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
1 other identifier
interventional
300
3 countries
48
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3 type-2-diabetes
Started Jun 2004
Typical duration for phase_3 type-2-diabetes
48 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2004
CompletedFirst Submitted
Initial submission to the registry
September 2, 2005
CompletedFirst Posted
Study publicly available on registry
September 7, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2006
CompletedJanuary 18, 2012
January 1, 2012
2.1 years
September 2, 2005
January 16, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To assess the additional lowering of HbA1C achieved by addition of colesevelam hydrochloride to current antidiabetic therapy
Secondary Outcomes (6)
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;
- +1 more secondary outcomes
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Daiichi Sankyolead
Study Sites (48)
CRO
Jonesboro, Arkansas, United States
Unknown Facility
Beverly Hills, California, United States
Unknown Facility
Carmichael, California, United States
Unknown Facility
Fresno, California, United States
Unknown Facility
Irvine, California, United States
Unknown Facility
La Jolla, California, United States
Unknown Facility
Los Gatos, California, United States
Unknown Facility
San Diego, California, United States
Unknown Facility
Spring Valley, California, United States
Unknown Facility
West Hills, California, United States
Unknown Facility
Washington D.C., District of Columbia, United States
Unknown Facility
Coco Beach, Florida, United States
Unknown Facility
Largo, Florida, United States
Unknown Facility
Miami, Florida, United States
Unknown Facility
Pembroke Pines, Florida, United States
Unknown Facility
West Palm Beach, Florida, United States
Unknown Facility
Atlanta, Georgia, United States
Unknown Facility
Evansville, Indiana, United States
Unknown Facility
Louisville, Kentucky, United States
Unknown Facility
Detroit, Michigan, United States
Unknown Facility
Troy, Michigan, United States
Unknown Facility
Edina, Minnesota, United States
Unknown Facility
Chesterfield, Missouri, United States
Unknown Facility
Bozeman, Montana, United States
Unknown Facility
Butte, Montana, United States
Unknown Facility
Las Vegas, Nevada, United States
Unknown Facility
Rochester, New York, United States
Unknown Facility
Charlotte, North Carolina, United States
Unknown Facility
Winston-Salem, North Carolina, United States
Unknown Facility
Cincinnati, Ohio, United States
Unknown Facility
Cleveland, Ohio, United States
Unknown Facility
Lyndhurst, Ohio, United States
Unknown Facility
Marion, Ohio, United States
Unknown Facility
Oklahoma City, Oklahoma, United States
Unknown Facility
Tulsa, Oklahoma, United States
Unknown Facility
Portland, Oregon, United States
Unknown Facility
Beaver, Pennsylvania, United States
Unknown Facility
Charleston, South Carolina, United States
Unknown Facility
Columbia, South Carolina, United States
Unknown Facility
Morristown, Tennessee, United States
Unknown Facility
Corpus Christi, Texas, United States
Unknown Facility
Dallas, Texas, United States
Unknown Facility
Pharr, Texas, United States
Unknown Facility
San Antonio, Texas, United States
Unknown Facility
Arlington, Virginia, United States
Unknown Facility
Richmond, Virginia, United States
Unknown Facility
Mexico City, Mexico
Unknown Facility
Lima, Peru
Related Publications (1)
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. doi: 10.1001/archinte.168.18.1975.
PMID: 18852398DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 2, 2005
First Posted
September 7, 2005
Study Start
June 1, 2004
Primary Completion
July 1, 2006
Study Completion
July 1, 2006
Last Updated
January 18, 2012
Record last verified: 2012-01