WelChol® and Insulin in Treating Patients With Type 2 Diabetes

Completed · Phase 3

Conditions studied: Type 2 Diabetes

In brief

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

Key facts

Study ID

NCT00151749

Run by

Daiichi Sankyo

People needed

260

Starts

2004-06-01

Expected to finish

2005-12-01

Last updated by the study team

2012-01-18

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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-

Where it is running

• Study site — Tuscumbia, Alabama, United States
• Study site — Sierra Vista, Arizona, United States
• Study site — Jonesboro, Arkansas, United States
• Study site — Searcy, Arkansas, United States
• Study site — Carmichael, California, United States
• Study site — Concord, California, United States
• Study site — Fullerton, California, United States
• Study site — La Jolla, California, United States
• Study site — San Diego, California, United States
• Study site — West Hills, California, United States
• Study site — Washington D.C., District of Columbia, United States
• Study site — Largo, Florida, United States
• Study site — Miami, Florida, United States
• Study site — New Port Richey, Florida, United States
• Study site — West Palm Beach, Florida, United States
• Study site — Chicago, Illinois, United States
• Study site — Indianapolis, Indiana, United States
• Study site — Lexington, Kentucky, United States
• Study site — Louisville, Kentucky, United States
• Study site — New Orleans, Louisiana, United States
• Study site — Boston, Massachusetts, United States
• Study site — Troy, Michigan, United States
• Study site — Edina, Minnesota, United States
• Study site — Chesterfield, Missouri, United States
• Study site — Kansas City, Missouri, United States

Full record on ClinicalTrials.gov

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