Text Size

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
History of Changes
  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:

U.S. FDA Resources

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
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:
King A, Armstrong D. Basal Bolus Dosing: A Clinical Experience. Current Diabetes Rev 2005; 1:215-220
King A, Armstrong D. A prospective evaluation of insulin dosing recommendations in patients with type i diabetes at near normal glucose control: Basal Dosing. J Diabetes Sci Technol 2007; 1:36-41
King A, Armstrong D 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; 1:42-46

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
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Pramlintide
Insulin
 Islet Amyloid Polypeptide
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Appetite Depressants
Anti-Obesity Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 16, 2013