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

NCT00094146 | Completed Phase 2

• 2 other identifiers: CSMS995GUS20US20
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 3

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.

Conditions

Primary Insulin Hypersecretion; Obesity

Keywords

Primary Insulin Hypersecretion; PIH; Obesity

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (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

Interventions

Sandostatin LAR Depot DRUG

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Novartis: lead

Study Sites (3)

New Orleans Center for Clinical Research

New Orleans, Louisiana, United States

Location

University of Tennessee

Memphis, Tennessee, 38103, United States

Location

University of Wisconsin Beers-Murphy Clinical Nutrition Clinic

Madison, Wisconsin, 537052, United States

Location

Related Links

• Visit NovartisClinicalTrials.com: Pre-qualify for a trial, and view a list of trials and participating study centers.

MeSH Terms

Conditions

Obesity

Interventions

Octreotide

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Peptides, Cyclic; Macrocyclic Compounds; Polycyclic Compounds; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Jennifer Hedrick, MBA

  Novartis

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: October 14, 2004
• First Posted: October 15, 2004
• Study Start: January 1, 2002
• Study Completion: December 1, 2002
• Last Updated: September 22, 2009

Record last verified: 2004-10

Locations

US (3)