Management of hyperglycemia associated with pasireotide (SOM230): Healthy volunteer study

Diabetes Research and Clinical Practice

Volumn 103, Issue 3, 2014, Pages 458-465

  Breitschaft, Astrid ^a   Hu, Ke ^b   Hermosillo Reséndiz, Karina ^b   Darstein, Christelle ^b   Golor, Georg ^a  

^a PAREXEL INTERNATIONAL   (United States)

^b NOVARTIS PHARMA AG   (Switzerland)

Author keywords

Glucose; Hyperglycemia; Pasireotide; Somatostatin analogue

Indexed keywords

GLUCOSE; HYPERGLYCEMIA; PASIREOTIDE; SOMATOSTATIN ANALOGUE;

ADAMANTANE; ADOLESCENT; ADULT; BLOOD GLUCOSE; CYCLOHEXANES; DIPEPTIDYL-PEPTIDASE IV INHIBITORS; DRUG THERAPY, COMBINATION; GLUCAGON; GLUCAGON-LIKE PEPTIDE 1; GLUCOSE TOLERANCE TEST; HEALTHY VOLUNTEERS; HUMANS; HYPERGLYCEMIA; HYPOGLYCEMIC AGENTS; INSULIN; MALE; MAXIMUM TOLERATED DOSE; METFORMIN; MIDDLE AGED; NITRILES; PHENYLALANINE; PROGNOSIS; PYRROLIDINES; SOMATOSTATIN; YOUNG ADULT;

EID: 84898875908     PISSN: 01688227     EISSN: 18728227     Source Type: Journal    
DOI: 10.1016/j.diabres.2013.12.011     Document Type: Article

References (15)

1. Colao A., Bronstein M.D., Freda P., Gu F., Shen C.-C., Gadelha M., et al. Pasireotide versus octreotide in acromegaly: a head-to-head superiority study. J Clin Endocrinol Metab 2014, [Epub ahead of print]. 10.1210/jc.2013-2480.
2. Kumar U., Sasi R., Suresh S., Patel A., Thangaraju M., Metrakos P., et al. Subtype-selective expression of the five somatostatin receptors (hSSTR1-5) in human pancreatic islet cells: a quantitative double-label immunohistochemical analysis. Diabetes 1999, 48(1):77-85.
3. Petersenn S., Unger N., Hu K., Weisshaar B., Zhang Y., Bouillaud E., et al. Pasireotide (SOM230), a novel multi-receptor-targeted somatostatin analogue, is well tolerated when administered as a continuous 7-day subcutaneous infusion in healthy male volunteers. J Clin Pharmacol 2012, 52(7):1017-1027.
4. Schmid H.A., Brueggen J. Effects of somatostatin analogues on glucose homeostasis in rats. J Endocrinol 2012, 212(1):49-60.
5. Boscaro M., Ludlam W.H., Atkinson B., Glusman J.E., Petersenn S., Reincke M., et al. Treatment of pituitary dependent Cushing's disease with the multi-receptor ligand somatostatin analog pasireotide (SOM230): a multicenter, phase II trial. J Clin Endocrinol Metab 2009, 94(1):115-122.
6. Colao A., Petersenn S., Newell-Price J., Findling J.W., Gu F., Maldonado M., et al. A 12-month Phase 3 study of pasireotide in Cushing's disease. N Engl J Med 2012, 366(10):914-924.
7. Petersenn S., Schopohl J., Barkan A., Mohideen P., Colao A., Abs R., et al. Pasireotide (SOM230) demonstrates efficacy and safety in patients with acromegaly: a randomized, multicenter, Phase II trial. J Clin Endocrinol Metab 2010, 95(6):2781-2789.
8. Kvols L., Oberg K.E., O'Dorisio T., Mohideen P., de Herder W.W., Arnold R., et al. 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. Endocr Relat Cancer 2012, 19(5):657-666.
9. Henry R.R., Ciaraldi T.P., Armstrong D., Burke P., Ligueros-Saylan M., Mudaliar S. Hyperglycemia associated with pasireotide: results from a mechanistic study in healthy volunteers. J Clin Endocrinol Metab 2013, 98(8):3446-3453.
10. National Cancer Institute. Common Terminology Criteria for Adverse Events v3.0 (CTCAE). 2006. Available at: http://ctep.cancer.gov/protocolDevelopment/electronic_applications/docs/ctcaev3.pdf.
11. Garber A., Henry R., Ratner R., Garcia-Hernandez P.A., Rodriguez-Pattzi H., Olvera-Alvarez I., et al. Liraglutide versus glimepiride monotherapy for type 2 diabetes (LEAD-3 Mono): a randomised, 52-week, phase III, double-blind, parallel-treatment trial. Lancet 2009, 373(9662):473-481.
12. Pivonello R., De Leo M., Vitale P., Cozzolino A., Simeoli C., De Martino M.C., et al. Pathophysiology of diabetes mellitus in Cushing's syndrome. Neuroendocrinology 2010, 92(Suppl 1):77-81.
13. Tauchmanova L., Rossi R., Biondi B., Pulcrano M., Nuzzo V., Palmieri E.A., et al. Patients with subclinical Cushing's syndrome due to adrenal adenoma have increased cardiovascular risk. J Clin Endocrinol Metab 2002, 87(11):4872-4878.
14. Newell-Price J., Bertagna X., Grossman A.B., Nieman L.K. Cushing's syndrome. Lancet 2006, 367(9522):1605-1617.
15. Feelders R.A., Pulgar S.J., Kempel A., Pereira A.M. The burden of Cushing's disease: clinical and health-related quality of life aspects. Eur J Endocrinol 2012, 167(3):311-326.