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

This study has been completed.
Sponsor:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00094146
First received: October 14, 2004
Last updated: September 21, 2009
Last verified: October 2004
  Purpose

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 Intervention Phase
Primary Insulin Hypersecretion
Obesity
Drug: Sandostatin LAR Depot
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Novartis:

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

Secondary Outcome Measures:
  • 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

Estimated Enrollment: 160
Study Start Date: January 2002
Estimated Study Completion Date: December 2002
  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00094146

Locations
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
Novartis
Investigators
Study Director: Jennifer Hedrick, MBA Novartis
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00094146     History of Changes
Other Study ID Numbers: CSMS995GUS20, US20
Study First Received: October 14, 2004
Last Updated: September 21, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by Novartis:
Primary Insulin Hypersecretion
PIH
Obesity

Additional relevant MeSH terms:
Obesity
Body Weight
Nutrition Disorders
Overnutrition
Overweight
Signs and Symptoms
Octreotide
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Gastrointestinal Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 29, 2014