A Trial In Diabetic Patients To Assess Effect Of CE-326,597 On Glucose Control And Body Weight

NCT ID: NCT00542009

Last Updated: 2012-11-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

252 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-12-31

Study Completion Date

2008-11-30

Brief Summary

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Study of whether the investigational drug CE-326,597 improves glucose control and results in body weight loss in patients with type 2 diabetes

Detailed Description

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Conditions

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Weight Management Treatment Of Obesity

Keywords

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Phase 2A, safety and efficacy trial with CE-326,597 in patients with T2DM.

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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CE-326,597 100 mg QD

Group Type EXPERIMENTAL

CE-326,597 100 mg QD

Intervention Type DRUG

Administered orally, once daily with morning meal for duration of trial (84 days).

CE-326,597 50 mg QD

Group Type EXPERIMENTAL

CE-326,597 50 mg QD

Intervention Type DRUG

Administered orally, once daily with morning meal for duration of trial (84 days).

CE-326,597 25 mg QD

Group Type EXPERIMENTAL

CE-326,597 25 mg QD

Intervention Type DRUG

Administered orally, once daily with morning meal for duration of trial (84 days).

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo to match CE-326,597 tablets to be administered orally, once daily with morning meal for duration of trial (84 days).

CE-326,597 5mg QD

Group Type EXPERIMENTAL

CE-326,597 5mg QD

Intervention Type DRUG

Administered orally, once daily with morning meal for duration of trial (84 days).

Interventions

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CE-326,597 100 mg QD

Administered orally, once daily with morning meal for duration of trial (84 days).

Intervention Type DRUG

CE-326,597 50 mg QD

Administered orally, once daily with morning meal for duration of trial (84 days).

Intervention Type DRUG

CE-326,597 25 mg QD

Administered orally, once daily with morning meal for duration of trial (84 days).

Intervention Type DRUG

Placebo

Placebo to match CE-326,597 tablets to be administered orally, once daily with morning meal for duration of trial (84 days).

Intervention Type DRUG

CE-326,597 5mg QD

Administered orally, once daily with morning meal for duration of trial (84 days).

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

Patients with type 2 diabetes, not on any or on oral (up to 2) anti-diabetic medications, otherwise medically stable.

Exclusion Criteria

Women of childbearing potential, people with unstable medical conditions, people with gallstones
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Pfizer Investigational Site

Phoenix, Arizona, United States

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Fresno, California, United States

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National City, California, United States

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San Diego, California, United States

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Miami, Florida, United States

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Ocala, Florida, United States

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West Palm Beach, Florida, United States

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Atlanta, Georgia, United States

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Conyers, Georgia, United States

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Honolulu, Hawaii, United States

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Idaho Falls, Idaho, United States

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Chicago, Illinois, United States

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Chicago, Illinois, United States

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Overland Park, Kansas, United States

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Bethesda, Maryland, United States

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Chaska, Minnesota, United States

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Minneapolis, Minnesota, United States

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Jackson, Mississippi, United States

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Henderson, Nevada, United States

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Las Vegas, Nevada, United States

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Las Vegas, Nevada, United States

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Fargo, North Dakota, United States

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Cincinnati, Ohio, United States

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Lansdale, Pennsylvania, United States

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Rapid City, South Dakota, United States

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Beaumont, Texas, United States

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Beaumont, Texas, United States

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Dallas, Texas, United States

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Dallas, Texas, United States

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Richmond, Virginia, United States

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Pleven, , Bulgaria

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Sofia, , Bulgaria

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Sofia, , Bulgaria

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Stara Zagora, , Bulgaria

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Coquitlam, British Columbia, Canada

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Winnipeg, Manitoba, Canada

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Winnipeg, Manitoba, Canada

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London, Ontario, Canada

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Laval, Quebec, Canada

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Montreal, Quebec, Canada

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Bangalore, Karnataka, India

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Indore, Madhya Pradesh, India

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Nagpur, Maharashtra, India

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Nashik, Maharashtra, India

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Ladrón de Guevara, Guadalajara, Jalisco, Mexico

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Guadalajara, Jalisco, Mexico

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Monterrey, Nuevo León, Mexico

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Ponce, , Puerto Rico

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San Juan, , Puerto Rico

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Tao Baja, , Puerto Rico

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Barcelona, Barcelona, Spain

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Santiago de Compostela, La Coruña, Spain

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Madrid, Madrid, Spain

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Seville, Sevilla, Spain

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Countries

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United States Bulgaria Canada India Mexico Puerto Rico Spain

Related Links

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Other Identifiers

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A7211005

Identifier Type: -

Identifier Source: org_study_id