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WelChol® and Sulfonylurea in Treating Patients With Type 2 Diabetes

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00147758
First Posted: September 7, 2005
Last Update Posted: January 18, 2012
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 (Responsible Party):
Daiichi Sankyo, Inc.
  Purpose
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 sulfonylurea 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
Intervention Model: Parallel Assignment
Masking: Double
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 Sulfonylurea Monotherapy or Sulfonylurea 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 efficacy;
  • To assess glycemic control response rate;
  • To assess the improvement in insulin sensitivity;
  • To assess the effect on C reactive protein;
  • To assess lipids and lipoproteins;
  • To assess the safety and tolerability of colesevelam hydrochloride as add-on therapy

Estimated Enrollment: 400
Study Start Date: June 2004
Study Completion Date: August 2006
Primary Completion Date: August 2006 (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 Criteria:

  • Age 18-75 years, inclusive
  • Diagnosed with type 2 diabetes
  • Stable dose of sulfonylurea alone or in combination with other anti-diabetic medications for 90 days
  • Hemoglobin A1c value 7.5% to 9.5%, inclusive
  • C peptide > 0.5 ng/mL
  • Prescribed ADA diet

Exclusion Criteria:

  • History of type 1 diabetes or ketoacidosis
  • History of pancreatitis
  • Uncontrolled hypertension
  • Allergy or toxic response to colesevelam or any of its components
  • Serum LDL-C < 60 mg/dL
  • Serum TG > 500 mg/dL
  • Body mass index (BMI) > 45 kg/m2
  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): NCT00147758


  Show 47 Study Locations
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: NCT00147758     History of Changes
Other Study ID Numbers: WEL-303
First Submitted: September 2, 2005
First Posted: September 7, 2005
Last Update Posted: January 18, 2012
Last Verified: January 2012

Keywords provided by Daiichi Sankyo, Inc.:
Diabetes Mellitus

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