The Effect of Pramlintide on Meal Time Insulin Bolus

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00460304
Recruitment Status : Completed
First Posted : April 13, 2007
Last Update Posted : April 3, 2009
Amylin Pharmaceuticals, LLC.
Information provided by:
Diabetes Care Center

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.

Condition or disease Intervention/treatment Phase
Type 1 Diabetes Drug: pramlintide Procedure: continuous glucose monitoring Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Effect of Pramlintide on Meal Time Insulin Bolus
Study Start Date : September 2007
Actual Primary Completion Date : November 2008
Actual Study Completion Date : November 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Primary Outcome Measures :
  1. 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 :
  1. 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 ]

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00460304

Sponsors and Collaborators
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

Publications: Identifier: NCT00460304     History of Changes
Other Study ID Numbers: 07-01
First Posted: April 13, 2007    Key Record Dates
Last Update Posted: April 3, 2009
Last Verified: April 2009

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

Additional relevant MeSH terms:
Diabetes Mellitus, Type 1
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Insulin, Globin Zinc
Islet Amyloid Polypeptide
Hypoglycemic Agents
Physiological Effects of Drugs
Appetite Depressants
Anti-Obesity Agents
Amylin Receptor Agonists
Molecular Mechanisms of Pharmacological Action