Clinical trial NCT00147719: WelChol® With Metformin 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 Metformin Monotherapy or Metformin 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: 300
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 metformin alone or in combination with other anti-diabetic drugs.


Eligibility criteria: Inclusion Criteria:

* Age 18-75 years, inclusive
* Diagnosed with type 2 diabetes
* Hemoglobin (HbA1c) between 7.5% to 9.5%
* Prescribed an ADA accepted diet
* Receiving stable dose of metformin alone or in combination with other oral anti-diabetic medications for 90 days before Visit 1

Exclusion Criteria:

* History of type 1 diabetes or ketoacidosis
* History of chronic (more than 2 months) insulin therapy or the initiation of insulin for chronic treatment
* History of pancreatitis
* Uncontrolled hypertension
* Recent severe cardiovascular disease
* Allergy or toxic response to colesevelam or any of its components
* 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 effect;
measure: To assess the glycemic control response rate;
measure: To assess the improvement in insulin sensitivity;
measure: To assess the effect on high sensitivity C-reactive protein;
measure: To assess the improvement in lipids, and lipoproteins;
measure: To assess the safety and tolerability of colesevelam hydrochloride when added on to current therapy
Other outcomes:
Locations:
city: Jonesboro
country: United States
facility: CRO
state: Arkansas
city: Beverly Hills
country: United States
state: California
city: Carmichael
country: United States
state: California
city: Fresno
country: United States
state: California
city: Irvine
country: United States
state: California
city: La Jolla
country: United States
state: California
city: Los Gatos
country: United States
state: California
city: San Diego
country: United States
state: California
city: Spring Valley
country: United States
state: California
city: West Hills
country: United States
state: California
city: Washington
country: United States
state: District of Columbia
city: Coco Beach
country: United States
state: Florida
city: Largo
country: United States
state: Florida
city: Miami
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: Evansville
country: United States
state: Indiana
city: Louisville
country: United States
state: Kentucky
city: Detroit
country: United States
state: Michigan
city: Troy
country: United States
state: Michigan
city: Edina
country: United States
state: Minnesota
city: Chesterfield
country: United States
state: Missouri
city: Bozeman
country: United States
state: Montana
city: Butte
country: United States
state: Montana
city: Las Vegas
country: United States
state: Nevada
city: Rochester
country: United States
state: New York
city: Charlotte
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: Lyndhurst
country: United States
state: Ohio
city: Marion
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: Columbia
country: United States
state: South Carolina
city: Morristown
country: United States
state: Tennessee
city: Corpus Christi
country: United States
state: Texas
city: Dallas
country: United States
state: Texas
city: Pharr
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: Mexico DF
country: Mexico
city: Lima
country: Peru
Study officials:
References:
citation: Bays HE, Goldberg RB, Truitt KE, Jones MR. Colesevelam hydrochloride therapy in patients with type 2 diabetes mellitus treated with metformin: glucose and lipid effects. Arch Intern Med. 2008 Oct 13;168(18):1975-83. doi: 10.1001/archinte.168.18.1975.