NCT03514576

Pasireotide in the Treatment of Hypoglycemia Following Gastric Bypass Surgery

Status unknown Phase 4 Last updated 5 July 2018

What this trial tests

Phase 4 trial testing Pasireotide 0.3 MG/ML in Hypoglycemia, Reactive in 5 participants. Status unknown.

Timeline

1 June 2018

Primary endpoint
1 August 2018

1 November 2018

Quick facts

Lead sponsor	Zealand University Hospital
Phase	Phase 4
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	non randomized
Design	crossover
Masking	none
Primary purpose	treatment
Enrollment	5
Start date	1 June 2018
Primary completion	1 August 2018
Estimated completion	1 November 2018
Sites	1 location across Denmark

Drugs / interventions tested

• Pasireotide 0.3 MG/ML — full drug profile →
• Meal tolerance test (MTT)

Conditions studied

• Hypoglycemia, Reactive — all drugs for Hypoglycemia, Reactive →

Sponsor

Zealand University Hospital

Who can join

Adults 18 to 65, female only, with Hypoglycemia, Reactive. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Postprandial hyperinsulinemic hypoglycemia is a well-known and potentially severe complication of Roux-en-Y gastric bypass (RYGB), and the treatment options are limited. Pasireotide has shown to be effective in preventing hypoglycemia in RYGB operated subjects, however treatment often leads to increased hyperglycemia.

The purpose of this study is to investigate two doses of pasireotide that are lower than doses previously used in RYGB operated subjects with postprandial hyperinsulinemic hypoglycemia.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.