Diabetes Mellitus, Type 2Phase 3NCT01734785

Safety and Efficacy of the Combination of Empagliflozin and Linagliptin Compared to Linagliptin Alone Over 24 Weeks in Patients With Type 2 Diabetes

A Phase 3 study testing Linagliptin and Empagliflozin + Linagliptin in people with Diabetes Mellitus, Type 2, run by Boehringer Ingelheim at 90 sites in 11 countries.

Completed

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

Official record

Search all trials

Trial summary

This trial compare the use of two different doses of Empagliflozin to placebo, in T2DM patients on 16 wks linagliptin treatment and metformin background therapy. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Diabetes Mellitus, Type 2
What is being tested?: Linagliptin and Empagliflozin + Linagliptin
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 607 participants
Where: 90 sitesin 11 countries
Study dates: 8 Feb 2013to 23 Mar 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 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Diagnosis of type 2 diabetes mellitus.
Male and female patients on diet and exercise regimen, pre-treated with immediate release metformin for at least 12 weeks, and patients should be on a dose higher or equal to 1500 mg/day of metformin, or maximum tolerated dose, or maximum dose as per local label.
HbA1c higher or equal to 8.0% and lower or equal to 10.5% at screening visit.
Age 18 years or more at screening.
Body Mass Index lower or equal to 45 kg/m2 at screening visit.
Signed and dated written informed consent.

Who cannot join

Uncontrolled hyperglycemia with glucose level above 270 mg/dl (above 15 mmol/dl) after an overnight fast.
Use of any other antidiabetic drug (except metformin background therapy).
Acute coronary syndrome, stroke or TIA within 3 months prior to informed consent.
Indication of liver disease.
Impaired renal function.
Gastrointestinal surgery.
Treatment with anti-obesity drugs within 3 months prior to screening, or any other treatment at the time of screening (i.e. surgery, aggressive diet regimen, etc.) leading to unstable body weight.
Current treatment with systemic steroids at time of informed consent or uncontrolled endocrine disorder except type 2 diabetes mellitus.

Trial locations and contacts

90 sites in 11 countries.

Country

City, postcode or hospital

90 sites in 11 countries

United States28 sites

1275.9.01016 Boehringer Ingelheim Investigational Site
Asheboro, North Carolina
1275.9.01029 Boehringer Ingelheim Investigational Site
Blue Ridge, Georgia
1275.9.01025 Boehringer Ingelheim Investigational Site
Burlington, North Carolina
1275.9.01031 Boehringer Ingelheim Investigational Site
Chicago, Illinois
1275.9.01010 Boehringer Ingelheim Investigational Site
Coral Gables, Florida
1275.9.01032 Boehringer Ingelheim Investigational Site
Corpus Christi, Texas
1275.9.01005 Boehringer Ingelheim Investigational Site
Corvallis, Oregon
1275.9.01018 Boehringer Ingelheim Investigational Site
Dayton, Ohio
1275.9.01013 Boehringer Ingelheim Investigational Site
Gulf Shores, Alabama
1275.9.01030 Boehringer Ingelheim Investigational Site
Houston, Texas
1275.9.01003 Boehringer Ingelheim Investigational Site
Marietta, Georgia
1275.9.01019 Boehringer Ingelheim Investigational Site
Methuen, Massachusetts
1275.9.01004 Boehringer Ingelheim Investigational Site
Miami, Florida
1275.9.01007 Boehringer Ingelheim Investigational Site
Newington, New Hampshire
1275.9.01011 Boehringer Ingelheim Investigational Site
Northglenn, Colorado
1275.9.01009 Boehringer Ingelheim Investigational Site
Norwalk, California
1275.9.01006 Boehringer Ingelheim Investigational Site
Oldsmar, Florida
1275.9.01002 Boehringer Ingelheim Investigational Site
Omaha, Nebraska
1275.9.01001 Boehringer Ingelheim Investigational Site
Palm Coast, Florida
1275.9.01027 Boehringer Ingelheim Investigational Site
Port Orange, Florida
1275.9.01021 Boehringer Ingelheim Investigational Site
San Antonio, Texas
1275.9.01015 Boehringer Ingelheim Investigational Site
San Diego, California
1275.9.01017 Boehringer Ingelheim Investigational Site
San Diego, California
1275.9.01022 Boehringer Ingelheim Investigational Site
Savannah, Georgia
1275.9.01014 Boehringer Ingelheim Investigational Site
Shelby, North Carolina
1275.9.01023 Boehringer Ingelheim Investigational Site
St Louis, Missouri
1275.9.01024 Boehringer Ingelheim Investigational Site
Troy, Michigan
1275.9.01028 Boehringer Ingelheim Investigational Site
Winston-Salem, North Carolina

Other trials in United States

South Korea9 sites

1275.9.82006 Boehringer Ingelheim Investigational Site
Daejeon
1275.9.82009 Boehringer Ingelheim Investigational Site
Deagu
1275.9.82002 Boehringer Ingelheim Investigational Site
Goyang
1275.9.82004 Boehringer Ingelheim Investigational Site
Seongnam
1275.9.82001 Boehringer Ingelheim Investigational Site
Seoul
1275.9.82005 Boehringer Ingelheim Investigational Site
Seoul
1275.9.82007 Boehringer Ingelheim Investigational Site
Seoul
1275.9.82008 Boehringer Ingelheim Investigational Site
Seoul
1275.9.82010 Boehringer Ingelheim Investigational Site
Seoul

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Spain9 sites

1275.9.34011 Boehringer Ingelheim Investigational Site
A Coruña
1275.9.34009 Boehringer Ingelheim Investigational Site
Alicante
1275.9.34005 Boehringer Ingelheim Investigational Site
Badía Del Vallès - Barcelona
1275.9.34001 Boehringer Ingelheim Investigational Site
Barcelona
1275.9.34003 Boehringer Ingelheim Investigational Site
Barcelona
1275.9.34004 Boehringer Ingelheim Investigational Site
Barcelona
1275.9.34002 Boehringer Ingelheim Investigational Site
Seville
1275.9.34010 Boehringer Ingelheim Investigational Site
Valencia
1275.9.34006 Boehringer Ingelheim Investigational Site
Vic

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New Zealand8 sites

1275.9.64005 Boehringer Ingelheim Investigational Site
Auckland, New Zealand
1275.9.64006 Boehringer Ingelheim Investigational Site
Auckland, New Zealand
1275.9.64008 Boehringer Ingelheim Investigational Site
Birkenhead Auckland
1275.9.64007 Boehringer Ingelheim Investigational Site
Christchurch Central
1275.9.64004 Boehringer Ingelheim Investigational Site
Christchurch, New Zealand
1275.9.64002 Boehringer Ingelheim Investigational Site
Otahuhu Auckland
1275.9.64001 Boehringer Ingelheim Investigational Site
Takapuna Auckland
1275.9.64003 Boehringer Ingelheim Investigational Site
Tauranga, New Zealand

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France7 sites

1275.9.33006 Boehringer Ingelheim Investigational Site
Bourg-des-Comptes
1275.9.33008 Boehringer Ingelheim Investigational Site
Dessenheim
1275.9.33003 Boehringer Ingelheim Investigational Site
La Riche
1275.9.33012 Boehringer Ingelheim Investigational Site
Paris
1275.9.33002 Boehringer Ingelheim Investigational Site
Saint-Avertin
1275.9.33005 Boehringer Ingelheim Investigational Site
Savonnières
1275.9.33004 Boehringer Ingelheim Investigational Site
Tours

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Australia6 sites

1275.9.61003 Boehringer Ingelheim Investigational Site
Carina Heights, Queensland
1275.9.61002 Boehringer Ingelheim Investigational Site
Herston, Queensland
1275.9.61009 Boehringer Ingelheim Investigational Site
Liverpool, New South Wales
1275.9.61006 Boehringer Ingelheim Investigational Site
Malvern, Victoria
1275.9.61007 Boehringer Ingelheim Investigational Site
Nedlands, Western Australia
1275.9.61001 Boehringer Ingelheim Investigational Site
St Leonards, New South Wales

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Canada6 sites

1275.9.01101 Boehringer Ingelheim Investigational Site
Burnaby, British Columbia
1275.9.01105 Boehringer Ingelheim Investigational Site
Cornwall, Ontario
1275.9.01106 Boehringer Ingelheim Investigational Site
Hamilton, Ontario
1275.9.01104 Boehringer Ingelheim Investigational Site
Toronto, Ontario
1275.9.01103 Boehringer Ingelheim Investigational Site
Victoria, British Columbia
1275.9.01102 Boehringer Ingelheim Investigational Site
Waterloo, Ontario

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Taiwan6 sites

1275.9.88606 Boehringer Ingelheim Investigational Site
Kaohsiung City
1275.9.88607 Boehringer Ingelheim Investigational Site
Kaohsiung City
1275.9.88602 Boehringer Ingelheim Investigational Site
New Taipei City
1275.9.88603 Boehringer Ingelheim Investigational Site
Taichung
1275.9.88604 Boehringer Ingelheim Investigational Site
Taichung
1275.9.88605 Boehringer Ingelheim Investigational Site
Tainan

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Brazil5 sites

1275.9.55002 Boehringer Ingelheim Investigational Site
Brasília
1275.9.55005 Boehringer Ingelheim Investigational Site
Goiânia
1275.9.55001 Boehringer Ingelheim Investigational Site
São Paulo
1275.9.55003 Boehringer Ingelheim Investigational Site
São Paulo
1275.9.55004 Boehringer Ingelheim Investigational Site
São Paulo

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Norway5 sites

1275.9.47001 Boehringer Ingelheim Investigational Site
Bergen
1275.9.47002 Boehringer Ingelheim Investigational Site
Oslo
1275.9.47003 Boehringer Ingelheim Investigational Site
Oslo
1275.9.47007 Boehringer Ingelheim Investigational Site
Oslo
1275.9.47006 Boehringer Ingelheim Investigational Site
Svelvik

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El Salvador1 site

1275.9.34008 Boehringer Ingelheim Investigational Site
Barcelona

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About this study

Official title: A Phase III, Randomised, Double-blind, Parallel Group, 24 Week Study to Evaluate Efficacy and Safety of Once Daily Empagliflozin 10 mg and 25 mg Compared to Placebo, All Administered as Oral Fixed Dose Combinations With Linagliptin 5 mg, in Patients With Type 2 Diabetes Mellitus and Insufficient Glycaemic Control After 16 Weeks Treatment With Linagliptin 5 mg Once Daily on Metformin Background Therapy.

This trial compare the use of two different doses of Empagliflozin to placebo, in T2DM patients on 16 wks linagliptin treatment and metformin background therapy.

Conditions: Diabetes Mellitus, Type 2
Being tested: Linagliptin, Empagliflozin + Linagliptin, Empagliflozin placebo + Linagliptin placebo
Medical subject headings: Diabetes Mellitus, Type 2

What participants receive

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

LinagliptinDrug
tablet
Empagliflozin + LinagliptinDrug
Fixed dose combination.
Empagliflozin + LinagliptinDrug
Fixed dose combination
Empagliflozin + LinagliptinDrug
Fixed dose combination
Empagliflozin placebo + Linagliptin placeboDrug
Matching Empagliflozin + Linagliptin low dose
Empagliflozin + LinagliptinDrug
Fixed dose combination.

Study groups in NCT01734785
Study group	Role	What they receive
Linagliptin	Active comparator	5 mg once daily Receives: Drug: Linagliptin; Drug: Empagliflozin placebo + Linagliptin placebo
Empagliflozin + Linagliptin low dose	Experimental	1 tablet once daily Receives: Drug: Empagliflozin + Linagliptin
Empagliflozin + Linagliptin high dose	Experimental	1 tablet once daily Receives: Drug: Empagliflozin + Linagliptin

What is being measured

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

HbA1c Change From Baseline After 24 Weeks Double-blind Randomized Treatment
Change from baseline in Glycated haemoglobin (HbA1c) [%] after 24 weeks of treatment with double-blind trial medication. Baseline was defined as the last observation before the first intake of any double-blind randomised trial medication. The term 'baseline' was not used to refer to measurements before the administration of open-label medication.
Measured: Baseline and 24 weeks

Secondary outcomes (2)

Fasting Plasma Glucose (FPG) Change From Baseline After 24 Weeks of Double-blind Treatment.
Change from baseline FPG (mmol/L) after 24 weeks of treatment with double-blind trial medication.
Measured: Baseline and 24 weeks
Body Weight Change From Baseline After 24 Weeks of Double-blind Treatment
Change from baseline Body weight after 24 weeks of treatment with double-blind trial medication.
Measured: Baseline and 24 weeks

Timeline

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

8 Feb 201323 Mar 2015

First posted28 Nov 2012 (estimated)
Study start8 Feb 2013
Primary completion23 Mar 2015
Study completion23 Mar 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 Mellitus, Type 2Studies of the same condition, open and under way.
More trials run by Boehringer IngelheimThe 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: Double blind
Enrolment: 607 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01734785
Sponsor's protocol ID: 1275.9
Other IDs: 2012-002270-31
Status last verified: Aug 2024
First submitted: 16 Nov 2012
Last updated: 19 Sep 2024
Results posted: Yes, on ClinicalTrials.gov

Publications

Softeland E, Meier JJ, Vangen B, Toorawa R, Maldonado-Lutomirsky M, Broedl UC. Empagliflozin as Add-on Therapy in Patients With Type 2 Diabetes Inadequately Controlled With Linagliptin and Metformin: A 24-Week Randomized, Double-Blind, Parallel-Group Trial. Diabetes Care. 2017 Feb;40(2):201-209. doi: 10.2337/dc16-1347. Epub 2016 Dec 2.
PubMed 27913576

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase III, Randomised, Double-blind, Parallel Group, 24 Week Study to Evaluate Efficacy and Safety of Once Daily Empagliflozin 10 mg and 25 mg Compared to Placebo, All Administered as Oral Fixed Dose Combinations With Linagliptin 5 mg, in Patients With Type 2 Diabetes Mellitus and Insufficient Glycaemic Control After 16 Weeks Treatment With Linagliptin 5 mg Once Daily on Metformin Background Therapy.
ClinicalTrials.gov ID: NCT01734785
Acronym / sponsor ID: 1275.9
Conditions: Diabetes Mellitus, Type 2
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 607 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Collaborators: Eli Lilly and Company
Study start: 8 Feb 2013 (actual)
Primary completion: 23 Mar 2015 (actual)
Study completion: 23 Mar 2015 (actual)
First posted: 28 Nov 2012 (estimated)
Results: Posted 18 Apr 2016

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

This trial compare the use of two different doses of Empagliflozin to placebo, in T2DM patients on 16 wks linagliptin treatment and metformin background therapy.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Number of arms: 3

Arm	Type	Receives
Linagliptin	Active comparator	Drug: Linagliptin, Drug: Empagliflozin placebo + Linagliptin placebo5 mg once daily
Empagliflozin + Linagliptin low dose	Experimental	Drug: Empagliflozin + Linagliptin1 tablet once daily
Empagliflozin + Linagliptin high dose	Experimental	Drug: Empagliflozin + Linagliptin1 tablet once daily

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

Diagnosis of type 2 diabetes mellitus.
Male and female patients on diet and exercise regimen, pre-treated with immediate release metformin for at least 12 weeks, and patients should be on a dose higher or equal to 1500 mg/day of metformin, or maximum tolerated dose, or maximum dose as per local label.
HbA1c higher or equal to 8.0% and lower or equal to 10.5% at screening visit.
Age 18 years or more at screening.
Body Mass Index lower or equal to 45 kg/m2 at screening visit.

Key exclusion criteria (8 listed)

Uncontrolled hyperglycemia with glucose level above 270 mg/dl (above 15 mmol/dl) after an overnight fast.
Use of any other antidiabetic drug (except metformin background therapy).
Acute coronary syndrome, stroke or TIA within 3 months prior to informed consent.
Indication of liver disease.
Impaired renal function.

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
Linagliptintablet	Drug	Linagliptin
Empagliflozin + LinagliptinFixed dose combination.	Drug	Empagliflozin + Linagliptin low dose
Empagliflozin + LinagliptinFixed dose combination	Drug	Empagliflozin + Linagliptin low dose
Empagliflozin + LinagliptinFixed dose combination	Drug	Empagliflozin + Linagliptin high dose
Empagliflozin placebo + Linagliptin placeboMatching Empagliflozin + Linagliptin low dose	Drug	Linagliptin
Empagliflozin + LinagliptinFixed dose combination.	Drug	Empagliflozin + Linagliptin high dose

Primary outcome

HbA1c Change From Baseline After 24 Weeks Double-blind Randomized Treatment
Time frame: Baseline and 24 weeks
Change from baseline in Glycated haemoglobin (HbA1c) [%] after 24 weeks of treatment with double-blind trial medication. Baseline was defined as the last observation before the first intake of any double-blind randomised trial medication. The term 'baseline' was not used to refer to measurements before the administration of open-label medication.

2 secondary outcomes

Fasting Plasma Glucose (FPG) Change From Baseline After 24 Weeks of Double-blind Treatment.
Time frame: Baseline and 24 weeks
Body Weight Change From Baseline After 24 Weeks of Double-blind Treatment
Time frame: Baseline and 24 weeks

Results and safety

Results posted to the registry on 18 Apr 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Empagliflozin 25 mg	0	0
Empagliflozin 10 mg	0	0
Placebo	0	0
Linagliptin 5 mg	606	333

Primary outcome: HbA1c Change From Baseline After 24 Weeks Double-blind Randomized Treatment

Time frame: Baseline and 24 weeks. Least squares mean (Standard Error). Unit: Percentage of HbA1c

Measure	Empagliflozin 25 mg n = 110	Empagliflozin 10 mg n = 109	Placebo n = 106
Value	-0.56 (0.08)	-0.65 (0.08)	0.14 (0.09)

Empagliflozin 25 mg vs Placebo: Mean Difference (Final Values): -0.70 (95% CI -0.93 to -0.46), p <0.0001, Mixed Models Analysis
Empagliflozin 10 mg vs Placebo: Mean Difference (Final Values): -0.79 (95% CI -1.02 to -0.55), p <0.0001, Mixed Models Analysis

Population analysed: The full analysis set (FAS) consisted of all patients in the treated set (TS) who had a baseline HbA1c assessment and at least 1 on-treatment HbA1c assessment during the double-blind part of the trial. Observed Case (OC): In the OC analysis, values after the use of rescue medication were set to missing.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: From first drug administration until 7 days after the last drug administration, up to 126 days (open label treatment period) and 176 days (double blind treatment period).. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Empagliflozin 25 mg	4 of 110 (3.6%)	11 of 110 (10%)	Not reported
Empagliflozin 10 mg	5 of 112 (4.5%)	19 of 112 (17%)	Not reported
Placebo	10 of 110 (9.1%)	34 of 110 (30.9%)	Not reported
Linagliptin 5 mg	18 of 606 (3%)	78 of 606 (12.9%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 27913576Softeland E, Meier JJ, Vangen B, Toorawa R, Maldonado-Lutomirsky M, Broedl UC. Empagliflozin as Add-on Therapy in Patients With Type 2 Diabetes Inadequately Controlled With Linagliptin and Metformin: A 24-Week Randomized, Double-Blind, Parallel-Group Trial. Diabetes Care. 2017 Feb;40(2):201-209. doi: 10.2337/dc16-1347. Epub 2016 Dec 2.
Related InfoLink provided by the sponsor.

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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.

Boehringer Ingelheim study chair

Boehringer Ingelheim

90 sites in 11 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Linagliptin and Empagliflozin + Linagliptin in people with Diabetes Mellitus, Type 2, run by Boehringer Ingelheim at 90 sites in 11 countries.

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 6 inclusion and 8 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 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 90 sites in United States, South Korea, Spain, New Zealand, France and 6 more countries. 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 18 Apr 2016). 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?

HbA1c Change From Baseline After 24 Weeks Double-blind Randomized Treatment (time frame: Baseline and 24 weeks). 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 NCT01734785, 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 19 Sep 2024.