Status:
COMPLETED
Pramlintide in Adolescents With Type 1 Diabetes
Lead Sponsor:
University of Colorado, Denver
Collaborating Sponsors:
Amylin Pharmaceuticals, LLC.
Conditions:
Type 1 Diabetes
Eligibility:
All Genders
13-17 years
Phase:
NA
Brief 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 mea...
Detailed Description
Participants aged 13-17 years who have been diagnosed with type 1 diabetes for more than 1 year will be invited to participate.Other inclusion factors are: * HbA1c level between 7.5 and 10% inclusive...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2009
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT00842075
Start Date
December 1 2006
End Date
December 1 2009
Last Update
June 23 2015
Active Locations (1)
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1
Barbara Davis Center
Aurora, Colorado, United States, 80010