Primary Insulin HypersecretionPhase 2NCT00094146
Sandostatin LAR® Depot in Patients With Primary Insulin Hypersecretion (PIH) and at Least Moderate Obesity
A Phase 2 study testing Sandostatin LAR Depot in people with Primary Insulin Hypersecretion and Obesity, run by Novartis at 3 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Primary Insulin Hypersecretion, Obesity
- What is being tested?
- Sandostatin LAR Depot
- How many people
- 160 participants
- Where
- 3 sitesUnited States
- Study dates
- Jan 2002to Dec 2002
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
United States3 sites
University of Wisconsin Beers-Murphy Clinical Nutrition Clinic
Madison, Wisconsin, 537052
University of Tennessee
Memphis, Tennessee, 38103
New Orleans Center for Clinical Research
New Orleans, Louisiana
About this study
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
- Being tested
- Sandostatin LAR Depot
- Keywords
- Primary Insulin Hypersecretion, PIH, Obesity
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sandostatin LAR DepotDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2004 (estimated)
- Study startJan 2002
- Study completionDec 2002
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Insulin HypersecretionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 160 participants
Sponsor and investigators
- Lead sponsor
- Novartis
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Jennifer Hedrick, MBA, Study director, Novartis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00094146
- Sponsor's protocol ID
- CSMS995GUS20
- Other IDs
- US20
- Status last verified
- Oct 2004
- First submitted
- 14 Oct 2004
- Last updated
- 22 Sep 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sandostatin LAR® Depot in Patients With Primary Insulin Hypersecretion (PIH) and at Least Moderate Obesity
- ClinicalTrials.gov ID
- NCT00094146
- Acronym / sponsor ID
- CSMS995GUS20
- Conditions
- Primary Insulin Hypersecretion, Obesity
- Keywords
- Primary Insulin Hypersecretion, PIH, Obesity
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants
- Lead sponsor
- NovartisIndustry (pharma, biotech, devices)
- Study start
- Jan 2002
- Study completion
- Dec 2002
- First posted
- 15 Oct 2004 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (4 listed)
- have diabetes
- have been able to lose weight with diet and exercise alone
- have previously received Sandostatin LAR® Depot
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sandostatin LAR Depot | Drug | – |
Primary outcome
The percent change at baseline compared to 6 months in body weight
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2009.
- Visit NovartisClinicalTrials.com: Pre-qualify for a trial, and view a list of trials and participating study centers.Link provided by the sponsor.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jennifer Hedrick, MBA study director
Novartis
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Sandostatin LAR Depot in people with Primary Insulin Hypersecretion and Obesity, run by Novartis at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Sep 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The percent change at baseline compared to 6 months in body weight. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2009.