The Effect of Pramlintide on Meal Time Insulin Bolus

The Effect of Pramlintide on Meal Time Insulin Bolus

The primary objective is to establish the mean percentage of change in the insulin-to-carbohydrate ratio due to pramlintide treatment once a maximum tolerated dose or 6 mcg before each meal is reached. The secondary objective is to establish which insulin bolus wave form is associated with the lowest post-bolus without hypoglycemia in subjects treated with maximum pramlintide dosage.

Pramlintide. an amylinomimetic, is effective in reducing post-meal glucose by non-insulin means. As such, when patients requiring insulin treatment are treated with pramlintide, the bolus insulin does must be reduced. Current recommendations suggest a 50% reduction but in our experience and that of a recent study this appears excessive. By using continuous glucose monitoring(CGM) to guide pre-meal insulin treatment, we will determine the percentage reduction in meal time insulin bolus comparing pre-pramlintide to maximum pramlintide treatment. We anticipate that the reduction in bolus dosage will be about 25%. In addition, the secondary aim of this study is to determine which bolus pattern, standard, square or dual wave, provides the best post-meal glucose control with pramlintide therapy.

Inclusion Criteria:

• Age: >17
• Type I diabetes
• Onset of diabetes >3 months
• Use of insulin pump >3 months
• Hb A1C <8.9%
• Demonstrated compliance to clinic visits
• Demonstrated knowledge and use of bolus dosing calculations, carbohydrate counting, use of insulin pump and blood glucose meter
• Monitor blood glucose >4/day

Exclusion Criteria:

• Pregnancy or nursing
• Recent (within last 3 months) factor that may cause change in insulin sensitivity, e.g. severe emotional or physical stress, recent significant infection or surgery. etc.
• Renal failure (creatinine >1.5 mg/dl
• Symptomatic gastroparesis
• Using a medication that would interfere with insulin sensitivity
• Treatment with extenatide or DPP IV inhibitor within the last 4 weeks
• HbA1C change >0.9 % within the last 3 months
• Significant change in eating or activity pattern
• Weight change of >1.9 kg within the last 3 months
• ALT >3 times upper limits of normal