The Effect of Pramlintide on Meal Time Insulin Bolus

NCT00460304 | Completed

• 1 other identifier: 07-01
• Study Type: interventional
• Target: 12
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Type 1 Diabetes

Keywords

Type I diabetes; Insulin pump; Continuous glucose monitoring; Insulin to carbohydrate ratio; Correction factor; Pramlintide

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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

Interventions

pramlintide DRUG

continuous glucose monitoring PROCEDURE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Diabetes Care Center: lead
• Amylin Pharmaceuticals, LLC.: collaborator

Related 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. doi: 10.2337/dc06-0042.

  PMID: 17003291 BACKGROUND

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

  BACKGROUND

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

  PMID: 18220597 BACKGROUND

• 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.

  PMID: 19888377 BACKGROUND

• 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.

  PMID: 19888378 BACKGROUND

• 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.

  PMID: 7672483 BACKGROUND

• 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.

  PMID: 9005972 BACKGROUND

• 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.

  PMID: 10741687 BACKGROUND

• 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.

  PMID: 11469628 BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

pramlintide; Continuous Glucose Monitoring

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Blood Chemical Analysis; Clinical Chemistry Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Endocrine; Monitoring, Physiologic; Investigative Techniques

Study Officials

• Allen B King, MD

  Diabetes Care Center

  PRINCIPAL INVESTIGATOR

• Gary S Wolfe, RN, CCM

  Diabetes Care Center

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: April 11, 2007
• First Posted: April 13, 2007
• Study Start: September 1, 2007
• Primary Completion: November 1, 2008
• Study Completion: November 1, 2008
• Last Updated: April 3, 2009

Record last verified: 2009-04