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

NCT00391196 | Terminated Phase 3 DMC

• 1 other identifier: A5351022
• Study Type: interventional
• Target: 975
• Locations: 11 countries
• Sites: 91

Brief Summary

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

Conditions

Obesity

Outcome Measures

Primary Outcomes (1)

• Percent change in body weight from baseline.

  1 year

Secondary Outcomes (24)

• Proportion of subjects who lose 5 and 10% baseline body weight at 1 year;

  1 year

• Proportion of subjects achieving HbA1c <6.5% and <7% at 1 year;

  1 year

• Change from baseline in waist circumference at 1 year;

  1 year

• Change from baseline fasting triglyceride and HDL concentrations at 1 year;

  1 year

• Change from baseline in Total cholesterol, LDL, TNF α, adiponectin, and hsCRP levels at month 6 and 1 year;

  1 year

Study Arms (3)

Placebo

PLACEBO COMPARATOR

Drug: Placebo

CP-945,598

EXPERIMENTAL

Drug: CP-945,598

CP-945,598 Treatment B

EXPERIMENTAL

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

Drug: CP-945,598 Treatment B

Interventions

Placebo DRUG

Subjects receive placebo plus non-pharmacological weight loss program.

Placebo

CP-945,598 DRUG

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

CP-945,598

CP-945,598 Treatment B DRUG

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

CP-945,598 Treatment B

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Pregnancy
• Serious or unstable current or past medical conditions

Sponsors & Collaborators

• Pfizer: lead

Study Sites (91)

Pfizer Investigational Site

Birmingham, Alabama, 35233, United States

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Birmingham, Alabama, 35294, United States

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Huntsville, Alabama, 35801, United States

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Mobile, Alabama, 36608, United States

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Chandler, Arizona, 85224, United States

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Mesa, Arizona, 85213, United States

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Phoenix, Arizona, 85014, United States

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Fresno, California, 93720, United States

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Palm Springs, California, 92262, United States

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Tustin, California, 92780, United States

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Walnut Creek, California, 94598, United States

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New Britain, Connecticut, 06050, United States

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Washington D.C., District of Columbia, 20003-4393, United States

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Orlando, Florida, 32809, United States

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West Palm Beach, Florida, 33401, United States

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Honolulu, Hawaii, 96814, United States

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Gurnee, Illinois, 60031, United States

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Madisonville, Kentucky, 42431, United States

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Baton Rouge, Louisiana, 70808, United States

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Metairie, Louisiana, 70002, United States

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Auburn, Maine, 04210, United States

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Scarborough, Maine, 04074, United States

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Baltimore, Maryland, 21204, United States

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Bay City, Michigan, 48706, United States

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Troy, Michigan, 48098, United States

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Edina, Minnesota, 55435, United States

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Jefferson City, Missouri, 65109, United States

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Albuquerque, New Mexico, 87108, United States

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Buffalo, New York, 14209, United States

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New York, New York, 10025, United States

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Greenville, North Carolina, 27834, United States

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Beaver, Pennsylvania, 15009, United States

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Cumberland, Rhode Island, 02864, United States

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Pawtucket, Rhode Island, 02860, United States

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Greer, South Carolina, 29651, United States

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Bristol, Tennessee, 37620, United States

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Nashville, Tennessee, 37203, United States

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Dallas, Texas, 75230, United States

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Dallas, Texas, 75246, United States

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San Antonio, Texas, 78229, United States

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San Antonio, Texas, 78237, United States

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Renton, Washington, 98057, United States

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Morgantown, West Virginia, 26506-9136, United States

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Buenos Aires, C1034ACO, Argentina

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Buenos Aires, C1405CWB, Argentina

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Buenos Aires, C1426ABP, Argentina

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Garran, Australian Capital Territory, 2605, Australia

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Wollongong, New South Wales, 2500, Australia

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Adelaide, South Australia, 5000, Australia

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Box Hill, Victoria, 3128, Australia

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Nedlands, Western Australia, 6009, Australia

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Curitiba, Paraná, 80030-110, Brazil

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Porto Alegre, Rio Grande do Sul, 90035-170, Brazil

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São Paulo, São Paulo, 01221-020, Brazil

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São Paulo, São Paulo, 01244-030, Brazil

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São Paulo, São Paulo, 04025-011, Brazil

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São Paulo, São Paulo, 05403-000, Brazil

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Red Deer, Alberta, T4N 6V7, Canada

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Coquitlam, British Columbia, V3K 3P4, Canada

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Winnipeg, Manitoba, R3E 3P4, Canada

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Thornhill, Ontario, L4J 8L7, Canada

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Charlottetown, Prince Edward Island, C1E 1J7, Canada

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L'Ancienne-Lorette, Quebec, G2E 2X1, Canada

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Saint-Marc-des-Carrieres, Quebec, G0A 4B0, Canada

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Břeclav, 690 02, Czechia

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České Budějovice, 370 87, Czechia

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Olomouc, 772 00, Czechia

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Prague, 128 08, Czechia

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Praha 4 - Krc, 140 21, Czechia

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Berlin, 13125, Germany

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Dresden, 01219, Germany

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Düsseldorf, 40225, Germany

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Hamburg, 20253, Germany

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Leipzig, 04103, Germany

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Mittweida, 09648, Germany

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Tampico, Cd. Madero, 89109, Mexico

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Guadalajara, Jalisco, 44340, Mexico

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Mexico City, Mexico City, 11850, Mexico

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Monterrey, Nuevo León, 64460, Mexico

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Bratislava, Slovakia, 813 69, Slovakia

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Ľubochňa, Slovakia, 034 91, Slovakia

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Nitra, Slovakia, 950 01, Slovakia

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Banská Bystrica, 975 17, Slovakia

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Gothenburg, 413 45, Sweden

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Huddinge, 141 86, Sweden

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Edinburgh, Lothian, EH4 2XU, United Kingdom

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Bath, Somerset, BA1 3NG, United Kingdom

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Coventry, CV2 2DX, United Kingdom

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Dumfries, DG1 4AP, United Kingdom

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Dundee, DD1 9SY, United Kingdom

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Luton, LU4 0DZ, United Kingdom

Location

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 19, 2006
• First Posted: October 23, 2006
• Study Start: November 1, 2006
• Primary Completion: December 1, 2008
• Study Completion: January 1, 2009
• Last Updated: November 7, 2012

Record last verified: 2012-11

Locations

US (43); ME (4); CA (7); SL (4); SE (2); GB (6); AR (3); CZ (5); AU (5); DE (6); BR (6)