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

Primary Purpose

Hypoglycemia

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
XOMA 358 single dose level A
XOMA 358 single dose level B
XOMA 358 single dose level C
XOMA 358 multiple dose level 1
Sponsored by
XOMA (US) LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypoglycemia focused on measuring Hypoglycemia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Part 1 - single dose

Part 2 - multiple doses

Arm Description

Cohorts A, B, and C

Cohort 1

Outcomes

Primary Outcome Measures

Single dose Part 1 and Multiple dose Part 2 - Incidence of treatment-emergent adverse events -
Safety assessed by treatment-emergent adverse events
Single dose Part 1 - Change from baseline in glucose levels
Glucose measured using a continuous glucose monitor
Single dose Part 1 - Blood glucose levels
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
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

Secondary Outcome Measures

Full Information

First Posted
May 3, 2016
Last Updated
May 19, 2021
Sponsor
XOMA (US) LLC
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1. Study Identification

Unique Protocol Identification Number
NCT02772718
Brief Title
An Open-Label Study of XOMA 358 in Patients With Hypoglycemia After Gastric Bypass Surgery
Acronym
XOMA 358
Official Title
An Open-Label Study of XOMA 358 in Patients With Hypoglycemia After Gastric Bypass Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
April 2016 (undefined)
Primary Completion Date
May 2021 (Actual)
Study Completion Date
May 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
XOMA (US) LLC

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypoglycemia
Keywords
Hypoglycemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Part 1 - single dose
Arm Type
Experimental
Arm Description
Cohorts A, B, and C
Arm Title
Part 2 - multiple doses
Arm Type
Experimental
Arm Description
Cohort 1
Intervention Type
Drug
Intervention Name(s)
XOMA 358 single dose level A
Intervention Description
XOMA 358 single dose level A administered by intravenous infusion
Intervention Type
Drug
Intervention Name(s)
XOMA 358 single dose level B
Intervention Description
XOMA 358 single dose level B administered by an intravenous infusion
Intervention Type
Drug
Intervention Name(s)
XOMA 358 single dose level C
Intervention Description
XOMA 358 single dose level C administered by an intravenous infusion
Intervention Type
Drug
Intervention Name(s)
XOMA 358 multiple dose level 1
Intervention Description
XOMA 358 multiple dose level 1 administered by an intravenous infusion
Primary Outcome Measure Information:
Title
Single dose Part 1 and Multiple dose Part 2 - Incidence of treatment-emergent adverse events -
Description
Safety assessed by treatment-emergent adverse events
Time Frame
42 days
Title
Single dose Part 1 - Change from baseline in glucose levels
Description
Glucose measured using a continuous glucose monitor
Time Frame
Baseline and 22 days
Title
Single dose Part 1 - Blood glucose levels
Description
Assessment of blood glucose with a bedside meter at multiple time points specified in the protocol
Time Frame
Daily through Day 11 and at Day 22
Title
Multiple dose Part 2 - Change from baseline of duration of glucose by CGM at various levels as specified in the protocol
Description
Glucose measured by continuous glucose monitoring every 5 min
Time Frame
28 days
Title
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
Time Frame
28 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Allan Gordon, MD, PhD
Organizational Affiliation
XOMA (US) LLC
Official's Role
Study Director
Facility Information:
City
Aurora
State/Province
Colorado
Country
United States
City
Chicago
State/Province
Illinois
Country
United States
City
Baltimore
State/Province
Maryland
Country
United States
City
Boston
State/Province
Massachusetts
Country
United States
City
Rochester
State/Province
Minnesota
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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