Clinical trial NCT02772718: An Open-Label Study of XOMA 358 in Patients With Hypoglycemia After Gastric Bypass Surgery
Official title: An Open-Label Study of XOMA 358 in Patients With Hypoglycemia After Gastric Bypass Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hypoglycemia
Keywords: Hypoglycemia
Lead sponsor: XOMA (US) LLC
Sponsor class: INDUSTRY
First posted: 2016-05-13
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the safety and clinical pharmacology of XOMA 358 in patients with hypoglycemia after gastric bypass surgery.


Eligibility criteria: Inclusion Criteria:

* Aged at least 18 years of age
* Body Mass Index \< 35 kg/m2 at baseline, unless discussed with Medical Monitor and patients with higher body mass index do not have significant medical co-morbidities that would confound ability to assess safety and efficacy of study drug.
* Received gastric bypass surgery more than 1 year before dosing
* Occurrence of postprandial hypoglycemia (blood glucose less than 60mg/dL) during the Baseline provocation assessments and/or by continuous glucose monitoring, as defined in the protocol.

Exclusion Criteria:

* History of type 1 diabetes
* Planned use of the following medications on or after Day -3 (Part 1):

  * Any agent for hypoglycemia, such as diazoxide or octreotide
  * Antihyperglycemic agents, including subcutaneous insulin therapy, sulfonylureas, SGLT2 inhibitors, and GLP-1 agonists
  * Systemic glucocorticoids or β agonists that may affect glucose metabolism
  * Long-acting somatostatin analogs or glucose-affecting medications
* During Part 2, the following therapies are prohibited as specified below:

  * Tramadol and any other medications not used in the treatment of post-bariatric surgery hypoglycemia that may cause hypoglycemia or fluctuations in blood glucose levels.
  * Acetaminophen-containing products during periods of continuous glucose monitoring.

Medications such as tramadol may cause hypoglycemia or fluctuations in blood glucose levels and, as such, use of such medications is subject to the restrictions as described above during the study. Acetaminophen can interfere with the accuracy of the glucose sensor of the continuous glucose monitoring system and is, therefore, prohibited during continuous glucose monitoring.

* Major general surgery within 3 months before study entry or anticipated during the study period

Other protocol-defined inclusion/exclusion criteria may apply

Primary outcomes:
measure: Single dose Part 1 and Multiple dose Part 2 - Incidence of treatment-emergent adverse events -
timeFrame: 42 days
measure: Single dose Part 1 - Change from baseline in glucose levels
timeFrame: Baseline and 22 days
measure: Single dose Part 1 - Blood glucose levels
timeFrame: Daily through Day 11 and at Day 22
measure: Multiple dose Part 2 - Change from baseline of duration of glucose by CGM at various levels as specified in the protocol
timeFrame: 28 days
measure: Multiple dose Part 2 - Change from baseline of number of episodes and percent of episodes of hypoglycemia per day with glucose by CGM at various levels as defined in the protocol
timeFrame: 28 days
Secondary outcomes:
Other outcomes:
Locations:
city: Aurora
country: United States
state: Colorado
city: Chicago
country: United States
state: Illinois
city: Baltimore
country: United States
state: Maryland
city: Boston
country: United States
state: Massachusetts
city: Rochester
country: United States
state: Minnesota
Study officials:
affiliation: XOMA (US) LLC
name: Allan Gordon, MD, PhD
role: STUDY_DIRECTOR
References: