The Effect of Pramlintide on Meal Time Insulin Bolus

• Status: Completed
• Trial end date: 2008-11-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Diabetes Care Center
• Collaborator: Amylin Pharmaceuticals, LLC.
• Treatments: Insulin; Insulin, Globin Zinc; Islet Amyloid Polypeptide; Pramlintide

Criteria

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