The Effect of Pramlintide on Meal Time Insulin Bolus

Type 1 Diabetes Clinical Trial

Official title:

The Effect of Pramlintide on Meal Time Insulin Bolus

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00460304
• Other study ID #: 07-01
• Status: Completed
• Phase: N/A
• First received: April 11, 2007
• Last updated: April 2, 2009
• Start date: September 2007
• Est. completion date: November 2008

Study information

• Verified date: April 2009
• Source: Diabetes Care Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: November 2008
• Est. primary completion date: November 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 1
• Type 1 Diabetes

Intervention

Drug:
• pramlintide

Procedure:
• continuous glucose monitoring

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Diabetes Care Center	Amylin Pharmaceuticals, LLC.

References & Publications (9)

Edelman S, Garg S, Frias J, Maggs D, Wang Y, Zhang B, Strobel S, Lutz K, Kolterman O. A double-blind, placebo-controlled trial assessing pramlintide treatment in the setting of intensive insulin therapy in type 1 diabetes. Diabetes Care. 2006 Oct;29(10):2189-95. — View Citation

Gedulin BR, Rink TJ, Young AA. Dose-response for glucagonostatic effect of amylin in rats. Metabolism. 1997 Jan;46(1):67-70. — View Citation

Gross TM, Mastrototaro JJ. Efficacy and reliability of the continuous glucose monitoring system. Diabetes Technol Ther. 2000;2 Suppl 1:S19-26. — View Citation

King AB, Armstrong DU. A prospective evaluation of insulin dosing recommendations in patients with type 1 diabetes at near normal glucose control: Basal dosing. J Diabetes Sci Technol. 2007 Jan;1(1):36-41. — View Citation

King AB, Armstrong DU. A prospective evaluation of insulin dosing recommendations in patients with type 1 diabetes at near normal glucose control: bolus dosing. J Diabetes Sci Technol. 2007 Jan;1(1):42-6. — View Citation

King AB, Armstrong DU. Basal bolus dosing: a clinical experience. Curr Diabetes Rev. 2005 May;1(2):215-20. Review. — View Citation

Rushing PA, Lutz TA, Seeley RJ, Woods SC. Amylin and insulin interact to reduce food intake in rats. Horm Metab Res. 2000 Feb;32(2):62-5. — View Citation

Symlin (package insert) San Diego, CA Amylin Pharmacetucials. 2005

Young AA, Gedulin B, Vine W, Percy A, Rink TJ. Gastric emptying is accelerated in diabetic BB rats and is slowed by subcutaneous injections of amylin. Diabetologia. 1995 Jun;38(6):642-8. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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