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
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
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
NCT ID
NCT00460304
First Posted
April 11, 2007
Last Updated
April 2, 2009
Sponsor
Diabetes Care Center
Collaborators
Amylin Pharmaceuticals, LLC.
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
background
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
background
Learn more about this trial
The Effect of Pramlintide on Meal Time Insulin Bolus
We'll reach out to this number within 24 hrs