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

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

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

Study Overview

• Status: Terminated
• Conditions: Obesity
• Intervention / Treatment: Drug: Placebo; Drug: CP-945,598; Drug: CP-945,598 Treatment B

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.

• Study Type: Interventional
• Enrollment (Actual): 975
• Phase: Phase 3

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo; Subjects receive placebo plus non-pharmacological weight loss program.
Experimental: CP-945,598	Drug: CP-945,598; Subjects receive CP-945,598 plus non-pharmacological weight loss program.
Experimental: CP-945,598 Treatment B; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Percent change in body weight from baseline.	1 year

Secondary Outcome Measures

Outcome Measure	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;	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

Collaborators and Investigators

• Sponsor: Pfizer

Publications and helpful links

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start: November 1, 2006
• Primary Completion (Actual): December 1, 2008
• Study Completion (Actual): January 1, 2009

Study Registration Dates

• First Submitted: October 19, 2006
• First Submitted That Met QC Criteria: October 19, 2006
• First Posted (Estimate): October 23, 2006

Study Record Updates

• Last Update Posted (Estimate): November 7, 2012
• Last Update Submitted That Met QC Criteria: November 5, 2012
• Last Verified: November 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Body Weight; Obesity; Overweight
• Other Study ID Numbers: A5351022