WelChol® and Insulin 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

NCT00151749

WEL-302

Details and patient eligibility

About

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

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

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 less than 60 mg/dL
• Serum TG greater than 500 mg/dL
• Body mass index (BMI) greater than 45 kg/m2-

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind