WelChol® and Sulfonylurea in Treating Patients With Type 2 Diabetes

Daiichi Sankyo

Status and phase: Completed; Phase 3

Conditions: Type 2 Diabetes

Treatments: Drug: Colesevelam hydrochloride

Study type: Interventional

Funder types: Industry

Identifiers

NCT00147758

WEL-303

Details and patient eligibility

About

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.

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind