Study Of Denagliptin In Subjects With Type 2 Diabetes Mellitus (T2DM)

NCT ID: NCT00387972

Last Updated: 2015-04-17

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

WITHDRAWN

Clinical Phase

PHASE2/PHASE3

Study Classification

INTERVENTIONAL

Study Start Date

2006-05-31

Study Completion Date

2007-10-31

Brief Summary

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GW823093 is a selective DPP-IV Inhibitor and is being investigated as a once a day oral therapy. The purpose of the Study is to evaluate the effectiveness, safety, and tolerability of 2 doses of GW823093, compared to placebo, taken once daily in patients with Type 2 diabetes mellitus.

Detailed Description

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Conditions

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Type 2 Diabetes Mellitus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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denagliptin (GW823093)

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Type 2 diabetes mellitus treated with diet and exercise or oral anti-diabetic treatment
* Body mass index between 20 and 40
* Females of childbearing potential must use adequate birth control.

Exclusion Criteria

* Subjects with previous use of insulin
* Type 1 diabetes
* Uncontrolled thyroid disease
* History of drug or alcohol abuse in the past year
* Any other clinically significant disease.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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GlaxoSmithKline

INDUSTRY

Sponsor Role lead

Principal Investigators

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GSK Clinical Trial, DM, FRCP

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

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GSK Clinical Trials Call Center

Tallassee, Alabama, United States

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GSK Clinical Trials Call Center

Phoenix, Arizona, United States

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GSK Clinical Trials Call Center

Tucson, Arizona, United States

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GSK Clinical Trials Call Center

Beverly Hills, California, United States

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GSK Clinical Trials Call Center

Carmichael, California, United States

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GSK Clinical Trials Call Center

Concord, California, United States

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GSK Clinical Trials Call Center

Torrance, California, United States

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GSK Clinical Trials Call Center

Victorville, California, United States

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Wilmington, Delaware, United States

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Boynton Beach, Florida, United States

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Clearwater, Florida, United States

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Coral Gables, Florida, United States

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Hialeah, Florida, United States

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Hollywood, Florida, United States

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Melbourne, Florida, United States

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Miami, Florida, United States

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Opa-locka, Florida, United States

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Plantation, Florida, United States

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Tampa, Florida, United States

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Calhoun, Georgia, United States

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Roswell, Georgia, United States

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Hayden Lake, Idaho, United States

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Chicago, Illinois, United States

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Chicago, Illinois, United States

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Lake Zurich, Illinois, United States

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Watseka, Illinois, United States

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Baton Rouge, Louisiana, United States

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Marrero, Louisiana, United States

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Oxon Hill, Maryland, United States

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Detroit, Michigan, United States

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GSK Clinical Trials Call Center

City of Saint Peters, Missouri, United States

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GSK Clinical Trials Call Center

Florissant, Missouri, United States

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St Louis, Missouri, United States

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Las Vegas, Nevada, United States

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Williamsville, New York, United States

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Charlotte, North Carolina, United States

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Morehead City, North Carolina, United States

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GSK Clinical Trials Call Center

Fargo, North Dakota, United States

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GSK Clinical Trials Call Center

Cincinnati, Ohio, United States

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Columbus, Ohio, United States

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GSK Clinical Trials Call Center

Guthrie, Oklahoma, United States

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Norman, Oklahoma, United States

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Oklahoma City, Oklahoma, United States

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Oklahoma City, Oklahoma, United States

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GSK Clinical Trials Call Center

Yukon, Oklahoma, United States

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Eugene, Oregon, United States

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GSK Clinical Trials Call Center

Medford, Oregon, United States

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GSK Clinical Trials Call Center

Beaver Falls, Pennsylvania, United States

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GSK Clinical Trials Call Center

Fleetwood, Pennsylvania, United States

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GSK Clinical Trials Call Center

Warminster, Pennsylvania, United States

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GSK Clinical Trials Call Center

Anderson, South Carolina, United States

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GSK Clinical Trials Call Center

Chattanooga, Tennessee, United States

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GSK Clinical Trials Call Center

Johnson City, Tennessee, United States

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GSK Clinical Trials Call Center

Cleburne, Texas, United States

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GSK Clinical Trials Call Center

San Antonio, Texas, United States

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GSK Clinical Trials Call Center

Seguin, Texas, United States

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GSK Clinical Trials Call Center

Weber City, Virginia, United States

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Countries

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United States

Other Identifiers

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DPB107246

Identifier Type: -

Identifier Source: org_study_id

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