Pasireotide for Low Blood Sugar (PASIPHY Trial)
Palo Alto (17 mi)Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Recruiting
Sponsor: RECORDATI GROUP
Prior Safety Data
Approved in 2 jurisdictions
Trial Summary
What is the purpose of this trial?The Total duration of trial participation for each participant with post-bariatric hypoglycemia will be a maximum of 59 weeks, with the following duration of trial periods
* 19 weeks for the Core Phase. It is composed of:
* a Screening period: a maximum of 3 weeks
* a Run-in period (no treatment): 4 weeks
* a Blinded Treatment Phase: 12 weeks
* 36 weeks Extension Phase = an open-label Treatment period
* 4 weeks for the safety follow-up period (without any treatment).
Do I need to stop my current medications to join the trial?Yes, you may need to stop certain medications. If you've been treated with therapies for post-bariatric hypoglycemia like acarbose, gama guar, pectin, or diazoxide, you must stop them at least 2 weeks before the screening. GLP-1 antagonists, GLP-1 agonists, and SGLT2 inhibitors must be stopped 4 weeks before screening. If you've used somatostatin receptor analogues, specific washout periods apply, such as 72 hours for Octreotide s.c. and 84 days for Pasireotide LAR. Additionally, medications that interfere with glucose metabolism must be stopped within 5 half-lives of the drug.
Is the drug Pasireotide a promising treatment for low blood sugar?Pasireotide is a drug that can target multiple receptors in the body, which makes it effective in treating conditions like Cushing's disease and acromegaly. It has shown promise in controlling symptoms in patients with certain types of tumors that don't respond to other treatments. This suggests it has potential as a treatment, but its specific effectiveness for low blood sugar isn't directly addressed in the available studies.34569
What data supports the idea that Pasireotide for Low Blood Sugar is an effective treatment?The available research does not provide direct evidence that Pasireotide is effective for treating low blood sugar. Instead, the studies focus on its use for other conditions like Cushing's disease and acromegaly. In these cases, Pasireotide has been shown to be effective, but it can also cause high blood sugar as a side effect. Therefore, there is no data supporting its effectiveness for low blood sugar, and it might actually worsen blood sugar levels.45679
What safety data exists for Pasireotide in treating low blood sugar?The provided research does not contain specific safety data for Pasireotide or its variants (Signifor, Pasireotide diaspartate, Pasireotide pamoate, Pasireotide acetate, SOM 230, SOM-230, SOM230) in the context of treating low blood sugar. The studies focus on other antidiabetic drugs and DPP-4 inhibitors, which are not related to Pasireotide.1281011
Eligibility Criteria
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.Inclusion Criteria
I've waited the required time after my last somatostatin treatment to start a new trial.
I have been diagnosed with low blood sugar after weight-loss surgery.
I can care for myself but may not be able to do active work.
Exclusion Criteria
I have been treated with pasireotide before.
I have a blood clotting disorder or I am on constant blood thinners.
I have a lap band from bariatric surgery.
I have an underactive thyroid and am not on treatment.
I have not been seriously ill in the last two weeks.
I am not on medications that affect blood sugar levels.
I have or had an insulin-producing tumor in my pancreas.
I have gallstones or pancreatitis that causes symptoms.
My heart rate and ECG results meet the study's requirements.
I had major surgery within the last month.
I am not pregnant, planning to become pregnant, or breastfeeding during the study.
I am not willing to use effective birth control methods.
Treatment Details
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.
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
Pasireotide is already approved in United States, European Union for the following indications:
🇺🇸 Approved in United States as Signifor for:
- Cushing's disease
🇪🇺 Approved in European Union as Signifor for:
- Cushing's disease
Find a clinic near you
Research locations nearbySelect from list below to view details:
Stanford University School of Medicine, Endocrinology, 800 Welch Road,Palo Alto,, CA
Mayo Clinic - Rochester, 200 First Street, SW, 55905Rochester,, MN
Vanderbilt University Medical CenterNashville, TN
Joslin Diabetes CenterJoslin Diabetes Center, One Joslin PlaceBoston, MA
More Trial Locations
Loading ...
Who is running the clinical trial?
RECORDATI GROUPLead Sponsor
References
New therapeutic options: management strategies to optimize glycemic control. [2022]Management of type 2 diabetes mellitus (T2DM) can be challenging. Patients frequently present with poor glycemic control despite therapy. Other patients may be nonadherent or resistant to continuing their treatment when confronted with undesirable adverse effects, such as weight gain, that are associated with many conventional therapies. Incretin-based therapies developed to treat patients with T2DM, including oral dipeptidyl peptidase-4 inhibitor agents or glucagon-like peptide-1 agonists, offer the potential of sustained glycemic control for many patients without the adverse events associated with other classes of antihyperglycemic medications. Available safety data from clinical trials indicate that incretin-based therapies have weight-neutral or weight-reducing effects, with no apparent adverse impact on other important safety parameters, such as cardiovascular disease. The integration of these therapies into treatment algorithms, as highlighted in three case presentations, will increase treatment options for patients with T2DM.
Safety of dipeptidyl peptidase 4 inhibitors for treatment of type 2 diabetes. [2019]Dipeptidyl peptidase 4 (DPP-4) inhibitors are a new class of drugs introduced in 2006 for treatment of type 2 diabetes. In clinical trials lasting up to 2 years, these agents are well tolerated. Incidence of hypoglycemia associated with the use of DPP-4 inhibitors is similar to placebo, but is markedly increased when used in conjunction with sulfonylureas (SUs). DPP-4 inhibitors have neutral effect on body weight but their combination with a thiazolidinedione (TZD) results in slight weight gain averaging 0.5 to 1.3 kg compared with placebo. Other adverse effects recorded more commonly with DPP-4 inhibitors versus placebo are mild, and include nasopharyngitis, headache, and possibly urinary tract infections (UTIs). In the postmarketing period, new adverse effects are reported such as angioedema, increased rates of infection, and skin toxicity. Pancreatitis is inconsistently reported in relationship to sitagliptin, and one analysis links this agent to elevated risk of pancreatic cancer. Pancreatitis is also a rare adverse effect observed in linagliptin clinical studies. There is no evidence that DPP-4 inhibitors increase cardiovascular events or death. Overall, although short-term safety of DPP-4 inhibitors is reassuring, their safety needs to be established by long-term clinical trials and close surveillance during the postmarketing period.
Pasireotide (SOM230) shows efficacy and tolerability in the treatment of patients with advanced neuroendocrine tumors refractory or resistant to octreotide LAR: results from a phase II study. [2014]Pasireotide (SOM230) is a novel multireceptor-targeted somatostatin (sst) analog with high binding affinity for sst receptor subtype 1, 2, 3 (sst(1,2,3)) and sst(5). Because of this binding profile, pasireotide may offer symptom control in patients with neuroendocrine tumors (NETs) and carcinoid syndrome no longer responsive to octreotide LAR. This was a phase II, open-label, multicenter study of pasireotide in patients with advanced NET whose symptoms of carcinoid syndrome (diarrhea/flushing) were inadequately controlled by octreotide LAR. Patients received s.c. pasireotide 150 μg twice daily (bid), escalated to a maximum dose of 1200 μg bid until a clinical response was achieved. Forty-four patients were evaluated for efficacy and 45 for tolerability. Pasireotide 600-900 μg s.c. bid effectively controlled the symptoms of diarrhea and flushing in 27% of patients. Evaluation of tumor response in 23 patients showed 13 with stable disease and ten with progressive disease at study end. The most common drug-related adverse events were nausea (27%), abdominal pain (20%), weight loss (20%), and hyperglycemia (16%) and most were of mild or moderate severity. Pasireotide 600-900 μg s.c. bid was effective and generally well tolerated in controlling the symptoms of carcinoid syndrome in 27% of patients with advanced NET refractory or resistant to octreotide LAR therapy.
Assessment of the absorption, metabolism and excretion of [¹⁴C]pasireotide in healthy volunteers using accelerator mass spectrometry. [2014]Pasireotide (SOM230) is a multireceptor-targeted somatostatin analog designed to have a broader somatostatin receptor binding profile than other currently available somatostatin analogs. The purpose of this study was to evaluate the absorption, metabolism and excretion of pasireotide in healthy male subjects (N = 4) following a single, subcutaneous (sc), 600 μg dose of [¹⁴C]pasireotide.
Hyperglycemia associated with pasireotide: results from a mechanistic study in healthy volunteers. [2022]Pasireotide (SOM230) is a somatostatin analog with affinity for somatostatin receptor subtypes sst₁₋₃ and sst₅. Clinical trials have demonstrated the efficacy of pasireotide in treating Cushing's disease and acromegaly but have also shown adverse effects on glucose metabolism.
Safety, tolerability, pharmacokinetics, and pharmacodynamics of a long-acting release (LAR) formulation of pasireotide (SOM230) in patients with gastroenteropancreatic neuroendocrine tumors: results from a randomized, multicenter, open-label, phase I study. [2022]Pasireotide (SOM230), a novel multireceptor ligand somatostatin analog (SSA), binds with high affinity to four of the five somatostatin receptor subtypes (sst1-3, 5). This study evaluated the safety, tolerability, pharmacokinetics, and pharmacodynamics profiles of pasireotide long-acting release (LAR) formulation in patients with advanced gastroenteropancreatic neuroendocrine tumor (GEP NET) refractory to other SSAs.
Up-to 5-year efficacy of pasireotide in a patient with Cushing's disease and pre-existing diabetes: literature review and clinical practice considerations. [2022]Pasireotide is a multi-receptor-targeted somatostatin analogue approved in the EU and in the US for the treatment of adults with Cushing's disease (CD). Pasireotide has a safety profile similar to other somatostatin analogues with the exception of hyperglycemia. In this report and literature review, the current understanding of predicting a positive treatment response to pasireotide in CD and the management of diabetes mellitus (DM) during pasireotide treatment are discussed and analyzed.
Alogliptin benzoate for management of type 2 diabetes. [2022]Dipeptidyl peptidase-4 (DPP-4) inhibitors, a new class of oral hypoglycemic agents, augment glucose-dependent insulin secretion and suppress glucagon levels through enhancement of the action of endogenous incretin by inhibiting DPP-4, an incretin-degrading enzyme. DPP-4 inhibitors are generally well tolerated because of their low risk of hypoglycemia and other adverse events. Moreover, with their potential to improve beta cell function, a core defect of type 2 diabetes, DPP-4 inhibitors are becoming a major component of treatment of type 2 diabetes. Alogliptin benzoate is a newly developed, highly selective DPP-4 inhibitor which has been approved in many countries throughout the world. Once-daily administration of alogliptin as either monotherapy or combination therapy with other oral antidiabetic drugs or insulin has a potent glucose-lowering effect which is similar to that of other DPP-4 inhibitors, with a low risk of hypoglycemia and weight gain. The cardiovascular safety of this drug has been confirmed in a recent randomized controlled trial. This review summarizes the efficacy and safety of alogliptin, and discusses the role of DPP-4 inhibitors in the treatment of type 2 diabetes.
Pasireotide - Mechanism of Action and Clinical Applications. [2018]Pasireotide (SOM230) is a multi-receptor ligand somatostatin analogue (SSA) developed as the successor of the first-generation SSAs. Currently, pasireotide is recommended for the treatment of patients with Cushing's disease in whom surgery was unsuccessful, and patients with acromegaly who either remain uncontrolled after surgical therapy or in whom tumor resection is not possible.
Systematic Review of Efficacy and Safety of Newer Antidiabetic Drugs Approved from 2013 to 2017 in Controlling HbA1c in Diabetes Patients. [2020]Type 2 Diabetes Mellitus (T2DM) is the most common form of diabetes mellitus and accounts for about 95% of all diabetes cases. Many newer oral as well as parenteral antidiabetic drugs have been introduced in to the market in recent years to control hyperglycemic conditions in diabetes patients and many of these drugs produce potential side effects in diabetes patients. Hence, this systematic review was aimed to analyze and compare the efficacy and safety of oral antidiabetic agents in controlling HbA1c in T2DM patients, that were approved by the United States-Food and Drug Administration (US-FDA) from 2013 to 2017. All randomized controlled, double-blind trials published in English during the search period involving the newer antidiabetic agents were selected. In the outcome assessment comparison, semaglutide demonstrated the highest efficacy in lowering HbA1c, with a 1.6% reduction (p < 0.0001) when given at a dose of 1.0 mg. The safety profile of all the agents as compared to placebo or control were similar, with no or slight increase in the occurrence of adverse events (AEs) but no fatal reaction was reported. The most common AEs of all the antidiabetic agents were gastrointestinal in nature, with several cases of hypoglycemic events. However, among all these agents, semaglutide seems to be the most efficacious drug to improve glycemic control in terms of HbA1c. Alogliptin has the least overall frequency of AEs compared to other treatment groups.
Comparison of Adverse Events Occurred During Administration of Dipeptidyl Peptidase-4 Inhibitor in Patients with Diabetes Using FDA Adverse Event Reporting System. [2023]Various dipeptidyl peptidase-4 (DPP-4) inhibitors have been approved for the treatment of diabetes. The frequencies of known serious side effects might differ among DPP-4 inhibitors, therefore a large sample size is needed to study them in prospective clinical trials. We examined the adverse events that occurred during the administration of a DPP-4 inhibitor in patients with diabetes using FDA Adverse Event Reporting System (FAERS) data.