The Effect of Pramlintide on Meal Time Insulin Bolus

NCT ID: NCT00460304

Last Updated: 2009-04-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-09-30
• Study Completion Date: 2008-11-30

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.

Conditions

Type 1 Diabetes

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

pramlintide

Intervention Type: DRUG

continuous glucose monitoring

Intervention Type: PROCEDURE

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Amylin Pharmaceuticals, LLC.

INDUSTRY

Sponsor Role: collaborator

Diabetes Care Center

INDUSTRY

Sponsor Role: lead

Principal Investigators

Allen B King, MD

Role: PRINCIPAL_INVESTIGATOR

Diabetes Care Center

Gary S Wolfe, RN, CCM

Role: STUDY_DIRECTOR

Diabetes Care Center

References

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. doi: 10.2337/dc06-0042.

Reference Type: BACKGROUND

PMID: 17003291 (View on PubMed)

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

Reference Type: BACKGROUND

King AB, Armstrong DU. Basal bolus dosing: a clinical experience. Curr Diabetes Rev. 2005 May;1(2):215-20. doi: 10.2174/1573399054022794.

Reference Type: BACKGROUND

PMID: 18220597 (View on PubMed)

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. doi: 10.1177/193229680700100106.

Reference Type: BACKGROUND

PMID: 19888377 (View on PubMed)

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. doi: 10.1177/193229680700100107.

Reference Type: BACKGROUND

PMID: 19888378 (View on PubMed)

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. doi: 10.1007/BF00401833.

Reference Type: BACKGROUND

PMID: 7672483 (View on PubMed)

Gedulin BR, Rink TJ, Young AA. Dose-response for glucagonostatic effect of amylin in rats. Metabolism. 1997 Jan;46(1):67-70. doi: 10.1016/s0026-0495(97)90170-0.

Reference Type: BACKGROUND

PMID: 9005972 (View on PubMed)

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. doi: 10.1055/s-2007-978590.

Reference Type: BACKGROUND

PMID: 10741687 (View on PubMed)

Gross TM, Mastrototaro JJ. Efficacy and reliability of the continuous glucose monitoring system. Diabetes Technol Ther. 2000;2 Suppl 1:S19-26. doi: 10.1089/15209150050214087. No abstract available.

Reference Type: BACKGROUND

PMID: 11469628 (View on PubMed)

Other Identifiers

07-01

Identifier Type: -

Identifier Source: org_study_id