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Diabetes Mellitus Type 1Phase 2LATE STAGENCT01788033

Effects of XOMA 052 on Insulin Production in Type 1 Diabetes

A Phase 2 study testing XOMA 052 in people with Diabetes Mellitus Type 1, run by University of Zurich at 1 site in Switzerland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

To assess the effects of treatment with XOMA 052 on beta-cell function and insulin production in subjects with well-controlled Type 1 diabetes. The safety, tolerability, and pharmacokinetics (PK) of XOMA 052 will also be assessed. Read more about this study

Who is it for?
Ages 18 to 55 years
Conditions the study is for
Diabetes Mellitus Type 1
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
1 siteSwitzerland
Study dates
Sep 2009to Sep 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

  • Type 1 diabetes (American Diabetes Association [ADA] criteria) of > 2 year duration that is judged to be stable by the investigator
  • No clinically significant change in treatment regimen for T1D (defined as a 20% change) during the 3 months prior to Screening
  • Age ≥ 18 years and ≤ 55 years
  • HbA1c < 7.5% for the previous two measurements including the measurement taken at Screening (both measurements must occur within 6 months prior to enrollment)
  • Positive glutamate decarboxylase-65 (GAD65) and/or IA-2 auto-antibodies
  • Body-mass index (BMI) > 18 and < 28 kg/m2
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  • Willingness to maintain current doses/regimens of vitamins and dietary supplements through the end of the study
  • For subjects with reproductive potential, a willingness to use contraceptive measures adequate to prevent the subject or the subject's partner from becoming pregnant during the study. Adequate contraceptive measures include hormonal methods used for two or more cycles prior to Screening (e.g., oral contraceptive pills, contraceptive patch, or contraceptive vaginal ring), double barrier methods (e.g., contraceptive sponge, diaphragm used in conjunction with contraceptive foam or jelly, and condom used in conjunction with contraceptive foam or jelly), intrauterine methods (IUD), sterilization (e.g., tubal ligation or a monogamous relationship with a vasectomized partner), and abstinence.
  • For females receiving hormone replacement therapy (including but not limited to oral contraceptives), must have been on a stable regimen for ≥ 6 months prior to Screening. Hormone therapy must not be initiated during the study

Who cannot join

  • Signs of current infection or history of infection during the 3 months prior to Day 0
  • Known to be positive for Hep B surface antigen (HBsAg), Hep C virus (HCV), or HIV
  • History of tuberculosis (TB) or positive PPD test. A subject who has had a positive PPD test but has completed a course of treatment for tuberculosis, had a documented vaccination against tuberculosis, or had a negative QuantiFERON®-TB test result is eligible.
  • High sensitivity C-reactive protein (hs-CRP) > 10 mg/L
  • Presence of foot, leg, or decubitus ulcers
  • Neutropenia
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  • Anemia
  • Clinically significant kidney or liver disease
  • From 1 week prior to Screening, use of anti-inflammatory therapy other than aspirin ≤ 100 mg/day or up to 5 consecutive days of treatment with non-steroidal anti-inflammatory drugs (NSAIDs) for treatment of an acute illness
  • Current immunosuppressive treatment or documented immunodeficiency
  • History of severe allergic or anaphylactic reactions
  • History of asthma requiring systemic corticosteroid therapy
  • Coronary intervention or hospitalization for cardiovascular condition within 12 months prior to Day 0
  • Uncontrolled hypertension
  • History of congestive heart failure
  • History of a coronary event within 12 months prior to Screening
  • Female subjects who are pregnant, planning to become pregnant during the course of the study, have recently delivered (within 3 month of Screening), or are breast-feeding
  • History of malignancy within 5 years prior to study entry other than carcinoma in situ of the cervix or thyroid, or adequately treated, non-metastatic squamous or basal cell carcinoma of the skin
  • Receipt of a live (attenuated) vaccine within 3 months prior to Screening
  • Use of any other investigational drug within 30 days prior to enrollment or within 5 half-lives of the investigational drug, whichever is longer
  • Any condition which, in the opinion of the investigator, would jeopardize the subject's safety following exposure to the study drug
  • Any condition (e.g., psychiatric illness) or situation that may compromise the ability of the subject to give written informed consent, may put the subject at significant risk, may confound the study results, or may interfere significantly with the subject's participation in the study

Trial locations and contacts

1 site in 1 country.

Switzerland1 site

  • University Hospital Basel

    Basel, Basel, 4031

Other trials in Switzerland

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

To assess the effects of treatment with XOMA 052 on beta-cell function and insulin production in subjects with well-controlled Type 1 diabetes. The safety, tolerability, and pharmacokinetics (PK) of XOMA 052 will also be assessed.

Being tested
XOMA 052, Placebo
Medical subject headings
Diabetes Mellitus, Type 1

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • XOMA 052Drug

    0.3 mg/kg XOMA 052. Beginning on Day 0, each subject will receive one subcutaneous (SC) injection of study drug every 4 weeks for 12 weeks, a total of four injections

  • PlaceboDrug

    0.3 mg/kg Placebo. Beginning on Day 0, each subject will receive one subcutaneous (SC) injection of study drug every 4 weeks for 12 weeks, a total of four injections

Study groups in NCT01788033
Study groupRoleWhat they receive
XOMA 052Active comparator0.3 mg/kg XOMA 052. Beginning on Day 0, each subject will receive one subcutaneous (SC) injection of study drug every 4 weeks for 12 weeks, a total of four injections
Receives: Drug: XOMA 052
PlaceboPlacebo comparator0.3 mg/kg placebo. Beginning on Day 0, each subject will receive one subcutaneous (SC) injection of study drug every 4 weeks for 12 weeks, a total of four injections
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. C-peptide level

    Measured: incremental AUC over 120 minutes during the MMTT at Day 112 compared to baseline (Day 0 pre-dose

Secondary outcomes (13)

  1. Change in insulin requirements

    Measured: 3-day average daily insulin dose at baseline (Day -3 through Day -1) compared to Day 112 (Day 109 through Day 111)

  2. HbA1c levels

    Measured: from baseline (Day 0 pre-dose) at Day 112

  3. fasting glucose

    Measured: from baseline (Day 0 pre-dose) at Day 112

  4. fasting glucagon

    Measured: from baseline (Day 0 pre-dose) at Day 112

  5. cortisol

    Measured: from baseline (Day 0 pre-dose) at Day 112

  6. markers of systemic inflammation (Interleukin-6, Interleukin-8, Tumor Necrosis Factor α, hs-CRP)

    Measured: from baseline (Day 0 pre-dose) at Day 112

  7. adipokines

    Measured: from baseline (Day 0 pre-dose) at Day 112

  8. meal-stimulated Glucagon like peptide-1

    Measured: AUC over 120 minutes at Day 112 compared to baseline (Day 0 pre-dose)

  9. meal-stimulated gastric inhibitory polypeptide

    Measured: AUC over 120 minutes at Day 112 compared to baseline (Day 0 pre-dose)

  10. lipids profile

    Measured: from baseline (Day 0 pre-dose) at Day 112

  11. Change in fatigue according to the Fatigue Scale for Motor and Cognitive Functions (FSMC) questionnaire

    Measured: from baseline at Day 112

  12. Anti XOMA 052 Antibodies

    Measured: from baseline (Day 0 pre-dose) at Day 112

  13. Number of Adverse Events

    Measured: from baseline (Day 0 pre-dose) at Day 364

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Feb 2013 (estimated)
  2. Study startSep 2009
  3. Primary completionSep 2013
  4. Study completionSep 2013

Resources

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
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
22 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01788033
Sponsor's protocol ID
EK-189/10
Acronym
LATE STAGE
Status last verified
Feb 2014
First submitted
1 Feb 2013
Last updated
11 Feb 2014
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing XOMA 052 in people with Diabetes Mellitus Type 1, run by University of Zurich at 1 site 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 9 inclusion and 22 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 11 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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?

C-peptide level (time frame: incremental AUC over 120 minutes during the MMTT at Day 112 compared to baseline (Day 0 pre-dose). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01788033.

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 11 Feb 2014.

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