WelChol® With Metformin in Treating Patients With Type 2 Diabetes

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Daiichi Sankyo Inc.
ClinicalTrials.gov Identifier:
NCT00147719
First received: September 2, 2005
Last updated: January 16, 2012
Last verified: January 2012

September 2, 2005
January 16, 2012
June 2004
July 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 NCT00147719 on ClinicalTrials.gov Archive Site
  • To assess the fasting plasma glucose and fructosamine lowering effect;
  • To assess the glycemic control response rate;
  • To assess the improvement in insulin sensitivity;
  • To assess the effect on high sensitivity C-reactive protein;
  • To assess the improvement in lipids, and lipoproteins;
  • To assess the safety and tolerability of colesevelam hydrochloride when added on to current therapy
  • -To assess the fasting plasma glucose and fructosamine lowering effect
  • -To assess the glycemic control response rate
  • -To assess the improvement in insulin sensitivity
  • -To assess the effect on high sensitivity C-reactive protein
  • -To assess the improvement in lipids, and lipoproteins
  • -To assess the safety and tolerability of colesevelam hydrochloride when added on to current therapy
Not Provided
Not Provided
 
WelChol® With Metformin 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 Metformin Monotherapy or Metformin 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 metformin alone or in combination with other anti-diabetic drugs.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Type 2 Diabetes
Drug: Colesevelam hydrochloride
Not Provided
Bays HE, Goldberg RB, Truitt KE, Jones MR. Colesevelam hydrochloride therapy in patients with type 2 diabetes mellitus treated with metformin: glucose and lipid effects. Arch Intern Med. 2008 Oct 13;168(18):1975-83.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
300
July 2006
July 2006   (final data collection date for primary outcome measure)

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
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Mexico,   Peru
 
NCT00147719
WEL-301
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