Colesevelam as Add-on to Pioglitazone Therapy for Type 2 Diabetes Mellitus
A Randomized, Double-Blind, Placebo Controlled, Parallel Group Study of the Efficacy and Safety of WELCHOL as Add-on to Pioglitazone Therapy for Type 2 Diabetes Mellitus (T2DM)
1 other identifier
interventional
562
1 country
141
Brief Summary
The current study investigates colesevelam as add-on therapy to pioglitazone to improve glycemic control in subjects with type 2 diabetes mellitus not adequately controlled with pioglitazone monotherapy or pioglitazone in combination with either metformin or a sulfonylurea. The study will evaluate if colesevelam add-on to pioglitazone therapy for type 2 diabetes mellitus will be safe, well tolerated, and efficacious.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 type-2-diabetes-mellitus
Started Apr 2009
Longer than P75 for phase_3 type-2-diabetes-mellitus
141 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 10, 2008
CompletedFirst Posted
Study publicly available on registry
November 13, 2008
CompletedStudy Start
First participant enrolled
April 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2012
CompletedResults Posted
Study results publicly available
June 26, 2017
CompletedJune 26, 2017
June 1, 2017
3.3 years
November 10, 2008
May 24, 2017
June 23, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Change From Baseline in Hemoglobin A1c (HbA1c) at Week 24
Baseline, Week 24
Secondary Outcomes (18)
Change From Baseline in HbA1c at Week 4
Baseline, Week 4
Change From Baseline in HbA1c at Week 8
Baseline, Week 8
Change From Baseline in HbA1c at Week 16
Baseline, Week 16
Number of Participants Achieving an HbA1c Goal of <7.0%
Week 24
Change From Baseline in Fasting Plasma Glucose (FPG)
Baseline, Week 24
- +13 more secondary outcomes
Study Arms (2)
Colesevelam
EXPERIMENTALParticipants receive six colesevelam tablets (3.8 grams/day) in addition to pioglitazone-based therapy (30 mg or 45 mg)
Placebo
PLACEBO COMPARATORParticipants receive six placebo tablets in addition to pioglitazone-based therapy (30 mg or 45 mg)
Interventions
Eligibility Criteria
You may qualify if:
- Diagnosis of Type 2 diabetes mellitus
- 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
You may not qualify if:
- History of Type 1 diabetes and/or history of ketoacidosis
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Daiichi Sankyolead
Study Sites (141)
Unknown Facility
Birmingham, Alabama, 35205, United States
Unknown Facility
Birmingham, Alabama, 35216, United States
Unknown Facility
Birmingham, Alabama, 35294, United States
Unknown Facility
Montgomery, Alabama, 36106, United States
Unknown Facility
Montgomery, Alabama, 36117, United States
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Green Valley, Arizona, 85614, United States
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Mesa, Arizona, 85210, United States
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Phoenix, Arizona, 85050, United States
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Tempe, Arizona, 85282, United States
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Tempe, Arizona, 85284, United States
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Searcy, Arkansas, 72143, United States
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Buena Park, California, 90620, United States
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Burbank, California, 91505, United States
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Chino, California, 91710, United States
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Garden Grove, California, 92844, United States
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Huntington Park, California, 90255, United States
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La Mirada, California, 90638, United States
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Lincoln, California, 95648, United States
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Lomita, California, 90717, United States
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Los Gatos, California, 95032, United States
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Modesto, California, 95355, United States
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San Diego, California, 92161, United States
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Santa Ana, California, 92701, United States
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Tustin, California, 92780, United States
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Walnut Creek, California, 94598, United States
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Coral Gables, Florida, 33134, United States
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DeLand, Florida, 32720, United States
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Delray Beach, Florida, 33484, United States
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Gulf Breeze, Florida, 32561, United States
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Hialeah, Florida, 33012, United States
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Jacksonville, Florida, 32223, United States
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Kissimmee, Florida, 34741, United States
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Miami, Florida, 33135, United States
Unknown Facility
Miami, Florida, 33156, United States
Unknown Facility
Miami, Florida, 33169, United States
Unknown Facility
Miami, Florida, 33175, United States
Unknown Facility
Miami, Florida, 33183, United States
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New Port Richey, Florida, 34652, United States
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Ocala, Florida, 34471, United States
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Ormond Beach, Florida, 32174, United States
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Pembroke Pines, Florida, 33026, United States
Unknown Facility
Pembroke Pines, Florida, 33027, United States
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Pinellas Park, Florida, 33781, United States
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Sanford, Florida, 32771, United States
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Tampa, Florida, 33607, United States
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Vero Beach, Florida, 32960, United States
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Wellington, Florida, 33449, United States
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Winter Haven, Florida, 33880, United States
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Winter Park, Florida, 32789, United States
Unknown Facility
Winter Park, Florida, 32792, United States
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Columbus, Georgia, 31904, United States
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Decatur, Georgia, 30035, United States
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East Point, Georgia, 30344, United States
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Marietta, Georgia, 30066, United States
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Roswell, Georgia, 30076, United States
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Stockbridge, Georgia, 30281, United States
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Tucker, Georgia, 30084, United States
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Waycross, Georgia, 31501, United States
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Nampa, Idaho, 83686, United States
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Arlington Heights, Illinois, 60004, United States
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Chicago, Illinois, 60607, United States
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Bloomington, Indiana, 47403, United States
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Evansville, Indiana, 47714, United States
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La Porte, Indiana, 46350, United States
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South Bend, Indiana, 46614, United States
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Crestview Hills, Kentucky, 41017, United States
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Paducah, Kentucky, 42003, United States
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Lafayette, Louisiana, 70503, United States
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Prince Frederick, Maryland, 20678, United States
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Silver Spring, Maryland, 20910, United States
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New Bedford, Massachusetts, 02740, United States
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Southfield, Michigan, 48034, United States
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Brooklyn Center, Minnesota, 55430, United States
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Jackson, Mississippi, 39216, United States
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Port Gibson, Mississippi, 39150, United States
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Kansas City, Missouri, 64111, United States
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St Louis, Missouri, 63141, United States
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Billings, Montana, 59101, United States
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Las Vegas, Nevada, 89123, United States
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Belvidere, New Jersey, 07823, United States
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Berlin, New Jersey, 08009, United States
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Clifton, New Jersey, 07013, United States
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Lumberton, New Jersey, 08048, United States
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Mine Hill, New Jersey, 07803, United States
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New Windsor, New York, 12553, United States
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North Massapequa, New York, 11758, United States
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Tonawanda, New York, 14150, United States
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West Seneca, New York, 14224, United States
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Lexington, North Carolina, 27293, United States
Unknown Facility
Statesville, North Carolina, 28625, United States
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Cincinnati, Ohio, 45219, United States
Unknown Facility
Cincinnati, Ohio, 45227, United States
Unknown Facility
Cincinnati, Ohio, 45245, United States
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Cleveland, Ohio, 44122, United States
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Columbus, Ohio, 43213, United States
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Cuyahoga Falls, Ohio, 44223, United States
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Marion, Ohio, 43302, United States
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Shaker Heights, Ohio, 44120, United States
Unknown Facility
Stow, Ohio, 44224, United States
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Oklahoma City, Oklahoma, 73103, United States
Unknown Facility
Oklahoma City, Oklahoma, 73132, United States
Unknown Facility
Oklahoma City, Oklahoma, 73159, United States
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Portland, Oregon, 97220, United States
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Harrisburg, Pennsylvania, 17112, United States
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Jersey Shore, Pennsylvania, 17740, United States
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Philadelphia, Pennsylvania, 19140, United States
Unknown Facility
Philadelphia, Pennsylvania, 19153, United States
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Upper Saint Clair, Pennsylvania, 15241, United States
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Charleston, South Carolina, 29412, United States
Unknown Facility
Charleston, South Carolina, 29414, United States
Unknown Facility
Columbia, South Carolina, 29201, United States
Unknown Facility
Greer, South Carolina, 29651, United States
Unknown Facility
Germantown, Tennessee, 38138, United States
Unknown Facility
Jackson, Tennessee, 38305, United States
Unknown Facility
Murfreesboro, Tennessee, 37130, United States
Unknown Facility
New Tazewell, Tennessee, 37825, United States
Unknown Facility
Arlington, Texas, 76012, United States
Unknown Facility
Dallas, Texas, 75230, United States
Unknown Facility
Dallas, Texas, 75231, United States
Unknown Facility
Dallas, Texas, 75235, United States
Unknown Facility
Fort Worth, Texas, 76117, United States
Unknown Facility
Grand Prairie, Texas, 75052, United States
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Houston, Texas, 77008, United States
Unknown Facility
Houston, Texas, 77074, United States
Unknown Facility
Houston, Texas, 77081, United States
Unknown Facility
Houston, Texas, 77083, United States
Unknown Facility
San Antonio, Texas, 78209, United States
Unknown Facility
San Antonio, Texas, 78229, United States
Unknown Facility
Sugar Land, Texas, 77478, United States
Unknown Facility
Sugar Land, Texas, 77479, United States
Unknown Facility
Tomball, Texas, 77375, United States
Unknown Facility
Salt Lake City, Utah, 84102, United States
Unknown Facility
Salt Lake City, Utah, 84107, United States
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Alexandria, Virginia, 22304, United States
Unknown Facility
Danville, Virginia, 24541, United States
Unknown Facility
Manassas, Virginia, 20110, United States
Unknown Facility
Richmond, Virginia, 23225, United States
Unknown Facility
Salem, Virginia, 24153, United States
Unknown Facility
Suffolk, Virginia, 23435, United States
Unknown Facility
Lakewood, Washington, 98499, United States
Unknown Facility
Kenosha, Wisconsin, 53142, United States
Related Publications (1)
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.
PMID: 25054436DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Global Clinical Leader
- Organization
- Daiichi Sankyo, Inc.
Study Officials
- STUDY DIRECTOR
Global Clinical Leader
Daiichi Sankyo
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 10, 2008
First Posted
November 13, 2008
Study Start
April 1, 2009
Primary Completion
July 1, 2012
Study Completion
July 1, 2012
Last Updated
June 26, 2017
Results First Posted
June 26, 2017
Record last verified: 2017-06