Not provided
Not provided
Not provided
Not provided
Not provided
See termination reason in detailed description.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to determine if CP-945,598 is effective in the treatment of obesity in type 2 diabetic patients.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator |
| |
| CP-945,598 | Experimental |
| |
| CP-945,598 Treatment B | Experimental | Subjects receive CP-945,598 plus non-pharmacological weight loss program. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | Subjects receive placebo plus non-pharmacological weight loss program. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Percent change in body weight from baseline. | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| 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; |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Investigational Site | Birmingham | Alabama | 35233 | United States | ||
| Pfizer Investigational Site |
Not provided
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| CP-945,598 |
| Drug |
Subjects receive CP-945,598 plus non-pharmacological weight loss program. |
|
| CP-945,598 Treatment B | Drug | Subjects receive CP-945,598 plus non-pharmacological weight loss program. |
|
| 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 |
| 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 D.C. | 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 | Paraná | 80030-110 | Brazil |
| Pfizer Investigational Site | Porto Alegre | Rio Grande do Sul | 90035-170 | Brazil |
| Pfizer Investigational Site | São Paulo | São Paulo | 01221-020 | Brazil |
| Pfizer Investigational Site | São Paulo | São Paulo | 01244-030 | Brazil |
| Pfizer Investigational Site | São Paulo | São Paulo | 04025-011 | Brazil |
| Pfizer Investigational Site | São Paulo | São Paulo | 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-Carrieres | Quebec | G0A 4B0 | Canada |
| Pfizer Investigational Site | Břeclav | 690 02 | Czechia |
| Pfizer Investigational Site | České Budějovice | 370 87 | Czechia |
| Pfizer Investigational Site | Olomouc | 772 00 | Czechia |
| Pfizer Investigational Site | Prague | 128 08 | Czechia |
| Pfizer Investigational Site | Praha 4 - Krc | 140 21 | Czechia |
| Pfizer Investigational Site | Berlin | 13125 | Germany |
| Pfizer Investigational Site | Dresden | 01219 | Germany |
| Pfizer Investigational Site | Düsseldorf | 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 | Guadalajara | Jalisco | 44340 | Mexico |
| Pfizer Investigational Site | Mexico City | Mexico City | 11850 | Mexico |
| Pfizer Investigational Site | Monterrey | Nuevo León | 64460 | Mexico |
| Pfizer Investigational Site | Bratislava | Slovakia | 813 69 | Slovakia |
| Pfizer Investigational Site | Ľubochňa | Slovakia | 034 91 | Slovakia |
| Pfizer Investigational Site | Nitra | Slovakia | 950 01 | Slovakia |
| Pfizer Investigational Site | Banská Bystrica | 975 17 | Slovakia |
| Pfizer Investigational Site | Gothenburg | 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 |
| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided