WelChol® and Insulin in Treating Patients With Type 2 Diabetes

Condition(s) targeted: Type 2 Diabetes

Intervention: Colesevelam hydrochloride (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Daiichi Sankyo Inc.

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

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 design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome:

- To assess the additional lowering of HbA1c achieved by

addition of WelChol® to current antidiabetic therapy

Secondary outcome:

To assess: the effects on fasting plasma glucose and

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-

on therapy to patients receiving insulin alone or with

other oral drugs

Minimum age: 18 Years. Maximum age: 75 Years. Gender(s): Both.

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-

Mexico DF, Mexico

Lima, Peru

Tuscumbia, Alabama, United States

Sierra Vista, Arizona, United States

Jonesboro, Arkansas, United States

Searcy, Arkansas, United States

Carmichael, California, United States

Concord, California, United States

Fullerton, California, United States

La Jolla, California, United States

San Diego, California, United States

West Hills, California, United States

Washington, District of Columbia, United States

Largo, Florida, United States

Miami, Florida, United States

New Port Richey, Florida, United States

West Palm Beach, Florida, United States

Chicago, Illinois, United States

Indianapolis, Indiana, United States

Lexington, Kentucky, United States

Louisville, Kentucky, United States

New Orleans, Louisiana, United States

Boston, Massachusetts, United States

Troy, Michigan, United States

Edina, Minnesota, United States

Chesterfield, Missouri, United States

Kansas City, Missouri, United States

St. Louis, Missouri, United States

Bozeman, Montana, United States

Butte, Montana, United States

Englewood, New Jersey, United States

Charlotte, North Carolina, United States

Hickory, North Carolina, United States

Raleigh, North Carolina, United States

Statesville, North Carolina, United States

Winston-Salem, North Carolina, United States

Cincinnati, Ohio, United States

Marion, Ohio, United States

Portland, Oregon, United States

Beaver, Pennsylvania, United States

Charleston, South Carolina, United States

Bristol, Tennessee, United States

Morristown, Tennessee, United States

Dallas, Texas, United States

Houston, Texas, United States

Midland, Texas, United States

San Antonio, Texas, United States

Starting date: June 2004
Last updated: March 27, 2007