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Clinical Trial Details

Trial ID: L4051
Source ID: NCT00391196
Associated Drug: Placebo
Title: A 1-Year Study On The Effects Of CP-945,598 For The Treatment Of Obesity In Overweight Type 2 Diabetic Patients
Acronym:
Status: TERMINATED
Study Results: NO
Results:
Conditions: Obesity
Interventions: DRUG: Placebo|DRUG: CP-945,598|DRUG: CP-945,598 Treatment B
Outcome Measures: Primary: Percent change in body weight from baseline., 1 year | Secondary: 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|Change in prevalence of metabolic syndrome based on accepted definition at the time of study completion;, 1 year|HOMA IR (HOMA IR=fasting insulin x fasting glucose/22.5) at 1 year;, 1 year|Percentage of subjects who require additional diabetes pharmacotherapy because they meet protocol criteria for inadequate glycemic control;, 1 year|Population pharmacokinetic analysis of data acquired at trough and by randomized sparse sampling and exploration of PK/PD relationships;, 1 year|Change from baseline fasting plasma glucose concentration at 1 year;, 1 year|Change from baseline in Patient Health Questionnaire 9 and Generalized Anxiety Disorder 7 scores at months 1, 2, 3, 5, 6, 9, and 1 year;, 1 year|Change from baseline in background sulfonylurea or meglitinide dose requirements in subjects taking these medications;, 1 year|Change from baseline in 7 point home glucose profiles in a subset of subjects at 1 year;, 1 year|Primary and key secondary endpoints at any measured intermediate time points including weight at week 2, months 1, 6, 9, and 11;, 1 year|HbA1c, fasting plasma glucose at months 1, 3, 6, and 9;, 1 year|Waist circumference at months 3, 6, and 9;, 1 year|Fasting triglyceride and HDL concentrations at month 6 and patient reported outcome subscales: uncontrolled eating/hunger, power of food, physical functioning, and self esteem at months 3 and 6;, 1 year|Change from baseline in laboratory tests and ECGs at 1 year; vitals signs at (at Week 2, Months 1 - 6, 9, 11 and 1 year) and adverse events;, 1 year|Change in fasting and postprandial insulin concentrations determined from OGTT in a subset of subjects at 1 year;, 1 year|Protocol defined hypoglycemia event rates and proportion of subjects with hypoglycemic events;, 1 year|Change from baseline postprandial glucose determined from OGTT in a subset of subjects at 1 year;, 1 year|Changes from baseline in patient reported outcome subscales: uncontrolled eating/hunger, power of food, physical functioning, and self esteem at 1 year;, 1 year|Changes in patient reported outcome subscales not identified as key secondary endpoints at months 3, 6, and 12, 1 year|Change from baseline HbA1c to 1 year;, 1 year
Sponsor/Collaborators: Sponsor: Pfizer
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 975
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2006-11
Completion Date: 2009-01
Results First Posted:
Last Update Posted: 2012-11-07
Locations: Pfizer Investigational Site, Birmingham, Alabama, 35233, United States|Pfizer Investigational Site, Birmingham, Alabama, 35294, United States|Pfizer Investigational Site, Huntsville, Alabama, 35801, United States|Pfizer Investigational Site, Mobile, Alabama, 36608, United States|Pfizer Investigational Site, Chandler, Arizona, 85224, United States|Pfizer Investigational Site, Mesa, Arizona, 85213, United States|Pfizer Investigational Site, Phoenix, Arizona, 85014, United States|Pfizer Investigational Site, Fresno, California, 93720, United States|Pfizer Investigational Site, Palm Springs, California, 92262, United States|Pfizer Investigational Site, Tustin, California, 92780, United States|Pfizer Investigational Site, Walnut Creek, California, 94598, United States|Pfizer Investigational Site, New Britain, Connecticut, 06050, United States|Pfizer Investigational Site, Washington, District of Columbia, 20003-4393, United States|Pfizer Investigational Site, Orlando, Florida, 32809, United States|Pfizer Investigational Site, West Palm Beach, Florida, 33401, United States|Pfizer Investigational Site, Honolulu, Hawaii, 96814, United States|Pfizer Investigational Site, Gurnee, Illinois, 60031, United States|Pfizer Investigational Site, Madisonville, Kentucky, 42431, United States|Pfizer Investigational Site, Baton Rouge, Louisiana, 70808, United States|Pfizer Investigational Site, Metairie, Louisiana, 70002, United States|Pfizer Investigational Site, Auburn, Maine, 04210, United States|Pfizer Investigational Site, Scarborough, Maine, 04074, United States|Pfizer Investigational Site, Baltimore, Maryland, 21204, United States|Pfizer Investigational Site, Bay City, Michigan, 48706, United States|Pfizer Investigational Site, Troy, Michigan, 48098, United States|Pfizer Investigational Site, Edina, Minnesota, 55435, United States|Pfizer Investigational Site, Jefferson City, Missouri, 65109, United States|Pfizer Investigational Site, Albuquerque, New Mexico, 87108, United States|Pfizer Investigational Site, Buffalo, New York, 14209, United States|Pfizer Investigational Site, New York, New York, 10025, United States|Pfizer Investigational Site, Greenville, North Carolina, 27834, United States|Pfizer Investigational Site, Beaver, Pennsylvania, 15009, United States|Pfizer Investigational Site, Cumberland, Rhode Island, 02864, United States|Pfizer Investigational Site, Pawtucket, Rhode Island, 02860, United States|Pfizer Investigational Site, Greer, South Carolina, 29651, United States|Pfizer Investigational Site, Bristol, Tennessee, 37620, United States|Pfizer Investigational Site, Nashville, Tennessee, 37203, United States|Pfizer Investigational Site, Dallas, Texas, 75230, United States|Pfizer Investigational Site, Dallas, Texas, 75246, United States|Pfizer Investigational Site, San Antonio, Texas, 78229, United States|Pfizer Investigational Site, San Antonio, Texas, 78237, United States|Pfizer Investigational Site, Renton, Washington, 98057, United States|Pfizer Investigational Site, Morgantown, West Virginia, 26506-9136, United States|Pfizer Investigational Site, Buenos Aires, C1034ACO, Argentina|Pfizer Investigational Site, Buenos Aires, C1405CWB, Argentina|Pfizer Investigational Site, Buenos Aires, C1426ABP, Argentina|Pfizer Investigational Site, Garran, Australian Capital Territory, 2605, Australia|Pfizer Investigational Site, Wollongong, New South Wales, 2500, Australia|Pfizer Investigational Site, Adelaide, South Australia, 5000, Australia|Pfizer Investigational Site, Box Hill, Victoria, 3128, Australia|Pfizer Investigational Site, Nedlands, Western Australia, 6009, Australia|Pfizer Investigational Site, Curitiba, PR, 80030-110, Brazil|Pfizer Investigational Site, Porto Alegre, RS, 90035-170, Brazil|Pfizer Investigational Site, São Paulo, SP, 01221-020, Brazil|Pfizer Investigational Site, São Paulo, SP, 01244-030, Brazil|Pfizer Investigational Site, São Paulo, SP, 04025-011, Brazil|Pfizer Investigational Site, São Paulo, SP, 05403-000, Brazil|Pfizer Investigational Site, Red Deer, Alberta, T4N 6V7, Canada|Pfizer Investigational Site, Coquitlam, British Columbia, V3K 3P4, Canada|Pfizer Investigational Site, Winnipeg, Manitoba, R3E 3P4, Canada|Pfizer Investigational Site, Thornhill, Ontario, L4J 8L7, Canada|Pfizer Investigational Site, Charlottetown, Prince Edward Island, C1E 1J7, Canada|Pfizer Investigational Site, L'Ancienne-Lorette, Quebec, G2E 2X1, Canada|Pfizer Investigational Site, Saint-Marc-des-Carrières, Quebec, G0A 4B0, Canada|Pfizer Investigational Site, Breclav, 690 02, Czech Republic|Pfizer Investigational Site, Ceske Budejovice, 370 87, Czech Republic|Pfizer Investigational Site, Olomouc, 772 00, Czech Republic|Pfizer Investigational Site, Praha 2, 128 08, Czech Republic|Pfizer Investigational Site, Praha 4 - Krc, 140 21, Czech Republic|Pfizer Investigational Site, Berlin, 13125, Germany|Pfizer Investigational Site, Dresden, 01219, Germany|Pfizer Investigational Site, Duesseldorf, 40225, Germany|Pfizer Investigational Site, Hamburg, 20253, Germany|Pfizer Investigational Site, Leipzig, 04103, Germany|Pfizer Investigational Site, Mittweida, 09648, Germany|Pfizer Investigational Site, Tampico, Cd. Madero, 89109, Mexico|Pfizer Investigational Site, Mexico, DF, 11850, Mexico|Pfizer Investigational Site, Guadalajara, Jalisco, 44340, Mexico|Pfizer Investigational Site, Monterrey, Nuevo León, 64460, Mexico|Pfizer Investigational Site, Banska Bystrica, 975 17, Slovakia|Pfizer Investigational Site, Bratislava, 813 69, Slovakia|Pfizer Investigational Site, Lubochna, 034 91, Slovakia|Pfizer Investigational Site, Nitra, 950 01, Slovakia|Pfizer Investigational Site, Goteborg, 413 45, Sweden|Pfizer Investigational Site, Huddinge, 141 86, Sweden|Pfizer Investigational Site, Edinburgh, Lothian, EH4 2XU, United Kingdom|Pfizer Investigational Site, Bath, Somerset, BA1 3NG, United Kingdom|Pfizer Investigational Site, Coventry, CV2 2DX, United Kingdom|Pfizer Investigational Site, Dumfries, DG1 4AP, United Kingdom|Pfizer Investigational Site, Dundee, DD1 9SY, United Kingdom|Pfizer Investigational Site, Luton, LU4 0DZ, United Kingdom
URL: https://clinicaltrials.gov/show/NCT00391196

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress