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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
21
3.75 grams of colesevelam HCl (6 tablets)
International Diabetes Center
Minneapolis, Minnesota, United States
Total Norm AUC Average by Group (Normalized)
Double Blinded CGM used for 2 week periods at the start of treatment 1, end of treatment 1, start of treatment 2, and end of treatment 2.
Time frame: 2 week periods at the start of treatment 1, end of treatment 1, start of treatment 2, and end of treatment 2.
Sleep Norm AUC Average by Group (Normalized)
Overnight glucose captured by CGM.
Time frame: 2 week periods at the start of treatment 1, end of treatment 1, start of treatment 2, and end of treatment 2.
Wake Norm AUC Average by Group (Normalized)
Wake glucose captured by continuous glucose monitoring (CGM).
Time frame: 2 week periods at the start of treatment 1, end of treatment 1, start of treatment 2, and end of treatment 2.
Hypoglycemia Percentage of Time <70 mg/dL Average by Group
Ambulatory glucose profile (AGP) reports were examined for the changes in the incidence of hypoglycemia (CGM\<70 mg/dL)
Time frame: 2 week periods at the start of treatment 1, end of treatment 1, start of treatment 2, and end of treatment 2.
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