12 Week Study Of PF-00734200 For The Treatment Of Type 2 Diabetes Mellitus In Subjects Treated With Metformin

NCT00473525 | Completed Phase 2

• 1 other identifier: A7941005
• Study Type: interventional
• Target: 303
• Locations: 6 countries
• Sites: 79

Brief Summary

The purpose of this Phase 2a study is to evaluate the efficacy, safety and tolerability, of multiple parallel doses of PF-00734200 following oral administration to adult human subjects with T2DM who currently are on a stable dose of metformin.

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (2)

• HbA1C levels (%)

  12 weeks

• Evaluation of Dose Response in HbA1c (%)

  12 weeks

Secondary Outcomes (3)

• Insulin and Glucose AUC following a mixed meal tolerance test

  12 weeks

• Proportion of subjects achieving ADA glycemic goal of Hb A1c <7%

  12 weeks

• Incidence of Adverse Events

  12 weeks

Study Arms (5)

Placebo

PLACEBO COMPARATOR

Drug: Placebo

PF-00734200 10 mg QD

EXPERIMENTAL

Drug: PF-00734200 10 mg QD

PF-00734200 20 mg QD

EXPERIMENTAL

Drug: PF-00734200 20 mg QD

PF-00734200 5 mg QD

EXPERIMENTAL

Drug: PF-00734200 5 mg QD

PF-00734200 2 mg QD

EXPERIMENTAL

Drug: PF-00734200 2 mg QD

Interventions

Placebo DRUG

Placebo QD

Placebo

PF-00734200 10 mg QD DRUG

10 mg QD

PF-00734200 10 mg QD

PF-00734200 20 mg QD DRUG

20 mg QD

PF-00734200 20 mg QD

PF-00734200 5 mg QD DRUG

5 mg QD

PF-00734200 5 mg QD

PF-00734200 2 mg QD DRUG

2 mg QD

PF-00734200 2 mg QD

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of type 2 diabetes
• Hb1AC \>7%-11% inclusive
• Male and females 18-70; females must be post-menopausal
• On a stable dose of metformin hydrochloride

You may not qualify if:

• Medical history of stroke, unstable angina, heart attack within one year of enrollment, and alcohol dependency or recent drug abuse.
• Women of childbearing potential, pregnant or nursing
• Evidence of diabetic complications with significant end-organ damage

Sponsors & Collaborators

• Pfizer: lead

Study Sites (79)

Pfizer Investigational Site

Birmingham, Alabama, 35209, United States

Location

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Gilbert, Arizona, 85296, United States

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Phoenix, Arizona, 85013, United States

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Phoenix, Arizona, 85016, United States

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Jonesboro, Arkansas, 72401, United States

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Little Rock, Arkansas, 72205-6217, United States

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Carmichael, California, 95608, United States

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Chula Vista, California, 91911, United States

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Fair Oaks, California, 95628, United States

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Los Angeles, California, 90057, United States

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National City, California, 91950, United States

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Paramount, California, 90273, United States

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Roseville, California, 95661, United States

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Sacramento, California, 95825, United States

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DeFuniak Springs, Florida, 32435, United States

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Destin, Florida, 32541, United States

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Jacksonville, Florida, 32216, United States

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New Port Richey, Florida, 34652, United States

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New Port Richey, Florida, 34653, United States

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Palm Harbor, Florida, 34684, 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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Chicago, Illinois, 60607, United States

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Skokie, Illinois, 60076, United States

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Skokie, Illinois, 60077, United States

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Wheeling, Illinois, 60090, United States

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Lexington, Kentucky, 40503, United States

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Lexington, Kentucky, 40504, United States

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Brockton, Massachusetts, 02301, United States

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Worcester, Massachusetts, 01602, United States

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Ann Arbor, Michigan, 48106, United States

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Canton, Michigan, 48187, United States

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Flint, Michigan, 48532, United States

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Biloxi, Mississippi, 39531, United States

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Picayune, Mississippi, 39466, United States

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St Louis, Missouri, 63141, United States

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Omaha, Nebraska, 68114, United States

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Las Vegas, Nevada, 89119, United States

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Las Vegas, Nevada, 89128, United States

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Las Vegas, Nevada, 89148, United States

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Trenton, New Jersey, 08611, United States

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Cary, North Carolina, 27518, United States

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Raleigh, North Carolina, 27609, United States

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Raleigh, North Carolina, 27612, United States

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Marion, Ohio, 43302, United States

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Oklahoma City, Oklahoma, 73103, United States

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Oklahoma City, Oklahoma, 73119, United States

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Carnegie, Pennsylvania, 15106, United States

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East Providence, Rhode Island, 02914, United States

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Bartlett, Tennessee, 38134, United States

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Collierville, Tennessee, 38017, United States

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Kingsport, Tennessee, 37660, United States

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Dallas, Texas, 75230, United States

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Houston, Texas, 77023, United States

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Houston, Texas, 77074, United States

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Houston, Texas, 77079, United States

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Houston, Texas, 77081, United States

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Irving, Texas, 75039, United States

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San Antonio, Texas, 78229, United States

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San Antonio, Texas, 78237, United States

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Richmond, Virginia, 23225, United States

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Virginia Beach, Virginia, 23455, United States

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Milwaukee, Wisconsin, 53209, United States

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Bogota, Cundinamarca, 0, Colombia

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Bogota, Cundinamarca, Colombia

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Floridablanca, Santander Department, 0, Colombia

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Berlin, 10787, Germany

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Giengen an der Brenz, 89537, Germany

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Hamburg, 21073, Germany

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München, 81241, Germany

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Roma, 00161, Italy

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Santiago de Compostela, La Coruña, 15706, Spain

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Alcalá de Henares, Madrid, 28805, Spain

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Valencia, Valencia, 46009, Spain

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Valencia, Valencia, 46014, Spain

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Gothenburg, 41665, Sweden

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Malmo, 21136, Sweden

Location

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Stockholm, 111 57, Sweden

Location

Related Links

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

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

gosogliptin

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: May 14, 2007
• First Posted: May 15, 2007
• Study Start: July 1, 2007
• Primary Completion: June 1, 2008
• Study Completion: June 1, 2008
• Last Updated: June 24, 2010

Record last verified: 2010-06

Locations

SE (3); US (64); CO (3); ES (4); DE (4); IT (1)