WelChol® and Insulin 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 Diabetes With Inadequate Glycemic Control on Insulin Therapy Alone or Insulin Therapy Combination With Other Oral Anti-diabetic Agents
1 other identifier
interventional
260
3 countries
47
Brief Summary
The purpose of the study is to see how safe and effective and tolerable the use of WelChol® is for type 2 diabetes when added to insulin 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 P25-P50 for phase_3 type-2-diabetes
Started Jun 2004
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 7, 2005
CompletedFirst Posted
Study publicly available on registry
September 9, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2005
CompletedJanuary 18, 2012
January 1, 2012
1.5 years
September 7, 2005
January 16, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
- To assess the additional lowering of HbA1c achieved by
addition of WelChol® to current antidiabetic therapy
Secondary Outcomes (4)
To assess: the effects on fasting plasma glucose and
fructosamine; glycemic control response rate; effect on adiponectin; the effect on c-peptide; effect on c-reactive protein; effects on lipids and lipoproteins; the safety and tolerability of WelChol® as add-
on therapy to patients receiving insulin alone or with
other oral drugs
Interventions
Eligibility Criteria
You may qualify if:
- Ages 18 - 75 years, inclusive
- Diagnosed with type 2 diabetes
- Stable insulin therapy for 6 weeks
- Stable dose of any other antidiabetic medications for 90 days
- Hemoglobin A1c value between 7.5% to 9.5%
- C peptide greater than 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 less than 60 mg/dL
- Serum TG greater than 500 mg/dL
- Body mass index (BMI) greater than 45 kg/m2-
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Daiichi Sankyolead
Study Sites (47)
Unknown Facility
Tuscumbia, Alabama, United States
Unknown Facility
Sierra Vista, Arizona, United States
Unknown Facility
Jonesboro, Arkansas, United States
Unknown Facility
Searcy, Arkansas, United States
Unknown Facility
Carmichael, California, United States
Unknown Facility
Concord, California, United States
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Fullerton, California, United States
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La Jolla, California, United States
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San Diego, California, United States
Unknown Facility
West Hills, California, United States
Unknown Facility
Washington D.C., District of Columbia, United States
Unknown Facility
Largo, Florida, United States
Unknown Facility
Miami, Florida, United States
Unknown Facility
New Port Richey, Florida, United States
Unknown Facility
West Palm Beach, Florida, United States
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Chicago, Illinois, United States
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Indianapolis, Indiana, United States
Unknown Facility
Lexington, Kentucky, United States
Unknown Facility
Louisville, Kentucky, United States
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New Orleans, Louisiana, United States
Unknown Facility
Boston, Massachusetts, United States
Unknown Facility
Troy, Michigan, United States
Unknown Facility
Edina, Minnesota, United States
Unknown Facility
Chesterfield, Missouri, United States
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Kansas City, Missouri, United States
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St Louis, Missouri, United States
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Bozeman, Montana, United States
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Butte, Montana, United States
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Englewood, New Jersey, United States
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Charlotte, North Carolina, United States
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Hickory, North Carolina, United States
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Raleigh, 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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Marion, Ohio, 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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Morristown, 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
Unknown Facility
San Antonio, Texas, United States
Unknown Facility
Mexico City, Mexico
Unknown Facility
Lima, Peru
Related Publications (1)
Goldberg RB, Fonseca VA, Truitt KE, Jones MR. Efficacy and safety of colesevelam in patients with type 2 diabetes mellitus and inadequate glycemic control receiving insulin-based therapy. Arch Intern Med. 2008 Jul 28;168(14):1531-40. doi: 10.1001/archinte.168.14.1531.
PMID: 18663165DERIVED
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 7, 2005
First Posted
September 9, 2005
Study Start
June 1, 2004
Primary Completion
December 1, 2005
Study Completion
December 1, 2005
Last Updated
January 18, 2012
Record last verified: 2012-01