HypoglycemiaPhase 2XOMA 358NCT02772718
An Open-Label Study of XOMA 358 in Patients With Hypoglycemia After Gastric Bypass Surgery
A Phase 2 study testing XOMA 358 single dose level A, XOMA 358 single dose level B and XOMA 358 single dose level C in people with Hypoglycemia, run by XOMA (US) LLC at 5 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypoglycemia
- What is being tested?
- XOMA 358 single dose level A, XOMA 358 single dose level B and XOMA 358 single dose level C
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 5 sitesUnited States
- Study dates
- Apr 2016to May 2021
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Study site
Aurora, Colorado
Study site
Baltimore, Maryland
Study site
Boston, Massachusetts
Study site
Chicago, Illinois
Study site
Rochester, Minnesota
About this study
The purpose of this study is to evaluate the safety and clinical pharmacology of XOMA 358 in patients with hypoglycemia after gastric bypass surgery.
- Conditions
- Hypoglycemia
- Being tested
- XOMA 358 single dose level A, XOMA 358 single dose level B, XOMA 358 single dose level C, XOMA 358 multiple dose level 1
- Keywords
- Hypoglycemia
- Medical subject headings
- Hypoglycemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
XOMA 358 single dose level ADrug
XOMA 358 single dose level A administered by intravenous infusion
XOMA 358 single dose level BDrug
XOMA 358 single dose level B administered by an intravenous infusion
XOMA 358 single dose level CDrug
XOMA 358 single dose level C administered by an intravenous infusion
XOMA 358 multiple dose level 1Drug
XOMA 358 multiple dose level 1 administered by an intravenous infusion
| Study group | Role | What they receive |
|---|---|---|
| Part 1 - single dose | Experimental | Cohorts A, B, and C Receives: Drug: XOMA 358 single dose level A; Drug: XOMA 358 single dose level B; Drug: XOMA 358 single dose level C |
| Part 2 - multiple doses | Experimental | Cohort 1 Receives: Drug: XOMA 358 multiple dose level 1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Single dose Part 1 and Multiple dose Part 2 - Incidence of treatment-emergent adverse events -
Safety assessed by treatment-emergent adverse events
Measured: 42 days
Single dose Part 1 - Change from baseline in glucose levels
Glucose measured using a continuous glucose monitor
Measured: Baseline and 22 days
Single dose Part 1 - Blood glucose levels
Assessment of blood glucose with a bedside meter at multiple time points specified in the protocol
Measured: Daily through Day 11 and at Day 22
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
Measured: 28 days
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
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2016 (estimated)
- Study startApr 2016
- Primary completionMay 2021
- Study completionMay 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypoglycemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- XOMA (US) LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Allan Gordon, MD, PhD, Study director, XOMA (US) LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02772718
- Sponsor's protocol ID
- X358603
- Acronym
- XOMA 358
- Status last verified
- May 2021
- First submitted
- 3 May 2016
- Last updated
- 21 May 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label Study of XOMA 358 in Patients With Hypoglycemia After Gastric Bypass Surgery
- ClinicalTrials.gov ID
- NCT02772718
- Acronym / sponsor ID
- XOMA 358 / X358603
- Conditions
- Hypoglycemia
- Keywords
- Hypoglycemia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- XOMA (US) LLCIndustry (pharma, biotech, devices)
- Study start
- Apr 2016
- Primary completion
- May 2021 (actual)
- Study completion
- May 2021 (actual)
- First posted
- 13 May 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the safety and clinical pharmacology of XOMA 358 in patients with hypoglycemia after gastric bypass surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Part 1 - single dose | Experimental | Drug: XOMA 358 single dose level A, Drug: XOMA 358 single dose level B, Drug: XOMA 358 single dose level CCohorts A, B, and C |
| Part 2 - multiple doses | Experimental | Drug: XOMA 358 multiple dose level 1Cohort 1 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (12 listed)
- History of type 1 diabetes
- Planned use of the following medications on or after Day -3 (Part 1):
- During Part 2, the following therapies are prohibited as specified below:
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| XOMA 358 single dose level AXOMA 358 single dose level A administered by intravenous infusion | Drug | Part 1 - single dose |
| XOMA 358 single dose level BXOMA 358 single dose level B administered by an intravenous infusion | Drug | Part 1 - single dose |
| XOMA 358 single dose level CXOMA 358 single dose level C administered by an intravenous infusion | Drug | Part 1 - single dose |
| XOMA 358 multiple dose level 1XOMA 358 multiple dose level 1 administered by an intravenous infusion | Drug | Part 2 - multiple doses |
Primary outcome
Single dose Part 1 and Multiple dose Part 2 - Incidence of treatment-emergent adverse events -
Time frame: 42 days
Safety assessed by treatment-emergent adverse events
Single dose Part 1 - Change from baseline in glucose levels
Time frame: Baseline and 22 days
Glucose measured using a continuous glucose monitor
Single dose Part 1 - Blood glucose levels
Time frame: 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
Time frame: 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
Time frame: 28 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Allan Gordon, MD, PhD study director
XOMA (US) LLC
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing XOMA 358 single dose level A, XOMA 358 single dose level B and XOMA 358 single dose level C in people with Hypoglycemia, run by XOMA (US) LLC at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Single dose Part 1 and Multiple dose Part 2 - Incidence of treatment-emergent adverse events - (time frame: 42 days). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 May 2021.