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

NCT00542009 | Completed Phase 2

• 1 other identifier: A7211005
• Study Type: interventional
• Target: 252
• Locations: 7 countries
• Sites: 54

Brief Summary

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

Conditions

Weight Management; Treatment Of Obesity

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Glucose control

  At Day 84

• Body weight

  At Day 84

Secondary Outcomes (7)

• Regimen (dose or number) of anti-diabetic agents

  At Day 84

• GlycoMark

  On Day 84

• Waist circumference

  On Day 84

• Proportion of subjects who achieve HbA1C <7% and <6.5%

  On Day 84

• Population PK to analyze CE-326,597 concentrations as well as explore relationship of concentration to effect on HbA1C and body weight over duration of trial.

  Throughout Study

Study Arms (5)

CE-326,597 100 mg QD

EXPERIMENTAL

Drug: CE-326,597 100 mg QD

CE-326,597 50 mg QD

EXPERIMENTAL

Drug: CE-326,597 50 mg QD

CE-326,597 25 mg QD

EXPERIMENTAL

Drug: CE-326,597 25 mg QD

Placebo

PLACEBO COMPARATOR

Drug: Placebo

CE-326,597 5mg QD

EXPERIMENTAL

Drug: CE-326,597 5mg QD

Interventions

CE-326,597 100 mg QD DRUG

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

CE-326,597 100 mg QD

CE-326,597 50 mg QD DRUG

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

CE-326,597 50 mg QD

CE-326,597 25 mg QD DRUG

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

CE-326,597 25 mg QD

Placebo DRUG

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

Placebo

CE-326,597 5mg QD DRUG

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

CE-326,597 5mg QD

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Women of childbearing potential, people with unstable medical conditions, people with gallstones

Sponsors & Collaborators

• Pfizer: lead

Study Sites (54)

Pfizer Investigational Site

Phoenix, Arizona, 85023, United States

Location

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Fresno, California, 93720, United States

Location

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National City, California, 91950, United States

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San Diego, California, 92128, United States

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Miami, Florida, 33143, United States

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Ocala, Florida, 34471, United States

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West Palm Beach, Florida, 33401, United States

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Atlanta, Georgia, 30342, United States

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Conyers, Georgia, 30094, United States

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Honolulu, Hawaii, 96814, United States

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Idaho Falls, Idaho, 83404, United States

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Chicago, Illinois, 60607, United States

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Chicago, Illinois, 60654, United States

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Overland Park, Kansas, 66212, United States

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Bethesda, Maryland, 20817, United States

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Chaska, Minnesota, 55318, United States

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Minneapolis, Minnesota, 55455, United States

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Jackson, Mississippi, 39202, United States

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Henderson, Nevada, 89052, United States

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Las Vegas, Nevada, 89101, United States

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Las Vegas, Nevada, 89117, United States

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Fargo, North Dakota, 58103, United States

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Cincinnati, Ohio, 45249, United States

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Lansdale, Pennsylvania, 19446, United States

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Rapid City, South Dakota, 57702, United States

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Beaumont, Texas, 77701, United States

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Beaumont, Texas, 77706, United States

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Dallas, Texas, 75231, United States

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Dallas, Texas, 75246, United States

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Richmond, Virginia, 23294, United States

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Pleven, 5800, Bulgaria

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Sofia, 1431, Bulgaria

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Sofia, 1606, Bulgaria

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Stara Zagora, 6000, Bulgaria

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Coquitlam, British Columbia, V3K 3P4, Canada

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Winnipeg, Manitoba, R3a 1R9, Canada

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Winnipeg, Manitoba, R3E 3P4, Canada

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London, Ontario, N6A 4V2, Canada

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Laval, Quebec, H7T 2P5, Canada

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Montreal, Quebec, H3A 1A1, Canada

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Bangalore, Karnataka, 560 052, India

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Indore, Madhya Pradesh, 452 001, India

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Nagpur, Maharashtra, 440 012, India

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Nashik, Maharashtra, 422 013, India

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Ladrón de Guevara, Guadalajara, Jalisco, 44656, Mexico

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Guadalajara, Jalisco, 44340, Mexico

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Monterrey, Nuevo León, 64460, Mexico

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Ponce, 00716, Puerto Rico

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San Juan, 00909, Puerto Rico

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Tao Baja, 00949, Puerto Rico

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Barcelona, Barcelona, 08036, Spain

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Santiago de Compostela, La Coruña, 15706, Spain

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Madrid, Madrid, 28040, Spain

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Pfizer Investigational Site

Seville, Sevilla, 41013, Spain

Location

Related Links

• To obtain contact information for a study center near you, click here.

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 5, 2007
• First Posted: October 10, 2007
• Study Start: December 1, 2007
• Primary Completion: November 1, 2008
• Study Completion: November 1, 2008
• Last Updated: November 7, 2012

Record last verified: 2012-11

Locations

ME (3); ES (4); BU (4); US (30); IN (4); CA (6); PR (3)