Treatment Plan for an Individual Patient With Pasireotide for Hyperinsulinemic Hypoglycemia
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|ClinicalTrials.gov Identifier: NCT03103009|
Recruitment Status : Recruiting
First Posted : April 6, 2017
Last Update Posted : April 11, 2017
|Condition or disease||Intervention/treatment||Phase|
|Hyperinsulinemic Hypoglycemia Post Gastrointestinal Tract Surgery Hypoglycaemia||Drug: Pasireotide||Phase 1|
Hyperinsulinemic hypoglycemia as a complication of gastric bypass surgery has been reported to occur between 6 months to 8-10 years after gastric bypass surgery. Although reported as a rare complication from surgery, the incidence is likely higher due to the condition being missed in many patients or being misdiagnosed as dumping syndrome. Unlike dumping syndrome which often presents early in the post-operative course and improves with dietary modification, patients with hyperinsulinemic hypoglycemia have severe postprandial hypoglycemia and sometimes fasting hypoglycemia with symptoms worsening over time despite dietary modification. Calcium stimulation testing often localizes the area of the pancreas where hyperinsulinemia is occurring due to islet cell dysfunction. The pathophysiology of islet cell hypertrophy with Nesidioblastosis is poorly understood. One theory is an increase in glucagon-like peptide-1 (GLP-1) concentration may be responsible for islet cell expansion and subsequent hyperinsulinemic hypoglycemia.
Unfortunately, hyperinsulinemia hypoglycemia is incapacitating where patients are restricted from driving, are unable to work, and must always have someone present with glucagon due to the acute severe onset of neuroglycopenia. Surgery to resect the area of the pancreas with Nesidioblastosis has a low success rate of about 60% with many patients developing type 1 diabetes as a result of pancreatic resection. Medical treatment options include calcium channel blockers, Diazoxide, and Octreotide yet patients often fail these treatments as well. Pasireotide would likely be a better option than the current medical therapy available. With Pasireotide, the inhibition of insulin release through inhibiting the somatostatin receptors as well as possible GLP-1 inhibition causing hyperglycemia should reduce hypoglycemic episodes in these patients.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||1 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Treatment Plan for an individual patient with pasireotide for Hyperinsulinemic Hypoglycemia (Compassionate Use Protocol for Pasireotide)|
|Masking:||None (Open Label)|
|Official Title:||Treatment Plan for an Individual Patient With Pasireotide for Hyperinsulinemic Hypoglycemia|
|Actual Study Start Date :||March 22, 2017|
|Estimated Primary Completion Date :||March 22, 2019|
|Estimated Study Completion Date :||March 22, 2019|
U.S. FDA Resources
Interventions - One patient will be given a drug, pasireotide (Signifor), on a compassionate use basis for treatment of post-gastric bypass hypoglycemia. The minimal dose will be 0.3 mg subcutaneous daily and the maximal dose will be 0.6 mg subcutaneous twice daily. The patient may continue treatment with pasireotide indefinitely unless the patient experiences unacceptable toxicity, disease progression and/or treatment is discontinued at the discretion of the treating physician or Novartis or withdrawal of consent.
Somatostatin analogues are a last resort for medical intervention in hyperinsulinemic hypoglycemia (HH). The hypoglycemia is very debilitating and can be even life threatening. There is limited experience with pasireotide in hyperinsulinemic hypoglycemia (only one publication); there is more experience with octreotide, both in adults and children and successful interventions with octreotide in hyperinsulinemic hypoglycemia have been published. Pasireotide via its different somatostatin receptor binding profile has clear effects on insulin, glucagon and incretin secretion and can ultimately lead to hyperglycemia. This mode of action (especially the effects on insulin and incretin secretion) could be very useful in the setting of hyperinsulinemic hypoglycemia.
Other Name: Signifor
- Recording of Hypoglycemic events [ Time Frame: Up to 2 years ]The primary outcome is the number of hypoglycemic events occurring.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03103009
|Contact: Emma Hulseberg-Dwyer, B.A.||(303)724-3921||EMMA.HULSEBERG-DWYER@UCDENVER.EDU|
|United States, Colorado|
|University of Colorado Denver||Recruiting|
|Aurora, Colorado, United States, 80045|
|Principal Investigator:||Helen Lawler, MD||University of Colorado, Denver|
|Principal Investigator:||Mike McDermott, MD||University of Colorado, Denver|