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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-09-19

Study Completion Date

2018-08-22

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Efficacy of Glucagon In the Prevention of Hypoglycemia During Mild Exercise

NCT03217175

Type 1 Diabetes Mellitus

TERMINATED NA

The Role of Glucagon in Glucose Metabolism in Humans With and Without Bariatric Surgery

NCT07212868

Non-Diabetic

NOT_YET_RECRUITING PHASE1

The Importance of GLP-1 in Post RYGB Improvement in Glycaemic Control Type 2 Diabetic Subjects

NCT01579981

Type 2 Diabetes

COMPLETED NA

Treatment of Post-bariatric Hypoglycaemia

NCT04836273

Hyperinsulinemic Hypoglycemia Postprandial Hypoglycemia

COMPLETED PHASE2

Role of GLP-1 in Hyperinsulinemic Hypoglycemia Post-bariatric Surgery

NCT02550145

Hypoglycemia

TERMINATED PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

A control system for sensor-guided delivery was previously developed and tested in a Proof-of-Concept (POC) study in a clinical research setting during 9 mixed meal tolerance tests in 8 unique patients with severe hypoglycemia following bariatric surgery. This optimized algorithm will now be implemented to deliver stable glucagon in a closed-loop system.

A randomized, placebo-controlled, masked trial will be conducted to assess the efficacy of the closed loop system to prevent and treat hypoglycemia occurring in patients with PBH in response to meals (part 1). Part 2 will test whether the closed loop system can also prevent and treat hypoglycemia in patients with PBH in response to exercise. A manufacturing program from our collaborating team at Xeris Pharmaceuticals will continue to produce supplies of glucagon for the clinical trial in a current good manufacturing practice (cGMP) facility, with continued shelf-life stability testing.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Post-bariatric Hypoglycemia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

A randomization scheme will be devised to assign half the subjects to receive glucagon during their first challenge visit and the other half to receive vehicle during their first challenge visit. At their second challenge subjects will be assigned to the product not received during their first challenge. The label will include a subject randomization number and information as to which vial should be administered during the first challenge and which should be administered during the second challenge.

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study medication will be provided in vials which are labeled with randomization information only but not contents of vial.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Study drug (glucagon) first, placebo second

Each subject will have two mixed meal tolerance tests performed. Each will be randomized to receive either glucagon or matched placebo during the first testing session. A participant could receive 2 doses of the study drug or placebo at each study visit. The opposite treatment will be given during the second testing session after a 1-2 week washout period. Both participants and the study team will be blinded to the intervention being used during each session.

Group Type OTHER

glucagon

Intervention Type DRUG

novel, stable non-aqueous glucagon formulation provided by Xeris Pharmaceuticals

Closed loop glucagon pump

Intervention Type DEVICE

a novel closed-loop glucagon system (CLG) incorporating a novel, stable non-aqueous glucagon formulation together with an infusion pump system (Omnipod) guided by real-time continuous glucose monitoring (Dexcom) that is triggered by a hypoglycemia alert algorithm.

Placebo first, study drug (glucagon) second

Each subject will have two mixed meal tolerance tests performed. Each will be randomized to receive either glucagon or matched placebo during the first testing session. A participant could receive 2 doses of the study drug or placebo at each study visit. The opposite treatment will be given during the second testing session after a 1-2 week washout period. Both participants and the study team will be blinded to the intervention being used during each session.

Group Type OTHER

Closed loop glucagon pump

Intervention Type DEVICE

a novel closed-loop glucagon system (CLG) incorporating a novel, stable non-aqueous glucagon formulation together with an infusion pump system (Omnipod) guided by real-time continuous glucose monitoring (Dexcom) that is triggered by a hypoglycemia alert algorithm.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

glucagon

novel, stable non-aqueous glucagon formulation provided by Xeris Pharmaceuticals

Intervention Type DRUG

Closed loop glucagon pump

a novel closed-loop glucagon system (CLG) incorporating a novel, stable non-aqueous glucagon formulation together with an infusion pump system (Omnipod) guided by real-time continuous glucose monitoring (Dexcom) that is triggered by a hypoglycemia alert algorithm.

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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 alanine transaminase (ALT) or aspartate aminotransferase (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, New York Heart Association (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 intrauterine device (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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No