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Corticosteroid

Pasireotide 200 mcg for Post-Bariatric Hypoglycemia (PASIPHY Trial)

Q: How many individuals are currently enrolled in this research investigation?

This clinical trial aims to enroll 72 qualifying participants. Eligible individuals have the opportunity to engage in this study at various locations, such as AP-HP Georges Pompidou European Hospital situated at 20 Leblanc Street in Paris, <a href="https://www.withpower.com/clinical-trials/texas">Texas</a> and Clinical Research Solution: Endocrine and Psychiatry Center located on 9539 Huffmeister Road in Houston, <a href="https://www.withpower.com/clinical-trials/georgia">Georgia</a>.

Q: Are there any available positions for patients in this ongoing clinical trial?

Indeed, as outlined on clinicaltrials.gov, this investigation is presently in search of suitable participants. The trial was initially disclosed on January 4th, 2024 and underwent its most recent update on February 15th, 2024. There is a need to enroll a total of 72 individuals across 20 different sites for the study.

Q: In how many locations is this trial currently being conducted?

Enrollment is open for 20 participants at sites like AP-HP Hopital Europeen Georges Pompidou on Rue Leblanc in Paris, Clinical Research Solution: Endocrine and Psychiatry Center on Huffmeister Rd in Houston, and <a href="https://www.withpower.com/clinical-trials/georgia">Georgia</a> Clinical Research, LLC on Five Forks Trickum SW in Lawrenceville. Additionally, there are opportunities available at another 20 undisclosed locations.

Q: Has Pasireotide 200 mcg received approval from the FDA?

Based on Power's evaluation for this Phase 2 trial, Pasireotide at a dosage of 200 mcg has been rated as a safety level of 2.

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 weeks

Awards & highlights

PASIPHY Trial 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.Check my eligibility

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.See study design

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.

PASIPHY Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I've waited the required time after my last somatostatin treatment to start a new trial.

Select...

I have been diagnosed with low blood sugar after weight-loss surgery.

Select...

I can care for myself but may not be able to do active work.

PASIPHY Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Level 2 hypoglycaemic events (plasma glucose <54 mg/dL) during a 3-hour MMTT (mixed meal tolerance test)

Side effects data

From 2018 Phase 4 trial • 249 Patients • NCT02060383

37%

Hyperglycaemia

34%

Nausea

29%

Diarrhoea

26%

Weight decreased

13%

Cholelithiasis

13%

Vomiting

13%

Diabetes mellitus

13%

Dizziness

13%

Hypoglycaemia

11%

Headache

11%

Fatigue

11%

Abdominal distension

Urinary tract infection

Glycosylated haemoglobin increased

Lipase increased

Decreased appetite

Hypokalaemia

Muscular weakness

Haematuria

Rash

Constipation

Hypertriglyceridaemia

Nasopharyngitis

Alanine aminotransferase increased

Asthenia

Abdominal pain

Blood glucose increased

Hypotension

Respiratory tract infection viral

Abdominal discomfort

Alopecia

Sepsis

Adrenal insufficiency

Blood creatinine increased

Gamma-glutamyltransferase increased

Dysgeusia

Aspartate aminotransferase increased

Upper respiratory tract infection

Blood creatine phosphokinase increased

Type 2 diabetes mellitus

Pruritus generalised

Lactic acidosis

Blood urea increased

Acute kidney injury

Dehydration

Cholecystitis acute

Infectious pleural effusion

Tubular breast carcinoma

Seizure

Mental status changes

Myalgia

Abdominal pain upper

Pyrexia

Hypovolaemia

Shock

Blood insulin increased

100%

80%

60%

40%

20%

Study treatment Arm

Incretin Based Therapy (Randomized Group)

Baseline Insulin (BL) (Non-randomized Group)

Insulin (Randomized Group)

Oral Antidiabetic Drugs (OAD) (Non-randomized Group)

No OAD (Non-randomized Group)

PASIPHY 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

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

RECORDATI GROUPLead Sponsor

12 Previous Clinical Trials

4,438 Total Patients Enrolled

Arnd H MUELLER, MDStudy DirectorRecordati AG

Arnd H Mueller, MDStudy DirectorRecordati AG

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many individuals are currently enrolled in this research investigation?

"This clinical trial aims to enroll 72 qualifying participants. Eligible individuals have the opportunity to engage in this study at various locations, such as AP-HP Georges Pompidou European Hospital situated at 20 Leblanc Street in Paris, Texas and Clinical Research Solution: Endocrine and Psychiatry Center located on 9539 Huffmeister Road in Houston, Georgia."

Answered by AI

Are there any available positions for patients in this ongoing clinical trial?

"Indeed, as outlined on clinicaltrials.gov, this investigation is presently in search of suitable participants. The trial was initially disclosed on January 4th, 2024 and underwent its most recent update on February 15th, 2024. There is a need to enroll a total of 72 individuals across 20 different sites for the study."

Answered by AI

In how many locations is this trial currently being conducted?

"Enrollment is open for 20 participants at sites like AP-HP Hopital Europeen Georges Pompidou on Rue Leblanc in Paris, Clinical Research Solution: Endocrine and Psychiatry Center on Huffmeister Rd in Houston, and Georgia Clinical Research, LLC on Five Forks Trickum SW in Lawrenceville. Additionally, there are opportunities available at another 20 undisclosed locations."

Answered by AI