Type 2 Diabetes MellitusPhase 1NCT01933672
Study Of Two Dosing Regimens Of PF-04937319 Compared To An Approved Agent (Sitagliptin) In Patients With Type 2 Diabetes
A Phase 1 study testing PF-04937319 once-daily, PF-04937319 split-dose and Sitagliptin once-daily in people with Type 2 Diabetes Mellitus, run by Pfizer at 8 sites in United States.
Trial summary
Study B1621019 will assess efficacy and safety of two different dosing regimens of an investigational agent (PF-04937319) compared to an approved drug (sitagliptin) in patients 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 once-daily, PF-04937319 split-dose and Sitagliptin once-daily
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 8 sitesUnited States
- Study dates
- Oct 2013to Mar 2014
- 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
- Patients with type 2 diabetes, on background metformin therapy either alone or with 1 other oral anti-diabetic agent (excluding Actos)
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
8 sites in 1 country.
8 sites in 1 country
United States8 sites
Community Research
Cincinnati, Ohio, 45255
Avail Clinical Research, LLC
DeLand, Florida, 32720
High Point Clinical Trials Center, LLC
High Point, North Carolina, 27265
Clinical Trials of Texas, Inc
San Antonio, Texas, 78229
Diabetes and Glandular Disease Clinic
San Antonio, Texas, 78229
Miami Research Associates, Inc.
South Miami, Florida, 33143
MRA Clinical Research, LLC
South Miami, Florida, 33143
Spaulding Clinical Research, LLC
West Bend, Wisconsin, 53095
About this study
Official title: A Phase 1b, Randomized, Double-blind, Active Comparator Controlled, 3-period, Cross-over Study To Characterize The Pharmacodynamics And Tolerability Of Two Dosing Regimens Of Pf-04937319 In Adults With Type 2 Diabetes Mellitus Inadequately Controlled On Metformin
Study B1621019 will assess efficacy and safety of two different dosing regimens of an investigational agent (PF-04937319) compared to an approved drug (sitagliptin) in patients with type 2 diabetes
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- PF-04937319 once-daily, PF-04937319 split-dose, Sitagliptin once-daily
- Keywords
- Phase 1b, type 2 diabetes, metformin background, 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 once-dailyDrug
Tablets, 300 mg once-daily with breakfast, 14-days
PF-04937319 split-doseDrug
tablets, 150 mg with breakfast plus 100 mg with lunch, 14-days
Sitagliptin once-dailyDrug
tablets, 100 mg once-daily with breakfast, 14-days
| Study group | Role | What they receive |
|---|---|---|
| PF-04937319 once-daily | Experimental | Not described Receives: Drug: PF-04937319 once-daily |
| PF-04937319 split-dose | Experimental | Not described Receives: Drug: PF-04937319 split-dose |
| Sitagliptin once-daily | Active comparator | Not described Receives: Drug: Sitagliptin once-daily |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Weighted Mean Daily Glucose (WMDG) at Day 14
Plasma glucose concentration was determined predose (Hour 0) and at 1.5, 3, 5, 6.5, 8, 11, 12.5, 14, 16, 20, and 24 hours postdose on Days 0 (baseline) and 14. WMDG was calculated as the area under the curve (AUC) of the 12-point plasma glucose concentration-time profile divided by 24 hours.
Measured: Prior to morning dose (Hour 0) and at 1.5, 3, 5, 6.5, 8, 11, 12.5, 14, 16, 20, and 24 hours post morning dose on Days 0 (baseline) and Day 14
Secondary outcomes (14)
Change From Baseline in Fasting Plasma Glucose (FPG) at Day 14
Blood samples for measurement of glucose to permit derivation of pre-meal collections at the pre-specified nominal timepoints of each period: predose (ie, time "0"), 1.5, 3, 5, 6.5, 8, 11, 12.5, 14, 16 and 20 hours on Day 0 (baseline) and Day 14; and predose on Days 1 and 15.
Measured: Day 14
Change From Baseline in Pre-meal C-Peptide on Day 14
Blood samples for measurement of glucose to permit derivation of pre-meal collections of blood samples for C-peptide at the pre-specified nominal timepoints at predose, 5 and 11 hours on Day 0 (baseline) and Day 14.
Measured: Day 14
Change From Baseline in Pre-meal Insulin on Day 14
Blood samples for measurement of glucose to permit derivation of pre-meal collections of blood samples for insulin at 0, 5 and 11 hours on Day 0 (baseline) and Day 14.
Measured: Day 14
Incidence of All Causality Treatment-Emergent Adverse Event by Preferred Term (Frequency Rate >5%)
Measured: Day 1 up to Day 14
Frequency of Laboratory Test Abnormalities Reported in Any Treatment Group
The total number of participants with laboratory test abnormalities (without regard to baseline abnormality) was assessed.
Measured: Day 1 up to Day 14
Change From Baseline in Body Weight (kg)
Measured: Day 1 up to Day 14
Number of Participants With Vital Signs Data Met Criteria of Potential Clinical Concern
Vital signs included blood pressure (BP; supine, sitting and standing) and pulse rate. Vital signs criteria of potential clinical concern were 1), BP: sitting systolic BP (SBP) greater than or equal to (>=) 30 millimeters of mercury (mm Hg) change from baseline, sitting SBP =<20 mmHg change from baseline, supine/sitting/standing SBP less than (<) 90 mm Hg; sitting diastolic BP (DBP) >=20 mm Hg change from baseline, sitting SBP =<20 mmHg change from baseline, supine/sitting/standing DBP <50 mm Hg; 2), pulse rate (supine): <40 or greater than (>) 120 beats per minute (bpm).
Measured: Day 1 up to Day 14
Number of Participants With Post-baseline Electrocardiograms (ECGs) Data Met Criteria of Potential Clinical Concern
ECG criteria of potential clinical concern were 1), PR interval: >=300 milliseconds (msec); >=25% increase when baseline >200 msec; or increase >=50% when baseline <=200 msec; 2), QRS interval: >=140 msec; >=50% increase from baseline; 3), QTc interval using Fridericia's formula (QTcF interval): absolute value >=450 - <480 msec, >=480-<500 msec, >500 msec; absolute change 30 - <60, >=60 msec.
Measured: Day 1 up to Day 14
Plasma PF-04937319 Area Under the Concentration Time Curve From Time 0 to 24 Hours (AUC24) of PF-04937319 at Day 14
The PK parameters were summarized descriptively by treatment as appropriate. Two (2) PK parameters specified in the protocol and SAP were not reported: AUClast was not reported since it was the same as AUC24 in this study, and apparent volume of distribution (Vz/F) was not reported since the log-linear terminal phase of the concentration-time profiles was not consistently well characterized in the 24-hour sampling period.
Measured: Predose, 1.5, 3, 5, 6.5, 8, 11, 12.5, and 14 hours on Days 0 and 14; and predose on Days 7 and 15.
Plasma PF-04937319 Apparent Clearance (CL/F) on Day 14
The PK parameters were summarized descriptively by treatment as appropriate. 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 fraction of the dose absorbed. Clearance was estimated from population PK modeling. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.
Measured: Predose, 1.5, 3, 5, 6.5, 8, 11, 12.5, and 14 hours on Days 0 and 14; and predose on Days 7 and 15.
Plasma PF-04937319 Average Concentration Over the 24-hour Period (Cav) on Day 14
Cav was average concentration over the 24-hour period. The PK parameters were summarized descriptively by treatment as appropriate.
Measured: Predose, 1.5, 3, 5, 6.5, 8, 11, 12.5, and 14 hours on Days 0 and 14; and predose on Days 7 and 15.
Plasma PF-04937319 Highest Observed Concentration (Cmax) on Day 14
Cmax was highest observed concentration. The PK parameters were summarized descriptively by treatment as appropriate.
Measured: Predose, 1.5, 3, 5, 6.5, 8, 11, 12.5, and 14 hours on Days 0 and 14; and predose on Days 7 and 15.
Plasma PF-04937319 Lowest Observed Concentration During the 24-hour Period (Cmin) on Day 14
Cmin lowest observed concentration during the 24-hour period. The PK parameters were summarized descriptively by treatment as appropriate.
Measured: Predose, 1.5, 3, 5, 6.5, 8, 11, 12.5, and 14 hours on Days 0 and 14; and predose on Days 7 and 15.
Plasma PF-04937319 Time for Cmax (Tmax) on Day 14
Tmax was time of maximum concentration. The PK parameters were summarized descriptively by treatment as appropriate.
Measured: Predose, 1.5, 3, 5, 6.5, 8, 11, 12.5, and 14 hours on Days 0 and 14; and predose on Days 7 and 15.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2013 (estimated)
- Study startOct 2013
- Primary completionMar 2014
- Study completionMar 2014
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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01933672
- Sponsor's protocol ID
- B1621019
- Status last verified
- Aug 2016
- First submitted
- 28 Aug 2013
- Last updated
- 27 Sep 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1b, Randomized, Double-blind, Active Comparator Controlled, 3-period, Cross-over Study To Characterize The Pharmacodynamics And Tolerability Of Two Dosing Regimens Of Pf-04937319 In Adults With Type 2 Diabetes Mellitus Inadequately Controlled On Metformin
- ClinicalTrials.gov ID
- NCT01933672
- Acronym / sponsor ID
- B1621019
- Conditions
- Type 2 Diabetes Mellitus
- Keywords
- Phase 1b, type 2 diabetes, metformin background, PF-04937319
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Oct 2013
- Primary completion
- Mar 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 2 Sep 2013 (estimated)
- Results
- Posted 27 Sep 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Study B1621019 will assess efficacy and safety of two different dosing regimens of an investigational agent (PF-04937319) compared to an approved drug (sitagliptin) in patients with type 2 diabetes
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| PF-04937319 once-daily | Experimental | Drug: PF-04937319 once-daily |
| PF-04937319 split-dose | Experimental | Drug: PF-04937319 split-dose |
| Sitagliptin once-daily | Active comparator | Drug: Sitagliptin once-daily |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with type 2 diabetes, on background metformin therapy either alone or with 1 other oral anti-diabetic agent (excluding Actos)
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 once-dailyTablets, 300 mg once-daily with breakfast, 14-days | Drug | PF-04937319 once-daily |
| PF-04937319 split-dosetablets, 150 mg with breakfast plus 100 mg with lunch, 14-days | Drug | PF-04937319 split-dose |
| Sitagliptin once-dailytablets, 100 mg once-daily with breakfast, 14-days | Drug | Sitagliptin once-daily |
Primary outcome
Change From Baseline in Weighted Mean Daily Glucose (WMDG) at Day 14
Time frame: Prior to morning dose (Hour 0) and at 1.5, 3, 5, 6.5, 8, 11, 12.5, 14, 16, 20, and 24 hours post morning dose on Days 0 (baseline) and Day 14
Plasma glucose concentration was determined predose (Hour 0) and at 1.5, 3, 5, 6.5, 8, 11, 12.5, 14, 16, 20, and 24 hours postdose on Days 0 (baseline) and 14. WMDG was calculated as the area under the curve (AUC) of the 12-point plasma glucose concentration-time profile divided by 24 hours.
14 secondary outcomes
Change From Baseline in Fasting Plasma Glucose (FPG) at Day 14
Time frame: Day 14
Change From Baseline in Pre-meal C-Peptide on Day 14
Time frame: Day 14
Change From Baseline in Pre-meal Insulin on Day 14
Time frame: Day 14
Incidence of All Causality Treatment-Emergent Adverse Event by Preferred Term (Frequency Rate >5%)
Time frame: Day 1 up to Day 14
Frequency of Laboratory Test Abnormalities Reported in Any Treatment Group
Time frame: Day 1 up to Day 14
Change From Baseline in Body Weight (kg)
Time frame: Day 1 up to Day 14
Number of Participants With Vital Signs Data Met Criteria of Potential Clinical Concern
Time frame: Day 1 up to Day 14
Number of Participants With Post-baseline Electrocardiograms (ECGs) Data Met Criteria of Potential Clinical Concern
Time frame: Day 1 up to Day 14
Plasma PF-04937319 Area Under the Concentration Time Curve From Time 0 to 24 Hours (AUC24) of PF-04937319 at Day 14
Time frame: Predose, 1.5, 3, 5, 6.5, 8, 11, 12.5, and 14 hours on Days 0 and 14; and predose on Days 7 and 15.
Plasma PF-04937319 Apparent Clearance (CL/F) on Day 14
Time frame: Predose, 1.5, 3, 5, 6.5, 8, 11, 12.5, and 14 hours on Days 0 and 14; and predose on Days 7 and 15.
Plasma PF-04937319 Average Concentration Over the 24-hour Period (Cav) on Day 14
Time frame: Predose, 1.5, 3, 5, 6.5, 8, 11, 12.5, and 14 hours on Days 0 and 14; and predose on Days 7 and 15.
Plasma PF-04937319 Highest Observed Concentration (Cmax) on Day 14
Time frame: Predose, 1.5, 3, 5, 6.5, 8, 11, 12.5, and 14 hours on Days 0 and 14; and predose on Days 7 and 15.
Plasma PF-04937319 Lowest Observed Concentration During the 24-hour Period (Cmin) on Day 14
Time frame: Predose, 1.5, 3, 5, 6.5, 8, 11, 12.5, and 14 hours on Days 0 and 14; and predose on Days 7 and 15.
Plasma PF-04937319 Time for Cmax (Tmax) on Day 14
Time frame: Predose, 1.5, 3, 5, 6.5, 8, 11, 12.5, and 14 hours on Days 0 and 14; and predose on Days 7 and 15.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 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
8 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 once-daily, PF-04937319 split-dose and Sitagliptin once-daily in people with Type 2 Diabetes Mellitus, run by Pfizer at 8 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 27 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 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 27 Sep 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?
Change From Baseline in Weighted Mean Daily Glucose (WMDG) at Day 14 (time frame: Prior to morning dose (Hour 0) and at 1.5, 3, 5, 6.5, 8, 11, 12.5, 14, 16, 20, and 24 hours post morning dose on Days 0 (baseline) and Day 14). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Sep 2016.