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WelChol® With Metformin in Treating Patients With Type 2 Diabetes

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.
ClinicalTrials.gov Identifier: NCT00147719
Recruitment Status : Completed
First Posted : September 7, 2005
Last Update Posted : January 18, 2012
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment Phase
Type 2 Diabetes Drug: Colesevelam hydrochloride Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
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 Metformin Monotherapy or Metformin Therapy in Combination With Other Oral Anti-Diabetic Agents
Study Start Date : June 2004
Primary Completion Date : July 2006
Study Completion Date : July 2006

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions


Outcome Measures

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

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

Eligibility Criteria

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
  • 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

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): NCT00147719


  Show 48 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: NCT00147719     History of Changes
Other Study ID Numbers: WEL-301
First Posted: September 7, 2005    Key Record Dates
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
Metformin
Colesevelam Hydrochloride
Hypoglycemic Agents
Physiological Effects of Drugs
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents