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

Pfizer

Status and phase: Terminated; Phase 3

Conditions: Obesity

Treatments: Drug: CP-945,598; Drug: Placebo; Drug: CP-945,598 Treatment B

Study type: Interventional

Funder types: Industry

Identifiers

NCT00391196

A5351022

Details and patient eligibility

About

The purpose of this study is to determine if CP-945,598 is effective in the treatment of obesity in type 2 diabetic patients.

Full 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.

Enrollment: 975 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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975 participants in 3 patient groups, including a placebo group

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo

CP-945,598

Experimental group

Treatment:

Drug: CP-945,598

CP-945,598 Treatment B

Experimental group

Description:

Subjects receive CP-945,598 plus non-pharmacological weight loss program.

Treatment:

Drug: CP-945,598 Treatment B