Status:
COMPLETED
Glycemic Effect of Colesevelam HCl (Welchol) in Patients With Type 2 Diabetes
Lead Sponsor:
HealthPartners Institute
Collaborating Sponsors:
International Diabetes Center at Park Nicollet
Daiichi Sankyo
Conditions:
Type 2 Diabetes
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
PHASE3
Brief Summary
The purpose of this study is to obtain continuous glucose monitoring (CGM) data from individuals taking Welchol compared to placebo. The CGM data will determine the effect on glucose control of adding...
Detailed Description
To understand the effect of the addition of colesevelam HCl to oral agent therapy in individuals with type 2 diabetes on glycemic control by utilizing a novel technology, continuous glucose monitoring...
Eligibility Criteria
Inclusion
- Male or female subjects ≥18 and ≤75 years of age
- Clinical diagnosis of type 2 diabetes
- Currently treated with metformin, a sulfonylurea, or combination metformin/sulfonylurea; stable dose for ≥3 months
- HbA1c of 7.0-9.0% inclusive
- If taking lipid lowering medications, stable dose for \>30 days
Exclusion
- Taken oral or injected prednisone or cortisone medications in the previous 30 days. (Topical or inhaled steroids will not be considered excluded medications.)
- Current use of insulin or TZD's, or incretins
- LDL \<70 mg/dL
- Serum triglycerides \>500 mg/dL
- History of hypertriglyceridemia-induced pancreatitis
- History of gastrointestinal disorder such as dysphagia, swallowing disorder, intestinal motility disorder or prior bowel obstruction
- History or presence of any severe medical or psychological condition or chronic conditions/infections that in the opinion of the Investigator would compromise the subject's safety or successful participation in the study
- Unable to follow the study protocol
- Unable to speak, read and write in English
- Pregnant, planning to become pregnant, breast feeding
Key Trial Info
Start Date :
September 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2011
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT00993824
Start Date
September 1 2009
End Date
September 1 2011
Last Update
November 30 2015
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
International Diabetes Center
Minneapolis, Minnesota, United States, 55416