Treatment of post-bariatric hypoglycemia with exendin (9-39)
View Patent ↗Compositions and methods for treating hyperinsulinemic hypoglycemia, such as hyperinsulinemic hypoglycemia after bariatric surgery, are provided. In some embodiments, an effective amount of the glucagon-like peptide-1 receptor antagonist exendin(9-39) is subcutaneously administered twice per day.
1. A method for treating hyperinsulinemic hypoglycemia in a subject, the method comprising subcutaneously administering to the subject in need thereof a therapeutically effective amount of exendin(9-39);
wherein the therapeutically effective amount is 10-30 mg of exendin(9-39);
wherein the exendin(9-39) is administered at a concentration of 4-20 mg/ml; and
wherein the subject exhibits one or more of Whipple's triad, the occurrence of capillary glucose≤50 mg/dL at least once per month, and a plasma glucose concentration of ≤60 mg/dL during a tolerance test.
2. The method of claim 1 , wherein the tolerance test is an oral glucose tolerance test or a meal tolerance test.
3. The method of claim 1 , wherein the subject exhibits a plasma glucose concentration of ≤55 mg/dL and plasma insulin≥3 uU/mL during the tolerance test, or wherein the subject exhibits a plasma glucose concentration of ≤55 mg/dL and c-peptide>0.3 mg/dL during the tolerance test.
4. The method of claim 1 , wherein the therapeutically effective amount is 10-20 mg of exendin(9-39).
5. The method of claim 1 , wherein the exendin(9-39) is administered once per day.
6. The method of claim 1 , wherein the exendin(9-39) is administered twice per day.
7. The method of claim 1 , wherein the patient has previously had bariatric surgery.
8. The method of claim 7 , wherein the bariatric surgery is Roux-en-Y gastric bypass, vertical sleeve gastrectomy, placement of an endosleeve device, duodenal mucosal resurfacing, partial bypass of the duodenum, vagal nerve blockade, or pyloroplasty.
9. The method of claim 1 , wherein the patient has previously had gastrointestinal surgery.
10. The method of claim 9 , wherein the gastrointestinal surgery is gastrectomy, Nissen Fundoplication, or esophagectomy.
11. A method for treating hyperinsulinemic hypoglycemia in a subject, the method comprising subcutaneously administering to the subject in need thereof a therapeutically effective amount of exendin(9-39),
wherein the therapeutically effective amount is 10-30 mg of exendin(9-39);
wherein the exendin(9-39) is administered at a concentration of 4-20 mg/ml; and
wherein the subject is prediabetic and/or insulin resistant.
12. The method of claim 11 , wherein the subject has a congenital, acquired, or induced form of hyperinsulinemic hypoglycemia.
13. The method of claim 11 , wherein the therapeutically effective amount is 10-20 mg of exendin(9-39).
14. The method of claim 11 , wherein the exendin(9-39) is administered once per day.
15. The method of claim 11 , wherein the exendin(9-39) is administered twice per day.
16. The method of claim 11 , wherein the patient has previously had bariatric surgery.
17. The method of claim 16 , wherein the bariatric surgery is Roux-en-Y gastric bypass, vertical sleeve gastrectomy, placement of an endosleeve device, duodenal mucosal resurfacing, partial bypass of the duodenum, vagal nerve blockade, or pyloroplasty.
18. The method of claim 11 , wherein the patient has previously had gastrointestinal surgery.
19. The method of claim 18 , wherein the gastrointestinal surgery is gastrectomy, Nissen Fundoplication, or esophagectomy.
20. A method for treating hyperinsulinemic hypoglycemia in a subject, the method comprising administering to the subject in need thereof a therapeutically effective amount of exendin(9-39) twice-per-day (BID);
wherein the therapeutically effective amount is 10-30 mg of exendin(9-39);
wherein the exendin(9-39) is administered at a concentration of 4-20 mg/ml; and
wherein the second daily dose is administered 9 to 15 hours after the first daily dose.
21. The method of claim 20 , wherein the therapeutically effective amount is 10-20 mg of exendin(9-39).
22. The method of claim 20 , wherein the patient has previously had bariatric surgery.
23. The method of claim 22 , wherein the bariatric surgery is Roux-en-Y gastric bypass, vertical sleeve gastrectomy, placement of an endosleeve device, duodenal mucosal resurfacing, partial bypass of the duodenum, vagal nerve blockade, or pyloroplasty.
24. The method of claim 20 , wherein the patient has previously had gastrointestinal surgery.
25. The method of claim 24 , wherein the gastrointestinal surgery is gastrectomy, Nissen Fundoplication, or esophagectomy.