Welchol as Monotherapy for Type 2 Diabetes Mellitus

NCT00789737 | Completed Phase 3 Results

• 1 other identifier: WEL-305
• Study Type: interventional
• Target: 357
• Locations: 1 country
• Sites: 107

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.

Conditions

Type 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• Percent Change in Hemoglobin A1c

  change in HbA1c from baseline to Week 24

  24 week

Secondary Outcomes (12)

• Change in Fasting Plasma Glucose

  from baseline to 24 weeks

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

  24 weeks

• % Subjects Achieving an HbA1C Goal of <7.0

  24 weeks

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

  from baseline to 24 weeks

• Changes in Total Cholesterol [TC]

  from baseline to 24 weeks

Study Arms (2)

Welchol

EXPERIMENTAL

Welchol 625mg tablets

Drug: Welchol

placebo

PLACEBO COMPARATOR

placebo

Drug: Placebo

Interventions

Welchol DRUG

Welchol 625mg tablets

Welchol

Placebo DRUG

placebo

placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Daiichi Sankyo: lead

Study Sites (107)

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Birmingham, Alabama, 35216, United States

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Birmingham, Alabama, 35294, United States

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Montgomery, Alabama, 36117, United States

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Muscle Shoals, Alabama, 35662, United States

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Green Valley, Arizona, 85614, United States

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Mesa, Arizona, 85203, United States

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Mesa, Arizona, 85210, United States

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Tucson, Arizona, 85705, United States

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Tucson, Arizona, 85723, United States

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Tucson, Arizona, 85741, United States

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Searcy, Arkansas, 72143, United States

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Buena Park, California, 90620, United States

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Burbank, California, 91505, United States

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Chula Vista, California, 91910, United States

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Garden Grove, California, 92844, United States

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Huntington Park, California, 90255, United States

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Irvine, California, 92618, United States

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La Mirada, California, 90638, United States

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Lincoln, California, 95648, United States

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Lomita, California, 90717, United States

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Los Angeles, California, 90015, United States

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Los Angeles, California, 90057, United States

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Los Gatos, California, 95032, United States

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Santa Ana, California, 92701, United States

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Tustin, California, 92780, United States

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Walnut Creek, California, 94598, United States

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Brooksville, Florida, 34601, United States

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Coral Gables, Florida, 33134, United States

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DeLand, Florida, 32720, United States

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Delray Beach, Florida, 33484, United States

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Gulf Breeze, Florida, 32561, United States

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Hialeah, Florida, 33012, United States

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Jacksonville, Florida, 32223, United States

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Kissimmee, Florida, 34741, United States

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Miami, Florida, 33135, United States

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Miami, Florida, 33169, United States

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Miami, Florida, 33175, United States

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New Port Richey, Florida, 34652, United States

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Ocala, Florida, 34471, United States

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Ormond Beach, Florida, 32174, United States

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Pembroke Pines, Florida, 33026, United States

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Vero Beach, Florida, 32960, United States

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Wellington, Florida, 33449, United States

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Winter Park, Florida, 32789, United States

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Decatur, Georgia, 30035, United States

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East Point, Georgia, 30344, United States

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Roswell, Georgia, 30076, United States

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Stockbridge, Georgia, 30281, United States

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Stone Mountain, Georgia, 30083, United States

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Nampa, Idaho, 83686, United States

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Chicago, Illinois, 60607, United States

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Evansville, Indiana, 47714, United States

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La Porte, Indiana, 46350, United States

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South Bend, Indiana, 46614, United States

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Crestview Hills, Kentucky, 41017, United States

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Lafayette, Louisiana, 70503, United States

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Prince Frederick, Maryland, 20678, United States

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Silver Spring, Maryland, 20910, United States

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New Bedford, Massachusetts, 02740, United States

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Southfield, Michigan, 48034, United States

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Port Gibson, Mississippi, 39150, United States

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St Louis, Missouri, 63128, United States

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St Louis, Missouri, 63141, United States

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Billings, Montana, 59101, United States

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Las Vegas, Nevada, 89123, United States

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Berlin, New Jersey, 08009, United States

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Clifton, New Jersey, 07013, United States

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Mine Hill, New Jersey, 07803, United States

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New Windsor, New York, 12553, United States

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North Massapequa, New York, 11758-1802, United States

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West Seneca, New York, 14224, United States

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Lexington, North Carolina, 27295, United States

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Statesville, North Carolina, 28625, United States

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Wilmington, North Carolina, 28401, United States

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Cincinnati, Ohio, 45219, United States

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Cincinnati, Ohio, 45227, United States

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Cincinnati, Ohio, 45245, United States

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Cleveland, Ohio, 44122, United States

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Cuyahoga Falls, Ohio, 44223, United States

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Marion, Ohio, 43302, United States

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Munroe Falls, Ohio, 44262, United States

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Shaker Heights, Ohio, 44120, United States

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Oklahoma City, Oklahoma, 73103, United States

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Oklahoma City, Oklahoma, 73159, United States

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Portland, Oregon, 97220, United States

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Harrisburg, Pennsylvania, 17112, United States

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Jersey Shore, Pennsylvania, 17740, United States

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Charleston, South Carolina, 29412, United States

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Charleston, South Carolina, 29414, United States

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Columbia, South Carolina, 29201, United States

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Greer, South Carolina, 29651, United States

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Arlington, Texas, 76012, United States

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Dallas, Texas, 75230, United States

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Dallas, Texas, 75235, United States

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Fort Worth, Texas, 76117, United States

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Houston, Texas, 77008, United States

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Houston, Texas, 77074, United States

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Houston, Texas, 77081, United States

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Houston, Texas, 77083, United States

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San Antonio, Texas, 78229, United States

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Sugar Land, Texas, 77479, United States

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Tomball, Texas, 77375, United States

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Salt Lake City, Utah, 84102, United States

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Salt Lake City, Utah, 84107, United States

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Manassas, Virginia, 20110, United States

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Salem, Virginia, 24153, United States

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Milwaukee, Wisconsin, 53209, United States

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Related Publications (1)

• Rosenstock J, Rigby SP, Ford DM, Tao B, Chou HS. The glucose and lipid effects of colesevelam as monotherapy in drug-naive type 2 diabetes. Horm Metab Res. 2014 May;46(5):348-53. doi: 10.1055/s-0033-1358759. Epub 2013 Dec 19.

  PMID: 24356792 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Colesevelam Hydrochloride

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Allylamine; Amines; Organic Chemicals; Allyl Compounds; Alkenes; Hydrocarbons, Acyclic; Hydrocarbons

Results Point of Contact

• Title: Director Metabolic Clinical Development
• Organization: Daiichi Sankyo Pharma Development

732-590-5000

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 10, 2008
• First Posted: November 13, 2008
• Study Start: January 1, 2009
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2011
• Last Updated: February 27, 2014
• Results First Posted: January 22, 2014

Record last verified: 2014-01

Locations

US (107)