Type 2 DiabetesPhase 3NCT00147719
WelChol® With Metformin 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 48 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 metformin 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
- 300 participants
- Where
- 48 sitesin 3 countries
- Study dates
- Jun 2004to Jul 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
- Hemoglobin (HbA1c) between 7.5% to 9.5%
- Prescribed an ADA accepted diet
- Receiving stable dose of metformin alone or in combination with other oral anti-diabetic medications for 90 days before Visit 1
Who cannot join
- History of type 1 diabetes or ketoacidosis
- History of chronic (more than 2 months) insulin therapy or the initiation of insulin for chronic treatment
- History of pancreatitis
- Uncontrolled hypertension
- Recent severe cardiovascular disease
- Allergy or toxic response to colesevelam or any of its components
- Body mass index (BMI) >45 kg/m2
Trial locations and contacts
48 sites in 3 countries.
48 sites in 3 countries
United States46 sites
Study site
Arlington, Virginia
Study site
Atlanta, Georgia
Study site
Beaver, Pennsylvania
Study site
Beverly Hills, California
Study site
Bozeman, Montana
Study site
Butte, Montana
Study site
Carmichael, California
Study site
Charleston, South Carolina
Study site
Charlotte, North Carolina
Study site
Chesterfield, Missouri
Study site
Cincinnati, Ohio
Study site
Cleveland, Ohio
Study site
Coco Beach, Florida
Study site
Columbia, South Carolina
Study site
Corpus Christi, Texas
Study site
Dallas, Texas
Study site
Detroit, Michigan
Study site
Edina, Minnesota
Study site
Evansville, Indiana
Study site
Fresno, California
Study site
Irvine, California
CRO
Jonesboro, Arkansas
Study site
La Jolla, California
Study site
Largo, Florida
Study site
Las Vegas, Nevada
Study site
Los Gatos, California
Study site
Louisville, Kentucky
Study site
Lyndhurst, Ohio
Study site
Marion, Ohio
Study site
Miami, Florida
Study site
Morristown, Tennessee
Study site
Oklahoma City, Oklahoma
Study site
Pembroke Pines, Florida
Study site
Pharr, Texas
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
Spring Valley, California
Study site
Troy, Michigan
Study site
Tulsa, Oklahoma
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, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study of the Efficacy and Safety of WelChol® in Type 2 Diabetics With Inadequate Glycemic Control on Metformin Monotherapy or Metformin 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 metformin 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 effect;
To assess the glycemic control response rate;
To assess the improvement in insulin sensitivity;
To assess the effect on high sensitivity C-reactive protein;
To assess the improvement in lipids, and lipoproteins;
To assess the safety and tolerability of colesevelam hydrochloride when added on to current 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 completionJul 2006
- Study completionJul 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
- 300 participants
Sponsor and investigators
- Lead sponsor
- Daiichi Sankyo
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00147719
- Sponsor's protocol ID
- WEL-301
- Status last verified
- Jan 2012
- First submitted
- 2 Sep 2005
- Last updated
- 18 Jan 2012
- Results posted
- No
Publications
Bays HE, Goldberg RB, Truitt KE, Jones MR. Colesevelam hydrochloride therapy in patients with type 2 diabetes mellitus treated with metformin: glucose and lipid effects. Arch Intern Med. 2008 Oct 13;168(18):1975-83. doi: 10.1001/archinte.168.18.1975.
PubMed 18852398
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 Metformin Monotherapy or Metformin Therapy in Combination With Other Oral Anti-Diabetic Agents
- ClinicalTrials.gov ID
- NCT00147719
- Acronym / sponsor ID
- WEL-301
- Conditions
- Type 2 Diabetes
- Keywords
- Diabetes Mellitus
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants
- Lead sponsor
- Daiichi SankyoIndustry (pharma, biotech, devices)
- Study start
- Jun 2004
- Primary completion
- Jul 2006 (actual)
- Study completion
- Jul 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 metformin 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 (5 listed)
- Age 18-75 years, inclusive
- Diagnosed with type 2 diabetes
- Hemoglobin (HbA1c) between 7.5% to 9.5%
- Prescribed an ADA accepted diet
- Receiving stable dose of metformin alone or in combination with other oral anti-diabetic medications for 90 days before Visit 1
Key exclusion criteria (7 listed)
- History of type 1 diabetes or ketoacidosis
- History of chronic (more than 2 months) insulin therapy or the initiation of insulin for chronic treatment
- History of pancreatitis
- Uncontrolled hypertension
- Recent severe cardiovascular disease
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 effect;
To assess the glycemic control response rate;
To assess the improvement in insulin sensitivity;
To assess the effect on high sensitivity C-reactive protein;
To assess the improvement in lipids, and lipoproteins;
To assess the safety and tolerability of colesevelam hydrochloride when added on to current 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 18852398Bays HE, Goldberg RB, Truitt KE, Jones MR. Colesevelam hydrochloride therapy in patients with type 2 diabetes mellitus treated with metformin: glucose and lipid effects. Arch Intern Med. 2008 Oct 13;168(18):1975-83. doi: 10.1001/archinte.168.18.1975.
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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.
48 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 48 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 5 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 48 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 NCT00147719, 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.