Long-Term Study of Safety and Efficacy of WelChol® as an Additional Therapy in Patients With Type 2 Diabetes
Sponsor
Daiichi Sankyo, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT00151762
Collaborator
(none)
780
64
30.9
12.2
0.4
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Study Type:
Interventional
Allocation:
Non-Randomized
Masking:
None (Open Label)
Primary Purpose:
Treatment
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 Start Date
:
Dec 1, 2004
Actual Primary Completion Date
:
Jul 1, 2007
Actual Study Completion Date
:
Jul 1, 2007
Outcome Measures
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 []
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Birmingham | Alabama | United States | ||
| 2 | Tuscumbia | Alabama | United States | ||
| 3 | Jonesboro | Arkansas | United States | ||
| 4 | Little Rock | Arkansas | United States | ||
| 5 | Searcy | Arkansas | United States | ||
| 6 | Carmichael | California | United States | ||
| 7 | Concord | California | United States | ||
| 8 | Irvine | California | United States | ||
| 9 | La Jolla | California | United States | ||
| 10 | Los Angeles | California | United States | ||
| 11 | Los Gatos | California | United States | ||
| 12 | San Diego | California | United States | ||
| 13 | Spring Valley | California | United States | ||
| 14 | West Hills | California | United States | ||
| 15 | Washington | District of Columbia | United States | ||
| 16 | Cocoa Beach | Florida | United States | ||
| 17 | Coral Gables | Florida | United States | ||
| 18 | Largo | Florida | United States | ||
| 19 | Miami | Florida | United States | ||
| 20 | New Port Richey | Florida | United States | ||
| 21 | Pembroke Pines | Florida | United States | ||
| 22 | West Palm Beach | Florida | United States | ||
| 23 | Atlanta | Georgia | United States | ||
| 24 | Chicago | Illinois | United States | ||
| 25 | Evansville | Indiana | United States | ||
| 26 | Indianapolis | Indiana | United States | ||
| 27 | Lexington | Kentucky | United States | ||
| 28 | Louisville | Kentucky | United States | ||
| 29 | New Orleans | Louisiana | United States | ||
| 30 | Boston | Massachusetts | United States | ||
| 31 | Detroit | Michigan | United States | ||
| 32 | Troy | Michigan | United States | ||
| 33 | Edina | Minnesota | United States | ||
| 34 | Kansas City | Missouri | United States | ||
| 35 | St. Louis | Missouri | United States | ||
| 36 | Bozeman | Montana | United States | ||
| 37 | Butte | Montana | United States | ||
| 38 | Las Vegas | Nevada | United States | ||
| 39 | Rochester | New York | United States | ||
| 40 | Charlotte | North Carolina | United States | ||
| 41 | Hickory | North Carolina | United States | ||
| 42 | Statesville | North Carolina | United States | ||
| 43 | Winston Salem | North Carolina | United States | ||
| 44 | Cincinnati | Ohio | United States | ||
| 45 | Cleveland | Ohio | United States | ||
| 46 | Marion | Ohio | United States | ||
| 47 | Perrysburg | Ohio | United States | ||
| 48 | Oklahoma City | Oklahoma | United States | ||
| 49 | Tulsa | Oklahoma | United States | ||
| 50 | Portland | Oregon | United States | ||
| 51 | Beaver | Pennsylvania | United States | ||
| 52 | Charleston | South Carolina | United States | ||
| 53 | Columbia | South Carolina | United States | ||
| 54 | Bristol | Tennessee | United States | ||
| 55 | Morristown | Tennessee | United States | ||
| 56 | Corpus Christi | Texas | United States | ||
| 57 | Dallas | Texas | United States | ||
| 58 | Houston | Texas | United States | ||
| 59 | Midland | Texas | United States | ||
| 60 | San Antonio | Texas | United States | ||
| 61 | Richmond | Virginia | United States | ||
| 62 | Lakewood | Washington | United States | ||
| 63 | Mexico DF | Mexico | |||
| 64 | Lima | Peru |
Sponsors and Collaborators
- Daiichi Sankyo, Inc.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
,
,
ClinicalTrials.gov Identifier:
NCT00151762
Other Study ID Numbers:
- WEL-304
First Posted:
Sep 9, 2005
Last Update Posted:
Jan 9, 2008
Last Verified:
Dec 1, 2007
Keywords provided by ,
,
Additional relevant MeSH terms: