WelChol® With Metformin in Treating Patients With Type 2 Diabetes

This study has been completed.
Information provided by (Responsible Party):
Daiichi Sankyo Inc.
ClinicalTrials.gov Identifier:
First received: September 2, 2005
Last updated: January 16, 2012
Last verified: January 2012
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.

Condition Intervention Phase
Type 2 Diabetes
Drug: Colesevelam hydrochloride
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study of the Efficacy and Safety of WelChol® in Type 2 Diabetics With Inadequate Glycemic Control on Metformin Monotherapy or Metformin Therapy in Combination With Other Oral Anti-Diabetic Agents

Resource links provided by NLM:

Further study details as provided by Daiichi Sankyo Inc.:

Primary Outcome Measures:
  • To assess the additional lowering of HbA1C achieved by addition of colesevelam hydrochloride to current antidiabetic therapy

Secondary Outcome Measures:
  • To assess the fasting plasma glucose and fructosamine lowering effect;
  • To assess the glycemic control response rate;
  • To assess the improvement in insulin sensitivity;
  • To assess the effect on high sensitivity C-reactive protein;
  • To assess the improvement in lipids, and lipoproteins;
  • To assess the safety and tolerability of colesevelam hydrochloride when added on to current therapy

Estimated Enrollment: 300
Study Start Date: June 2004
Study Completion Date: July 2006
Primary Completion Date: July 2006 (Final data collection date for primary outcome measure)

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00147719

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Sponsors and Collaborators
Daiichi Sankyo Inc.
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Daiichi Sankyo Inc.
ClinicalTrials.gov Identifier: NCT00147719     History of Changes
Other Study ID Numbers: WEL-301 
Study First Received: September 2, 2005
Last Updated: January 16, 2012
Health Authority: United States: Food and Drug Administration
Peru: General Directorate of Pharmaceuticals, Devices, and Drugs
Mexico: National Institute of Public Health, Health Secretariat

Keywords provided by Daiichi Sankyo Inc.:
Diabetes Mellitus

Additional relevant MeSH terms:
Diabetes Mellitus, Type 2
Diabetes Mellitus
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Colesevelam Hydrochloride
Anticholesteremic Agents
Hypolipidemic Agents
Lipid Regulating Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 22, 2016