WelChol® and Sulfonylurea in Treating Patients With Type 2 Diabetes
Sponsor
Daiichi Sankyo, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT00147758
Collaborator
(none)
400
47
26
8.5
0.3
Study Details
Study Description
Brief Summary
The purpose of the study is to see how safe and effective and tolerable the use of colesevelam hydrochloride is for type 2 diabetes when added to sulfonylurea alone or in combination with other anti-diabetic drugs.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Study Type:
Interventional
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double
Primary Purpose:
Treatment
Official Title:
A Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study of the Efficacy and Safety of WelChol® in Type 2 Diabetics With Inadequate Glycemic Control on Sulfonylurea Monotherapy or Sulfonylurea Therapy in Combination With Other Oral Anti-Diabetic Agents
Study Start Date
:
Jun 1, 2004
Actual Primary Completion Date
:
Aug 1, 2006
Actual Study Completion Date
:
Aug 1, 2006
Outcome Measures
Primary Outcome Measures
- To assess the additional lowering of HbA1c achieved by addition of colesevelam hydrochloride to current antidiabetic therapy []
Secondary Outcome Measures
- To assess the fasting plasma glucose and fructosamine lowering efficacy; []
- To assess glycemic control response rate; []
- To assess the improvement in insulin sensitivity; []
- To assess the effect on C reactive protein; []
- To assess lipids and lipoproteins; []
- To assess the safety and tolerability of colesevelam hydrochloride as add-on therapy []
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Age 18-75 years, inclusive
-
Diagnosed with type 2 diabetes
-
Stable dose of sulfonylurea alone or in combination with other anti-diabetic medications for 90 days
-
Hemoglobin A1c value 7.5% to 9.5%, inclusive
-
C peptide > 0.5 ng/mL
-
Prescribed ADA diet
Exclusion Criteria:
-
History of type 1 diabetes or ketoacidosis
-
History of pancreatitis
-
Uncontrolled hypertension
-
Allergy or toxic response to colesevelam or any of its components
-
Serum LDL-C < 60 mg/dL
-
Serum TG > 500 mg/dL
-
Body mass index (BMI) > 45 kg/m2
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Birmingham | Alabama | United States | ||
| 2 | Tuscumbia | Alabama | United States | ||
| 3 | Little Rock | Arkansas | United States | ||
| 4 | Searcy | Arkansas | United States | ||
| 5 | Concord | California | United States | ||
| 6 | Irvine | California | United States | ||
| 7 | La Jolla | California | United States | ||
| 8 | Los Angeles | California | United States | ||
| 9 | Los Gatos | California | United States | ||
| 10 | West Hills | California | United States | ||
| 11 | Coral Gables | Florida | United States | ||
| 12 | Miami | Florida | United States | ||
| 13 | New Port Richey | Florida | United States | ||
| 14 | Pembroke Pines | Florida | United States | ||
| 15 | West Palm Beach | Florida | United States | ||
| 16 | Atlanta | Georgia | United States | ||
| 17 | Chicago | Illinois | United States | ||
| 18 | Indianapolis | Indiana | United States | ||
| 19 | New Orleans | Louisiana | United States | ||
| 20 | Boston | Massachusetts | United States | ||
| 21 | Kansas City | Missouri | United States | ||
| 22 | St. Louis | Missouri | United States | ||
| 23 | Rochester | New York | United States | ||
| 24 | Charlotte | North Carolina | United States | ||
| 25 | Hickory | North Carolina | United States | ||
| 26 | Statesville | North Carolina | United States | ||
| 27 | Winston-Salem | North Carolina | United States | ||
| 28 | Cincinnati | Ohio | United States | ||
| 29 | Cleveland | Ohio | United States | ||
| 30 | Marion | Ohio | United States | ||
| 31 | Perrysburg | Ohio | United States | ||
| 32 | Oklahoma City | Oklahoma | United States | ||
| 33 | Tulsa | Oklahoma | United States | ||
| 34 | Portland | Oregon | United States | ||
| 35 | Beaver | Pennsylvania | United States | ||
| 36 | Charleston | South Carolina | United States | ||
| 37 | Bristol | Tennessee | United States | ||
| 38 | Dallas | Texas | United States | ||
| 39 | Houston | Texas | United States | ||
| 40 | Midland | Texas | United States | ||
| 41 | San Antonio | Texas | United States | ||
| 42 | Arlington | Virginia | United States | ||
| 43 | Richmond | Virginia | United States | ||
| 44 | Lakewood | Washington | United States | ||
| 45 | Renton | Washington | United States | ||
| 46 | Mexico DF | Mexico | |||
| 47 | Lima | Peru |
Sponsors and Collaborators
- Daiichi Sankyo, Inc.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Daiichi Sankyo, Inc.
ClinicalTrials.gov Identifier:
NCT00147758
Other Study ID Numbers:
- WEL-303
First Posted:
Sep 7, 2005
Last Update Posted:
Jan 18, 2012
Last Verified:
Jan 1, 2012
Keywords provided by Daiichi Sankyo, Inc.
Additional relevant MeSH terms: