Diabetes MellitusPhase 3NCT01777282
A Study to Determine the Long Term Safety and Efficacy of Albiglutide in Combination With Oral Monotherapy Antihyperglycemic Medications in Japanese Patients With Type 2 Diabetes Mellitus
A Phase 3 study testing Albiglutide, Sulfonylurea and Biguanide in people with Diabetes Mellitus, run by GlaxoSmithKline at 49 sites in Japan.
Trial summary
This study is designed to examine the long term safety and efficacy of weekly subcutaneously injected albiglutide in combination with a single oral antidiabetic drug for 52 weeks in Japanese subjects with type 2 diabetes mellitus. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Diabetes Mellitus
- What is being tested?
- Albiglutide, Sulfonylurea and Biguanide
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 374 participants
- Where
- 49 sitesJapan
- Study dates
- 23 Feb 2013to 27 Jan 2015
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects with diagnosis of Type 2 Diabetes Mellitus, who are experiencing inadequate glycemic control and receiving treatment with a stable dose of a single oral antidiabetic medication
- Body mass index (BMI) 17 to 40 kg/ m2 inclusive
- Subjects with an HbA1c between 7.0% and 10.0% at Screening
- Creatinine clearance >30 mL/min (calculated using the Cockcroft-Gault formula)
Who cannot join
- History of type 1 diabetes mellitus
- Female subject is pregnant, lactating, or <6 weeks postpartum
- Clinically significant cardiovascular and/or cerebrovascular disease
- Current ongoing symptomatic biliary disease, clinical signs or symptoms of pancreatitis, or a history of chronic or acute pancreatitis, as determined by the investigator
- Serum amylase >=3 ×ULN and/or serum lipase >=2 × ULN and/or subject is experiencing any symptoms possibly related to pancreatitis
- Prior use of a GLP-1R agonist or DPP-IV inhibitor within 6 months before Screening
Trial locations and contacts
49 sites in 1 country.
49 sites in 1 country
Japan49 sites
GSK Investigational Site
Aichi, 456-0058
GSK Investigational Site
Chiba, 263-0043
GSK Investigational Site
Ehime, 792-8586
GSK Investigational Site
Fukuoka, 810-0014
GSK Investigational Site
Fukuoka, 815-8588
GSK Investigational Site
Fukuoka, 819-0168
GSK Investigational Site
Fukushima, 960-0418
GSK Investigational Site
Fukushima, 963-8851
GSK Investigational Site
Gunma, 370-3573
GSK Investigational Site
Gunma, 379-0116
GSK Investigational Site
Hokkaido, 040-8585
GSK Investigational Site
Hokkaido, 070-0002
GSK Investigational Site
Ibaraki, 300-0835
GSK Investigational Site
Ibaraki, 311-0113
GSK Investigational Site
Kagawa, 760-0076
GSK Investigational Site
Kagoshima, 890-0061
GSK Investigational Site
Kanagawa, 232-0064
GSK Investigational Site
Kanagawa, 235-0045
GSK Investigational Site
Kanagawa, 252-0302
GSK Investigational Site
Kanagawa, 253-0044
GSK Investigational Site
Kochi, 780-0088
GSK Investigational Site
Kumamoto, 862-0960
GSK Investigational Site
Kumamoto, 867-0041
GSK Investigational Site
Kyoto, 600-8558
GSK Investigational Site
Kyoto, 601-1495
GSK Investigational Site
Kyoto, 601-8325
GSK Investigational Site
Miyagi, 980-0021
GSK Investigational Site
Miyagi, 985-0852
GSK Investigational Site
Nagano, 399-0006
GSK Investigational Site
Nagano, 399-0036
GSK Investigational Site
Ōita, 870-0039
GSK Investigational Site
Okinawa, 900-0029
GSK Investigational Site
Osaka, 530-0012
GSK Investigational Site
Osaka, 536-0023
GSK Investigational Site
Osaka, 538-0044
GSK Investigational Site
Osaka, 577-0803
GSK Investigational Site
Osaka, 582-0019
GSK Investigational Site
Saitama, 332-0012
GSK Investigational Site
Saitama, 350-0035
GSK Investigational Site
Saitama, 350-0851
GSK Investigational Site
Saitama, 354-0031
GSK Investigational Site
Saitama, 355-0321
GSK Investigational Site
Saitama, 358-0011
GSK Investigational Site
Shizuoka, 424-0855
GSK Investigational Site
Tochigi, 329-0433
GSK Investigational Site
Tokyo, 103-0002
GSK Investigational Site
Tokyo, 103-0027
GSK Investigational Site
Tokyo, 125-0054
GSK Investigational Site
Tokyo, 143-0015
About this study
Official title: A 52-Week, Open-Label, Multicenter Study to Determine the Long Term Safety and Efficacy of Albiglutide in Combination With Monotherapy of Oral Antihyperglycemic Medications in Japanese Patients With Type 2 Diabetes Mellitus
This study is designed to examine the long term safety and efficacy of weekly subcutaneously injected albiglutide in combination with a single oral antidiabetic drug for 52 weeks in Japanese subjects with type 2 diabetes mellitus.
Read the detailed description
This study is designed to examine the long term safety and efficacy of weekly subcutaneously injected albiglutide in combination with a single oral antidiabetic drug for 52 weeks in Japanese subjects with type 2 diabetes mellitus. Subjects with a historical diagnosis of type 2 diabetes mellitus who are inadequately controlled on a single oral antidiabetic agent will be recruited into the study. Subjects will continue on their single antidiabetic agent and once weekly albiglutide will be added.
- Conditions
- Diabetes Mellitus
- Being tested
- Albiglutide, Sulfonylurea, Biguanide, Glinide, Thiazolidinedione
- Keywords
- albiglutide, Japanese, glucagon-like peptide-1, GSK716155
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AlbiglutideDrug
Albiglutide is a fixed-dose, fully disposable pen injector system for delivery of albiglutide from a prefilled dual chamber glass cartridge that is an integral part of the pen. It is intended for single use by the subject. It is designed for manual reconstitution of the dose, priming, and insertion of the pen needle, and manual injection by the subject. The subject will inject albiglutide 30 mg weekly for 52 weeks (with optional uptitration to 50 mg weekly) subcutaneously into the abdomen, alternating between left and right sides. The pen is designed to work with standard pen needles.
SulfonylureaDrug
Single oral antidiabetic drug as a background therapy, to be continued as previously prescribed.
BiguanideDrug
Single oral antidiabetic drug as a background therapy, to be continued as previously prescribed.
GlinideDrug
Single oral antidiabetic drug as a background therapy, to be continued as previously prescribed.
ThiazolidinedioneDrug
Single oral antidiabetic drug as a background therapy, to be continued as previously prescribed.
Alpha-glucosidase inhibitorDrug
Single oral antidiabetic drug as a background therapy, to be continued as previously prescribed.
| Study group | Role | What they receive |
|---|---|---|
| Albiglutide + Sulfonylurea | Active comparator | Albiglutide in combination with background sulfonylurea Receives: Drug: Albiglutide; Drug: Sulfonylurea |
| Albiglutide + Biguanide | Active comparator | Albiglutide in combination with background biguanide Receives: Drug: Albiglutide; Drug: Biguanide |
| Albiglutide + Glinide | Active comparator | Albiglutide in combination with background glinide Receives: Drug: Albiglutide; Drug: Glinide |
| Albiglutide + Thiazolidinedione | Active comparator | Albiglutide in combination with background thiazolidinedione Receives: Drug: Albiglutide; Drug: Thiazolidinedione |
| Albiglutide + Alpha-glucosidase inhibitor | Active comparator | Albiglutide in combination with background alpha-glucosidase inhibitor Receives: Drug: Albiglutide; Drug: Alpha-glucosidase inhibitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Any Adverse Event (AE) or Any Serious Adverse Event (SAE)
An AE is defined as any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, may jeopardize the participant or may require medical or surgical intervention to prevent one of the other outcomes listed in this definition, or is an event of possible drug-induced liver injury. Refer to the general AE/SAE module for a list of non-serious AEs and SAEs. Non-serious hypoglycemia events are not included.
Measured: From Baseline through Week 52
Number of Participants With Any Hypoglycemic Event
Hypoglycemia events are defined with respect to low plasma glucose level, mostly accompanied by typical symptoms and/or assistance needed from third party with glucose administration. These events were reported by the investigators upon verification of the plasma glucose levels, symptoms and assistance recorded by the participants, and/or plasma glucose values obtained from laboratory evaluations.
Measured: From Baseline through Week 52
Secondary outcomes (5)
Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 52
HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over a 2- to 3-month period. The Baseline HbA1c value is defined as the last non-missing value before the start of treatment. Change from Baseline was calculated as the value at Week 52 minus the value at Baseline. Participants who discontinued from study treatment before Week 52 had their last on-treatment, post-Baseline HbA1c observation carried forward for the analysis.
Measured: Baseline and Week 52
Percentage of Participants Achieving Clinically Meaningful Levels of HbA1c (i.e., the Percentage of Participants Achieving Treatment Goal of <6.5% and <7.0% at Week 52)
HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over a 2- to 3 month period. The Baseline HbA1c value is defined as the last non-missing value before the start of treatment. Participants who discontinued from study treatment before Week 52 had their last on-treatment, post-Baseline HbA1c observation carried forward for the analysis. Clinically meaningful levels of response in HbA1c are defined as <6.5% and <7.0%.
Measured: Week 52
Change From Baseline in Fasting Plasma Glucose (FPG) at Week 52
FPG is an indicator of efficacy. The Baseline FPG value is defined as the last non-missing value before the start of treatment. Change from Baseline was calculated as the FPG value at Week 52 minus the FPG value at Baseline. Participants who discontinued from study treatment before Week 52 had their last on-treatment, post-Baseline FPG observation carried forward for the analysis.
Measured: Baseline and Week 52
Change From Baseline in Body Weight at Week 52
The Baseline body weight value is defined as the last non-missing value before the start of treatment. Change from Baseline was calculated as the body weight value at Week 52 minus the value at Baseline. Participants who discontinued from study treatment before Week 52 had their last on-treatment, post-Baseline weight observation carried forward for the analysis.
Measured: Baseline and Week 52
Time to Study Withdrawal Due to Hyperglycemia
Participants who experienced persistent hyperglycemia after uptitration were to be withdrawn from the study. Hyperglycemia is defined as a fasting plasma glucose >=280 mg/dL (>=15.5 mmol/L) from >=Week 2 to <Week 12 or >=230 mg/dL (>=12.8 mmol/L) from >=Week 12 to <Week 52.
Measured: Week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2013 (estimated)
- Study start23 Feb 2013
- Primary completion27 Jan 2015
- Study completion27 Jan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 374 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01777282
- Sponsor's protocol ID
- 116170
- Status last verified
- Mar 2017
- First submitted
- 24 Jan 2013
- Last updated
- 3 May 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Yes: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Publications
Okuda I, Wilson TH, Yue L, Nakajima H, Carr MC, Tsuboi M, Nino A, Seino Y. Albiglutide, a weekly GLP-1 receptor agonist, improves glycemic parameters in Japanese patients with type 2 diabetes over 1 year when added to single oral antidiabetic drugs. Curr Med Res Opin. 2017 Mar;33(3):431-438. doi: 10.1080/03007995.2016.1261817. Epub 2016 Dec 21.
PubMed 27852119
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 52-Week, Open-Label, Multicenter Study to Determine the Long Term Safety and Efficacy of Albiglutide in Combination With Monotherapy of Oral Antihyperglycemic Medications in Japanese Patients With Type 2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT01777282
- Acronym / sponsor ID
- 116170
- Conditions
- Diabetes Mellitus
- Keywords
- albiglutide, Japanese, glucagon-like peptide-1, GSK716155
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 374 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 23 Feb 2013 (actual)
- Primary completion
- 27 Jan 2015 (actual)
- Study completion
- 27 Jan 2015 (actual)
- First posted
- 28 Jan 2013 (estimated)
- Results
- Posted 14 Oct 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is designed to examine the long term safety and efficacy of weekly subcutaneously injected albiglutide in combination with a single oral antidiabetic drug for 52 weeks in Japanese subjects with type 2 diabetes mellitus.
Detailed description
This study is designed to examine the long term safety and efficacy of weekly subcutaneously injected albiglutide in combination with a single oral antidiabetic drug for 52 weeks in Japanese subjects with type 2 diabetes mellitus. Subjects with a historical diagnosis of type 2 diabetes mellitus who are inadequately controlled on a single oral antidiabetic agent will be recruited into the study. Subjects will continue on their single antidiabetic agent and once weekly albiglutide will be added.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Albiglutide + Sulfonylurea | Active comparator | Drug: Albiglutide, Drug: SulfonylureaAlbiglutide in combination with background sulfonylurea |
| Albiglutide + Biguanide | Active comparator | Drug: Albiglutide, Drug: BiguanideAlbiglutide in combination with background biguanide |
| Albiglutide + Glinide | Active comparator | Drug: Albiglutide, Drug: GlinideAlbiglutide in combination with background glinide |
| Albiglutide + Thiazolidinedione | Active comparator | Drug: Albiglutide, Drug: ThiazolidinedioneAlbiglutide in combination with background thiazolidinedione |
| Albiglutide + Alpha-glucosidase inhibitor | Active comparator | Drug: Albiglutide, Drug: Alpha-glucosidase inhibitorAlbiglutide in combination with background alpha-glucosidase inhibitor |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Subjects with diagnosis of Type 2 Diabetes Mellitus, who are experiencing inadequate glycemic control and receiving treatment with a stable dose of a single oral antidiabetic medication
- Body mass index (BMI) 17 to 40 kg/ m2 inclusive
- Subjects with an HbA1c between 7.0% and 10.0% at Screening
- Creatinine clearance >30 mL/min (calculated using the Cockcroft-Gault formula)
Key exclusion criteria (6 listed)
- History of type 1 diabetes mellitus
- Female subject is pregnant, lactating, or <6 weeks postpartum
- Clinically significant cardiovascular and/or cerebrovascular disease
- Current ongoing symptomatic biliary disease, clinical signs or symptoms of pancreatitis, or a history of chronic or acute pancreatitis, as determined by the investigator
- Serum amylase >=3 ×ULN and/or serum lipase >=2 × ULN and/or subject is experiencing any symptoms possibly related to pancreatitis
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 |
|---|---|---|
| AlbiglutideAlbiglutide is a fixed-dose, fully disposable pen injector system for delivery of albiglutide from a prefilled dual chamber glass cartridge that is an integral part of the pen. It is intended for single use by the subject. It is designed for manual reconstitution of the dose, priming, and insertion of the pen needle, and manual injection by the subject. The subject will inject albiglutide 30 mg weekly for 52 weeks (with optional uptitration to 50 mg weekly) subcutaneously into the abdomen, alternating between left and right sides. The pen is designed to work with standard pen needles. | Drug | Albiglutide + Alpha-glucosidase inhibitor, Albiglutide + Biguanide, Albiglutide + Glinide, Albiglutide + Sulfonylurea, Albiglutide + Thiazolidinedione |
| SulfonylureaSingle oral antidiabetic drug as a background therapy, to be continued as previously prescribed. | Drug | Albiglutide + Sulfonylurea |
| BiguanideSingle oral antidiabetic drug as a background therapy, to be continued as previously prescribed. | Drug | Albiglutide + Biguanide |
| GlinideSingle oral antidiabetic drug as a background therapy, to be continued as previously prescribed. | Drug | Albiglutide + Glinide |
| ThiazolidinedioneSingle oral antidiabetic drug as a background therapy, to be continued as previously prescribed. | Drug | Albiglutide + Thiazolidinedione |
| Alpha-glucosidase inhibitorSingle oral antidiabetic drug as a background therapy, to be continued as previously prescribed. | Drug | Albiglutide + Alpha-glucosidase inhibitor |
Primary outcome
Number of Participants With Any Adverse Event (AE) or Any Serious Adverse Event (SAE)
Time frame: From Baseline through Week 52
An AE is defined as any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, may jeopardize the participant or may require medical or surgical intervention to prevent one of the other outcomes listed in this definition, or is an event of possible drug-induced liver injury. Refer to the general AE/SAE module for a list of non-serious AEs and SAEs. Non-serious hypoglycemia events are not included.
Number of Participants With Any Hypoglycemic Event
Time frame: From Baseline through Week 52
Hypoglycemia events are defined with respect to low plasma glucose level, mostly accompanied by typical symptoms and/or assistance needed from third party with glucose administration. These events were reported by the investigators upon verification of the plasma glucose levels, symptoms and assistance recorded by the participants, and/or plasma glucose values obtained from laboratory evaluations.
5 secondary outcomes
Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 52
Time frame: Baseline and Week 52
Percentage of Participants Achieving Clinically Meaningful Levels of HbA1c (i.e., the Percentage of Participants Achieving Treatment Goal of <6.5% and <7.0% at Week 52)
Time frame: Week 52
Change From Baseline in Fasting Plasma Glucose (FPG) at Week 52
Time frame: Baseline and Week 52
Change From Baseline in Body Weight at Week 52
Time frame: Baseline and Week 52
Time to Study Withdrawal Due to Hyperglycemia
Time frame: Week 52
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 27852119Okuda I, Wilson TH, Yue L, Nakajima H, Carr MC, Tsuboi M, Nino A, Seino Y. Albiglutide, a weekly GLP-1 receptor agonist, improves glycemic parameters in Japanese patients with type 2 diabetes over 1 year when added to single oral antidiabetic drugs. Curr Med Res Opin. 2017 Mar;33(3):431-438. doi: 10.1080/03007995.2016.1261817. Epub 2016 Dec 21.
- Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
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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.
GSK Clinical Trials study director
GlaxoSmithKline
49 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Albiglutide, Sulfonylurea and Biguanide in people with Diabetes Mellitus, run by GlaxoSmithKline at 49 sites in Japan.
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 4 inclusion and 6 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 3 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 49 sites in Japan. 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. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Oct 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants With Any Adverse Event (AE) or Any Serious Adverse Event (SAE) (time frame: From Baseline through Week 52). 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?
On the ClinicalTrials.gov record for NCT01777282, which also lists 1 linked publication.
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 3 May 2017.