Weight ManagementPhase 2NCT00542009
A Trial In Diabetic Patients To Assess Effect Of CE-326,597 On Glucose Control And Body Weight
A Phase 2 study testing CE-326,597 100 mg QD, CE-326,597 50 mg QD and CE-326,597 25 mg QD in people with Weight Management and Treatment Of Obesity, run by Pfizer at 54 sites in 7 countries.
Trial summary
Study of whether the investigational drug CE-326,597 improves glucose control and results in body weight loss in patients with type 2 diabetes Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Weight Management, Treatment Of Obesity
- What is being tested?
- CE-326,597 100 mg QD, CE-326,597 50 mg QD and CE-326,597 25 mg QD
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 252 participants
- Where
- 54 sitesin 7 countries
- Study dates
- Dec 2007to Nov 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with type 2 diabetes, not on any or on oral (up to 2) anti-diabetic medications, otherwise medically stable.
Who cannot join
- Women of childbearing potential, people with unstable medical conditions, people with gallstones
Trial locations and contacts
54 sites in 7 countries.
54 sites in 7 countries
United States30 sites
Pfizer Investigational Site
Atlanta, Georgia, 30342
Pfizer Investigational Site
Beaumont, Texas, 77701
Pfizer Investigational Site
Beaumont, Texas, 77706
Pfizer Investigational Site
Bethesda, Maryland, 20817
Pfizer Investigational Site
Chaska, Minnesota, 55318
Pfizer Investigational Site
Chicago, Illinois, 60607
Pfizer Investigational Site
Chicago, Illinois, 60654
Pfizer Investigational Site
Cincinnati, Ohio, 45249
Pfizer Investigational Site
Conyers, Georgia, 30094
Pfizer Investigational Site
Dallas, Texas, 75231
Pfizer Investigational Site
Dallas, Texas, 75246
Pfizer Investigational Site
Fargo, North Dakota, 58103
Pfizer Investigational Site
Fresno, California, 93720
Pfizer Investigational Site
Henderson, Nevada, 89052
Pfizer Investigational Site
Honolulu, Hawaii, 96814
Pfizer Investigational Site
Idaho Falls, Idaho, 83404
Pfizer Investigational Site
Jackson, Mississippi, 39202
Pfizer Investigational Site
Lansdale, Pennsylvania, 19446
Pfizer Investigational Site
Las Vegas, Nevada, 89101
Pfizer Investigational Site
Las Vegas, Nevada, 89117
Pfizer Investigational Site
Miami, Florida, 33143
Pfizer Investigational Site
Minneapolis, Minnesota, 55455
Pfizer Investigational Site
National City, California, 91950
Pfizer Investigational Site
Ocala, Florida, 34471
Pfizer Investigational Site
Overland Park, Kansas, 66212
Pfizer Investigational Site
Phoenix, Arizona, 85023
Pfizer Investigational Site
Rapid City, South Dakota, 57702
Pfizer Investigational Site
Richmond, Virginia, 23294
Pfizer Investigational Site
San Diego, California, 92128
Pfizer Investigational Site
West Palm Beach, Florida, 33401
Canada6 sites
Pfizer Investigational Site
Coquitlam, British Columbia, V3K 3P4
Pfizer Investigational Site
Laval, Quebec, H7T 2P5
Pfizer Investigational Site
London, Ontario, N6A 4V2
Pfizer Investigational Site
Montreal, Quebec, H3A 1A1
Pfizer Investigational Site
Winnipeg, Manitoba, R3a 1R9
Pfizer Investigational Site
Winnipeg, Manitoba, R3E 3P4
Bulgaria4 sites
Pfizer Investigational Site
Pleven, 5800
Pfizer Investigational Site
Sofia, 1431
Pfizer Investigational Site
Sofia, 1606
Pfizer Investigational Site
Stara Zagora, 6000
India4 sites
Pfizer Investigational Site
Bangalore, Karnataka, 560 052
Pfizer Investigational Site
Indore, Madhya Pradesh, 452 001
Pfizer Investigational Site
Nagpur, Maharashtra, 440 012
Pfizer Investigational Site
Nashik, Maharashtra, 422 013
Spain4 sites
Pfizer Investigational Site
Barcelona, Barcelona, 08036
Pfizer Investigational Site
Madrid, Madrid, 28040
Pfizer Investigational Site
Santiago de Compostela, La Coruña, 15706
Pfizer Investigational Site
Seville, Sevilla, 41013
Mexico3 sites
Pfizer Investigational Site
Guadalajara, Jalisco, 44340
Pfizer Investigational Site
Ladrón de Guevara, Guadalajara, Jalisco, 44656
Pfizer Investigational Site
Monterrey, Nuevo León, 64460
Puerto Rico3 sites
Pfizer Investigational Site
Ponce, 00716
Pfizer Investigational Site
San Juan, 00909
Pfizer Investigational Site
Tao Baja, 00949
About this study
Official title: A 12-Week, Phase 2A, Randomized, Subject And Investigator Blinded, Placebo-Controlled Trial To Evaluate The Safety, Tolerability And Efficacy Of CE-326,597 On Glucose Control And Body Weight In Overweight Adult Subjects With Type 2 Diabetes Mellitus
Study of whether the investigational drug CE-326,597 improves glucose control and results in body weight loss in patients with type 2 diabetes
- Conditions
- Weight Management, Treatment Of Obesity
- Being tested
- CE-326,597 100 mg QD, CE-326,597 50 mg QD, CE-326,597 25 mg QD, Placebo, CE-326,597 5mg QD
- Keywords
- Phase 2A, safety and efficacy trial with CE-326,597 in patients with T2DM.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CE-326,597 100 mg QDDrug
Administered orally, once daily with morning meal for duration of trial (84 days).
CE-326,597 50 mg QDDrug
Administered orally, once daily with morning meal for duration of trial (84 days).
CE-326,597 25 mg QDDrug
Administered orally, once daily with morning meal for duration of trial (84 days).
PlaceboDrug
Placebo to match CE-326,597 tablets to be administered orally, once daily with morning meal for duration of trial (84 days).
CE-326,597 5mg QDDrug
Administered orally, once daily with morning meal for duration of trial (84 days).
| Study group | Role | What they receive |
|---|---|---|
| CE-326,597 100 mg QD | Experimental | Not described Receives: Drug: CE-326,597 100 mg QD |
| CE-326,597 50 mg QD | Experimental | Not described Receives: Drug: CE-326,597 50 mg QD |
| CE-326,597 25 mg QD | Experimental | Not described Receives: Drug: CE-326,597 25 mg QD |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
| CE-326,597 5mg QD | Experimental | Not described Receives: Drug: CE-326,597 5mg QD |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glucose control
Measured: At Day 84
Body weight
Measured: At Day 84
Secondary outcomes (7)
Regimen (dose or number) of anti-diabetic agents
Measured: At Day 84
GlycoMark
Measured: On Day 84
Waist circumference
Measured: On Day 84
Proportion of subjects who achieve HbA1C <7% and <6.5%
Measured: On Day 84
Population PK to analyze CE-326,597 concentrations as well as explore relationship of concentration to effect on HbA1C and body weight over duration of trial.
Measured: Throughout Study
Standard safety (via AEs, SAEs, vitals, 12-lead ECG, abdominal ultrasound) will be monitored throughout the trial.
Measured: Throughout Study
Change in following parameters: Post-prandial and fasting glucose, and insulin
Measured: On Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2007 (estimated)
- Study startDec 2007
- Primary completionNov 2008
- Study completionNov 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Weight ManagementStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 252 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
- NCT00542009
- Sponsor's protocol ID
- A7211005
- Status last verified
- Nov 2012
- First submitted
- 5 Oct 2007
- Last updated
- 7 Nov 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 12-Week, Phase 2A, Randomized, Subject And Investigator Blinded, Placebo-Controlled Trial To Evaluate The Safety, Tolerability And Efficacy Of CE-326,597 On Glucose Control And Body Weight In Overweight Adult Subjects With Type 2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT00542009
- Acronym / sponsor ID
- A7211005
- Conditions
- Weight Management, Treatment Of Obesity
- Keywords
- Phase 2A, safety and efficacy trial with CE-326,597 in patients with T2DM.
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 252 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Dec 2007
- Primary completion
- Nov 2008 (actual)
- Study completion
- Nov 2008 (actual)
- First posted
- 10 Oct 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.
Study of whether the investigational drug CE-326,597 improves glucose control and results in body weight loss in patients with type 2 diabetes
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| CE-326,597 100 mg QD | Experimental | Drug: CE-326,597 100 mg QD |
| CE-326,597 50 mg QD | Experimental | Drug: CE-326,597 50 mg QD |
| CE-326,597 25 mg QD | Experimental | Drug: CE-326,597 25 mg QD |
| Placebo | Placebo comparator | Drug: Placebo |
| CE-326,597 5mg QD | Experimental | Drug: CE-326,597 5mg QD |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with type 2 diabetes, not on any or on oral (up to 2) anti-diabetic medications, otherwise medically stable.
Key exclusion criteria (1 listed)
- Women of childbearing potential, people with unstable medical conditions, people with gallstones
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 |
|---|---|---|
| CE-326,597 100 mg QDAdministered orally, once daily with morning meal for duration of trial (84 days). | Drug | CE-326,597 100 mg QD |
| CE-326,597 50 mg QDAdministered orally, once daily with morning meal for duration of trial (84 days). | Drug | CE-326,597 50 mg QD |
| CE-326,597 25 mg QDAdministered orally, once daily with morning meal for duration of trial (84 days). | Drug | CE-326,597 25 mg QD |
| PlaceboPlacebo to match CE-326,597 tablets to be administered orally, once daily with morning meal for duration of trial (84 days). | Drug | Placebo |
| CE-326,597 5mg QDAdministered orally, once daily with morning meal for duration of trial (84 days). | Drug | CE-326,597 5mg QD |
Primary outcome
Glucose control
Time frame: At Day 84
Body weight
Time frame: At Day 84
7 secondary outcomes
Regimen (dose or number) of anti-diabetic agents
Time frame: At Day 84
GlycoMark
Time frame: On Day 84
Waist circumference
Time frame: On Day 84
Proportion of subjects who achieve HbA1C <7% and <6.5%
Time frame: On Day 84
Population PK to analyze CE-326,597 concentrations as well as explore relationship of concentration to effect on HbA1C and body weight over duration of trial.
Time frame: Throughout Study
Standard safety (via AEs, SAEs, vitals, 12-lead ECG, abdominal ultrasound) will be monitored throughout the trial.
Time frame: Throughout Study
Change in following parameters: Post-prandial and fasting glucose, and insulin
Time frame: On Day 28
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 7 Nov 2012.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
Related trials for Weight Management
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
RecruitingPhase 3
A Study to Learn About the Study Medicine Called PF-08653944 Taken Once-Monthly Compared to Placebo in Chinese Adults With Overweight or Obesity
Obesity, Overweight
RecruitingPhase 1
A Study of HB0017 Injection in Healthy Volunteers to Evaluate Safety and Tolerability of a Single Subcutaneous Injection in Low-Body-Weight Subjects; and Pharmacokinetics at Different Subcutaneous Injection Sites at the Same Dose
Psoriasis, Ankylosing Spondylitis
Not yet recruiting
Use and Acceptability of an AI-Assisted Health Application for Individuals Living With a Chronic Condition
Hypertension, Diabetes Mellitus, Type 2
Active, not recruiting
Optimal Digital Weight Loss Treatment for Rural Individuals
Overweight and Obesity
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
54 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing CE-326,597 100 mg QD, CE-326,597 50 mg QD and CE-326,597 25 mg QD in people with Weight Management and Treatment Of Obesity, run by Pfizer at 54 sites in 7 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 7 Nov 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 54 sites in United States, Canada, Bulgaria, India, Spain and 2 more countries. 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?
Glucose control (time frame: At Day 84). 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 7 Nov 2012.