This extension study is designed to evaluate the long term safety and tolerability of colesevelam hydrochloride in patients with type 2 diabetes

Condition	Intervention	Phase
Type 2 Diabetes	Drug: Colesevelam hydrochloride	Phase III

Further Study Details: 

Primary Outcomes: To evaluate safety and tolerability of colesevelam hydrochloride as add-on therapy
Secondary Outcomes: -To assess the long-term effect on hemoglobin A1c; -To assess the long-term effect on fasting plasma glucose; -To assess effects on lipids and lipoproteins
Expected Total Enrollment:  780

Ages Eligible for Study:  18 Years   -   75 Years,  Genders Eligible for Study:  Both

Criteria

Inclusion /Rollover Criteria

• Patients who have completed studies WEL-301, WEL-302, or WEL-303 with treatment compliance at least 80%
• Patients who have completed studies WEL-301, WEL-302, or WEL-303 who have not met withdrawal criteria

Please refer to this study by ClinicalTrials.gov identifier  NCT00151762

Medpace Inc      800-794-4608 

Alabama
      Birmingham,  Alabama,  United States; Recruiting
      Tuscumbia,  Alabama,  United States; Recruiting
Arkansas
      Jonesboro,  Arkansas,  United States; Recruiting
      Little Rock,  Arkansas,  United States; Recruiting
      Searcy,  Arkansas,  United States; Recruiting
California
      Carmichael,  California,  United States; Recruiting
      Concord,  California,  United States; Recruiting
      Irvine,  California,  United States; Recruiting
      La Jolla,  California,  United States; Recruiting
      Los Angeles,  California,  United States; Recruiting
      Los Gatos,  California,  United States; Recruiting
      San Diego,  California,  United States; Recruiting
      Spring Valley,  California,  United States; Recruiting
      West Hills,  California,  United States; Recruiting
District of Columbia
      Washington,  District of Columbia,  United States; Recruiting
Florida
      Cocoa Beach,  Florida,  United States; Recruiting
      Coral Gables,  Florida,  United States; Recruiting
      Largo,  Florida,  United States; Recruiting
      Miami,  Florida,  United States; Recruiting
      New Port Richey,  Florida,  United States; Recruiting
      Pembroke Pines,  Florida,  United States; Recruiting
      West Palm Beach,  Florida,  United States; Recruiting
Georgia
      Atlanta,  Georgia,  United States; Recruiting
Illinois
      Chicago,  Illinois,  United States; Recruiting
Indiana
      Evansville,  Indiana,  United States; Recruiting
      Indianapolis,  Indiana,  United States; Recruiting
Kentucky
      Lexington,  Kentucky,  United States; Recruiting
      Louisville,  Kentucky,  United States; Recruiting
Louisiana
      New Orleans,  Louisiana,  United States; Recruiting
Massachusetts
      Boston,  Massachusetts,  United States; Recruiting
Michigan
      Detroit,  Michigan,  United States; Recruiting
      Troy,  Michigan,  United States; Recruiting
Minnesota
      Edina,  Minnesota,  United States; Recruiting
Missouri
      Kansas City,  Missouri,  United States; Recruiting
      St. Louis,  Missouri,  United States; Recruiting
Montana
      Bozeman,  Montana,  United States; Recruiting
      Butte,  Montana,  United States; Recruiting
Nevada
      Las Vegas,  Nevada,  United States; Recruiting
New York
      Rochester,  New York,  United States; Recruiting
North Carolina
      Charlotte,  North Carolina,  United States; Recruiting
      Hickory,  North Carolina,  United States; Recruiting
      Statesville,  North Carolina,  United States; Recruiting
      Winston Salem,  North Carolina,  United States; Recruiting
Ohio
      Cincinnati,  Ohio,  United States; Recruiting
      Cleveland,  Ohio,  United States; Recruiting
      Marion,  Ohio,  United States; Recruiting
      Perrysburg,  Ohio,  United States; Recruiting
Oklahoma
      Oklahoma City,  Oklahoma,  United States; Recruiting
      Tulsa,  Oklahoma,  United States; Recruiting
Oregon
      Portland,  Oregon,  United States; Recruiting
Pennsylvania
      Beaver,  Pennsylvania,  United States; Recruiting
South Carolina
      Charleston,  South Carolina,  United States; Recruiting
      Columbia,  South Carolina,  United States; Recruiting
Tennessee
      Bristol,  Tennessee,  United States; Recruiting
      Morristown,  Tennessee,  United States; Recruiting
Texas
      Corpus Christi,  Texas,  United States; Recruiting
      Dallas,  Texas,  United States; Recruiting
      Houston,  Texas,  United States; Recruiting
      Midland,  Texas,  United States; Recruiting
      San Antonio,  Texas,  United States; Recruiting
Virginia
      Richmond,  Virginia,  United States; Recruiting
Washington
      Lakewood,  Washington,  United States; Recruiting
Mexico
      Mexico DF,  Mexico; Recruiting
Peru
      Lima,  Peru; Recruiting

Study ID Numbers:  WEL-304
Last Updated:  September 8, 2005
Record first received:  September 7, 2005
ClinicalTrials.gov Identifier:  NCT00151762
Health Authority: United States: Food and Drug Administration; Peru: General Directorate of Pharmaceuticals, Devices, and Drugs; Mexico: National Institute of Public Health, Health Secretariat
ClinicalTrials.gov processed this record on 2005-09-13