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

Phase 2

Completed

• Conditions: Primary Insulin Hypersecretion; Obesity

• Registration Number: NCT00094146
• Lead Sponsor: Novartis

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2002-01
• Study Completion: 2002-12
• Status Verified: 2004-10
• Study First Submitted: 2004-10-14
• Study First Submitted QC: 2004-10-14
• Study First Posted: 2004-10-15
• Last Update Submitted: 2009-09-21
• Last Update Posted: 2009-09-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 160

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
The percent change at baseline compared to 6 months in body weight

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (3)

University of Wisconsin Beers-Murphy Clinical Nutrition Clinic; 🇺🇸 Madison, Wisconsin, United States

New Orleans Center for Clinical Research; 🇺🇸 New Orleans, Louisiana, United States

University of Tennessee; 🇺🇸 Memphis, Tennessee, United States