Post-meal Insulin Dosing With Adjuvant Pre-meal Pramlintide in Children With Type 1 Diabetes Mellitus

• Status: Completed
• Trial end date: 2009-02-01
• Target enrollment: 0
• Participant gender: All

Summary

The primary objective of this study is to examine the effect of pramlintide given pre-meal and insulin given just after a meal vs. standard therapy of pre-meal insulin on post-prandial glucose excursions.

The secondary objective is to examine the effect of pramlintide and insulin on glucagon suppression in type 1 diabetes.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Baylor College of Medicine; Montefiore Medical Center
• Collaborator: Amylin Pharmaceuticals, LLC.
• Treatments: Insulin; Insulin, Globin Zinc; Islet Amyloid Polypeptide; Pramlintide

Criteria

Inclusion Criteria:

• Type 1 diabetes only

• Diagnosed with T1DM for at least 1 year

• HbA1C less than or equal to 8.5%

• Currently treated using insulin glargine with or without Humalog/ Novolog or on the insulin pump

• Hemoglobin equal to or greater than 12mg/dL

• Otherwise healthy, EXCEPT for T1DM and treated hypothyroidism

• Negative pregnancy test, in the case of females

Exclusion Criteria:

• Lack of supportive family

• Evidence or history of chemical abuse

• BMI (body mass index) greater than the 90th percentile OR less than the 10th percentile for age

• Patient who is poorly compliant with current insulin management and/or Prescribed self blood glucose monitoring

• Patient who experiences recurrent severe hypoglycemia episodes (requiring assistance/ hospitalizations) in the past 6 months

• Have hypoglycemia unawareness

• Have a confirmed diagnosis of gastroparesis, and/ or require medications that stimulate gastrointestinal motility

• Pregnant or lactating patients, or patients planning on becoming pregnant