Type 1 DiabetesPhase 1/2DPP-ⅣLADANCT01159847

Protective Effects of Sitagliptin on β Cell Function in Patients With Adult-onset Latent Autoimmune Diabetes (LADA)

A Phase 1/2 study testing sitagliptin and Insulin in people with Type 1 Diabetes, run by European Foundation for the Study of Diabetes at 1 site in China.

Completed

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

Official record

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Trial summary

The aim of this study is to investigate the protective effects of sitagliptin on β cell function in patients with adult-onset latent autoimmune diabetes (LADA) and its mechanisms. Read more about this study

Who is it for?: Ages 25 to 70 years
Conditions the study is for: Type 1 Diabetes
What is being tested?: sitagliptin and Insulin
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 30 participants
Where: 1 siteChina
Study dates: Jan 2010to Dec 2012
Phase: Phase 1/2
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 25 to 70 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Diabetes diagnosed according to the report of WHO in 1999.
Age at onset between 25~70 years.
Disease duration of less than 3 year.
No ketoacidosis within the first 6 months after diagnosis of diabetes.
GADA positive twice within one month.
Fasting C-peptide (FCP) level of 0.2 nmol/L or more.

Who cannot join

Insulin requirements more than 0.8 units/kg/day.
Evidence of chronic infection or acute infection affected blood glucose control within 4 weeks prior to visit 1.
History of any malignancy.
Pregnancy, breastfeeding or planned pregnancy within two years.
Secondary diabetes.
Congestive heart failure requiring pharmacologic treatment.
Renal disease or renal dysfunction or diabetic nephropathy suggested by serum creatinine levels≥1.5 mg/dL (132μmol/L) for males and ≥1.4mg/dL (123μmol/L) for females or abnormal creatinine clearance at Visit 1.
Concurrent medical condition that may interfere with the interpretation of efficacy and safety data during the study.

Trial locations and contacts

1 site in 1 country.

China1 site

Diabetes Center, Institute of Metabolism and Endocrinology, Second Xiangya Hospital, Central South University
Changsha, Hunan, 410011

Other trials in China

About this study

The aim of this study is to investigate the protective effects of sitagliptin on β cell function in patients with adult-onset latent autoimmune diabetes (LADA) and its mechanisms.

Read the detailed description

Adult-onset latent autoimmune diabetes (LADA), etiologically belongs to type 1 diabetes (T1D), is characterized by the presence of islet autoantibodies, such as islet cell antibody (ICA) and glutamic acid decarboxylase antibody (GADA), and is prone to develop β-cell failure. The goals of treatment for LADA are suppression of autoimmune β cell destruction, preservation of islet function and prevention of diabetic complications. Recently two classes of compounds have been approved by the FDA as type 2 diabetes (T2D) therapeutics: the glucagon-like peptide-1 (GLP-1) receptor agonist (incretin mimetic) exenatide (Byetta) and the dipeptidyl peptidase IV (DPP-IV) inhibitor sitagliptin (Januvia) and vildagliptin (Galvus). They have been shown to reduce HbA1c, fasting glucose and to improve β cell function in T2D patients, as a mono-therapy or in combination with metformin or thiazolidinediones. Besides, in vitro studies showed incretin-based therapy can stimulate β-cell proliferation and survival, increase β cell insulin content and inhibit apoptosis. Moreover, several short-term pilot studies suggest GLP-1 may also have the potential for treating T1D. Several findings suggest that Ex-4 may also act as a regulator of the immune response in addition to its potential effects on β cell proliferation. Therefore, we hypothesized DPP-IV inhibitors might provide therapeutic advantages in T1D though no study has been reported. Besides the β cell function, another important target is insulin sensitivity. As for DPP-IV inhibitor, clinical trials demonstrated their beneficial effects on insulin sensitivity in subjects with T2D and impaired fasting glucose (IFG) and in diabetic rat model. We'd like to further explore the possible effect of sitagliptin on insulin sensitivity in LADA patients by homeostasis model assessment for insulin resistance (HOMA-IR) index and euglycemic clamp technique. In addition, the systemic inflammation associated with a wide array of plasma proteins and pro-inflammatory cytokines (i.e., C reactive protein (CRP), tumor necrosis factor-α (TNF-α), interleukin-6) play an additional role in the pathogenesis of insulin resistance in diabetes. It will be of interest to investigate the adipokines and proinflammatory cytokines after the sitagliptin therapy in the study. Hence, we aim to explore the effects of sitagliptin plus insulin on β cell function, insulin sensitivity, pro-inflammatory cytokines and immune regulation including Teff and Treg frequency, and function in patients with LADA.

Conditions: Type 1 Diabetes
Being tested: sitagliptin, Insulin
Keywords: sitagliptin, LADA, C-Peptide, Flow Cytometry, ELISPOT
Medical subject headings: Diabetes Mellitus, Type 1

What participants receive

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

sitagliptinDrug
Also called Januvia
sitagliptin tablet,100 mg p.o. qd,2 year
InsulinDrug

Study groups in NCT01159847
Study group	Role	What they receive
Sitagliptin	Experimental	Patients will receive insulin therapy with sitagliptin. Receives: Drug: sitagliptin; Drug: Insulin
Insulin	Active comparator	Patients will receive insulin therapy without sitagliptin. Receives: Drug: Insulin

What is being measured

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

The effects of sitagliptin on β cell function and insulin sensitivity of LADA patients
1. The assessment of the change of β cell function in patients with LADA treated with sitagliptin plus insulin by the standardized mixed meal stimulation test and insulin sensitivity by HOMA-IR.
2. The assessment of the change of insulin sensitivity in LADA patients by sequential insulin infusion with the euglycemic glucose clamp technique.
Measured: 2 years

Secondary outcomes (5)

The possible immunomodulatory effects of sitagliptin on LADA patients
The change of the frequency of pathogenic Teff (CD4+Th1, Th2, Th17 and CD8+) cells and CD4+CD25+Foxp3+Treg cells before and after sitagliptin treatment in LADA patients.
Measured: 2 years
The possible immunomodulatory effects of sitagliptin on LADA patients
Effect of sitagliptin on cytokine production of Teff and Treg cells before and after sitagliptin treatment in LADA patients.
Measured: 2 years
The possible immunomodulatory effects of sitagliptin on LADA patients
Effect of sitagliptin on Foxp3 mRNA expression of Treg cells and RORγT mRNA expression of Th17 cells before and after sitagliptin treatment in LADA patients.
Measured: 2 years
The possible immunomodulatory effects of sitagliptin on LADA patients
The comparison of glutamic acid decarboxylase 65 (GAD65) reactive interferon-γ-Th1, IL-4-Th2, IL-17-Th17 and IL-10-Treg cells detected by enzyme-linked immunospot (ELISPOT) before and after sitagliptin treatment in LADA patients.
Measured: 2 years
The possible immunomodulatory effects of sitagliptin on LADA patients
The change of the adiponectin, IL-6, IL-17 and CRP etc. before and after the sitagliptin treatment in LADA patients.
Measured: 2 years

Timeline

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

Jan 2010Dec 2012

First posted12 Jul 2010 (estimated)
Study startJan 2010
Primary completionJul 2012
Study completionDec 2012

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (28)Papers the sponsor has linked to this study.
Other trials for Type 1 DiabetesStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1/2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 30 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01159847
Sponsor's protocol ID: EFSD DPP-Ⅳ LADA
Acronym: DPP-ⅣLADA
Status last verified: Jul 2018
First submitted: 5 May 2010
Last updated: 31 Jul 2018
Results posted: No
Data monitoring committee: Yes

Publications

Tuomi T, Groop LC, Zimmet PZ, Rowley MJ, Knowles W, Mackay IR. Antibodies to glutamic acid decarboxylase reveal latent autoimmune diabetes mellitus in adults with a non-insulin-dependent onset of disease. Diabetes. 1993 Feb;42(2):359-62. doi: 10.2337/diab.42.2.359.
PubMed 8425674
Dupre J. Glycaemic effects of incretins in Type 1 diabetes mellitus: a concise review, with emphasis on studies in humans. Regul Pept. 2005 Jun 15;128(2):149-57. doi: 10.1016/j.regpep.2004.06.003.
PubMed 15780434
Dupre J, Behme MT, Hramiak IM, McFarlane P, Williamson MP, Zabel P, McDonald TJ. Glucagon-like peptide I reduces postprandial glycemic excursions in IDDM. Diabetes. 1995 Jun;44(6):626-30. doi: 10.2337/diab.44.6.626.
PubMed 7789625
Behme MT, Dupre J, McDonald TJ. Glucagon-like peptide 1 improved glycemic control in type 1 diabetes. BMC Endocr Disord. 2003 Apr 10;3(1):3. doi: 10.1186/1472-6823-3-3.
PubMed 12697069
Creutzfeldt WO, Kleine N, Willms B, Orskov C, Holst JJ, Nauck MA. Glucagonostatic actions and reduction of fasting hyperglycemia by exogenous glucagon-like peptide I(7-36) amide in type I diabetic patients. Diabetes Care. 1996 Jun;19(6):580-6. doi: 10.2337/diacare.19.6.580.
PubMed 8725855
Zhang J, Tokui Y, Yamagata K, Kozawa J, Sayama K, Iwahashi H, Okita K, Miuchi M, Konya H, Hamaguchi T, Namba M, Shimomura I, Miyagawa JI. Continuous stimulation of human glucagon-like peptide-1 (7-36) amide in a mouse model (NOD) delays onset of autoimmune type 1 diabetes. Diabetologia. 2007 Sep;50(9):1900-1909. doi: 10.1007/s00125-007-0737-6. Epub 2007 Jul 14.
PubMed 17632702
Pospisilik JA, Martin J, Doty T, Ehses JA, Pamir N, Lynn FC, Piteau S, Demuth HU, McIntosh CH, Pederson RA. Dipeptidyl peptidase IV inhibitor treatment stimulates beta-cell survival and islet neogenesis in streptozotocin-induced diabetic rats. Diabetes. 2003 Mar;52(3):741-50. doi: 10.2337/diabetes.52.3.741.
PubMed 12606516
Pospisilik JA, Ehses JA, Doty T, McIntosh CH, Demuth HU, Pederson RA. Dipeptidyl peptidase IV inhibition in animal models of diabetes. Adv Exp Med Biol. 2003;524:281-91. doi: 10.1007/0-306-47920-6_34. No abstract available.
PubMed 12675250
Kim SJ, Nian C, Doudet DJ, McIntosh CH. Inhibition of dipeptidyl peptidase IV with sitagliptin (MK0431) prolongs islet graft survival in streptozotocin-induced diabetic mice. Diabetes. 2008 May;57(5):1331-9. doi: 10.2337/db07-1639. Epub 2008 Feb 25.
PubMed 18299314
Flentke GR, Munoz E, Huber BT, Plaut AG, Kettner CA, Bachovchin WW. Inhibition of dipeptidyl aminopeptidase IV (DP-IV) by Xaa-boroPro dipeptides and use of these inhibitors to examine the role of DP-IV in T-cell function. Proc Natl Acad Sci U S A. 1991 Feb 15;88(4):1556-9. doi: 10.1073/pnas.88.4.1556.
PubMed 1671716
Reinhold D, Bank U, Buhling F, Lendeckel U, Faust J, Neubert K, Ansorge S. Inhibitors of dipeptidyl peptidase IV induce secretion of transforming growth factor-beta 1 in PWM-stimulated PBMC and T cells. Immunology. 1997 Jul;91(3):354-60. doi: 10.1046/j.1365-2567.1997.d01-2258.x.
PubMed 9301523
Kahne T, Neubert K, Faust J, Ansorge S. Early phosphorylation events induced by DPIV/CD26-specific inhibitors. Cell Immunol. 1998 Oct 10;189(1):60-6. doi: 10.1006/cimm.1998.1355.
PubMed 9758695
Yang Z, Zhou Z, Huang G, Ling H, Yan X, Peng J, Li X. The CD4(+) regulatory T-cells is decreased in adults with latent autoimmune diabetes. Diabetes Res Clin Pract. 2007 Apr;76(1):126-31. doi: 10.1016/j.diabres.2006.08.013. Epub 2006 Sep 26.
PubMed 17005288
Xue S, Wasserfall CH, Parker M, Brusko TM, McGrail S, McGrail K, Moore M, Campbell-Thompson M, Schatz DA, Atkinson MA, Haller MJ. Exendin-4 therapy in NOD mice with new-onset diabetes increases regulatory T cell frequency. Ann N Y Acad Sci. 2008 Dec;1150:152-6. doi: 10.1196/annals.1447.049.
PubMed 19120286
Utzschneider KM, Tong J, Montgomery B, Udayasankar J, Gerchman F, Marcovina SM, Watson CE, Ligueros-Saylan MA, Foley JE, Holst JJ, Deacon CF, Kahn SE. The dipeptidyl peptidase-4 inhibitor vildagliptin improves beta-cell function and insulin sensitivity in subjects with impaired fasting glucose. Diabetes Care. 2008 Jan;31(1):108-13. doi: 10.2337/dc07-1441. Epub 2007 Oct 1.
PubMed 17909087

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?

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Study at a glance

From the registry record, last updated by the sponsor on 31 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Protective Effects of Sitagliptin on β Cell Function in Patients With Adult-onset Latent Autoimmune Diabetes (LADA)
ClinicalTrials.gov ID: NCT01159847
Acronym / sponsor ID: DPP-ⅣLADA / EFSD DPP-Ⅳ LADA
Conditions: Type 1 Diabetes
Keywords: sitagliptin, LADA, C-Peptide, Flow Cytometry, ELISPOT
Phase: Phase 1/2
Study type: Interventional
Recruitment status: Completed
Enrolment: 30 participants (actual)
Lead sponsor: European Foundation for the Study of DiabetesUniversity, hospital or other
Collaborators: Chinese Medical Association, Eli Lilly and Company
Study start: Jan 2010
Primary completion: Jul 2012 (actual)
Study completion: Dec 2012 (actual)
First posted: 12 Jul 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 aim of this study is to investigate the protective effects of sitagliptin on β cell function in patients with adult-onset latent autoimmune diabetes (LADA) and its mechanisms.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Sitagliptin	Experimental	Drug: sitagliptin, Drug: InsulinPatients will receive insulin therapy with sitagliptin.
Insulin	Active comparator	Drug: InsulinPatients will receive insulin therapy without sitagliptin.

Who may qualify

Ages: 25 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

Diabetes diagnosed according to the report of WHO in 1999.
Age at onset between 25~70 years.
Disease duration of less than 3 year.
No ketoacidosis within the first 6 months after diagnosis of diabetes.
GADA positive twice within one month.

Key exclusion criteria (8 listed)

Insulin requirements more than 0.8 units/kg/day.
Evidence of chronic infection or acute infection affected blood glucose control within 4 weeks prior to visit 1.
History of any malignancy.
Pregnancy, breastfeeding or planned pregnancy within two years.
Secondary diabetes.

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
sitagliptinAlso: Januviasitagliptin tablet,100 mg p.o. qd,2 year	Drug	Sitagliptin
Insulin	Drug	Insulin, Sitagliptin

Primary outcome

The effects of sitagliptin on β cell function and insulin sensitivity of LADA patients
Time frame: 2 years
1. The assessment of the change of β cell function in patients with LADA treated with sitagliptin plus insulin by the standardized mixed meal stimulation test and insulin sensitivity by HOMA-IR. 2. The assessment of the change of insulin sensitivity in LADA patients by sequential insulin infusion with the euglycemic glucose clamp technique.

5 secondary outcomes

The possible immunomodulatory effects of sitagliptin on LADA patients
Time frame: 2 years
The possible immunomodulatory effects of sitagliptin on LADA patients
Time frame: 2 years
The possible immunomodulatory effects of sitagliptin on LADA patients
Time frame: 2 years
The possible immunomodulatory effects of sitagliptin on LADA patients
Time frame: 2 years
The possible immunomodulatory effects of sitagliptin on LADA patients
Time frame: 2 years

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 31 Jul 2018.
Background: PubMed 8425674Tuomi T, Groop LC, Zimmet PZ, Rowley MJ, Knowles W, Mackay IR. Antibodies to glutamic acid decarboxylase reveal latent autoimmune diabetes mellitus in adults with a non-insulin-dependent onset of disease. Diabetes. 1993 Feb;42(2):359-62. doi: 10.2337/diab.42.2.359.
Background: PubMed 15780434Dupre J. Glycaemic effects of incretins in Type 1 diabetes mellitus: a concise review, with emphasis on studies in humans. Regul Pept. 2005 Jun 15;128(2):149-57. doi: 10.1016/j.regpep.2004.06.003.
Background: PubMed 7789625Dupre J, Behme MT, Hramiak IM, McFarlane P, Williamson MP, Zabel P, McDonald TJ. Glucagon-like peptide I reduces postprandial glycemic excursions in IDDM. Diabetes. 1995 Jun;44(6):626-30. doi: 10.2337/diab.44.6.626.
Background: PubMed 12697069Behme MT, Dupre J, McDonald TJ. Glucagon-like peptide 1 improved glycemic control in type 1 diabetes. BMC Endocr Disord. 2003 Apr 10;3(1):3. doi: 10.1186/1472-6823-3-3.
Background: PubMed 8725855Creutzfeldt WO, Kleine N, Willms B, Orskov C, Holst JJ, Nauck MA. Glucagonostatic actions and reduction of fasting hyperglycemia by exogenous glucagon-like peptide I(7-36) amide in type I diabetic patients. Diabetes Care. 1996 Jun;19(6):580-6. doi: 10.2337/diacare.19.6.580.
Background: PubMed 17632702Zhang J, Tokui Y, Yamagata K, Kozawa J, Sayama K, Iwahashi H, Okita K, Miuchi M, Konya H, Hamaguchi T, Namba M, Shimomura I, Miyagawa JI. Continuous stimulation of human glucagon-like peptide-1 (7-36) amide in a mouse model (NOD) delays onset of autoimmune type 1 diabetes. Diabetologia. 2007 Sep;50(9):1900-1909. doi: 10.1007/s00125-007-0737-6. Epub 2007 Jul 14.
Background: PubMed 12606516Pospisilik JA, Martin J, Doty T, Ehses JA, Pamir N, Lynn FC, Piteau S, Demuth HU, McIntosh CH, Pederson RA. Dipeptidyl peptidase IV inhibitor treatment stimulates beta-cell survival and islet neogenesis in streptozotocin-induced diabetic rats. Diabetes. 2003 Mar;52(3):741-50. doi: 10.2337/diabetes.52.3.741.
Background: PubMed 12675250Pospisilik JA, Ehses JA, Doty T, McIntosh CH, Demuth HU, Pederson RA. Dipeptidyl peptidase IV inhibition in animal models of diabetes. Adv Exp Med Biol. 2003;524:281-91. doi: 10.1007/0-306-47920-6_34. No abstract available.
Background: PubMed 18299314Kim SJ, Nian C, Doudet DJ, McIntosh CH. Inhibition of dipeptidyl peptidase IV with sitagliptin (MK0431) prolongs islet graft survival in streptozotocin-induced diabetic mice. Diabetes. 2008 May;57(5):1331-9. doi: 10.2337/db07-1639. Epub 2008 Feb 25.
Background: PubMed 1671716Flentke GR, Munoz E, Huber BT, Plaut AG, Kettner CA, Bachovchin WW. Inhibition of dipeptidyl aminopeptidase IV (DP-IV) by Xaa-boroPro dipeptides and use of these inhibitors to examine the role of DP-IV in T-cell function. Proc Natl Acad Sci U S A. 1991 Feb 15;88(4):1556-9. doi: 10.1073/pnas.88.4.1556.
Background: PubMed 9301523Reinhold D, Bank U, Buhling F, Lendeckel U, Faust J, Neubert K, Ansorge S. Inhibitors of dipeptidyl peptidase IV induce secretion of transforming growth factor-beta 1 in PWM-stimulated PBMC and T cells. Immunology. 1997 Jul;91(3):354-60. doi: 10.1046/j.1365-2567.1997.d01-2258.x.
Background: PubMed 9758695Kahne T, Neubert K, Faust J, Ansorge S. Early phosphorylation events induced by DPIV/CD26-specific inhibitors. Cell Immunol. 1998 Oct 10;189(1):60-6. doi: 10.1006/cimm.1998.1355.

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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.

Zhiguang Zhou, M.D., Ph.D. principal investigator

Diabetes Center, Institute of Metabolism and Endocrinology, Second Xiangya Hospital, Central South University, China

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing sitagliptin and Insulin in people with Type 1 Diabetes, run by European Foundation for the Study of Diabetes at 1 site in China.

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 31 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. 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 combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The effects of sitagliptin on β cell function and insulin sensitivity of LADA patients (time frame: 2 years). 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 NCT01159847, which also lists 28 linked publications.

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 31 Jul 2018.