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Type 2 Diabetes MellitusPhase 3NCT00789737

Welchol as Monotherapy for Type 2 Diabetes Mellitus

A Phase 3 study testing Welchol in people with Type 2 Diabetes Mellitus, run by Daiichi Sankyo at 107 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The current study investigates Welchol as monotherapy to improve glycemic control in subjects with Type 2 Diabetes Mellitus not adequately controlled with diet and exercise alone. The study will evaluate if Welchol monotherapy for Type 2 Diabetes Mellitus will be safe, well tolerated and efficacious. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Type 2 Diabetes Mellitus
What is being tested?
Welchol
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
357 participants
Where
107 sitesUnited States
Study dates
Jan 2009to Dec 2011
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male or female subjects >= 18 years of age;
  • Women of childbearing potential (WOCBP) must be using an adequate method of contraception as detailed in the protocol.
  • Diagnosis of Type 2 Diabetes Mellitus;
  • HbA1C >= 7.5% and =< 9.5 % at screening;
  • Fasting C-peptide >0.5 ng/mL at screening;
  • Drug naïve (no prior treatment with OAD) or having received no pharmacologic therapy for diabetes for the 3 month period prior to screening;
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  • Clinically stable in regards to medical conditions other than type 2 diabetes;
  • Concomitant medications must be at stable doses for at least 30 days prior to enrollment, and are not anticipated to need adjustment during the study period; and
  • Fasting glucose =< 240 mg/dL at randomization

Who cannot join

  • A history of type 1 diabetes and/or a history of ketoacidosis;
  • History of bowel obstruction;
  • History of hypertriglyceridemia-induced pancreatitis;
  • Fasting serum triglyceride concentrations >500 mg/dL;
  • History of dysphagia, swallowing disorders, gastroparesis, other gastrointestinal (GI) motility disorders, or major GI surgery;
  • History of insulin use of >= 2 weeks duration in the previous 3 months or a total of > 2 months of insulin therapy at any time prior to screening;
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  • Two or more fasting self-monitored blood glucose (SMBG) levels >240 mg/dL during the placebo lead-in period.
  • Previous treatment with a bile acid sequestrant, including Welchol within the 3 months prior to screening;
  • Body mass index (BMI) >40 kg/m2;
  • Weight loss > 3% in prior 3 months; and
  • LDL <60 mg/dL.

Trial locations and contacts

107 sites in 1 country.

107 sites in 1 country

United States107 sites

  • Study site

    Arlington, Texas, 76012

  • Study site

    Berlin, New Jersey, 08009

  • Study site

    Billings, Montana, 59101

  • Study site

    Birmingham, Alabama, 35216

  • Study site

    Birmingham, Alabama, 35294

  • Study site

    Brooksville, Florida, 34601

  • Study site

    Buena Park, California, 90620

  • Study site

    Burbank, California, 91505

  • Study site

    Charleston, South Carolina, 29412

  • Study site

    Charleston, South Carolina, 29414

  • Study site

    Chicago, Illinois, 60607

  • Study site

    Chula Vista, California, 91910

  • Study site

    Cincinnati, Ohio, 45219

  • Study site

    Cincinnati, Ohio, 45227

  • Study site

    Cincinnati, Ohio, 45245

  • Study site

    Cleveland, Ohio, 44122

  • Study site

    Clifton, New Jersey, 07013

  • Study site

    Columbia, South Carolina, 29201

  • Study site

    Coral Gables, Florida, 33134

  • Study site

    Crestview Hills, Kentucky, 41017

  • Study site

    Cuyahoga Falls, Ohio, 44223

  • Study site

    Dallas, Texas, 75230

  • Study site

    Dallas, Texas, 75235

  • Study site

    Decatur, Georgia, 30035

  • Study site

    DeLand, Florida, 32720

  • Study site

    Delray Beach, Florida, 33484

  • Study site

    East Point, Georgia, 30344

  • Study site

    Evansville, Indiana, 47714

  • Study site

    Fort Worth, Texas, 76117

  • Study site

    Garden Grove, California, 92844

  • Study site

    Green Valley, Arizona, 85614

  • Study site

    Greer, South Carolina, 29651

  • Study site

    Gulf Breeze, Florida, 32561

  • Study site

    Harrisburg, Pennsylvania, 17112

  • Study site

    Hialeah, Florida, 33012

  • Study site

    Houston, Texas, 77008

  • Study site

    Houston, Texas, 77074

  • Study site

    Houston, Texas, 77081

  • Study site

    Houston, Texas, 77083

  • Study site

    Huntington Park, California, 90255

  • Study site

    Irvine, California, 92618

  • Study site

    Jacksonville, Florida, 32223

  • Study site

    Jersey Shore, Pennsylvania, 17740

  • Study site

    Kissimmee, Florida, 34741

  • Study site

    La Mirada, California, 90638

  • Study site

    La Porte, Indiana, 46350

  • Study site

    Lafayette, Louisiana, 70503

  • Study site

    Las Vegas, Nevada, 89123

  • Study site

    Lexington, North Carolina, 27295

  • Study site

    Lincoln, California, 95648

  • Study site

    Lomita, California, 90717

  • Study site

    Los Angeles, California, 90015

  • Study site

    Los Angeles, California, 90057

  • Study site

    Los Gatos, California, 95032

  • Study site

    Manassas, Virginia, 20110

  • Study site

    Marion, Ohio, 43302

  • Study site

    Mesa, Arizona, 85203

  • Study site

    Mesa, Arizona, 85210

  • Study site

    Miami, Florida, 33135

  • Study site

    Miami, Florida, 33169

  • Study site

    Miami, Florida, 33175

  • Study site

    Milwaukee, Wisconsin, 53209

  • Study site

    Mine Hill, New Jersey, 07803

  • Study site

    Montgomery, Alabama, 36117

  • Study site

    Munroe Falls, Ohio, 44262

  • Study site

    Muscle Shoals, Alabama, 35662

  • Study site

    Nampa, Idaho, 83686

  • Study site

    New Bedford, Massachusetts, 02740

  • Study site

    New Port Richey, Florida, 34652

  • Study site

    New Windsor, New York, 12553

  • Study site

    North Massapequa, New York, 11758-1802

  • Study site

    Ocala, Florida, 34471

  • Study site

    Oklahoma City, Oklahoma, 73103

  • Study site

    Oklahoma City, Oklahoma, 73159

  • Study site

    Ormond Beach, Florida, 32174

  • Study site

    Pembroke Pines, Florida, 33026

  • Study site

    Port Gibson, Mississippi, 39150

  • Study site

    Portland, Oregon, 97220

  • Study site

    Prince Frederick, Maryland, 20678

  • Study site

    Roswell, Georgia, 30076

  • Study site

    Salem, Virginia, 24153

  • Study site

    Salt Lake City, Utah, 84102

  • Study site

    Salt Lake City, Utah, 84107

  • Study site

    San Antonio, Texas, 78229

  • Study site

    Santa Ana, California, 92701

  • Study site

    Searcy, Arkansas, 72143

  • Study site

    Shaker Heights, Ohio, 44120

  • Study site

    Silver Spring, Maryland, 20910

  • Study site

    South Bend, Indiana, 46614

  • Study site

    Southfield, Michigan, 48034

  • Study site

    St Louis, Missouri, 63128

  • Study site

    St Louis, Missouri, 63141

  • Study site

    Statesville, North Carolina, 28625

  • Study site

    Stockbridge, Georgia, 30281

  • Study site

    Stone Mountain, Georgia, 30083

  • Study site

    Sugar Land, Texas, 77479

  • Study site

    Tomball, Texas, 77375

  • Study site

    Tucson, Arizona, 85705

  • Study site

    Tucson, Arizona, 85723

  • Study site

    Tucson, Arizona, 85741

  • Study site

    Tustin, California, 92780

  • Study site

    Vero Beach, Florida, 32960

  • Study site

    Walnut Creek, California, 94598

  • Study site

    Wellington, Florida, 33449

  • Study site

    West Seneca, New York, 14224

  • Study site

    Wilmington, North Carolina, 28401

  • Study site

    Winter Park, Florida, 32789

Other trials in United States

About this study

Official title: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study of the Efficacy and Safety of Welchol as Monotherapy for Type 2 Diabetes Mellitus

The current study investigates Welchol as monotherapy to improve glycemic control in subjects with Type 2 Diabetes Mellitus not adequately controlled with diet and exercise alone. The study will evaluate if Welchol monotherapy for Type 2 Diabetes Mellitus will be safe, well tolerated and efficacious.

Being tested
Welchol, Placebo
Medical subject headings
Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • WelcholDrug

    Welchol 625mg tablets

  • PlaceboDrug

    placebo

Study groups in NCT00789737
Study groupRoleWhat they receive
WelcholExperimentalWelchol 625mg tablets
Receives: Drug: Welchol
placeboPlacebo comparatorplacebo
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percent Change in Hemoglobin A1c

    change in HbA1c from baseline to Week 24

    Measured: 24 week

Secondary outcomes (12)

  1. Change in Fasting Plasma Glucose

    to determine changes in Glycemic control after 24 weeks on therapy

    Measured: from baseline to 24 weeks

  2. % Subjects With a Decrease in HbA1c of >= 0.7 Percentage Units

    to determine the percentage of participants who experience a reduction in HbA1c of at least 0.7 percentage units at 24 weeks from baseline.

    Measured: 24 weeks

  3. % Subjects Achieving an HbA1C Goal of <7.0

    % Subjects achieving an HbA1C goal of <7.0 at 24 weeks

    Measured: 24 weeks

  4. % Subjects With a Decrease in FPG >=30 mg/dL

    % Subjects with a decrease in Fasting Plasma Glucose >=30 mg/dL from baseline to 24 weeks

    Measured: from baseline to 24 weeks

  5. Changes in Total Cholesterol [TC]

    To assess the effects of Welchol on changes in total cholesterol [TC]

    Measured: from baseline to 24 weeks

  6. Changes in Low Density Lipoprotein Cholesterol [LDL-C]

    To assess the effects of Welchol on changes in low density lipoprotein cholesterol [LDL-C]

    Measured: from baseline to 24 weeks

  7. Changes in High Density Lipoprotein Cholesterol [HDL-C]

    To assess the effects of Welchol on changes in high density lipoprotein cholesterol [HDL-C]

    Measured: from baseline to 24 weeks

  8. Changes in Non-HDL-C

    To assess the effects of Welchol on changes in non-HDL-C

    Measured: from baseline to 24 weeks

  9. Changes in Triglycerides [TG]

    To assess the effects of Welchol on changes in triglycerides [TG]

    Measured: from baseline to 24 weeks

  10. Changes in Apolipoprotein A-I (apoA-I)

    To assess the effects of Welchol on changes in apolipoprotein A-I (apoA-I)

    Measured: from baseline to 24 weeks

  11. Changes in Apolipoprotein B (apoB)

    To assess the effects of Welchol on changes in apolipoprotein B (apoB)

    Measured: from baseline to 24 weeks

  12. Change in Postprandial Plasma Glucose, 2 Hours After a Meal Tolerance Test

    To assess the change from baseline on postprandial plasma glucose, 2 hours after a meal tolerance test

    Measured: from baseline to 24 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Nov 2008 (estimated)
  2. Study startJan 2009
  3. Primary completionDec 2011
  4. Study completionDec 2011

Resources

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
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
357 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00789737
Sponsor's protocol ID
WEL-305
Status last verified
Jan 2014
First submitted
10 Nov 2008
Last updated
27 Feb 2014
Data monitoring committee
No

Publications

  • Rosenstock J, Rigby SP, Ford DM, Tao B, Chou HS. The glucose and lipid effects of colesevelam as monotherapy in drug-naive type 2 diabetes. Horm Metab Res. 2014 May;46(5):348-53. doi: 10.1055/s-0033-1358759. Epub 2013 Dec 19.

    PubMed 24356792

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Welchol in people with Type 2 Diabetes Mellitus, run by Daiichi Sankyo at 107 sites in United States.

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 9 inclusion and 11 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 27 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 107 sites in United States. 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. Some participants in this study may receive a placebo. 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?

Yes. Results are posted in the registry (first posted 22 Jan 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Percent Change in Hemoglobin A1c (time frame: 24 week). 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 NCT00789737, 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 27 Feb 2014.

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