WelChol® With Metformin in Treating Patients With Type 2 Diabetes

• Status: Completed
• Trial end date: 2006-07-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Daiichi Sankyo Inc.; Daiichi Sankyo, Inc.
• Treatments: Colesevelam Hydrochloride; Metformin

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