Type 1 Diabetes Mellitus
Conditions
Keywords
Type 1 Diabetes, pediatric, pramlintide, Symlin, Amylin
Brief summary
This study will be the first evaluation of Symlin in adolescent subjects with type 1 diabetes mellitus and is designed to evaluate the blood levels (pharmacokinetics), biochemical and physiological effects (pharmacodynamics), and safety and tolerability of Symlin in these subjects.
Interventions
single subcutaneous doses of 15mcg and 30mcg
Sponsors
AstraZeneca
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
12 Years to 17 Years
Healthy volunteers
No
Inclusion criteria
* Diagnosed with type 1 diabetes mellitus for at least 1 year prior to screening * Be on a stable regimen requiring multiple daily injections of basal and mealtime insulin or continuous subcutaneous insulin infusion for at least 2 weeks prior to screening * HbA1c between 6.0% and 10.0%, inclusive, at screening * Body weight \>=50 kg at screening
Exclusion criteria
* Currently being treated with the following medications: \*Any oral antihyperglycemic agent; \*Drugs that directly affect gastrointestinal motility * Has been previously treated with Symlin/pramlintide (or has participated in a Symlin/pramlintide clinical study) * Has received any investigational drug within 1 month of screening
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the pharmacokinetics of Symlin in adolescent subjects with type 1 diabetes | single doses |
| To assess the safety and tolerability of Symlin in adolescent subjects with type 1 diabetes | single doses |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate the effects of Symlin compared to placebo in adolescent subjects with type 1 diabetes on various pharmacodynamic endpoints | single doses |
Countries
United States
Outcome results
None listed