Type 1 DiabetesPhase 2NCT00998699
Study of the Effects of XOMA 052 on Insulin Production in Subjects With Well Controlled Type 1 Diabetes
A Phase 2 study testing Xoma 052 in people with Type 1 Diabetes, run by XOMA (US) LLC at 2 sites in Switzerland.
Trial summary
The study hypothesis is that XOMA 052 may inhibit beta-cell destruction and enhance beta-cell regeneration. The purpose of this study is to assess the effects of XOMA 052 on beta-cell function and insulin production. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Type 1 Diabetes
- What is being tested?
- Xoma 052
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 22 participants
- Where
- 2 sitesSwitzerland
- Study dates
- Feb 2010to Aug 2013
- 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 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Stable Type 1 diabetes of > 2 year duration
- No clinically significant change in treatment regimen for T1D
- Age ≥ 18 years and ≤ 55 years
- HbA1c < 7.0%
- Positive GAD65 and/or IA-2 auto-antibodies
- Peak C-peptide > 100 pM following IV injection of 1 mg glucagon
- Body-mass index (BMI) > 18 and < 28 kg/m2
- Willingness to maintain current doses/regimens of vitamins and dietary supplements through the end of the study
Who cannot join
- Current infection or history of infection
- Positive for Hep B surface antigen (HBsAg), Hep C virus (HCV), or HIV
- History of tuberculosis or positive PPD test
- Presence of foot, leg, or decubitus ulcers
- Current immunosuppressive treatment or documented immunodeficiency
- History of severe allergic or anaphylactic reactions
Show all 15Show fewer
- History of asthma requiring systemic corticosteroid therapy
- Coronary intervention (PCI, stent placement) or hospitalization for cardiovascular condition within the last 12 months
- Uncontrolled hypertension
- History of congestive heart failure (NYHA Class III or IV)
- History of a coronary event within the last 12 months
- Female subjects who are pregnant, planning to become pregnant, have recently delivered, or are breast-feeding
- History of malignancy within the last 5 years
- Receipt of a live (attenuated) vaccine within the last 3 months
- Other protocol-defined inclusion/exclusion criteria may apply
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: A Randomized, Double-blind, Placebo-controlled, Phase 2 Study of the Effects of XOMA 052 on Insulin Production in Subjects With Well-controlled Type 1 Diabetes
The study hypothesis is that XOMA 052 may inhibit beta-cell destruction and enhance beta-cell regeneration.
The purpose of this study is to assess the effects of XOMA 052 on beta-cell function and insulin production.
- Conditions
- Type 1 Diabetes
- Being tested
- Xoma 052, Placebo
- Keywords
- Diabetes, Type 1
- Medical subject headings
- Diabetes Mellitus, Type 1, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Xoma 052Drug
Sterile solution subcutaneously administered every 4 weeks for 12 weeks
PlaceboDrug
Sterile solution subcutaneously administered every 4 weeks for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| XOMA 052 | Active comparator | Not described Receives: Drug: Xoma 052 |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in beta-cell function as measured by change in C-peptide level during thd MMTT (Mixed meal tolerance test) at Day 112 compared to baseline (Day 0 pre-dose)
Measured: Day 0 pre-dose and Day 112
Secondary outcomes (9)
Safety assessed by pre- and post-treatment serial measurements of vital signs, clinical laboratory assessments, and treatment-emergent adverse events.
Measured: Day 0 (baseline) through Day 364
Change in insulin requirements
Measured: Day -3 through Day 0 pre-dose and Day 109 through Day 112)
Change in HbA1c levels
Measured: Day 0 pre-dose and Day 112
Change in fasting glucose
Measured: Day 0 pre-dose and Day 112
Change in fasting glucagon and cortisol
Measured: Day 0 pre-dose and Day 112
Change in systemic inflammation markers
Measured: Day 0 pre-dose and Day 112
Change in meal-stimulated GLP-1 and GIP
Measured: Day 0 pre-dose and Day 112
Change in lipids profile
Measured: Day 0 pre-dose and Day 112
Measurement of serum concentrations of XOMA 052
Measured: Day 0 pre-dose, Day 28, Day 56, Day 84, Day 112, Day 182, and Day 364
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2009 (estimated)
- Study startFeb 2010
- Primary completionAug 2013
- Study completionAug 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 DiabetesStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- XOMA (US) LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Juvenile Diabetes Research Foundation
- Responsible party
- Sponsor
- Investigators
- Marc Donath, MD, Principal investigator, UniversitaetsSpital Zuerich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00998699
- Sponsor's protocol ID
- X052076
- Status last verified
- Mar 2014
- First submitted
- 19 Oct 2009
- Last updated
- 4 Mar 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled, Phase 2 Study of the Effects of XOMA 052 on Insulin Production in Subjects With Well-controlled Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT00998699
- Acronym / sponsor ID
- X052076
- Conditions
- Type 1 Diabetes
- Keywords
- Diabetes, Type 1
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- XOMA (US) LLCIndustry (pharma, biotech, devices)
- Collaborators
- Juvenile Diabetes Research Foundation
- Study start
- Feb 2010
- Primary completion
- Aug 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 20 Oct 2009 (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 study hypothesis is that XOMA 052 may inhibit beta-cell destruction and enhance beta-cell regeneration.
The purpose of this study is to assess the effects of XOMA 052 on beta-cell function and insulin production.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| XOMA 052 | Active comparator | Drug: Xoma 052 |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Stable Type 1 diabetes of > 2 year duration
- No clinically significant change in treatment regimen for T1D
- Age ≥ 18 years and ≤ 55 years
- HbA1c < 7.0%
- Positive GAD65 and/or IA-2 auto-antibodies
Key exclusion criteria (15 listed)
- Current infection or history of infection
- Positive for Hep B surface antigen (HBsAg), Hep C virus (HCV), or HIV
- History of tuberculosis or positive PPD test
- Presence of foot, leg, or decubitus ulcers
- Current immunosuppressive treatment or documented immunodeficiency
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 052Sterile solution subcutaneously administered every 4 weeks for 12 weeks | Drug | XOMA 052 |
| PlaceboSterile solution subcutaneously administered every 4 weeks for 12 weeks | Drug | Placebo |
Primary outcome
Change in beta-cell function as measured by change in C-peptide level during thd MMTT (Mixed meal tolerance test) at Day 112 compared to baseline (Day 0 pre-dose)
Time frame: Day 0 pre-dose and Day 112
9 secondary outcomes
Safety assessed by pre- and post-treatment serial measurements of vital signs, clinical laboratory assessments, and treatment-emergent adverse events.
Time frame: Day 0 (baseline) through Day 364
Change in insulin requirements
Time frame: Day -3 through Day 0 pre-dose and Day 109 through Day 112)
Change in HbA1c levels
Time frame: Day 0 pre-dose and Day 112
Change in fasting glucose
Time frame: Day 0 pre-dose and Day 112
Change in fasting glucagon and cortisol
Time frame: Day 0 pre-dose and Day 112
Change in systemic inflammation markers
Time frame: Day 0 pre-dose and Day 112
Change in meal-stimulated GLP-1 and GIP
Time frame: Day 0 pre-dose and Day 112
Change in lipids profile
Time frame: Day 0 pre-dose and Day 112
Measurement of serum concentrations of XOMA 052
Time frame: Day 0 pre-dose, Day 28, Day 56, Day 84, Day 112, Day 182, and Day 364
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 4 Mar 2014.
Related trials for Type 1 Diabetes
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
RecruitingPhase 1
Pharmacokinetics, Safety, and Immunogenicity Comparison of Bmab1700 and Opdivo® as Adjuvant Monotherapy in Participants With Melanoma
Melanoma
Active, not recruitingPhase 2
A Study of Botensilimab and Balstilimab for the Treatment of Colorectal Cancer
Metastatic Colorectal Cancer
Not yet recruiting
Inter-Arm Differences in Continuous Glucose Monitor Readings in Adults With Diabetes
Continuous Glucose Monitoring, Type 1 Diabetes
RecruitingObservational study
Estimated Risk of Preeclampsia in the First Trimester and Its Association With Subclinical Atherosclerosis and Cardiovascular Risk in Women With Type 1 Diabetes
Type 1 Diabetes, Preeclampsia
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.
Marc Donath, MD principal investigator
UniversitaetsSpital Zuerich
2 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 052 in people with Type 1 Diabetes, run by XOMA (US) LLC at 2 sites in Switzerland.
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 8 inclusion and 15 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 4 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Switzerland. 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. Some participants in this study may receive a placebo. 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?
Change in beta-cell function as measured by change in C-peptide level during thd MMTT (Mixed meal tolerance test) at Day 112 compared to baseline (Day 0 pre-dose) (time frame: Day 0 pre-dose and Day 112). 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 4 Mar 2014.