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CompletedNCT01044537Updated Mar 10, 2017Results posted

A Trial To Assess The Safety, Tolerability, Pharmacokinetics, And Pharmacodynamics Of Single Doses Of PF-04937319 In Subjects With Type 2 Diabetes Mellitus

A Phase 1 interventional study of Placebo and PF-04937319 in Type 2 Diabetes Mellitus, sponsored by Pfizer. Completed at 3 sites in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2017-03-10.

Sponsored by Pfizer · Phase 1, Interventional, and Other

Phase
Phase 1
Study type
Interventional
Enrollment
50
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

The purpose of this study is to characterize the safety, tolerability, pharmacokinetics, and pharmacodynamics of PF-04937319 following single escalating oral doses in adult subjects with Type 2 Diabetes Mellitus (T2DM).

Read the detailed description

The purpose of this phase 1 study is to characterize the safety, tolerability, pharmacokinetics, and pharmacodynamics of PF04937319 following single escalating oral doses in adult subjects with T2DM.

02

Conditions studied

  • Type 2 Diabetes Mellitus

Keywords

  • phase 1
  • safety and tolerability
  • PK
  • PD
  • type 2 diabetes mellitus
  • T2DM
03

In context

Diabetes Mellitus, Type 2

9,590 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,332 are open to participants now.

This study's enrollment of 50 is below the median of 81 across 7,713 interventional studies indexed under Diabetes Mellitus, Type 2.

Browse Diabetes Mellitus, Type 2 studies →

Lead sponsor

Pfizer is the lead sponsor of 3,323 studies on the registry; 145 are open to participants now.

Of its 597 completed or terminated interventional studies of FDA-regulated products, 391 (65%) have results posted.

Browse Pfizer studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patients with type 2 diabetes mellitus who are taking stable doses of metformin only. Subjects treated with a sulfonylurea (SU) or a dipeptidyl peptidase-IV inhibitor (DPP-IVi) in combination with metformin may be eligible if washed off the SU or DPP-IVi to metformin only for a minimum of 4 weeks before dosing.
  • Male and/or female subjects (females will be women of non childbearing potential) between the ages of 18 and 65 years, inclusive, with a body mass index (BMI) of 18.5 to 45.0 kg/m2 and C-peptide >0.8 ng/mL.
  • Screening and Day -2 troponin I concentration \</=0.05 ng/mL as measured by the Bayer Centaur Ultra assay.
  • HbA1c >/=7% and \</=11%. If the patient requires to be washed off an SU or DPP-IVi, the HbA1c limits will be >/=7% and \</=9.5%.

Exclusion criteria

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).
  • Evidence or history of diabetic complications with significant end organ damage, eg, proliferative retinopathy and/or macular edema, creatinine clearance \</=60 mL/min based on the Cockcroft-Gault equation, diabetic neuropathy complicated by neuropathic ulcers.
  • History of stroke, transient ischemic attack, or myocardial infarction within the past 6 months. Additionally, history of coronary artery bypass graft or stent implantation, clinically significant peripheral vascular disease, or congestive heart failure (NYHA Classes II-IV). Furthermore, a current history of angina/unstable angina. Also, 12 lead electrocardiogram (ECG) demonstrating QTc >450 msec at screening, ECG findings suggestive of asymptomatic myocardial ischemia, or supine blood pressure >/=160 mm Hg (systolic) or \</=100 mm Hg (diastolic).
  • One or more self reported episodes of hypoglycemia within the last 3 months, or two or more self reported episodes of hypoglycemia within the last 6 months.
  • Screening or Day -2 fasting (>/=8 hours) blood glucose, \</=70 or >/=270 mg/dL, confirmed by a single repeat if deemed necessary.
05

Study design

Phase
Phase 1
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
50 participants (actual)

Study arms

  • Placebo comparator
    Placebo

    In each ascending-dose cohort, approximately 6 subjects will receive active treatment and 3 will receive placebo.

    Drug: Placebo

  • Experimental
    PF-04937319

    In each ascending-dose cohort, approximately 6 subjects will receive active treatment and 3 will receive placebo. There will be approximately 6 dosing levels of PF-04937319

    Drug: PF-04937319

Interventions

  • DrugPlacebo

    Placebo to match PF-04937319 will be provided.

  • DrugPF-04937319

    The initial planned dosing schedule is: 10, 30, 100, 200, and 400 mg, with one cohort to be determined. Doses shown may be adjusted upwards or downwards and may be adjusted to include intermediate doses. All doses will be administered as a single oral dose as a powder-in-capsule (PIC) formulation. PF-04937319 will be supplied as 10 mg and 80 mg (and potentially 1 mg) PIC.

06

What researchers measure

Primary outcomes

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

    An AE was any untoward medical occurrence in a participant who received study medication 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 medication and up to 10 days after last dose that were absent before treatment or that worsened relative to pretreatment state.

    Time frame: Day 1 up to 10 days after last dose of study medication (up to 11 days)

  2. Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)

    Area under the plasma concentration-time curve from zero to the last measured concentration (AUClast).

    Time frame: 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 hours post-dose

  3. Maximum Observed Plasma Concentration (Cmax)

    Time frame: 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 hours post-dose

  4. Time to Reach Maximum Observed Plasma Concentration (Tmax)

    Time frame: 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 hours post-dose

  5. Apparent Oral Clearance (CL/F)

    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, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 hours post-dose

  6. Apparent Volume of Distribution (Vz/F)

    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, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 hours post-dose

  7. Plasma Decay Half-Life (t1/2)

    Plasma decay half-life (t1/2) is the time measured for the plasma concentration to decrease by one half.

    Time frame: 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 hours post-dose

  8. Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf)

    AUCinf is the area under the plasma concentration versus time curve from time zero to extrapolated infinite time.

    Time frame: 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 hours post-dose

Secondary outcomes

  1. Change From Baseline in Ratio of C-peptide Area Under Curve (C-peptide AUC) to Glucose Area Under Curve (Glucose AUC) After a Mixed Meal Tolerance Test (MMTT) on Day 1

    Ratio of area under the plasma C-peptide concentration-time curve from time 2 to 6 hrs (in terms of nanogram\*deciliter\*hour \[ng\*dL\*hour\]) to area under the plasma glucose concentration-time curve from time 2 to 6 hrs (in terms of milligram\*milliliter\*hour \[mg\*mL\*hour\]) was calculated. Linear trapezoidal method was used to compute AUC. The change in ratio from baseline (Day -1) was calculated at Day 1.

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

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

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

  3. Percent Change From Baseline in Post-Prandial Insulin Area Under the Curve From Time 2 to 6 Hours (AUC [2-6]) After a Mixed Meal Tolerance Test (MMTT) on Day 1

    Percent change from baseline in post-prandial 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

  4. Percent Change From Baseline in Post-Prandial C-peptide Area Under the Curve From Time 2 to 6 Hours (AUC [2-6]) After a Mixed Meal Tolerance Test (MMTT) on Day 1

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

  5. Change From Baseline in Ratio of Insulin Delta C30 to Glucose Delta C30 After a Mixed Meal Tolerance Test (MMTT) on Day 1

    Ratio of insulin delta C30 (in terms of milliunits\*deciliter \[mU\*dL\]) to glucose delta C30 (in terms of milligram\*liter \[mg\*liter\]) was calculated. The change in ratio from baseline (Day -1) was calculated at Day 1.

    Time frame: -46, -45.5 hrs pre-dose on Day -1; 2, 2.5 hrs post-dose on Day 1

  6. Change From Baseline in Ratio of C-peptide Delta C30 to Glucose Delta C30 After a Mixed Meal Tolerance Test (MMTT)

    Ratio of C-peptide Delta C30 (in terms of nanogram\*deciliter \[ng\*dL\]) to glucose delta C30 (in terms of milligram\*milliliter \[mg\*mL\]) was calculated. The change in ratio from baseline (Day -1) was calculated at Day 1.

    Time frame: -46, -45.5 hrs pre-dose on Day -1; 2, 2.5 hrs post-dose on Day 1

  7. Change From Baseline in Ratio of Insulin Area Under Curve (Insulin AUC) to Glucose Area Under Curve (Glucose AUC) After a Mixed Meal Tolerance Test (MMTT) on Day 1

    Ratio of area under the plasma insulin concentration-time curve from time 2 to 6 hrs (in terms of milliunit\*deciliter\*hour \[mU\*dL\*hour\]) to area under the plasma glucose concentration-time curve from time 2 to 6 hrs (in terms of milligram\*liter\*hour \[mg\*liter\*hour\]) was calculated. Linear trapezoidal method was used to compute AUC. The change in ratio from baseline (Day -1) was calculated at 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

07

Results

Posted Mar 10, 2017

Participant flow

Participant flow — Overall Study
MilestonePF-04937319 10 mgPF-04937319 30 mgPF-04937319 100 mgPF-04937319 300 mgPF-04937319 480 mgPF-04937319 640 mgPlacebo
Started66665516
Completed66665516
Not completed0000000

Outcome measures

PrimaryNumber of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)

An AE was any untoward medical occurrence in a participant who received study medication 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 medication and up to 10 days after last dose that were absent before treatment or that worsened relative to pretreatment state.

Time frame:
Day 1 up to 10 days after last dose of study medication (up to 11 days)
Reported as:
Number · participants
Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)
participantsPF-04937319 10 mgPF-04937319 30 mgPF-04937319 100 mgPF-04937319 300 mgPF-04937319 480 mgPF-04937319 640 mgPlacebo
AEs1413330
SAEs0000000
SecondaryChange From Baseline in Ratio of C-peptide Area Under Curve (C-peptide AUC) to Glucose Area Under Curve (Glucose AUC) After a Mixed Meal Tolerance Test (MMTT) on Day 1

Ratio of area under the plasma C-peptide concentration-time curve from time 2 to 6 hrs (in terms of nanogram\*deciliter\*hour \[ng\*dL\*hour\]) to area under the plasma glucose concentration-time curve from time 2 to 6 hrs (in terms of milligram\*milliliter\*hour \[mg\*mL\*hour\]) was calculated. Linear trapezoidal method was used to compute AUC. The change in ratio from baseline (Day -1) was calculated at Day 1.

Time frame:
-46, -45.75, -45.5, -45, -44.5, -44, -43, -42 hours pre-dose on Day -1; 2, 2.25, 2.5, 3, 3.5, 4, 5, 6 hours post-dose on Day 1
Reported as:
Mean · (ng*dL*hour)/(mg*mL*hour)
Change From Baseline in Ratio of C-peptide Area Under Curve (C-peptide AUC) to Glucose Area Under Curve (Glucose AUC) After a Mixed Meal Tolerance Test (MMTT) on Day 1
(ng*dL*hour)/(mg*mL*hour)PF-04937319 10 mgPF-04937319 30 mgPF-04937319 100 mgPF-04937319 300 mgPF-04937319 480 mgPF-04937319 640 mgPlacebo
Baseline (n= 5,6,6,6,5,5,15)0.02 ± 0.0120.03 ± 0.0140.03 ± 0.0200.03 ± 0.0090.03 ± 0.0090.03 ± 0.0090.03 ± 0.013
Change at Day 1 (n= 5,5,6,6,5,5,15)0.00 ± 0.0020.00 ± 0.0040.00 ± 0.0130.01 ± 0.0030.01 ± 0.0050.01 ± 0.0080.00 ± 0.005
PrimaryArea Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)

Area under the plasma concentration-time curve from zero to the last measured concentration (AUClast).

Time frame:
0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 hours post-dose
Reported as:
Geometric mean · nanogram*hour per milliliter
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)
nanogram*hour per milliliterPF-04937319 10 mgPF-04937319 30 mgPF-04937319 100 mgPF-04937319 300 mgPF-04937319 480 mgPF-04937319 640 mg
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)475.2 ± 131362 ± 344418 ± 2110640 ± 3310830 ± 2919970 ± 11
PrimaryMaximum Observed Plasma Concentration (Cmax)
Time frame:
0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 hours post-dose
Reported as:
Geometric mean · nanogram per milliliter (ng/mL)
Maximum Observed Plasma Concentration (Cmax)
nanogram per milliliter (ng/mL)PF-04937319 10 mgPF-04937319 30 mgPF-04937319 100 mgPF-04937319 300 mgPF-04937319 480 mgPF-04937319 640 mg
Maximum Observed Plasma Concentration (Cmax)72.29 ± 25124.9 ± 17339.8 ± 34756.6 ± 59769.9 ± 501050 ± 24
PrimaryTime to Reach Maximum Observed Plasma Concentration (Tmax)
Time frame:
0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 hours post-dose
Reported as:
Median · hour
Time to Reach Maximum Observed Plasma Concentration (Tmax)
hourPF-04937319 10 mgPF-04937319 30 mgPF-04937319 100 mgPF-04937319 300 mgPF-04937319 480 mgPF-04937319 640 mg
Time to Reach Maximum Observed Plasma Concentration (Tmax)2.48 (1.95 to 3.00)2.50 (1.00 to 6.00)3.00 (1.95 to 8.00)3.50 (3.00 to 6.00)6.00 (1.92 to 6.00)7.98 (3.00 to 12.0)
PrimaryApparent Oral Clearance (CL/F)

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, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 hours post-dose
Reported as:
Geometric mean · milliliter per minute (mL/min)
Apparent Oral Clearance (CL/F)
milliliter per minute (mL/min)PF-04937319 10 mgPF-04937319 30 mgPF-04937319 100 mgPF-04937319 300 mgPF-04937319 480 mgPF-04937319 640 mg
Apparent Oral Clearance (CL/F)344.8 ± 13360.9 ± 37364.4 ± 26464.2 ± 40690.3 ± 28481.8 ± 10
PrimaryApparent Volume of Distribution (Vz/F)

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, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 hours post-dose
Reported as:
Geometric mean · liter
Apparent Volume of Distribution (Vz/F)
literPF-04937319 10 mgPF-04937319 30 mgPF-04937319 100 mgPF-04937319 300 mgPF-04937319 480 mgPF-04937319 640 mg
Apparent Volume of Distribution (Vz/F)154.0 ± 12204.6 ± 42254.4 ± 25284.1 ± 76379.2 ± 25399.3 ± 23
PrimaryPlasma Decay Half-Life (t1/2)

Plasma decay half-life (t1/2) is the time measured for the plasma concentration to decrease by one half.

Time frame:
0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 hours post-dose
Reported as:
Mean · hour
Plasma Decay Half-Life (t1/2)
hourPF-04937319 10 mgPF-04937319 30 mgPF-04937319 100 mgPF-04937319 300 mgPF-04937319 480 mgPF-04937319 640 mg
Plasma Decay Half-Life (t1/2)5.203 ± 0.748886.592 ± 0.798938.632 ± 3.37567.366 ± 2.42256.410 ± 1.042212.79 ± 6.3392
SecondaryPercent Change From Baseline in Post-Prandial Glucose Area Under the Curve From Time 2 to 6 Hours (AUC [2-6]) After a Mixed Meal Tolerance Test (MMTT) on Day 1

Percent change from baseline in post-prandial area under the plasma glucose concentration-time curve as determined by standardized MMTT. Linear trapezoidal method was used to compute AUC. 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
Reported as:
Mean · percent change
Percent Change From Baseline in Post-Prandial Glucose Area Under the Curve From Time 2 to 6 Hours (AUC [2-6]) After a Mixed Meal Tolerance Test (MMTT) on Day 1
percent changePF-04937319 10 mgPF-04937319 30 mgPF-04937319 100 mgPF-04937319 300 mgPF-04937319 480 mgPF-04937319 640 mgPlacebo
Percent Change From Baseline in Post-Prandial Glucose Area Under the Curve From Time 2 to 6 Hours (AUC [2-6]) After a Mixed Meal Tolerance Test (MMTT) on Day 18.58 ± 8.428-15.22 ± 8.8874.96 ± 31.567-11.72 ± 8.350-10.81 ± 10.017-23.21 ± 10.207-0.45 ± 13.041
SecondaryPercent Change From Baseline in Post-Prandial Insulin Area Under the Curve From Time 2 to 6 Hours (AUC [2-6]) After a Mixed Meal Tolerance Test (MMTT) on Day 1

Percent change from baseline in post-prandial 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
Reported as:
Mean · percent change
Percent Change From Baseline in Post-Prandial Insulin Area Under the Curve From Time 2 to 6 Hours (AUC [2-6]) After a Mixed Meal Tolerance Test (MMTT) on Day 1
percent changePF-04937319 10 mgPF-04937319 30 mgPF-04937319 100 mgPF-04937319 300 mgPF-04937319 480 mgPF-04937319 640 mgPlacebo
Percent Change From Baseline in Post-Prandial Insulin Area Under the Curve From Time 2 to 6 Hours (AUC [2-6]) After a Mixed Meal Tolerance Test (MMTT) on Day 130.98 ± 21.32710.72 ± 13.4240.22 ± 26.0862.03 ± 15.62235.61 ± 28.2359.30 ± 38.5566.35 ± 25.752
SecondaryPercent Change From Baseline in Post-Prandial C-peptide Area Under the Curve From Time 2 to 6 Hours (AUC [2-6]) After a Mixed Meal Tolerance Test (MMTT) on Day 1

Percent change from baseline in post-prandial area under the plasma C-peptide concentration-time curve as determined by standardized MMTT. Linear trapezoidal method was used to compute AUC. 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
Reported as:
Mean · percent change
Percent Change From Baseline in Post-Prandial C-peptide Area Under the Curve From Time 2 to 6 Hours (AUC [2-6]) After a Mixed Meal Tolerance Test (MMTT) on Day 1
percent changePF-04937319 10 mgPF-04937319 30 mgPF-04937319 100 mgPF-04937319 300 mgPF-04937319 480 mgPF-04937319 640 mgPlacebo
Percent Change From Baseline in Post-Prandial C-peptide Area Under the Curve From Time 2 to 6 Hours (AUC [2-6]) After a Mixed Meal Tolerance Test (MMTT) on Day 114.10 ± 3.749-0.63 ± 14.6641.79 ± 17.4268.23 ± 8.10121.13 ± 8.03712.51 ± 19.1886.09 ± 18.625
SecondaryChange From Baseline in Ratio of Insulin Delta C30 to Glucose Delta C30 After a Mixed Meal Tolerance Test (MMTT) on Day 1

Ratio of insulin delta C30 (in terms of milliunits\*deciliter \[mU\*dL\]) to glucose delta C30 (in terms of milligram\*liter \[mg\*liter\]) was calculated. The change in ratio from baseline (Day -1) was calculated at Day 1.

Time frame:
-46, -45.5 hrs pre-dose on Day -1; 2, 2.5 hrs post-dose on Day 1
Reported as:
Mean · (mU*dL)/(mg*Liter)
Change From Baseline in Ratio of Insulin Delta C30 to Glucose Delta C30 After a Mixed Meal Tolerance Test (MMTT) on Day 1
(mU*dL)/(mg*Liter)PF-04937319 10 mgPF-04937319 30 mgPF-04937319 100 mgPF-04937319 300 mgPF-04937319 480 mgPF-04937319 640 mgPlacebo
Baseline0.70 ± 0.6274.59 ± 6.9351.92 ± 2.7590.77 ± 0.2890.73 ± 0.2650.85 ± 0.6311.15 ± 0.798
Change at Day 1-0.04 ± 0.427-3.20 ± 7.093-0.81 ± 1.8910.25 ± 0.0901.89 ± 3.8940.74 ± 0.675-0.05 ± 0.607
SecondaryChange From Baseline in Ratio of C-peptide Delta C30 to Glucose Delta C30 After a Mixed Meal Tolerance Test (MMTT)

Ratio of C-peptide Delta C30 (in terms of nanogram\*deciliter \[ng\*dL\]) to glucose delta C30 (in terms of milligram\*milliliter \[mg\*mL\]) was calculated. The change in ratio from baseline (Day -1) was calculated at Day 1.

Time frame:
-46, -45.5 hrs pre-dose on Day -1; 2, 2.5 hrs post-dose on Day 1
Reported as:
Mean · (ng*dL)/(mg*mL)
Change From Baseline in Ratio of C-peptide Delta C30 to Glucose Delta C30 After a Mixed Meal Tolerance Test (MMTT)
(ng*dL)/(mg*mL)PF-04937319 10 mgPF-04937319 30 mgPF-04937319 100 mgPF-04937319 300 mgPF-04937319 480 mgPF-04937319 640 mgPlacebo
Baseline0.04 ± 0.0340.16 ± 0.2930.05 ± 0.0640.03 ± 0.0110.02 ± 0.0080.05 ± 0.0380.04 ± 0.023
Change at Day 1-0.01 ± 0.018-0.12 ± 0.283-0.02 ± 0.0500.01 ± 0.0060.13 ± 0.2400.02 ± 0.0290.00 ± 0.025
SecondaryChange From Baseline in Ratio of Insulin Area Under Curve (Insulin AUC) to Glucose Area Under Curve (Glucose AUC) After a Mixed Meal Tolerance Test (MMTT) on Day 1

Ratio of area under the plasma insulin concentration-time curve from time 2 to 6 hrs (in terms of milliunit\*deciliter\*hour \[mU\*dL\*hour\]) to area under the plasma glucose concentration-time curve from time 2 to 6 hrs (in terms of milligram\*liter\*hour \[mg\*liter\*hour\]) was calculated. Linear trapezoidal method was used to compute AUC. The change in ratio from baseline (Day -1) was calculated at 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
Reported as:
Mean · (mU*dL*hour)/(mg*liter*hour)
Change From Baseline in Ratio of Insulin Area Under Curve (Insulin AUC) to Glucose Area Under Curve (Glucose AUC) After a Mixed Meal Tolerance Test (MMTT) on Day 1
(mU*dL*hour)/(mg*liter*hour)PF-04937319 10 mgPF-04937319 30 mgPF-04937319 100 mgPF-04937319 300 mgPF-04937319 480 mgPF-04937319 640 mgPlacebo
Baseline (n= 5,5,6,6,5,5,14)0.24 ± 0.1180.32 ± 0.2570.48 ± 0.4520.36 ± 0.1420.29 ± 0.0850.38 ± 0.3100.34 ± 0.222
Change at Day 1 (n= 5,4,6,5,5,5,14)0.03 ± 0.0360.10 ± 0.104-0.12 ± 0.2350.04 ± 0.0620.16 ± 0.1040.10 ± 0.1690.01 ± 0.071
PrimaryArea Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf)

AUCinf is the area under the plasma concentration versus time curve from time zero to extrapolated infinite time.

Time frame:
0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 hours post-dose
Reported as:
Geometric mean · nanogram*hour per milliliter
Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf)
nanogram*hour per milliliterPF-04937319 10 mgPF-04937319 30 mgPF-04937319 100 mgPF-04937319 300 mgPF-04937319 480 mgPF-04937319 640 mg
Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf)483.3 ± 131385 ± 344570 ± 2310770 ± 3511590 ± 2822130 ± 9

Adverse events

Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
PF-04937319 10 mg—0/6 (0%)1/6 (16.7%)
PF-04937319 30 mg—0/6 (0%)4/6 (66.7%)
PF-04937319 100 mg—0/6 (0%)1/6 (16.7%)
PF-04937319 300 mg—0/6 (0%)3/6 (50%)
PF-04937319 480 mg—0/5 (0%)3/5 (60%)
PF-04937319 640 mg—0/5 (0%)3/5 (60%)
Placebo—0/16 (0%)0/16 (0%)
Most frequent other events
Showing 10 of 13
Most frequent other events
EventPF-04937319 10 mgPF-04937319 30 mgPF-04937319 100 mgPF-04937319 300 mgPF-04937319 480 mgPF-04937319 640 mgPlacebo
HypoglycaemiaMetabolism and nutrition disorders0/61/60/62/62/52/50/16
HeadacheNervous system disorders0/61/60/61/62/50/50/16
FlatulenceGastrointestinal disorders0/60/60/60/60/51/50/16
NauseaGastrointestinal disorders0/60/60/60/60/51/50/16
VomitingGastrointestinal disorders0/60/60/60/60/51/50/16
Application site dermatitisGeneral disorders0/60/60/60/60/51/50/16
DizzinessNervous system disorders0/60/60/60/61/50/50/16
Dermatitis contactSkin and subcutaneous tissue disorders0/60/60/60/60/51/50/16
Sinus tachycardiaCardiac disorders1/60/60/60/60/50/50/16
ExcoriationInjury, poisoning and procedural complications0/61/60/60/60/50/50/16

Baseline characteristics

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

Age, Continuous
Age, Continuous(years)PF-04937319 10 mgPF-04937319 30 mgPF-04937319 100 mgPF-04937319 300 mgPF-04937319 480 mgPF-04937319 640 mgPlaceboTotal
Mean55.0 ± 9.052.2 ± 8.852.0 ± 6.858.8 ± 4.655.0 ± 8.149.0 ± 10.053.7 ± 7.853.7 ± 7.9
Sex: Female, Male
Sex: Female, Male(Participants)PF-04937319 10 mgPF-04937319 30 mgPF-04937319 100 mgPF-04937319 300 mgPF-04937319 480 mgPF-04937319 640 mgPlaceboTotal
Female423201416
Male2434541234
08

Study locations

3 sites
  • Dedicated Phase 1
    Phoenix, Arizona 85013, United States
  • West Coast Clinical Trials, LLC
    Cypress, California 90630, United States
  • Elite Research Institute
    Miami, Florida 33169, United States
09

References and documents

10

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Feb 2010, a primary completion of May 2010 and a completion of May 2010. It does not say whether these dates are actual or estimated.

Results were first posted in Mar 2017, 6 years 10 months after primary completion.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 7, 2010
First posted
Jan 8, 2010
Start
Feb 2010
Primary completionActual
May 2010
CompletionActual
May 2010
Results first posted
Mar 10, 2017
Last update
Mar 10, 2017
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 10, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT01044537
Lead sponsor
Pfizer
Responsible party
Sponsor
First posted
Jan 8, 2010
Start date
Feb 2010
Primary completion
May 2010
Completion
May 2010
Results posted
Mar 10, 2017
Last update
Mar 10, 2017

Study contacts

Pfizer CT.gov Call Center
study director · Pfizer

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jan 2017. You cannot join it, but the record below documents what was studied.

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Discussion

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