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

AstraZeneca

Status and phase: Completed; Phase 2

Conditions: Type 1 Diabetes Mellitus

Treatments: Drug: pramlintide acetate

Study type: Interventional

Funder types: Industry

Identifiers

NCT00313183

137-162

Details and patient eligibility

About

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.

Enrollment: 12 patients

Sex: All

Ages: 12 to 17 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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12 participants in 1 patient group

1

Experimental group

Description:

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

Treatment:

Drug: pramlintide acetate