WelChol® and Insulin in Treating Patients With Type 2 Diabetes
Phase 3
Completed
- Conditions
- Type 2 Diabetes
- Registration Number
- NCT00151749
- Lead Sponsor
- Daiichi Sankyo
- Brief Summary
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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 260
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-
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method - To assess the additional lowering of HbA1c achieved by addition of WelChol® to current antidiabetic therapy
- Secondary Outcome Measures
Name Time Method To assess: the effects on fasting plasma glucose and fructosamine; glycemic control response rate; effect on adiponectin; the effect on c-peptide; effect on c-reactive protein; effects on lipids and lipoproteins; the safety and tolerability of WelChol® as add- on therapy to patients receiving insulin alone or with other oral drugs