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Welchol as Monotherapy 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)

Phase: Phase 3

Status: Completed

Sponsored by: Daiichi Sankyo Inc.

Summary

The current study investigates Welchol as monotherapy to improve glycemic control in subjects with Type 2 Diabetes Mellitus not adequately controlled with diet and exercise alone. The study will evaluate if Welchol monotherapy 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 Monotherapy for Type 2 Diabetes Mellitus

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: Percent Change in Hemoglobin A1c

Secondary outcome:

Change in Fasting Plasma Glucose

% Subjects With a Decrease in HbA1c of >= 0.7 Percentage Units

% Subjects Achieving an HbA1C Goal of <7.0

% Subjects With a Decrease in FPG >=30 mg/dL

Changes in Total Cholesterol [TC]

Changes in Low Density Lipoprotein Cholesterol [LDL-C]

Changes in High Density Lipoprotein Cholesterol [HDL-C]

Changes in Non-HDL-C

Changes in Triglycerides [TG]

Changes in Apolipoprotein A-I (apoA-I)

Changes in Apolipoprotein B (apoB)

Change in Postprandial Plasma Glucose, 2 Hours After a Meal Tolerance Test

Eligibility

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

Criteria:

Inclusion Criteria:

- Male or female subjects >= 18 years of age;

- 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:

- A history of type 1 diabetes and/or a history of ketoacidosis;

- 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.

Locations and Contacts

Birmingham, Alabama 35216, United States

Birmingham, Alabama 35294, United States

Montgomery, Alabama 36117, United States

Muscle Shoals, Alabama 35662, United States

Green Valley, Arizona 85614, United States

Mesa, Arizona 85203, United States

Mesa, Arizona 85210, United States

Tucson, Arizona 85705, United States

Tucson, Arizona 85723, United States

Tucson, Arizona 85741, United States

Searcy, Arkansas 72143, United States

Buena Park, California 90620, United States

Burbank, California 91505, United States

Chula Vista, California 91910, United States

Garden Grove, California 92844, United States

Huntington Park, California 90255, United States

Irvine, California 92618, United States

La Mirada, California 90638, United States

Lincoln, California 95648, United States

Lomita, California 90717, United States

Los Angeles, California 90015, United States

Los Angeles, California 90057, United States

Los Gatos, California 95032, United States

Santa Ana, California 92701, United States

Tustin, California 92780, United States

Walnut creek, California 94598, United States

Brooksville, Florida 34601, 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 33135, United States

Miami, Florida 33169, United States

Miami, Florida 33175, 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

Vero Beach, Florida 32960, United States

Wellington, Florida 33449, United States

Winter Park, Florida 32789, United States

Decatur, Georgia 30035, United States

East Point, Georgia 30344, United States

Roswell, Georgia 30076, United States

Stockbridge, Georgia 30281, United States

Stone Mountain, Georgia 30083, United States

Nampa, Idaho 83686, United States

Chicago, Illinois 60607, United States

Evansville, Indiana 47714, United States

LaPorte, Indiana 46350, United States

South Bend, Indiana 46614, United States

Crestview Hills, Kentucky 41017, 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

Port Gibson, Mississippi 39150, United States

St. Louis, Missouri 63128, United States

St. Louis, Missouri 63141, United States

Billings, Montana 59101, United States

Las Vegas, Nevada 89123, United States

Berlin, New Jersey 08009, United States

Clifton, New Jersey 07013, United States

Mine Hill, New Jersey 07803, United States

New Windsor, New York 12553, United States

North Massapequa, New York 11758-1802, United States

West Seneca, New York 14224, United States

Lexington, North Carolina 27295, United States

Statesville, North Carolina 28625, United States

Wilmington, North Carolina 28401, United States

Cincinnati, Ohio 45219, United States

Cincinnati, Ohio 45227, United States

Cincinnati, Ohio 45245, United States

Cleveland, Ohio 44122, United States

Cuyahoga Falls, Ohio 44223, United States

Marion, Ohio 43302, United States

Munroe Falls, Ohio 44262, United States

Shaker Heights, Ohio 44120, United States

Oklahoma City, Oklahoma 73103, United States

Oklahoma City, Oklahoma 73159, United States

Portland, Oregon 97220, United States

Harrisburg, Pennsylvania 17112, United States

Jersey Shore, Pennsylvania 17740, 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

Arlington, Texas 76012, United States

Dallas, Texas 75235, United States

Dallas, Texas 75230, United States

Fort Worth, Texas 76117, 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 78229, United States

Sugar Land, Texas 77479, United States

Tomball, Texas 77375, United States

Salt Lake City, Utah 84102, United States

Salt Lake City, Utah 84107, United States

Manassas, Virginia 20110, United States

Salem, Virginia 24153, United States

Milwaukee, Wisconsin 53209, United States

Additional Information

Starting date: January 2009
Last updated: January 24, 2014

Page last updated: August 23, 2015

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