An Open-Label Study of XOMA 358 in Patients With Hypoglycemia After Gastric Bypass Surgery

Hypoglycemia Clinical Trial

— XOMA 358  

Official title:

An Open-Label Study of XOMA 358 in Patients With Hypoglycemia After Gastric Bypass Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02772718
• Other study ID #: X358603
• Status: Completed
• Phase: Phase 2
• Start date: April 2016
• Est. completion date: May 2021

Study information

• Verified date: May 2021
• Source: XOMA (US) LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: May 2021
• Est. primary completion date: May 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 ß 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

Related Conditions & MeSH terms

• Hypoglycemia

Intervention

Drug:
• XOMA 358 single dose level A
XOMA 358 single dose level A administered by intravenous infusion
• XOMA 358 single dose level B
XOMA 358 single dose level B administered by an intravenous infusion
• XOMA 358 single dose level C
XOMA 358 single dose level C administered by an intravenous infusion
• XOMA 358 multiple dose level 1
XOMA 358 multiple dose level 1 administered by an intravenous infusion

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
XOMA (US) LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Single dose Part 1 and Multiple dose Part 2 - Incidence of treatment-emergent adverse events -	Safety assessed by treatment-emergent adverse events	42 days
Primary	Single dose Part 1 - Change from baseline in glucose levels	Glucose measured using a continuous glucose monitor	Baseline and 22 days
Primary	Single dose Part 1 - Blood glucose levels	Assessment of blood glucose with a bedside meter at multiple time points specified in the protocol	Daily through Day 11 and at Day 22
Primary	Multiple dose Part 2 - Change from baseline of duration of glucose by CGM at various levels as specified in the protocol	Glucose measured by continuous glucose monitoring every 5 min	28 days
Primary	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