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Pasireotide in Hyperinsulinemic Hypoglycemia

This study is not yet open for participant recruitment.
Verified November 2016 by Montefiore Medical Center
Sponsor:
ClinicalTrials.gov Identifier:
NCT03053284
First Posted: February 15, 2017
Last Update Posted: February 15, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
Novartis Pharmaceuticals
Information provided by (Responsible Party):
Montefiore Medical Center
  Purpose
This is a small controlled pilot study to assess the effect of subcutaneous pasireotide on preventing hypoglycemia due to hyperinsulinism, including congenital hyperinsulinism and insulinoma.

Condition Intervention Phase
Congenital Hyperinsulinism Insulinoma Hyperinsulinism Drug: Pasireotide 0.6Mg Solution for Injection Drug: Saline Solution Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Pasireotide for Prevention of Hypoglycemia in Patients With Hyperinsulinemic Hypoglycemia

Resource links provided by NLM:


Further study details as provided by Montefiore Medical Center:

Primary Outcome Measures:
  • Hypoglycemia [ Time Frame: 7 hours ]
    Occurence, frequency and severity of hypoglycemia (serum glucose < 55 mg/dL)


Secondary Outcome Measures:
  • Serum glucose regulators [ Time Frame: 7 hours ]
    Insulin, GLP-1, glucagon and cortisol levels


Other Outcome Measures:
  • Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] [ Time Frame: 7 hours ]
    Collection of safety and adverse event data


Estimated Enrollment: 4
Anticipated Study Start Date: April 2017
Estimated Study Completion Date: April 2018
Estimated Primary Completion Date: January 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
Normal saline s.c. injection once
Drug: Saline Solution
Saline Solution injection will be given once per study visit
Other Name: Placebo
Experimental: Pasireotide
Pasireotide 0.6mg s.c. once
Drug: Pasireotide 0.6Mg Solution for Injection
Pasireotide 0.6Mg Solution for Injection will be given once per study visit
Other Name: SOM230

Detailed Description:

Pasireotide is a somatostatin analog with affinity for several somatostatin receptors including those on pancreatic beta cells; when activated these receptors affect the secretion of glucagon and insulin. Pasireotide is also known to decrease glucagon-like peptide 1 (GLP-1) and gastric inhibitory polypeptide (GIP) secretion. Hyperglycemia is a well-documented adverse effect of pasireotide in its approved indications for treatment of Cushing's disease and acromegaly.

In light of this, the investigators hypothesize that pasireotide may be an effective therapy for hypoglycemia due to hyperinsulinism. Therefore a small controlled pilot study to assess the effect of subcutaneous (s.c.) pasireotide on preventing hypoglycemia due to hyperinsulinism over 7 hours of observation in both fasting and fed states is proposed.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  1. Male or female patients aged 18 to 70 years old
  2. Patients with hyperinsulinemic hypoglycemia due to either congenital hyperinsulinemic hypoglycemia or insulinoma, as determined by an endocrinologist
  3. If no prior diagnosis of either insulinoma or congenital hyperinsulinemic hypoglycemia by an endocrinologist, the participant must meet the following criteria:

    • A history of symptoms of hypoglycemia, (with or without a blood glucose <50mg/dL at time of symptoms)
    • Improvement of symptoms with ingestion of carbohydrates
    • At least one documented blood glucose <50mg/dL with concomitant insulin >3 mmol/L and c-peptide >0.2nmol/L, with a negative sulfonylurea screen
    • At least 1 episode of glucose <50mg/dL in the last year
  4. Written informed consent obtained prior to treatment to be consistent with local regulatory requirements
  5. No evidence of significant liver disease:

    • Serum total bilirubin < 2 x ULN
    • INR < 1.3 unless on anticoagulation
    • ALT and AST < 2 x ULN
    • Alkaline phosphatase < 2.5 x ULN
  6. Patients receiving anti-hypoglycemic treatment are eligible
  7. Patients who are treatment naïve, or those who were previously, but not currently, treated with anti-hypoglycemic therapy are also eligible
  8. Patients with insulinoma who are operative candidates are eligible if surgery is not emergently needed, and study participation would not delay the timing of a surgical intervention

Exclusion criteria:

  1. Age <18, age >70 (for both insulinoma and congenital hyperinsulinism)
  2. Known hypersensitivity to somatostatin or analogues
  3. Diabetic patients with poor glycemic control as evidenced by HbA1c >8%
  4. Patients who are hypothyroid and not on adequate replacement therapy
  5. Patients with symptomatic cholelithiasis and acute or chronic pancreatitis
  6. QTcF at screening > 450 msec in males and QTcF > 460 msec in females
  7. Hypokalaemia, hypomagnesaemia, family history of long QT syndrome or concomitant medications with known risk of Torsades de pointes (TdP)
  8. Patients who have congestive heart failure (NYHA Class III or IV), unstable angina, sustained ventricular tachycardia, clinically significant bradycardia, advanced heart block, history of acute MI less than one year prior to study entry or clinically significant impairment in cardiovascular function
  9. Severe non-malignant medical illness that may be jeopardized by treatment with a single dose of pasireotide
  10. History of another primary malignancy, with the exception of locally excised non-melanoma skin cancer and carcinoma in situ of uterine cervix unless there is no evidence of disease in the last year
  11. Patients with serum creatinine >2.0 X ULN
  12. Patients with WBC <3 X 109/L; Hb 90% < LLN; PLT <100 X 109/L
  13. Patients with the presence of active or suspected acute or chronic uncontrolled infection
  14. Patients who have undergone major surgery/surgical therapy for any cause within 4 weeks prior screening
  15. History of unexplained syncope or family history of idiopathic sudden death
  16. Sexually active males unless they use a condom during intercourse while taking drug and for 3 months following last dose of pasireotide and should not father a child in this period. A condom is required to be used also by vasectomized men in order to prevent delivery of the drug via seminal fluid.
  17. Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test
  18. Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception during dosing and 30 days following last dose of pasireotide.
  Contacts and Locations
Information from the National Library of Medicine

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): NCT03053284


Contacts
Contact: Erika Brutsaert, M.D., M.P.H. 718-839 7961 ebrutsae@montefiore.org

Sponsors and Collaborators
Montefiore Medical Center
Novartis Pharmaceuticals
Investigators
Principal Investigator: Erika Brutsaert, M.D., M.P.H. Montefiore Medical Center
  More Information

Publications:

Responsible Party: Montefiore Medical Center
ClinicalTrials.gov Identifier: NCT03053284     History of Changes
Other Study ID Numbers: 2016-7044
First Submitted: February 9, 2017
First Posted: February 15, 2017
Last Update Posted: February 15, 2017
Last Verified: November 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Hyperinsulinism
Congenital Hyperinsulinism
Hypoglycemia
Insulinoma
Glucose Metabolism Disorders
Metabolic Diseases
Adenoma, Islet Cell
Adenoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Infant, Newborn, Diseases
Pharmaceutical Solutions
Pasireotide
Somatostatin
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs