Sandostatin LAR® Depot in Patients With Primary Insulin Hypersecretion (PIH) and at Least Moderate Obesity

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

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-01-31

Study Completion Date

2002-12-31

Brief Summary

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This study is in patients with at least moderate obesity (Body Mass Index \[BMI\] \> 30 kg/m2 or approximately 30 or more pounds overweight) and who also produce too much insulin (insulin stores sugar as fat). Sandostatin LAR® Depot suppresses insulin, and is being developed to help with weight loss in people who find it hard to lose weight on their own because they produce too much insulin.

The main purpose of the study is to find the lowest dose of Sandostatin LAR® Depot that safely helps overweight people lose weight. The study will also compare weight loss in obese patients who receive one of three different dosages of Sandostatin LAR Depot or placebo.

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Detailed Description

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Conditions

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Primary Insulin Hypersecretion Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Sandostatin LAR Depot

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

You may qualify for this study if you:

* are between the ages of 18-70 (male or female)
* are at least moderately obese (BMI \> 30 kg/m2 or approximately 30 or more pounds overweight)
* and pass an oral glucose tolerance test (a 3 hour test to determine if your body produces too much insulin)

Exclusion Criteria

You are not qualified for this study if you:

* have diabetes
* have been able to lose weight with diet and exercise alone
* have previously received Sandostatin LAR® Depot

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No