WelChol® With Metformin 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 metformin alone or in combination with other anti-diabetic drugs.

Key facts

Study ID

NCT00147719

Run by

Daiichi Sankyo

People needed

300

Starts

2004-06-01

Expected to finish

2006-07-01

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
• 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

You may not qualify if…

• 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

Where it is running

• CRO — Jonesboro, Arkansas, United States
• Study site — Beverly Hills, California, United States
• Study site — Carmichael, California, United States
• Study site — Fresno, California, United States
• Study site — Irvine, California, United States
• Study site — La Jolla, California, United States
• Study site — Los Gatos, California, United States
• Study site — San Diego, California, United States
• Study site — Spring Valley, California, United States
• Study site — West Hills, California, United States
• Study site — Washington D.C., District of Columbia, United States
• Study site — Coco Beach, Florida, United States
• Study site — Largo, Florida, United States
• Study site — Miami, 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 — Evansville, Indiana, United States
• Study site — Louisville, Kentucky, United States
• Study site — Detroit, Michigan, United States
• Study site — Troy, Michigan, United States
• Study site — Edina, Minnesota, United States
• Study site — Chesterfield, Missouri, United States
• Study site — Bozeman, Montana, United States
• Study site — Butte, Montana, United States

Full record on ClinicalTrials.gov

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