Clinical trial NCT00789737: Welchol as Monotherapy for Type 2 Diabetes Mellitus
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Type 2 Diabetes Mellitus
Lead sponsor: Daiichi Sankyo
Sponsor class: INDUSTRY
First posted: 2008-11-13
Enrollment: 357
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Percent Change in Hemoglobin A1c
timeFrame: 24 week
Secondary outcomes:
measure: Change in Fasting Plasma Glucose
timeFrame: from baseline to 24 weeks
measure: % Subjects With a Decrease in HbA1c of >= 0.7 Percentage Units
timeFrame: 24 weeks
measure: % Subjects Achieving an HbA1C Goal of <7.0
timeFrame: 24 weeks
measure: % Subjects With a Decrease in FPG >=30 mg/dL
timeFrame: from baseline to 24 weeks
measure: Changes in Total Cholesterol [TC]
timeFrame: from baseline to 24 weeks
measure: Changes in Low Density Lipoprotein Cholesterol [LDL-C]
timeFrame: from baseline to 24 weeks
measure: Changes in High Density Lipoprotein Cholesterol [HDL-C]
timeFrame: from baseline to 24 weeks
measure: Changes in Non-HDL-C
timeFrame: from baseline to 24 weeks
measure: Changes in Triglycerides [TG]
timeFrame: from baseline to 24 weeks
measure: Changes in Apolipoprotein A-I (apoA-I)
timeFrame: from baseline to 24 weeks
measure: Changes in Apolipoprotein B (apoB)
timeFrame: from baseline to 24 weeks
measure: Change in Postprandial Plasma Glucose, 2 Hours After a Meal Tolerance Test
timeFrame: from baseline to 24 weeks
Other outcomes:
Locations:
city: Birmingham
country: United States
state: Alabama
city: Birmingham
country: United States
state: Alabama
city: Montgomery
country: United States
state: Alabama
city: Muscle Shoals
country: United States
state: Alabama
city: Green Valley
country: United States
state: Arizona
city: Mesa
country: United States
state: Arizona
city: Mesa
country: United States
state: Arizona
city: Tucson
country: United States
state: Arizona
city: Tucson
country: United States
state: Arizona
city: Tucson
country: United States
state: Arizona
city: Searcy
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state: Arkansas
city: Buena Park
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state: California
city: Burbank
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state: California
city: Chula Vista
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state: California
city: Garden Grove
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state: California
city: Huntington Park
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state: California
city: Irvine
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state: California
city: La Mirada
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state: California
city: Lincoln
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state: California
city: Lomita
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state: California
city: Los Angeles
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state: California
city: Los Angeles
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state: California
city: Los Gatos
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state: California
city: Santa Ana
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state: California
city: Tustin
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state: California
city: Walnut creek
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state: California
city: Brooksville
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state: Florida
city: Coral Gables
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state: Florida
city: DeLand
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state: Florida
city: Delray Beach
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state: Florida
city: Gulf Breeze
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state: Florida
city: Hialeah
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state: Florida
city: Jacksonville
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state: Florida
city: Kissimmee
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state: Florida
city: Miami
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state: Florida
city: Miami
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state: Florida
city: Miami
country: United States
state: Florida
city: New Port Richey
country: United States
state: Florida
city: Ocala
country: United States
state: Florida
city: Ormond Beach
country: United States
state: Florida
city: Pembroke Pines
country: United States
state: Florida
city: Vero Beach
country: United States
state: Florida
city: Wellington
country: United States
state: Florida
city: Winter Park
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state: Florida
city: Decatur
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state: Georgia
city: East Point
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state: Georgia
city: Roswell
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state: Georgia
city: Stockbridge
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state: Georgia
city: Stone Mountain
country: United States
state: Georgia
city: Nampa
country: United States
state: Idaho
city: Chicago
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state: Illinois
city: Evansville
country: United States
state: Indiana
city: LaPorte
country: United States
state: Indiana
city: South Bend
country: United States
state: Indiana
city: Crestview Hills
country: United States
state: Kentucky
city: Lafayette
country: United States
state: Louisiana
city: Prince Frederick
country: United States
state: Maryland
city: Silver Spring
country: United States
state: Maryland
city: New Bedford
country: United States
state: Massachusetts
city: Southfield
country: United States
state: Michigan
city: Port Gibson
country: United States
state: Mississippi
city: St. Louis
country: United States
state: Missouri
city: St. Louis
country: United States
state: Missouri
city: Billings
country: United States
state: Montana
city: Las Vegas
country: United States
state: Nevada
city: Berlin
country: United States
state: New Jersey
city: Clifton
country: United States
state: New Jersey
city: Mine Hill
country: United States
state: New Jersey
city: New Windsor
country: United States
state: New York
city: North Massapequa
country: United States
state: New York
city: West Seneca
country: United States
state: New York
city: Lexington
country: United States
state: North Carolina
city: Statesville
country: United States
state: North Carolina
city: Wilmington
country: United States
state: North Carolina
city: Cincinnati
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state: Ohio
city: Cincinnati
country: United States
state: Ohio
city: Cincinnati
country: United States
state: Ohio
city: Cleveland
country: United States
state: Ohio
city: Cuyahoga Falls
country: United States
state: Ohio
city: Marion
country: United States
state: Ohio
city: Munroe Falls
country: United States
state: Ohio
city: Shaker Heights
country: United States
state: Ohio
city: Oklahoma City
country: United States
state: Oklahoma
city: Oklahoma City
country: United States
state: Oklahoma
city: Portland
country: United States
state: Oregon
city: Harrisburg
country: United States
state: Pennsylvania
city: Jersey Shore
country: United States
state: Pennsylvania
city: Charleston
country: United States
state: South Carolina
city: Charleston
country: United States
state: South Carolina
city: Columbia
country: United States
state: South Carolina
city: Greer
country: United States
state: South Carolina
city: Arlington
country: United States
state: Texas
city: Dallas
country: United States
state: Texas
city: Dallas
country: United States
state: Texas
city: Fort Worth
country: United States
state: Texas
city: Houston
country: United States
state: Texas
city: Houston
country: United States
state: Texas
city: Houston
country: United States
state: Texas
city: Houston
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: Sugar Land
country: United States
state: Texas
city: Tomball
country: United States
state: Texas
city: Salt Lake City
country: United States
state: Utah
city: Salt Lake City
country: United States
state: Utah
city: Manassas
country: United States
state: Virginia
city: Salem
country: United States
state: Virginia
city: Milwaukee
country: United States
state: Wisconsin
Study officials:
References:
citation: 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.