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Trial · Interventional

Status unknownPhase 4Registry data

Pasireotide in the Treatment of Hypoglycemia Following Gastric Bypass Surgery

NCTNCT03514576 (opens ClinicalTrials.gov in a new tab)Other idPasHypo
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Overview

Status
Status unknown
Phase
Phase 4
Enrollment
5 participants (estimated)
Sponsor
Zealand University Hospital · Other
Design
Not randomized · Open label (no masking)
Countries
1 country

Denmark

Start
1 Jun 2018
Primary completion
1 Aug 2018 (estimated)
Completion
1 Nov 2018 (estimated)
First posted
2 May 2018
Last update posted
5 Jul 2018
Conditions
Hypoglycemia, Reactive

Timeline

1 trial

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20182019
  1. Ph 4

    Pasireotide in the Treatment of Hypoglycemia Following Gastric Bypass Surgery

    NCT03514576

    1 Jun 2018 to est. 1 Nov 2018

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • Pasireotide 0.3 MG/MLDrug
  • Meal tolerance test (MTT)Diagnostic test

Arms2

  • Experimental

    Pasireotide75

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

  • Experimental

    Pasireotide150

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

Primary outcomes1

Outcomes the sponsor listed as primary.

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

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

    Registry description

    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

Secondary outcomes(6)

  1. Heart rate

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

    Registry description

    Changes heart rate (beats/min) during the course of a meal tolerance test (MTT)

  2. Serum insulin levels

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

    Registry description

    Changes in insulin (pmol/L) in response to a meal tolerance test (MTT)

  3. Serum C-peptide levels

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

    Registry description

    Changes in C-peptide (nmol/L) in response to a meal tolerance test (MTT)

  4. Plasma glucagon levels

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

    Registry description

    Changes in glucagon (pmol/L) in response to a meal tolerance test (MTT)

  5. Plasma GLP-1 levels

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

    Registry description

    Changes in glucagon-like peptide 1 (pmol/L) in response to a meal tolerance test (MTT)

  6. Blood pressure

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

    Registry description

    Changes in blood pressure (mmHg) in response to a meal tolerance test (MTT)

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
Female
Age
from 18 Years up to 65 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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

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