Diabetes Mellitus, Type 2Phase 2NCT00473525
12 Week Study Of PF-00734200 For The Treatment Of Type 2 Diabetes Mellitus In Subjects Treated With Metformin
A Phase 2 study testing PF-00734200 10 mg QD, PF-00734200 20 mg QD and PF-00734200 5 mg QD in people with Diabetes Mellitus, Type 2, run by Pfizer at 79 sites in 6 countries.
Trial summary
The purpose of this Phase 2a study is to evaluate the efficacy, safety and tolerability, of multiple parallel doses of PF-00734200 following oral administration to adult human subjects with T2DM who currently are on a stable dose of metformin. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- PF-00734200 10 mg QD, PF-00734200 20 mg QD and PF-00734200 5 mg QD
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 303 participants
- Where
- 79 sitesin 6 countries
- Study dates
- Jul 2007to Jun 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of type 2 diabetes
- Hb1AC >7%-11% inclusive
- Male and females 18-70; females must be post-menopausal
- On a stable dose of metformin hydrochloride
Who cannot join
- Medical history of stroke, unstable angina, heart attack within one year of enrollment, and alcohol dependency or recent drug abuse.
- Women of childbearing potential, pregnant or nursing
- Evidence of diabetic complications with significant end-organ damage
Trial locations and contacts
79 sites in 6 countries.
79 sites in 6 countries
United States64 sites
Pfizer Investigational Site
Ann Arbor, Michigan, 48106
Pfizer Investigational Site
Atlanta, Georgia, 30342
Pfizer Investigational Site
Bartlett, Tennessee, 38134
Pfizer Investigational Site
Biloxi, Mississippi, 39531
Pfizer Investigational Site
Birmingham, Alabama, 35209
Pfizer Investigational Site
Brockton, Massachusetts, 02301
Pfizer Investigational Site
Canton, Michigan, 48187
Pfizer Investigational Site
Carmichael, California, 95608
Pfizer Investigational Site
Carnegie, Pennsylvania, 15106
Pfizer Investigational Site
Cary, North Carolina, 27518
Pfizer Investigational Site
Chicago, Illinois, 60607
Pfizer Investigational Site
Chula Vista, California, 91911
Pfizer Investigational Site
Collierville, Tennessee, 38017
Pfizer Investigational Site
Conyers, Georgia, 30094
Pfizer Investigational Site
Dallas, Texas, 75230
Pfizer Investigational Site
DeFuniak Springs, Florida, 32435
Pfizer Investigational Site
Destin, Florida, 32541
Pfizer Investigational Site
East Providence, Rhode Island, 02914
Pfizer Investigational Site
Fair Oaks, California, 95628
Pfizer Investigational Site
Flint, Michigan, 48532
Pfizer Investigational Site
Gilbert, Arizona, 85296
Pfizer Investigational Site
Houston, Texas, 77023
Pfizer Investigational Site
Houston, Texas, 77074
Pfizer Investigational Site
Houston, Texas, 77079
Pfizer Investigational Site
Houston, Texas, 77081
Pfizer Investigational Site
Irving, Texas, 75039
Pfizer Investigational Site
Jacksonville, Florida, 32216
Pfizer Investigational Site
Jonesboro, Arkansas, 72401
Pfizer Investigational Site
Kingsport, Tennessee, 37660
Pfizer Investigational Site
Las Vegas, Nevada, 89119
Pfizer Investigational Site
Las Vegas, Nevada, 89128
Pfizer Investigational Site
Las Vegas, Nevada, 89148
Pfizer Investigational Site
Lexington, Kentucky, 40503
Pfizer Investigational Site
Lexington, Kentucky, 40504
Pfizer Investigational Site
Little Rock, Arkansas, 72205-6217
Pfizer Investigational Site
Los Angeles, California, 90057
Pfizer Investigational Site
Marion, Ohio, 43302
Pfizer Investigational Site
Milwaukee, Wisconsin, 53209
Pfizer Investigational Site
National City, California, 91950
Pfizer Investigational Site
New Port Richey, Florida, 34652
Pfizer Investigational Site
New Port Richey, Florida, 34653
Pfizer Investigational Site
Oklahoma City, Oklahoma, 73103
Pfizer Investigational Site
Oklahoma City, Oklahoma, 73119
Pfizer Investigational Site
Omaha, Nebraska, 68114
Pfizer Investigational Site
Palm Harbor, Florida, 34684
Pfizer Investigational Site
Paramount, California, 90273
Pfizer Investigational Site
Phoenix, Arizona, 85013
Pfizer Investigational Site
Phoenix, Arizona, 85016
Pfizer Investigational Site
Picayune, Mississippi, 39466
Pfizer Investigational Site
Raleigh, North Carolina, 27609
Pfizer Investigational Site
Raleigh, North Carolina, 27612
Pfizer Investigational Site
Richmond, Virginia, 23225
Pfizer Investigational Site
Roseville, California, 95661
Pfizer Investigational Site
Sacramento, California, 95825
Pfizer Investigational Site
San Antonio, Texas, 78229
Pfizer Investigational Site
San Antonio, Texas, 78237
Pfizer Investigational Site
Skokie, Illinois, 60076
Pfizer Investigational Site
Skokie, Illinois, 60077
Pfizer Investigational Site
St Louis, Missouri, 63141
Pfizer Investigational Site
Trenton, New Jersey, 08611
Pfizer Investigational Site
Virginia Beach, Virginia, 23455
Pfizer Investigational Site
West Palm Beach, Florida, 33401
Pfizer Investigational Site
Wheeling, Illinois, 60090
Pfizer Investigational Site
Worcester, Massachusetts, 01602
Germany4 sites
Pfizer Investigational Site
Berlin, 10787
Pfizer Investigational Site
Giengen an der Brenz, 89537
Pfizer Investigational Site
Hamburg, 21073
Pfizer Investigational Site
München, 81241
Spain4 sites
Pfizer Investigational Site
Alcalá de Henares, Madrid, 28805
Pfizer Investigational Site
Santiago de Compostela, La Coruña, 15706
Pfizer Investigational Site
Valencia, Valencia, 46009
Pfizer Investigational Site
Valencia, Valencia, 46014
Colombia3 sites
Pfizer Investigational Site
Bogota, Cundinamarca, 0
Pfizer Investigational Site
Bogota, Cundinamarca
Pfizer Investigational Site
Floridablanca, Santander Department, 0
Sweden3 sites
Pfizer Investigational Site
Gothenburg, 41665
Pfizer Investigational Site
Malmö, 21136
Pfizer Investigational Site
Stockholm, 111 57
About this study
Official title: A Phase 2a, Randomized, Placebo-Controlled, Parallel Group, Multiple-Dose Study To Evaluate The Efficacy, Safety, And Tolerability Of 12-Week Oral Administration Of PF-00734200 Tablets To Subjects With Type 2 Diabetes Mellitus On Stable Treatment With Metformin
The purpose of this Phase 2a study is to evaluate the efficacy, safety and tolerability, of multiple parallel doses of PF-00734200 following oral administration to adult human subjects with T2DM who currently are on a stable dose of metformin.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Placebo, PF-00734200 10 mg QD, PF-00734200 20 mg QD, PF-00734200 5 mg QD, PF-00734200 2 mg QD
- 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.
PlaceboDrug
Placebo QD
PF-00734200 10 mg QDDrug
10 mg QD
PF-00734200 20 mg QDDrug
20 mg QD
PF-00734200 5 mg QDDrug
5 mg QD
PF-00734200 2 mg QDDrug
2 mg QD
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
| PF-00734200 10 mg QD | Experimental | Not described Receives: Drug: PF-00734200 10 mg QD |
| PF-00734200 20 mg QD | Experimental | Not described Receives: Drug: PF-00734200 20 mg QD |
| PF-00734200 5 mg QD | Experimental | Not described Receives: Drug: PF-00734200 5 mg QD |
| PF-00734200 2 mg QD | Experimental | Not described Receives: Drug: PF-00734200 2 mg QD |
What is being measured
The primary outcome is the main question the study is designed to answer.
HbA1C levels (%)
Measured: 12 weeks
Evaluation of Dose Response in HbA1c (%)
Measured: 12 weeks
Secondary outcomes (3)
Insulin and Glucose AUC following a mixed meal tolerance test
Measured: 12 weeks
Proportion of subjects achieving ADA glycemic goal of Hb A1c <7%
Measured: 12 weeks
Incidence of Adverse Events
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 posted15 May 2007 (estimated)
- Study startJul 2007
- Primary completionJun 2008
- Study completionJun 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
- 303 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
- NCT00473525
- Sponsor's protocol ID
- A7941005
- Status last verified
- Jun 2010
- First submitted
- 14 May 2007
- Last updated
- 24 Jun 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2a, Randomized, Placebo-Controlled, Parallel Group, Multiple-Dose Study To Evaluate The Efficacy, Safety, And Tolerability Of 12-Week Oral Administration Of PF-00734200 Tablets To Subjects With Type 2 Diabetes Mellitus On Stable Treatment With Metformin
- ClinicalTrials.gov ID
- NCT00473525
- Acronym / sponsor ID
- A7941005
- Conditions
- Diabetes Mellitus, Type 2
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 303 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Jul 2007
- Primary completion
- Jun 2008 (actual)
- Study completion
- Jun 2008 (actual)
- First posted
- 15 May 2007 (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.
The purpose of this Phase 2a study is to evaluate the efficacy, safety and tolerability, of multiple parallel doses of PF-00734200 following oral administration to adult human subjects with T2DM who currently are on a stable dose of metformin.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Placebo |
| PF-00734200 10 mg QD | Experimental | Drug: PF-00734200 10 mg QD |
| PF-00734200 20 mg QD | Experimental | Drug: PF-00734200 20 mg QD |
| PF-00734200 5 mg QD | Experimental | Drug: PF-00734200 5 mg QD |
| PF-00734200 2 mg QD | Experimental | Drug: PF-00734200 2 mg QD |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosis of type 2 diabetes
- Hb1AC >7%-11% inclusive
- Male and females 18-70; females must be post-menopausal
- On a stable dose of metformin hydrochloride
Key exclusion criteria (3 listed)
- Medical history of stroke, unstable angina, heart attack within one year of enrollment, and alcohol dependency or recent drug abuse.
- Women of childbearing potential, pregnant or nursing
- Evidence of diabetic complications with significant end-organ damage
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 |
|---|---|---|
| PlaceboPlacebo QD | Drug | Placebo |
| PF-00734200 10 mg QD10 mg QD | Drug | PF-00734200 10 mg QD |
| PF-00734200 20 mg QD20 mg QD | Drug | PF-00734200 20 mg QD |
| PF-00734200 5 mg QD5 mg QD | Drug | PF-00734200 5 mg QD |
| PF-00734200 2 mg QD2 mg QD | Drug | PF-00734200 2 mg QD |
Primary outcome
HbA1C levels (%)
Time frame: 12 weeks
Evaluation of Dose Response in HbA1c (%)
Time frame: 12 weeks
3 secondary outcomes
Insulin and Glucose AUC following a mixed meal tolerance test
Time frame: 12 weeks
Proportion of subjects achieving ADA glycemic goal of Hb A1c <7%
Time frame: 12 weeks
Incidence of Adverse Events
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 24 Jun 2010.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
Related trials for Diabetes Mellitus, Type 2
Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
Not yet recruiting
Impact of Endoscopic Sleeve Gastroplasty (ESG) in Obese Adults With Type 2 Diabetes (T2D)
Type 2 Diabetes Mellitus (T2D), Obesity (BMI>30)
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 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing PF-00734200 10 mg QD, PF-00734200 20 mg QD and PF-00734200 5 mg QD in people with Diabetes Mellitus, Type 2, run by Pfizer at 79 sites in 6 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 4 inclusion and 3 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 24 Jun 2010. 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, Germany, Spain, Colombia, Sweden and 1 more country. 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 levels (%) (time frame: 12 weeks). 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?
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 24 Jun 2010.