Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
357 participants
INTERVENTIONAL
2009-01-31
2011-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Welchol
Welchol 625mg tablets
Welchol
Welchol 625mg tablets
placebo
placebo
Placebo
placebo
Interventions
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Welchol
Welchol 625mg tablets
Placebo
placebo
Eligibility Criteria
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Inclusion Criteria
* 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;
* 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
Exclusion Criteria
* 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;
* 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.
18 Years
ALL
No
Sponsors
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Daiichi Sankyo
INDUSTRY
Responsible Party
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Locations
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Birmingham, Alabama, United States
Birmingham, Alabama, United States
Montgomery, Alabama, United States
Muscle Shoals, Alabama, United States
Green Valley, Arizona, United States
Mesa, Arizona, United States
Mesa, Arizona, United States
Tucson, Arizona, United States
Tucson, Arizona, United States
Tucson, Arizona, United States
Searcy, Arkansas, United States
Buena Park, California, United States
Burbank, California, United States
Chula Vista, California, United States
Garden Grove, California, United States
Huntington Park, California, United States
Irvine, California, United States
La Mirada, California, United States
Lincoln, California, United States
Lomita, California, United States
Los Angeles, California, United States
Los Angeles, California, United States
Los Gatos, California, United States
Santa Ana, California, United States
Tustin, California, United States
Walnut Creek, California, United States
Brooksville, Florida, United States
Coral Gables, Florida, United States
DeLand, Florida, United States
Delray Beach, Florida, United States
Gulf Breeze, Florida, United States
Hialeah, Florida, United States
Jacksonville, Florida, United States
Kissimmee, Florida, United States
Miami, Florida, United States
Miami, Florida, United States
Miami, Florida, United States
New Port Richey, Florida, United States
Ocala, Florida, United States
Ormond Beach, Florida, United States
Pembroke Pines, Florida, United States
Vero Beach, Florida, United States
Wellington, Florida, United States
Winter Park, Florida, United States
Decatur, Georgia, United States
East Point, Georgia, United States
Roswell, Georgia, United States
Stockbridge, Georgia, United States
Stone Mountain, Georgia, United States
Nampa, Idaho, United States
Chicago, Illinois, United States
Evansville, Indiana, United States
La Porte, Indiana, United States
South Bend, Indiana, United States
Crestview Hills, Kentucky, United States
Lafayette, Louisiana, United States
Prince Frederick, Maryland, United States
Silver Spring, Maryland, United States
New Bedford, Massachusetts, United States
Southfield, Michigan, United States
Port Gibson, Mississippi, United States
St Louis, Missouri, United States
St Louis, Missouri, United States
Billings, Montana, United States
Las Vegas, Nevada, United States
Berlin, New Jersey, United States
Clifton, New Jersey, United States
Mine Hill, New Jersey, United States
New Windsor, New York, United States
North Massapequa, New York, United States
West Seneca, New York, United States
Lexington, North Carolina, United States
Statesville, North Carolina, United States
Wilmington, North Carolina, United States
Cincinnati, Ohio, United States
Cincinnati, Ohio, United States
Cincinnati, Ohio, United States
Cleveland, Ohio, United States
Cuyahoga Falls, Ohio, United States
Marion, Ohio, United States
Munroe Falls, Ohio, United States
Shaker Heights, Ohio, United States
Oklahoma City, Oklahoma, United States
Oklahoma City, Oklahoma, United States
Portland, Oregon, United States
Harrisburg, Pennsylvania, United States
Jersey Shore, Pennsylvania, United States
Charleston, South Carolina, United States
Charleston, South Carolina, United States
Columbia, South Carolina, United States
Greer, South Carolina, United States
Arlington, Texas, United States
Dallas, Texas, United States
Dallas, Texas, United States
Fort Worth, Texas, United States
Houston, Texas, United States
Houston, Texas, United States
Houston, Texas, United States
Houston, Texas, United States
San Antonio, Texas, United States
Sugar Land, Texas, United States
Tomball, Texas, United States
Salt Lake City, Utah, United States
Salt Lake City, Utah, United States
Manassas, Virginia, United States
Salem, Virginia, United States
Milwaukee, Wisconsin, United States
Countries
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References
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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.
Other Identifiers
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WEL-305
Identifier Type: -
Identifier Source: org_study_id
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