Evaluation of the Bioavailability of Pramlintide

AstraZeneca

Status and phase: Completed; Phase 2

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

Treatments: Drug: Pramlintide acetate

Study type: Interventional

Funder types: Industry

Identifiers

NCT00042471

137-153

Details and patient eligibility

About

This is a randomized, open-label, crossover study to examine the bioavailability of pramlintide in normal weight and overweight subjects with type 1 and type 2 diabetes mellitus using insulin.

Enrollment: 75 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• HbA1c value between 6-12%
• BMI <= 27 kg/m2 or BMI >=30 to <= 45 kg/m2
• Consistent insulin regimen for 2 months prior to screening

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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75 participants in 1 patient group

Pramlintide acetate (AC137) injection

Experimental group

Description:

Pramlintide acetate (AC137) injection is a clear, colorless, sterile solution for injection. It consists of pramlintide in sodium acetate buffer, pH 4.0, containing 43mg/mL mannitol as an iso-osmolality modifier and 2.25 mg/mL metacresol as a preservative. The strength of pramlintide is 1.0 mg/mL for SC injection and 0.6 mg/mL for IV bolus injection.

Treatment:

Drug: Pramlintide acetate