Pasireotide in the Treatment of Hypoglycemia Following Gastric Bypass Surgery

NCT03514576 | Unknown Phase 4 DMC

• 1 other identifier: PasHypo
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hypoglycemia, Reactive

Keywords

gastric bypass; hypoglycemia; hyperinsulinemia

Outcome Measures

Primary Outcomes (1)

• Changes in glucose (mmol/L) in response to a meal tolerance test (MTT)

  Changes in incremental area under the curve (iAUC) for glucose, nadir glucose values, peak glucose values, time spent with glucose values in the hyperglycemic (\>7.8 mmol/L) and the hypoglycemic (\<3.9 mmol/L) range

  From 20 minutes prior to a liquid test meal to 180 minutes following the meal ingestion

Secondary Outcomes (6)

• Heart rate

  From 20 minutes prior to a liquid test meal to 180 minutes following the meal ingestion

• Serum insulin levels

  From 20 minutes prior to a liquid test meal to 180 minutes following the meal ingestion

• Serum C-peptide levels

  From 20 minutes prior to a liquid test meal to 180 minutes following the meal ingestion

• Plasma glucagon levels

  From 20 minutes prior to a liquid test meal to 180 minutes following the meal ingestion

• Plasma GLP-1 levels

  From 20 minutes prior to a liquid test meal to 180 minutes following the meal ingestion

Study Arms (2)

Pasireotide75

EXPERIMENTAL

75 micrograms Pasireotide 0.3 MG/ML s.c. before a meal tolerance test (MTT)

Drug: Pasireotide 0.3 MG/ML; Diagnostic Test: Meal tolerance test (MTT)

Pasireotide150

EXPERIMENTAL

150 micrograms Pasireotide 0.3 MG/ML s.c. before a meal tolerance test (MTT)

Drug: Pasireotide 0.3 MG/ML; Diagnostic Test: Meal tolerance test (MTT)

Interventions

Pasireotide 0.3 MG/ML DRUG

See arm description

Also known as: Signifor

Pasireotide150; Pasireotide75

Meal tolerance test (MTT) DIAGNOSTIC_TEST

Subjects will consume the liquid meal at baseline and blood will be drawn for continuous blood sampling.

Pasireotide150; Pasireotide75

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Zealand University Hospital: lead

Study Sites (1)

Zealand University Hospital

Køge, 4600, Denmark

Location

MeSH Terms

Conditions

Hypoglycemia; Hyperinsulinism

Interventions

pasireotide

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Caroline C Øhrstrøm, MD

  Department of Medicine, Zealand University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, ph.d. student

Study Record Dates

• First Submitted: April 19, 2018
• First Posted: May 2, 2018
• Study Start: June 1, 2018
• Primary Completion: August 1, 2018
• Study Completion: November 1, 2018
• Last Updated: July 5, 2018

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)