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

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

Official Title

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

Obesity, Type 2 Diabetes Mellitus

Study Type

Interventional

Study Design

Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Further Details

• Primary Outcome Measures: Change in body weight over one year.
• Secondary Outcome Measures: HbA1c, BP, blood lipids, fasting glucose, waist circumference, quality of life over 1 year.

Study Start

November 2006

Eligibility & Criteria

• Ages Eligible for Study: 18 Years – 70 Years
• Genders Eligible for Study: Both

Inclusion Criteria:

• Subjects must be overweight (BMI 27-45 kg/m²).
• Subjects must have type 2 diabetes mellitus

Exclusion Criteria:

• Pregnancy
• Serious or unstable current or past medical conditions

Total Enrolment

900

Contact Details

Australian Locations:

• Pfizer Investigational Site, Garran, Australian Capital Territory, Australia; Recruiting
• Pfizer Investigational Site, Wollongong, New South Wales, Australia; Recruiting
• Pfizer Investigational Site, Adelaide, South Australia, Australia; Recruiting
• Pfizer Investigational Site, Box Hill, Victoria, Australia; Recruiting
• Pfizer Investigational Site, Nedlands, Western Australia, Australia; Recruiting

Contact Pfizer for more information about this trial.