The Effect of Pramlintide on Meal Time Insulin Bolus
- Conditions
- Type 1 Diabetes
- Registration Number
- NCT00460304
- Lead Sponsor
- Diabetes Care Center
- Brief 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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 12
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method The mean ICR from Vist 3a-e and 4a-e will be compared. Percentage reduction of ICR will be calculated. From these the mean ICR will be calculated. 12-10-07
- Secondary Outcome Measures
Name Time Method The mean post-meal glucose from the four hour period after beginning a meal will be averaged for each bolus wave form. Then the three wave form mean glucose results will be compared. 12-10-07