Pramlintide in Adolescents With Type 1 Diabetes

Completed · Not applicable

Conditions studied: Type 1 Diabetes

In brief

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).

Key facts

Study ID

NCT00842075

Run by

University of Colorado, Denver

People needed

10

Starts

2006-12-01

Expected to finish

2009-12-01

Last updated by the study team

2015-06-23

Who can join

Age: 13 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Barbara Davis Center — Aurora, Colorado, United States

Full record on ClinicalTrials.gov

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