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

Daiichi Sankyo logo

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  • Antidiabetic treatments may include sulfonylurea agents (non-sulfonylurea agents must be withdrawn)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)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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