Effects of Colesevelam on How the Body Responds to Insulin in Patients With Type 2 Diabetes

Daiichi Sankyo

Status and phase: Completed; Phase 2

Conditions: Type 2 Diabetes

Treatments: Drug: Colesevelam; Drug: Insulin glargine (Lantus); Drug: Colesevelam matching placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00147745

WEL-201

Details and patient eligibility

About

This study is designed to assess the potential mechanism of action by which WelChol® (colesevelam) may improve blood glucose control in patients with type 2 diabetes

Enrollment: 36 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients between the ages of 18 - 75, inclusive
• Diagnosed with type 2 diabetes
• Hemoglobin A1c value greater than or equal to 8.0%
• Antidiabetic treatments may include sulfonylurea agents (non-sulfonylurea agents must be withdrawn)
• Overweight, obese (body mass index 25-45 kg/m2)

Exclusion criteria

• Change of dose of lipid or blood pressure lowering therapy within past three months
• Previous treatment with colesevelam for hyperlipidemia
• Serum triglyceride greater than 500 mg/dL
• Serum low density lipoprotein-cholesterol less than 60 mg/dL

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

36 participants in 3 patient groups, including a placebo group

1

Experimental group

Description:

colesevelam 3.8g administered daily for 12 weeks

Treatment:

Drug: Colesevelam

2

Placebo Comparator group

Description:

Colesevelam matching placebo for 12 weeks

Treatment:

Drug: Colesevelam matching placebo

3

Active Comparator group

Description:

open-label Insulin Glargine for 12 weeks

Treatment:

Drug: Insulin glargine (Lantus)