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WelChol® and Insulin 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. Identifier: NCT00151749
Recruitment Status : Completed
First Posted : September 9, 2005
Last Update Posted : January 18, 2012
Information provided by (Responsible Party):
Daiichi Sankyo, Inc.

Brief Summary:
The purpose of the study is to see how safe and effective and tolerable the use of WelChol® is for type 2 diabetes when added to insulin alone or in combination with other anti-diabetic drugs

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

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Study Type : Interventional  (Clinical Trial)
Enrollment : 260 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 Diabetes With Inadequate Glycemic Control on Insulin Therapy Alone or Insulin Therapy Combination With Other Oral Anti-diabetic Agents
Study Start Date : June 2004
Actual Primary Completion Date : December 2005
Actual Study Completion Date : December 2005

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. - To assess the additional lowering of HbA1c achieved by
  2. addition of WelChol® to current antidiabetic therapy

Secondary Outcome Measures :
  1. To assess: the effects on fasting plasma glucose and
  2. fructosamine; glycemic control response rate; effect on adiponectin; the effect on c-peptide; effect on c-reactive protein; effects on lipids and lipoproteins; the safety and tolerability of WelChol® as add-
  3. on therapy to patients receiving insulin alone or with
  4. other oral drugs

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

Inclusion Criteria:

  • Ages 18 - 75 years, inclusive
  • Diagnosed with type 2 diabetes
  • Stable insulin therapy for 6 weeks
  • Stable dose of any other antidiabetic medications for 90 days
  • Hemoglobin A1c value between 7.5% to 9.5%
  • C peptide greater than 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 less than 60 mg/dL
  • Serum TG greater than 500 mg/dL
  • Body mass index (BMI) greater than 45 kg/m2-

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 identifier (NCT number): NCT00151749

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Sponsors and Collaborators
Daiichi Sankyo, Inc.

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Daiichi Sankyo, Inc. Identifier: NCT00151749     History of Changes
Other Study ID Numbers: WEL-302
First Posted: September 9, 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:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Colesevelam Hydrochloride
Hypoglycemic Agents
Physiological Effects of Drugs
Anticholesteremic Agents
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents