Hypoglycemia
Conditions
Keywords
Hypoglycemia
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.
Interventions
DRUGXOMA 358 single dose level A
XOMA 358 single dose level A administered by intravenous infusion
DRUGXOMA 358 single dose level B
XOMA 358 single dose level B administered by an intravenous infusion
DRUGXOMA 358 single dose level C
XOMA 358 single dose level C administered by an intravenous infusion
DRUGXOMA 358 multiple dose level 1
XOMA 358 multiple dose level 1 administered by an intravenous infusion
Sponsors
XOMA (US) LLC
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 - Change from baseline in glucose levels | Baseline and 22 days | Glucose measured using a continuous glucose monitor |
| 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 duration of glucose by CGM at various levels as specified in the protocol | 28 days | Glucose measured by continuous glucose monitoring every 5 min |
| 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 | — |
Countries
United States
Outcome results
None listed