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

Phase 3

Terminated

Conditions: Obesity

Interventions: Drug: Placebo
Drug: CP-945,598
Drug: CP-945,598 Treatment B

Registration Number: NCT00391196

Lead Sponsor: Pfizer

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.

Recruitment & Eligibility

Status: TERMINATED

Sex: All

Target Recruitment: 975

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
CP-945,598	CP-945,598	-
CP-945,598 Treatment B	CP-945,598 Treatment B	Subjects receive CP-945,598 plus non-pharmacological weight loss program.

Primary Outcome Measures

Name	Time	Method
Percent change in body weight from baseline.	1 year

Secondary Outcome Measures

Name	Time	Method
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
Proportion of subjects who lose 5 and 10% baseline body weight at 1 year;	1 year
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
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
Change from baseline in 7 point home glucose profiles in a subset of subjects 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