Colesevelam as Add-on to Pioglitazone Therapy for Type 2 Diabetes Mellitus
NCT ID: NCT00789750
Last Updated: 2017-06-26
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
562 participants
INTERVENTIONAL
2009-04-30
2012-07-31
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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Colesevelam
Participants receive six colesevelam tablets (3.8 grams/day) in addition to pioglitazone-based therapy (30 mg or 45 mg)
Colesevelam
Colesevelam 625 mg tablets
Pioglitazone
30 mg or 45 mg pioglitazone therapy
Placebo
Participants receive six placebo tablets in addition to pioglitazone-based therapy (30 mg or 45 mg)
Placebo
Placebo tablets appearing to be colesevelam
Pioglitazone
30 mg or 45 mg pioglitazone therapy
Interventions
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Colesevelam
Colesevelam 625 mg tablets
Placebo
Placebo tablets appearing to be colesevelam
Pioglitazone
30 mg or 45 mg pioglitazone therapy
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Inadequate glycemic control on a stable dose (at least 2 months prior to screening) of pioglitazone at 30 or 45 mg/day, with or without one or two other oral antidiabetic medications \[metformin or a sulfonylurea, or dipeptidyl peptidase (DPP-IV) inhibitor\]
* Hemoglobin A1c (HbA1c) \>= 7.5% and =\< 9.5% at screening
* Fasting plasma glucose =\<240 mg/dL at randomization (Week 0/Day 1).
* Male or female \>= 18 years of age.
* Women of childbearing potential must be using an adequate method of contraception as detailed per-protocol
* Fasting C-peptide level \>0.5 ng/mL at screening
* Clinically stable in regards to medical conditions other than type 2 diabetes
* Concomitant medications are at stable doses for at least 30 days prior to enrollment, and are not anticipated to need adjustment during the study period
Exclusion Criteria
* History of bowel obstruction
* History of hypertriglyceridemia-induced pancreatitis
* Fasting serum triglyceride concentration \>500 mg/dL
* History of dysphagia, swallowing disorders, gastroparesis, other gastrointestinal motility disorders, major gastrointestinal surgery
* History of insulin use \>= 2 weeks duration during the previous 3 months or a total of \>2 months insulin therapy at any time prior to screening
* Treatment with bile acid sequestrants, including colesevelam within 3 months prior to screening
* Female subject who is pregnant or breastfeeding
* History of unstable angina, myocardial infarction, cerebrovascular accident, transient ischemic attack, or any revascularization within 6 months prior to screening
18 Years
ALL
No
Sponsors
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Daiichi Sankyo
INDUSTRY
Responsible Party
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Principal Investigators
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Global Clinical Leader
Role: STUDY_DIRECTOR
Daiichi Sankyo
Locations
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Birmingham, Alabama, United States
Birmingham, Alabama, United States
Birmingham, Alabama, United States
Montgomery, Alabama, United States
Montgomery, Alabama, United States
Green Valley, Arizona, United States
Mesa, Arizona, United States
Phoenix, Arizona, United States
Tempe, Arizona, United States
Tempe, Arizona, United States
Searcy, Arkansas, United States
Buena Park, California, United States
Burbank, California, United States
Chino, California, United States
Garden Grove, California, United States
Huntington Park, California, United States
La Mirada, California, United States
Lincoln, California, United States
Lomita, California, United States
Los Gatos, California, United States
Modesto, California, United States
San Diego, California, United States
Santa Ana, California, United States
Tustin, California, United States
Walnut Creek, California, 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
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
Pembroke Pines, Florida, United States
Pinellas Park, Florida, United States
Sanford, Florida, United States
Tampa, Florida, United States
Vero Beach, Florida, United States
Wellington, Florida, United States
Winter Haven, Florida, United States
Winter Park, Florida, United States
Winter Park, Florida, United States
Columbus, Georgia, United States
Decatur, Georgia, United States
East Point, Georgia, United States
Marietta, Georgia, United States
Roswell, Georgia, United States
Stockbridge, Georgia, United States
Tucker, Georgia, United States
Waycross, Georgia, United States
Nampa, Idaho, United States
Arlington Heights, Illinois, United States
Chicago, Illinois, United States
Bloomington, Indiana, United States
Evansville, Indiana, United States
La Porte, Indiana, United States
South Bend, Indiana, United States
Crestview Hills, Kentucky, United States
Paducah, 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
Brooklyn Center, Minnesota, United States
Jackson, Mississippi, United States
Port Gibson, Mississippi, United States
Kansas City, Missouri, United States
St Louis, Missouri, United States
Billings, Montana, United States
Las Vegas, Nevada, United States
Belvidere, New Jersey, United States
Berlin, New Jersey, United States
Clifton, New Jersey, United States
Lumberton, New Jersey, United States
Mine Hill, New Jersey, United States
New Windsor, New York, United States
North Massapequa, New York, United States
Tonawanda, New York, United States
West Seneca, New York, United States
Lexington, North Carolina, United States
Statesville, North Carolina, United States
Cincinnati, Ohio, United States
Cincinnati, Ohio, United States
Cincinnati, Ohio, United States
Cleveland, Ohio, United States
Columbus, Ohio, United States
Cuyahoga Falls, Ohio, United States
Marion, Ohio, United States
Shaker Heights, Ohio, United States
Stow, Ohio, United States
Oklahoma City, Oklahoma, 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
Philadelphia, Pennsylvania, United States
Philadelphia, Pennsylvania, United States
Upper Saint Clair, Pennsylvania, United States
Charleston, South Carolina, United States
Charleston, South Carolina, United States
Columbia, South Carolina, United States
Greer, South Carolina, United States
Germantown, Tennessee, United States
Jackson, Tennessee, United States
Murfreesboro, Tennessee, United States
New Tazewell, Tennessee, United States
Arlington, Texas, United States
Dallas, Texas, United States
Dallas, Texas, United States
Dallas, Texas, United States
Fort Worth, Texas, United States
Grand Prairie, Texas, United States
Houston, Texas, United States
Houston, Texas, United States
Houston, Texas, United States
Houston, Texas, United States
San Antonio, Texas, United States
San Antonio, Texas, United States
Sugar Land, Texas, United States
Sugar Land, Texas, United States
Tomball, Texas, United States
Salt Lake City, Utah, United States
Salt Lake City, Utah, United States
Alexandria, Virginia, United States
Danville, Virginia, United States
Manassas, Virginia, United States
Richmond, Virginia, United States
Salem, Virginia, United States
Suffolk, Virginia, United States
Lakewood, Washington, United States
Kenosha, Wisconsin, United States
Countries
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References
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Rosenstock J, Truitt KE, Baz-Hecht M, Ford DM, Tao B, Chou HS. Efficacy and safety of colesevelam in combination with pioglitazone in patients with type 2 diabetes mellitus. Horm Metab Res. 2014 Dec;46(13):943-9. doi: 10.1055/s-0034-1383648. Epub 2014 Jul 23.
Other Identifiers
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WEL-A-U306
Identifier Type: -
Identifier Source: org_study_id
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