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

Obesity Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00391196
• Other study ID #: A5351022
• Status: Terminated
• Phase: Phase 3
• First received: October 19, 2006
• Last updated: November 5, 2012
• Start date: November 2006
• Est. completion date: January 2009

Study information

• Verified date: November 2012
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 975
• Est. completion date: January 2009
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Obesity

Intervention

Drug:
• Placebo
Subjects receive placebo plus non-pharmacological weight loss program.
• CP-945,598
Subjects receive CP-945,598 plus non-pharmacological weight loss program.
• CP-945,598 Treatment B
Subjects receive CP-945,598 plus non-pharmacological weight loss program.

Locations

Country	Name	City	State
Argentina	Pfizer Investigational Site	Buenos Aires
Argentina	Pfizer Investigational Site	Buenos Aires
Argentina	Pfizer Investigational Site	Buenos Aires
Australia	Pfizer Investigational Site	Adelaide	South Australia
Australia	Pfizer Investigational Site	Box Hill	Victoria
Australia	Pfizer Investigational Site	Garran	Australian Capital Territory
Australia	Pfizer Investigational Site	Nedlands	Western Australia
Australia	Pfizer Investigational Site	Wollongong	New South Wales
Brazil	Pfizer Investigational Site	Curitiba	PR
Brazil	Pfizer Investigational Site	Porto Alegre	RS
Brazil	Pfizer Investigational Site	São Paulo	SP
Brazil	Pfizer Investigational Site	São Paulo	SP
Brazil	Pfizer Investigational Site	São Paulo	SP
Brazil	Pfizer Investigational Site	São Paulo	SP
Canada	Pfizer Investigational Site	Charlottetown	Prince Edward Island
Canada	Pfizer Investigational Site	Coquitlam	British Columbia
Canada	Pfizer Investigational Site	L'Ancienne-Lorette	Quebec
Canada	Pfizer Investigational Site	Red Deer	Alberta
Canada	Pfizer Investigational Site	Saint-Marc-des-Carrières	Quebec
Canada	Pfizer Investigational Site	Thornhill	Ontario
Canada	Pfizer Investigational Site	Winnipeg	Manitoba
Czech Republic	Pfizer Investigational Site	Breclav
Czech Republic	Pfizer Investigational Site	Ceske Budejovice
Czech Republic	Pfizer Investigational Site	Olomouc
Czech Republic	Pfizer Investigational Site	Praha 2
Czech Republic	Pfizer Investigational Site	Praha 4 - Krc
Germany	Pfizer Investigational Site	Berlin
Germany	Pfizer Investigational Site	Dresden
Germany	Pfizer Investigational Site	Duesseldorf
Germany	Pfizer Investigational Site	Hamburg
Germany	Pfizer Investigational Site	Leipzig
Germany	Pfizer Investigational Site	Mittweida
Mexico	Pfizer Investigational Site	Guadalajara	Jalisco
Mexico	Pfizer Investigational Site	Mexico	DF
Mexico	Pfizer Investigational Site	Monterrey	Nuevo León
Mexico	Pfizer Investigational Site	Tampico	Cd. Madero
Slovakia	Pfizer Investigational Site	Banska Bystrica
Slovakia	Pfizer Investigational Site	Bratislava
Slovakia	Pfizer Investigational Site	Lubochna
Slovakia	Pfizer Investigational Site	Nitra
Sweden	Pfizer Investigational Site	Goteborg
Sweden	Pfizer Investigational Site	Huddinge
United Kingdom	Pfizer Investigational Site	Bath	Somerset
United Kingdom	Pfizer Investigational Site	Coventry
United Kingdom	Pfizer Investigational Site	Dumfries
United Kingdom	Pfizer Investigational Site	Dundee
United Kingdom	Pfizer Investigational Site	Edinburgh	Lothian
United Kingdom	Pfizer Investigational Site	Luton
United States	Pfizer Investigational Site	Albuquerque	New Mexico
United States	Pfizer Investigational Site	Auburn	Maine
United States	Pfizer Investigational Site	Baltimore	Maryland
United States	Pfizer Investigational Site	Baton Rouge	Louisiana
United States	Pfizer Investigational Site	Bay City	Michigan
United States	Pfizer Investigational Site	Beaver	Pennsylvania
United States	Pfizer Investigational Site	Birmingham	Alabama
United States	Pfizer Investigational Site	Birmingham	Alabama
United States	Pfizer Investigational Site	Bristol	Tennessee
United States	Pfizer Investigational Site	Buffalo	New York
United States	Pfizer Investigational Site	Chandler	Arizona
United States	Pfizer Investigational Site	Cumberland	Rhode Island
United States	Pfizer Investigational Site	Dallas	Texas
United States	Pfizer Investigational Site	Dallas	Texas
United States	Pfizer Investigational Site	Edina	Minnesota
United States	Pfizer Investigational Site	Fresno	California
United States	Pfizer Investigational Site	Greenville	North Carolina
United States	Pfizer Investigational Site	Greer	South Carolina
United States	Pfizer Investigational Site	Gurnee	Illinois
United States	Pfizer Investigational Site	Honolulu	Hawaii
United States	Pfizer Investigational Site	Huntsville	Alabama
United States	Pfizer Investigational Site	Jefferson City	Missouri
United States	Pfizer Investigational Site	Madisonville	Kentucky
United States	Pfizer Investigational Site	Mesa	Arizona
United States	Pfizer Investigational Site	Metairie	Louisiana
United States	Pfizer Investigational Site	Mobile	Alabama
United States	Pfizer Investigational Site	Morgantown	West Virginia
United States	Pfizer Investigational Site	Nashville	Tennessee
United States	Pfizer Investigational Site	New Britain	Connecticut
United States	Pfizer Investigational Site	New York	New York
United States	Pfizer Investigational Site	Orlando	Florida
United States	Pfizer Investigational Site	Palm Springs	California
United States	Pfizer Investigational Site	Pawtucket	Rhode Island
United States	Pfizer Investigational Site	Phoenix	Arizona
United States	Pfizer Investigational Site	Renton	Washington
United States	Pfizer Investigational Site	San Antonio	Texas
United States	Pfizer Investigational Site	San Antonio	Texas
United States	Pfizer Investigational Site	Scarborough	Maine
United States	Pfizer Investigational Site	Troy	Michigan
United States	Pfizer Investigational Site	Tustin	California
United States	Pfizer Investigational Site	Walnut Creek	California
United States	Pfizer Investigational Site	Washington	District of Columbia
United States	Pfizer Investigational Site	West Palm Beach	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Brazil,  Canada,  Czech Republic,  Germany,  Mexico,  Slovakia,  Sweden,  United Kingdom, 

Outcome

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

External Links

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