Pasireotide in the Treatment of Hypoglycemia Following Gastric Bypass Surgery

• Status: Unknown status
• Trial end date: 2018-11-01
• Target enrollment: 0
• Participant gender: Female

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Zealand University Hospital
• Treatments: Pasireotide; Somatostatin

Criteria

Inclusion Criteria:

• RYGB operated patients with documented hypoglycemia (blood glucose <3.9 mmol/L) who have previously completed the study 'Treatment of hypoglycemia following gastric bypass surgery' (HypoGB2015)

• Hemoglobin > 7,3 mmol/L

• Negative human chorionic gonadotropin (hCG) urine test

• Females of reproductive age: use of safe contraception

Exclusion Criteria:

• Treatment for cardiovascular disease

• Treatment with antipsychotic medication

• Treatment for thyroid disease

• Prior medical treatment of postprandial hyperinsulinemic hypoglycemia

• Prior allergic reactions to the study medicine