The current study investigates Welchol 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 Welchol add-on to pioglitazone therapy for Type 2
Diabetes Mellitus will be safe, well tolerated, and efficacious.
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Inclusion Criteria:
- 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 DPP-IV inhibitor)
- A1C >= 7. 5% and =< 9. 5% at screening.
- Fasting plasma glucose =<240 mg/dL at randomization (Week0/Day 1).
- Male or female >= 18 years of age.
- Women of childbearing potential (WOCBP) 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 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
- Two or more fasting self-monitored blood glucose (SMBG) levels >240 mg/dL during the
placebo lead-in period
- Body mass index >40 kg/m2 at screening
- Weight loss >3% in the 3 months prior to screening
- Treatment with bile acid sequestrants, including Welchol within 3 months prior to
screening
- LDL level <60 mg/dL
- Female subject who is pregnant or breastfeeding
- SBP >= 180 mmHg and/or DBP >= 110 mmHg
- History of unstable angina, myocardial infarction, cerebrovascular accident,
transient ischemic attack, or any revascularization within 6 months prior to
screening
- History of malignancy, except subjects who have been disease-free for >10 years or
whose malignancy was a basal or squamous cell skin carcinoma. Women with a history of
cervical dysplasia (CIN2 or higher) should be excluded unless 2 consecutive normal
cervical smears have subsequently been recorded prior to enrollment
- Known (or evidence of) infection with human immunodeficiency virus (HIV)
- History of alcohol or drug abuse within 1 year prior to screening
- History of untreated major psychiatric disorders that could inhibit abilities to
comply with the protocol
- Any condition, lab abnormality or concomitant therapy which, in the opinion of the
investigator, might pose a risk to the subject or make participation not in the
subject's best interest
- Known or suspected allergy, hypersensitivity or intolerance to the excipients of the
investigational study medication
- Participation in an interventional medical, surgical, or pharmaceutical study within
30 days prior to the screening visit
- A direct or familial relationship with the sponsor, investigator, or site personnel
affiliated with the study.
Birmingham, Alabama 35294, United States
Birmingham, Alabama 35216, United States
Birmingham, Alabama 35205, United States
Montgomery, Alabama 36106, United States
Montgomery, Alabama 36117, United States
Green Valley, Arizona 85614, United States
Mesa, Arizona 85210, United States
Phoenix, Arizona 85050, United States
Tempe, Arizona 85284, United States
Tempe, Arizona 85282, United States
Searcy, Arkansas 72143, United States
Buena Park, California 90620, United States
Burbank, California 91505, United States
Chino, California 91710, United States
Garden Grove, California 92844, United States
Huntington Park, California 90255, United States
La Mirada, California 90638, United States
Lincoln, California 95648, United States
Lomita, California 90717, United States
Los Gatos, California 95032, United States
Modesto, California 95355, United States
San Diego, California 92161, United States
Santa Ana, California 92701, United States
Tustin, California 92780, United States
Walnut Creek, California 94598, United States
Coral Gables, Florida 33134, United States
DeLand, Florida 32720, United States
Delray Beach, Florida 33484, United States
Gulf Breeze, Florida 32561, United States
Hialeah, Florida 33012, United States
Jacksonville, Florida 32223, United States
Kissimmee, Florida 34741, United States
Miami, Florida 33183, United States
Miami, Florida 33156, United States
Miami, Florida 33169, United States
Miami, Florida 33175, United States
Miami, Florida 33135, United States
New Port Richey, Florida 34652, United States
Ocala, Florida 34471, United States
Ormond Beach, Florida 32174, United States
Pembroke Pines, Florida 33026, United States
Pembroke Pines, Florida 33027, United States
Pinellas Park, Florida 33781, United States
Sanford, Florida 32771, United States
Tampa, Florida 33607, United States
Vero Beach, Florida 32960, United States
Wellington, Florida 33449, United States
Winter Haven, Florida 33880, United States
Winter Park, Florida 32789, United States
Winter Park, Florida 32792, United States
Columbus, Georgia 31904, United States
Decatur, Georgia 30035, United States
East Point, Georgia 30344, United States
Marietta, Georgia 30066, United States
Roswell, Georgia 30076, United States
Stockbridge, Georgia 30281, United States
Tucker, Georgia 30084, United States
Waycross, Georgia 31501, United States
Nampa, Idaho 83686, United States
Arlington Heights, Illinois 60004, United States
Chicago, Illinois 60607, United States
Bloomington, Indiana 47403, United States
Evansville, Indiana 47714, United States
LaPorte, Indiana 46350, United States
South Bend, Indiana 46614, United States
Crestview Hills, Kentucky 41017, United States
Paducah, Kentucky 42003, United States
Lafayette, Louisiana 70503, United States
Prince Frederick, Maryland 20678, United States
Silver Spring, Maryland 20910, United States
New Bedford, Massachusetts 02740, United States
Southfield, Michigan 48034, United States
Brooklyn Center, Minnesota 55430, United States
Jackson, Mississippi 39216, United States
Port Gibson, Mississippi 39150, United States
Kansas City, Missouri 64111, United States
St. Louis, Missouri 63141, United States
Billings, Montana 59101, United States
Las Vegas, Nevada 89123, United States
Belvidere, New Jersey 07823, United States
Berlin, New Jersey 08009, United States
Clifton, New Jersey 07013, United States
Lumberton, New Jersey 08048, United States
Mine Hill, New Jersey 07803, United States
New Windsor, New York 12553, United States
North Massapequa, New York 11758, United States
Tonawanda, New York 14150, United States
West Seneca, New York 14224, United States
Lexington, North Carolina 27293, United States
Statesville, North Carolina 28625, United States
Cincinnati, Ohio 45219, United States
Cincinnati, Ohio 45227, United States
Cincinnati, Ohio 45245, United States
Cleveland, Ohio 44122, United States
Columbus, Ohio 43213, United States
Cuyahoga Falls, Ohio 44223, United States
Marion, Ohio 43302, United States
Shaker Heights, Ohio 44120, United States
Stow, Ohio 44224, United States
Oklahoma City, Oklahoma 73103, United States
Oklahoma City, Oklahoma 73132, United States
Oklahoma City, Oklahoma 73159, United States
Portland, Oregon 97220, United States
Harrisburg, Pennsylvania 17112, United States
Jersey Shore, Pennsylvania 17740, United States
Philadelphia, Pennsylvania 19140, United States
Philadelphia, Pennsylvania 19153, United States
Upper Saint Clair, Pennsylvania 15241, United States
Charleston, South Carolina 29412, United States
Charleston, South Carolina 29414, United States
Columbia, South Carolina 29201, United States
Greer, South Carolina 29651, United States
Germantown, Tennessee 38138, United States
Jackson, Tennessee 38305, United States
Murfreesboro, Tennessee 37130, United States
New Tazewell, Tennessee 37825, United States
Arlington, Texas 76012, United States
Dallas, Texas 75231, United States
Dallas, Texas 75235, United States
Dallas, Texas 75230, United States
Fort Worth, Texas 76117, United States
Grand Prairie, Texas 75052, United States
Houston, Texas 77083, United States
Houston, Texas 77008, United States
Houston, Texas 77074, United States
Houston, Texas 77081, United States
San Antonio, Texas 78209, United States
San Antonio, Texas 78229, United States
Sugar Land, Texas 77478, United States
Sugar Land, Texas 77479, United States
Tomball, Texas 77375, United States
Salt Lake City, Utah 84107, United States
Salt Lake City, Utah 84102, United States
Alexandria, Virginia 22304, United States
Danville, Virginia 24541, United States
Manassas, Virginia 20110, United States
Richmond, Virginia 23225, United States
Salem, Virginia 24153, United States
Suffolk, Virginia 23435, United States
Lakewood, Washington 98499, United States
Kenosha, Wisconsin 53142, United States