Evaluation of an Orally Administered Medication When Taken in Conjunction With Pramlintide

AstraZeneca

Status and phase: Completed; Phase 2

Conditions: Diabetes Mellitus, Non-Insulin-Dependent

Treatments: Drug: Pramlintide acetate

Study type: Interventional

Funder types: Industry

Identifiers

NCT00044707

137-154

Details and patient eligibility

About

This is a randomized, single-blind, placebo-controlled, crossover study to examine the effect of pramlintide on the pharmacokinetics of an orally administered medication

Enrollment: 24 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• Type 2 diabetes mellitus treated with diet and/or oral agents
• HbA1c 6.5-11.0

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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24 participants in 2 patient groups, including a placebo group

Pramlintide acetate (AC137)

Active Comparator group

Description:

Pramlintide acetate (AC137) injection is a clear, colorless, sterile solution for SC injection. It consists of pramlintide 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. The strength of pramlintide injection is 0.6 mg/mL

Treatment:

Drug: Pramlintide acetate

Placebo

Placebo Comparator group

Description:

Placebo solution is the same, sterile preserved formulation, except the active ingredient, pramlintide, is omitted