An Open-Label Study of XOMA 358 in Patients With Hypoglycemia After Gastric Bypass Surgery
- Conditions
- Hypoglycemia
- Interventions
- Drug: XOMA 358 single dose level ADrug: XOMA 358 multiple dose level 1Drug: XOMA 358 single dose level BDrug: XOMA 358 single dose level C
- Registration Number
- NCT02772718
- Lead Sponsor
- XOMA (US) LLC
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 20
- 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.
-
History of type 1 diabetes
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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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Part 1 - single dose XOMA 358 single dose level C Cohorts A, B, and C Part 1 - single dose XOMA 358 single dose level A Cohorts A, B, and C Part 1 - single dose XOMA 358 single dose level B Cohorts A, B, and C Part 2 - multiple doses XOMA 358 multiple dose level 1 Cohort 1
- Primary Outcome Measures
Name Time Method Single dose Part 1 - Change from baseline in glucose levels Baseline and 22 days Glucose measured using a continuous glucose monitor
Multiple dose Part 2 - Change from baseline of duration of glucose by CGM at various levels as specified in the protocol 28 days Glucose measured by continuous glucose monitoring every 5 min
Single dose Part 1 and Multiple dose Part 2 - Incidence of treatment-emergent adverse events - 42 days Safety assessed by treatment-emergent adverse events
Single dose Part 1 - Blood glucose levels Daily through Day 11 and at Day 22 Assessment of blood glucose with a bedside meter at multiple time points specified in the protocol
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 28 days
- Secondary Outcome Measures
Name Time Method