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

Sponsor:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00391196

Purpose

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

Condition	Intervention	Phase
Obesity	Drug: Placebo Drug: CP-945,598 Drug: CP-945,598 Treatment B	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study
Official Title:	A 1-Year, Randomized, Double-Blind, Placebo-Controlled Phase 3 Study To Evaluate The Efficacy And Safety Of CP-945,598 In The Treatment Of Overweight, Oral Agent-Treated Subjects With Type 2 Diabetes Mellitus

Resource links provided by NLM:

MedlinePlus related topics: Ataxia Telangiectasia Diabetes Obesity

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:

Percent change in body weight from baseline. [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Proportion of subjects who lose 5 and 10% baseline body weight at 1 year; [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Proportion of subjects achieving HbA1c <6.5% and <7% at 1 year; [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Change from baseline in waist circumference at 1 year; [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Change from baseline fasting triglyceride and HDL concentrations at 1 year; [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Change from baseline in Total cholesterol, LDL, TNF α, adiponectin, and hsCRP levels at month 6 and 1 year; [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Change in prevalence of metabolic syndrome based on accepted definition at the time of study completion; [ Time Frame: 1 year ] [ Designated as safety issue: No ]
HOMA IR (HOMA IR=fasting insulin x fasting glucose/22.5) at 1 year; [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Percentage of subjects who require additional diabetes pharmacotherapy because they meet protocol criteria for inadequate glycemic control; [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Population pharmacokinetic analysis of data acquired at trough and by randomized sparse sampling and exploration of PK/PD relationships; [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Change from baseline fasting plasma glucose concentration at 1 year; [ Time Frame: 1 year ] [ Designated as safety issue: No ]
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; [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Change from baseline in background sulfonylurea or meglitinide dose requirements in subjects taking these medications; [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Change from baseline in 7 point home glucose profiles in a subset of subjects at 1 year; [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Primary and key secondary endpoints at any measured intermediate time points including weight at week 2, months 1, 6, 9, and 11; [ Time Frame: 1 year ] [ Designated as safety issue: No ]
HbA1c, fasting plasma glucose at months 1, 3, 6, and 9; [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Waist circumference at months 3, 6, and 9; [ Time Frame: 1 year ] [ Designated as safety issue: No ]
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; [ Time Frame: 1 year ] [ Designated as safety issue: No ]
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; [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Change in fasting and postprandial insulin concentrations determined from OGTT in a subset of subjects at 1 year; [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Protocol defined hypoglycemia event rates and proportion of subjects with hypoglycemic events; [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Change from baseline postprandial glucose determined from OGTT in a subset of subjects at 1 year; [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Changes from baseline in patient reported outcome subscales: uncontrolled eating/hunger, power of food, physical functioning, and self esteem at 1 year; [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Changes in patient reported outcome subscales not identified as key secondary endpoints at months 3, 6, and 12 [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Change from baseline HbA1c to 1 year; [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Enrollment:	975
Study Start Date:	November 2006
Study Completion Date:	January 2009
Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Placebo: Placebo Comparator	Drug: Placebo Subjects receive placebo plus non-pharmacological weight loss program.
CP-945,598: Experimental	Drug: CP-945,598 Subjects receive CP-945,598 plus non-pharmacological weight loss program.
CP-945,598 Treatment B: Experimental Subjects receive CP-945,598 plus non-pharmacological weight loss program.	Drug: CP-945,598 Treatment B Subjects receive CP-945,598 plus non-pharmacological weight loss program.

Detailed Description:

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00391196

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Locations

United States, Alabama
Pfizer Investigational Site
Birmingham, Alabama, United States, 35233
Pfizer Investigational Site
Birmingham, Alabama, United States, 35294
Pfizer Investigational Site
Mobile, Alabama, United States, 36608
Pfizer Investigational Site
Huntsville, Alabama, United States, 35801
United States, Arizona
Pfizer Investigational Site
Chandler, Arizona, United States, 85224
Pfizer Investigational Site
Mesa, Arizona, United States, 85213
Pfizer Investigational Site
Phoenix, Arizona, United States, 85014
United States, California
Pfizer Investigational Site
Walnut Creek, California, United States, 94598
Pfizer Investigational Site
Tustin, California, United States, 92780
Pfizer Investigational Site
Fresno, California, United States, 93720
Pfizer Investigational Site
Palm Springs, California, United States, 92262
United States, Connecticut
Pfizer Investigational Site
New Britain, Connecticut, United States, 06050
United States, District of Columbia
Pfizer Investigational Site
Washington, District of Columbia, United States, 20003-4393
United States, Florida
Pfizer Investigational Site
Orlando, Florida, United States, 32809
Pfizer Investigational Site
West Palm Beach, Florida, United States, 33401
United States, Hawaii
Pfizer Investigational Site
Honolulu, Hawaii, United States, 96814
United States, Illinois
Pfizer Investigational Site
Gurnee, Illinois, United States, 60031
United States, Kentucky
Pfizer Investigational Site
Madisonville, Kentucky, United States, 42431
United States, Louisiana
Pfizer Investigational Site
Baton Rouge, Louisiana, United States, 70808
Pfizer Investigational Site
Metairie, Louisiana, United States, 70002
United States, Maine
Pfizer Investigational Site
Scarborough, Maine, United States, 04074
Pfizer Investigational Site
Auburn, Maine, United States, 04210
United States, Maryland
Pfizer Investigational Site
Baltimore, Maryland, United States, 21204
United States, Michigan
Pfizer Investigational Site
Troy, Michigan, United States, 48098
Pfizer Investigational Site
Bay City, Michigan, United States, 48706
United States, Minnesota
Pfizer Investigational Site
Edina, Minnesota, United States, 55435
United States, Missouri
Pfizer Investigational Site
Jefferson City, Missouri, United States, 65109
United States, New Mexico
Pfizer Investigational Site
Albuquerque, New Mexico, United States, 87108
United States, New York
Pfizer Investigational Site
New York, New York, United States, 10025
Pfizer Investigational Site
Buffalo, New York, United States, 14209
United States, North Carolina
Pfizer Investigational Site
Greenville, North Carolina, United States, 27834
United States, Pennsylvania
Pfizer Investigational Site
Beaver, Pennsylvania, United States, 15009
United States, Rhode Island
Pfizer Investigational Site
Cumberland, Rhode Island, United States, 02864
Pfizer Investigational Site
Pawtucket, Rhode Island, United States, 02860
United States, South Carolina
Pfizer Investigational Site
Greer, South Carolina, United States, 29651
United States, Tennessee
Pfizer Investigational Site
Nashville, Tennessee, United States, 37203
Pfizer Investigational Site
Bristol, Tennessee, United States, 37620
United States, Texas
Pfizer Investigational Site
Dallas, Texas, United States, 75246
Pfizer Investigational Site
Dallas, Texas, United States, 75230
Pfizer Investigational Site
San Antonio, Texas, United States, 78229
Pfizer Investigational Site
San Antonio, Texas, United States, 78237
United States, Washington
Pfizer Investigational Site
Renton, Washington, United States, 98057
United States, West Virginia
Pfizer Investigational Site
Morgantown, West Virginia, United States, 26506-9136
Argentina
Pfizer Investigational Site
Buenos Aires, Argentina, C1426ABP
Pfizer Investigational Site
Buenos Aires, Argentina, C1034ACO
Pfizer Investigational Site
Buenos Aires, Argentina, C1405CWB
Australia, Australian Capital Territory
Pfizer Investigational Site
Garran, Australian Capital Territory, Australia, 2605
Australia, New South Wales
Pfizer Investigational Site
Wollongong, New South Wales, Australia, 2500
Australia, South Australia
Pfizer Investigational Site
Adelaide, South Australia, Australia, 5000
Australia, Victoria
Pfizer Investigational Site
Box Hill, Victoria, Australia, 3128
Australia, Western Australia
Pfizer Investigational Site
Nedlands, Western Australia, Australia, 6009
Brazil, PR
Pfizer Investigational Site
Curitiba, PR, Brazil, 80030-110
Brazil, RS
Pfizer Investigational Site
Porto Alegre, RS, Brazil, 90035-170
Brazil, SP
Pfizer Investigational Site
São Paulo, SP, Brazil, 01221-020
Pfizer Investigational Site
São Paulo, SP, Brazil, 04025-011
Pfizer Investigational Site
São Paulo, SP, Brazil, 01244-030
Pfizer Investigational Site
São Paulo, SP, Brazil, 05403-000
Canada, Alberta
Pfizer Investigational Site
Red Deer, Alberta, Canada, T4N 6V7
Canada, British Columbia
Pfizer Investigational Site
Coquitlam, British Columbia, Canada, V3K 3P4
Canada, Manitoba
Pfizer Investigational Site
Winnipeg, Manitoba, Canada, R3E 3P4
Canada, Ontario
Pfizer Investigational Site
Thornhill, Ontario, Canada, L4J 8L7
Canada, Prince Edward Island
Pfizer Investigational Site
Charlottetown, Prince Edward Island, Canada, C1E 1J7
Canada, Quebec
Pfizer Investigational Site
Saint-Marc-des-Carrières, Quebec, Canada, G0A 4B0
Pfizer Investigational Site
L'Ancienne-Lorette, Quebec, Canada, G2E 2X1
Czech Republic
Pfizer Investigational Site
Praha 2, Czech Republic, 128 08
Pfizer Investigational Site
Olomouc, Czech Republic, 772 00
Pfizer Investigational Site
Ceske Budejovice, Czech Republic, 370 87
Pfizer Investigational Site
Breclav, Czech Republic, 690 02
Pfizer Investigational Site
Praha 4 - Krc, Czech Republic, 140 21
Germany
Pfizer Investigational Site
Dresden, Germany, 01219
Pfizer Investigational Site
Mittweida, Germany, 09648
Pfizer Investigational Site
Hamburg, Germany, 20253
Pfizer Investigational Site
Duesseldorf, Germany, 40225
Pfizer Investigational Site
Berlin, Germany, 13125
Pfizer Investigational Site
Leipzig, Germany, 04103
Mexico, Cd. Madero
Pfizer Investigational Site
Tampico, Cd. Madero, Mexico, 89109
Mexico, DF
Pfizer Investigational Site
Mexico, DF, Mexico, 11850
Mexico, Jalisco
Pfizer Investigational Site
Guadalajara, Jalisco, Mexico, 44340
Mexico, Nuevo León
Pfizer Investigational Site
Monterrey, Nuevo León, Mexico, 64460
Slovakia
Pfizer Investigational Site
Banska Bystrica, Slovakia, 975 17
Pfizer Investigational Site
Bratislava, Slovakia, 813 69
Pfizer Investigational Site
Nitra, Slovakia, 950 01
Pfizer Investigational Site
Lubochna, Slovakia, 034 91
Sweden
Pfizer Investigational Site
Huddinge, Sweden, 141 86
Pfizer Investigational Site
Goteborg, Sweden, 413 45
United Kingdom
Pfizer Investigational Site
Dundee, United Kingdom, DD1 9SY
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Luton, United Kingdom, LU4 0DZ
Pfizer Investigational Site
Dumfries, United Kingdom, DG1 4AP
Pfizer Investigational Site
Coventry, United Kingdom, CV2 2DX
United Kingdom, Lothian
Pfizer Investigational Site
Edinburgh, Lothian, United Kingdom, EH4 2XU
United Kingdom, Somerset
Pfizer Investigational Site
Bath, Somerset, United Kingdom, BA1 3NG

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Responsible Party:	Pfizer, Inc. ( Director, Clinical Trial Disclosure Group )
Study ID Numbers:	A5351022
Study First Received:	October 19, 2006
Last Updated:	October 27, 2009
ClinicalTrials.gov Identifier:	NCT00391196 History of Changes
Health Authority:	United States: Food and Drug Administration