Diabetes MellitusPhase 2NCT00763347
Efficacy and Safety Study of SYR-619 in Treating Subjects With Type 2 Diabetes Mellitus
A Phase 2 study testing SYR-619 and Alogliptin in people with Diabetes Mellitus, run by Takeda.
Trial summary
The purpose of this study is to determine the efficacy and safety of SYR-619, once daily (QD), in subjects with type 2 diabetes mellitus who have not achieved glycemic control with diet and exercise, or by taking metformin. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Diabetes Mellitus
- What is being tested?
- SYR-619 and Alogliptin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 82 participants
- Where
- No sites listed yet
- Study dates
- Nov 2006to Feb 2007
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female, with a historical diagnosis of type 2 diabetes mellitus.
- Treatment for diabetes with either lifestyle modification or metformin or sulfonylurea alone for at least the 2 months prior to Screening; and a stable dose of either metformin or sulfonylurea for at least 12 weeks prior to randomization for subjects receiving metformin or sulfonylurea at Screening.
- Those subjects receiving metformin or sulfonylurea monotherapy at randomization must have been at least 75% compliant with their metformin or sulfonylurea regimen during the run in/stabilization period, as assessed by subject diary and investigator assessment.
- No treatment with antidiabetic agents other than metformin alone or sulfonylurea alone within the 3 months prior to Screening.
- Glycosylated hemoglobin concentration between 7.0% and 10.0%, inclusive, and a fasting plasma glucose <275 mg/dL (<15.27 mmol/L) at the Week -1 visit.
- Body mass index ≥23 and ≤45 kg/m2.
Show all 17Show fewer
- Fasting C-peptide concentration ≥0.8 ng/mL (≥0.26 nmol/L). (If this screening criterion is not met, the subject still qualifies if C-peptide ≥1.5 ng/mL [≥0.50 nmol/L] after a challenge test).
- If regular use of other non-excluded medications, must be on a stable dose for at least the 4 weeks prior to Screening. However, as needed use of prescription or over-the-counter medications is allowed at the discretion of the investigator.
- Systolic blood pressure <160 mm Hg and diastolic pressure <100 mm Hg.
- Hemoglobin ≥12 g/dL (≥120 gm/L) for males and ≥10 g/dL (≥100 gm/L) for females.
- Alanine aminotransferase ≤3 x upper limit of normal.
- Serum creatinine <1.5 mg/dL (<133 micromol/L) for males and <1.4 mg/dL (<124 micromol/L) for females.
- Urine albumin/creatinine ratio of <1000 μg/mg (113 mg/mol) at Screening. If elevated, the subject may be rescreened within 1 week.
- Thyroid-stimulating hormone level ≤ the upper limit of the normal range and the subject has normal thyroid function (clinically euthyroid)
- A female subject of childbearing potential who is sexually active must agree to use adequate contraception, and must be neither pregnant nor lactating from Screening and throughout the duration of the study.
- Able and willing to monitor their own blood glucose concentrations with a home glucose monitor.
- No major illness or debility that in the investigator's opinion prohibits the subject from completing the study.
Who cannot join
- Concurrently treated with combined metformin and sulfonylurea antidiabetic therapy.
- History of cancer, other than squamous cell or basal cell carcinoma of the skin, that has not been in full remission for at least 5 years prior to Screening.
- History of laser treatment for proliferative diabetic retinopathy within the 6 months prior to Screening.
- History of treated diabetic gastric paresis.
- New York Heart Association Class III or IV heart failure regardless of therapy.
- Currently treated subjects who are stable at Class I or II are candidates for the study.
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- History of coronary angioplasty, coronary stent placement, coronary bypass surgery, or myocardial infarction within the 6 months prior to Screening.
- History of any hemoglobinopathy that may affect determination of glycosylated hemoglobin.
- History of infection with hepatitis B, hepatitis C, or human immunodeficiency virus.
- History of a psychiatric disorder that in the investigator's opinion will affect the subject's ability to participate in the study.
- History of alcohol abuse or substance abuse within the 2 years prior to Screening.
- The subject is required to take or intends to continue taking any disallowed medication, any prescription medication, herbal treatment or over-the counter medication that may interfere with evaluation of the study medication, including:
- Treatment with antidiabetic agents other than study drug or metformin or sulfonylurea is not allowed within the 3 months prior to Screening and through the completion of the end-of-treatment/early termination procedures.
- Treatment with weight-loss drugs, any investigational antidiabetic drugs, or oral or systemically injected glucocorticoids is not allowed from 3 months prior to randomization through the completion of the end-of-treatment/early termination procedures.
- Receipt of any investigational drug within the 30 days prior to Screening or a history of receipt of an investigational antidiabetic drug within the 3 months prior to Screening.
- Prior treatment in an investigational study of SYR-619 or alogliptin.
- The subject has a known hypersensitivity to any compound related to SYR-619 or alogliptin.
About this study
Official title: A Phase 2, Double-Blind Randomized, Placebo-Controlled, Parallel Group, Multicenter Study to Evaluate Treatment With SYR-619 in Subjects With Type 2 Diabetes
The purpose of this study is to determine the efficacy and safety of SYR-619, once daily (QD), in subjects with type 2 diabetes mellitus who have not achieved glycemic control with diet and exercise, or by taking metformin.
Read the detailed description
There are approximately 19 million people in the United States who have been diagnosed with diabetes mellitus, of which 90% to 95% is type 2. The prevalence of type 2 diabetes varies among racial and ethnic populations and has been shown to correlate with age, obesity, family history, history of gestational diabetes, and physical inactivity. Over the next decade, a marked increase in the number of adults with diabetes mellitus is expected, placing an ever increasing burden on families and the health care system.
SYR-619 is an inhibitor of the dipeptidyl peptidase IV enzyme. Dipeptidyl peptidase IV is thought to be primarily responsible for the in vivo degradation of 2 peptide hormones released in response to nutrient ingestion, namely glucagon-like peptide-1 and glucose-dependent insulinotropic peptide.
The aim of this study is to evaluate the dose-response efficacy, safety and tolerability of treatment with SYR-619 in subjects with type 2 diabetes who do not previously achieve adequate glycemic control with lifestyle modification (diet/exercise) or metformin or sulfonylurea oral antidiabetic monotherapy.
Individuals who want to participate in this study will be required to provide written informed consent. Study participation is anticipated to be about 14 Weeks. Multiple procedures will occur at each visit which may include fasting, blood collection, urine collection, vital signs including sitting and standing blood pressure and pulse, body height and weight, physical examinations, electrocardiogram.
- Conditions
- Diabetes Mellitus
- Being tested
- SYR-619, Placebo, Alogliptin
- Keywords
- Glucose Metabolism Disorder, Dysmetabolic Syndrome, Type II Diabetes, Diabetes Mellitus, Lipoatrophic, Dyslipidemia, Drug Therapy
- Medical subject headings
- Diabetes Mellitus, Glucose Metabolism Disorders, Diabetes Mellitus, Type 2, Diabetes Mellitus, Lipoatrophic, Dyslipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SYR-619Drug
SYR-619 12.5 mg, tablets, orally, once daily for up to 12 weeks.
SYR-619Drug
SYR-619 50 mg, tablets, orally, once daily for up to 12 weeks.
SYR-619Drug
SYR-619 100 mg, tablets, orally, once daily for up to 12 weeks.
SYR-619Drug
SYR-619 200 mg, tablets, orally, once daily for up to 12 weeks.
PlaceboDrug
SYR-619 placebo-matching tablets, orally, once daily for up to 12 weeks.
AlogliptinDrug
Also called SYR-322
Alogliptin 25 mg, tablets, orally, once daily for up to 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| SYR-619 12.5 mg QD | Experimental | Not described Receives: Drug: SYR-619 |
| SYR-619 50 mg QD | Experimental | Not described Receives: Drug: SYR-619 |
| SYR-619 100 mg QD | Experimental | Not described Receives: Drug: SYR-619 |
| SYR-619 200 mg QD | Experimental | Not described Receives: Drug: SYR-619 |
| Placebo QD | Placebo comparator | Not described Receives: Drug: Placebo |
| Alogliptin 25 mg QD | Active comparator | Not described Receives: Drug: Alogliptin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in glycosylated hemoglobin.
Measured: Week 12 or Final Visit..
Secondary outcomes (27)
Change from baseline in glycosylated hemoglobin.
Measured: Weeks 4, 8 and 12 or Final Visit.
Change from baseline in fasting plasma glucose.
Measured: Weeks: 1, 2, 4, 8 and 12 or Final Visit.
Change from baseline in 1,5 anhydroglucitol.
Measured: Weeks 2, 4, 8 and 12 or Final Visit.
Change from baseline in proinsulin.
Measured: Weeks 4, 8 and 12 or Final Visit.
Change from baseline in insulin.
Measured: Weeks 4, 8 and 12 or Final Visit.
Change from baseline in proinsulin/insulin ratio.
Measured: Weeks 4, 8 and 12 or Final Visit.
Change from baseline in C-peptide.
Measured: Weeks 4, 8 and 12 or Final Visit.
Homeostasis model assessment insulin resistance.
Measured: Weeks 4, 8 and 12 or Final Visit.
Homeostasis model assessment beta-cell function.
Measured: Weeks 4, 8 and 12 or Final Visit.
Incidence of marked hyperglycemia (fasting plasma glucose ≥200 mg/dL [≥11.10 mmol/L]).
Measured: Weeks 1, 2, 4, 8 and 12 or Final Visit.
Incidence of rescue.
Measured: Weeks 1, 2, 4, 8 and 12 or Final Visit.
Clinical response endpoint incidence of glycosylated hemoglobin ≤6.5%.
Measured: Week 12 or Final Visit.
Clinical response endpoint incidence of glycosylated hemoglobin ≤7.0%.
Measured: Week 12 or Final Visit.
Clinical response endpoint incidence of glycosylated hemoglobin improvement ≥1.0%.
Measured: Week 12 or Final Visit.
Clinical response endpoint incidence of glycosylated hemoglobin improvement ≥1.5%.
Measured: Week 12 or Final Visit.
Clinical response endpoint incidence of glycosylated hemoglobin improvement ≥2.0%.
Measured: Week 12 or Final Visit.
Fasting lipids (triglycerides, total cholesterol, high-density lipoprotein and low-density lipoprotein cholesterol).
Measured: Weeks 4, 8, and 12 or Final Visit.
Postprandial area under the concentration-time curve and peak 2-hour values of plasma glucose, insulin and C-peptide during a 3-hour mixed-meal tolerance test in a subset of subjects.
Measured: Week 12 or Final Visit.
Plasma concentration of SYR-619.
Measured: Week 8.
Physical examination findings (including a clinical examination of skin and digits).
Measured: At All Visits
Vital sign measurements.
Measured: At All Visits
Body temperature measurements.
Measured: Week 12 or Final Visit.
12-lead electrocardiogram tracings.
Measured: Week 12 or Final Visit.
Incidence of adverse events.
Measured: At All Visits
Incidence of hypoglycemia (blood glucose <60 mg/dL [<3.33 mmol/L]) in the presence of symptoms or blood glucose <50 mg/dL [<2.78 mmol/L]) regardless of symptoms).
Measured: At All Visits
Clinical laboratory evaluations (hematology and serum chemistry).
Measured: At All Visits
Clinical laboratory evaluation (urinalysis).
Measured: Week 12 or Final Visit.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2008 (estimated)
- Study startNov 2006
- Primary completionFeb 2007
- Study completionFeb 2007
Why it stopped: Voluntarily terminated based on preliminary non-clinical findings.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by TakedaThe sponsor's other registered studies.
- 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
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- Takeda
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- VP Biological Sciences, Study director, Takeda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00763347
- Sponsor's protocol ID
- 01-06-TL-SYR-619-003
- Other IDs
- U1111-1124-2377
- Status last verified
- May 2012
- First submitted
- 26 Sep 2008
- Last updated
- 21 May 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Double-Blind Randomized, Placebo-Controlled, Parallel Group, Multicenter Study to Evaluate Treatment With SYR-619 in Subjects With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT00763347
- Acronym / sponsor ID
- 01-06-TL-SYR-619-003
- Conditions
- Diabetes Mellitus
- Keywords
- Glucose Metabolism Disorder, Dysmetabolic Syndrome, Type II Diabetes, Diabetes Mellitus, Lipoatrophic, Dyslipidemia, Drug Therapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Voluntarily terminated based on preliminary non-clinical findings.
- Enrolment
- 82 participants (actual)
- Lead sponsor
- TakedaIndustry (pharma, biotech, devices)
- Study start
- Nov 2006
- Primary completion
- Feb 2007 (actual)
- Study completion
- Feb 2007 (actual)
- First posted
- 30 Sep 2008 (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 determine the efficacy and safety of SYR-619, once daily (QD), in subjects with type 2 diabetes mellitus who have not achieved glycemic control with diet and exercise, or by taking metformin.
Detailed description
There are approximately 19 million people in the United States who have been diagnosed with diabetes mellitus, of which 90% to 95% is type 2. The prevalence of type 2 diabetes varies among racial and ethnic populations and has been shown to correlate with age, obesity, family history, history of gestational diabetes, and physical inactivity. Over the next decade, a marked increase in the number of adults with diabetes mellitus is expected, placing an ever increasing burden on families and the health care system.
SYR-619 is an inhibitor of the dipeptidyl peptidase IV enzyme. Dipeptidyl peptidase IV is thought to be primarily responsible for the in vivo degradation of 2 peptide hormones released in response to nutrient ingestion, namely glucagon-like peptide-1 and glucose-dependent insulinotropic peptide.
The aim of this study is to evaluate the dose-response efficacy, safety and tolerability of treatment with SYR-619 in subjects with type 2 diabetes who do not previously achieve adequate glycemic control with lifestyle modification (diet/exercise) or metformin or sulfonylurea oral antidiabetic monotherapy.
Individuals who want to participate in this study will be required to provide written informed consent. Study participation is anticipated to be about 14 Weeks. Multiple procedures will occur at each visit which may include fasting, blood collection, urine collection, vital signs including sitting and standing blood pressure and pulse, body height and weight, physical examinations, electrocardiogram.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| SYR-619 12.5 mg QD | Experimental | Drug: SYR-619 |
| SYR-619 50 mg QD | Experimental | Drug: SYR-619 |
| SYR-619 100 mg QD | Experimental | Drug: SYR-619 |
| SYR-619 200 mg QD | Experimental | Drug: SYR-619 |
| Placebo QD | Placebo comparator | Drug: Placebo |
| Alogliptin 25 mg QD | Active comparator | Drug: Alogliptin |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Male or female, with a historical diagnosis of type 2 diabetes mellitus.
- Treatment for diabetes with either lifestyle modification or metformin or sulfonylurea alone for at least the 2 months prior to Screening; and a stable dose of either metformin or sulfonylurea for at least 12 weeks prior to randomization for subjects receiving metformin or sulfonylurea at Screening.
- Those subjects receiving metformin or sulfonylurea monotherapy at randomization must have been at least 75% compliant with their metformin or sulfonylurea regimen during the run in/stabilization period, as assessed by subject diary and investigator assessment.
- No treatment with antidiabetic agents other than metformin alone or sulfonylurea alone within the 3 months prior to Screening.
- Glycosylated hemoglobin concentration between 7.0% and 10.0%, inclusive, and a fasting plasma glucose <275 mg/dL (<15.27 mmol/L) at the Week -1 visit.
Key exclusion criteria (17 listed)
- Concurrently treated with combined metformin and sulfonylurea antidiabetic therapy.
- History of cancer, other than squamous cell or basal cell carcinoma of the skin, that has not been in full remission for at least 5 years prior to Screening.
- History of laser treatment for proliferative diabetic retinopathy within the 6 months prior to Screening.
- History of treated diabetic gastric paresis.
- New York Heart Association Class III or IV heart failure regardless of therapy.
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 |
|---|---|---|
| SYR-619SYR-619 12.5 mg, tablets, orally, once daily for up to 12 weeks. | Drug | SYR-619 12.5 mg QD |
| SYR-619SYR-619 50 mg, tablets, orally, once daily for up to 12 weeks. | Drug | SYR-619 50 mg QD |
| SYR-619SYR-619 100 mg, tablets, orally, once daily for up to 12 weeks. | Drug | SYR-619 100 mg QD |
| SYR-619SYR-619 200 mg, tablets, orally, once daily for up to 12 weeks. | Drug | SYR-619 200 mg QD |
| PlaceboSYR-619 placebo-matching tablets, orally, once daily for up to 12 weeks. | Drug | Placebo QD |
| AlogliptinAlso: SYR-322Alogliptin 25 mg, tablets, orally, once daily for up to 12 weeks. | Drug | Alogliptin 25 mg QD |
Primary outcome
Change from baseline in glycosylated hemoglobin.
Time frame: Week 12 or Final Visit..
27 secondary outcomes
Change from baseline in glycosylated hemoglobin.
Time frame: Weeks 4, 8 and 12 or Final Visit.
Change from baseline in fasting plasma glucose.
Time frame: Weeks: 1, 2, 4, 8 and 12 or Final Visit.
Change from baseline in 1,5 anhydroglucitol.
Time frame: Weeks 2, 4, 8 and 12 or Final Visit.
Change from baseline in proinsulin.
Time frame: Weeks 4, 8 and 12 or Final Visit.
Change from baseline in insulin.
Time frame: Weeks 4, 8 and 12 or Final Visit.
Change from baseline in proinsulin/insulin ratio.
Time frame: Weeks 4, 8 and 12 or Final Visit.
Change from baseline in C-peptide.
Time frame: Weeks 4, 8 and 12 or Final Visit.
Homeostasis model assessment insulin resistance.
Time frame: Weeks 4, 8 and 12 or Final Visit.
Homeostasis model assessment beta-cell function.
Time frame: Weeks 4, 8 and 12 or Final Visit.
Incidence of marked hyperglycemia (fasting plasma glucose ≥200 mg/dL [≥11.10 mmol/L]).
Time frame: Weeks 1, 2, 4, 8 and 12 or Final Visit.
Incidence of rescue.
Time frame: Weeks 1, 2, 4, 8 and 12 or Final Visit.
Clinical response endpoint incidence of glycosylated hemoglobin ≤6.5%.
Time frame: Week 12 or Final Visit.
Clinical response endpoint incidence of glycosylated hemoglobin ≤7.0%.
Time frame: Week 12 or Final Visit.
Clinical response endpoint incidence of glycosylated hemoglobin improvement ≥1.0%.
Time frame: Week 12 or Final Visit.
Clinical response endpoint incidence of glycosylated hemoglobin improvement ≥1.5%.
Time frame: Week 12 or Final Visit.
Clinical response endpoint incidence of glycosylated hemoglobin improvement ≥2.0%.
Time frame: Week 12 or Final Visit.
Fasting lipids (triglycerides, total cholesterol, high-density lipoprotein and low-density lipoprotein cholesterol).
Time frame: Weeks 4, 8, and 12 or Final Visit.
Postprandial area under the concentration-time curve and peak 2-hour values of plasma glucose, insulin and C-peptide during a 3-hour mixed-meal tolerance test in a subset of subjects.
Time frame: Week 12 or Final Visit.
Plasma concentration of SYR-619.
Time frame: Week 8.
Physical examination findings (including a clinical examination of skin and digits).
Time frame: At All Visits
Vital sign measurements.
Time frame: At All Visits
Body temperature measurements.
Time frame: Week 12 or Final Visit.
12-lead electrocardiogram tracings.
Time frame: Week 12 or Final Visit.
Incidence of adverse events.
Time frame: At All Visits
Incidence of hypoglycemia (blood glucose <60 mg/dL [<3.33 mmol/L]) in the presence of symptoms or blood glucose <50 mg/dL [<2.78 mmol/L]) regardless of symptoms).
Time frame: At All Visits
Clinical laboratory evaluations (hematology and serum chemistry).
Time frame: At All Visits
Clinical laboratory evaluation (urinalysis).
Time frame: Week 12 or Final Visit.
Results and safety
The study was stopped early (reason given: Voluntarily terminated based on preliminary non-clinical findings.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2012.
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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.
VP Biological Sciences study director
Takeda
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SYR-619 and Alogliptin in people with Diabetes Mellitus, run by Takeda.
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 17 inclusion and 17 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: stopped early, as of the sponsor's last update on 21 May 2012. Status can change between updates, so confirm with the study contact before making plans.
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 was stopped early (reason given: Voluntarily terminated based on preliminary non-clinical findings.). Results are not available in the source record.
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 from baseline in glycosylated hemoglobin. (time frame: Week 12 or Final Visit..). 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 2012.