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WelChol® and Sulfonylurea in Treating Patients With Type 2 Diabetes

Daiichi Sankyo logo

Daiichi Sankyo

Status and phase

Completed
Phase 3

Conditions

Type 2 Diabetes

Treatments

Drug: Colesevelam hydrochloride

Study type

Interventional

Funder types

Industry

Identifiers

NCT00147758
WEL-303

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 sulfonylurea 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
  • Stable dose of sulfonylurea alone or in combination with other anti-diabetic medications for 90 days
  • Hemoglobin A1c value 7.5% to 9.5%, inclusive
  • C peptide > 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 < 60 mg/dL
  • Serum TG > 500 mg/dL
  • Body mass index (BMI) > 45 kg/m2

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

Trial contacts and locations

47

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Data sourced from clinicaltrials.gov

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