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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:
Information provided by:
Daiichi Sankyo Inc.
ClinicalTrials.gov Identifier:
NCT00151762
First received: September 7, 2005
Last updated: December 26, 2007
Last verified: December 2007
History of Changes
  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
Endpoint Classification: Safety Study
Masking: 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:

U.S. FDA Resources

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

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00151762

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

No publications provided

Responsible Party: Kenneth Truitt, Daiichi Sankyo
ClinicalTrials.gov Identifier: NCT00151762     History of Changes
Other Study ID Numbers: WEL-304
Study First Received: September 7, 2005
Last Updated: December 26, 2007
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.:
Open label, Diabetes Mellitus
Long term safety study, extension study

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

ClinicalTrials.gov processed this record on May 16, 2013