- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00151749
WelChol® and Insulin in Treating Patients With Type 2 Diabetes
January 16, 2012 updated by: Daiichi Sankyo, Inc.
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
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
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment
260
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Mexico DF, Mexico
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Lima, Peru
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Alabama
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Tuscumbia, Alabama, United States
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Arizona
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Sierra Vista, Arizona, United States
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Arkansas
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Jonesboro, Arkansas, United States
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Searcy, Arkansas, United States
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California
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Carmichael, California, United States
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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
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West Hills, California, United States
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District of Columbia
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Washington, District of Columbia, United States
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Florida
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Largo, 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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West Palm Beach, Florida, United States
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Illinois
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Chicago, Illinois, United States
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Indiana
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Indianapolis, Indiana, United States
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Kentucky
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Lexington, Kentucky, United States
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Louisville, Kentucky, United States
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Louisiana
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New Orleans, Louisiana, United States
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Massachusetts
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Boston, Massachusetts, United States
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Michigan
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Troy, Michigan, United States
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Minnesota
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Edina, Minnesota, United States
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Missouri
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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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Montana
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Bozeman, Montana, United States
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Butte, Montana, United States
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New Jersey
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Englewood, New Jersey, United States
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North Carolina
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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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Ohio
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Cincinnati, Ohio, United States
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Marion, Ohio, United States
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Oregon
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Portland, Oregon, United States
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Pennsylvania
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Beaver, Pennsylvania, United States
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South Carolina
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Charleston, South Carolina, United States
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Tennessee
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Bristol, Tennessee, United States
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Morristown, Tennessee, United States
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Texas
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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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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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
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 less than 60 mg/dL
- Serum TG greater than 500 mg/dL
- Body mass index (BMI) greater than 45 kg/m2-
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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- To assess the additional lowering of HbA1c achieved by
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addition of WelChol® to current antidiabetic therapy
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Secondary Outcome Measures
Outcome Measure |
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To assess: the effects on fasting plasma glucose and
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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-
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on therapy to patients receiving insulin alone or with
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other oral drugs
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2004
Primary Completion (Actual)
December 1, 2005
Study Completion (Actual)
December 1, 2005
Study Registration Dates
First Submitted
September 7, 2005
First Submitted That Met QC Criteria
September 7, 2005
First Posted (Estimate)
September 9, 2005
Study Record Updates
Last Update Posted (Estimate)
January 18, 2012
Last Update Submitted That Met QC Criteria
January 16, 2012
Last Verified
January 1, 2012
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- WEL-302
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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