Evaluation of the Effect of Pramlintide on Satiety and Food Intake

AstraZeneca

Status and phase: Completed; Phase 2

Conditions: Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2

Treatments: Drug: Placebo; Drug: Pramlintide acetate

Study type: Interventional

Funder types: Industry

Identifiers

NCT00042601

137-149

Details and patient eligibility

About

This is a single center, randomized, blinded, placebo-controlled, two-period, cross-over study to evaluate the effect of pramlintide on satiety and food intake in normal-weight and obese non-diabetic subjects and in insulin-treated subjects with type 1 and type 2 diabetes.

Enrollment: 51 patients

Sex: Male

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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51 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

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.

Treatment:

Drug: Placebo

Pramlintide

Active Comparator group

Description:

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.

Treatment:

Drug: Pramlintide acetate