Evaluation of the Effect of Pramlintide on Satiety and Food Intake
Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2
About this trial
This is an interventional treatment trial for Diabetes Mellitus, Type 1
Eligibility Criteria
For Healthy Volunteers: •BMI >=20 to <=25kg/m2 or >=30 to <=40 kg/m2 For Subjects with Type 1 or Type 2 Diabetes: Treated with insulin for at least 6 months prior to screening HbA1c value between 6.5-10% inclusive BMI between 20-40kg/m2
Sites / Locations
- Royal Adelaide Hospital
Arms of the Study
Arm 1
Arm 2
Placebo Comparator
Active Comparator
Placebo
Pramlintide
A clear, colorless, sterile solution for SC injection manufactured by Amylin Pharmaceuticals, Inc. Placebo solution is the same, sterile preserved formulation, except the active ingredient, pramlintide, is omitted.
Pramlintide acetate (AC137) injection is a clear, colorless, sterile solution for SC injection manufactured by Amylin Pharmaceuticals, Inc. It consists of pramlintide (AC137) 0.6 mg/mL in sodium acetate buffer, pH 4.0, containing 43 mg/mL mannitol as an iso-osmolality modifier and 2.25 mg/mL metacresol as a preservative.