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Corticosteroid

Pasireotide for Low Blood Sugar (PASIPHY Trial)

Phase 2
Recruiting
Research Sponsored by RECORDATI GROUP
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients who have been treated with somatostatin receptor analogues must have an appropriate interval between the last administration of treatment and the start of the run-in period as specified
Patients with a documented diagnosis of Post-Bariatric Hypoglycaemia (PBH) as defined in the criteria provided
Must not have
Patients previously treated with pasireotide at any time
Patients with abnormal coagulation or on continuous anticoagulation therapy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 16,20,24,32,40 and 48 weeks

Summary

This trial will last for a maximum of 59 weeks for participants with post-bariatric hypoglycemia. It includes a Core Phase lasting 19 weeks with different stages such as screening,

Who is the study for?
This trial is for adults over 18 who've had bariatric surgery at least 6 months ago and suffer from low blood sugar after meals but not when fasting. They must be able to self-inject medication after training, have a history of specific symptoms related to low blood sugar, and provide written consent.
What is being tested?
The study tests Pasireotide Diaspartate in patients with post-bariatric hypoglycemia over a maximum of 59 weeks. It includes a no-treatment run-in period, a blinded treatment phase for 12 weeks, followed by an open-label extension phase for 36 weeks, and ends with a safety follow-up without treatment.
What are the potential side effects?
While the side effects are not detailed here, Pasireotide can typically cause gastrointestinal issues like nausea or diarrhea, increased blood sugar levels, headache, abdominal pain or discomfort among others.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I've waited the required time after my last somatostatin treatment to start a new trial.
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I have been diagnosed with low blood sugar after weight-loss surgery.
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I can care for myself but may not be able to do active work.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have been treated with pasireotide before.
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I have a blood clotting disorder or I am on constant blood thinners.
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I have a lap band from bariatric surgery.
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I have an underactive thyroid and am not on treatment.
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I have not been seriously ill in the last two weeks.
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I am not on medications that affect blood sugar levels.
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I have or had an insulin-producing tumor in my pancreas.
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I have gallstones or pancreatitis that causes symptoms.
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My heart rate and ECG results meet the study's requirements.
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I had major surgery within the last month.
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I am not pregnant, planning to become pregnant, or breastfeeding during the study.
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I am not willing to use effective birth control methods.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~16,20,24,32,40 and 48 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 16,20,24,32,40 and 48 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Evaluation of the efficacy of pasireotide s.c. on blood glucose concentration during an MMTT in patients with PBH after 12 weeks of treatment.
Secondary study objectives
Effect of pasireotide s.c. on HRQoL in SF-36 health survey
Effect of pasireotide s.c. on the changes of GLP-1 secretion
Effect of pasireotide s.c. on the changes of glucagon
+17 more
Other study objectives
Effect of pasireotide s.c. on HRQoL in Dumping Score Questionnaire
Effect of pasireotide s.c. on HRQoL in Hypoglycaemia Fear Survey-II
Effect of pasireotide s.c. on HRQoL in Patient Global Assessment

Trial Design

4Treatment groups
Experimental Treatment
Placebo Group
Group I: Pasireotide s.c. 50 mcgExperimental Treatment1 Intervention
Pasireotide 50 mcg s.c. tid
Group II: Pasireotide 200 mcgExperimental Treatment1 Intervention
Pasireotide 200 mcg s.c. tid
Group III: Pasireotide 100 mcgExperimental Treatment1 Intervention
Pasireotide 100 mcg s.c. tid
Group IV: PlaceboPlacebo Group1 Intervention
Placebo s.c. tid

Find a Location

Who is running the clinical trial?

RECORDATI GROUPLead Sponsor
12 Previous Clinical Trials
4,416 Total Patients Enrolled
Arnd H Mueller, MDStudy DirectorRecordati AG
Arnd H MUELLER, MDStudy DirectorRecordati AG
~21 spots leftby Apr 2025
Unbiased ResultsWe believe in providing patients with all the options.
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