WelChol® and Sulfonylurea in Treating Patients With Type 2 Diabetes
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
1 other identifier
interventional
400
3 countries
47
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3 type-2-diabetes
Started Jun 2004
Typical duration for phase_3 type-2-diabetes
47 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2004
CompletedFirst Submitted
Initial submission to the registry
September 2, 2005
CompletedFirst Posted
Study publicly available on registry
September 7, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2006
CompletedJanuary 18, 2012
January 1, 2012
2.2 years
September 2, 2005
January 16, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To assess the additional lowering of HbA1c achieved by addition of colesevelam hydrochloride to current antidiabetic therapy
Secondary Outcomes (6)
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;
- +1 more secondary outcomes
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Daiichi Sankyolead
Study Sites (47)
Unknown Facility
Birmingham, Alabama, United States
Unknown Facility
Tuscumbia, Alabama, United States
Unknown Facility
Little Rock, Arkansas, United States
Unknown Facility
Searcy, Arkansas, United States
Unknown Facility
Concord, California, United States
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Irvine, California, United States
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La Jolla, California, United States
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Los Angeles, California, United States
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Los Gatos, California, United States
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West Hills, California, United States
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Coral Gables, Florida, United States
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Miami, Florida, United States
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New Port Richey, Florida, United States
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Pembroke Pines, Florida, United States
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West Palm Beach, Florida, United States
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Atlanta, Georgia, United States
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Chicago, Illinois, United States
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Indianapolis, Indiana, United States
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New Orleans, Louisiana, United States
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Boston, Massachusetts, United States
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Kansas City, Missouri, United States
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St Louis, Missouri, United States
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Rochester, New York, United States
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Charlotte, North Carolina, United States
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Hickory, North Carolina, United States
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Statesville, North Carolina, United States
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Winston-Salem, North Carolina, United States
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Cincinnati, Ohio, United States
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Cleveland, Ohio, United States
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Marion, Ohio, United States
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Perrysburg, Ohio, United States
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Oklahoma City, Oklahoma, United States
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Tulsa, Oklahoma, United States
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Portland, Oregon, United States
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Beaver, Pennsylvania, United States
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Charleston, South Carolina, United States
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Bristol, Tennessee, United States
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Dallas, Texas, United States
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Houston, Texas, United States
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Midland, Texas, United States
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San Antonio, Texas, United States
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Arlington, Virginia, United States
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Richmond, Virginia, United States
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Lakewood, Washington, United States
Unknown Facility
Renton, Washington, United States
Unknown Facility
Mexico City, Mexico
Unknown Facility
Lima, Peru
Related Publications (1)
Fonseca VA, Rosenstock J, Wang AC, Truitt KE, Jones MR. Colesevelam HCl improves glycemic control and reduces LDL cholesterol in patients with inadequately controlled type 2 diabetes on sulfonylurea-based therapy. Diabetes Care. 2008 Aug;31(8):1479-84. doi: 10.2337/dc08-0283. Epub 2008 May 5.
PMID: 18458145DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 2, 2005
First Posted
September 7, 2005
Study Start
June 1, 2004
Primary Completion
August 1, 2006
Study Completion
August 1, 2006
Last Updated
January 18, 2012
Record last verified: 2012-01