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

September 21, 2009 updated by: Novartis

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

160

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Louisiana
      • New Orleans, Louisiana, United States
        • New Orleans Center for Clinical Research
    • Tennessee
      • Memphis, Tennessee, United States, 38103
        • University of Tennessee
    • Wisconsin
      • Madison, Wisconsin, United States, 537052
        • University of Wisconsin Beers-Murphy Clinical Nutrition Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
The percent change at baseline compared to 6 months in body weight

Secondary Outcome Measures

Outcome Measure
Compare changes from baseline and at 6 months in body mass index (BMI), percentage of total body fat percentage of abdominal fat, leptin, and waist-to-hip ratio

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis

Investigators

  • Study Director: Jennifer Hedrick, MBA, Novartis

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2002

Study Completion

December 1, 2002

Study Registration Dates

First Submitted

October 14, 2004

First Submitted That Met QC Criteria

October 14, 2004

First Posted (ESTIMATE)

October 15, 2004

Study Record Updates

Last Update Posted (ESTIMATE)

September 22, 2009

Last Update Submitted That Met QC Criteria

September 21, 2009

Last Verified

October 1, 2004

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CSMS995GUS20
  • US20

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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