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 an isotonic solution comprising a therapeutically effective amount of exendin(9-39) and at least one of an antimicrobial preservative, a tonicity adjusting agent, or a buffer;
wherein the therapeutically effective amount is 10-30 mg of exendin(9-39); and
wherein the exendin(9-39) is administered at a concentration of 4-20 mg/ml.
2. The method of claim 1 , wherein the tonicity adjusting agent comprises mannitol.
3. The method of claim 1 , wherein the therapeutically effective amount is 10-20 mg of exendin(9-39).
4. The method of claim 1 , wherein the exendin(9-39) is administered once per day.
5. The method of claim 1 , wherein the exendin(9-39) is administered twice per day.
6. The method of claim 1 , wherein the patient has previously had bariatric surgery.
7. The method of claim 6 , 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.
8. The method of claim 1 , wherein the patient has previously had gastrointestinal surgery.
9. The method of claim 8 , wherein the gastrointestinal surgery is gastrectomy, Nissen Fundoplication, or esophagectomy.
10. 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 exendin(9-39) is encapsulated in an extended release capsule.
11. The method of claim 10 , wherein the extended release capsule comprises a microsphere.
12. The method of claim 11 , wherein the microsphere comprises a biopolymer.
13. The method of claim 10 , wherein the extended release capsule is a nano-lipocapsule.
14. The method of claim 10 , wherein the therapeutically effective amount is 10-20 mg of exendin(9-39).
15. The method of claim 10 , wherein the exendin(9-39) is administered once per day.
16. The method of claim 10 , wherein the exendin(9-39) is administered twice per day.
17. The method of claim 10 , wherein the patient has previously had bariatric surgery.
18. The method of claim 17 , 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.
19. The method of claim 10 , wherein the patient has previously had gastrointestinal surgery.
20. The method of claim 19 , wherein the gastrointestinal surgery is gastrectomy, Nissen Fundoplication, or esophagectomy.
21. A method for treating hyperinsulinemic hypoglycemia in a subject, the method comprising:
solubilizing lyophilized exendin(9-39) with saline or other pharmacologically acceptable diluent to form an exendin(9-39) solution; and
subcutaneously administering to the subject in need thereof a therapeutically effective amount of the exendin(9-39) solution;
wherein the therapeutically effective amount is 10-30 mg of exendin(9-39); and
wherein the exendin(9-39) is administered at a concentration of 4-20 mg/ml.
22. The method of claim 21 , wherein the lyophilized exendin(9-39) is provided in dual-chamber cartridge.
23. The method of claim 21 , wherein the exendin(9-39) solution is administered using a pen injector.
24. 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) for a first treatment period, wherein the exendin(9-39) is administered at a first dosage; and
subcutaneously administering to the subject a therapeutically effective amount of exendin(9-39) for a second treatment period after the first treatment period, wherein the exendin(9-39) is administered at a second dosage.
25. The method of claim 24 , wherein the second dosage is greater than the first dosage.
26. The method of claim 24 , wherein the first dosage is a morning dosage.
27. The method of claim 24 , wherein the second dosage is an evening dosage.
28. The method of claim 24 , wherein the first dosage is from 10-15 mg of exendin(9-39).
29. The method of claim 24 , wherein the second dosage is from 10-20 mg of exendin(9-39).