Clinical trial NCT00151762: Long-Term Study of Safety and Efficacy of WelChol® as an Additional Therapy in Patients With Type 2 Diabetes
Official title: A Multi-Center, 52-Week, Open-Label Extension Study (From Studies WEL-301, WEL-302, and WEL-303) to Evaluate the Long-Term Safety and Tolerability of WelChol® in Type 2 Diabetic Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Type 2 Diabetes
Keywords: Open label, Diabetes Mellitus
Long term safety study, extension study
Lead sponsor: Daiichi Sankyo
Sponsor class: INDUSTRY
First posted: 2005-09-09
Enrollment: 780
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Primary purpose: TREATMENT

Brief summary: This extension study is designed to evaluate the long-term safety and tolerability of colesevelam hydrochloride (WelChol®) in patients with type 2 diabetes.


Eligibility 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

Primary outcomes:
measure: To evaluate safety and tolerability of colesevelam hydrochloride as add-on therapy
Secondary outcomes:
measure: To assess the long-term effect on hemoglobin A1c
measure: To assess the long-term effect on fasting plasma glucose
measure: To assess effects on lipids and lipoproteins
Other outcomes:
Locations:
city: Birmingham
country: United States
state: Alabama
city: Tuscumbia
country: United States
state: Alabama
city: Jonesboro
country: United States
state: Arkansas
city: Little Rock
country: United States
state: Arkansas
city: Searcy
country: United States
state: Arkansas
city: Carmichael
country: United States
state: California
city: Concord
country: United States
state: California
city: Irvine
country: United States
state: California
city: La Jolla
country: United States
state: California
city: Los Angeles
country: United States
state: California
city: Los Gatos
country: United States
state: California
city: San Diego
country: United States
state: California
city: Spring Valley
country: United States
state: California
city: West Hills
country: United States
state: California
city: Washington
country: United States
state: District of Columbia
city: Cocoa Beach
country: United States
state: Florida
city: Coral Gables
country: United States
state: Florida
city: Largo
country: United States
state: Florida
city: Miami
country: United States
state: Florida
city: New Port Richey
country: United States
state: Florida
city: Pembroke Pines
country: United States
state: Florida
city: West Palm Beach
country: United States
state: Florida
city: Atlanta
country: United States
state: Georgia
city: Chicago
country: United States
state: Illinois
city: Evansville
country: United States
state: Indiana
city: Indianapolis
country: United States
state: Indiana
city: Lexington
country: United States
state: Kentucky
city: Louisville
country: United States
state: Kentucky
city: New Orleans
country: United States
state: Louisiana
city: Boston
country: United States
state: Massachusetts
city: Detroit
country: United States
state: Michigan
city: Troy
country: United States
state: Michigan
city: Edina
country: United States
state: Minnesota
city: Kansas City
country: United States
state: Missouri
city: St. Louis
country: United States
state: Missouri
city: Bozeman
country: United States
state: Montana
city: Butte
country: United States
state: Montana
city: Las Vegas
country: United States
state: Nevada
city: Rochester
country: United States
state: New York
city: Charlotte
country: United States
state: North Carolina
city: Hickory
country: United States
state: North Carolina
city: Statesville
country: United States
state: North Carolina
city: Winston Salem
country: United States
state: North Carolina
city: Cincinnati
country: United States
state: Ohio
city: Cleveland
country: United States
state: Ohio
city: Marion
country: United States
state: Ohio
city: Perrysburg
country: United States
state: Ohio
city: Oklahoma City
country: United States
state: Oklahoma
city: Tulsa
country: United States
state: Oklahoma
city: Portland
country: United States
state: Oregon
city: Beaver
country: United States
state: Pennsylvania
city: Charleston
country: United States
state: South Carolina
city: Columbia
country: United States
state: South Carolina
city: Bristol
country: United States
state: Tennessee
city: Morristown
country: United States
state: Tennessee
city: Corpus Christi
country: United States
state: Texas
city: Dallas
country: United States
state: Texas
city: Houston
country: United States
state: Texas
city: Midland
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: Richmond
country: United States
state: Virginia
city: Lakewood
country: United States
state: Washington
city: Mexico DF
country: Mexico
city: Lima
country: Peru
Study officials:
References: