Type 2 Diabetes MellitusPhase 1NCT02292433

A Phase 1 Study In Japanese Subjects With Type 2 Diabetes Mellitus As Monotherapy

A Phase 1 study testing PF-04937319 high dose and PF-04937319 low dose in people with Type 2 Diabetes Mellitus, run by Pfizer at 1 site in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Study B1621018 will assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Two Dose Levels of Pf-04937319 in Japanese Subjects with Type 2 Diabetes Mellitus As Monotherapy Read more about this study

Who is it for?: Ages 20 to 64 years
Conditions the study is for: Type 2 Diabetes Mellitus
What is being tested?: PF-04937319 high dose and PF-04937319 low dose
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 12 participants
Where: 1 siteJapan
Study dates: Jan 2015to Mar 2015
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 20 to 64 years
All sexes
No healthy volunteers
Adult

Who may be able to join

Patients with type 2 diabetes, on diet/exercise therapy only or background therapy with 1 oral anti-diabetic agent (excluding Actos)

Who cannot join

Patients with cardiovascular event
Patients with diabetic complications
Female subjects who are pregnant or planning to become pregnant
Subjects with unstable medical conditions (eg, hypertension)

Trial locations and contacts

1 site in 1 country.

Japan1 site

P-one Clinic, Keikokai Medical Corporation
Hachioji-shi, Tokyo, 192-0071

Other trials in Japan

About this study

Official title: A Phase 1, Randomized, Double-blind, Placebo-controlled, 3- Period, Crossover Study To Assess The Safety, Tolerability, Pharmacokinetics, And Pharmacodynamics Of Two Dose Levels of Pf-04937319 In Japanese Subjects With Type 2 Diabetes Mellitus as Monotherapy

Study B1621018 will assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Two Dose Levels of Pf-04937319 in Japanese Subjects with Type 2 Diabetes Mellitus As Monotherapy

Conditions: Type 2 Diabetes Mellitus
Being tested: PF-04937319 high dose, PF-04937319 low dose, Placebo
Keywords: Phase 1, type 2 diabetes, monotherapy, PF-04937319
Medical subject headings: Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

PF-04937319 high doseDrug
tablets, 150 mg with breakfast plus 100 mg with lunch, 7 days
PF-04937319 low doseDrug
tablets, 50 mg with breakfast plus 50 mg with lunch, 7 days
PlaceboDrug
tablets, breakfast plus lunch, 7 days

Study groups in NCT02292433
Study group	Role	What they receive
PF-04937319	Experimental	PF-04937319 Split dose Receives: Drug: PF-04937319 high dose; Drug: PF-04937319 low dose
Placebo	Placebo comparator	Placebo split dose Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants With Treatment Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 14 days after last dose that were absent before treatment or that worsened relative to pre-treatment state.
Measured: Baseline up to 14 days after the last dose of study drug (minimum 8 weeks to maximum of 17 weeks)
Number of Participants With Protocol Defined Hypoglycaemic Adverse Events (HAEs)
A hypoglycemic event (HAE) was identified by characteristic symptoms or blood glucose levels. HAE was defined as 1 of the given definitions: 1) Characteristic symptoms of HAE with no home glucose monitoring performed where clinical picture included prompt resolution with food intake, subcutaneous glucagon, or intravenous glucose; 2) Characteristic symptoms of HAE with home glucose monitoring measurement of less than or equal to (=<) 70 milligram per deciliter (mg/dL) using sponsor-provided, plasma-referenced, home glucometers (or central laboratory); 3) any glucose value =<49 mg/dL using sponsor-provided, plasma-referenced, home glucometers (or central laboratory) with or without accompanying symptoms.
Measured: Baseline up to 14 days after the last dose of study drug (minimum 8 weeks to maximum of 17 weeks)
Maximum Observed Plasma Concentration (Cmax) on Day 1 for PF-04937319
Measured: 0 hour (pre-dose), 1.5, 3, 5, 6.5, 8, 11, 12.5, 14, 24 hours post morning dose on Day 1
Time to Reach Maximum Observed Plasma Concentration (Tmax) on Day 1 for PF-04937319
Measured: 0 hour (pre-dose), 1.5, 3, 5, 6.5, 8, 11, 12.5, 14, 24 hours post morning dose on Day 1
Area Under the Concentration-Time Curve (AUC24) From Time Zero to 24 Hour on Day 1 for PF-04937319
AUC24 is the area under the plasma concentration versus time curve from time zero (pre-dose) to 24 hours post-dose (0 to 24).
Measured: 0 hour (pre-dose), 1.5, 3, 5, 6.5, 8, 11, 12.5, 14, 24 hours post-dose on Day 1
Maximum Observed Plasma Concentration (Cmax) on Day 7 for PF-04937319
Measured: 0 hour (pre-dose), 1.5, 3, 5, 6.5, 8, 11, 12.5, 14, 24, 36, 48 hours post morning dose on Day 7
Time to Reach Maximum Observed Plasma Concentration (Tmax) on Day 7 for PF-04937319
Measured: 0 hour (pre-dose), 1.5, 3, 5, 6.5, 8, 11, 12.5, 14, 24, 36, 48 hours post morning dose on Day 7
Area Under the Concentration-Time Curve (AUC24) From Time Zero to 24 Hour on Day 7 for PF-04937319
AUC24 is the area under the plasma concentration versus time curve from time zero (pre-dose) to 24 hours post-dose (0 to 24).
Measured: 0 hour (pre-dose), 1.5, 3, 5, 6.5, 8, 11, 12.5, 14, 24 hours post morning dose on Day 7
Pre-dose Plasma Concentration (Ctrough) on Day 7 for PF-04937319
Ctrough is the concentration prior to study drug administration.
Measured: 0 hour (pre-dose) on Day 7
Average Plasma Concentration (Cav) on Day 7 for PF-04937319
Cav is the average plasma concentration during the 0 to 24 hour time period.
Measured: 0 hour (pre-dose), 1.5, 3, 5, 6.5, 8, 11, 12.5, 14, 24 hours post morning dose on Day 7
Apparent Oral Clearance on Day 7 for PF-04937319
Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the oral bioavailability. It is calculated as the total oral daily dose divided by AUC24, where AUC24 is the area under the plasma concentration-time profile from time 0 to 24 hours.
Measured: 0 hour (pre-dose), 1.5, 3, 5, 6.5, 8, 11, 12.5, 14, 24 hours post morning dose on Day 7
Terminal Half-Life (t1/2) on Day 7 for PF-04937319
Terminal half-life is the time measured for the plasma concentration to decrease by one half. Terminal half-life is calculated by dividing the natural logarithm to the base e (Log e) multiplied by (*) 2/k el, where 'k el' is the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve. Only those data points judged to describe the terminal log-linear decline were used in the regression.
Measured: 0 hour (pre-dose), 1.5, 3, 5, 6.5, 8, 11, 12.5, 14, 24, 36, 48 hours post morning dose on Day 7
Apparent Volume of Distribution on Day 7 for PF-04937319
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. Apparent volume of distribution after oral dose is influenced by the oral bioavailability. It is calculated as the total oral daily dose divided by AUC24* k el, where AUC24 is the area under the plasma concentration-time profile from time 0 to 24 hours and terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve.
Measured: 0 hour (pre-dose), 1.5, 3, 5, 6.5, 8, 11, 12.5, 14, 24 hours post morning dose on Day 7
Accumulation Ratio (Rac) on Day 7 for PF-04937319
Rac is based on AUC24. It is the ratio of AUC24 of Day 7 and AUC24 of Day 1, where AUC24 is the area under the plasma concentration-time profile from time 0 to 24 hours.
Measured: 0 hour (pre-dose), 1.5, 3, 5, 6.5, 8, 11, 12.5, 14, 24 hours post morning dose on Day 7

Secondary outcomes (16)

Maximum Observed Plasma Concentration (Cmax) on Day 1 for PF-06455349
PF-06455349 is a metabolite of PF-04937319.
Measured: 0 hour (pre-dose), 1.5, 3, 5, 6.5, 8, 11, 12.5, 14, 24 hours post morning dose on Day 1
Time to Reach Maximum Observed Plasma Concentration (Tmax) on Day 1 for PF-06455349
PF-06455349 is a metabolite of PF-04937319.
Measured: 0 hour (pre-dose), 1.5, 3, 5, 6.5, 8, 11, 12.5, 14, 24 hours post morning dose on Day 1
Area Under the Concentration-Time Curve (AUC24) From Time Zero to 24 Hour on Day 1 for PF--06455349
AUC24 is the area under the plasma concentration versus time curve from time zero (pre-dose) to 24 hours post-dose (0 to 24). PF-06455349 is a metabolite of PF-04937319.
Measured: 0 hour (pre-dose), 1.5, 3, 5, 6.5, 8, 11, 12.5, 14, 24 hours post morning dose on Day 1
Metabolite to Parent Ratio for AUC24 (MRAUC24) on Day 1
MRAUC24 is the ratio of AUC24 of PF-06455349 (metabolite) to AUC24 of PF-04937319 (parent drug) * ratio of molecular weight of PF-04937319 to molecular weight of PF-06455349, where AUC24 is the area under the plasma concentration-time profile from time 0 to 24 hours.
Measured: 0 hour (pre-dose), 1.5, 3, 5, 6.5, 8, 11, 12.5, 14, 24 hours post morning dose on Day 1
Maximum Observed Plasma Concentration (Cmax) on Day 7 for PF--06455349
PF-06455349 is a metabolite of PF-04937319.
Measured: 0 hour (pre-dose), 1.5, 3, 5, 6.5, 8, 11, 12.5, 14, 24, 36, 48 hours post morning dose on Day 7
Time to Reach Maximum Observed Plasma Concentration (Tmax) on Day 7 for PF-06455349
PF-06455349 is a metabolite of PF-04937319.
Measured: 0 hour (pre-dose), 1.5, 3, 5, 6.5, 8, 11, 12.5, 14, 24, 36, 48 hours post morning dose on Day 7
Area Under the Concentration-Time Curve (AUC24) From Time Zero to 24 Hour on Day 7 for PF--06455349
AUC24 is the area under the plasma concentration versus time curve from time zero (pre-dose) to 24 hours post-dose (0 to 24). PF-06455349 is a metabolite of PF-04937319.
Measured: 0 hour (pre-dose), 1.5, 3, 5, 6.5, 8, 11, 12.5, 14, 24 hours post morning dose on Day 7
Pre-dose Plasma Concentration (Ctrough) on Day 7 for PF--06455349
Ctrough is the concentration prior to study drug administration. PF-06455349 is a metabolite of PF-04937319.
Measured: 0 hour (pre-dose) on Day 7
Average Plasma Concentration (Cav) on Day 7 for PF--06455349
Cav is the average plasma concentration during the 0 to 24 hour time period. PF-06455349 is a metabolite of PF-04937319.
Measured: 0 hour (pre-dose), 1.5, 3, 5, 6.5, 8, 11, 12.5, 14, 24 hours post morning dose on Day 7
Terminal Half-Life (t1/2) on Day 7 for PF-06455349
Terminal half-life is the time measured for the plasma concentration to decrease by one half. Terminal half-life is calculated by dividing the natural logarithm to the base e (Log e) * 2/k el, where 'k el' is the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve. Only those data points judged to describe the terminal log-linear decline were used in the regression. PF-06455349 is a metabolite of PF-04937319.
Measured: 0 hour (pre-dose), 1.5, 3, 5, 6.5, 8, 11, 12.5, 14, 24, 36, 48 hours post morning dose on Day 7
Accumulation Ratio (Rac) on Day 7 for PF-06455349
Rac is based on AUC24. It is the ratio of AUC24 of Day 7 and AUC24 of Day 1, where AUC24 is the area under the plasma concentration-time profile from time 0 to 24 hours. PF-06455349 is a metabolite of PF-04937319.
Measured: 0 hour (pre-dose), 1.5, 3, 5, 6.5, 8, 11, 12.5, 14, 24 hours post morning dose on Day 7
Metabolite to Parent Ratio for AUC24 (MRAUC24) on Day 7
MRAUC24 is the ratio of AUC24 of PF-06455349 (metabolite) to AUC24 of PF-04937319 (parent drug) * ratio of molecular weight of PF-04937319 to molecular weight of PF-06455349, where AUC24 is the area under the plasma concentration-time profile from time 0 to 24 hours. PF-06455349 is a metabolite of PF-04937319.
Measured: 0 hour (pre-dose), 1.5, 3, 5, 6.5, 8, 11, 12.5, 14, 24 hours post morning dose on Day 7
Change From Baseline in Weighted Mean Daily Glucose (WMDG) at Day 7
WMDG was defined as time-weighted mean daily glucose. WMDG was calculated by as the time-weighted mean of glucose levels at actual time points for glucose sampling, for Day 0 (Baseline) and Day 7.
Measured: Pre-morning meal, 1.5, 3, 5, 6.5, 8, 11, 12.5, 14, 16 and 20 hours post- morning meal on Day 0; pre-morning dose, 1.5, 3, 5, 6.5, 8, 11, 12.5, 14, 16, 20 hours post-morning dose on Day 7
Change From Baseline in Fasting Plasma Glucose (FPG) at Last Day of Treatment
FPG was defined as plasma glucose measurements taken pre-breakfast, in the fasted state, and prior to dosing with study drug. Baseline was defined as the average of Hour 0 measurements taken on Day 0 and Day 1 in each intervention period. The measurement on the last day of treatment was defined as the average of Hour 0 measurements taken on Day 7 and Day 8 in each period.
Measured: Pre-morning meal on Day 0, pre-morning dose on Day 1, pre-morning dose on Day 7, pre-morning meal on Day 8
Change From Baseline in Pre-Meal Insulin at Day 7
Time-matched change from baseline in pre-meal serum insulin on Day 7 of each period was analyzed. Pre-meal insulin levels therefore, pre-breakfast, pre-lunch, and pre-dinner were analyzed.
Measured: Pre-morning meal (pre-breakfast), 5 hours (pre-lunch), 11 hours (pre-dinner) after morning meal on Day 0 (Baseline); pre-morning dose (pre-breakfast), 5 hours (pre-lunch), 11 hours (pre-dinner) post-morning dose on Day 7
Change From Baseline in Pre-Meal C-Peptide at Day 7
Time-matched change from baseline in pre-meal serum C-peptide on Day 7 of each period was analyzed. Pre-meal C-peptide levels therefore, pre-breakfast, pre-lunch, and pre-dinner were analyzed.
Measured: Pre-morning meal (pre-breakfast), 5 hours (pre-lunch), 11 hours (pre-dinner) after morning meal on Day 0 (Baseline); pre-morning dose (pre-breakfast), 5 hours (pre-lunch), 11 hours (pre-dinner) post-morning dose on Day 7

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2015Mar 2015

First posted17 Nov 2014 (estimated)
Study startJan 2015
Primary completionMar 2015
Study completionMar 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
More trials run by PfizerThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 12 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02292433
Sponsor's protocol ID: B1621018
Status last verified: Feb 2016
First submitted: 12 Nov 2014
Last updated: 15 Mar 2016
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 15 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 1, Randomized, Double-blind, Placebo-controlled, 3- Period, Crossover Study To Assess The Safety, Tolerability, Pharmacokinetics, And Pharmacodynamics Of Two Dose Levels of Pf-04937319 In Japanese Subjects With Type 2 Diabetes Mellitus as Monotherapy
ClinicalTrials.gov ID: NCT02292433
Acronym / sponsor ID: B1621018
Conditions: Type 2 Diabetes Mellitus
Keywords: Phase 1, type 2 diabetes, monotherapy, PF-04937319
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 12 participants (actual)
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Study start: Jan 2015
Primary completion: Mar 2015 (actual)
Study completion: Mar 2015 (actual)
First posted: 17 Nov 2014 (estimated)
Results: Posted 15 Mar 2016

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study B1621018 will assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Two Dose Levels of Pf-04937319 in Japanese Subjects with Type 2 Diabetes Mellitus As Monotherapy

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
PF-04937319	Experimental	Drug: PF-04937319 high dose, Drug: PF-04937319 low dosePF-04937319 Split dose
Placebo	Placebo comparator	Drug: PlaceboPlacebo split dose

Who may qualify

Ages: 20 to 64 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (1 listed)

Patients with type 2 diabetes, on diet/exercise therapy only or background therapy with 1 oral anti-diabetic agent (excluding Actos)

Key exclusion criteria (4 listed)

Patients with cardiovascular event
Patients with diabetic complications
Female subjects who are pregnant or planning to become pregnant
Subjects with unstable medical conditions (eg, hypertension)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
PF-04937319 high dosetablets, 150 mg with breakfast plus 100 mg with lunch, 7 days	Drug	PF-04937319
PF-04937319 low dosetablets, 50 mg with breakfast plus 50 mg with lunch, 7 days	Drug	PF-04937319
Placebotablets, breakfast plus lunch, 7 days	Drug	Placebo

Primary outcome

Number of Participants With Treatment Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)
Time frame: Baseline up to 14 days after the last dose of study drug (minimum 8 weeks to maximum of 17 weeks)
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.
Number of Participants With Protocol Defined Hypoglycaemic Adverse Events (HAEs)
Time frame: Baseline up to 14 days after the last dose of study drug (minimum 8 weeks to maximum of 17 weeks)
A hypoglycemic event (HAE) was identified by characteristic symptoms or blood glucose levels. HAE was defined as 1 of the given definitions: 1) Characteristic symptoms of HAE with no home glucose monitoring performed where clinical picture included prompt resolution with food intake, subcutaneous glucagon, or intravenous glucose; 2) Characteristic symptoms of HAE with home glucose monitoring measurement of less than or equal to (=<) 70 milligram per deciliter (mg/dL) using sponsor-provided, plasma-referenced, home glucometers (or central laboratory); 3) any glucose value =<49 mg/dL using sponsor-provided, plasma-referenced, home glucometers (or central laboratory) with or without accompanying symptoms.
Maximum Observed Plasma Concentration (Cmax) on Day 1 for PF-04937319
Time frame: 0 hour (pre-dose), 1.5, 3, 5, 6.5, 8, 11, 12.5, 14, 24 hours post morning dose on Day 1
Time to Reach Maximum Observed Plasma Concentration (Tmax) on Day 1 for PF-04937319
Time frame: 0 hour (pre-dose), 1.5, 3, 5, 6.5, 8, 11, 12.5, 14, 24 hours post morning dose on Day 1
Area Under the Concentration-Time Curve (AUC24) From Time Zero to 24 Hour on Day 1 for PF-04937319
Time frame: 0 hour (pre-dose), 1.5, 3, 5, 6.5, 8, 11, 12.5, 14, 24 hours post-dose on Day 1
AUC24 is the area under the plasma concentration versus time curve from time zero (pre-dose) to 24 hours post-dose (0 to 24).
Maximum Observed Plasma Concentration (Cmax) on Day 7 for PF-04937319
Time frame: 0 hour (pre-dose), 1.5, 3, 5, 6.5, 8, 11, 12.5, 14, 24, 36, 48 hours post morning dose on Day 7
Time to Reach Maximum Observed Plasma Concentration (Tmax) on Day 7 for PF-04937319
Time frame: 0 hour (pre-dose), 1.5, 3, 5, 6.5, 8, 11, 12.5, 14, 24, 36, 48 hours post morning dose on Day 7
Area Under the Concentration-Time Curve (AUC24) From Time Zero to 24 Hour on Day 7 for PF-04937319
Time frame: 0 hour (pre-dose), 1.5, 3, 5, 6.5, 8, 11, 12.5, 14, 24 hours post morning dose on Day 7
AUC24 is the area under the plasma concentration versus time curve from time zero (pre-dose) to 24 hours post-dose (0 to 24).
Pre-dose Plasma Concentration (Ctrough) on Day 7 for PF-04937319
Time frame: 0 hour (pre-dose) on Day 7
Ctrough is the concentration prior to study drug administration.
Average Plasma Concentration (Cav) on Day 7 for PF-04937319
Time frame: 0 hour (pre-dose), 1.5, 3, 5, 6.5, 8, 11, 12.5, 14, 24 hours post morning dose on Day 7
Cav is the average plasma concentration during the 0 to 24 hour time period.
Apparent Oral Clearance on Day 7 for PF-04937319
Time frame: 0 hour (pre-dose), 1.5, 3, 5, 6.5, 8, 11, 12.5, 14, 24 hours post morning dose on Day 7
Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the oral bioavailability. It is calculated as the total oral daily dose divided by AUC24, where AUC24 is the area under the plasma concentration-time profile from time 0 to 24 hours.
Terminal Half-Life (t1/2) on Day 7 for PF-04937319
Time frame: 0 hour (pre-dose), 1.5, 3, 5, 6.5, 8, 11, 12.5, 14, 24, 36, 48 hours post morning dose on Day 7
Terminal half-life is the time measured for the plasma concentration to decrease by one half. Terminal half-life is calculated by dividing the natural logarithm to the base e (Log e) multiplied by (*) 2/k el, where 'k el' is the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve. Only those data points judged to describe the terminal log-linear decline were used in the regression.
Apparent Volume of Distribution on Day 7 for PF-04937319
Time frame: 0 hour (pre-dose), 1.5, 3, 5, 6.5, 8, 11, 12.5, 14, 24 hours post morning dose on Day 7
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. Apparent volume of distribution after oral dose is influenced by the oral bioavailability. It is calculated as the total oral daily dose divided by AUC24* k el, where AUC24 is the area under the plasma concentration-time profile from time 0 to 24 hours and terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve.
Accumulation Ratio (Rac) on Day 7 for PF-04937319
Time frame: 0 hour (pre-dose), 1.5, 3, 5, 6.5, 8, 11, 12.5, 14, 24 hours post morning dose on Day 7
Rac is based on AUC24. It is the ratio of AUC24 of Day 7 and AUC24 of Day 1, where AUC24 is the area under the plasma concentration-time profile from time 0 to 24 hours.

16 secondary outcomes

Maximum Observed Plasma Concentration (Cmax) on Day 1 for PF-06455349
Time frame: 0 hour (pre-dose), 1.5, 3, 5, 6.5, 8, 11, 12.5, 14, 24 hours post morning dose on Day 1
Time to Reach Maximum Observed Plasma Concentration (Tmax) on Day 1 for PF-06455349
Time frame: 0 hour (pre-dose), 1.5, 3, 5, 6.5, 8, 11, 12.5, 14, 24 hours post morning dose on Day 1
Area Under the Concentration-Time Curve (AUC24) From Time Zero to 24 Hour on Day 1 for PF--06455349
Time frame: 0 hour (pre-dose), 1.5, 3, 5, 6.5, 8, 11, 12.5, 14, 24 hours post morning dose on Day 1
Metabolite to Parent Ratio for AUC24 (MRAUC24) on Day 1
Time frame: 0 hour (pre-dose), 1.5, 3, 5, 6.5, 8, 11, 12.5, 14, 24 hours post morning dose on Day 1
Maximum Observed Plasma Concentration (Cmax) on Day 7 for PF--06455349
Time frame: 0 hour (pre-dose), 1.5, 3, 5, 6.5, 8, 11, 12.5, 14, 24, 36, 48 hours post morning dose on Day 7
Time to Reach Maximum Observed Plasma Concentration (Tmax) on Day 7 for PF-06455349
Time frame: 0 hour (pre-dose), 1.5, 3, 5, 6.5, 8, 11, 12.5, 14, 24, 36, 48 hours post morning dose on Day 7
Area Under the Concentration-Time Curve (AUC24) From Time Zero to 24 Hour on Day 7 for PF--06455349
Time frame: 0 hour (pre-dose), 1.5, 3, 5, 6.5, 8, 11, 12.5, 14, 24 hours post morning dose on Day 7
Pre-dose Plasma Concentration (Ctrough) on Day 7 for PF--06455349
Time frame: 0 hour (pre-dose) on Day 7
Average Plasma Concentration (Cav) on Day 7 for PF--06455349
Time frame: 0 hour (pre-dose), 1.5, 3, 5, 6.5, 8, 11, 12.5, 14, 24 hours post morning dose on Day 7
Terminal Half-Life (t1/2) on Day 7 for PF-06455349
Time frame: 0 hour (pre-dose), 1.5, 3, 5, 6.5, 8, 11, 12.5, 14, 24, 36, 48 hours post morning dose on Day 7
Accumulation Ratio (Rac) on Day 7 for PF-06455349
Time frame: 0 hour (pre-dose), 1.5, 3, 5, 6.5, 8, 11, 12.5, 14, 24 hours post morning dose on Day 7
Metabolite to Parent Ratio for AUC24 (MRAUC24) on Day 7
Time frame: 0 hour (pre-dose), 1.5, 3, 5, 6.5, 8, 11, 12.5, 14, 24 hours post morning dose on Day 7
Change From Baseline in Weighted Mean Daily Glucose (WMDG) at Day 7
Time frame: Pre-morning meal, 1.5, 3, 5, 6.5, 8, 11, 12.5, 14, 16 and 20 hours post- morning meal on Day 0; pre-morning dose, 1.5, 3, 5, 6.5, 8, 11, 12.5, 14, 16, 20 hours post-morning dose on Day 7
Change From Baseline in Fasting Plasma Glucose (FPG) at Last Day of Treatment
Time frame: Pre-morning meal on Day 0, pre-morning dose on Day 1, pre-morning dose on Day 7, pre-morning meal on Day 8
Change From Baseline in Pre-Meal Insulin at Day 7
Time frame: Pre-morning meal (pre-breakfast), 5 hours (pre-lunch), 11 hours (pre-dinner) after morning meal on Day 0 (Baseline); pre-morning dose (pre-breakfast), 5 hours (pre-lunch), 11 hours (pre-dinner) post-morning dose on Day 7
Change From Baseline in Pre-Meal C-Peptide at Day 7
Time frame: Pre-morning meal (pre-breakfast), 5 hours (pre-lunch), 11 hours (pre-dinner) after morning meal on Day 0 (Baseline); pre-morning dose (pre-breakfast), 5 hours (pre-lunch), 11 hours (pre-dinner) post-morning dose on Day 7

Results and safety

Results posted to the registry on 15 Mar 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
PF-04937319 100 mg Then PF-04937319 250 mg Then Placebo	4	4
PF-04937319 100 mg Then Placebo Then PF-04937319 250 mg	4	4
Placebo Then PF-04937319 100 mg Then PF-04937319 250 mg	4	4

Primary outcome: Number of Participants With Treatment Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)

Time frame: Baseline up to 14 days after the last dose of study drug (minimum 8 weeks to maximum of 17 weeks). Number. Unit: participants

Measure	PF--04937319 100 mg n = 12	PF--04937319 250 mg n = 12	Placebo n = 12
AEs	1	6	1
SAEs	0	0	0

Population analysed: Safety analysis set included all participants who received at least 1 dose of study medication (including placebo) in at least 1 period.

Primary outcome: Number of Participants With Protocol Defined Hypoglycaemic Adverse Events (HAEs)

Time frame: Baseline up to 14 days after the last dose of study drug (minimum 8 weeks to maximum of 17 weeks). Number. Unit: participants

Measure	PF--04937319 100 mg n = 12	PF--04937319 250 mg n = 12	Placebo n = 12
Value	1	4	0

Population analysed: Safety analysis set included all participants who received at least 1 dose of study medication (including placebo) in at least 1 period.

Primary outcome: Maximum Observed Plasma Concentration (Cmax) on Day 1 for PF-04937319

Time frame: 0 hour (pre-dose), 1.5, 3, 5, 6.5, 8, 11, 12.5, 14, 24 hours post morning dose on Day 1. Geometric mean (Geometric Coefficient of Variation). Unit: nanogram per milliliter (ng/mL)

Measure	PF--04937319 100 mg n = 12	PF--04937319 250 mg n = 12
Value	345.8 (13)	614.6 (20)

Population analysed: Pharmacokinetic (PK) parameter analysis population included all randomized participants who received at least 1 dose of PF-04937319 and who had at least 1 of PK parameters of interest calculated and available in at least 1 period.

Primary outcome: Time to Reach Maximum Observed Plasma Concentration (Tmax) on Day 1 for PF-04937319

Time frame: 0 hour (pre-dose), 1.5, 3, 5, 6.5, 8, 11, 12.5, 14, 24 hours post morning dose on Day 1. Median (Full Range). Unit: hour

Measure	PF--04937319 100 mg n = 12	PF--04937319 250 mg n = 12
Value	6.50 (13)	6.50 (20)

Population analysed: PK parameter analysis population included all randomized participants who received at least 1 dose of PF-04937319 and who had at least 1 of PK parameters of interest calculated and available in at least 1 period.

16 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
PF--04937319 100 mg	0 of 12 (0%)	1 of 12 (8.3%)	Not reported
PF--04937319 250 mg	0 of 12 (0%)	6 of 12 (50%)	Not reported
Placebo	0 of 12 (0%)	1 of 12 (8.3%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
To obtain contact information for a study center near you, click here.Link provided by the sponsor.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Pfizer CT.gov Call Center study director

Pfizer

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing PF-04937319 high dose and PF-04937319 low dose in people with Type 2 Diabetes Mellitus, run by Pfizer at 1 site in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 15 Mar 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Treatment Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) (time frame: Baseline up to 14 days after the last dose of study drug (minimum 8 weeks to maximum of 17 weeks)). The study lists 14 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02292433.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Mar 2016.