Trial Review

The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00391196




Registration number
NCT00391196
Ethics application status
Date submitted
19/10/2006
Date registered
23/10/2006
Date last updated
7/11/2012

Titles & IDs
Public title
A 1-Year Study On The Effects Of CP-945,598 For The Treatment Of Obesity In Overweight Type 2 Diabetic Patients
Scientific 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
Secondary ID [1] 0 0
A5351022
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obesity 0 0
Condition category
Condition code
Diet and Nutrition 0 0 0 0
Obesity
Metabolic and Endocrine 0 0 0 0
Other metabolic disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Placebo
Treatment: Drugs - CP-945,598
Treatment: Drugs - CP-945,598 Treatment B

Placebo comparator: Placebo -

Experimental: CP-945,598 -

Experimental: CP-945,598 Treatment B - Subjects receive CP-945,598 plus non-pharmacological weight loss program.


Treatment: Drugs: Placebo
Subjects receive placebo plus non-pharmacological weight loss program.

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

Treatment: Drugs: CP-945,598 Treatment B
Subjects receive CP-945,598 plus non-pharmacological weight loss program.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percent change in body weight from baseline.
Timepoint [1] 0 0
1 year
Secondary outcome [1] 0 0
Proportion of subjects who lose 5 and 10% baseline body weight at 1 year;
Timepoint [1] 0 0
1 year
Secondary outcome [2] 0 0
Proportion of subjects achieving HbA1c <6.5% and <7% at 1 year;
Timepoint [2] 0 0
1 year
Secondary outcome [3] 0 0
Change from baseline in waist circumference at 1 year;
Timepoint [3] 0 0
1 year
Secondary outcome [4] 0 0
Change from baseline fasting triglyceride and HDL concentrations at 1 year;
Timepoint [4] 0 0
1 year
Secondary outcome [5] 0 0
Change from baseline in Total cholesterol, LDL, TNF a, adiponectin, and hsCRP levels at month 6 and 1 year;
Timepoint [5] 0 0
1 year
Secondary outcome [6] 0 0
Change in prevalence of metabolic syndrome based on accepted definition at the time of study completion;
Timepoint [6] 0 0
1 year
Secondary outcome [7] 0 0
HOMA IR (HOMA IR=fasting insulin x fasting glucose/22.5) at 1 year;
Timepoint [7] 0 0
1 year
Secondary outcome [8] 0 0
Percentage of subjects who require additional diabetes pharmacotherapy because they meet protocol criteria for inadequate glycemic control;
Timepoint [8] 0 0
1 year
Secondary outcome [9] 0 0
Population pharmacokinetic analysis of data acquired at trough and by randomized sparse sampling and exploration of PK/PD relationships;
Timepoint [9] 0 0
1 year
Secondary outcome [10] 0 0
Change from baseline fasting plasma glucose concentration at 1 year;
Timepoint [10] 0 0
1 year
Secondary outcome [11] 0 0
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;
Timepoint [11] 0 0
1 year
Secondary outcome [12] 0 0
Change from baseline in background sulfonylurea or meglitinide dose requirements in subjects taking these medications;
Timepoint [12] 0 0
1 year
Secondary outcome [13] 0 0
Change from baseline in 7 point home glucose profiles in a subset of subjects at 1 year;
Timepoint [13] 0 0
1 year
Secondary outcome [14] 0 0
Primary and key secondary endpoints at any measured intermediate time points including weight at week 2, months 1, 6, 9, and 11;
Timepoint [14] 0 0
1 year
Secondary outcome [15] 0 0
HbA1c, fasting plasma glucose at months 1, 3, 6, and 9;
Timepoint [15] 0 0
1 year
Secondary outcome [16] 0 0
Waist circumference at months 3, 6, and 9;
Timepoint [16] 0 0
1 year
Secondary outcome [17] 0 0
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;
Timepoint [17] 0 0
1 year
Secondary outcome [18] 0 0
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;
Timepoint [18] 0 0
1 year
Secondary outcome [19] 0 0
Change in fasting and postprandial insulin concentrations determined from OGTT in a subset of subjects at 1 year;
Timepoint [19] 0 0
1 year
Secondary outcome [20] 0 0
Protocol defined hypoglycemia event rates and proportion of subjects with hypoglycemic events;
Timepoint [20] 0 0
1 year
Secondary outcome [21] 0 0
Change from baseline postprandial glucose determined from OGTT in a subset of subjects at 1 year;
Timepoint [21] 0 0
1 year
Secondary outcome [22] 0 0
Changes from baseline in patient reported outcome subscales: uncontrolled eating/hunger, power of food, physical functioning, and self esteem at 1 year;
Timepoint [22] 0 0
1 year
Secondary outcome [23] 0 0
Changes in patient reported outcome subscales not identified as key secondary endpoints at months 3, 6, and 12
Timepoint [23] 0 0
1 year
Secondary outcome [24] 0 0
Change from baseline HbA1c to 1 year;
Timepoint [24] 0 0
1 year

Eligibility
Key inclusion criteria
* Subjects must be overweight (BMI 27- 50 kg/m2)
* Subjects must have type 2 diabetes mellitus
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Pregnancy
* Serious or unstable current or past medical conditions

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/11/2006
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/01/2009
Sample size
Target
Accrual to date
Final
975
Recruitment in Australia
Recruitment state(s)
ACT,NSW,SA,VIC,WA
Recruitment hospital [1] 0 0
Pfizer Investigational Site - Garran
Recruitment hospital [2] 0 0
Pfizer Investigational Site - Wollongong
Recruitment hospital [3] 0 0
Pfizer Investigational Site - Adelaide
Recruitment hospital [4] 0 0
Pfizer Investigational Site - Box Hill
Recruitment hospital [5] 0 0
Pfizer Investigational Site - Nedlands
Recruitment postcode(s) [1] 0 0
2605 - Garran
Recruitment postcode(s) [2] 0 0
2500 - Wollongong
Recruitment postcode(s) [3] 0 0
5000 - Adelaide
Recruitment postcode(s) [4] 0 0
3128 - Box Hill
Recruitment postcode(s) [5] 0 0
6009 - Nedlands
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
Connecticut
Country [5] 0 0
United States of America
State/province [5] 0 0
District of Columbia
Country [6] 0 0
United States of America
State/province [6] 0 0
Florida
Country [7] 0 0
United States of America
State/province [7] 0 0
Hawaii
Country [8] 0 0
United States of America
State/province [8] 0 0
Illinois
Country [9] 0 0
United States of America
State/province [9] 0 0
Kentucky
Country [10] 0 0
United States of America
State/province [10] 0 0
Louisiana
Country [11] 0 0
United States of America
State/province [11] 0 0
Maine
Country [12] 0 0
United States of America
State/province [12] 0 0
Maryland
Country [13] 0 0
United States of America
State/province [13] 0 0
Michigan
Country [14] 0 0
United States of America
State/province [14] 0 0
Minnesota
Country [15] 0 0
United States of America
State/province [15] 0 0
Missouri
Country [16] 0 0
United States of America
State/province [16] 0 0
New Mexico
Country [17] 0 0
United States of America
State/province [17] 0 0
New York
Country [18] 0 0
United States of America
State/province [18] 0 0
North Carolina
Country [19] 0 0
United States of America
State/province [19] 0 0
Pennsylvania
Country [20] 0 0
United States of America
State/province [20] 0 0
Rhode Island
Country [21] 0 0
United States of America
State/province [21] 0 0
South Carolina
Country [22] 0 0
United States of America
State/province [22] 0 0
Tennessee
Country [23] 0 0
United States of America
State/province [23] 0 0
Texas
Country [24] 0 0
United States of America
State/province [24] 0 0
Washington
Country [25] 0 0
United States of America
State/province [25] 0 0
West Virginia
Country [26] 0 0
Argentina
State/province [26] 0 0
Buenos Aires
Country [27] 0 0
Brazil
State/province [27] 0 0
PR
Country [28] 0 0
Brazil
State/province [28] 0 0
RS
Country [29] 0 0
Brazil
State/province [29] 0 0
SP
Country [30] 0 0
Canada
State/province [30] 0 0
Alberta
Country [31] 0 0
Canada
State/province [31] 0 0
British Columbia
Country [32] 0 0
Canada
State/province [32] 0 0
Manitoba
Country [33] 0 0
Canada
State/province [33] 0 0
Ontario
Country [34] 0 0
Canada
State/province [34] 0 0
Prince Edward Island
Country [35] 0 0
Canada
State/province [35] 0 0
Quebec
Country [36] 0 0
Czech Republic
State/province [36] 0 0
Breclav
Country [37] 0 0
Czech Republic
State/province [37] 0 0
Ceske Budejovice
Country [38] 0 0
Czech Republic
State/province [38] 0 0
Olomouc
Country [39] 0 0
Czech Republic
State/province [39] 0 0
Praha 2
Country [40] 0 0
Czech Republic
State/province [40] 0 0
Praha 4 - Krc
Country [41] 0 0
Germany
State/province [41] 0 0
Berlin
Country [42] 0 0
Germany
State/province [42] 0 0
Dresden
Country [43] 0 0
Germany
State/province [43] 0 0
Duesseldorf
Country [44] 0 0
Germany
State/province [44] 0 0
Hamburg
Country [45] 0 0
Germany
State/province [45] 0 0
Leipzig
Country [46] 0 0
Germany
State/province [46] 0 0
Mittweida
Country [47] 0 0
Mexico
State/province [47] 0 0
Cd. Madero
Country [48] 0 0
Mexico
State/province [48] 0 0
DF
Country [49] 0 0
Mexico
State/province [49] 0 0
Jalisco
Country [50] 0 0
Mexico
State/province [50] 0 0
Nuevo León
Country [51] 0 0
Slovakia
State/province [51] 0 0
Banska Bystrica
Country [52] 0 0
Slovakia
State/province [52] 0 0
Bratislava
Country [53] 0 0
Slovakia
State/province [53] 0 0
Lubochna
Country [54] 0 0
Slovakia
State/province [54] 0 0
Nitra
Country [55] 0 0
Sweden
State/province [55] 0 0
Goteborg
Country [56] 0 0
Sweden
State/province [56] 0 0
Huddinge
Country [57] 0 0
United Kingdom
State/province [57] 0 0
Lothian
Country [58] 0 0
United Kingdom
State/province [58] 0 0
Somerset
Country [59] 0 0
United Kingdom
State/province [59] 0 0
Coventry
Country [60] 0 0
United Kingdom
State/province [60] 0 0
Dumfries
Country [61] 0 0
United Kingdom
State/province [61] 0 0
Dundee
Country [62] 0 0
United Kingdom
State/province [62] 0 0
Luton

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Pfizer
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Pfizer CT.gov Call Center
Address 0 0
Pfizer
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT00391196