WelChol® and Insulin in Treating Patients With Type 2 Diabetes

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Daiichi Sankyo

Status and phase

Completed
Phase 3

Conditions

Type 2 Diabetes

Treatments

Drug: Colesevelam hydrochloride

Study type

Interventional

Funder types

Industry

Identifiers

NCT00151749
WEL-302

Details and patient eligibility

About

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

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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-

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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