A multi-Center, intra-Patient dose escalation Phase II study to evaluate the preliminary efficacy, safety and pharmacokinetics of pasireotide (SOM230) subcutaneous (s.c.) followed by pasireotide LAR in patients with Dumping syndrome

A multi-Center, intra-Patient dose escalation Phase II study to evaluate the preliminary efficacy, safety and pharmacokinetics of pasireotide (SOM230) subcutaneous (s.c.) followed by pasireotide LAR in patients with Dumping syndrome - Dumping syndrome

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

DRKS

Registry ID

DRKS00004215

Enrollment

Registered

2015-05-28

Start date

2013-08-15

Completion date

Unknown

Last updated

2025-04-07

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

Conditions

K91.1

Interventions

Group 1: study will be divided in 4 phases: 1. Screening, 2. s.c. dose escalation Phase (3 month): patients recieve pasireotide 50 µg s.c. as the first Treatment dose-Level, doese will be increased by

3. LAR Phase (3 months): patients recieve pasireotide LAR 10 or 20 mg depending on which dose they finished in phase 2

4.: LAR Extension phase (6 months), all patients which experienced benefits under phase 3 are allowed to enter the Extension phase, in this phase dose can be up-titrated to a Maximum of 60 mg.

Eligibility

Sex/Gender

All

Age

18 Years to 65 Years

Inclusion criteria

Inclusion criteria: Patients with documented dumping syndrome defined as postprandial tachycardia , bloating and diarrhea, as well as documented hypoglycemia (glucose <50 mg / dl sporadic, or < 60 mg / dl at 120 , 150 and 180 min during OGTT

Exclusion criteria

Exclusion criteria: Age <18 years No dumping syndrome

Design outcomes

Primary

Measure	Time frame
To evaluate the Treatment effect of pasireotide (SOM230) s.c. on Plasma Glucose Levels during a 3-hour OGTT (Oral Glucose Tolerance Test) at the end of s.c. doese escalation Phase defined as proportion of patients with no hypoglycemia at 120, 150 and 180 min during OGTT	—

Secondary

Measure	Time frame
Effect on pulse rate and hematocrit during OGTT defined in pulse rate and hematocrit level at the end of s-c- dose escalation Phase 30 min after OGTT compared to baseline Impact on dumping specific symptoms as measured by the dumping severity score compared to baseline Impact on quality of life measured by the HRQOL questionnaire at end of escalation Phase compared to baseline, Changes of insulin , glucagon, GLP-1 and GIP secretion during 3 h OGTT compared to baseline Evaluation of the safety and toxicity of pasireotide by incidence of adverse Events, laboratory and electrocardiographic abnormalities, changes from baseline. Adverse Event is defined as the appearance or worsening of undesirable signs, symptoms, or medical conditions that occur after study enrollment. Adverse Events will be assessed according to the CTCAE Version 3.0 Phase 3 is evaluated analoge to phase 2	—

Measure

Time frame

Effect on pulse rate and hematocrit during OGTT defined in pulse rate and hematocrit level at the end of s-c- dose escalation Phase 30 min after OGTT compared to baseline Impact on dumping specific symptoms as measured by the dumping severity score compared to baseline Impact on quality of life measured by the HRQOL questionnaire at end of escalation Phase compared to baseline, Changes of insulin , glucagon, GLP-1 and GIP secretion during 3 h OGTT compared to baseline Evaluation of the safety and toxicity of pasireotide by incidence of adverse Events, laboratory and electrocardiographic abnormalities, changes from baseline. Adverse Event is defined as the appearance or worsening of undesirable signs, symptoms, or medical conditions that occur after study enrollment. Adverse Events will be assessed according to the CTCAE Version 3.0 Phase 3 is evaluated analoge to phase 2

—

Countries

Belgium, Germany, Netherlands, United States

Contacts

Public ContactJens Aberle

III. Medizinische Klinik, Sektion Diabetologie und Endokrinologie, Universitätsklinikum Hamburg Eppendorf

aberle@uke.de040-7410-50085

Outcome results

None listed

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