Evaluation of the Effect of Pramlintide on Satiety and Food Intake

NCT ID: NCT00042601

Last Updated: 2015-10-21

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

51 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-07-31

Study Completion Date

2003-10-31

Brief Summary

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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.

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

TRIPLE

Participants Caregivers Investigators

Study Groups

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Placebo

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.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

placebo injection will be supplied in 5-mL multidose glass vials with a rubber stopper

Pramlintide

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.

Group Type ACTIVE_COMPARATOR

Pramlintide acetate

Intervention Type DRUG

Pramlintide injection will be supplied in 5-mL multidose glass vials with rubber stoppers.

Interventions

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Pramlintide acetate

Pramlintide injection will be supplied in 5-mL multidose glass vials with rubber stoppers.

Intervention Type DRUG

Placebo

placebo injection will be supplied in 5-mL multidose glass vials with a rubber stopper

Intervention Type DRUG

Eligibility Criteria

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Inclusion 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

MALE

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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Royal Adelaide Hospital

Adelaide, South Australia, Australia

Site Status

Countries

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Australia

Other Identifiers

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137-149

Identifier Type: -

Identifier Source: org_study_id

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