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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00094146
Recruitment Status : Completed
First Posted : October 15, 2004
Last Update Posted : September 22, 2009
Information provided by:

Brief Summary:

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.

Condition or disease Intervention/treatment Phase
Primary Insulin Hypersecretion Obesity Drug: Sandostatin LAR Depot Phase 2

Study Type : Interventional  (Clinical Trial)
Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Study Start Date : January 2002
Study Completion Date : December 2002

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. The percent change at baseline compared to 6 months in body weight

Secondary Outcome Measures :
  1. 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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00094146

United States, Louisiana
New Orleans Center for Clinical Research
New Orleans, Louisiana, United States
United States, Tennessee
University of Tennessee
Memphis, Tennessee, United States, 38103
United States, Wisconsin
University of Wisconsin Beers-Murphy Clinical Nutrition Clinic
Madison, Wisconsin, United States, 537052
Sponsors and Collaborators
Study Director: Jennifer Hedrick, MBA Novartis Identifier: NCT00094146     History of Changes
Other Study ID Numbers: CSMS995GUS20
First Posted: October 15, 2004    Key Record Dates
Last Update Posted: September 22, 2009
Last Verified: October 2004

Keywords provided by Novartis:
Primary Insulin Hypersecretion

Additional relevant MeSH terms:
Nutrition Disorders
Body Weight
Signs and Symptoms
Gastrointestinal Agents
Antineoplastic Agents, Hormonal
Antineoplastic Agents