Clinical trial NCT00151749: WelChol® and Insulin 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 Diabetes With Inadequate Glycemic Control on Insulin Therapy Alone or Insulin Therapy 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: 2005-09-09
Enrollment: 260
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 WelChol® is for type 2 diabetes when added to insulin alone or in combination with other anti-diabetic drugs


Eligibility criteria: Inclusion Criteria:

* Ages 18 - 75 years, inclusive
* Diagnosed with type 2 diabetes
* Stable insulin therapy for 6 weeks
* Stable dose of any other antidiabetic medications for 90 days
* Hemoglobin A1c value between 7.5% to 9.5%
* C peptide greater than 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 less than 60 mg/dL
* Serum TG greater than 500 mg/dL
* Body mass index (BMI) greater than 45 kg/m2-

Primary outcomes:
measure: - To assess the additional lowering of HbA1c achieved by
measure: addition of WelChol® to current antidiabetic therapy
Secondary outcomes:
measure: To assess: the effects on fasting plasma glucose and
measure: fructosamine; glycemic control response rate; effect on adiponectin; the effect on c-peptide; effect on c-reactive protein; effects on lipids and lipoproteins; the safety and tolerability of WelChol® as add-
measure: on therapy to patients receiving insulin alone or with
measure: other oral drugs
Other outcomes:
Locations:
city: Tuscumbia
country: United States
state: Alabama
city: Sierra Vista
country: United States
state: Arizona
city: Jonesboro
country: United States
state: Arkansas
city: Searcy
country: United States
state: Arkansas
city: Carmichael
country: United States
state: California
city: Concord
country: United States
state: California
city: Fullerton
country: United States
state: California
city: La Jolla
country: United States
state: California
city: San Diego
country: United States
state: California
city: West Hills
country: United States
state: California
city: Washington
country: United States
state: District of Columbia
city: Largo
country: United States
state: Florida
city: Miami
country: United States
state: Florida
city: New Port Richey
country: United States
state: Florida
city: West Palm Beach
country: United States
state: Florida
city: Chicago
country: United States
state: Illinois
city: Indianapolis
country: United States
state: Indiana
city: Lexington
country: United States
state: Kentucky
city: Louisville
country: United States
state: Kentucky
city: New Orleans
country: United States
state: Louisiana
city: Boston
country: United States
state: Massachusetts
city: Troy
country: United States
state: Michigan
city: Edina
country: United States
state: Minnesota
city: Chesterfield
country: United States
state: Missouri
city: Kansas City
country: United States
state: Missouri
city: St. Louis
country: United States
state: Missouri
city: Bozeman
country: United States
state: Montana
city: Butte
country: United States
state: Montana
city: Englewood
country: United States
state: New Jersey
city: Charlotte
country: United States
state: North Carolina
city: Hickory
country: United States
state: North Carolina
city: Raleigh
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: Marion
country: United States
state: Ohio
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: Morristown
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: Mexico DF
country: Mexico
city: Lima
country: Peru
Study officials:
References:
citation: Goldberg RB, Fonseca VA, Truitt KE, Jones MR. Efficacy and safety of colesevelam in patients with type 2 diabetes mellitus and inadequate glycemic control receiving insulin-based therapy. Arch Intern Med. 2008 Jul 28;168(14):1531-40. doi: 10.1001/archinte.168.14.1531.