WelChol® With Metformin 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

NCT00147719

WEL-301

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 metformin 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
• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind