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Welchol as Add-on to Pioglitazone Therapy for Type 2 Diabetes Mellitus

Information source: Daiichi Sankyo Inc.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Type 2 Diabetes Mellitus

Intervention: Welchol (Drug); placebo (Drug); Pioglitazone (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Daiichi Sankyo Inc.

Summary

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.

Clinical Details

Official title: 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)

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: mean change from baseline in HbA1C

Secondary outcome:

mean change from baseline in fasting plasma glucose

Subjects with a decrease of >= 0.7 percentage units in HbA1C

Subjects achieving an HbA1C goal of <7.0%

Subjects with a reduction of FPG of >= 30 mg/dL

change from baseline and percent change from baseline in TC

change from baseline and percent change from baseline in LDL-C

change from baseline and percent change from baseline in HDL-C

change from baseline and percent change from baseline in non-HDL-C

change from baseline and percent change from baseline in TG

change from baseline and percent change from baseline in apoA-I

change from baseline and percent change from baseline in apoB

effects on insulin levels

effects on HOMA indices

effects on hs-CRP.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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.

Locations and Contacts

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

Additional Information

Starting date: April 2009
Last updated: August 27, 2013

Page last updated: August 23, 2015

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