The Effect of Pramlintide on Meal Time Insulin Bolus

This study has been completed.
Sponsor:
Collaborator:
Amylin Pharmaceuticals, LLC.
Information provided by:
Diabetes Care Center
ClinicalTrials.gov Identifier:
NCT00460304
First received: April 11, 2007
Last updated: April 2, 2009
Last verified: April 2009

April 11, 2007
April 2, 2009
September 2007
November 2008   (final data collection date for primary outcome measure)
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 ]
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.
Complete list of historical versions of study NCT00460304 on ClinicalTrials.gov Archive Site
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 ]
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.
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The Effect of Pramlintide on Meal Time Insulin Bolus
The Effect of Pramlintide on Meal Time Insulin Bolus

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.

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.

Interventional
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Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Type 1 Diabetes
  • Drug: pramlintide
  • Procedure: continuous glucose monitoring
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
12
November 2008
November 2008   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00460304
07-01
No
Not Provided
Diabetes Care Center
Amylin Pharmaceuticals, LLC.
Principal Investigator: Allen B King, MD Diabetes Care Center
Study Director: Gary S Wolfe, RN, CCM Diabetes Care Center
Diabetes Care Center
April 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP