Clinical trial NCT00147758: WelChol® and Sulfonylurea in Treating Patients With Type 2 Diabetes
Official title: A Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study of the Efficacy and Safety of WelChol® in Type 2 Diabetics With Inadequate Glycemic Control on Sulfonylurea Monotherapy or Sulfonylurea Therapy in Combination With Other Oral Anti-Diabetic Agents
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Type 2 Diabetes
Keywords: Diabetes Mellitus
Lead sponsor: Daiichi Sankyo
Sponsor class: INDUSTRY
First posted: 2005-09-07
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to see how safe and effective and tolerable the use of colesevelam hydrochloride is for type 2 diabetes when added to sulfonylurea alone or in combination with other anti-diabetic drugs.


Eligibility criteria: Inclusion Criteria:

* Age 18-75 years, inclusive
* Diagnosed with type 2 diabetes
* Stable dose of sulfonylurea alone or in combination with other anti-diabetic medications for 90 days
* Hemoglobin A1c value 7.5% to 9.5%, inclusive
* C peptide \> 0.5 ng/mL
* Prescribed ADA diet

Exclusion Criteria:

* History of type 1 diabetes or ketoacidosis
* History of pancreatitis
* Uncontrolled hypertension
* Allergy or toxic response to colesevelam or any of its components
* Serum LDL-C \< 60 mg/dL
* Serum TG \> 500 mg/dL
* Body mass index (BMI) \> 45 kg/m2

Primary outcomes:
measure: To assess the additional lowering of HbA1c achieved by addition of colesevelam hydrochloride to current antidiabetic therapy
Secondary outcomes:
measure: To assess the fasting plasma glucose and fructosamine lowering efficacy;
measure: To assess glycemic control response rate;
measure: To assess the improvement in insulin sensitivity;
measure: To assess the effect on C reactive protein;
measure: To assess lipids and lipoproteins;
measure: To assess the safety and tolerability of colesevelam hydrochloride as add-on therapy
Other outcomes:
Locations:
city: Birmingham
country: United States
state: Alabama
city: Tuscumbia
country: United States
state: Alabama
city: Little Rock
country: United States
state: Arkansas
city: Searcy
country: United States
state: Arkansas
city: Concord
country: United States
state: California
city: Irvine
country: United States
state: California
city: La Jolla
country: United States
state: California
city: Los Angeles
country: United States
state: California
city: Los Gatos
country: United States
state: California
city: West Hills
country: United States
state: California
city: Coral Gables
country: United States
state: Florida
city: Miami
country: United States
state: Florida
city: New Port Richey
country: United States
state: Florida
city: Pembroke Pines
country: United States
state: Florida
city: West Palm Beach
country: United States
state: Florida
city: Atlanta
country: United States
state: Georgia
city: Chicago
country: United States
state: Illinois
city: Indianapolis
country: United States
state: Indiana
city: New Orleans
country: United States
state: Louisiana
city: Boston
country: United States
state: Massachusetts
city: Kansas City
country: United States
state: Missouri
city: St. Louis
country: United States
state: Missouri
city: Rochester
country: United States
state: New York
city: Charlotte
country: United States
state: North Carolina
city: Hickory
country: United States
state: North Carolina
city: Statesville
country: United States
state: North Carolina
city: Winston-Salem
country: United States
state: North Carolina
city: Cincinnati
country: United States
state: Ohio
city: Cleveland
country: United States
state: Ohio
city: Marion
country: United States
state: Ohio
city: Perrysburg
country: United States
state: Ohio
city: Oklahoma City
country: United States
state: Oklahoma
city: Tulsa
country: United States
state: Oklahoma
city: Portland
country: United States
state: Oregon
city: Beaver
country: United States
state: Pennsylvania
city: Charleston
country: United States
state: South Carolina
city: Bristol
country: United States
state: Tennessee
city: Dallas
country: United States
state: Texas
city: Houston
country: United States
state: Texas
city: Midland
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: Arlington
country: United States
state: Virginia
city: Richmond
country: United States
state: Virginia
city: Lakewood
country: United States
state: Washington
city: Renton
country: United States
state: Washington
city: Mexico DF
country: Mexico
city: Lima
country: Peru
Study officials:
References:
citation: Fonseca VA, Rosenstock J, Wang AC, Truitt KE, Jones MR. Colesevelam HCl improves glycemic control and reduces LDL cholesterol in patients with inadequately controlled type 2 diabetes on sulfonylurea-based therapy. Diabetes Care. 2008 Aug;31(8):1479-84. doi: 10.2337/dc08-0283. Epub 2008 May 5.