Type 2 Diabetes MellitusPhase 1NCT02206607

Study To Compare Single Dose Of Three Modified Release Formulations Of PF-04937319 With Immediate Release Material-Sparing-Tablet (IR MST) Formulation Previously Studied In Adults With Type 2 Diabetes Mellitus.

A Phase 1 study testing PF-04937319 IR MST, PF-04937319 MR 1 and PF-04937319 MR 2 in people with Type 2 Diabetes Mellitus, run by Pfizer at 2 sites in United States.

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 B1621015 will characterize bioavailability, tolerability and pharmacodynamics of three modified release formulations of PF-04937319 compared with the immediate release material-sparing-tablet (IR MST) formulation in adults with type 2 diabetes. Read more about this study

Who is it for?: Ages 18 to 70 years
Conditions the study is for: Type 2 Diabetes Mellitus
What is being tested?: PF-04937319 IR MST, PF-04937319 MR 1 and PF-04937319 MR 2
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 39 participants
Where: 2 sitesUnited States
Study dates: Sep 2014to Jan 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 18 to 70 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Adults with type 2 diabetes, on stable background metformin therapy either alone or in combination with another oral anti-diabetic agent (OAD) excluding thiazolidinediones (TZDs)

Who cannot join

Patients with cardiovascular event within 6 months of screening
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

2 sites in 1 country.

United States2 sites

High Point Clinical Trials Center
High Point, North Carolina, 27265
Clinical Trials of Texas, Inc.
San Antonio, Texas, 78229

Other trials in United States

About this study

Official title: A Phase 1, Randomized, Open-label, Cross-over, Single-day Study Of Pf-04937319 To Characterize Relative Bioavailability, Tolerability, And Pharmacodynamics Of Four Oral Formulations In Adults With Type 2 Diabetes Mellitus Inadequately Controlled On Metformin

Conditions: Type 2 Diabetes Mellitus
Being tested: PF-04937319 IR MST, PF-04937319 MR 1, PF-04937319 MR 2, PF-04937319 MR 3
Keywords: Phase 1, bioavailability, type 2 diabetes mellitus, 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 IR MSTDrug
Immediate release material sparing tablet (IR MST) administered as 150 mg with morning meal and 100 mg with lunch
PF-04937319 MR 1Drug
Modified release formulation #1 administered with the morning meal at a dose predicted to yield exposure (AUC24) equivalent to 300 mg IR MST
PF-04937319 MR 2Drug
Modified release formulation #2 administered with the morning meal at a dose predicted to yield exposure (AUC24) equivalent to 300 mg IR MST
PF-04937319 MR 3Drug
Modified release formulation #3 administered with the morning meal at a dose predicted to yield exposure (AUC24) equivalent to 300 mg IR MST

Study groups in NCT02206607
Study group	Role	What they receive
PF-04937319 IR MST	Experimental	Reference formulation Receives: Drug: PF-04937319 IR MST
PF-04937319 MR 1	Experimental	Test MR #1 Receives: Drug: PF-04937319 MR 1
PF-04937319 MR 2	Experimental	Test MR #2 Receives: Drug: PF-04937319 MR 2
PF-04937319 MR 3	Experimental	Test MR #3 Receives: Drug: PF-04937319 MR 3

What is being measured

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

Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUCinf]
AUCinf is the area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time.
Measured: 0 (pre-dose) and 1, 2, 3, 4, 5, 6, 7, 8, 11, 12.5, 14, 16, 20, 24, 36, 48, and 72 hours post-dose
Change From Reference in Weighted-Mean-Daily-Glucose (WMDG) on Day 1
MWG was calculated as the area under the curve (AUC) for the full 24 hours expressed.
Measured: 0 (pre-dose) and 1, 2, 3, 4, 5, 6, 7, 8, 11, 12.5, 14, 16, 20, and 24 hours post-dose

Secondary outcomes (9)

Maximum Observed PF-04937319 Plasma Concentration (Cmax)
Measured: 0 (pre-dose) and 1, 2, 3, 4, 5, 6, 7, 8, 11, 12.5, 14, 16, 20, 24, 36, 48, and 72 hours post-dose
PF-04937319 Plasma Concentration at 5 Hours After Morning Dose (C5)
Measured: 0 (pre-dose) and 1, 2, 3, 4, 5, 6, 7, 8, 11, 12.5, 14, 16, 20, 24, 36, 48, and 72 hours post-dose
PF-04937319 Plasma Concentration at 16 Hours After Morning Dose (C16)
Measured: 0 (pre-dose) and 1, 2, 3, 4, 5, 6, 7, 8, 11, 12.5, 14, 16, 20, 24, 36, 48, and 72 hours post-dose
PF-04937319 Plasma Concentration at 24 Hours After Morning Dose (C24)
Measured: 0 (pre-dose) and 1, 2, 3, 4, 5, 6, 7, 8, 11, 12.5, 14, 16, 20, 24, 36, 48, and 72 hours post-dose
Ratio of Maximum to Approximate Trough PF-04937319 Concentration (Cmax/C24)
Cmax/C24 is the ratio of maximum to approximate trough concentration, where Cmax is the overall maximum observed plasma concentration and C24 is the plasma concentration at 24 hours after the morning dose.
Measured: 0 (pre-dose) and 1, 2, 3, 4, 5, 6, 7, 8, 11, 12.5, 14, 16, 20, 24, 36, 48, and 72 hours post-dose
Time to Reach Maximum Observed PF-04937319 Plasma Concentration (Tmax)
Measured: 0 (pre-dose) and 1, 2, 3, 4, 5, 6, 7, 8, 11, 12.5, 14, 16, 20, 24, 36, 48, and 72 hours post-dose
Area Under the Curve From Time Zero to Last Quantifiable PF-04937319 Concentration (AUClast)
Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)
Measured: 0 (pre-dose) and 1, 2, 3, 4, 5, 6, 7, 8, 11, 12.5, 14, 16, 20, 24, 36, 48, and 72 hours post-dose
Terminal Elimination Half-Life (t1/2)
t1/2 is the time measured for the plasma concentration to decrease by one half.
Measured: 0 (pre-dose) and 1, 2, 3, 4, 5, 6, 7, 8, 11, 12.5, 14, 16, 20, 24, 36, 48, and 72 hours post-dose
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. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pre-treatment state. AEs included both SAEs and non-SAEs.
Measured: Baseline up to 28 days after last study drug administration in Period 4

Timeline

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

Sep 2014Jan 2015

First posted1 Aug 2014 (estimated)
Study startSep 2014
Primary completionJan 2015
Study completionJan 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: None (open label)
Enrolment: 39 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02206607
Sponsor's protocol ID: B1621015
Status last verified: Feb 2016
First submitted: 30 Jul 2014
Last updated: 4 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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All Type 2 Diabetes Mellitus trials

Study at a glance

From the registry record, last updated by the sponsor on 4 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 1, Randomized, Open-label, Cross-over, Single-day Study Of Pf-04937319 To Characterize Relative Bioavailability, Tolerability, And Pharmacodynamics Of Four Oral Formulations In Adults With Type 2 Diabetes Mellitus Inadequately Controlled On Metformin
ClinicalTrials.gov ID: NCT02206607
Acronym / sponsor ID: B1621015
Conditions: Type 2 Diabetes Mellitus
Keywords: Phase 1, bioavailability, type 2 diabetes mellitus, PF-04937319
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 39 participants (actual)
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Study start: Sep 2014
Primary completion: Jan 2015 (actual)
Study completion: Jan 2015 (actual)
First posted: 1 Aug 2014 (estimated)
Results: Posted 4 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 design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 4

Arm	Type	Receives
PF-04937319 IR MST	Experimental	Drug: PF-04937319 IR MSTReference formulation
PF-04937319 MR 1	Experimental	Drug: PF-04937319 MR 1Test MR #1
PF-04937319 MR 2	Experimental	Drug: PF-04937319 MR 2Test MR #2
PF-04937319 MR 3	Experimental	Drug: PF-04937319 MR 3Test MR #3

Who may qualify

Ages: 18 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

Adults with type 2 diabetes, on stable background metformin therapy either alone or in combination with another oral anti-diabetic agent (OAD) excluding thiazolidinediones (TZDs)

Key exclusion criteria (4 listed)

Patients with cardiovascular event within 6 months of screening
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 IR MSTImmediate release material sparing tablet (IR MST) administered as 150 mg with morning meal and 100 mg with lunch	Drug	PF-04937319 IR MST
PF-04937319 MR 1Modified release formulation #1 administered with the morning meal at a dose predicted to yield exposure (AUC24) equivalent to 300 mg IR MST	Drug	PF-04937319 MR 1
PF-04937319 MR 2Modified release formulation #2 administered with the morning meal at a dose predicted to yield exposure (AUC24) equivalent to 300 mg IR MST	Drug	PF-04937319 MR 2
PF-04937319 MR 3Modified release formulation #3 administered with the morning meal at a dose predicted to yield exposure (AUC24) equivalent to 300 mg IR MST	Drug	PF-04937319 MR 3

Primary outcome

Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUCinf]
Time frame: 0 (pre-dose) and 1, 2, 3, 4, 5, 6, 7, 8, 11, 12.5, 14, 16, 20, 24, 36, 48, and 72 hours post-dose
AUCinf is the area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time.
Change From Reference in Weighted-Mean-Daily-Glucose (WMDG) on Day 1
Time frame: 0 (pre-dose) and 1, 2, 3, 4, 5, 6, 7, 8, 11, 12.5, 14, 16, 20, and 24 hours post-dose
MWG was calculated as the area under the curve (AUC) for the full 24 hours expressed.

9 secondary outcomes

Maximum Observed PF-04937319 Plasma Concentration (Cmax)
Time frame: 0 (pre-dose) and 1, 2, 3, 4, 5, 6, 7, 8, 11, 12.5, 14, 16, 20, 24, 36, 48, and 72 hours post-dose
PF-04937319 Plasma Concentration at 5 Hours After Morning Dose (C5)
Time frame: 0 (pre-dose) and 1, 2, 3, 4, 5, 6, 7, 8, 11, 12.5, 14, 16, 20, 24, 36, 48, and 72 hours post-dose
PF-04937319 Plasma Concentration at 16 Hours After Morning Dose (C16)
Time frame: 0 (pre-dose) and 1, 2, 3, 4, 5, 6, 7, 8, 11, 12.5, 14, 16, 20, 24, 36, 48, and 72 hours post-dose
PF-04937319 Plasma Concentration at 24 Hours After Morning Dose (C24)
Time frame: 0 (pre-dose) and 1, 2, 3, 4, 5, 6, 7, 8, 11, 12.5, 14, 16, 20, 24, 36, 48, and 72 hours post-dose
Ratio of Maximum to Approximate Trough PF-04937319 Concentration (Cmax/C24)
Time frame: 0 (pre-dose) and 1, 2, 3, 4, 5, 6, 7, 8, 11, 12.5, 14, 16, 20, 24, 36, 48, and 72 hours post-dose
Time to Reach Maximum Observed PF-04937319 Plasma Concentration (Tmax)
Time frame: 0 (pre-dose) and 1, 2, 3, 4, 5, 6, 7, 8, 11, 12.5, 14, 16, 20, 24, 36, 48, and 72 hours post-dose
Area Under the Curve From Time Zero to Last Quantifiable PF-04937319 Concentration (AUClast)
Time frame: 0 (pre-dose) and 1, 2, 3, 4, 5, 6, 7, 8, 11, 12.5, 14, 16, 20, 24, 36, 48, and 72 hours post-dose
Terminal Elimination Half-Life (t1/2)
Time frame: 0 (pre-dose) and 1, 2, 3, 4, 5, 6, 7, 8, 11, 12.5, 14, 16, 20, 24, 36, 48, and 72 hours post-dose
Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)
Time frame: Baseline up to 28 days after last study drug administration in Period 4

Results and safety

Results posted to the registry on 4 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
Metformin Run-In	42	39
Sequence ADBC: PF-04937319 150+100 mg IR First	0	0
Sequence BACD: PF-04937319 250 mg MR1 First	0	0
Sequence CBDA: PF-04937319 300 mg MR2 First	0	0
Sequence DCAB: PF-04937319 330 mg MR3 First	0	0

Primary outcome: Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUCinf]

Time frame: 0 (pre-dose) and 1, 2, 3, 4, 5, 6, 7, 8, 11, 12.5, 14, 16, 20, 24, 36, 48, and 72 hours post-dose. Geometric mean (Geometric Coefficient of Variation). Unit: nanogram*hour/milliliter (ng*hr/mL)

Measure	PF-04937319 150+100 mg IR n = 38	PF-04937319 250 mg MR1 n = 31	PF-04937319 300 mg MR2 n = 37	PF-04937319 330 mg MR3 n = 36
Value	10690 (26)	3187 (59)	2725 (35)	3430 (37)

PF-04937319 150+100 mg IR vs PF-04937319 250 mg MR1: Adjusted Geometric Mean Ratio MR1/IR: 31.27 (90% CI 28.09 to 34.80)
PF-04937319 150+100 mg IR vs PF-04937319 300 mg MR2: Adjusted Geometric Mean Ratio MR2/IR: 25.56 (90% CI 23.11 to 28.27)
PF-04937319 150+100 mg IR vs PF-04937319 330 mg MR3: Adjusted Geometric Mean Ratio MR3/IR: 32.04 (90% CI 28.93 to 35.49)

Population analysed: The 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 the PK parameters of interest measured and available in at least 1 period; number of participants analyzed (N) is number of evaluable participants for this outcome measure.

Primary outcome: Change From Reference in Weighted-Mean-Daily-Glucose (WMDG) on Day 1

Time frame: 0 (pre-dose) and 1, 2, 3, 4, 5, 6, 7, 8, 11, 12.5, 14, 16, 20, and 24 hours post-dose. Mean (Standard Deviation). Unit: milligrams per deciliter (mg/dL)

Measure	PF-04937319 150+100 mg IR n = 36	PF-04937319 250 mg MR1 n = 36	PF-04937319 300 mg MR2 n = 36	PF-04937319 330 mg MR3 n = 36
Observed (n=36,33,32,35)	159.47 (42.949)	176.24 (42.648)	170.85 (38.928)	180.47 (50.099)
Change From Reference (36,33,32,35)	NA (NA)	15.55 (19.358)	15.96 (17.122)	20.15 (20.005)

PF-04937319 150+100 mg IR vs PF-04937319 250 mg MR1: Least Square Mean: 15.72 (80% CI 11.39 to 20.06), p = 1.0000, Mixed Models Analysis
PF-04937319 150+100 mg IR vs PF-04937319 300 mg MR2: Least Square Mean: 16.31 (80% CI 11.93 to 20.70), p = 1.000, Mixed Models Analysis
PF-04937319 150+100 mg IR vs PF-04937319 330 mg MR3: Least Square Mean: 20.38 (80% CI 16.13 to 24.62), p = 1.0000, Mixed Models Analysis

Population analysed: The pharmacodynamic analysis included participants who had taken at least 1 dose of PF-04937319 and who had WMDG assessment for at least 1 modified-release formulation and the Reference (IR MST) formulation; n=number of participants evaluated in respective arms for category.

9 secondary outcomes are reported in the full results.

Adverse events

Time frame: Baseline up to 28 days after last study drug administration in Period 4. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Metformin Run-In	0 of 42 (0%)	1 of 42 (2.4%)	Not reported
PF-04937319 150+100 mg IR	0 of 38 (0%)	11 of 38 (28.9%)	Not reported
PF-04937319 250 mg MR1	0 of 39 (0%)	6 of 39 (15.4%)	Not reported
PF-04937319 300 mg MR2	0 of 39 (0%)	10 of 39 (25.6%)	Not reported
PF-04937319 330 mg MR3	0 of 38 (0%)	5 of 38 (13.2%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 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

2 sites 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 IR MST, PF-04937319 MR 1 and PF-04937319 MR 2 in people with Type 2 Diabetes Mellitus, run by Pfizer at 2 sites in United States.

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 4 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 2 sites in United States. 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. 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 4 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?

Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUCinf] (time frame: 0 (pre-dose) and 1, 2, 3, 4, 5, 6, 7, 8, 11, 12.5, 14, 16, 20, 24, 36, 48, and 72 hours post-dose). The study lists 2 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 NCT02206607.

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 4 Mar 2016.