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

What Was Tested

This registered phase 2 trial tested Octreotide.

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 registry classes the interventions as drug.

Who Took Part

Enrollment: 160 planned participants were the target.

It was open to people of any sex aged from 18 years up to 70 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: 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).

The full record lists 3 inclusion and 3 exclusion criteria; among the exclusions: have diabetes; have been able to lose weight with diet and exercise alone; have previously received sandostatin lar® depot.

How the Study Was Run

It was run as a randomized, parallel-group and double-blind study.

Because people in this Octreotide study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

Groups ran in parallel: each of the participants stayed in one arm throughout.

As a double-blind Octreotide study, the assignments were hidden from both participants and investigators until the end.

It started in 2002-01 with completion listed for 2002-12.

It ran at 3 sites in United States (3).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: The percent change at baseline compared to 6 months in body weight.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Octreotide in 160 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Octreotide compound page, all human trials.