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
  Purpose

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.


Condition Intervention
Type 1 Diabetes
Drug: pramlintide
Procedure: continuous glucose monitoring

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Effect of Pramlintide on Meal Time Insulin Bolus

Resource links provided by NLM:


Further study details as provided by Diabetes Care Center:

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. [ Time Frame: 12-10-07 ]

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. [ Time Frame: 12-10-07 ]

Estimated Enrollment: 12
Study Start Date: September 2007
Study Completion Date: November 2008
Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00460304

Sponsors and Collaborators
Diabetes Care Center
Amylin Pharmaceuticals, LLC.
Investigators
Principal Investigator: Allen B King, MD Diabetes Care Center
Study Director: Gary S Wolfe, RN, CCM Diabetes Care Center
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00460304     History of Changes
Other Study ID Numbers: 07-01
Study First Received: April 11, 2007
Last Updated: April 2, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by Diabetes Care Center:
Type I diabetes
Insulin pump
Continuous glucose monitoring
Insulin to carbohydrate ratio
Correction factor
Pramlintide

Additional relevant MeSH terms:
Diabetes Mellitus, Type 1
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Pramlintide
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 01, 2014