Pasireotide in the treatment of low blood sugar following gastric bypass surgery

Pasireotide in the treatment of hypoglycemia following gastric bypass surgery

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2018-001067-23-DK

Enrollment

Registered

2018-04-05

Start date

2018-05-07

Completion date

Unknown

Last updated

2018-08-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postprandial reactive hypoglycemia in patients with prior Roux-en-Y gastric bypass surgery. MedDRA version: 20.1 Level: LLT Classification code 10059038 Term: Postprandial hypoglycemia System Organ Class: 100000004861

Interventions

Trade Name: Signifor Pharmaceutical Form: Injection INN or Proposed INN: PASIREOTIDE DIASPARTATE CAS Number: 396091-73-9 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Con

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Prior participation in our study 'Treatment of hypoglycemia following gastric bypass surgery (EudraCT 2015-001086-50). hemoglobin > 7,3 mmol/L, Age 20-60 years Normal ECG Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 5 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: pregnancy, breastfeeding, allergic reactions to the study medicine, treatment for cardiovascular disease, treatment for thyroid disease, treatment with antipsychotica or trycyclic antidepressants, impaired liver function (Child Pugh C)

Design outcomes

Primary

Measure	Time frame
Main Objective: To investigate the effects of both 75 ug pasireotide (P75) and 150 ug pasireotide (P150) on the postprandial blood glucose response in RYGB operated patients with hypoglycemia.;Secondary Objective: - To compare the effects of P75 and P150 on the postprandial blood glucose response with the effects of 300 ug pasireotide (P300) and a baseline recording with no treatment (NT) (results from a prior study with the same study participants). - to investigate the effects of P75 and P150 on the postprandial secretion of insulin, C-peptide, GLP-1, glucagon, IGF-1, norepinephrine and epinephrine, and to compare these effects with the effects of P300 and NT on the same parameters (results from a prior study with the same study participants). ;Primary end point(s): The postprandial blood glucose response for P75 and P150, defined as the incremental area under the curve for glucose (iAUCglucose);Timepoint(s) of evaluation of this end point: End of study	—

Measure

Time frame

Main Objective: To investigate the effects of both 75 ug pasireotide (P75) and 150 ug pasireotide (P150) on the postprandial blood glucose response in RYGB operated patients with hypoglycemia.;Secondary Objective: - To compare the effects of P75 and P150 on the postprandial blood glucose response with the effects of 300 ug pasireotide (P300) and a baseline recording with no treatment (NT) (results from a prior study with the same study participants). - to investigate the effects of P75 and P150 on the postprandial secretion of insulin, C-peptide, GLP-1, glucagon, IGF-1, norepinephrine and epinephrine, and to compare these effects with the effects of P300 and NT on the same parameters (results from a prior study with the same study participants). ;Primary end point(s): The postprandial blood glucose response for P75 and P150, defined as the incremental area under the curve for glucose (iAUCglucose);Timepoint(s) of evaluation of this end point: End of study

—

Secondary

Measure	Time frame
Secondary end point(s): - nadir glucose, peak glucose, time in hyperglycemia (time with glucose values =7,8 mmol/l) and time in hypoglycemia (time with glucose values =3,9 mmol/l) for both P75 and P150. - Area under the curve for insulin, C-peptide, GLP-1, glucagon, IGF-1, norepinephrine, epinephrine (AUCinsulin, AUCC-peptide, AUCGLP-1, AUCglucagon, AUCIGF-1, AUCnorepinephrine, AUCepinephrine) for both P75 og P150. - Changes in heart rate (HR) and blood pressure (BP) for both P75 and P150. - Comparison of iAUCglucose, nadir glucose, peak glucose, time in hyperglycemia, time in hypoglycemia, AUCinsulin, AUCC-peptide, AUCGLP-1, AUCglucagon, AUCIGF-1, AUCnorepinephrine, AUCepinephrine, HR and BP for P75 and P150 with the same parameters for P300 and NT (results from a prior study with the same study participants).;Timepoint(s) of evaluation of this end point: End of study	—

Measure

Time frame

Secondary end point(s): - nadir glucose, peak glucose, time in hyperglycemia (time with glucose values =7,8 mmol/l) and time in hypoglycemia (time with glucose values =3,9 mmol/l) for both P75 and P150. - Area under the curve for insulin, C-peptide, GLP-1, glucagon, IGF-1, norepinephrine, epinephrine (AUCinsulin, AUCC-peptide, AUCGLP-1, AUCglucagon, AUCIGF-1, AUCnorepinephrine, AUCepinephrine) for both P75 og P150. - Changes in heart rate (HR) and blood pressure (BP) for both P75 and P150. - Comparison of iAUCglucose, nadir glucose, peak glucose, time in hyperglycemia, time in hypoglycemia, AUCinsulin, AUCC-peptide, AUCGLP-1, AUCglucagon, AUCIGF-1, AUCnorepinephrine, AUCepinephrine, HR and BP for P75 and P150 with the same parameters for P300 and NT (results from a prior study with the same study participants).;Timepoint(s) of evaluation of this end point: End of study

—

Countries

Denmark

Contacts

Public ContactCaroline Øhrstrøm

Zealand University Hospital

cacg@regionsjaelland.dk

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026