Somatostatin Analogue SOM230 (Pasireotide) in Healthy Male Volunteers

What Was Tested

In this phase 2 trial, researchers set out to test Pasireotide.

Glucose refers to the amount of sugar in your blood and insulin and glucagon levels are amounts of hormones that lower and raise blood sugar.

The purpose of the study is to evaluate the effects of pasireotide on insulin resistance and secretion.

It had three arms (groups): one (experimental), one (experimental) and one (experimental).

The registry classes the interventions as drug.

More on the Plan

This was a Phase 2, double-blinded, single-center study to assess the effects of pasireotide on insulin secretion and glucose metabolism in healthy male volunteers.

An oral glucose tolerance test (OGTT) was administered on Day 1.

If the OGTT results confirmed normal glycemia, the subject continued with baseline testing on Day 2 (2-step hyperglycemic clamp test with arginine stimulation) and Day 3 (2-step hyperinsulinemic euglycemic clamp (HEC) test with \[3-3H\]glucose).

Subcutaneous injections of pasireotide were given twice daily from Days 3-10 (for 8 consecutive days, starting from the evening of Day 3 and up to the morning injection on Day 10).

Who Took Part

Enrollment: 45 actual participants took part.

It was open to men only aged from 18 years up to 50 years.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: Lean, healthy, non-diabetic male.

The full record lists 1 inclusion and 1 exclusion criteria; among the exclusions: family history of diabetes, bmi over 25.

How the Study Was Run

The set-up was randomized, parallel-group and double-blind.

Random assignment meant chance, not the researchers, decided who got Pasireotide and who got the comparison, which limits bias.

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

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

Those kept unaware of assignments: participant and outcomes assessor.

It started in 2009-08 with completion listed for 2010-04.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Change in Insulin Basal Level (time frame: -30 min and -15 min on Day 2 and Day 9). Change in Area Under the Curve (AUC) of Plasma Insulin Level 0-10mins, 10-180mins, 0-180mins During Hyperglycemic Clamp (time frame: 0-10 mins, 10-180 mins, 0-180 mins (Day 2 and Day 9)). Change in Basal Endogenous Glucose Production (EGP) (time frame: Day 3 and Day 10).

It also tracked 4 secondary outcomes, for example Change in Fasting Plasma Glucose Level, Change in Area Under the Curve (AUC) of Plasma Glucose 0-30mins, 30-180mins, 0-180mins During Oral Glucose Tolerance Test (OGTT), Change Fasting Plasma Insulin Level and Change in Area Under the Curve (AUC) of Plasma Insulin 0-30mins, 30-180mins, 0-180mins During Oral Glucose Tolerance Test (OGTT).

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Pasireotide in 45 people.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

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