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Long-Term Study of Safety and Efficacy of WelChol® as an Additional Therapy in Patients With Type 2 Diabetes

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00151762
First Posted: September 9, 2005
Last Update Posted: January 9, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Daiichi Sankyo, Inc.
  Purpose
This extension study is designed to evaluate the long-term safety and tolerability of colesevelam hydrochloride (WelChol®) in patients with type 2 diabetes.

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

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multi-Center, 52-Week, Open-Label Extension Study (From Studies WEL-301, WEL-302, and WEL-303) to Evaluate the Long-Term Safety and Tolerability of WelChol® in Type 2 Diabetic Patients

Resource links provided by NLM:


Further study details as provided by Daiichi Sankyo, Inc.:

Primary Outcome Measures:
  • To evaluate safety and tolerability of colesevelam hydrochloride as add-on therapy

Secondary Outcome Measures:
  • To assess the long-term effect on hemoglobin A1c
  • To assess the long-term effect on fasting plasma glucose
  • To assess effects on lipids and lipoproteins

Estimated Enrollment: 780
Study Start Date: December 2004
Study Completion Date: July 2007
Primary Completion Date: July 2007 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion/Rollover Criteria:

  • Patients who have completed studies WEL-301, WEL-302, or WEL-303 with treatment compliance at least 80%
  • Patients who have completed studies WEL-301, WEL-302, or WEL-303 who have not met withdrawal criteria
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00151762


  Show 64 Study Locations
Sponsors and Collaborators
Daiichi Sankyo, Inc.
  More Information

Responsible Party: Kenneth Truitt, Daiichi Sankyo
ClinicalTrials.gov Identifier: NCT00151762     History of Changes
Other Study ID Numbers: WEL-304
First Submitted: September 7, 2005
First Posted: September 9, 2005
Last Update Posted: January 9, 2008
Last Verified: December 2007

Keywords provided by Daiichi Sankyo, Inc.:
Open label, Diabetes Mellitus
Long term safety study, extension study

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