AzTrials
AzTrials

Type 2 DiabetesGUARDNCT05349955

Effects and Safety of Diabetic GUideline Algorithm Implementation Performed by Primary Care Physicians in the Community

A study testing Intensive guideline algorithm implementation and Conventional guideline algorithm implementation in people with Type 2 Diabetes and Cardiovascular Complication, run by Shanghai Zhongshan Hospital at 13 sites in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

The Effects and Safety of Diabetic GUideline Algorithm Implementation in the Community (GUARD-Community) study is a 2-arm, cluster-randomized control trial to evaluate the effect and safety of guideline algorithm intervention performed by primary care physicians on cardiovascular and renal outcomes in elderly patients… Read more about this study

Who is it for?
Ages 65 years and older
What is being tested?
Intensive guideline algorithm implementation and Conventional guideline algorithm implementation
Could I receive a placebo?
No, everyone receives an active treatment
How many people
5,600 participants
Where
13 sitesChina
Study dates
21 Nov 2022to 30 Nov 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

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 65 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • ①Males or females aged 65 and above (≥65) receive treatment from the local community health service center;
  • ②Diagnosed type 2 diabetes (ADA criteria):
  • A. Typical symptoms of diabetes + random blood sugar ≥ 11.1mmol/L;
  • B. Fasting blood glucose (FPG) ≥ 7.0mmol/L (fasting blood glucose is defined as no caloric intake within 8 hours);
  • C. Oral glucose tolerance test 2h blood glucose (OGTT) ≥ 11.1mmol/L (2h after meal);
  • D. have been treated with antidiabetic drugs;
Show all 12Show fewer
  • Each blood sugar test must be repeated to confirm the diagnosis;
  • ③Complicated with chronic kidney disease and/or very high/high risk of cardiovascular disease, meet any one of the following:
  • A. ASCVD, including coronary heart disease, cerebral infarction, peripheral vascular disease;
  • B. Or target organ damage (albuminuria, renal impairment with eGFR ≥ 30 ml/min/1.73m2, left ventricular hypertrophy or retinopathy);
  • C. ≥ 3 major risk factors (age ≥ 65 years old, hypertension, dyslipidemia, smoking, obesity );
  • D. Diabetes duration ≥ 10 years, with any one traditional cardiovascular risk factor such as advanced age, obesity, smoking, sedentary, family history of cardiovascular disease, hypertension, abnormal lipid metabolism.

Who cannot join

  • ①Pregnant women or women planning to become pregnant;
  • ②eGFR<30 mL/min/1.73m2 (CKD-EPI formula);
  • ③Patient cannot be followed up for 36 months (due to health condition or migration);
  • ④Unwilling or unable to sign the informed consent;
  • ⑤Type 1 diabetes;

Trial locations and contacts

13 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Xiaoying Li, MD contact

13651913857

li.xiaoying@zs-hospital.sh.cn

Xiaomu Li, MD contact

13661676591

li.xiaomu@zs-hospital.sh.cn

13 sites in 1 country

China13 sites, 13 recruiting

  • Xiangcheng Second People's Hospital

    Suzhou, Jaingsu, 215501

    Recruiting

  • Caohu Community Healthcare Center

    Suzhou, Jiangsu, 215006

    Recruiting

  • Huangqiao Community Healthcare Center

    Suzhou, Jiangsu, 215006

    Recruiting

  • Xiangcheng People's Hospital.

    Suzhou, Jiangsu, 215131

    Xuefei Xu, Bachelor, 18818211531, pyu15@fudan.edu.cn

    Recruiting

  • Yuanhe Community Healthcare Center

    Suzhou, Jiangsu, 215131

    Recruiting

  • Xiangcheng Third People's Hospital

    Suzhou, Jiangsu, 215134

    Recruiting

  • Taiping Community Healthcare Center

    Suzhou, Jiangsu, 215137

    Xuejian Ni, Bachelor, 2314831056@qq.com

    Recruiting

  • Yangchenghu People's Hospital

    Suzhou, Jiangsu, 215138

    Recruiting

  • Health Center of Xiangcheng Tourism Resort

    Suzhou, Jiangsu, 215141

    Recruiting

  • Caohu People's Hospital

    Suzhou, Jiangsu, 215144

    Recruiting

  • Dongqiao Community Healthcare Center

    Suzhou, Jiangsu, 215152

    Recruiting

  • Xiangcheng Traditional Chinese Medicine Hospital

    Suzhou, Jiangsu, 215155

    Jichao Yu, Bachelor, 344314300@qq.com

    Recruiting

  • Chengyang Community Healthcare Center

    Suzhou, Jiangsu

    Recruiting

Other trials in China

About this study

Official title: Effects and Safety of GUideline Algorithm Based Intervention on CaRdiovascular and Renal Outcomes in Elderly Diabetic Patients With High Cardiovascular Risk in the Community- A Cluster Randomized Controlled Trial (GUARD-Community Study)

The Effects and Safety of Diabetic GUideline Algorithm Implementation in the Community (GUARD-Community) study is a 2-arm, cluster-randomized control trial to evaluate the effect and safety of guideline algorithm intervention performed by primary care physicians on cardiovascular and renal outcomes in elderly patients with high risk in community.

Read the detailed description

Diabetes is an important public health concern. Elderly diabetic patients are characterized by a long duration and complications, including chronic kidney disease and/or cardiovascular disease. In the past 30 years, the guidelines of CDS, EASD or ADA have been frequently updated. The latest guideline on pharmacological algorithm recommend that patients with cardiovascular, renal disease or very high/high CV risk patients should be treated with anti-diabetic drugs presenting target organ protection, including SGLT2i and GLP1RA. And the guideline recommend comprehensive control of the cardiovascular risk factors, such as hypertension and dyslipidemia.

This GUARD-Community study is a community based cluster-randomized controlled trial and will enroll 5600 or more participants in more than 120 clusters aged ≥ 65 years with T2DM and complicated with high/very high cardiovascular risk factors . The trial will evaluate the the effects and safety of intensive "Guideline" algorithm implementation on CVD and renal outcomes. The primary hypothesis is that guideline algorithm intervention implemented by primary care physicians will significantly reduce the risk of 4-point MACE (comprised of cardiovascular death, nonfatal myocardial infarction, nonfatal stroke or hospitalization of heart failure) rates. In Phase 1 study, the control of blood sugar, blood pressure and lipids will be evaluated at 18 months after intervention. In Phase 2 study, the CVD and renal outcomes will be evaluated at 3 years. The study will last for 4 years.

Being tested
Intensive guideline algorithm implementation, Conventional guideline algorithm implementation
Keywords
Diabetes implementation study, Diabetes guideline algorithm, Cardiovascular disease, Chronic kidney disease
Medical subject headings
Diabetes Mellitus, Type 2, Diabetic Nephropathies, Cardiovascular Diseases, Renal Insufficiency, Chronic

What participants receive

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

  • Intensive guideline algorithm implementationOther

    Diabetes guideline pharmacological algorithm will be implemented by primary care physicians in community. In brief, SGLT2i or GLP-1RA will be recommended to control blood glucose in priority when subjects at very high/high CV risk and meet the target HbA1C<7%, control blood pressure <130/80mmHg， LDL-c<1.8mmol/L at very high CV risk patients or <2.6mmol/L at high CV risk patients, and antiplatelet as secondary prevention of ASCVD.

  • Conventional guideline algorithm implementationOther

    The guideline intervention is based the guidance which the local physicians followed through self learning and education. The management of diabetes paitients will be decided by local physicians.

Study groups in NCT05349955
Study groupRoleWhat they receive
Intensive guideline algorithm implementationExperimentalSGLT2i or GLP-1RA recommended in priority in subjects at very high/high CV risk. The targets of intervention will be achieved at HbA1C <7%, blood pressure <130/80mmHg， LDL-c<1.8mmol/L at very high CV risk or <2.6mmol/L at high CV risk patients, antiplatelet as secondary prevention of ASCVD.
Receives: Other: Intensive guideline algorithm implementation
Conventional guideline algorithm implementationActive comparatorTreatment based on the current approaches implemented by local physicians(primary care physicians). Guideline based education and consults will be conducted to primary care physicians.
Receives: Other: Conventional guideline algorithm implementation

What is being measured

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

  1. Primary Outcome of Phase 1: Comprehensive management effect of various cardiovascular risk factors in T2D，meeting control targets for a combination of A1c, BP, LDL-C.

    The proportion of participants with HbA1C<7.0%, blood pressure< 130/80 mm Hg，LDL-c<1.8mmol/L at very high CV risk or <2.6mmol/L at high CV risk.

    Measured: 18 months since randomization

  2. Primary Outcome of Phase 2: Composite of 3P MACE and hospitalization for heart failure.

    Time to occurrence of cardiovascular and cerebrovascular death, non-fatal myocardial infarction, non-fatal Stroke, hospitalization for heart failure.

    Measured: 3 years since randomization

Secondary outcomes (22)

  1. Secondary Outcome of Phase 1: Glycemic control rate

    The proportion of participants with tight glucose control, targeting HbA1c <7.0%

    Measured: 18 months since randomization

  2. Secondary Outcome of Phase 1: Mean HbA1C changes

    Mean HbA1C changes of participants

    Measured: 18 months since randomization

  3. Secondary Outcome of Phase 1: Mean systolic and diastolic pressure changes

    Mean systolic and diastolic pressure changes of participants

    Measured: 18 months since randomization

  4. Secondary Outcome of Phase 1: Mean LDL-c changes

    Mean LDL-c changes of participants

    Measured: 18 months since randomization

  5. Secondary Outcome of Phase 1: Adherence to guideline algorithm medication recommendation rate

    Use electronic medical recorded prescription and questionnaires to assess the proportion of participants who adhere to guideline recommended medication

    Measured: 18 months since randomization

  6. Secondary Outcome of Phase 2: Incident or worsening nephropathy

    Time to composite of incident macroalbuminuria (UACR >300 mg/g), a sustained decline in eGFR (decrease in the eGFR of 30% or more to a value of less than 60 when baseline ≥60ml per minute per 1.73 m2, decrease in the eGFR of 50% or more when baseline <60ml per minute per 1.73 m2)from baseline, or chronic renal replacement therapy, or renal death.

    Measured: 3 years since randomization

  7. Secondary Outcome of Phase 2: Cardiorenal composite endpoint

    Time to eGFR (CKD-EPI formula) decrease, renal replacement therapy, renal or cardiovascular death

    Measured: 3 years since randomization

  8. Secondary Outcome of Phase 2: 3P MACE

    Time to events occurence: cardiovascular death, non-fatal myocardial infarction, non-fatal stroke

    Measured: 3 years since randomization

  9. Secondary Outcome of Phase 2: New onset of macroalbuminuria.

    Time to UACR>300mg/g

    Measured: 3 years since randomization

  10. Secondary Outcome of Phase 2: Changes of myocardial ischemia in electrocardiogram (ECG)

    Participants number of ECG ischemia demonstration occurence: ST-T segment depression more than 0.1mv in two adjacent leads of ECG compared with baseline, poor R wave progression.

    Measured: 3 years since randomization

  11. Secondary Outcome of Phase 2: New onset of albuminuria

    Time to UACR increase from <30mg/g to ≥30mg/g

    Measured: 3 years since randomization

  12. Secondary Outcome of Phase 2: Albuminuria progression

    Time to albuminuria progression: UACR increased by ≥30% and grade progression (ie, from normal to micro or macro, or from micro to macro)

    Measured: 3 years since randomization

  13. Secondary Outcome of Phase 2: Albuminuria regression

    Time to albuminuria regression: UACR grade regression(ie, from macro to micro or normal, or from micro to normal), and the UACR value decreases by more than or equal to 30%

    Measured: 3 years since randomization

  14. Secondary Outcome of Phase 2: Changes in the ratio of patients with normal or abnormal urine protein at the end of the study

    Rate change of normal or abnormal UACR. Normal means UACR<30mg/g. Abnormal means UACR≥30mg/g

    Measured: 3 years since randomization

  15. Secondary Outcome of Phase 2: Slope of eGFR decline

    Decrease of the eGFR over time

    Measured: 3 years since randomization

  16. Secondary Outcome of Phase 2: Retinopathy changes

    Occurrence or regression of retinopathy(ETDRS-DRSS)

    Measured: 3 years since randomization

  17. Secondary Outcome of Phase 2: Body weight change

    Absolute weight change and the percentage change of body weight

    Measured: 3 years since randomization

  18. Secondary Outcome of Phase 2: Changes of fatty liver prevalence

    Rate change of fatty liver.

    Measured: 3 years since randomization

  19. Secondary Outcome of Phase 2: Changes in beta-cell function

    Absolute change assessed by HOMA2-%β method

    Measured: 3 years since randomization

  20. Secondary Outcome of Phase 2: Changes in cognitive function

    Improvement or progression of cognitive function: The Mini-CogTM scale

    Measured: 3 years since randomization

  21. Secondary Outcome of Phase 2: The FRAIL scale

    Changes of the simple frailty questionnaire score

    Measured: 3 years since randomization

  22. Secondary Outcome of Phase 2: All-cause death

    Time to the death due to any cause

    Measured: 3 years since randomization

Timeline

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

  1. First posted27 Apr 2022
  2. Study start21 Nov 2022
  3. Primary completion30 Nov 2026 (estimated)
  4. Study completion30 Nov 2026 (estimated)

Resources

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 N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Guideline based comprehensive management on the diabetic patients. In brief, SGLT2i or GLP-1RA will be used in priority in elderly diabetic patients with very high/high CV risk, and blood pressure controlled under 130/80mmHg， LDL-c\<1.8mmol/L in the very high-risk patients or \<2.6mmol/L in the high risk patients according to ESC/EASD guidelines.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
5,600 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05349955
Sponsor's protocol ID
ZSE 20220401
Acronym
GUARD
Status last verified
May 2025
First submitted
16 Apr 2022
Last updated
14 May 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: The data will be available from the principle investigator on reasonable request.

Publications

  • Gu TW, Zhu DL. [Interpretation of treatment part of national guideline for the prevention and control of diabetes in primary care (2018)]. Zhonghua Nei Ke Za Zhi. 2019 Jul 1;58(7):538-540. doi: 10.3760/cma.j.issn.0578-1426.2019.07.011. Chinese.

    PubMed 31269573

  • Intensive blood-glucose control with sulphonylureas or insulin compared with conventional treatment and risk of complications in patients with type 2 diabetes (UKPDS 33). UK Prospective Diabetes Study (UKPDS) Group. Lancet. 1998 Sep 12;352(9131):837-53.

    PubMed 9742976

  • Gross JL, de Azevedo MJ, Silveiro SP, Canani LH, Caramori ML, Zelmanovitz T. Diabetic nephropathy: diagnosis, prevention, and treatment. Diabetes Care. 2005 Jan;28(1):164-76. doi: 10.2337/diacare.28.1.164.

    PubMed 15616252

  • Zinman B, Wanner C, Lachin JM, Fitchett D, Bluhmki E, Hantel S, Mattheus M, Devins T, Johansen OE, Woerle HJ, Broedl UC, Inzucchi SE; EMPA-REG OUTCOME Investigators. Empagliflozin, Cardiovascular Outcomes, and Mortality in Type 2 Diabetes. N Engl J Med. 2015 Nov 26;373(22):2117-28. doi: 10.1056/NEJMoa1504720. Epub 2015 Sep 17.

    PubMed 26378978

  • Wiviott SD, Raz I, Bonaca MP, Mosenzon O, Kato ET, Cahn A, Silverman MG, Zelniker TA, Kuder JF, Murphy SA, Bhatt DL, Leiter LA, McGuire DK, Wilding JPH, Ruff CT, Gause-Nilsson IAM, Fredriksson M, Johansson PA, Langkilde AM, Sabatine MS; DECLARE-TIMI 58 Investigators. Dapagliflozin and Cardiovascular Outcomes in Type 2 Diabetes. N Engl J Med. 2019 Jan 24;380(4):347-357. doi: 10.1056/NEJMoa1812389. Epub 2018 Nov 10.

    PubMed 30415602

  • Neal B, Perkovic V, Mahaffey KW, de Zeeuw D, Fulcher G, Erondu N, Shaw W, Law G, Desai M, Matthews DR; CANVAS Program Collaborative Group. Canagliflozin and Cardiovascular and Renal Events in Type 2 Diabetes. N Engl J Med. 2017 Aug 17;377(7):644-657. doi: 10.1056/NEJMoa1611925. Epub 2017 Jun 12.

    PubMed 28605608

  • Bhatt DL, Szarek M, Steg PG, Cannon CP, Leiter LA, McGuire DK, Lewis JB, Riddle MC, Voors AA, Metra M, Lund LH, Komajda M, Testani JM, Wilcox CS, Ponikowski P, Lopes RD, Verma S, Lapuerta P, Pitt B; SOLOIST-WHF Trial Investigators. Sotagliflozin in Patients with Diabetes and Recent Worsening Heart Failure. N Engl J Med. 2021 Jan 14;384(2):117-128. doi: 10.1056/NEJMoa2030183. Epub 2020 Nov 16.

    PubMed 33200892

  • Heerspink HJL, Stefansson BV, Correa-Rotter R, Chertow GM, Greene T, Hou FF, Mann JFE, McMurray JJV, Lindberg M, Rossing P, Sjostrom CD, Toto RD, Langkilde AM, Wheeler DC; DAPA-CKD Trial Committees and Investigators. Dapagliflozin in Patients with Chronic Kidney Disease. N Engl J Med. 2020 Oct 8;383(15):1436-1446. doi: 10.1056/NEJMoa2024816. Epub 2020 Sep 24.

    PubMed 32970396

  • Perkovic V, Jardine MJ, Neal B, Bompoint S, Heerspink HJL, Charytan DM, Edwards R, Agarwal R, Bakris G, Bull S, Cannon CP, Capuano G, Chu PL, de Zeeuw D, Greene T, Levin A, Pollock C, Wheeler DC, Yavin Y, Zhang H, Zinman B, Meininger G, Brenner BM, Mahaffey KW; CREDENCE Trial Investigators. Canagliflozin and Renal Outcomes in Type 2 Diabetes and Nephropathy. N Engl J Med. 2019 Jun 13;380(24):2295-2306. doi: 10.1056/NEJMoa1811744. Epub 2019 Apr 14.

    PubMed 30990260

  • Marso SP, Daniels GH, Brown-Frandsen K, Kristensen P, Mann JF, Nauck MA, Nissen SE, Pocock S, Poulter NR, Ravn LS, Steinberg WM, Stockner M, Zinman B, Bergenstal RM, Buse JB; LEADER Steering Committee; LEADER Trial Investigators. Liraglutide and Cardiovascular Outcomes in Type 2 Diabetes. N Engl J Med. 2016 Jul 28;375(4):311-22. doi: 10.1056/NEJMoa1603827. Epub 2016 Jun 13.

    PubMed 27295427

  • Gerstein HC, Colhoun HM, Dagenais GR, Diaz R, Lakshmanan M, Pais P, Probstfield J, Riesmeyer JS, Riddle MC, Ryden L, Xavier D, Atisso CM, Dyal L, Hall S, Rao-Melacini P, Wong G, Avezum A, Basile J, Chung N, Conget I, Cushman WC, Franek E, Hancu N, Hanefeld M, Holt S, Jansky P, Keltai M, Lanas F, Leiter LA, Lopez-Jaramillo P, Cardona Munoz EG, Pirags V, Pogosova N, Raubenheimer PJ, Shaw JE, Sheu WH, Temelkova-Kurktschiev T; REWIND Investigators. Dulaglutide and cardiovascular outcomes in type 2 diabetes (REWIND): a double-blind, randomised placebo-controlled trial. Lancet. 2019 Jul 13;394(10193):121-130. doi: 10.1016/S0140-6736(19)31149-3. Epub 2019 Jun 9.

    PubMed 31189511

  • Marso SP, Bain SC, Consoli A, Eliaschewitz FG, Jodar E, Leiter LA, Lingvay I, Rosenstock J, Seufert J, Warren ML, Woo V, Hansen O, Holst AG, Pettersson J, Vilsboll T; SUSTAIN-6 Investigators. Semaglutide and Cardiovascular Outcomes in Patients with Type 2 Diabetes. N Engl J Med. 2016 Nov 10;375(19):1834-1844. doi: 10.1056/NEJMoa1607141. Epub 2016 Sep 15.

    PubMed 27633186

  • Cosentino F, Grant PJ, Aboyans V, Bailey CJ, Ceriello A, Delgado V, Federici M, Filippatos G, Grobbee DE, Hansen TB, Huikuri HV, Johansson I, Juni P, Lettino M, Marx N, Mellbin LG, Ostgren CJ, Rocca B, Roffi M, Sattar N, Seferovic PM, Sousa-Uva M, Valensi P, Wheeler DC; ESC Scientific Document Group. 2019 ESC Guidelines on diabetes, pre-diabetes, and cardiovascular diseases developed in collaboration with the EASD. Eur Heart J. 2020 Jan 7;41(2):255-323. doi: 10.1093/eurheartj/ehz486. No abstract available.

    PubMed 31497854

  • American Diabetes Association. 9. Pharmacologic Approaches to Glycemic Treatment: Standards of Medical Care in Diabetes-2021. Diabetes Care. 2021 Jan;44(Suppl 1):S111-S124. doi: 10.2337/dc21-S009.

    PubMed 33298420

  • Mosenzon O, Wiviott SD, Heerspink HJL, Dwyer JP, Cahn A, Goodrich EL, Rozenberg A, Schechter M, Yanuv I, Murphy SA, Zelniker TA, Gause-Nilsson IAM, Langkilde AM, Fredriksson M, Johansson PA, Bhatt DL, Leiter LA, McGuire DK, Wilding JPH, Sabatine MS, Raz I. The Effect of Dapagliflozin on Albuminuria in DECLARE-TIMI 58. Diabetes Care. 2021 Aug;44(8):1805-1815. doi: 10.2337/dc21-0076. Epub 2021 Jul 7.

    PubMed 34233928

Questions about this trial

What is this clinical trial studying?

A study testing Intensive guideline algorithm implementation and Conventional guideline algorithm implementation in people with Type 2 Diabetes and Cardiovascular Complication, run by Shanghai Zhongshan Hospital at 13 sites 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 12 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 14 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 sites 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.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

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

Contact Xiaoying Li, MD (13651913857, li.xiaoying@zs-hospital.sh.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Primary Outcome of Phase 1: Comprehensive management effect of various cardiovascular risk factors in T2D，meeting control targets for a combination of A1c, BP, LDL-C. (time frame: 18 months since randomization). 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 NCT05349955, which also lists 16 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 14 May 2025.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in