WelChol® With Metformin 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 metformin 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 Metformin Monotherapy or Metformin 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 effect;

To assess the glycemic control response rate;

To assess the improvement in insulin sensitivity;

To assess the effect on high sensitivity C-reactive protein;

To assess the improvement in lipids, and lipoproteins;

To assess the safety and tolerability of colesevelam hydrochloride when added on to current 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

- 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

Mexico DF, Mexico

Lima, Peru

CRO, Jonesboro, Arkansas, United States

Beverly Hills, California, United States

Carmichael, California, United States

Fresno, California, United States

Irvine, California, United States

La Jolla, California, United States

Los Gatos, California, United States

San Diego, California, United States

Spring Valley, California, United States

West Hills, California, United States

Washington, District of Columbia, United States

Coco Beach, Florida, United States

Largo, Florida, United States

Miami, Florida, United States

Pembroke Pines, Florida, United States

West Palm Beach, Florida, United States

Atlanta, Georgia, United States

Evansville, Indiana, United States

Louisville, Kentucky, United States

Detroit, Michigan, United States

Troy, Michigan, United States

Edina, Minnesota, United States

Chesterfield, Missouri, United States

Bozeman, Montana, United States

Butte, Montana, United States

Las Vegas, Nevada, United States

Rochester, New York, United States

Charlotte, North Carolina, United States

Winston-Salem, North Carolina, United States

Cincinnati, Ohio, United States

Cleveland, Ohio, United States

Lyndhurst, Ohio, United States

Marion, 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

Columbia, South Carolina, United States

Morristown, Tennessee, United States

Corpus Christi, Texas, United States

Dallas, Texas, United States

Pharr, Texas, United States

San Antonio, Texas, United States

Arlington, Virginia, United States

Richmond, Virginia, United States

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