analysis population included all enrolled participants who received at least 1 dose of study medication and had at least 1 PD parameter. Here 'n' signifies participants evaluable for this measure at specified time point for each arm group, respectively.

ArmMeasureGroupValue (MEAN)Dispersion
PF-04937319 10 mgChange From Baseline in Fasting Plasma Glucose at Day 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15Change at Day 14 (n=8,9,9,9,7,15)-33.63 mg/dLStandard Deviation 26.175
PF-04937319 10 mgChange From Baseline in Fasting Plasma Glucose at Day 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15Change at Day 15 (n=8,9,9,9,7,15)-13.38 mg/dLStandard Deviation 22.595
PF-04937319 10 mgChange From Baseline in Fasting Plasma Glucose at Day 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15Change at Day 4 (n=9,9,9,9,8,16)-13.44 mg/dLStandard Deviation 19.603
PF-04937319 10 mgChange From Baseline in Fasting Plasma Glucose at Day 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15Change at Day 8 (n=8,9,9,9,7,15)-23.25 mg/dLStandard Deviation 21.212
PF-04937319 10 mgChange From Baseline in Fasting Plasma Glucose at Day 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15Change at Day 7 (n=8,9,9,9,7,15)-13.50 mg/dLStandard Deviation 21.314
PF-04937319 10 mgChange From Baseline in Fasting Plasma Glucose at Day 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15Change at Day 12 (n=8,9,9,9,7,15)-27.13 mg/dLStandard Deviation 28.423
PF-04937319 10 mgChange From Baseline in Fasting Plasma Glucose at Day 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15Change at Day 3 (n=9,9,9,9,9,16)-19.11 mg/dLStandard Deviation 10.216
PF-04937319 10 mgChange From Baseline in Fasting Plasma Glucose at Day 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15Change at Day 11 (n=8,9,9,9,7,15)-17.38 mg/dLStandard Deviation 28.54
PF-04937319 10 mgChange From Baseline in Fasting Plasma Glucose at Day 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15Change at Day 5 (n=9,9,9,9,9,16)-19.67 mg/dLStandard Deviation 16.256
PF-04937319 10 mgChange From Baseline in Fasting Plasma Glucose at Day 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15Change at Day 9 (n=8,9,9,9,7,15)-19.63 mg/dLStandard Deviation 20.784
PF-04937319 10 mgChange From Baseline in Fasting Plasma Glucose at Day 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15Change at Day 2 (n=9,9,9,9,9,16)-5.00 mg/dLStandard Deviation 10.84
PF-04937319 10 mgChange From Baseline in Fasting Plasma Glucose at Day 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15Baseline (n=9,9,9,9,9,16)173.78 mg/dLStandard Deviation 31.952
PF-04937319 10 mgChange From Baseline in Fasting Plasma Glucose at Day 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15Change at Day 10 (n=8,9,9,9,7,15)-23.88 mg/dLStandard Deviation 23.503
PF-04937319 10 mgChange From Baseline in Fasting Plasma Glucose at Day 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15Change at Day 13 (n=8,9,9,9,7,15)-18.13 mg/dLStandard Deviation 30.258
PF-04937319 10 mgChange From Baseline in Fasting Plasma Glucose at Day 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15Change at Day 6 (n=9,9,9,9,7,15)-10.89 mg/dLStandard Deviation 18.21
PF-04937319 30 mgChange From Baseline in Fasting Plasma Glucose at Day 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15Baseline (n=9,9,9,9,9,16)181.33 mg/dLStandard Deviation 50.621
PF-04937319 30 mgChange From Baseline in Fasting Plasma Glucose at Day 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15Change at Day 2 (n=9,9,9,9,9,16)-4.67 mg/dLStandard Deviation 12.845
PF-04937319 30 mgChange From Baseline in Fasting Plasma Glucose at Day 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15Change at Day 8 (n=8,9,9,9,7,15)-8.56 mg/dLStandard Deviation 20.415
PF-04937319 30 mgChange From Baseline in Fasting Plasma Glucose at Day 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15Change at Day 7 (n=8,9,9,9,7,15)-12.78 mg/dLStandard Deviation 13.664
PF-04937319 30 mgChange From Baseline in Fasting Plasma Glucose at Day 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15Change at Day 14 (n=8,9,9,9,7,15)-23.67 mg/dLStandard Deviation 25.441
PF-04937319 30 mgChange From Baseline in Fasting Plasma Glucose at Day 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15Change at Day 13 (n=8,9,9,9,7,15)-23.44 mg/dLStandard Deviation 23.807
PF-04937319 30 mgChange From Baseline in Fasting Plasma Glucose at Day 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15Change at Day 3 (n=9,9,9,9,9,16)-5.78 mg/dLStandard Deviation 10.171
PF-04937319 30 mgChange From Baseline in Fasting Plasma Glucose at Day 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15Change at Day 6 (n=9,9,9,9,7,15)-16.33 mg/dLStandard Deviation 17.804
PF-04937319 30 mgChange From Baseline in Fasting Plasma Glucose at Day 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15Change at Day 12 (n=8,9,9,9,7,15)-18.56 mg/dLStandard Deviation 28.183
PF-04937319 30 mgChange From Baseline in Fasting Plasma Glucose at Day 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15Change at Day 4 (n=9,9,9,9,8,16)-9.44 mg/dLStandard Deviation 16.001
PF-04937319 30 mgChange From Baseline in Fasting Plasma Glucose at Day 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15Change at Day 15 (n=8,9,9,9,7,15)-21.44 mg/dLStandard Deviation 26.034
PF-04937319 30 mgChange From Baseline in Fasting Plasma Glucose at Day 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15Change at Day 11 (n=8,9,9,9,7,15)-22.56 mg/dLStandard Deviation 22.49
PF-04937319 30 mgChange From Baseline in Fasting Plasma Glucose at Day 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15Change at Day 5 (n=9,9,9,9,9,16)-9.89 mg/dLStandard Deviation 15.358
PF-04937319 30 mgChange From Baseline in Fasting Plasma Glucose at Day 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15Change at Day 10 (n=8,9,9,9,7,15)-16.89 mg/dLStandard Deviation 20.847
PF-04937319 30 mgChange From Baseline in Fasting Plasma Glucose at Day 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15Change at Day 9 (n=8,9,9,9,7,15)-22.11 mg/dLStandard Deviation 20.709
PF-04937319 50 mgChange From Baseline in Fasting Plasma Glucose at Day 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15Change at Day 12 (n=8,9,9,9,7,15)-16.89 mg/dLStandard Deviation 41.87
PF-04937319 50 mgChange From Baseline in Fasting Plasma Glucose at Day 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15Baseline (n=9,9,9,9,9,16)190.11 mg/dLStandard Deviation 34.505
PF-04937319 50 mgChange From Baseline in Fasting Plasma Glucose at Day 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15Change at Day 2 (n=9,9,9,9,9,16)-6.78 mg/dLStandard Deviation 25.43
PF-04937319 50 mgChange From Baseline in Fasting Plasma Glucose at Day 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15Change at Day 3 (n=9,9,9,9,9,16)-18.78 mg/dLStandard Deviation 27.124
PF-04937319 50 mgChange From Baseline in Fasting Plasma Glucose at Day 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15Change at Day 4 (n=9,9,9,9,8,16)-13.78 mg/dLStandard Deviation 28.9
PF-04937319 50 mgChange From Baseline in Fasting Plasma Glucose at Day 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15Change at Day 5 (n=9,9,9,9,9,16)-22.56 mg/dLStandard Deviation 29.56
PF-04937319 50 mgChange From Baseline in Fasting Plasma Glucose at Day 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15Change at Day 6 (n=9,9,9,9,7,15)-18.00 mg/dLStandard Deviation 34.38
PF-04937319 50 mgChange From Baseline in Fasting Plasma Glucose at Day 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15Change at Day 7 (n=8,9,9,9,7,15)-14.44 mg/dLStandard Deviation 37.27
PF-04937319 50 mgChange From Baseline in Fasting Plasma Glucose at Day 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15Change at Day 8 (n=8,9,9,9,7,15)-5.56 mg/dLStandard Deviation 37.964
PF-04937319 50 mgChange From Baseline in Fasting Plasma Glucose at Day 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15Change at Day 9 (n=8,9,9,9,7,15)-9.78 mg/dLStandard Deviation 42.825
PF-04937319 50 mgChange From Baseline in Fasting Plasma Glucose at Day 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15Change at Day 10 (n=8,9,9,9,7,15)-16.33 mg/dLStandard Deviation 32.427
PF-04937319 50 mgChange From Baseline in Fasting Plasma Glucose at Day 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15Change at Day 11 (n=8,9,9,9,7,15)-18.11 mg/dLStandard Deviation 39.81
PF-04937319 50 mgChange From Baseline in Fasting Plasma Glucose at Day 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15Change at Day 13 (n=8,9,9,9,7,15)-24.78 mg/dLStandard Deviation 40.822
PF-04937319 50 mgChange From Baseline in Fasting Plasma Glucose at Day 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15Change at Day 14 (n=8,9,9,9,7,15)-26.56 mg/dLStandard Deviation 39.768
PF-04937319 50 mgChange From Baseline in Fasting Plasma Glucose at Day 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15Change at Day 15 (n=8,9,9,9,7,15)-23.89 mg/dLStandard Deviation 38.238
PF-04937319 100 mgChange From Baseline in Fasting Plasma Glucose at Day 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15Change at Day 9 (n=8,9,9,9,7,15)-24.78 mg/dLStandard Deviation 17.817
PF-04937319 100 mgChange From Baseline in Fasting Plasma Glucose at Day 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15Change at Day 6 (n=9,9,9,9,7,15)-29.11 mg/dLStandard Deviation 16.027
PF-04937319 100 mgChange From Baseline in Fasting Plasma Glucose at Day 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15Change at Day 11 (n=8,9,9,9,7,15)-32.89 mg/dLStandard Deviation 20.294
PF-04937319 100 mgChange From Baseline in Fasting Plasma Glucose at Day 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15Change at Day 7 (n=8,9,9,9,7,15)-30.22 mg/dLStandard Deviation 16.672
PF-04937319 100 mgChange From Baseline in Fasting Plasma Glucose at Day 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15Change at Day 13 (n=8,9,9,9,7,15)-30.89 mg/dLStandard Deviation 19.548
PF-04937319 100 mgChange From Baseline in Fasting Plasma Glucose at Day 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15Change at Day 4 (n=9,9,9,9,8,16)-19.67 mg/dLStandard Deviation 20.899
PF-04937319 100 mgChange From Baseline in Fasting Plasma Glucose at Day 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15Change at Day 3 (n=9,9,9,9,9,16)-13.22 mg/dLStandard Deviation 15.571
PF-04937319 100 mgChange From Baseline in Fasting Plasma Glucose at Day 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15Change at Day 15 (n=8,9,9,9,7,15)-44.11 mg/dLStandard Deviation 19.586
PF-04937319 100 mgChange From Baseline in Fasting Plasma Glucose at Day 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15Change at Day 12 (n=8,9,9,9,7,15)-32.22 mg/dLStandard Deviation 17.88
PF-04937319 100 mgChange From Baseline in Fasting Plasma Glucose at Day 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15Change at Day 5 (n=9,9,9,9,9,16)-26.56 mg/dLStandard Deviation 21.03
PF-04937319 100 mgChange From Baseline in Fasting Plasma Glucose at Day 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15Baseline (n=9,9,9,9,9,16)193.67 mg/dLStandard Deviation 45.695
PF-04937319 100 mgChange From Baseline in Fasting Plasma Glucose at Day 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15Change at Day 10 (n=8,9,9,9,7,15)-37.11 mg/dLStandard Deviation 19.877
PF-04937319 100 mgChange From Baseline in Fasting Plasma Glucose at Day 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15Change at Day 8 (n=8,9,9,9,7,15)-24.11 mg/dLStandard Deviation 19.934
PF-04937319 100 mgChange From Baseline in Fasting Plasma Glucose at Day 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15Change at Day 2 (n=9,9,9,9,9,16)-1.78 mg/dLStandard Deviation 14.507
PF-04937319 100 mgChange From Baseline in Fasting Plasma Glucose at Day 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15Change at Day 14 (n=8,9,9,9,7,15)-43.78 mg/dLStandard Deviation 22.725
PF-04937319 300 mgChange From Baseline in Fasting Plasma Glucose at Day 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15Change at Day 7 (n=8,9,9,9,7,15)-43.71 mg/dLStandard Deviation 18.117
PF-04937319 300 mgChange From Baseline in Fasting Plasma Glucose at Day 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15Change at Day 15 (n=8,9,9,9,7,15)-40.57 mg/dLStandard Deviation 25.553
PF-04937319 300 mgChange From Baseline in Fasting Plasma Glucose at Day 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15Change at Day 9 (n=8,9,9,9,7,15)-38.00 mg/dLStandard Deviation 19.502
PF-04937319 300 mgChange From Baseline in Fasting Plasma Glucose at Day 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15Change at Day 5 (n=9,9,9,9,9,16)-30.33 mg/dLStandard Deviation 22.17
PF-04937319 300 mgChange From Baseline in Fasting Plasma Glucose at Day 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15Change at Day 10 (n=8,9,9,9,7,15)-34.29 mg/dLStandard Deviation 24.452
PF-04937319 300 mgChange From Baseline in Fasting Plasma Glucose at Day 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15Change at Day 4 (n=9,9,9,9,8,16)-42.88 mg/dLStandard Deviation 20.972
PF-04937319 300 mgChange From Baseline in Fasting Plasma Glucose at Day 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15Baseline (n=9,9,9,9,9,16)162.33 mg/dLStandard Deviation 50.269
PF-04937319 300 mgChange From Baseline in Fasting Plasma Glucose at Day 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15Change at Day 11 (n=8,9,9,9,7,15)-38.57 mg/dLStandard Deviation 22.24
PF-04937319 300 mgChange From Baseline in Fasting Plasma Glucose at Day 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15Change at Day 3 (n=9,9,9,9,9,16)-32.78 mg/dLStandard Deviation 17.527
PF-04937319 300 mgChange From Baseline in Fasting Plasma Glucose at Day 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15Change at Day 12 (n=8,9,9,9,7,15)-43.57 mg/dLStandard Deviation 26.576
PF-04937319 300 mgChange From Baseline in Fasting Plasma Glucose at Day 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15Change at Day 13 (n=8,9,9,9,7,15)-39.71 mg/dLStandard Deviation 22.706
PF-04937319 300 mgChange From Baseline in Fasting Plasma Glucose at Day 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15Change at Day 2 (n=9,9,9,9,9,16)-23.44 mg/dLStandard Deviation 18.662
PF-04937319 300 mgChange From Baseline in Fasting Plasma Glucose at Day 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15Change at Day 14 (n=8,9,9,9,7,15)-41.86 mg/dLStandard Deviation 22.386
PF-04937319 300 mgChange From Baseline in Fasting Plasma Glucose at Day 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15Change at Day 8 (n=8,9,9,9,7,15)-31.71 mg/dLStandard Deviation 20.155
PF-04937319 300 mgChange From Baseline in Fasting Plasma Glucose at Day 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15Change at Day 6 (n=9,9,9,9,7,15)-43.00 mg/dLStandard Deviation 15.61
PlaceboChange From Baseline in Fasting Plasma Glucose at Day 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15Change at Day 6 (n=9,9,9,9,7,15)-8.27 mg/dLStandard Deviation 12.708
PlaceboChange From Baseline in Fasting Plasma Glucose at Day 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15Change at Day 13 (n=8,9,9,9,7,15)-12.27 mg/dLStandard Deviation 18.718
PlaceboChange From Baseline in Fasting Plasma Glucose at Day 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15Change at Day 4 (n=9,9,9,9,8,16)-4.13 mg/dLStandard Deviation 18.722
PlaceboChange From Baseline in Fasting Plasma Glucose at Day 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15Change at Day 8 (n=8,9,9,9,7,15)-4.93 mg/dLStandard Deviation 16.434
PlaceboChange From Baseline in Fasting Plasma Glucose at Day 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15Change at Day 14 (n=8,9,9,9,7,15)-11.80 mg/dLStandard Deviation 16.545
PlaceboChange From Baseline in Fasting Plasma Glucose at Day 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15Change at Day 10 (n=8,9,9,9,7,15)-6.20 mg/dLStandard Deviation 10.544
PlaceboChange From Baseline in Fasting Plasma Glucose at Day 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15Baseline (n=9,9,9,9,9,16)172.44 mg/dLStandard Deviation 42.527
PlaceboChange From Baseline in Fasting Plasma Glucose at Day 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15Change at Day 15 (n=8,9,9,9,7,15)-11.47 mg/dLStandard Deviation 17.916
PlaceboChange From Baseline in Fasting Plasma Glucose at Day 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15Change at Day 9 (n=8,9,9,9,7,15)-2.80 mg/dLStandard Deviation 15.857
PlaceboChange From Baseline in Fasting Plasma Glucose at Day 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15Change at Day 5 (n=9,9,9,9,9,16)-14.06 mg/dLStandard Deviation 21.402
PlaceboChange From Baseline in Fasting Plasma Glucose at Day 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15Change at Day 12 (n=8,9,9,9,7,15)-7.73 mg/dLStandard Deviation 17.91
PlaceboChange From Baseline in Fasting Plasma Glucose at Day 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15Change at Day 3 (n=9,9,9,9,9,16)-7.81 mg/dLStandard Deviation 16.885
PlaceboChange From Baseline in Fasting Plasma Glucose at Day 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15Change at Day 2 (n=9,9,9,9,9,16)0.94 mg/dLStandard Deviation 12.588
PlaceboChange From Baseline in Fasting Plasma Glucose at Day 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15Change at Day 7 (n=8,9,9,9,7,15)-5.60 mg/dLStandard Deviation 12.704
PlaceboChange From Baseline in Fasting Plasma Glucose at Day 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15Change at Day 11 (n=8,9,9,9,7,15)-5.73 mg/dLStandard Deviation 19.374
Secondary

Change From Baseline in High Density Lipoprotein-Cholesterol (HDL-C) Level at Day 3, 6, 10, 14, 16 and Follow-up

Blood sample for lipid biomarker was taken following 12-hours fasting. Baseline value was collected on Day -2 for lipids.

Time frame: Baseline (Day -2), Day 3, 6, 10, 14, 16 and Follow-up (7 to 14 days after last dose of study medication)

Population: PD analysis population included all enrolled participants who received at least 1 dose of study medication and had at least 1 PD parameter. Here 'n' signifies participants evaluable for this measure at specified time point for each arm group, respectively.

ArmMeasureGroupValue (MEAN)Dispersion
PF-04937319 10 mgChange From Baseline in High Density Lipoprotein-Cholesterol (HDL-C) Level at Day 3, 6, 10, 14, 16 and Follow-upChange at Day 14 (n=8,9,9,9,7,15)-10.50 mg/dLStandard Deviation 5.78
PF-04937319 10 mgChange From Baseline in High Density Lipoprotein-Cholesterol (HDL-C) Level at Day 3, 6, 10, 14, 16 and Follow-upChange at Day 10 (n=8,9,9,9,7,15)-7.63 mg/dLStandard Deviation 4.21
PF-04937319 10 mgChange From Baseline in High Density Lipoprotein-Cholesterol (HDL-C) Level at Day 3, 6, 10, 14, 16 and Follow-upChange at Day 6 (n=9,9,9,9,7,15)-4.00 mg/dLStandard Deviation 2.65
PF-04937319 10 mgChange From Baseline in High Density Lipoprotein-Cholesterol (HDL-C) Level at Day 3, 6, 10, 14, 16 and Follow-upChange at Follow-up (n=9,9,9,9,7,16)-4.89 mg/dLStandard Deviation 3.98
PF-04937319 10 mgChange From Baseline in High Density Lipoprotein-Cholesterol (HDL-C) Level at Day 3, 6, 10, 14, 16 and Follow-upChange at Day 16 (n=8,9,9,9,7,14)-11.0 mg/dLStandard Deviation 5.1
PF-04937319 10 mgChange From Baseline in High Density Lipoprotein-Cholesterol (HDL-C) Level at Day 3, 6, 10, 14, 16 and Follow-upChange at Day 3 (n=9,9,9,9,9,16)-3.56 mg/dLStandard Deviation 4.1
PF-04937319 10 mgChange From Baseline in High Density Lipoprotein-Cholesterol (HDL-C) Level at Day 3, 6, 10, 14, 16 and Follow-upBaseline (n=9,9,9,9,9,16)48.11 mg/dLStandard Deviation 10.96
PF-04937319 30 mgChange From Baseline in High Density Lipoprotein-Cholesterol (HDL-C) Level at Day 3, 6, 10, 14, 16 and Follow-upChange at Day 14 (n=8,9,9,9,7,15)-5.78 mg/dLStandard Deviation 10.59
PF-04937319 30 mgChange From Baseline in High Density Lipoprotein-Cholesterol (HDL-C) Level at Day 3, 6, 10, 14, 16 and Follow-upBaseline (n=9,9,9,9,9,16)43.33 mg/dLStandard Deviation 9.51
PF-04937319 30 mgChange From Baseline in High Density Lipoprotein-Cholesterol (HDL-C) Level at Day 3, 6, 10, 14, 16 and Follow-upChange at Day 3 (n=9,9,9,9,9,16)-3.67 mg/dLStandard Deviation 6.36
PF-04937319 30 mgChange From Baseline in High Density Lipoprotein-Cholesterol (HDL-C) Level at Day 3, 6, 10, 14, 16 and Follow-upChange at Day 10 (n=8,9,9,9,7,15)-3.44 mg/dLStandard Deviation 5.98
PF-04937319 30 mgChange From Baseline in High Density Lipoprotein-Cholesterol (HDL-C) Level at Day 3, 6, 10, 14, 16 and Follow-upChange at Day 16 (n=8,9,9,9,7,14)-5.78 mg/dLStandard Deviation 7.61
PF-04937319 30 mgChange From Baseline in High Density Lipoprotein-Cholesterol (HDL-C) Level at Day 3, 6, 10, 14, 16 and Follow-upChange at Follow-up (n=9,9,9,9,7,16)-5.22 mg/dLStandard Deviation 6.5
PF-04937319 30 mgChange From Baseline in High Density Lipoprotein-Cholesterol (HDL-C) Level at Day 3, 6, 10, 14, 16 and Follow-upChange at Day 6 (n=9,9,9,9,7,15)-4.33 mg/dLStandard Deviation 7.73
PF-04937319 50 mgChange From Baseline in High Density Lipoprotein-Cholesterol (HDL-C) Level at Day 3, 6, 10, 14, 16 and Follow-upChange at Day 3 (n=9,9,9,9,9,16)1.33 mg/dLStandard Deviation 6.75
PF-04937319 50 mgChange From Baseline in High Density Lipoprotein-Cholesterol (HDL-C) Level at Day 3, 6, 10, 14, 16 and Follow-upChange at Day 14 (n=8,9,9,9,7,15)0.00 mg/dLStandard Deviation 5.15
PF-04937319 50 mgChange From Baseline in High Density Lipoprotein-Cholesterol (HDL-C) Level at Day 3, 6, 10, 14, 16 and Follow-upChange at Follow-up (n=9,9,9,9,7,16)-3.22 mg/dLStandard Deviation 7.24
PF-04937319 50 mgChange From Baseline in High Density Lipoprotein-Cholesterol (HDL-C) Level at Day 3, 6, 10, 14, 16 and Follow-upChange at Day 10 (n=8,9,9,9,7,15)1.22 mg/dLStandard Deviation 5.7
PF-04937319 50 mgChange From Baseline in High Density Lipoprotein-Cholesterol (HDL-C) Level at Day 3, 6, 10, 14, 16 and Follow-upChange at Day 6 (n=9,9,9,9,7,15)1.00 mg/dLStandard Deviation 4.66
PF-04937319 50 mgChange From Baseline in High Density Lipoprotein-Cholesterol (HDL-C) Level at Day 3, 6, 10, 14, 16 and Follow-upBaseline (n=9,9,9,9,9,16)46.44 mg/dLStandard Deviation 11.51
PF-04937319 50 mgChange From Baseline in High Density Lipoprotein-Cholesterol (HDL-C) Level at Day 3, 6, 10, 14, 16 and Follow-upChange at Day 16 (n=8,9,9,9,7,14)-1.56 mg/dLStandard Deviation 5.7
PF-04937319 100 mgChange From Baseline in High Density Lipoprotein-Cholesterol (HDL-C) Level at Day 3, 6, 10, 14, 16 and Follow-upChange at Day 16 (n=8,9,9,9,7,14)-4.22 mg/dLStandard Deviation 4.12
PF-04937319 100 mgChange From Baseline in High Density Lipoprotein-Cholesterol (HDL-C) Level at Day 3, 6, 10, 14, 16 and Follow-upChange at Follow-up (n=9,9,9,9,7,16)-4.44 mg/dLStandard Deviation 6.98
PF-04937319 100 mgChange From Baseline in High Density Lipoprotein-Cholesterol (HDL-C) Level at Day 3, 6, 10, 14, 16 and Follow-upChange at Day 6 (n=9,9,9,9,7,15)-3.11 mg/dLStandard Deviation 3.69
PF-04937319 100 mgChange From Baseline in High Density Lipoprotein-Cholesterol (HDL-C) Level at Day 3, 6, 10, 14, 16 and Follow-upChange at Day 3 (n=9,9,9,9,9,16)-4.56 mg/dLStandard Deviation 4.07
PF-04937319 100 mgChange From Baseline in High Density Lipoprotein-Cholesterol (HDL-C) Level at Day 3, 6, 10, 14, 16 and Follow-upChange at Day 14 (n=8,9,9,9,7,15)-4.44 mg/dLStandard Deviation 4.93
PF-04937319 100 mgChange From Baseline in High Density Lipoprotein-Cholesterol (HDL-C) Level at Day 3, 6, 10, 14, 16 and Follow-upChange at Day 10 (n=8,9,9,9,7,15)-4.44 mg/dLStandard Deviation 3.21
PF-04937319 100 mgChange From Baseline in High Density Lipoprotein-Cholesterol (HDL-C) Level at Day 3, 6, 10, 14, 16 and Follow-upBaseline (n=9,9,9,9,9,16)43.89 mg/dLStandard Deviation 13.66
PF-04937319 300 mgChange From Baseline in High Density Lipoprotein-Cholesterol (HDL-C) Level at Day 3, 6, 10, 14, 16 and Follow-upChange at Day 3 (n=9,9,9,9,9,16)-0.67 mg/dLStandard Deviation 7.07
PF-04937319 300 mgChange From Baseline in High Density Lipoprotein-Cholesterol (HDL-C) Level at Day 3, 6, 10, 14, 16 and Follow-upChange at Day 10 (n=8,9,9,9,7,15)1.14 mg/dLStandard Deviation 4.49
PF-04937319 300 mgChange From Baseline in High Density Lipoprotein-Cholesterol (HDL-C) Level at Day 3, 6, 10, 14, 16 and Follow-upChange at Day 14 (n=8,9,9,9,7,15)-0.86 mg/dLStandard Deviation 4.38
PF-04937319 300 mgChange From Baseline in High Density Lipoprotein-Cholesterol (HDL-C) Level at Day 3, 6, 10, 14, 16 and Follow-upBaseline (n=9,9,9,9,9,16)49.44 mg/dLStandard Deviation 14.05
PF-04937319 300 mgChange From Baseline in High Density Lipoprotein-Cholesterol (HDL-C) Level at Day 3, 6, 10, 14, 16 and Follow-upChange at Day 16 (n=8,9,9,9,7,14)1.00 mg/dLStandard Deviation 3.79
PF-04937319 300 mgChange From Baseline in High Density Lipoprotein-Cholesterol (HDL-C) Level at Day 3, 6, 10, 14, 16 and Follow-upChange at Follow-up (n=9,9,9,9,7,16)-2.29 mg/dLStandard Deviation 4.07
PF-04937319 300 mgChange From Baseline in High Density Lipoprotein-Cholesterol (HDL-C) Level at Day 3, 6, 10, 14, 16 and Follow-upChange at Day 6 (n=9,9,9,9,7,15)-2.43 mg/dLStandard Deviation 2.64
PlaceboChange From Baseline in High Density Lipoprotein-Cholesterol (HDL-C) Level at Day 3, 6, 10, 14, 16 and Follow-upChange at Follow-up (n=9,9,9,9,7,16)-3.50 mg/dLStandard Deviation 6.86
PlaceboChange From Baseline in High Density Lipoprotein-Cholesterol (HDL-C) Level at Day 3, 6, 10, 14, 16 and Follow-upChange at Day 16 (n=8,9,9,9,7,14)-3.36 mg/dLStandard Deviation 9.04
PlaceboChange From Baseline in High Density Lipoprotein-Cholesterol (HDL-C) Level at Day 3, 6, 10, 14, 16 and Follow-upChange at Day 14 (n=8,9,9,9,7,15)-6.93 mg/dLStandard Deviation 9.52
PlaceboChange From Baseline in High Density Lipoprotein-Cholesterol (HDL-C) Level at Day 3, 6, 10, 14, 16 and Follow-upChange at Day 3 (n=9,9,9,9,9,16)-3.88 mg/dLStandard Deviation 8.02
PlaceboChange From Baseline in High Density Lipoprotein-Cholesterol (HDL-C) Level at Day 3, 6, 10, 14, 16 and Follow-upChange at Day 10 (n=8,9,9,9,7,15)-5.00 mg/dLStandard Deviation 7.99
PlaceboChange From Baseline in High Density Lipoprotein-Cholesterol (HDL-C) Level at Day 3, 6, 10, 14, 16 and Follow-upChange at Day 6 (n=9,9,9,9,7,15)-6.20 mg/dLStandard Deviation 7.8
PlaceboChange From Baseline in High Density Lipoprotein-Cholesterol (HDL-C) Level at Day 3, 6, 10, 14, 16 and Follow-upBaseline (n=9,9,9,9,9,16)48.94 mg/dLStandard Deviation 9.33
Secondary

Change From Baseline in Lactate Level at Day 6 and 14

Baseline value was collected at 0 hour on Day 1 for lactate.

Time frame: Baseline (Day 1), Day 6 and 14

Population: PD analysis population included all enrolled participants who received at least 1 dose of study medication and had at least 1 PD parameter. Here 'n' signifies participants evaluable for this measure at specified time point for each arm group, respectively.

ArmMeasureGroupValue (MEAN)Dispersion
PF-04937319 10 mgChange From Baseline in Lactate Level at Day 6 and 14Change at Day 6 (n=9,9,9,9,7,15)-2.44 mg/dLStandard Deviation 7.95
PF-04937319 10 mgChange From Baseline in Lactate Level at Day 6 and 14Baseline (n=9,9,9,9,9,16)17.64 mg/dLStandard Deviation 5.14
PF-04937319 10 mgChange From Baseline in Lactate Level at Day 6 and 14Change at Day 14 (n=8,9,9,9,7,15)0.21 mg/dLStandard Deviation 3.07
PF-04937319 30 mgChange From Baseline in Lactate Level at Day 6 and 14Change at Day 6 (n=9,9,9,9,7,15)1.02 mg/dLStandard Deviation 1.77
PF-04937319 30 mgChange From Baseline in Lactate Level at Day 6 and 14Baseline (n=9,9,9,9,9,16)10.17 mg/dLStandard Deviation 3.07
PF-04937319 30 mgChange From Baseline in Lactate Level at Day 6 and 14Change at Day 14 (n=8,9,9,9,7,15)-0.09 mg/dLStandard Deviation 2.02
PF-04937319 50 mgChange From Baseline in Lactate Level at Day 6 and 14Change at Day 6 (n=9,9,9,9,7,15)-2.08 mg/dLStandard Deviation 7.14
PF-04937319 50 mgChange From Baseline in Lactate Level at Day 6 and 14Baseline (n=9,9,9,9,9,16)14.14 mg/dLStandard Deviation 7.82
PF-04937319 50 mgChange From Baseline in Lactate Level at Day 6 and 14Change at Day 14 (n=8,9,9,9,7,15)-3.88 mg/dLStandard Deviation 6.63
PF-04937319 100 mgChange From Baseline in Lactate Level at Day 6 and 14Change at Day 6 (n=9,9,9,9,7,15)-6.08 mg/dLStandard Deviation 10.72
PF-04937319 100 mgChange From Baseline in Lactate Level at Day 6 and 14Baseline (n=9,9,9,9,9,16)21.66 mg/dLStandard Deviation 9.45
PF-04937319 100 mgChange From Baseline in Lactate Level at Day 6 and 14Change at Day 14 (n=8,9,9,9,7,15)-6.97 mg/dLStandard Deviation 10.42
PF-04937319 300 mgChange From Baseline in Lactate Level at Day 6 and 14Change at Day 6 (n=9,9,9,9,7,15)2.61 mg/dLStandard Deviation 6.6
PF-04937319 300 mgChange From Baseline in Lactate Level at Day 6 and 14Baseline (n=9,9,9,9,9,16)11.57 mg/dLStandard Deviation 4.3
PF-04937319 300 mgChange From Baseline in Lactate Level at Day 6 and 14Change at Day 14 (n=8,9,9,9,7,15)2.60 mg/dLStandard Deviation 2.98
PlaceboChange From Baseline in Lactate Level at Day 6 and 14Baseline (n=9,9,9,9,9,16)14.74 mg/dLStandard Deviation 8.58
PlaceboChange From Baseline in Lactate Level at Day 6 and 14Change at Day 14 (n=8,9,9,9,7,15)-2.59 mg/dLStandard Deviation 8.67
PlaceboChange From Baseline in Lactate Level at Day 6 and 14Change at Day 6 (n=9,9,9,9,7,15)-1.45 mg/dLStandard Deviation 9.27
Secondary

Change From Baseline in Low Density Lipoprotein-Cholesterol (LDL-C) Level at Day 3, 6, 10, 14, 16 and Follow-up

Blood sample for lipid biomarker was taken following 12-hours fasting. Baseline value was collected on Day -2 for lipids.

Time frame: Baseline (Day -2), Day 3, 6, 10, 14, 16 and Follow-up (7 to 14 days after last dose of study medication)

Population: PD analysis population included all enrolled participants who received at least 1 dose of study medication and had at least 1 PD parameter. Here 'n' signifies participants evaluable for this measure at specified time point for each arm group, respectively.

ArmMeasureGroupValue (MEAN)Dispersion
PF-04937319 10 mgChange From Baseline in Low Density Lipoprotein-Cholesterol (LDL-C) Level at Day 3, 6, 10, 14, 16 and Follow-upChange at Day 14 (n=8,9,9,9,7,15)-17.13 mg/dLStandard Deviation 21.14
PF-04937319 10 mgChange From Baseline in Low Density Lipoprotein-Cholesterol (LDL-C) Level at Day 3, 6, 10, 14, 16 and Follow-upChange at Day 6 (n=9,9,9,9,7,15)-8.78 mg/dLStandard Deviation 23.21
PF-04937319 10 mgChange From Baseline in Low Density Lipoprotein-Cholesterol (LDL-C) Level at Day 3, 6, 10, 14, 16 and Follow-upChange at Follow-up (n=9,8,9,9,7,16)-6.22 mg/dLStandard Deviation 24.4
PF-04937319 10 mgChange From Baseline in Low Density Lipoprotein-Cholesterol (LDL-C) Level at Day 3, 6, 10, 14, 16 and Follow-upBaseline (n=9,9,9,9,9,16)116.67 mg/dLStandard Deviation 37.41
PF-04937319 10 mgChange From Baseline in Low Density Lipoprotein-Cholesterol (LDL-C) Level at Day 3, 6, 10, 14, 16 and Follow-upChange at Day 3 (n=9,9,9,9,9,16)-19.22 mg/dLStandard Deviation 22.22
PF-04937319 10 mgChange From Baseline in Low Density Lipoprotein-Cholesterol (LDL-C) Level at Day 3, 6, 10, 14, 16 and Follow-upChange at Day 16 (n=8,9,9,9,7,14)-17.88 mg/dLStandard Deviation 22.22
PF-04937319 10 mgChange From Baseline in Low Density Lipoprotein-Cholesterol (LDL-C) Level at Day 3, 6, 10, 14, 16 and Follow-upChange at Day 10 (n=8,9,9,9,7,15)-19.00 mg/dLStandard Deviation 24.94
PF-04937319 30 mgChange From Baseline in Low Density Lipoprotein-Cholesterol (LDL-C) Level at Day 3, 6, 10, 14, 16 and Follow-upChange at Day 14 (n=8,9,9,9,7,15)-22.44 mg/dLStandard Deviation 16.49
PF-04937319 30 mgChange From Baseline in Low Density Lipoprotein-Cholesterol (LDL-C) Level at Day 3, 6, 10, 14, 16 and Follow-upChange at Day 10 (n=8,9,9,9,7,15)-11.44 mg/dLStandard Deviation 16.84
PF-04937319 30 mgChange From Baseline in Low Density Lipoprotein-Cholesterol (LDL-C) Level at Day 3, 6, 10, 14, 16 and Follow-upChange at Follow-up (n=9,8,9,9,7,16)-10.38 mg/dLStandard Deviation 15.15
PF-04937319 30 mgChange From Baseline in Low Density Lipoprotein-Cholesterol (LDL-C) Level at Day 3, 6, 10, 14, 16 and Follow-upChange at Day 3 (n=9,9,9,9,9,16)-5.89 mg/dLStandard Deviation 19.37
PF-04937319 30 mgChange From Baseline in Low Density Lipoprotein-Cholesterol (LDL-C) Level at Day 3, 6, 10, 14, 16 and Follow-upBaseline (n=9,9,9,9,9,16)133.56 mg/dLStandard Deviation 43.47
PF-04937319 30 mgChange From Baseline in Low Density Lipoprotein-Cholesterol (LDL-C) Level at Day 3, 6, 10, 14, 16 and Follow-upChange at Day 6 (n=9,9,9,9,7,15)-20.44 mg/dLStandard Deviation 22.32
PF-04937319 30 mgChange From Baseline in Low Density Lipoprotein-Cholesterol (LDL-C) Level at Day 3, 6, 10, 14, 16 and Follow-upChange at Day 16 (n=8,9,9,9,7,14)-15.00 mg/dLStandard Deviation 14.11
PF-04937319 50 mgChange From Baseline in Low Density Lipoprotein-Cholesterol (LDL-C) Level at Day 3, 6, 10, 14, 16 and Follow-upChange at Day 6 (n=9,9,9,9,7,15)-13.67 mg/dLStandard Deviation 14.74
PF-04937319 50 mgChange From Baseline in Low Density Lipoprotein-Cholesterol (LDL-C) Level at Day 3, 6, 10, 14, 16 and Follow-upBaseline (n=9,9,9,9,9,16)123.44 mg/dLStandard Deviation 35.72
PF-04937319 50 mgChange From Baseline in Low Density Lipoprotein-Cholesterol (LDL-C) Level at Day 3, 6, 10, 14, 16 and Follow-upChange at Day 3 (n=9,9,9,9,9,16)-6.89 mg/dLStandard Deviation 15.26
PF-04937319 50 mgChange From Baseline in Low Density Lipoprotein-Cholesterol (LDL-C) Level at Day 3, 6, 10, 14, 16 and Follow-upChange at Day 10 (n=8,9,9,9,7,15)-30.89 mg/dLStandard Deviation 14.08
PF-04937319 50 mgChange From Baseline in Low Density Lipoprotein-Cholesterol (LDL-C) Level at Day 3, 6, 10, 14, 16 and Follow-upChange at Day 14 (n=8,9,9,9,7,15)-19.89 mg/dLStandard Deviation 14.68
PF-04937319 50 mgChange From Baseline in Low Density Lipoprotein-Cholesterol (LDL-C) Level at Day 3, 6, 10, 14, 16 and Follow-upChange at Day 16 (n=8,9,9,9,7,14)-20.22 mg/dLStandard Deviation 16.75
PF-04937319 50 mgChange From Baseline in Low Density Lipoprotein-Cholesterol (LDL-C) Level at Day 3, 6, 10, 14, 16 and Follow-upChange at Follow-up (n=9,8,9,9,7,16)-27.11 mg/dLStandard Deviation 22.05
PF-04937319 100 mgChange From Baseline in Low Density Lipoprotein-Cholesterol (LDL-C) Level at Day 3, 6, 10, 14, 16 and Follow-upBaseline (n=9,9,9,9,9,16)130.67 mg/dLStandard Deviation 33.83
PF-04937319 100 mgChange From Baseline in Low Density Lipoprotein-Cholesterol (LDL-C) Level at Day 3, 6, 10, 14, 16 and Follow-upChange at Day 3 (n=9,9,9,9,9,16)-6.67 mg/dLStandard Deviation 19.46
PF-04937319 100 mgChange From Baseline in Low Density Lipoprotein-Cholesterol (LDL-C) Level at Day 3, 6, 10, 14, 16 and Follow-upChange at Day 6 (n=9,9,9,9,7,15)-2.33 mg/dLStandard Deviation 22.11
PF-04937319 100 mgChange From Baseline in Low Density Lipoprotein-Cholesterol (LDL-C) Level at Day 3, 6, 10, 14, 16 and Follow-upChange at Day 10 (n=8,9,9,9,7,15)-7.89 mg/dLStandard Deviation 17.92
PF-04937319 100 mgChange From Baseline in Low Density Lipoprotein-Cholesterol (LDL-C) Level at Day 3, 6, 10, 14, 16 and Follow-upChange at Day 14 (n=8,9,9,9,7,15)-11.56 mg/dLStandard Deviation 17.92
PF-04937319 100 mgChange From Baseline in Low Density Lipoprotein-Cholesterol (LDL-C) Level at Day 3, 6, 10, 14, 16 and Follow-upChange at Day 16 (n=8,9,9,9,7,14)-0.67 mg/dLStandard Deviation 16.86
PF-04937319 100 mgChange From Baseline in Low Density Lipoprotein-Cholesterol (LDL-C) Level at Day 3, 6, 10, 14, 16 and Follow-upChange at Follow-up (n=9,8,9,9,7,16)-19.78 mg/dLStandard Deviation 22.97
PF-04937319 300 mgChange From Baseline in Low Density Lipoprotein-Cholesterol (LDL-C) Level at Day 3, 6, 10, 14, 16 and Follow-upChange at Day 3 (n=9,9,9,9,9,16)-11.00 mg/dLStandard Deviation 23.51
PF-04937319 300 mgChange From Baseline in Low Density Lipoprotein-Cholesterol (LDL-C) Level at Day 3, 6, 10, 14, 16 and Follow-upChange at Follow-up (n=9,8,9,9,7,16)-17.43 mg/dLStandard Deviation 16.7
PF-04937319 300 mgChange From Baseline in Low Density Lipoprotein-Cholesterol (LDL-C) Level at Day 3, 6, 10, 14, 16 and Follow-upChange at Day 6 (n=9,9,9,9,7,15)-0.29 mg/dLStandard Deviation 38.98
PF-04937319 300 mgChange From Baseline in Low Density Lipoprotein-Cholesterol (LDL-C) Level at Day 3, 6, 10, 14, 16 and Follow-upBaseline (n=9,9,9,9,9,16)96.11 mg/dLStandard Deviation 37.88
PF-04937319 300 mgChange From Baseline in Low Density Lipoprotein-Cholesterol (LDL-C) Level at Day 3, 6, 10, 14, 16 and Follow-upChange at Day 10 (n=8,9,9,9,7,15)-9.57 mg/dLStandard Deviation 35.69
PF-04937319 300 mgChange From Baseline in Low Density Lipoprotein-Cholesterol (LDL-C) Level at Day 3, 6, 10, 14, 16 and Follow-upChange at Day 16 (n=8,9,9,9,7,14)-3.86 mg/dLStandard Deviation 38.21
PF-04937319 300 mgChange From Baseline in Low Density Lipoprotein-Cholesterol (LDL-C) Level at Day 3, 6, 10, 14, 16 and Follow-upChange at Day 14 (n=8,9,9,9,7,15)-1.00 mg/dLStandard Deviation 38.18
PlaceboChange From Baseline in Low Density Lipoprotein-Cholesterol (LDL-C) Level at Day 3, 6, 10, 14, 16 and Follow-upChange at Day 16 (n=8,9,9,9,7,14)5.79 mg/dLStandard Deviation 27.5
PlaceboChange From Baseline in Low Density Lipoprotein-Cholesterol (LDL-C) Level at Day 3, 6, 10, 14, 16 and Follow-upChange at Day 14 (n=8,9,9,9,7,15)4.80 mg/dLStandard Deviation 30.59
PlaceboChange From Baseline in Low Density Lipoprotein-Cholesterol (LDL-C) Level at Day 3, 6, 10, 14, 16 and Follow-upChange at Day 3 (n=9,9,9,9,9,16)-3.63 mg/dLStandard Deviation 14.8
PlaceboChange From Baseline in Low Density Lipoprotein-Cholesterol (LDL-C) Level at Day 3, 6, 10, 14, 16 and Follow-upChange at Day 6 (n=9,9,9,9,7,15)2.73 mg/dLStandard Deviation 20.35
PlaceboChange From Baseline in Low Density Lipoprotein-Cholesterol (LDL-C) Level at Day 3, 6, 10, 14, 16 and Follow-upBaseline (n=9,9,9,9,9,16)102.44 mg/dLStandard Deviation 31.64
PlaceboChange From Baseline in Low Density Lipoprotein-Cholesterol (LDL-C) Level at Day 3, 6, 10, 14, 16 and Follow-upChange at Follow-up (n=9,8,9,9,7,16)-2.25 mg/dLStandard Deviation 23.61
PlaceboChange From Baseline in Low Density Lipoprotein-Cholesterol (LDL-C) Level at Day 3, 6, 10, 14, 16 and Follow-upChange at Day 10 (n=8,9,9,9,7,15)5.07 mg/dLStandard Deviation 24.99
Secondary

Change From Baseline in Total Cholesterol (TC) Level at Day 3, 6, 10, 14, 16 and Follow-up

Blood sample for lipid biomarker was taken following 12-hours fasting. Baseline value was collected on Day -2 for lipids.

Time frame: Baseline (Day -2), Day 3, 6, 10, 14, 16 and Follow-up (7 to 14 days after last dose of study medication)

Population: PD analysis population included all enrolled participants who received at least 1 dose of study medication and had at least 1 PD parameter. Here 'n' signifies participants evaluable for this measure at specified time point for each arm group, respectively.

ArmMeasureGroupValue (MEAN)Dispersion
PF-04937319 10 mgChange From Baseline in Total Cholesterol (TC) Level at Day 3, 6, 10, 14, 16 and Follow-upChange at Day 10 (n=8,9,9,9,7,15)-30.00 mg/dLStandard Deviation 24.51
PF-04937319 10 mgChange From Baseline in Total Cholesterol (TC) Level at Day 3, 6, 10, 14, 16 and Follow-upChange at Follow-up (n=9,9,9,9,7,16)-19.44 mg/dLStandard Deviation 25.73
PF-04937319 10 mgChange From Baseline in Total Cholesterol (TC) Level at Day 3, 6, 10, 14, 16 and Follow-upChange at Day 16 (n=8,9,9,9,7,14)-26.38 mg/dLStandard Deviation 26.72
PF-04937319 10 mgChange From Baseline in Total Cholesterol (TC) Level at Day 3, 6, 10, 14, 16 and Follow-upBaseline (n=9,9,9,9,9,16)200.56 mg/dLStandard Deviation 34.32
PF-04937319 10 mgChange From Baseline in Total Cholesterol (TC) Level at Day 3, 6, 10, 14, 16 and Follow-upChange at Day 14 (n=8,9,9,9,7,15)-31.50 mg/dLStandard Deviation 21.08
PF-04937319 10 mgChange From Baseline in Total Cholesterol (TC) Level at Day 3, 6, 10, 14, 16 and Follow-upChange at Day 6 (n=9,9,9,9,7,15)-19.11 mg/dLStandard Deviation 20.95
PF-04937319 10 mgChange From Baseline in Total Cholesterol (TC) Level at Day 3, 6, 10, 14, 16 and Follow-upChange at Day 3 (n=9,9,9,9,9,16)-24.00 mg/dLStandard Deviation 17.21
PF-04937319 30 mgChange From Baseline in Total Cholesterol (TC) Level at Day 3, 6, 10, 14, 16 and Follow-upChange at Day 6 (n=9,9,9,9,7,15)-25.11 mg/dLStandard Deviation 19.47
PF-04937319 30 mgChange From Baseline in Total Cholesterol (TC) Level at Day 3, 6, 10, 14, 16 and Follow-upChange at Day 10 (n=8,9,9,9,7,15)-14.67 mg/dLStandard Deviation 14.4
PF-04937319 30 mgChange From Baseline in Total Cholesterol (TC) Level at Day 3, 6, 10, 14, 16 and Follow-upChange at Follow-up (n=9,9,9,9,7,16)-12.44 mg/dLStandard Deviation 24.7
PF-04937319 30 mgChange From Baseline in Total Cholesterol (TC) Level at Day 3, 6, 10, 14, 16 and Follow-upChange at Day 3 (n=9,9,9,9,9,16)-9.33 mg/dLStandard Deviation 13.46
PF-04937319 30 mgChange From Baseline in Total Cholesterol (TC) Level at Day 3, 6, 10, 14, 16 and Follow-upChange at Day 14 (n=8,9,9,9,7,15)-29.11 mg/dLStandard Deviation 14.42
PF-04937319 30 mgChange From Baseline in Total Cholesterol (TC) Level at Day 3, 6, 10, 14, 16 and Follow-upChange at Day 16 (n=8,9,9,9,7,14)-22.11 mg/dLStandard Deviation 13.6
PF-04937319 30 mgChange From Baseline in Total Cholesterol (TC) Level at Day 3, 6, 10, 14, 16 and Follow-upBaseline (n=9,9,9,9,9,16)207.33 mg/dLStandard Deviation 41.11
PF-04937319 50 mgChange From Baseline in Total Cholesterol (TC) Level at Day 3, 6, 10, 14, 16 and Follow-upChange at Follow-up (n=9,9,9,9,7,16)-29.44 mg/dLStandard Deviation 27.13
PF-04937319 50 mgChange From Baseline in Total Cholesterol (TC) Level at Day 3, 6, 10, 14, 16 and Follow-upChange at Day 3 (n=9,9,9,9,9,16)-14.22 mg/dLStandard Deviation 16.93
PF-04937319 50 mgChange From Baseline in Total Cholesterol (TC) Level at Day 3, 6, 10, 14, 16 and Follow-upChange at Day 6 (n=9,9,9,9,7,15)-20.78 mg/dLStandard Deviation 19.39
PF-04937319 50 mgChange From Baseline in Total Cholesterol (TC) Level at Day 3, 6, 10, 14, 16 and Follow-upChange at Day 10 (n=8,9,9,9,7,15)-30.89 mg/dLStandard Deviation 17.41
PF-04937319 50 mgChange From Baseline in Total Cholesterol (TC) Level at Day 3, 6, 10, 14, 16 and Follow-upBaseline (n=9,9,9,9,9,16)205.00 mg/dLStandard Deviation 50.52
PF-04937319 50 mgChange From Baseline in Total Cholesterol (TC) Level at Day 3, 6, 10, 14, 16 and Follow-upChange at Day 14 (n=8,9,9,9,7,15)-27.44 mg/dLStandard Deviation 17.08
PF-04937319 50 mgChange From Baseline in Total Cholesterol (TC) Level at Day 3, 6, 10, 14, 16 and Follow-upChange at Day 16 (n=8,9,9,9,7,14)-29.11 mg/dLStandard Deviation 20.26
PF-04937319 100 mgChange From Baseline in Total Cholesterol (TC) Level at Day 3, 6, 10, 14, 16 and Follow-upChange at Day 3 (n=9,9,9,9,9,16)-16.33 mg/dLStandard Deviation 18.33
PF-04937319 100 mgChange From Baseline in Total Cholesterol (TC) Level at Day 3, 6, 10, 14, 16 and Follow-upChange at Follow-up (n=9,9,9,9,7,16)-33.56 mg/dLStandard Deviation 40.73
PF-04937319 100 mgChange From Baseline in Total Cholesterol (TC) Level at Day 3, 6, 10, 14, 16 and Follow-upChange at Day 16 (n=8,9,9,9,7,14)-12.11 mg/dLStandard Deviation 24.49
PF-04937319 100 mgChange From Baseline in Total Cholesterol (TC) Level at Day 3, 6, 10, 14, 16 and Follow-upChange at Day 6 (n=9,9,9,9,7,15)-11.33 mg/dLStandard Deviation 21.17
PF-04937319 100 mgChange From Baseline in Total Cholesterol (TC) Level at Day 3, 6, 10, 14, 16 and Follow-upBaseline (n=9,9,9,9,9,16)213.22 mg/dLStandard Deviation 53.38
PF-04937319 100 mgChange From Baseline in Total Cholesterol (TC) Level at Day 3, 6, 10, 14, 16 and Follow-upChange at Day 10 (n=8,9,9,9,7,15)-15.11 mg/dLStandard Deviation 20.76
PF-04937319 100 mgChange From Baseline in Total Cholesterol (TC) Level at Day 3, 6, 10, 14, 16 and Follow-upChange at Day 14 (n=8,9,9,9,7,15)-24.22 mg/dLStandard Deviation 25.73
PF-04937319 300 mgChange From Baseline in Total Cholesterol (TC) Level at Day 3, 6, 10, 14, 16 and Follow-upChange at Day 3 (n=9,9,9,9,9,16)-11.56 mg/dLStandard Deviation 31.13
PF-04937319 300 mgChange From Baseline in Total Cholesterol (TC) Level at Day 3, 6, 10, 14, 16 and Follow-upBaseline (n=9,9,9,9,9,16)170.22 mg/dLStandard Deviation 41.37
PF-04937319 300 mgChange From Baseline in Total Cholesterol (TC) Level at Day 3, 6, 10, 14, 16 and Follow-upChange at Day 10 (n=8,9,9,9,7,15)-2.29 mg/dLStandard Deviation 41.43
PF-04937319 300 mgChange From Baseline in Total Cholesterol (TC) Level at Day 3, 6, 10, 14, 16 and Follow-upChange at Day 14 (n=8,9,9,9,7,15)1.29 mg/dLStandard Deviation 41.63
PF-04937319 300 mgChange From Baseline in Total Cholesterol (TC) Level at Day 3, 6, 10, 14, 16 and Follow-upChange at Day 16 (n=8,9,9,9,7,14)1.86 mg/dLStandard Deviation 45.05
PF-04937319 300 mgChange From Baseline in Total Cholesterol (TC) Level at Day 3, 6, 10, 14, 16 and Follow-upChange at Day 6 (n=9,9,9,9,7,15)0.00 mg/dLStandard Deviation 42.9
PF-04937319 300 mgChange From Baseline in Total Cholesterol (TC) Level at Day 3, 6, 10, 14, 16 and Follow-upChange at Follow-up (n=9,9,9,9,7,16)-15.29 mg/dLStandard Deviation 8.24
PlaceboChange From Baseline in Total Cholesterol (TC) Level at Day 3, 6, 10, 14, 16 and Follow-upChange at Follow-up (n=9,9,9,9,7,16)-5.50 mg/dLStandard Deviation 29.57
PlaceboChange From Baseline in Total Cholesterol (TC) Level at Day 3, 6, 10, 14, 16 and Follow-upChange at Day 6 (n=9,9,9,9,7,15)-6.47 mg/dLStandard Deviation 26.19
PlaceboChange From Baseline in Total Cholesterol (TC) Level at Day 3, 6, 10, 14, 16 and Follow-upChange at Day 10 (n=8,9,9,9,7,15)0.33 mg/dLStandard Deviation 30
PlaceboChange From Baseline in Total Cholesterol (TC) Level at Day 3, 6, 10, 14, 16 and Follow-upChange at Day 3 (n=9,9,9,9,9,16)-7.50 mg/dLStandard Deviation 18.4
PlaceboChange From Baseline in Total Cholesterol (TC) Level at Day 3, 6, 10, 14, 16 and Follow-upBaseline (n=9,9,9,9,9,16)181.94 mg/dLStandard Deviation 34.45
PlaceboChange From Baseline in Total Cholesterol (TC) Level at Day 3, 6, 10, 14, 16 and Follow-upChange at Day 16 (n=8,9,9,9,7,14)-1.43 mg/dLStandard Deviation 32.9
PlaceboChange From Baseline in Total Cholesterol (TC) Level at Day 3, 6, 10, 14, 16 and Follow-upChange at Day 14 (n=8,9,9,9,7,15)-6.60 mg/dLStandard Deviation 37.37
Secondary

Change From Baseline in Triglyceride (TG) Level at Day 3, 6, 10, 14, 16 and Follow-up

Blood sample for lipid biomarker was taken following 12-hours fasting. Baseline value was collected on Day -2 for lipids.

Time frame: Baseline (Day -2), Day 3, 6, 10, 14, 16 and Follow-up (7 to 14 days after last dose of study medication)

Population: PD analysis population included all enrolled participants who received at least 1 dose of study medication and had at least 1 PD parameter. Here 'n' signifies participants evaluable for this measure at specified time point for each arm group, respectively.

ArmMeasureGroupValue (MEAN)Dispersion
PF-04937319 10 mgChange From Baseline in Triglyceride (TG) Level at Day 3, 6, 10, 14, 16 and Follow-upChange at Follow-up (n=9,9,9,9,7,16)-41.22 mg/dLStandard Deviation 73.73
PF-04937319 10 mgChange From Baseline in Triglyceride (TG) Level at Day 3, 6, 10, 14, 16 and Follow-upChange at Day 14 (n=8,9,9,9,7,15)-19.25 mg/dLStandard Deviation 76.2
PF-04937319 10 mgChange From Baseline in Triglyceride (TG) Level at Day 3, 6, 10, 14, 16 and Follow-upChange at Day 3 (n=9,9,9,9,9,16)-5.89 mg/dLStandard Deviation 82.19
PF-04937319 10 mgChange From Baseline in Triglyceride (TG) Level at Day 3, 6, 10, 14, 16 and Follow-upChange at Day 16 (n=8,9,9,9,7,14)13.25 mg/dLStandard Deviation 108.99
PF-04937319 10 mgChange From Baseline in Triglyceride (TG) Level at Day 3, 6, 10, 14, 16 and Follow-upBaseline (n=9,9,9,9,9,16)178.89 mg/dLStandard Deviation 63.21
PF-04937319 10 mgChange From Baseline in Triglyceride (TG) Level at Day 3, 6, 10, 14, 16 and Follow-upChange at Day 6 (n=9,9,9,9,7,15)-32.00 mg/dLStandard Deviation 70.4
PF-04937319 10 mgChange From Baseline in Triglyceride (TG) Level at Day 3, 6, 10, 14, 16 and Follow-upChange at Day 10 (n=8,9,9,9,7,15)-16.88 mg/dLStandard Deviation 58.15
PF-04937319 30 mgChange From Baseline in Triglyceride (TG) Level at Day 3, 6, 10, 14, 16 and Follow-upChange at Day 3 (n=9,9,9,9,9,16)1.67 mg/dLStandard Deviation 63.16
PF-04937319 30 mgChange From Baseline in Triglyceride (TG) Level at Day 3, 6, 10, 14, 16 and Follow-upChange at Day 10 (n=8,9,9,9,7,15)1.78 mg/dLStandard Deviation 66.28
PF-04937319 30 mgChange From Baseline in Triglyceride (TG) Level at Day 3, 6, 10, 14, 16 and Follow-upBaseline (n=9,9,9,9,9,16)152.33 mg/dLStandard Deviation 43.88
PF-04937319 30 mgChange From Baseline in Triglyceride (TG) Level at Day 3, 6, 10, 14, 16 and Follow-upChange at Day 6 (n=9,9,9,9,7,15)-1.33 mg/dLStandard Deviation 65.02
PF-04937319 30 mgChange From Baseline in Triglyceride (TG) Level at Day 3, 6, 10, 14, 16 and Follow-upChange at Day 14 (n=8,9,9,9,7,15)-4.44 mg/dLStandard Deviation 65.79
PF-04937319 30 mgChange From Baseline in Triglyceride (TG) Level at Day 3, 6, 10, 14, 16 and Follow-upChange at Day 16 (n=8,9,9,9,7,14)-6.67 mg/dLStandard Deviation 80.27
PF-04937319 30 mgChange From Baseline in Triglyceride (TG) Level at Day 3, 6, 10, 14, 16 and Follow-upChange at Follow-up (n=9,9,9,9,7,16)38.78 mg/dLStandard Deviation 163.3
PF-04937319 50 mgChange From Baseline in Triglyceride (TG) Level at Day 3, 6, 10, 14, 16 and Follow-upChange at Day 3 (n=9,9,9,9,9,16)-44.44 mg/dLStandard Deviation 45.88
PF-04937319 50 mgChange From Baseline in Triglyceride (TG) Level at Day 3, 6, 10, 14, 16 and Follow-upChange at Follow-up (n=9,9,9,9,7,16)4.56 mg/dLStandard Deviation 73.52
PF-04937319 50 mgChange From Baseline in Triglyceride (TG) Level at Day 3, 6, 10, 14, 16 and Follow-upChange at Day 10 (n=8,9,9,9,7,15)-6.44 mg/dLStandard Deviation 59.39
PF-04937319 50 mgChange From Baseline in Triglyceride (TG) Level at Day 3, 6, 10, 14, 16 and Follow-upChange at Day 16 (n=8,9,9,9,7,14)-36.22 mg/dLStandard Deviation 50.27
PF-04937319 50 mgChange From Baseline in Triglyceride (TG) Level at Day 3, 6, 10, 14, 16 and Follow-upChange at Day 14 (n=8,9,9,9,7,15)-37.33 mg/dLStandard Deviation 48.75
PF-04937319 50 mgChange From Baseline in Triglyceride (TG) Level at Day 3, 6, 10, 14, 16 and Follow-upChange at Day 6 (n=9,9,9,9,7,15)-40.44 mg/dLStandard Deviation 50.85
PF-04937319 50 mgChange From Baseline in Triglyceride (TG) Level at Day 3, 6, 10, 14, 16 and Follow-upBaseline (n=9,9,9,9,9,16)175.56 mg/dLStandard Deviation 53.32
PF-04937319 100 mgChange From Baseline in Triglyceride (TG) Level at Day 3, 6, 10, 14, 16 and Follow-upChange at Day 3 (n=9,9,9,9,9,16)-25.44 mg/dLStandard Deviation 59.99
PF-04937319 100 mgChange From Baseline in Triglyceride (TG) Level at Day 3, 6, 10, 14, 16 and Follow-upBaseline (n=9,9,9,9,9,16)192.78 mg/dLStandard Deviation 91.62
PF-04937319 100 mgChange From Baseline in Triglyceride (TG) Level at Day 3, 6, 10, 14, 16 and Follow-upChange at Day 6 (n=9,9,9,9,7,15)-29.00 mg/dLStandard Deviation 62.9
PF-04937319 100 mgChange From Baseline in Triglyceride (TG) Level at Day 3, 6, 10, 14, 16 and Follow-upChange at Day 10 (n=8,9,9,9,7,15)-13.56 mg/dLStandard Deviation 51.83
PF-04937319 100 mgChange From Baseline in Triglyceride (TG) Level at Day 3, 6, 10, 14, 16 and Follow-upChange at Day 14 (n=8,9,9,9,7,15)-40.33 mg/dLStandard Deviation 55.72
PF-04937319 100 mgChange From Baseline in Triglyceride (TG) Level at Day 3, 6, 10, 14, 16 and Follow-upChange at Day 16 (n=8,9,9,9,7,14)-35.33 mg/dLStandard Deviation 53.61
PF-04937319 100 mgChange From Baseline in Triglyceride (TG) Level at Day 3, 6, 10, 14, 16 and Follow-upChange at Follow-up (n=9,9,9,9,7,16)-45.44 mg/dLStandard Deviation 120.43
PF-04937319 300 mgChange From Baseline in Triglyceride (TG) Level at Day 3, 6, 10, 14, 16 and Follow-upChange at Day 16 (n=8,9,9,9,7,14)23.57 mg/dLStandard Deviation 50.04
PF-04937319 300 mgChange From Baseline in Triglyceride (TG) Level at Day 3, 6, 10, 14, 16 and Follow-upChange at Day 10 (n=8,9,9,9,7,15)30.71 mg/dLStandard Deviation 43.77
PF-04937319 300 mgChange From Baseline in Triglyceride (TG) Level at Day 3, 6, 10, 14, 16 and Follow-upChange at Follow-up (n=9,9,9,9,7,16)22.29 mg/dLStandard Deviation 57.79
PF-04937319 300 mgChange From Baseline in Triglyceride (TG) Level at Day 3, 6, 10, 14, 16 and Follow-upChange at Day 6 (n=9,9,9,9,7,15)13.14 mg/dLStandard Deviation 51.5
PF-04937319 300 mgChange From Baseline in Triglyceride (TG) Level at Day 3, 6, 10, 14, 16 and Follow-upChange at Day 3 (n=9,9,9,9,9,16)0.22 mg/dLStandard Deviation 42.4
PF-04937319 300 mgChange From Baseline in Triglyceride (TG) Level at Day 3, 6, 10, 14, 16 and Follow-upBaseline (n=9,9,9,9,9,16)123.33 mg/dLStandard Deviation 47.89
PF-04937319 300 mgChange From Baseline in Triglyceride (TG) Level at Day 3, 6, 10, 14, 16 and Follow-upChange at Day 14 (n=8,9,9,9,7,15)15.57 mg/dLStandard Deviation 38.25
PlaceboChange From Baseline in Triglyceride (TG) Level at Day 3, 6, 10, 14, 16 and Follow-upBaseline (n=9,9,9,9,9,16)152.31 mg/dLStandard Deviation 70.46
PlaceboChange From Baseline in Triglyceride (TG) Level at Day 3, 6, 10, 14, 16 and Follow-upChange at Day 10 (n=8,9,9,9,7,15)2.13 mg/dLStandard Deviation 46.04
PlaceboChange From Baseline in Triglyceride (TG) Level at Day 3, 6, 10, 14, 16 and Follow-upChange at Day 3 (n=9,9,9,9,9,16)0.88 mg/dLStandard Deviation 47.31
PlaceboChange From Baseline in Triglyceride (TG) Level at Day 3, 6, 10, 14, 16 and Follow-upChange at Day 6 (n=9,9,9,9,7,15)-14.67 mg/dLStandard Deviation 51.85
PlaceboChange From Baseline in Triglyceride (TG) Level at Day 3, 6, 10, 14, 16 and Follow-upChange at Day 16 (n=8,9,9,9,7,14)-19.07 mg/dLStandard Deviation 47.96
PlaceboChange From Baseline in Triglyceride (TG) Level at Day 3, 6, 10, 14, 16 and Follow-upChange at Day 14 (n=8,9,9,9,7,15)-21.67 mg/dLStandard Deviation 44.03
PlaceboChange From Baseline in Triglyceride (TG) Level at Day 3, 6, 10, 14, 16 and Follow-upChange at Follow-up (n=9,9,9,9,7,16)1.94 mg/dLStandard Deviation 52.43
Secondary

Percent Change From Baseline in C-peptide Area Under the Curve From Time 2 to 6 Hours (AUC [2-6]) After a Mixed Meal Tolerance Test (MMTT) at Day 1 and 14

Percent change from baseline in area under the plasma C-peptide concentration-time curve as determined by standardized MMTT. Linear trapezoidal method was used to compute AUC. Baseline value was the AUC (2-6) calculated on Day -1.

Time frame: -46, -45.75, -45.5, -45, -44.5, -44, -43, -42 hrs pre-dose on Day -1; 2, 2.25, 2.5, 3, 3.5, 4, 5, 6 hrs post-dose on Day 1 and 14 (fasted condition)

Population: PD analysis population included all enrolled participants who received at least 1 dose of study medication and had at least 1 PD parameter. Here 'n' signifies participants evaluable for this measure at specified time point for each arm group, respectively.

ArmMeasureGroupValue (MEAN)Dispersion
PF-04937319 10 mgPercent Change From Baseline in C-peptide Area Under the Curve From Time 2 to 6 Hours (AUC [2-6]) After a Mixed Meal Tolerance Test (MMTT) at Day 1 and 14Percent Change at Day 1 (n=9,9,9,9,9,16)-2.36 percent changeStandard Deviation 10.17
PF-04937319 10 mgPercent Change From Baseline in C-peptide Area Under the Curve From Time 2 to 6 Hours (AUC [2-6]) After a Mixed Meal Tolerance Test (MMTT) at Day 1 and 14Percent Change at Day 14 (n=8,9,9,9,7,15)8.66 percent changeStandard Deviation 11.069
PF-04937319 30 mgPercent Change From Baseline in C-peptide Area Under the Curve From Time 2 to 6 Hours (AUC [2-6]) After a Mixed Meal Tolerance Test (MMTT) at Day 1 and 14Percent Change at Day 1 (n=9,9,9,9,9,16)8.53 percent changeStandard Deviation 13.383
PF-04937319 30 mgPercent Change From Baseline in C-peptide Area Under the Curve From Time 2 to 6 Hours (AUC [2-6]) After a Mixed Meal Tolerance Test (MMTT) at Day 1 and 14Percent Change at Day 14 (n=8,9,9,9,7,15)13.49 percent changeStandard Deviation 14.403
PF-04937319 50 mgPercent Change From Baseline in C-peptide Area Under the Curve From Time 2 to 6 Hours (AUC [2-6]) After a Mixed Meal Tolerance Test (MMTT) at Day 1 and 14Percent Change at Day 1 (n=9,9,9,9,9,16)12.65 percent changeStandard Deviation 9.974
PF-04937319 50 mgPercent Change From Baseline in C-peptide Area Under the Curve From Time 2 to 6 Hours (AUC [2-6]) After a Mixed Meal Tolerance Test (MMTT) at Day 1 and 14Percent Change at Day 14 (n=8,9,9,9,7,15)16.51 percent changeStandard Deviation 27.962
PF-04937319 100 mgPercent Change From Baseline in C-peptide Area Under the Curve From Time 2 to 6 Hours (AUC [2-6]) After a Mixed Meal Tolerance Test (MMTT) at Day 1 and 14Percent Change at Day 1 (n=9,9,9,9,9,16)2.37 percent changeStandard Deviation 12.421
PF-04937319 100 mgPercent Change From Baseline in C-peptide Area Under the Curve From Time 2 to 6 Hours (AUC [2-6]) After a Mixed Meal Tolerance Test (MMTT) at Day 1 and 14Percent Change at Day 14 (n=8,9,9,9,7,15)-1.44 percent changeStandard Deviation 14.463
PF-04937319 300 mgPercent Change From Baseline in C-peptide Area Under the Curve From Time 2 to 6 Hours (AUC [2-6]) After a Mixed Meal Tolerance Test (MMTT) at Day 1 and 14Percent Change at Day 1 (n=9,9,9,9,9,16)16.34 percent changeStandard Deviation 8.94
PF-04937319 300 mgPercent Change From Baseline in C-peptide Area Under the Curve From Time 2 to 6 Hours (AUC [2-6]) After a Mixed Meal Tolerance Test (MMTT) at Day 1 and 14Percent Change at Day 14 (n=8,9,9,9,7,15)22.50 percent changeStandard Deviation 14.809
PlaceboPercent Change From Baseline in C-peptide Area Under the Curve From Time 2 to 6 Hours (AUC [2-6]) After a Mixed Meal Tolerance Test (MMTT) at Day 1 and 14Percent Change at Day 1 (n=9,9,9,9,9,16)-1.43 percent changeStandard Deviation 9.488
PlaceboPercent Change From Baseline in C-peptide Area Under the Curve From Time 2 to 6 Hours (AUC [2-6]) After a Mixed Meal Tolerance Test (MMTT) at Day 1 and 14Percent Change at Day 14 (n=8,9,9,9,7,15)1.80 percent changeStandard Deviation 16.722
Secondary

Percent Change From Baseline in Insulin Area Under the Curve From Time 2 to 6 Hours (AUC [2-6]) After a Mixed Meal Tolerance Test (MMTT) at Day 1 and 14

Percent change from baseline in area under the plasma insulin concentration-time curve as determined by standardized MMTT. Linear trapezoidal method was used to compute AUC. Baseline value was the AUC (2-6) calculated on Day -1.

Time frame: -46, -45.75, -45.5, -45, -44.5, -44, -43, -42 hrs pre-dose on Day -1; 2, 2.25, 2.5, 3, 3.5, 4, 5, 6 hrs post-dose on Day 1 and 14 (fasted condition)

Population: PD analysis population included all enrolled participants who received at least 1 dose of study medication and had at least 1 PD parameter. Here 'n' signifies participants evaluable for this measure at specified time point for each arm group, respectively.

ArmMeasureGroupValue (MEAN)Dispersion
PF-04937319 10 mgPercent Change From Baseline in Insulin Area Under the Curve From Time 2 to 6 Hours (AUC [2-6]) After a Mixed Meal Tolerance Test (MMTT) at Day 1 and 14Percent Change at Day 1 (n=9,9,9,9,9,16)-2.22 percent changeStandard Deviation 17.843
PF-04937319 10 mgPercent Change From Baseline in Insulin Area Under the Curve From Time 2 to 6 Hours (AUC [2-6]) After a Mixed Meal Tolerance Test (MMTT) at Day 1 and 14Percent Change at Day 14 (n=8,9,9,9,7,15)15.77 percent changeStandard Deviation 21.452
PF-04937319 30 mgPercent Change From Baseline in Insulin Area Under the Curve From Time 2 to 6 Hours (AUC [2-6]) After a Mixed Meal Tolerance Test (MMTT) at Day 1 and 14Percent Change at Day 1 (n=9,9,9,9,9,16)13.24 percent changeStandard Deviation 22.221
PF-04937319 30 mgPercent Change From Baseline in Insulin Area Under the Curve From Time 2 to 6 Hours (AUC [2-6]) After a Mixed Meal Tolerance Test (MMTT) at Day 1 and 14Percent Change at Day 14 (n=8,9,9,9,7,15)17.98 percent changeStandard Deviation 26.499
PF-04937319 50 mgPercent Change From Baseline in Insulin Area Under the Curve From Time 2 to 6 Hours (AUC [2-6]) After a Mixed Meal Tolerance Test (MMTT) at Day 1 and 14Percent Change at Day 1 (n=9,9,9,9,9,16)24.11 percent changeStandard Deviation 13.772
PF-04937319 50 mgPercent Change From Baseline in Insulin Area Under the Curve From Time 2 to 6 Hours (AUC [2-6]) After a Mixed Meal Tolerance Test (MMTT) at Day 1 and 14Percent Change at Day 14 (n=8,9,9,9,7,15)30.86 percent changeStandard Deviation 41.063
PF-04937319 100 mgPercent Change From Baseline in Insulin Area Under the Curve From Time 2 to 6 Hours (AUC [2-6]) After a Mixed Meal Tolerance Test (MMTT) at Day 1 and 14Percent Change at Day 1 (n=9,9,9,9,9,16)4.41 percent changeStandard Deviation 17.47
PF-04937319 100 mgPercent Change From Baseline in Insulin Area Under the Curve From Time 2 to 6 Hours (AUC [2-6]) After a Mixed Meal Tolerance Test (MMTT) at Day 1 and 14Percent Change at Day 14 (n=8,9,9,9,7,15)0.38 percent changeStandard Deviation 21.14
PF-04937319 300 mgPercent Change From Baseline in Insulin Area Under the Curve From Time 2 to 6 Hours (AUC [2-6]) After a Mixed Meal Tolerance Test (MMTT) at Day 1 and 14Percent Change at Day 1 (n=9,9,9,9,9,16)18.10 percent changeStandard Deviation 17.059
PF-04937319 300 mgPercent Change From Baseline in Insulin Area Under the Curve From Time 2 to 6 Hours (AUC [2-6]) After a Mixed Meal Tolerance Test (MMTT) at Day 1 and 14Percent Change at Day 14 (n=8,9,9,9,7,15)39.23 percent changeStandard Deviation 26.876
PlaceboPercent Change From Baseline in Insulin Area Under the Curve From Time 2 to 6 Hours (AUC [2-6]) After a Mixed Meal Tolerance Test (MMTT) at Day 1 and 14Percent Change at Day 1 (n=9,9,9,9,9,16)-2.92 percent changeStandard Deviation 15.768
PlaceboPercent Change From Baseline in Insulin Area Under the Curve From Time 2 to 6 Hours (AUC [2-6]) After a Mixed Meal Tolerance Test (MMTT) at Day 1 and 14Percent Change at Day 14 (n=8,9,9,9,7,15)7.62 percent changeStandard Deviation 26.034

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