Closed-Loop Glucagon Pump for Treatment of Post-Bariatric Hypoglycemia

• Status: Completed
• Trial end date: 2018-08-22
• Target enrollment: 0
• Participant gender: All

Summary

To assess the efficacy of a closed loop glucagon system to prevent and treat hypoglycemia occurring in patients with Post-Bariatric Hypoglycemia (PBH) in response to meals and exercise.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Joslin Diabetes Center
• Collaborators: Harvard University; National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK); National Institutes of Health (NIH); Xeris Pharmaceuticals
• Treatments: Glucagon; Glucagon-Like Peptide 1

Criteria

Inclusion Criteria:

1. Males or females diagnosed with ongoing post-bariatric hypoglycemia with prior episodes of neuroglycopenia, unresponsive to dietary intervention (low glycemic index, controlled carbohydrate portions) and trial of acarbose therapy at the maximally tolerated dose.

2. Age 18-65 years of age, inclusive, at screening.

3. Willingness to provide informed consent and follow all study procedures, including attending all scheduled visits.

Exclusion Criteria:

1. Documented hypoglycemia occurring in the fasting state (> 12 hours fast);

2. Chronic kidney disease stage 4 or 5 (including end-stage renal disease);

3. Hepatic disease, including serum ALT or AST greater than or equal to 3 times the upper limit of normal; hepatic synthetic insufficiency as defined as serum albumin < 3.0 g/dL; or serum bilirubin > 2.0;

4. Congestive heart failure, NYHA class II, III or IV;

5. History of myocardial infarction, unstable angina or revascularization within the past 6 months or 2 or more risk factors for coronary artery disease including diabetes, uncontrolled hypertension, uncontrolled hyperlipidemia, and active tobacco use;

6. History of cardiac arrhythmia or arrhythmia detected by EKG during the screening visit;

7. History of syncope (unrelated to hypoglycemia) or diagnosed cardiac arrhythmia

8. Concurrent administration of β-blocker therapy;

9. History of a cerebrovascular accident;

10. Seizure disorder (other than with suspect or documented hypoglycemia);

11. Active treatment with any diabetes medications except for acarbose;

12. Active malignancy, except basal cell or squamous cell skin cancers;

13. Personal or family history of pheochromocytoma or disorder with increased risk of pheochromocytoma (MEN 2, neurofibromatosis, or Von Hippel-Lindau disease);

14. Known insulinoma or glucagonoma;

15. Major surgical operation within 30 days prior to screening;

16. Hematocrit < 33%;

17. Bleeding disorder, treatment with warfarin, or platelet count <50,000;

18. Blood donation (1 pint of whole blood) within the past 2 months;

19. Active alcohol abuse or substance abuse;

20. Current administration of oral or parenteral corticosteroids;

21. Pregnancy and/ or Lactation: For women of childbearing potential: there is a requirement for a negative urine pregnancy test and for agreement to use contraception during the study and for at least 1 month after participating in the study. Acceptable contraception includes birth control pill / patch / vaginal ring, Depo-Provera, Norplant, an IUD, the double barrier method (the woman uses a diaphragm and spermicide and the man uses a condom), or abstinence;

22. Use of an investigational drug within 30 days prior to screening;

23. Current use of anticholinergic medications;

24. Allergy to a component of the study drug.