Glycemic Effect of Colesevelam HCl (Welchol) in Patients With Type 2 Diabetes

Use of Continuous Glucose Monitoring With Ambulatory Glucose Profile Analysis to Demonstrate the Glycemic Effect of Colesevelam HCl (Welchol) in Patients With Type 2 Diabetes

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.

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 with ambulatory glucose profile analysis. To date there are no studies of this compound that have employed continuous glucose monitoring (CGM) with ambulatory glucose profile (AGP) analysis to obtain data that will detail the diurnal glucose patterns associated with this therapy. We plan to employ CGM at critical points throughout the study. AGP analysis will enable rapid assessment of the clinical status of the subject. Using statistically stable estimates of hourly values represented by five percentile curves AGP depicts glucose exposure, variability and stability. Previously, we have used AGP analysis to characterize glucose perturbations in individuals ranging from normal glucose tolerance to overt type 2 diabetes.

Inclusion Criteria:

• 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 Criteria:

• 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