Type 2 DiabetesPhase 1/2NCT00513214
Safety and Pharmacokinetics Study of XOMA 052 in Subjects With Type 2 Diabetes Mellitus
A Phase 1/2 study testing XOMA 052 in people with Type 2 Diabetes, run by XOMA (US) LLC at 4 sites in United States.
Trial summary
The purpose of this study is to evaluate the safety and pharmacokinetics (PK) of XOMA 052 in subjects with stable Type 2 Diabetes Mellitus (T2D). The study is a dose-escalation study designed to evaluate route of administration (intravenous or subcutaneous), doses, and dosing regimens for future studies. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Type 2 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
- 68 participants
- Where
- 4 sitesUnited States
- Study dates
- Jul 2007to Feb 2010
- Phase
- Phase 1/2
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- American Diabetes Association (ADA) diagnostic criteria for T2D - Fasting blood glucose concentration ≥ 126 mg/dL (≥ 7.0 mmol/L) (must be measured within 35 days prior to Day 0) OR Symptoms of hyperglycemia (e.g., thirst, polyuria, weight loss, visual blurring) AND a casual/random plasma glucose value of ≥ 200 mg/dL (≥ 11.1 mmol/L) (must be measured within 35 days prior to Day 0)
- HbA1c ≥ 7.5% and ≤ 12% (DCCT standard)
- Current T2D of duration > 6 months at Screening
- T2D and other diseases must be stable. Stable disease is defined as disease that is judged stable by the investigator and which did not require a change in medications or dosing level on 4 or more consecutive days or 7 days in total within 35 days prior to Day 0.
- Age ≥ 18 and ≤ 70 at Screening
- Weight ≥ 80 lbs (36.3 kg) and ≤ 325 lbs (147.4 kg)
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- BMI ≥ 23 and ≤ 40 kg/m2
- For female subjects of child-bearing age, a negative serum pregnancy test. 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.
- Agree not to change diet and exercise regimen during the trial
Who cannot join
- Use of the following medications - Anti-inflammatory therapy other than aspirin ≤ 100 mg/day; Immunosuppressive treatment; Beta 2 and non-selective adrenergic blockers (Note: selective beta 1 blockers are permitted); Thiazolidinediones; Glucagon-like peptide (GLP) agonists including DPP4 inhibitors
- Change in medication for diabetes within 35 days prior to Day 0, defined as a change in dosing level on 4 or more consecutive days or 7 days in total
- Fasting C-peptide < 400 pM (< 1.20 μg/L)
- Hemoglobin < 8.0 g/dL, WBC < 3.0 X 103/mm3, platelet count < 125 X 103/mm3, creatinine > 1.5 mg/dL, AST/ALT > 2 X ULN, alkaline phosphatase > 2 X ULN
- Positive for GAD65 or IA-2 auto-antibodies
- Known HIV antibody, hepatitis B surface antigen, and/or hepatitis C antibody
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- History of malignancy within 5 years prior to study entry other than carcinoma in situ of the cervix, or adequately treated, non-metastatic squamous or basal cell carcinoma of the skin
- History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies
- History of tuberculosis, positive PPD test, active atopic disease requiring medication, or asthma
- Infectious disease - CRP > 30 mg/L, fever, or infection requiring treatment with antibiotics within 3 weeks prior to Screening; History of recurrent infection or predisposition to infection; Active leg or foot ulcer
- Immunodeficiency
- Female subjects who are pregnant, planning to become pregnant during the course of the study, or breast-feeding
- History or symptoms of a demyelinating disease
- Clinically significant diabetic macular edema and/or proliferative diabetic retinopathy by history or fundoscopy
- Receipt of a live (attenuated) vaccine within 3 months prior to Screening
- Major surgery within 35 days prior to Day 0
- Participation in an investigational drug or device trial within 30 days prior to Screening
- Use of a therapeutic monoclonal antibody within 90 days prior to Screening
- Any condition which, in the opinion of the investigator, would jeopardize the subject's safety following exposure to the study drug
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Study site
Escondido, California, 92026
Study site
Miami Gardens, Florida, 33169
Study site
Omaha, Nebraska, 68154
Study site
San Antonio, Texas, 78229
About this study
Official title: A Phase 1/2a, Double-blind, Placebo-controlled Study of the Safety and Pharmacokinetics of XOMA 052 in Subjects With Type 2 Diabetes Mellitus
The purpose of this study is to evaluate the safety and pharmacokinetics (PK) of XOMA 052 in subjects with stable Type 2 Diabetes Mellitus (T2D).
The study is a dose-escalation study designed to evaluate route of administration (intravenous or subcutaneous), doses, and dosing regimens for future studies.
- Conditions
- Type 2 Diabetes
- Being tested
- XOMA 052, Placebo
- Keywords
- Diabetes, Type 2, Mellitus
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
XOMA 052Drug
- Part 1, Single IV infusion at one of six dose levels (mg/kg).
- Part 2, Single SC injection at one of three dose levels (mg/kg).
- Part 3, Three biweekly SC injections at one of two dose levels (mg/kg).
PlaceboDrug
- Part 1, Single IV infusion at one of six dose levels (mg/kg).
- Part 2, Single SC injection at one of three dose levels (mg/kg).
- Part 3, Three biweekly SC injections at one of two dose levels (mg/kg).
| 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.
Safety assessed by pre- and post-treatment serial measurements of vital signs.
Measured: Part 1: Day 0 pre-treatment through Day 56. Part 2: Day 0 pre-treatment through Day 56. Part 3: Day 0 pre-treatment through Day 84.
Safety assessed by treatment-emergent adverse events.
Measured: Part 1: Day 0 post-treatment through Day 56. Part 2: Day 0 post-treatment through Day 56. Part 3: Day 0 post-treatment through Day 84.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2007 (estimated)
- Study startJul 2007
- Primary completionJun 2009
- Study completionFeb 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- XOMA (US) LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pedro Urquilla, MD, Study director, XOMA (US) LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00513214
- Sponsor's protocol ID
- X052073
- Status last verified
- Sep 2011
- First submitted
- 7 Aug 2007
- Last updated
- 4 Oct 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1/2a, Double-blind, Placebo-controlled Study of the Safety and Pharmacokinetics of XOMA 052 in Subjects With Type 2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT00513214
- Acronym / sponsor ID
- X052073
- Conditions
- Type 2 Diabetes
- Keywords
- Diabetes, Type 2, Mellitus
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- XOMA (US) LLCIndustry (pharma, biotech, devices)
- Study start
- Jul 2007
- Primary completion
- Jun 2009 (actual)
- Study completion
- Feb 2010 (actual)
- First posted
- 8 Aug 2007 (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 pharmacokinetics (PK) of XOMA 052 in subjects with stable Type 2 Diabetes Mellitus (T2D).
The study is a dose-escalation study designed to evaluate route of administration (intravenous or subcutaneous), doses, and dosing regimens for future studies.
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 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- American Diabetes Association (ADA) diagnostic criteria for T2D - Fasting blood glucose concentration ≥ 126 mg/dL (≥ 7.0 mmol/L) (must be measured within 35 days prior to Day 0) OR Symptoms of hyperglycemia (e.g., thirst, polyuria, weight loss, visual blurring) AND a casual/random plasma glucose value of ≥ 200 mg/dL (≥ 11.1 mmol/L) (must be measured within 35 days prior to Day 0)
- HbA1c ≥ 7.5% and ≤ 12% (DCCT standard)
- Current T2D of duration > 6 months at Screening
- T2D and other diseases must be stable. Stable disease is defined as disease that is judged stable by the investigator and which did not require a change in medications or dosing level on 4 or more consecutive days or 7 days in total within 35 days prior to Day 0.
- Age ≥ 18 and ≤ 70 at Screening
Key exclusion criteria (19 listed)
- Use of the following medications - Anti-inflammatory therapy other than aspirin ≤ 100 mg/day; Immunosuppressive treatment; Beta 2 and non-selective adrenergic blockers (Note: selective beta 1 blockers are permitted); Thiazolidinediones; Glucagon-like peptide (GLP) agonists including DPP4 inhibitors
- Change in medication for diabetes within 35 days prior to Day 0, defined as a change in dosing level on 4 or more consecutive days or 7 days in total
- Fasting C-peptide < 400 pM (< 1.20 μg/L)
- Hemoglobin < 8.0 g/dL, WBC < 3.0 X 103/mm3, platelet count < 125 X 103/mm3, creatinine > 1.5 mg/dL, AST/ALT > 2 X ULN, alkaline phosphatase > 2 X ULN
- Positive for GAD65 or IA-2 auto-antibodies
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 052* Part 1, Single IV infusion at one of six dose levels (mg/kg). * Part 2, Single SC injection at one of three dose levels (mg/kg). * Part 3, Three biweekly SC injections at one of two dose levels (mg/kg). | Drug | XOMA 052 |
| Placebo* Part 1, Single IV infusion at one of six dose levels (mg/kg). * Part 2, Single SC injection at one of three dose levels (mg/kg). * Part 3, Three biweekly SC injections at one of two dose levels (mg/kg). | Drug | Placebo |
Primary outcome
Safety assessed by pre- and post-treatment serial measurements of vital signs.
Time frame: Part 1: Day 0 pre-treatment through Day 56. Part 2: Day 0 pre-treatment through Day 56. Part 3: Day 0 pre-treatment through Day 84.
Safety assessed by treatment-emergent adverse events.
Time frame: Part 1: Day 0 post-treatment through Day 56. Part 2: Day 0 post-treatment through Day 56. Part 3: Day 0 post-treatment through Day 84.
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 Oct 2011.
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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.
Pedro Urquilla, MD study director
XOMA (US) LLC
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing XOMA 052 in people with Type 2 Diabetes, run by XOMA (US) LLC at 4 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 9 inclusion and 19 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 Oct 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Safety assessed by pre- and post-treatment serial measurements of vital signs. (time frame: Part 1: Day 0 pre-treatment through Day 56. Part 2: Day 0 pre-treatment through Day 56. Part 3: Day 0 pre-treatment through Day 84.). The study lists 2 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 4 Oct 2011.