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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/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
Gender
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
Terminated
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
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
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United States of America
State/province [2] 0 0
Arizona
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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
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United States of America
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Kentucky
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Louisiana
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Maine
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Maryland
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Michigan
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Minnesota
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Missouri
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New Mexico
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New York
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North Carolina
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Pennsylvania
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Rhode Island
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South Carolina
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Tennessee
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Texas
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Washington
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West Virginia
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Argentina
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Buenos Aires
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Brazil
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PR
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Brazil
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RS
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Brazil
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SP
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Alberta
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Canada
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British Columbia
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Canada
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Manitoba
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Canada
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Ontario
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Canada
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Prince Edward Island
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Canada
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Quebec
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Czech Republic
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Breclav
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Czech Republic
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Ceske Budejovice
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Czech Republic
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Olomouc
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Czech Republic
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Praha 2
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Czech Republic
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Praha 4 - Krc
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Germany
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Berlin
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Germany
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Dresden
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Germany
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Duesseldorf
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Germany
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Hamburg
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Germany
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Leipzig
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Germany
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Mittweida
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Mexico
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Cd. Madero
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Mexico
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DF
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Mexico
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Jalisco
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Mexico
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Nuevo León
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Slovakia
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Banska Bystrica
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Slovakia
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Bratislava
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Slovakia
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Lubochna
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Slovakia
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Nitra
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Sweden
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Goteborg
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Sweden
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Huddinge
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United Kingdom
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Lothian
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United Kingdom
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Somerset
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United Kingdom
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Coventry
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United Kingdom
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Dumfries
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United Kingdom
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Dundee
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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
The purpose of this study is to determine if CP-945,598 is effective in the treatment of
obesity in type 2 diabetic patients.
Trial website
https://clinicaltrials.gov/show/NCT00391196
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

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT00391196