A 1-Year Study On The Effects Of CP-945,598 For The Treatment Of Obesity In Overweight Type 2 Diabetic Patients

NCT ID: NCT00391196

Last Updated: 2012-11-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

975 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-11-30

Study Completion Date

2009-01-31

Brief Summary

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The purpose of this study is to determine if CP-945,598 is effective in the treatment of obesity in type 2 diabetic patients.

Detailed Description

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The CP-945,598 program was terminated on November 3, 2008 due to changing regulatory perspectives on the risk/benefit profile of the CB1 class and likely new regulatory requirements for approval. No safety issues were involved in the termination decision.

Conditions

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Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Subjects receive placebo plus non-pharmacological weight loss program.

CP-945,598

Group Type EXPERIMENTAL

CP-945,598

Intervention Type DRUG

Subjects receive CP-945,598 plus non-pharmacological weight loss program.

CP-945,598 Treatment B

Subjects receive CP-945,598 plus non-pharmacological weight loss program.

Group Type EXPERIMENTAL

CP-945,598 Treatment B

Intervention Type DRUG

Subjects receive CP-945,598 plus non-pharmacological weight loss program.

Interventions

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Placebo

Subjects receive placebo plus non-pharmacological weight loss program.

Intervention Type DRUG

CP-945,598

Subjects receive CP-945,598 plus non-pharmacological weight loss program.

Intervention Type DRUG

CP-945,598 Treatment B

Subjects receive CP-945,598 plus non-pharmacological weight loss program.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Subjects must be overweight (BMI 27- 50 kg/m2)
* Subjects must have type 2 diabetes mellitus

Exclusion Criteria

* Pregnancy
* Serious or unstable current or past medical conditions
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Pfizer Investigational Site

Birmingham, Alabama, United States

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Birmingham, Alabama, United States

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Huntsville, Alabama, United States

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Mobile, Alabama, United States

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Chandler, Arizona, United States

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Mesa, Arizona, United States

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Phoenix, Arizona, United States

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Fresno, California, United States

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Palm Springs, California, United States

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Tustin, California, United States

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Walnut Creek, California, United States

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New Britain, Connecticut, United States

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Washington D.C., District of Columbia, United States

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Orlando, Florida, United States

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West Palm Beach, Florida, United States

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Honolulu, Hawaii, United States

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Gurnee, Illinois, United States

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Madisonville, Kentucky, United States

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Baton Rouge, Louisiana, United States

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Metairie, Louisiana, United States

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Auburn, Maine, United States

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Scarborough, Maine, United States

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Baltimore, Maryland, United States

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Bay City, Michigan, United States

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Troy, Michigan, United States

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Edina, Minnesota, United States

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Jefferson City, Missouri, United States

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Albuquerque, New Mexico, United States

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Buffalo, New York, United States

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New York, New York, United States

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Greenville, North Carolina, United States

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Beaver, Pennsylvania, United States

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Cumberland, Rhode Island, United States

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Pawtucket, Rhode Island, United States

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Greer, South Carolina, United States

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Bristol, Tennessee, United States

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Nashville, Tennessee, United States

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Dallas, Texas, United States

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Dallas, Texas, United States

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San Antonio, Texas, United States

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San Antonio, Texas, United States

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Renton, Washington, United States

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Morgantown, West Virginia, United States

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Buenos Aires, , Argentina

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Buenos Aires, , Argentina

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Buenos Aires, , Argentina

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Garran, Australian Capital Territory, Australia

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Wollongong, New South Wales, Australia

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Adelaide, South Australia, Australia

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Box Hill, Victoria, Australia

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Nedlands, Western Australia, Australia

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Curitiba, Paraná, Brazil

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Porto Alegre, Rio Grande do Sul, Brazil

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São Paulo, São Paulo, Brazil

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São Paulo, São Paulo, Brazil

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São Paulo, São Paulo, Brazil

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São Paulo, São Paulo, Brazil

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Red Deer, Alberta, Canada

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Coquitlam, British Columbia, Canada

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Winnipeg, Manitoba, Canada

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Thornhill, Ontario, Canada

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Charlottetown, Prince Edward Island, Canada

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L'Ancienne-Lorette, Quebec, Canada

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Saint-Marc-des-Carrieres, Quebec, Canada

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Břeclav, , Czechia

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České Budějovice, , Czechia

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Olomouc, , Czechia

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Prague, , Czechia

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Praha 4 - Krc, , Czechia

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Berlin, , Germany

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Dresden, , Germany

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Düsseldorf, , Germany

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Hamburg, , Germany

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Leipzig, , Germany

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Mittweida, , Germany

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Tampico, Cd. Madero, Mexico

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Guadalajara, Jalisco, Mexico

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Mexico City, Mexico City, Mexico

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Monterrey, Nuevo León, Mexico

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Bratislava, Slovakia, Slovakia

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Ľubochňa, Slovakia, Slovakia

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Nitra, Slovakia, Slovakia

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Banská Bystrica, , Slovakia

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Gothenburg, , Sweden

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Huddinge, , Sweden

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Edinburgh, Lothian, United Kingdom

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Bath, Somerset, United Kingdom

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Coventry, , United Kingdom

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Dumfries, , United Kingdom

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Dundee, , United Kingdom

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Luton, , United Kingdom

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Countries

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United States Argentina Australia Brazil Canada Czechia Germany Mexico Slovakia Sweden United Kingdom

Related Links

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Other Identifiers

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A5351022

Identifier Type: -

Identifier Source: org_study_id