Welchol as Monotherapy for Type 2 Diabetes Mellitus

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Daiichi Sankyo Inc.
ClinicalTrials.gov Identifier:
NCT00789737
First received: November 10, 2008
Last updated: January 24, 2014
Last verified: January 2014
  Purpose

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 Intervention Phase
Type 2 Diabetes Mellitus
Drug: Welchol
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Daiichi Sankyo Inc.:

Primary Outcome Measures:
  • Percent Change in Hemoglobin A1c [ Time Frame: 24 week ] [ Designated as safety issue: No ]
    change in HbA1c from baseline to Week 24


Secondary Outcome Measures:
  • Change in Fasting Plasma Glucose [ Time Frame: from baseline to 24 weeks ] [ Designated as safety issue: No ]
    to determine changes in Glycemic control after 24 weeks on therapy

  • % Subjects With a Decrease in HbA1c of >= 0.7 Percentage Units [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    to determine the percentage of participants who experience a reduction in HbA1c of at least 0.7 percentage units at 24 weeks from baseline.

  • % Subjects Achieving an HbA1C Goal of <7.0 [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    % Subjects achieving an HbA1C goal of <7.0 at 24 weeks

  • % Subjects With a Decrease in FPG >=30 mg/dL [ Time Frame: from baseline to 24 weeks ] [ Designated as safety issue: No ]
    % Subjects with a decrease in Fasting Plasma Glucose >=30 mg/dL from baseline to 24 weeks

  • Changes in Total Cholesterol [TC] [ Time Frame: from baseline to 24 weeks ] [ Designated as safety issue: No ]
    To assess the effects of Welchol on changes in total cholesterol [TC]

  • Changes in Low Density Lipoprotein Cholesterol [LDL-C] [ Time Frame: from baseline to 24 weeks ] [ Designated as safety issue: No ]
    To assess the effects of Welchol on changes in low density lipoprotein cholesterol [LDL-C]

  • Changes in High Density Lipoprotein Cholesterol [HDL-C] [ Time Frame: from baseline to 24 weeks ] [ Designated as safety issue: No ]
    To assess the effects of Welchol on changes in high density lipoprotein cholesterol [HDL-C]

  • Changes in Non-HDL-C [ Time Frame: from baseline to 24 weeks ] [ Designated as safety issue: No ]
    To assess the effects of Welchol on changes in non-HDL-C

  • Changes in Triglycerides [TG] [ Time Frame: from baseline to 24 weeks ] [ Designated as safety issue: No ]
    To assess the effects of Welchol on changes in triglycerides [TG]

  • Changes in Apolipoprotein A-I (apoA-I) [ Time Frame: from baseline to 24 weeks ] [ Designated as safety issue: No ]
    To assess the effects of Welchol on changes in apolipoprotein A-I (apoA-I)

  • Changes in Apolipoprotein B (apoB) [ Time Frame: from baseline to 24 weeks ] [ Designated as safety issue: No ]
    To assess the effects of Welchol on changes in apolipoprotein B (apoB)

  • Change in Postprandial Plasma Glucose, 2 Hours After a Meal Tolerance Test [ Time Frame: from baseline to 24 weeks ] [ Designated as safety issue: No ]
    To assess the change from baseline on postprandial plasma glucose, 2 hours after a meal tolerance test


Enrollment: 357
Study Start Date: January 2009
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Welchol
Welchol 625mg tablets
Drug: Welchol
Welchol 625mg tablets
Placebo Comparator: placebo
placebo
Drug: Placebo
placebo

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00789737

  Hide Study Locations
Locations
United States, Alabama
Birmingham, Alabama, United States, 35294
Birmingham, Alabama, United States, 35216
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, 85741
Tucson, Arizona, United States, 85705
Tucson, Arizona, United States, 85723
United States, Arkansas
Searcy, Arkansas, United States, 72143
United States, California
Buena Park, California, United States, 90620
Burbank, California, United States, 91505
Chula Vista, California, United States, 91910
Garden Grove, California, United States, 92844
Huntington Park, California, United States, 90255
Irvine, California, United States, 92618
La Mirada, California, United States, 90638
Lincoln, California, United States, 95648
Lomita, California, United States, 90717
Los Angeles, California, United States, 90015
Los Angeles, California, United States, 90057
Los Gatos, California, United States, 95032
Santa Ana, California, United States, 92701
Tustin, California, United States, 92780
Walnut creek, California, United States, 94598
United States, Florida
Brooksville, Florida, United States, 34601
Coral Gables, Florida, United States, 33134
DeLand, Florida, United States, 32720
Delray Beach, Florida, United States, 33484
Gulf Breeze, Florida, United States, 32561
Hialeah, Florida, United States, 33012
Jacksonville, Florida, United States, 32223
Kissimmee, Florida, United States, 34741
Miami, Florida, United States, 33175
Miami, Florida, United States, 33135
Miami, Florida, United States, 33169
New Port Richey, Florida, United States, 34652
Ocala, Florida, United States, 34471
Ormond Beach, Florida, United States, 32174
Pembroke Pines, Florida, United States, 33026
Vero Beach, Florida, United States, 32960
Wellington, Florida, United States, 33449
Winter Park, Florida, United States, 32789
United States, Georgia
Decatur, Georgia, United States, 30035
East Point, Georgia, United States, 30344
Roswell, Georgia, United States, 30076
Stockbridge, Georgia, United States, 30281
Stone Mountain, Georgia, United States, 30083
United States, Idaho
Nampa, Idaho, United States, 83686
United States, Illinois
Chicago, Illinois, United States, 60607
United States, Indiana
Evansville, Indiana, United States, 47714
LaPorte, Indiana, United States, 46350
South Bend, Indiana, United States, 46614
United States, Kentucky
Crestview Hills, Kentucky, United States, 41017
United States, Louisiana
Lafayette, Louisiana, United States, 70503
United States, Maryland
Prince Frederick, Maryland, United States, 20678
Silver Spring, Maryland, United States, 20910
United States, Massachusetts
New Bedford, Massachusetts, United States, 02740
United States, Michigan
Southfield, Michigan, United States, 48034
United States, Mississippi
Port Gibson, Mississippi, United States, 39150
United States, Missouri
St. Louis, Missouri, United States, 63141
St. Louis, Missouri, United States, 63128
United States, Montana
Billings, Montana, United States, 59101
United States, Nevada
Las Vegas, Nevada, United States, 89123
United States, New Jersey
Berlin, New Jersey, United States, 08009
Clifton, New Jersey, United States, 07013
Mine Hill, New Jersey, United States, 07803
United States, New York
New Windsor, New York, United States, 12553
North Massapequa, New York, United States, 11758-1802
West Seneca, New York, United States, 14224
United States, North Carolina
Lexington, North Carolina, United States, 27295
Statesville, North Carolina, United States, 28625
Wilmington, North Carolina, United States, 28401
United States, Ohio
Cincinnati, Ohio, United States, 45219
Cincinnati, Ohio, United States, 45227
Cincinnati, Ohio, United States, 45245
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
United States, Oklahoma
Oklahoma City, Oklahoma, United States, 73159
Oklahoma City, Oklahoma, United States, 73103
United States, Oregon
Portland, Oregon, United States, 97220
United States, Pennsylvania
Harrisburg, Pennsylvania, United States, 17112
Jersey Shore, Pennsylvania, United States, 17740
United States, South Carolina
Charleston, South Carolina, United States, 29414
Charleston, South Carolina, United States, 29412
Columbia, South Carolina, United States, 29201
Greer, South Carolina, United States, 29651
United States, Texas
Arlington, Texas, United States, 76012
Dallas, Texas, United States, 75230
Dallas, Texas, United States, 75235
Fort Worth, Texas, United States, 76117
Houston, Texas, United States, 77083
Houston, Texas, United States, 77008
Houston, Texas, United States, 77074
Houston, Texas, United States, 77081
San Antonio, Texas, United States, 78229
Sugar Land, Texas, United States, 77479
Tomball, Texas, United States, 77375
United States, Utah
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.
  More Information

No publications provided

Responsible Party: Daiichi Sankyo Inc.
ClinicalTrials.gov Identifier: NCT00789737     History of Changes
Other Study ID Numbers: WEL-305
Study First Received: November 10, 2008
Results First Received: December 4, 2013
Last Updated: January 24, 2014
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on August 21, 2014