Type 2 Diabetes MellitusPhase 2NCT01066715
Safety and Efficacy of XOMA 052 in Subjects With Type 2 Diabetes Mellitus on Stable Metformin Monotherapy
A Phase 2 study testing XOMA 052 in people with Type 2 Diabetes Mellitus, run by XOMA (US) LLC at 67 sites in United States.
Trial summary
The study hypothesis is that XOMA 052 improves glycemic control in subjects with Type 2 Diabetes. Study X052078 is designed to establish efficacious dose(s) for future studies based on improvement in HbA1c. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Type 2 Diabetes Mellitus
- 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
- 421 participants
- Where
- 67 sitesUnited States
- Study dates
- Jan 2010to Jul 2011
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed with T2D (disease duration ≥ 6 months)
- HbA1c ≥ 6.8% and ≤ 10.0%
- Have been on a stable regimen of metformin monotherapy for at least 12 weeks prior to Day 0
- Willingness to maintain stable diet and exercise regime throughout the study
- Willingness to maintain current doses/regimens of vitamins and dietary supplements through the end of the study
Who cannot join
- Uncontrolled hypertension
- History of malignancy within 5 years
- History of allergic or anaphylactic reactions to humanized or murine monoclonal antibodies
- Advanced stage heart failure (New York Heart Association [NYHA] class 3 or 4)
- Clinically significant uncontrolled arrhythmias
- History of tuberculosis
Show all 13Show fewer
- Active leg, foot, or decubitus ulcer
- Any significant inflammatory, rheumatologic, or systemic autoimmune disease
- History of chronic infections
- History or any symptoms of a demyelinating disease
- Major surgery within 3 months
- Female subjects who are pregnant, planning to become pregnant
- Other protocol-defined inclusion/exclusion criteria may apply
Trial locations and contacts
67 sites in 1 country.
67 sites in 1 country
United States67 sites
Study site
Arlington, Texas
Study site
Arlington Heights, Illinois
Study site
Atlanta, Georgia
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Austin, Texas
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Bradenton, Florida
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Brooksville, Florida
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Burke, Virginia
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Butte, Montana
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Chandler, Arizona
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Charlotte, North Carolina
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Chicago, Illinois
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Chino, California
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Cincinnati, Ohio
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Cleveland, Ohio
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Columbia, Maryland
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Coral Gables, Florida
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DeLand, Florida
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Edina, Minnesota
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Escondido, California
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Eugene, Oregon
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Fort Lauderdale, Florida
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Greenville, North Carolina
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Greer, South Carolina
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Henderson, Nevada
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Hialeah, Florida
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Hickory, North Carolina
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Houston, Texas
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Huntsville, Alabama
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Indianapolis, Indiana
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Jacksonville, Florida
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Kettering, Ohio
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Kingsport, Tennessee
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Las Vegas, Nevada
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Los Angeles, California
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Los Gatos, California
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Lynhurst, Ohio
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Marietta, Georgia
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Mesa, Arizona
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Miami, Florida
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National City, California
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New York, New York
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Newton, Kansas
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Oklahoma City, Oklahoma
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Orem, Utah
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Oxon Hill, Maryland
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Palm Springs, California
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Phoenix, Arizona
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Port Orange, Florida
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Renton, Washington
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Rochester, New York
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Sacramento, California
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San Antonio, Texas
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San Diego, California
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St Louis, Missouri
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St. Petersburg, Florida
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Statesville, North Carolina
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Tarzana, California
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Tempe, Arizona
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Virginia Beach, Virginia
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Wadsworth, Ohio
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Walunt Creek, California
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West Jordan, Utah
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West Palm Beach, Florida
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Willoughby Hills, Ohio
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Wilmington, North Carolina
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Wilson, North Carolina
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Winston-Salem, North Carolina
About this study
Official title: A Randomized, Double-blind, Placebo-controlled, Dose-ranging Study of the Safety and Efficacy of XOMA 052 in Subjects With Type 2 Diabetes Mellitus on Stable Metformin Monotherapy
The study hypothesis is that XOMA 052 improves glycemic control in subjects with Type 2 Diabetes.
Study X052078 is designed to establish efficacious dose(s) for future studies based on improvement in HbA1c.
- Conditions
- Type 2 Diabetes Mellitus
- 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
Sterile solution subcutaneously administered monthly for 6 months
PlaceboDrug
Sterile solution subcutaneously administered monthly for 6 months
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
| XOMA 052 | Experimental | Not described Receives: Drug: XOMA 052 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean change from baseline (Day 0 pre-dose) in HbA1c at Day 182
Measured: Day 0 pre-dose and Day 182
Secondary outcomes (5)
Safety assessed by pre- and post-treatment serial measurements of vital signs, clinical laboratory assessments, daily fasting blood glucose measured by the subject using a glucose monitor, and treatment-emergent adverse events.
Measured: Day 0 through Day 182
Diabetic parameters: mean change from baseline (Day 0 pre-dose) at measured time points
Measured: Day 0 pre-dose through Day 182
Inflammatory markers: mean change from baseline (Day 0 pre-dose) at measured time points
Measured: Day 0 pre-dose through Day 182
Markers of cardiovascular disease: mean change from baseline (Day 0 pre-dose) at measured time points
Measured: Day 0 pre-dose through Day 182
Serum levels of XOMA 052 (select sites only)
Measured: Day 28 pre-dose, Day 168 pre-dose, and Day 182
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2010 (estimated)
- Study startJan 2010
- Primary completionJul 2011
- Study completionJul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes MellitusStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 421 participants (actual)
Sponsor and investigators
- Lead sponsor
- XOMA (US) LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01066715
- Sponsor's protocol ID
- X052078
- Status last verified
- Sep 2011
- First submitted
- 8 Feb 2010
- 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 Randomized, Double-blind, Placebo-controlled, Dose-ranging Study of the Safety and Efficacy of XOMA 052 in Subjects With Type 2 Diabetes Mellitus on Stable Metformin Monotherapy
- ClinicalTrials.gov ID
- NCT01066715
- Acronym / sponsor ID
- X052078
- Conditions
- Type 2 Diabetes Mellitus
- Keywords
- Diabetes, Type 2, Mellitus
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 421 participants (actual)
- Lead sponsor
- XOMA (US) LLCIndustry (pharma, biotech, devices)
- Study start
- Jan 2010
- Primary completion
- Jul 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 10 Feb 2010 (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 improves glycemic control in subjects with Type 2 Diabetes.
Study X052078 is designed to establish efficacious dose(s) for future studies based on improvement in HbA1c.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Placebo |
| XOMA 052 | Experimental | Drug: XOMA 052 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Diagnosed with T2D (disease duration ≥ 6 months)
- HbA1c ≥ 6.8% and ≤ 10.0%
- Have been on a stable regimen of metformin monotherapy for at least 12 weeks prior to Day 0
- Willingness to maintain stable diet and exercise regime throughout the study
- Willingness to maintain current doses/regimens of vitamins and dietary supplements through the end of the study
Key exclusion criteria (13 listed)
- Uncontrolled hypertension
- History of malignancy within 5 years
- History of allergic or anaphylactic reactions to humanized or murine monoclonal antibodies
- Advanced stage heart failure (New York Heart Association [NYHA] class 3 or 4)
- Clinically significant uncontrolled arrhythmias
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 monthly for 6 months | Drug | XOMA 052 |
| PlaceboSterile solution subcutaneously administered monthly for 6 months | Drug | Placebo |
Primary outcome
Mean change from baseline (Day 0 pre-dose) in HbA1c at Day 182
Time frame: Day 0 pre-dose and Day 182
5 secondary outcomes
Safety assessed by pre- and post-treatment serial measurements of vital signs, clinical laboratory assessments, daily fasting blood glucose measured by the subject using a glucose monitor, and treatment-emergent adverse events.
Time frame: Day 0 through Day 182
Diabetic parameters: mean change from baseline (Day 0 pre-dose) at measured time points
Time frame: Day 0 pre-dose through Day 182
Inflammatory markers: mean change from baseline (Day 0 pre-dose) at measured time points
Time frame: Day 0 pre-dose through Day 182
Markers of cardiovascular disease: mean change from baseline (Day 0 pre-dose) at measured time points
Time frame: Day 0 pre-dose through Day 182
Serum levels of XOMA 052 (select sites only)
Time frame: Day 28 pre-dose, Day 168 pre-dose, and Day 182
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.
The record lists no contact. Use the official record to reach the sponsor.
67 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 2 Diabetes Mellitus, run by XOMA (US) LLC at 67 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 5 inclusion and 13 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 67 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 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?
Mean change from baseline (Day 0 pre-dose) in HbA1c at Day 182 (time frame: Day 0 pre-dose and Day 182). 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.