Glycemic Effect of Colesevelam HCl (Welchol) in Patients With Type 2 Diabetes
Completed · Phase 2/Phase 3 · Has a placebo group
Conditions studied: Type 2 Diabetes
In brief
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 Welchol to an anti-diabetic medication regimen.
Key facts
- Study ID
- NCT00993824
- Run by
- HealthPartners Institute
- People needed
- 21
- Starts
- 2009-09-01
- Expected to finish
- 2011-09-01
- Last updated by the study team
- 2015-11-30
Who can join
Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- International Diabetes Center — Minneapolis, Minnesota, United States
Full record on ClinicalTrials.gov
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