A Study to Evaluate Symlin in Adolescent Subjects With Type 1 Diabetes Mellitus

Phase 2

Completed

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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
1	pramlintide acetate	single doses of pramlintide acetate or placebo, given in three different sequences to three cohorts of subjects

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
To evaluate the effects of Symlin compared to placebo in adolescent subjects with type 1 diabetes on various pharmacodynamic endpoints	single doses

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