The purpose of this study is to determine if CP-945,598 is effective in the treatment of obesity in type 2 diabetic patients.
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
975
Subjects receive placebo plus non-pharmacological weight loss program.
Subjects receive CP-945,598 plus non-pharmacological weight loss program.
Subjects receive CP-945,598 plus non-pharmacological weight loss program.
Percent change in body weight from baseline.
Time frame: 1 year
Proportion of subjects who lose 5 and 10% baseline body weight at 1 year;
Time frame: 1 year
Proportion of subjects achieving HbA1c <6.5% and <7% at 1 year;
Time frame: 1 year
Change from baseline in waist circumference at 1 year;
Time frame: 1 year
Change from baseline fasting triglyceride and HDL concentrations at 1 year;
Time frame: 1 year
Change from baseline in Total cholesterol, LDL, TNF α, adiponectin, and hsCRP levels at month 6 and 1 year;
Time frame: 1 year
Change in prevalence of metabolic syndrome based on accepted definition at the time of study completion;
Time frame: 1 year
HOMA IR (HOMA IR=fasting insulin x fasting glucose/22.5) at 1 year;
Time frame: 1 year
Percentage of subjects who require additional diabetes pharmacotherapy because they meet protocol criteria for inadequate glycemic control;
Time frame: 1 year
Population pharmacokinetic analysis of data acquired at trough and by randomized sparse sampling and exploration of PK/PD relationships;
Time frame: 1 year
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Pfizer Investigational Site
Birmingham, Alabama, United States
Pfizer Investigational Site
Birmingham, Alabama, United States
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Change from baseline fasting plasma glucose concentration at 1 year;
Time frame: 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;
Time frame: 1 year
Change from baseline in background sulfonylurea or meglitinide dose requirements in subjects taking these medications;
Time frame: 1 year
Change from baseline in 7 point home glucose profiles in a subset of subjects at 1 year;
Time frame: 1 year
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
HbA1c, fasting plasma glucose at months 1, 3, 6, and 9;
Time frame: 1 year
Waist circumference at months 3, 6, and 9;
Time frame: 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;
Time frame: 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;
Time frame: 1 year
Change in fasting and postprandial insulin concentrations determined from OGTT in a subset of subjects at 1 year;
Time frame: 1 year
Protocol defined hypoglycemia event rates and proportion of subjects with hypoglycemic events;
Time frame: 1 year
Change from baseline postprandial glucose determined from OGTT in a subset of subjects at 1 year;
Time frame: 1 year
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
Changes in patient reported outcome subscales not identified as key secondary endpoints at months 3, 6, and 12
Time frame: 1 year
Change from baseline HbA1c to 1 year;
Time frame: 1 year