Clinical trial NCT00391196: A 1-Year Study On The Effects Of CP-945,598 For The Treatment Of Obesity In Overweight Type 2 Diabetic Patients
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Obesity
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2006-10-23
Enrollment: 975
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Percent change in body weight from baseline.
timeFrame: 1 year
Secondary outcomes:
measure: Proportion of subjects who lose 5 and 10% baseline body weight at 1 year;
timeFrame: 1 year
measure: Proportion of subjects achieving HbA1c <6.5% and <7% at 1 year;
timeFrame: 1 year
measure: Change from baseline in waist circumference at 1 year;
timeFrame: 1 year
measure: Change from baseline fasting triglyceride and HDL concentrations at 1 year;
timeFrame: 1 year
measure: Change from baseline in Total cholesterol, LDL, TNF α, adiponectin, and hsCRP levels at month 6 and 1 year;
timeFrame: 1 year
measure: Change in prevalence of metabolic syndrome based on accepted definition at the time of study completion;
timeFrame: 1 year
measure: HOMA IR (HOMA IR=fasting insulin x fasting glucose/22.5) at 1 year;
timeFrame: 1 year
measure: Percentage of subjects who require additional diabetes pharmacotherapy because they meet protocol criteria for inadequate glycemic control;
timeFrame: 1 year
measure: Population pharmacokinetic analysis of data acquired at trough and by randomized sparse sampling and exploration of PK/PD relationships;
timeFrame: 1 year
measure: Change from baseline fasting plasma glucose concentration at 1 year;
timeFrame: 1 year
measure: 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;
timeFrame: 1 year
measure: Change from baseline in background sulfonylurea or meglitinide dose requirements in subjects taking these medications;
timeFrame: 1 year
measure: Change from baseline in 7 point home glucose profiles in a subset of subjects at 1 year;
timeFrame: 1 year
measure: Primary and key secondary endpoints at any measured intermediate time points including weight at week 2, months 1, 6, 9, and 11;
timeFrame: 1 year
measure: HbA1c, fasting plasma glucose at months 1, 3, 6, and 9;
timeFrame: 1 year
measure: Waist circumference at months 3, 6, and 9;
timeFrame: 1 year
measure: 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;
timeFrame: 1 year
measure: 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;
timeFrame: 1 year
measure: Change in fasting and postprandial insulin concentrations determined from OGTT in a subset of subjects at 1 year;
timeFrame: 1 year
measure: Protocol defined hypoglycemia event rates and proportion of subjects with hypoglycemic events;
timeFrame: 1 year
measure: Change from baseline postprandial glucose determined from OGTT in a subset of subjects at 1 year;
timeFrame: 1 year
measure: Changes from baseline in patient reported outcome subscales: uncontrolled eating/hunger, power of food, physical functioning, and self esteem at 1 year;
timeFrame: 1 year
measure: Changes in patient reported outcome subscales not identified as key secondary endpoints at months 3, 6, and 12
timeFrame: 1 year
measure: Change from baseline HbA1c to 1 year;
timeFrame: 1 year
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Pfizer Investigational Site
state: Alabama
city: Birmingham
country: United States
facility: Pfizer Investigational Site
state: Alabama
city: Huntsville
country: United States
facility: Pfizer Investigational Site
state: Alabama
city: Mobile
country: United States
facility: Pfizer Investigational Site
state: Alabama
city: Chandler
country: United States
facility: Pfizer Investigational Site
state: Arizona
city: Mesa
country: United States
facility: Pfizer Investigational Site
state: Arizona
city: Phoenix
country: United States
facility: Pfizer Investigational Site
state: Arizona
city: Fresno
country: United States
facility: Pfizer Investigational Site
state: California
city: Palm Springs
country: United States
facility: Pfizer Investigational Site
state: California
city: Tustin
country: United States
facility: Pfizer Investigational Site
state: California
city: Walnut Creek
country: United States
facility: Pfizer Investigational Site
state: California
city: New Britain
country: United States
facility: Pfizer Investigational Site
state: Connecticut
city: Washington
country: United States
facility: Pfizer Investigational Site
state: District of Columbia
city: Orlando
country: United States
facility: Pfizer Investigational Site
state: Florida
city: West Palm Beach
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Honolulu
country: United States
facility: Pfizer Investigational Site
state: Hawaii
city: Gurnee
country: United States
facility: Pfizer Investigational Site
state: Illinois
city: Madisonville
country: United States
facility: Pfizer Investigational Site
state: Kentucky
city: Baton Rouge
country: United States
facility: Pfizer Investigational Site
state: Louisiana
city: Metairie
country: United States
facility: Pfizer Investigational Site
state: Louisiana
city: Auburn
country: United States
facility: Pfizer Investigational Site
state: Maine
city: Scarborough
country: United States
facility: Pfizer Investigational Site
state: Maine
city: Baltimore
country: United States
facility: Pfizer Investigational Site
state: Maryland
city: Bay City
country: United States
facility: Pfizer Investigational Site
state: Michigan
city: Troy
country: United States
facility: Pfizer Investigational Site
state: Michigan
city: Edina
country: United States
facility: Pfizer Investigational Site
state: Minnesota
city: Jefferson City
country: United States
facility: Pfizer Investigational Site
state: Missouri
city: Albuquerque
country: United States
facility: Pfizer Investigational Site
state: New Mexico
city: Buffalo
country: United States
facility: Pfizer Investigational Site
state: New York
city: New York
country: United States
facility: Pfizer Investigational Site
state: New York
city: Greenville
country: United States
facility: Pfizer Investigational Site
state: North Carolina
city: Beaver
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Cumberland
country: United States
facility: Pfizer Investigational Site
state: Rhode Island
city: Pawtucket
country: United States
facility: Pfizer Investigational Site
state: Rhode Island
city: Greer
country: United States
facility: Pfizer Investigational Site
state: South Carolina
city: Bristol
country: United States
facility: Pfizer Investigational Site
state: Tennessee
city: Nashville
country: United States
facility: Pfizer Investigational Site
state: Tennessee
city: Dallas
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Dallas
country: United States
facility: Pfizer Investigational Site
state: Texas
city: San Antonio
country: United States
facility: Pfizer Investigational Site
state: Texas
city: San Antonio
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Renton
country: United States
facility: Pfizer Investigational Site
state: Washington
city: Morgantown
country: United States
facility: Pfizer Investigational Site
state: West Virginia
city: Buenos Aires
country: Argentina
facility: Pfizer Investigational Site
city: Buenos Aires
country: Argentina
facility: Pfizer Investigational Site
city: Buenos Aires
country: Argentina
facility: Pfizer Investigational Site
city: Garran
country: Australia
facility: Pfizer Investigational Site
state: Australian Capital Territory
city: Wollongong
country: Australia
facility: Pfizer Investigational Site
state: New South Wales
city: Adelaide
country: Australia
facility: Pfizer Investigational Site
state: South Australia
city: Box Hill
country: Australia
facility: Pfizer Investigational Site
state: Victoria
city: Nedlands
country: Australia
facility: Pfizer Investigational Site
state: Western Australia
city: Curitiba
country: Brazil
facility: Pfizer Investigational Site
state: PR
city: Porto Alegre
country: Brazil
facility: Pfizer Investigational Site
state: RS
city: São Paulo
country: Brazil
facility: Pfizer Investigational Site
state: SP
city: São Paulo
country: Brazil
facility: Pfizer Investigational Site
state: SP
city: São Paulo
country: Brazil
facility: Pfizer Investigational Site
state: SP
city: São Paulo
country: Brazil
facility: Pfizer Investigational Site
state: SP
city: Red Deer
country: Canada
facility: Pfizer Investigational Site
state: Alberta
city: Coquitlam
country: Canada
facility: Pfizer Investigational Site
state: British Columbia
city: Winnipeg
country: Canada
facility: Pfizer Investigational Site
state: Manitoba
city: Thornhill
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Charlottetown
country: Canada
facility: Pfizer Investigational Site
state: Prince Edward Island
city: L'Ancienne-Lorette
country: Canada
facility: Pfizer Investigational Site
state: Quebec
city: Saint-Marc-des-Carrières
country: Canada
facility: Pfizer Investigational Site
state: Quebec
city: Breclav
country: Czech Republic
facility: Pfizer Investigational Site
city: Ceske Budejovice
country: Czech Republic
facility: Pfizer Investigational Site
city: Olomouc
country: Czech Republic
facility: Pfizer Investigational Site
city: Praha 2
country: Czech Republic
facility: Pfizer Investigational Site
city: Praha 4 - Krc
country: Czech Republic
facility: Pfizer Investigational Site
city: Berlin
country: Germany
facility: Pfizer Investigational Site
city: Dresden
country: Germany
facility: Pfizer Investigational Site
city: Duesseldorf
country: Germany
facility: Pfizer Investigational Site
city: Hamburg
country: Germany
facility: Pfizer Investigational Site
city: Leipzig
country: Germany
facility: Pfizer Investigational Site
city: Mittweida
country: Germany
facility: Pfizer Investigational Site
city: Tampico
country: Mexico
facility: Pfizer Investigational Site
state: Cd. Madero
city: Mexico
country: Mexico
facility: Pfizer Investigational Site
state: DF
city: Guadalajara
country: Mexico
facility: Pfizer Investigational Site
state: Jalisco
city: Monterrey
country: Mexico
facility: Pfizer Investigational Site
state: Nuevo León
city: Banska Bystrica
country: Slovakia
facility: Pfizer Investigational Site
city: Bratislava
country: Slovakia
facility: Pfizer Investigational Site
city: Lubochna
country: Slovakia
facility: Pfizer Investigational Site
city: Nitra
country: Slovakia
facility: Pfizer Investigational Site
city: Goteborg
country: Sweden
facility: Pfizer Investigational Site
city: Huddinge
country: Sweden
facility: Pfizer Investigational Site
city: Edinburgh
country: United Kingdom
facility: Pfizer Investigational Site
state: Lothian
city: Bath
country: United Kingdom
facility: Pfizer Investigational Site
state: Somerset
city: Coventry
country: United Kingdom
facility: Pfizer Investigational Site
city: Dumfries
country: United Kingdom
facility: Pfizer Investigational Site
city: Dundee
country: United Kingdom
facility: Pfizer Investigational Site
city: Luton
country: United Kingdom
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: