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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Obesity

Intervention / Treatment
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* Drug: Placebo
* Drug: CP-945,598
* Drug: CP-945,598 Treatment B


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Subjects receive placebo plus non-pharmacological weight loss program.<br>|
| Experimental: CP-945,598<br> | Drug: CP-945,598<br>* Subjects receive CP-945,598 plus non-pharmacological weight loss program.<br>|
| Experimental: CP-945,598 Treatment B<br>Subjects receive CP-945,598 plus non-pharmacological weight loss program. | Drug: CP-945,598 Treatment B<br>* Subjects receive CP-945,598 plus non-pharmacological weight loss program.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent change in body weight from baseline. |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 |