Evaluation of the Bioavailability of Pramlintide

NCT ID: NCT00042471

Last Updated: 2015-09-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

75 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-06-30

Study Completion Date

2002-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Diabetes Mellitus, Type 1 Diabetes Mellitus, Type 2

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Pramlintide acetate (AC137) injection

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.

Group Type EXPERIMENTAL

Pramlintide acetate

Intervention Type DRUG

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.

Interventions

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Pramlintide acetate

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.

Intervention Type DRUG

Other Intervention Names

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Symlin (pramlintide acetate)

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Orlando Clinical Research Center

Orlando, Florida, United States

Site Status

New Orleans Center for Clinical Research

New Orleans, Louisiana, United States

Site Status

DaVita Clinical Research

Minneapolis, Minnesota, United States

Site Status

CEDRA Clinical Research, LLC

Austin, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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137-153

Identifier Type: -

Identifier Source: org_study_id

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