Obesity
Conditions
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.
Interventions
DRUGPlacebo
Subjects receive placebo plus non-pharmacological weight loss program.
DRUGCP-945,598
Subjects receive CP-945,598 plus non-pharmacological weight loss program.
Subjects receive CP-945,598 plus non-pharmacological weight loss program.
Sponsors
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percent change in body weight from baseline. | 1 year |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
| Proportion of subjects who lose 5 and 10% baseline body weight 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 |
| Change from baseline in 7 point home glucose profiles in a subset of subjects at 1 year; | 1 year |
Countries
Argentina, Australia, Brazil, Canada, Czechia, Germany, Mexico, Slovakia, Sweden, United Kingdom, United States
Outcome results
None listed