WelChol® and Sulfonylurea 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 colesevelam hydrochloride is for type 2 diabetes when added to sulfonylurea alone or in combination with other anti-diabetic drugs.

Key facts

Study ID

NCT00147758

Run by

Daiichi Sankyo

People needed

400

Starts

2004-06-01

Expected to finish

2006-08-01

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…

• 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

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 < 60 mg/dL
• Serum TG > 500 mg/dL
• Body mass index (BMI) > 45 kg/m2

Where it is running

• Study site — Birmingham, Alabama, United States
• Study site — Tuscumbia, Alabama, United States
• Study site — Little Rock, Arkansas, United States
• Study site — Searcy, Arkansas, United States
• Study site — Concord, California, United States
• Study site — Irvine, California, United States
• Study site — La Jolla, California, United States
• Study site — Los Angeles, California, United States
• Study site — Los Gatos, California, United States
• Study site — West Hills, California, United States
• Study site — Coral Gables, Florida, United States
• Study site — Miami, Florida, United States
• Study site — New Port Richey, Florida, United States
• Study site — Pembroke Pines, Florida, United States
• Study site — West Palm Beach, Florida, United States
• Study site — Atlanta, Georgia, United States
• Study site — Chicago, Illinois, United States
• Study site — Indianapolis, Indiana, United States
• Study site — New Orleans, Louisiana, United States
• Study site — Boston, Massachusetts, United States
• Study site — Kansas City, Missouri, United States
• Study site — St Louis, Missouri, United States
• Study site — Rochester, New York, United States
• Study site — Charlotte, North Carolina, United States
• Study site — Hickory, North Carolina, United States

Full record on ClinicalTrials.gov

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