WelChol® With Metformin 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

NCT00147719
WEL-301

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 metformin 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
  • Hemoglobin (HbA1c) between 7.5% to 9.5%
  • Prescribed an ADA accepted diet
  • Receiving stable dose of metformin alone or in combination with other oral anti-diabetic medications for 90 days before Visit 1

Exclusion criteria

  • History of type 1 diabetes or ketoacidosis
  • History of chronic (more than 2 months) insulin therapy or the initiation of insulin for chronic treatment
  • History of pancreatitis
  • Uncontrolled hypertension
  • Recent severe cardiovascular disease
  • Allergy or toxic response to colesevelam or any of its components
  • 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

48

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Data sourced from clinicaltrials.gov

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