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WelChol® and Sulfonylurea in Treating Patients With Type 2 Diabetes

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ClinicalTrials.gov Identifier: NCT00147758
Recruitment Status : Completed
First Posted : September 7, 2005
Last Update Posted : January 18, 2012
Sponsor:
Information provided by (Responsible Party):
Daiichi Sankyo, Inc.

September 2, 2005
September 7, 2005
January 18, 2012
June 2004
August 2006   (Final data collection date for primary outcome measure)
To assess the additional lowering of HbA1c achieved by addition of colesevelam hydrochloride to current antidiabetic therapy
Same as current
Complete list of historical versions of study NCT00147758 on ClinicalTrials.gov Archive Site
  • 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
  • -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
Not Provided
Not Provided
 
WelChol® and Sulfonylurea in Treating Patients With Type 2 Diabetes
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
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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Type 2 Diabetes
Drug: Colesevelam hydrochloride
Not Provided
Fonseca VA, Rosenstock J, Wang AC, Truitt KE, Jones MR. Colesevelam HCl improves glycemic control and reduces LDL cholesterol in patients with inadequately controlled type 2 diabetes on sulfonylurea-based therapy. Diabetes Care. 2008 Aug;31(8):1479-84. doi: 10.2337/dc08-0283. Epub 2008 May 5.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
400
Same as current
August 2006
August 2006   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 75 Years   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
Mexico,   Peru,   United States
 
 
NCT00147758
WEL-303
Not Provided
Not Provided
Not Provided
Daiichi Sankyo, Inc.
Daiichi Sankyo, Inc.
Not Provided
Not Provided
Daiichi Sankyo, Inc.
January 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP