Diabetes Mellitus, Type 2Phase 2NCT00618007
Effect of PF-00734200 in Subjects With Type 2 Diabetes
A Phase 2 study testing PF-00734200 30 mg QD and PF-00734200 20 mg QD in people with Diabetes Mellitus, Type 2, run by Pfizer at 79 sites in 4 countries.
Trial summary
To determine the effect of PF-00734200 on HbA1c in type 2 diabetic subjects receiving metformin Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- PF-00734200 30 mg QD and PF-00734200 20 mg QD
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 289 participants
- Where
- 79 sitesin 4 countries
- Study dates
- Feb 2008to Aug 2008
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men or women between 18-80 years of age with poorly controlled Type 2 diabetes
Who cannot join
- Type 1 or secondary forms of diabetes Currently using insulin
Trial locations and contacts
79 sites in 4 countries.
79 sites in 4 countries
United States69 sites
Pfizer Investigational Site
Aiken, South Carolina, 29801
Pfizer Investigational Site
Albuquerque, New Mexico, 87106
Pfizer Investigational Site
Ann Arbor, Michigan, 48106
Pfizer Investigational Site
Artesia, California, 90701
Pfizer Investigational Site
Baltimore, Maryland, 21204
Pfizer Investigational Site
Bay City, Michigan, 48706
Pfizer Investigational Site
Bennington, Vermont, 05201-5018
Pfizer Investigational Site
Birmingham, Alabama, 35205
Pfizer Investigational Site
Canton, Michigan, 48187
Pfizer Investigational Site
Cerritos, California, 90703
Pfizer Investigational Site
Chandler, Arizona, 85225
Pfizer Investigational Site
City of Saint Peters, Missouri, 63376
Pfizer Investigational Site
Conyers, Georgia, 30094
Pfizer Investigational Site
Cumberland, Rhode Island, 02864
Pfizer Investigational Site
Dallas, Texas, 75230
Pfizer Investigational Site
Dallas, Texas, 75235
Pfizer Investigational Site
DeFuniak Springs, Florida, 32435
Pfizer Investigational Site
El Paso, Texas, 79935
Pfizer Investigational Site
Elizabeth, New Jersey, 07202
Pfizer Investigational Site
Ettrick, Virginia, 23803
Pfizer Investigational Site
Eugene, Oregon, 97401
Pfizer Investigational Site
Florence, South Carolina, 29501
Pfizer Investigational Site
Fresno, California, 93720
Pfizer Investigational Site
Greenbrea, California, 94904
Pfizer Investigational Site
Houston, Texas, 77023
Pfizer Investigational Site
Houston, Texas, 77081
Pfizer Investigational Site
Huntington Beach, California, 92648
Pfizer Investigational Site
Hurst, Texas, 76054
Pfizer Investigational Site
Idaho Falls, Idaho, 83404
Pfizer Investigational Site
Indianapolis, Indiana, 46260
Pfizer Investigational Site
Jackson, Mississippi, 39209
Pfizer Investigational Site
Jacksonville, Florida, 32205
Pfizer Investigational Site
Kenosha, Wisconsin, 53142
Pfizer Investigational Site
Kingsport, Tennessee, 37660
Pfizer Investigational Site
Las Vegas, Nevada, 89128
Pfizer Investigational Site
Lexington, Kentucky, 40504
Pfizer Investigational Site
Litchfield Park, Arizona, 85340
Pfizer Investigational Site
Los Angeles, California, 90057
Pfizer Investigational Site
Madisonville, Kentucky, 42431
Pfizer Investigational Site
Marion, Ohio, 43302
Pfizer Investigational Site
Miami, Florida, 33143
Pfizer Investigational Site
Miami, Florida, 33169
Pfizer Investigational Site
National City, California, 91950
Pfizer Investigational Site
New Port Richey, Florida, 34652
Pfizer Investigational Site
Ocala, Florida, 34471
Pfizer Investigational Site
Odessa, Texas, 79761
Pfizer Investigational Site
Oxon Hill, Maryland, 20745
Pfizer Investigational Site
Pearland, Texas, 77584
Pfizer Investigational Site
Phoenix, Arizona, 85051
Pfizer Investigational Site
Picayune, Mississippi, 39466
Pfizer Investigational Site
Pinecrest, Florida, 33156
Pfizer Investigational Site
Richmond, Virginia, 23225
Pfizer Investigational Site
Roseville, California, 95661
Pfizer Investigational Site
Salt Lake City, Utah, 84107
Pfizer Investigational Site
San Antonio, Texas, 78229
Pfizer Investigational Site
Scarborough, Maine, 04074
Pfizer Investigational Site
Spokane, Washington, 99208
Pfizer Investigational Site
St Louis, Missouri, 63117
Pfizer Investigational Site
St Louis, Missouri, 63141
Pfizer Investigational Site
St. Petersburg, Florida, 33702
Pfizer Investigational Site
Syracuse, New York, 13210
Pfizer Investigational Site
Trenton, New Jersey, 08611
Pfizer Investigational Site
Troy, Michigan, 48098
Pfizer Investigational Site
Valley Village, California, 91607
Pfizer Investigational Site
Virginia Beach, Virginia, 23454
Pfizer Investigational Site
Virginia Beach, Virginia, 23455
Pfizer Investigational Site
West Covina, California, 91790
Pfizer Investigational Site
Wichita, Kansas, 67203
Pfizer Investigational Site
Winston-Salem, North Carolina, 27103
Canada5 sites
Pfizer Investigational Site
Coquitlam, British Columbia, V3K 3P4
Pfizer Investigational Site
Laval, Quebec, H7T 2P5
Pfizer Investigational Site
Pointe-Claire, Quebec, H9R 4S3
Pfizer Investigational Site
Québec, Quebec, G1V 4M6
Pfizer Investigational Site
Toronto, Ontario, M9W 4L6
South Korea4 sites
Pfizer Investigational Site
Seoul, 110-744
Pfizer Investigational Site
Seoul, 120-752
Pfizer Investigational Site
Seoul, 135-710
Pfizer Investigational Site
Seoul, 136-705
About this study
Official title: A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study To Evaluate The Efficacy And Safety Of 12-Week Administration Of PF-00734200 To Subjects With Type 2 Diabetes Mellitus And Insufficient Glycemic Control On Metformin Treatment
To determine the effect of PF-00734200 on HbA1c in type 2 diabetic subjects receiving metformin
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- PF-00734200 30 mg QD, PF-00734200 20 mg QD, Placebo
- 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-00734200 30 mg QDDrug
30 mg QD
PF-00734200 20 mg QDDrug
20 mg QD
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| 30 mg QD | Experimental | Not described Receives: Drug: PF-00734200 30 mg QD |
| 20 mg QD | Experimental | Not described Receives: Drug: PF-00734200 20 mg QD |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
HbA1c
Measured: 12 weeks
Secondary outcomes (2)
Fasting Glucose
Measured: 12 weeks
Fasting Insulin
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2008 (estimated)
- Study startFeb 2008
- Primary completionAug 2008
- Study completionAug 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 289 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00618007
- Sponsor's protocol ID
- A7941006
- Status last verified
- Jun 2011
- First submitted
- 5 Feb 2008
- Last updated
- 27 Jun 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study To Evaluate The Efficacy And Safety Of 12-Week Administration Of PF-00734200 To Subjects With Type 2 Diabetes Mellitus And Insufficient Glycemic Control On Metformin Treatment
- ClinicalTrials.gov ID
- NCT00618007
- Acronym / sponsor ID
- A7941006
- Conditions
- Diabetes Mellitus, Type 2
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 289 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Feb 2008
- Primary completion
- Aug 2008 (actual)
- Study completion
- Aug 2008 (actual)
- First posted
- 18 Feb 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To determine the effect of PF-00734200 on HbA1c in type 2 diabetic subjects receiving metformin
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 30 mg QD | Experimental | Drug: PF-00734200 30 mg QD |
| 20 mg QD | Experimental | Drug: PF-00734200 20 mg QD |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Men or women between 18-80 years of age with poorly controlled Type 2 diabetes
Key exclusion criteria (1 listed)
- Type 1 or secondary forms of diabetes Currently using insulin
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-00734200 30 mg QD30 mg QD | Drug | 30 mg QD |
| PF-00734200 20 mg QD20 mg QD | Drug | 20 mg QD |
| PlaceboPlacebo | Drug | Placebo |
Primary outcome
HbA1c
Time frame: 12 weeks
2 secondary outcomes
Fasting Glucose
Time frame: 12 weeks
Fasting Insulin
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2011.
- 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
79 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing PF-00734200 30 mg QD and PF-00734200 20 mg QD in people with Diabetes Mellitus, Type 2, run by Pfizer at 79 sites in 4 countries.
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 1 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 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 79 sites in United States, Canada, South Korea, Puerto Rico. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
HbA1c (time frame: 12 weeks). 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 Jun 2011.