Long-Term Study of Safety and Efficacy of WelChol® as an Additional Therapy in Patients With Type 2 Diabetes
Primary Purpose
Type 2 Diabetes
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Colesevelam hydrochloride
Sponsored by
About this trial
This is an interventional treatment trial for Type 2 Diabetes focused on measuring Open label, Diabetes Mellitus, Long term safety study, extension study
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
Sites / Locations
Outcomes
Primary Outcome Measures
To evaluate safety and tolerability of colesevelam hydrochloride as add-on therapy
Secondary Outcome Measures
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
Full Information
NCT ID
NCT00151762
First Posted
September 7, 2005
Last Updated
December 26, 2007
Sponsor
Daiichi Sankyo, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT00151762
Brief Title
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
2. Study Status
Record Verification Date
December 2007
Overall Recruitment Status
Completed
Study Start Date
December 2004 (undefined)
Primary Completion Date
July 2007 (Actual)
Study Completion Date
July 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Daiichi Sankyo, Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes
Keywords
Open label, Diabetes Mellitus, Long term safety study, extension study
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
780 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Colesevelam hydrochloride
Primary Outcome Measure Information:
Title
To evaluate safety and tolerability of colesevelam hydrochloride as add-on therapy
Secondary Outcome Measure Information:
Title
To assess the long-term effect on hemoglobin A1c
Title
To assess the long-term effect on fasting plasma glucose
Title
To assess effects on lipids and lipoproteins
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Facility Information:
City
Birmingham
State/Province
Alabama
Country
United States
City
Tuscumbia
State/Province
Alabama
Country
United States
City
Jonesboro
State/Province
Arkansas
Country
United States
City
Little Rock
State/Province
Arkansas
Country
United States
City
Searcy
State/Province
Arkansas
Country
United States
City
Carmichael
State/Province
California
Country
United States
City
Concord
State/Province
California
Country
United States
City
Irvine
State/Province
California
Country
United States
City
La Jolla
State/Province
California
Country
United States
City
Los Angeles
State/Province
California
Country
United States
City
Los Gatos
State/Province
California
Country
United States
City
San Diego
State/Province
California
Country
United States
City
Spring Valley
State/Province
California
Country
United States
City
West Hills
State/Province
California
Country
United States
City
Washington
State/Province
District of Columbia
Country
United States
City
Cocoa Beach
State/Province
Florida
Country
United States
City
Coral Gables
State/Province
Florida
Country
United States
City
Largo
State/Province
Florida
Country
United States
City
Miami
State/Province
Florida
Country
United States
City
New Port Richey
State/Province
Florida
Country
United States
City
Pembroke Pines
State/Province
Florida
Country
United States
City
West Palm Beach
State/Province
Florida
Country
United States
City
Atlanta
State/Province
Georgia
Country
United States
City
Chicago
State/Province
Illinois
Country
United States
City
Evansville
State/Province
Indiana
Country
United States
City
Indianapolis
State/Province
Indiana
Country
United States
City
Lexington
State/Province
Kentucky
Country
United States
City
Louisville
State/Province
Kentucky
Country
United States
City
New Orleans
State/Province
Louisiana
Country
United States
City
Boston
State/Province
Massachusetts
Country
United States
City
Detroit
State/Province
Michigan
Country
United States
City
Troy
State/Province
Michigan
Country
United States
City
Edina
State/Province
Minnesota
Country
United States
City
Kansas City
State/Province
Missouri
Country
United States
City
St. Louis
State/Province
Missouri
Country
United States
City
Bozeman
State/Province
Montana
Country
United States
City
Butte
State/Province
Montana
Country
United States
City
Las Vegas
State/Province
Nevada
Country
United States
City
Rochester
State/Province
New York
Country
United States
City
Charlotte
State/Province
North Carolina
Country
United States
City
Hickory
State/Province
North Carolina
Country
United States
City
Statesville
State/Province
North Carolina
Country
United States
City
Winston Salem
State/Province
North Carolina
Country
United States
City
Cincinnati
State/Province
Ohio
Country
United States
City
Cleveland
State/Province
Ohio
Country
United States
City
Marion
State/Province
Ohio
Country
United States
City
Perrysburg
State/Province
Ohio
Country
United States
City
Oklahoma City
State/Province
Oklahoma
Country
United States
City
Tulsa
State/Province
Oklahoma
Country
United States
City
Portland
State/Province
Oregon
Country
United States
City
Beaver
State/Province
Pennsylvania
Country
United States
City
Charleston
State/Province
South Carolina
Country
United States
City
Columbia
State/Province
South Carolina
Country
United States
City
Bristol
State/Province
Tennessee
Country
United States
City
Morristown
State/Province
Tennessee
Country
United States
City
Corpus Christi
State/Province
Texas
Country
United States
City
Dallas
State/Province
Texas
Country
United States
City
Houston
State/Province
Texas
Country
United States
City
Midland
State/Province
Texas
Country
United States
City
San Antonio
State/Province
Texas
Country
United States
City
Richmond
State/Province
Virginia
Country
United States
City
Lakewood
State/Province
Washington
Country
United States
City
Mexico DF
Country
Mexico
City
Lima
Country
Peru
12. IPD Sharing Statement
Learn more about this trial
Long-Term Study of Safety and Efficacy of WelChol® as an Additional Therapy in Patients With Type 2 Diabetes
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