Welchol as Monotherapy for Type 2 Diabetes Mellitus

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00789737
Recruitment Status : Completed
First Posted : November 13, 2008
Results First Posted : January 22, 2014
Last Update Posted : February 27, 2014
Information provided by (Responsible Party):
Daiichi Sankyo, Inc.

Brief 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.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Drug: Welchol Drug: Placebo Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 357 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : January 2009
Actual Primary Completion Date : December 2011
Actual Study Completion Date : December 2011

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Welchol
Welchol 625mg tablets
Drug: Welchol
Welchol 625mg tablets

Placebo Comparator: placebo
Drug: Placebo

Primary Outcome Measures :
  1. Percent Change in Hemoglobin A1c [ Time Frame: 24 week ]
    change in HbA1c from baseline to Week 24

Secondary Outcome Measures :
  1. Change in Fasting Plasma Glucose [ Time Frame: from baseline to 24 weeks ]
    to determine changes in Glycemic control after 24 weeks on therapy

  2. % Subjects With a Decrease in HbA1c of >= 0.7 Percentage Units [ Time Frame: 24 weeks ]
    to determine the percentage of participants who experience a reduction in HbA1c of at least 0.7 percentage units at 24 weeks from baseline.

  3. % Subjects Achieving an HbA1C Goal of <7.0 [ Time Frame: 24 weeks ]
    % Subjects achieving an HbA1C goal of <7.0 at 24 weeks

  4. % Subjects With a Decrease in FPG >=30 mg/dL [ Time Frame: from baseline to 24 weeks ]
    % Subjects with a decrease in Fasting Plasma Glucose >=30 mg/dL from baseline to 24 weeks

  5. Changes in Total Cholesterol [TC] [ Time Frame: from baseline to 24 weeks ]
    To assess the effects of Welchol on changes in total cholesterol [TC]

  6. Changes in Low Density Lipoprotein Cholesterol [LDL-C] [ Time Frame: from baseline to 24 weeks ]
    To assess the effects of Welchol on changes in low density lipoprotein cholesterol [LDL-C]

  7. Changes in High Density Lipoprotein Cholesterol [HDL-C] [ Time Frame: from baseline to 24 weeks ]
    To assess the effects of Welchol on changes in high density lipoprotein cholesterol [HDL-C]

  8. Changes in Non-HDL-C [ Time Frame: from baseline to 24 weeks ]
    To assess the effects of Welchol on changes in non-HDL-C

  9. Changes in Triglycerides [TG] [ Time Frame: from baseline to 24 weeks ]
    To assess the effects of Welchol on changes in triglycerides [TG]

  10. Changes in Apolipoprotein A-I (apoA-I) [ Time Frame: from baseline to 24 weeks ]
    To assess the effects of Welchol on changes in apolipoprotein A-I (apoA-I)

  11. Changes in Apolipoprotein B (apoB) [ Time Frame: from baseline to 24 weeks ]
    To assess the effects of Welchol on changes in apolipoprotein B (apoB)

  12. Change in Postprandial Plasma Glucose, 2 Hours After a Meal Tolerance Test [ Time Frame: from baseline to 24 weeks ]
    To assess the change from baseline on postprandial plasma glucose, 2 hours after a meal tolerance test

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00789737

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United States, Alabama
Birmingham, Alabama, United States, 35216
Birmingham, Alabama, United States, 35294
Montgomery, Alabama, United States, 36117
Muscle Shoals, Alabama, United States, 35662
United States, Arizona
Green Valley, Arizona, United States, 85614
Mesa, Arizona, United States, 85203
Mesa, Arizona, United States, 85210
Tucson, Arizona, United States, 85705
Tucson, Arizona, United States, 85723
Tucson, Arizona, United States, 85741
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Searcy, Arkansas, United States, 72143
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Buena Park, California, United States, 90620
Burbank, California, United States, 91505
Chula Vista, California, United States, 91910
Garden Grove, California, United States, 92844
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Los Angeles, California, United States, 90015
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Santa Ana, California, United States, 92701
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Walnut creek, California, United States, 94598
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Brooksville, Florida, United States, 34601
Coral Gables, Florida, United States, 33134
DeLand, Florida, United States, 32720
Delray Beach, Florida, United States, 33484
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Evansville, Indiana, United States, 47714
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Crestview Hills, Kentucky, United States, 41017
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New Bedford, Massachusetts, United States, 02740
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Southfield, Michigan, United States, 48034
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Port Gibson, Mississippi, United States, 39150
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St. Louis, Missouri, United States, 63128
St. Louis, Missouri, United States, 63141
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Billings, Montana, United States, 59101
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Las Vegas, Nevada, United States, 89123
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Berlin, New Jersey, United States, 08009
Clifton, New Jersey, United States, 07013
Mine Hill, New Jersey, United States, 07803
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New Windsor, New York, United States, 12553
North Massapequa, New York, United States, 11758-1802
West Seneca, New York, United States, 14224
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Lexington, North Carolina, United States, 27295
Statesville, North Carolina, United States, 28625
Wilmington, North Carolina, United States, 28401
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Cincinnati, Ohio, United States, 45219
Cincinnati, Ohio, United States, 45227
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Cleveland, Ohio, United States, 44122
Cuyahoga Falls, Ohio, United States, 44223
Marion, Ohio, United States, 43302
Munroe Falls, Ohio, United States, 44262
Shaker Heights, Ohio, United States, 44120
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Oklahoma City, Oklahoma, United States, 73103
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Portland, Oregon, United States, 97220
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Harrisburg, Pennsylvania, United States, 17112
Jersey Shore, Pennsylvania, United States, 17740
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Charleston, South Carolina, United States, 29412
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Arlington, Texas, United States, 76012
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Sugar Land, Texas, United States, 77479
Tomball, Texas, United States, 77375
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Salt Lake City, Utah, United States, 84102
Salt Lake City, Utah, United States, 84107
United States, Virginia
Manassas, Virginia, United States, 20110
Salem, Virginia, United States, 24153
United States, Wisconsin
Milwaukee, Wisconsin, United States, 53209
Sponsors and Collaborators
Daiichi Sankyo, Inc.

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Daiichi Sankyo, Inc. Identifier: NCT00789737     History of Changes
Other Study ID Numbers: WEL-305
First Posted: November 13, 2008    Key Record Dates
Results First Posted: January 22, 2014
Last Update Posted: February 27, 2014
Last Verified: January 2014

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Colesevelam Hydrochloride
Anticholesteremic Agents
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents