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The Effect of Pramlintide on Meal Time Insulin Bolus

Primary Purpose

Type 1 Diabetes

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
pramlintide
continuous glucose monitoring
Sponsored by
Diabetes Care Center
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 1 Diabetes focused on measuring Type I diabetes, Insulin pump, Continuous glucose monitoring, Insulin to carbohydrate ratio, Correction factor, Pramlintide

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    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.

    Full Information

    First Posted
    April 11, 2007
    Last Updated
    April 2, 2009
    Sponsor
    Diabetes Care Center
    Collaborators
    Amylin Pharmaceuticals, LLC.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00460304
    Brief Title
    The Effect of Pramlintide on Meal Time Insulin Bolus
    Official Title
    The Effect of Pramlintide on Meal Time Insulin Bolus
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2009
    Overall Recruitment Status
    Completed
    Study Start Date
    September 2007 (undefined)
    Primary Completion Date
    November 2008 (Actual)
    Study Completion Date
    November 2008 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Diabetes Care Center
    Collaborators
    Amylin Pharmaceuticals, LLC.

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Type 1 Diabetes
    Keywords
    Type I diabetes, Insulin pump, Continuous glucose monitoring, Insulin to carbohydrate ratio, Correction factor, Pramlintide

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    12 (Anticipated)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    pramlintide
    Intervention Type
    Procedure
    Intervention Name(s)
    continuous glucose monitoring
    Primary Outcome Measure Information:
    Title
    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.
    Time Frame
    12-10-07
    Secondary Outcome Measure Information:
    Title
    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.
    Time Frame
    12-10-07

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Allen B King, MD
    Organizational Affiliation
    Diabetes Care Center
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Gary S Wolfe, RN, CCM
    Organizational Affiliation
    Diabetes Care Center
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    17003291
    Citation
    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.
    Results Reference
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    Citation
    Symlin (package insert) San Diego, CA Amylin Pharmacetucials. 2005
    Results Reference
    background
    PubMed Identifier
    18220597
    Citation
    King AB, Armstrong DU. Basal bolus dosing: a clinical experience. Curr Diabetes Rev. 2005 May;1(2):215-20. doi: 10.2174/1573399054022794.
    Results Reference
    background
    PubMed Identifier
    19888377
    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. doi: 10.1177/193229680700100106.
    Results Reference
    background
    PubMed Identifier
    19888378
    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. doi: 10.1177/193229680700100107.
    Results Reference
    background
    PubMed Identifier
    7672483
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    9005972
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    10741687
    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. doi: 10.1055/s-2007-978590.
    Results Reference
    background
    PubMed Identifier
    11469628
    Citation
    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.
    Results Reference
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    The Effect of Pramlintide on Meal Time Insulin Bolus

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