Status:
COMPLETED
The Effect of Pramlintide on Meal Time Insulin Bolus
Lead Sponsor:
Diabetes Care Center
Collaborating Sponsors:
Amylin Pharmaceuticals, LLC.
Conditions:
Type 1 Diabetes
Eligibility:
All Genders
18+ years
Phase:
NA
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...
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2008
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT00460304
Start Date
September 1 2007
End Date
November 1 2008
Last Update
April 3 2009
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.