WelChol® and Sulfonylurea 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 colesevelam hydrochloride is for type 2 diabetes when added to sulfonylurea 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 Diabetics With Inadequate Glycemic Control on Sulfonylurea Monotherapy or Sulfonylurea Therapy in 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 colesevelam hydrochloride to current antidiabetic therapy

Secondary outcome:

To assess the fasting plasma glucose and fructosamine lowering efficacy;

To assess glycemic control response rate;

To assess the improvement in insulin sensitivity;

To assess the effect on C reactive protein;

To assess lipids and lipoproteins;

To assess the safety and tolerability of colesevelam hydrochloride as add-on therapy

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

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

Mexico DF, Mexico

Lima, Peru

Birmingham, Alabama, United States

Tuscumbia, Alabama, United States

Little Rock, Arkansas, United States

Searcy, Arkansas, United States

Concord, California, United States

Irvine, California, United States

La Jolla, California, United States

Los Angeles, California, United States

Los Gatos, California, United States

West Hills, California, United States

Coral Gables, Florida, United States

Miami, Florida, United States

New Port Richey, Florida, United States

Pembroke Pines, Florida, United States

West Palm Beach, Florida, United States

Atlanta, Georgia, United States

Chicago, Illinois, United States

Indianapolis, Indiana, United States

New Orleans, Louisiana, United States

Boston, Massachusetts, United States

Kansas City, Missouri, United States

St. Louis, Missouri, United States

Rochester, New York, United States

Charlotte, North Carolina, United States

Hickory, North Carolina, United States

Statesville, North Carolina, United States

Winston-Salem, North Carolina, United States

Cincinnati, Ohio, United States

Cleveland, Ohio, United States

Marion, Ohio, United States

Perrysburg, Ohio, United States

Oklahoma City, Oklahoma, United States

Tulsa, Oklahoma, United States

Portland, Oregon, United States

Beaver, Pennsylvania, United States

Charleston, South Carolina, United States

Bristol, Tennessee, United States

Dallas, Texas, United States

Houston, Texas, United States

Midland, Texas, United States

San Antonio, Texas, United States

Arlington, Virginia, United States

Richmond, Virginia, United States

Lakewood, Washington, United States

Renton, Washington, United States

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