Type 2 DiabetesPhase 3NCT00147758
WelChol® and Sulfonylurea in Treating Patients With Type 2 Diabetes
A Phase 3 study testing Colesevelam hydrochloride in people with Type 2 Diabetes, run by Daiichi Sankyo at 47 sites in 3 countries.
Trial 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. 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
- 400 participants
- Where
- 47 sitesin 3 countries
- Study dates
- Jun 2004to Aug 2006
- 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
- 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
Who cannot join
- 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
Trial locations and contacts
47 sites in 3 countries.
47 sites in 3 countries
United States45 sites
Study site
Arlington, Virginia
Study site
Atlanta, Georgia
Study site
Beaver, Pennsylvania
Study site
Birmingham, Alabama
Study site
Boston, Massachusetts
Study site
Bristol, Tennessee
Study site
Charleston, South Carolina
Study site
Charlotte, North Carolina
Study site
Chicago, Illinois
Study site
Cincinnati, Ohio
Study site
Cleveland, Ohio
Study site
Concord, California
Study site
Coral Gables, Florida
Study site
Dallas, Texas
Study site
Hickory, North Carolina
Study site
Houston, Texas
Study site
Indianapolis, Indiana
Study site
Irvine, California
Study site
Kansas City, Missouri
Study site
La Jolla, California
Study site
Lakewood, Washington
Study site
Little Rock, Arkansas
Study site
Los Angeles, California
Study site
Los Gatos, California
Study site
Marion, Ohio
Study site
Miami, Florida
Study site
Midland, Texas
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
Renton, Washington
Study site
Richmond, Virginia
Study site
Rochester, New York
Study site
San Antonio, Texas
Study site
Searcy, Arkansas
Study site
St Louis, Missouri
Study site
Statesville, North Carolina
Study site
Tulsa, Oklahoma
Study site
Tuscumbia, Alabama
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, 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
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.
- Conditions
- Type 2 Diabetes
- Being tested
- Colesevelam hydrochloride
- Keywords
- Diabetes Mellitus
- 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 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;
To assess the safety and tolerability of colesevelam hydrochloride as add-on therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2005 (estimated)
- Study startJun 2004
- Primary completionAug 2006
- Study completionAug 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 400 participants
Sponsor and investigators
- Lead sponsor
- Daiichi Sankyo
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00147758
- Sponsor's protocol ID
- WEL-303
- Status last verified
- Jan 2012
- First submitted
- 2 Sep 2005
- Last updated
- 18 Jan 2012
- Results posted
- No
Publications
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.
PubMed 18458145
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00147758
- Acronym / sponsor ID
- WEL-303
- Conditions
- Type 2 Diabetes
- Keywords
- Diabetes Mellitus
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 400 participants
- Lead sponsor
- Daiichi SankyoIndustry (pharma, biotech, devices)
- Study start
- Jun 2004
- Primary completion
- Aug 2006 (actual)
- Study completion
- Aug 2006 (actual)
- First posted
- 7 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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (7 listed)
- 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
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 assess the additional lowering of HbA1c achieved by addition of colesevelam hydrochloride to current antidiabetic therapy
6 secondary outcomes
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
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 18 Jan 2012.
- Derived from this study: PubMed 18458145Fonseca 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.
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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.
47 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 47 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 6 inclusion and 7 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 18 Jan 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 47 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 assess the additional lowering of HbA1c achieved by addition of colesevelam hydrochloride to current antidiabetic therapy. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00147758, which also lists 1 linked publication.
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 18 Jan 2012.