Pramlintide in Adolescents With Type 1 Diabetes

• Status: Completed
• Trial end date: 2009-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The investigators hypothesize that subcutaneous pramlintide as an adjunct to mealtime insulin immediately prior to meals can significantly reduce post-prandial glucose concentrations compared with mealtime insulin alone in children with type 1 diabetes.

This is a 36 day, randomized, two-arm, open-label study with a treatment arm (taking pramlintide before all meals) and a control arm (diabetes regimen as usual).

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Colorado, Denver
• Collaborator: Amylin Pharmaceuticals, LLC.
• Treatments: Islet Amyloid Polypeptide; Pramlintide

Criteria

Inclusion Criteria:

• Between 13 and 17 years of age, inclusive

• Diagnosed with type 1 diabetes for > 1 year

• Hemoglobin A1c between 7.5 and 10% inclusive

• Currently using carbohydrate to insulin ratio

• Acceptable form of birth control

Exclusion Criteria:

• Use of oral hyperglycemic agents or medications affecting blood sugar levels

• Recurrent severe hypoglycemia requiring assistance in past 6 months

• History of hypoglycemia unawareness

• History of gastroparesis requiring use of drugs that stimulate gastrointestinal motility

• Previous use of pramlintide