Status:
COMPLETED
WelChol® With Metformin in Treating Patients With Type 2 Diabetes
Lead Sponsor:
Daiichi Sankyo
Conditions:
Type 2 Diabetes
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
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-diab...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2004
Trial Type :
INTERVENTIONAL
End Date :
July 1 2006
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT00147719
Start Date
June 1 2004
End Date
July 1 2006
Last Update
January 18 2012
Active Locations (48)
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1
CRO
Jonesboro, Arkansas, United States
2
Beverly Hills, California, United States
3
Carmichael, California, United States
4
Fresno, California, United States