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

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ClinicalTrials.gov Identifier: NCT00151762
Recruitment Status : Completed
First Posted : September 9, 2005
Last Update Posted : January 9, 2008
Sponsor:
Information provided by:
Daiichi Sankyo, Inc.

Brief Summary:
This extension study is designed to evaluate the long-term safety and tolerability of colesevelam hydrochloride (WelChol®) in patients with type 2 diabetes.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Drug: Colesevelam hydrochloride Phase 3

Study Type : Interventional  (Clinical Trial)
Enrollment : 780 participants
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
Study Start Date : December 2004
Actual Primary Completion Date : July 2007
Actual Study Completion Date : July 2007

Resource links provided by the National Library of Medicine





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

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


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
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

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


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Sponsors and Collaborators
Daiichi Sankyo, Inc.

Responsible Party: Kenneth Truitt, Daiichi Sankyo
ClinicalTrials.gov Identifier: NCT00151762     History of Changes
Other Study ID Numbers: WEL-304
First Posted: September 9, 2005    Key Record Dates
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