WelChol® and Sulfonylurea in Treating Patients With Type 2 Diabetes

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Daiichi Sankyo Inc.
ClinicalTrials.gov Identifier:
NCT00147758
First received: September 2, 2005
Last updated: January 16, 2012
Last verified: January 2012
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00147758

  Show 47 Study Locations
Sponsors and Collaborators
Daiichi Sankyo Inc.
  More Information

No publications provided by Daiichi Sankyo Inc.

Additional 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
Study First Received: September 2, 2005
Last Updated: January 16, 2012
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.:
Diabetes Mellitus

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

ClinicalTrials.gov processed this record on October 29, 2014