Type 2 DiabetesPhase 3NCT00151762
Long-Term Study of Safety and Efficacy of WelChol® as an Additional Therapy in Patients With Type 2 Diabetes
A Phase 3 study testing Colesevelam hydrochloride in people with Type 2 Diabetes, run by Daiichi Sankyo at 64 sites in 3 countries.
Trial summary
This extension study is designed to evaluate the long-term safety and tolerability of colesevelam hydrochloride (WelChol®) in patients with type 2 diabetes. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- Colesevelam hydrochloride
- How many people
- 780 participants
- Where
- 64 sitesin 3 countries
- Study dates
- Dec 2004to Jul 2007
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
None listed.
Trial locations and contacts
64 sites in 3 countries.
64 sites in 3 countries
United States62 sites
Study site
Atlanta, Georgia
Study site
Beaver, Pennsylvania
Study site
Birmingham, Alabama
Study site
Boston, Massachusetts
Study site
Bozeman, Montana
Study site
Bristol, Tennessee
Study site
Butte, Montana
Study site
Carmichael, California
Study site
Charleston, South Carolina
Study site
Charlotte, North Carolina
Study site
Chicago, Illinois
Study site
Cincinnati, Ohio
Study site
Cleveland, Ohio
Study site
Cocoa Beach, Florida
Study site
Columbia, South Carolina
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Concord, California
Study site
Coral Gables, Florida
Study site
Corpus Christi, Texas
Study site
Dallas, Texas
Study site
Detroit, Michigan
Study site
Edina, Minnesota
Study site
Evansville, Indiana
Study site
Hickory, North Carolina
Study site
Houston, Texas
Study site
Indianapolis, Indiana
Study site
Irvine, California
Study site
Jonesboro, Arkansas
Study site
Kansas City, Missouri
Study site
La Jolla, California
Study site
Lakewood, Washington
Study site
Largo, Florida
Study site
Las Vegas, Nevada
Study site
Lexington, Kentucky
Study site
Little Rock, Arkansas
Study site
Los Angeles, California
Study site
Los Gatos, California
Study site
Louisville, Kentucky
Study site
Marion, Ohio
Study site
Miami, Florida
Study site
Midland, Texas
Study site
Morristown, Tennessee
Study site
New Orleans, Louisiana
Study site
New Port Richey, Florida
Study site
Oklahoma City, Oklahoma
Study site
Pembroke Pines, Florida
Study site
Perrysburg, Ohio
Study site
Portland, Oregon
Study site
Richmond, Virginia
Study site
Rochester, New York
Study site
San Antonio, Texas
Study site
San Diego, California
Study site
Searcy, Arkansas
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Spring Valley, California
Study site
St Louis, Missouri
Study site
Statesville, North Carolina
Study site
Troy, Michigan
Study site
Tulsa, Oklahoma
Study site
Tuscumbia, Alabama
Study site
Washington D.C., District of Columbia
Study site
West Hills, California
Study site
West Palm Beach, Florida
Study site
Winston-Salem, North Carolina
About this study
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
This extension study is designed to evaluate the long-term safety and tolerability of colesevelam hydrochloride (WelChol®) in patients with type 2 diabetes.
- Conditions
- Type 2 Diabetes
- Being tested
- Colesevelam hydrochloride
- Keywords
- Open label, Diabetes Mellitus, Long term safety study, extension study
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Colesevelam hydrochlorideDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate safety and tolerability of colesevelam hydrochloride as add-on therapy
Secondary outcomes (3)
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2005 (estimated)
- Study startDec 2004
- Primary completionJul 2007
- Study completionJul 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- More trials run by Daiichi SankyoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Masking
- None (open label)
- Enrolment
- 780 participants
Sponsor and investigators
- Lead sponsor
- Daiichi Sankyo
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00151762
- Sponsor's protocol ID
- WEL-304
- Status last verified
- Dec 2007
- First submitted
- 7 Sep 2005
- Last updated
- 9 Jan 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00151762
- Acronym / sponsor ID
- WEL-304
- Conditions
- Type 2 Diabetes
- Keywords
- Open label, Diabetes Mellitus, Long term safety study, extension study
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 780 participants
- Lead sponsor
- Daiichi SankyoIndustry (pharma, biotech, devices)
- Study start
- Dec 2004
- Primary completion
- Jul 2007 (actual)
- Study completion
- Jul 2007 (actual)
- First posted
- 9 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This extension study is designed to evaluate the long-term safety and tolerability of colesevelam hydrochloride (WelChol®) in patients with type 2 diabetes.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Colesevelam hydrochloride | Drug | – |
Primary outcome
To evaluate safety and tolerability of colesevelam hydrochloride as add-on therapy
3 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
64 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Colesevelam hydrochloride in people with Type 2 Diabetes, run by Daiichi Sankyo at 64 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jan 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 64 sites in United States, Mexico, Peru. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate safety and tolerability of colesevelam hydrochloride as add-on therapy. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2008.