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

Primary Purpose

Obesity

Status
Terminated
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Placebo
CP-945,598
CP-945,598 Treatment B
Sponsored by
Pfizer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
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  • Pfizer Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Experimental

Experimental

Arm Label

Placebo

CP-945,598

CP-945,598 Treatment B

Arm Description

Subjects receive CP-945,598 plus non-pharmacological weight loss program.

Outcomes

Primary Outcome Measures

Percent change in body weight from baseline.

Secondary Outcome Measures

Proportion of subjects who lose 5 and 10% baseline body weight at 1 year;
Proportion of subjects achieving HbA1c <6.5% and <7% at 1 year;
Change from baseline in waist circumference at 1 year;
Change from baseline fasting triglyceride and HDL concentrations at 1 year;
Change from baseline in Total cholesterol, LDL, TNF α, adiponectin, and hsCRP levels at month 6 and 1 year;
Change in prevalence of metabolic syndrome based on accepted definition at the time of study completion;
HOMA IR (HOMA IR=fasting insulin x fasting glucose/22.5) at 1 year;
Percentage of subjects who require additional diabetes pharmacotherapy because they meet protocol criteria for inadequate glycemic control;
Population pharmacokinetic analysis of data acquired at trough and by randomized sparse sampling and exploration of PK/PD relationships;
Change from baseline fasting plasma glucose concentration at 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;
Change from baseline in background sulfonylurea or meglitinide dose requirements in subjects taking these medications;
Change from baseline in 7 point home glucose profiles in a subset of subjects at 1 year;
Primary and key secondary endpoints at any measured intermediate time points including weight at week 2, months 1, 6, 9, and 11;
HbA1c, fasting plasma glucose at months 1, 3, 6, and 9;
Waist circumference at months 3, 6, and 9;
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;
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;
Change in fasting and postprandial insulin concentrations determined from OGTT in a subset of subjects at 1 year;
Protocol defined hypoglycemia event rates and proportion of subjects with hypoglycemic events;
Change from baseline postprandial glucose determined from OGTT in a subset of subjects at 1 year;
Changes from baseline in patient reported outcome subscales: uncontrolled eating/hunger, power of food, physical functioning, and self esteem at 1 year;
Changes in patient reported outcome subscales not identified as key secondary endpoints at months 3, 6, and 12
Change from baseline HbA1c to 1 year;

Full Information

First Posted
October 19, 2006
Last Updated
November 5, 2012
Sponsor
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT00391196
Brief Title
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

2. Study Status

Record Verification Date
November 2012
Overall Recruitment Status
Terminated
Why Stopped
See termination reason in detailed description.
Study Start Date
November 2006 (undefined)
Primary Completion Date
December 2008 (Actual)
Study Completion Date
January 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
975 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Title
CP-945,598
Arm Type
Experimental
Arm Title
CP-945,598 Treatment B
Arm Type
Experimental
Arm Description
Subjects receive CP-945,598 plus non-pharmacological weight loss program.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Subjects receive placebo plus non-pharmacological weight loss program.
Intervention Type
Drug
Intervention Name(s)
CP-945,598
Intervention Description
Subjects receive CP-945,598 plus non-pharmacological weight loss program.
Intervention Type
Drug
Intervention Name(s)
CP-945,598 Treatment B
Intervention Description
Subjects receive CP-945,598 plus non-pharmacological weight loss program.
Primary Outcome Measure Information:
Title
Percent change in body weight from baseline.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Proportion of subjects who lose 5 and 10% baseline body weight at 1 year;
Time Frame
1 year
Title
Proportion of subjects achieving HbA1c <6.5% and <7% at 1 year;
Time Frame
1 year
Title
Change from baseline in waist circumference at 1 year;
Time Frame
1 year
Title
Change from baseline fasting triglyceride and HDL concentrations at 1 year;
Time Frame
1 year
Title
Change from baseline in Total cholesterol, LDL, TNF α, adiponectin, and hsCRP levels at month 6 and 1 year;
Time Frame
1 year
Title
Change in prevalence of metabolic syndrome based on accepted definition at the time of study completion;
Time Frame
1 year
Title
HOMA IR (HOMA IR=fasting insulin x fasting glucose/22.5) at 1 year;
Time Frame
1 year
Title
Percentage of subjects who require additional diabetes pharmacotherapy because they meet protocol criteria for inadequate glycemic control;
Time Frame
1 year
Title
Population pharmacokinetic analysis of data acquired at trough and by randomized sparse sampling and exploration of PK/PD relationships;
Time Frame
1 year
Title
Change from baseline fasting plasma glucose concentration at 1 year;
Time Frame
1 year
Title
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
Title
Change from baseline in background sulfonylurea or meglitinide dose requirements in subjects taking these medications;
Time Frame
1 year
Title
Change from baseline in 7 point home glucose profiles in a subset of subjects at 1 year;
Time Frame
1 year
Title
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
Title
HbA1c, fasting plasma glucose at months 1, 3, 6, and 9;
Time Frame
1 year
Title
Waist circumference at months 3, 6, and 9;
Time Frame
1 year
Title
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
Title
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
Title
Change in fasting and postprandial insulin concentrations determined from OGTT in a subset of subjects at 1 year;
Time Frame
1 year
Title
Protocol defined hypoglycemia event rates and proportion of subjects with hypoglycemic events;
Time Frame
1 year
Title
Change from baseline postprandial glucose determined from OGTT in a subset of subjects at 1 year;
Time Frame
1 year
Title
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
Title
Changes in patient reported outcome subscales not identified as key secondary endpoints at months 3, 6, and 12
Time Frame
1 year
Title
Change from baseline HbA1c to 1 year;
Time Frame
1 year

10. Eligibility

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

12. IPD Sharing Statement

Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A5351022&StudyName=A%201-Year%20Study%20On%20The%20Effects%20Of%20CP-945%2C598%20For%20The%20Treatment%20Of%20Obesity%20In%20Overweight%20Type%202%20Diabetic%20Patients
Description
To obtain contact information for a study center near you, click here.

Learn more about this trial

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

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