Diabetes Mellitus Type 2Phase 4NCT02655770
Effect of Liraglutide on Diastolic Dysfunction on Cardiac MRI in Type 2 Diabetes Patients
A Phase 4 study testing Liraglutide in people with Diabetes Mellitus Type 2 and Diastolic Dysfunction, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
Trial summary
The purpose of this study is to determine whether liraglutide a GLP-1 analogue are effective in the treatment of diastolic dysfunction in type 2 diabetes patients analyzed by cardiac MRI. Secondary if the treatment has any effect on the perfusion of the heart on a cardiac-MRI. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Diabetes Mellitus Type 2, Diastolic Dysfunction, Cardiac MRI
- What is being tested?
- Liraglutide
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteDenmark
- Study dates
- Feb 2016to Dec 2019
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female patient fully capable of informed consent
- Informed consent
- Age 18-80 years (both years inclusive)
- T2DM diagnosed at least 3 months prior to visit 0
- NYHA class I-III at visit 0
- E/e* ≥ 9 or e* (lateral) ≤10 cm/sec, or both
Show all 11Show fewer
- LVEF > 50%
- LVEDV/BSA < 97 ml/m2
- Stable on heart medication for 6 weeks prior to randomisation
- Stable on antidiabetic treatment for 30 days prior to randomisation
- T2DM must be either treated with one or more oral anti-diabetic drugs or treated with human NPH-insulin or long-acting insulin analogue, alone or in combination with oral drugs
Who cannot join
- Lack of consent.
- NYHA class IV
- Type 1 diabetes mellitus
- Incretin-based therapy (GLP-1 receptor agonists; exenatide, liraglutide or other and DPP-IV inhibitors) within 30 days prior to randomisation (visit 1)
- Glitazon therapy within 30 days prior to randomisation (visit 1)
- Hypertension with inadequate blood pressure control: Systolic blood pressure > 140 mmHg and/or diastolic blood pressure >85 mmHg*
Show all 36Show fewer
- Supine systolic blood pressure <85 mmHg measured at visit 0
- Significant valvular heart disease
- Hypertrophic cardiomyopathy, ARVC/D, non-compaction or amyloidosis
- Myocardial infarction, unstable angina, angina on exertion (≥CCS class 2) or coronary revascularization within 3 months prior to randomisation (visit 1)
- Hospitalisation due to incompensated heart disease within 30 days to randomisation (visit 1)
- HbA1c >10% at visit 0
- eGFR< 60 ml/min/1,73 m2 at visit 0
- Liver disease with aspartate aminotransferase/alanine aminotransferase >3 times upper limit of normal measured at visit 0**
- Hypokalaemia (P-potassium <3.5 mmol/L) or hyperkalaemia (P-potassium >5.5 mmol/L) measured at visit 0**
- Anaemia (haemoglobin <6.5 mmol/L) measured at visit 0**
- Conditions that may be associated with changes in markers of fibroses or collagen turnover (eg. on-going or active rheumatological disease requiring anti-inflammatory agents, immunosuppression, pulmonary fibrosis, active cancer)
- Prolonged use (> 2 weeks) of glucocorticoids or NSAIDs within 2 weeks prior to visit 0
- Women of childbearing potential who are not on acceptable contraception. See below.
- Pregnant or breastfeeding women
- Cancer (except basal cell skin cancer or squamous cell skin cancer) unless complete remission for ≥ 5 years
- Alcohol/drug abuse
- Chronic or previous acute pancreatitis
- History of thyroid adenoma or carcinoma
- Inflammatory bowel disease
- Clinical signs of diabetic gastroparesis
- ICD/pacemaker or other contraindications to MRI scan
- Severe claustrophobia
- Atrial fibrillation
- Contraindications to glycopyrrolate: closed-angle glaucoma, prostate hyperplasia, tachycardia, bladder atony, cardia insufficiency, non-congenital pylorus stenosis and gastroparesis
- Known or suspected hypersensitivity to trial product or related products
- Current participation in any other clinical intervention trial
- Receipt of an investigational drug with 30 days prior to visit 0
- Other concominant disease or treatment that according to investigator's assessment makes the patient unsuitable for participation in the study
- Measured twice at visit 0. In case of elevation, an ambulatory (24-hour) blood pressure will be performed, and the result of this will be conclusive
- Measured at visit 0 with the possibility of one repeat analysis within a week, and the last measured value will be conclusive.
Trial locations and contacts
1 site in 1 country.
Denmark1 site
The department of cardiology, Rigshospitalet Denmark
Copenhagen Ø, 210
About this study
Official title: Influence of Liraglutide on Diastolic Cardiac Function and Myocardial Perfusion as Determined by Magnetic Resonance Imaging in Patients With Type 2 Diabetes: a Double-blind Randomized Parallel-group Trial
The purpose of this study is to determine whether liraglutide a GLP-1 analogue are effective in the treatment of diastolic dysfunction in type 2 diabetes patients analyzed by cardiac MRI. Secondary if the treatment has any effect on the perfusion of the heart on a cardiac-MRI.
Read the detailed description
Aim: To test if treatment with liraglutide a GLP-1 analogue in 18 weeks improves diastolic performance in type 2 diabetes (DM2) patients with diastolic dysfunction, compared to placebo. Furthermore, analyzing cardiac MRI indices of fibrosis and the effect on myocardial perfusion.
The investigators find that especially diastolic dysfunction is of interest, because it is highly overrepresented in DM2 patients and no treatment exists. Glucagon-like peptide 1 analogue could be a possible treatment agent, by increasing the energy level in the myocardium. No previous study has tested the effect of treatment with a glucagon-like peptide 1 analogue on diastolic dysfunction.
Design: A randomised double-blinded placebo-controlled clinical trial. Sample size: 40 patients, 20 in each group. The superior inter-study reproducibility results in considerably lower calculated sample sizes (reductions of 55% to 93%) required by cardiac MR compared with echocardiography to show clinically relevant changes. Power calculations show that only 30 patients are needed form our primary outcome, to allow for dropouts the investigators have chosen to include 40 patients.
Intervention: After randomization, patients will be treated with placebo or liraglutide (up to 1.8 mg s.c. once daily). Total treatment period will be 18 weeks. A cardiac MRI scan and an echocardiography will be preformed at baseline and after 18 weeks.
- Being tested
- Liraglutide, 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.
LiraglutideDrug
Also called Victoza
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Liraglutide arm | Active comparator | Patients will be treated with liraglutide (up to 1.8 mg s.c. once daily). Total treatment period will be 18 weeks. Receives: Drug: Liraglutide |
| Placebo arm | Placebo comparator | Patients will be treated with placebo (up to equal to 1.8 mg drug dose s.c. once daily). Total treatment period will be 18 weeks. The study will be placebo-controlled with placebo as an add-on to conventional diabetes treatment. Thus, no patient will receive a sub-standard treatment. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in diastolic properties as assessed by CMR.
LA passive emptying fraction (%) (before and after glycopyrolate)
Measured: Measured in week 18 and compared to baseline.
Change in diastolic properties as assessed by CMR.
LV peak filling rate (ml/s) (before and after glycopyrolate)
Measured: Measured in week 18 and compared to baseline.
Secondary outcomes (2)
MRI indices of myocardial perfusion
Measured: Measured in week 18 and compared to baseline.
Echocardiographic indices of diastolic dysfunction
Measured: Measured in week 18 and compared to baseline.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2016 (estimated)
- Study startFeb 2016
- Primary completionDec 2019
- Study completionDec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)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 Copenhagen University Hospital, RigshospitaletThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Collaborators
- Slagelse Hospital, Novo Nordisk A/S
- Responsible party
- Principal investigator, Annemie Stege Bojer, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Niels Vejlstrup, MD, Med.Sc.D, Study director, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02655770
- Sponsor's protocol ID
- 2015-000410-22
- Other IDs
- 2015-000410-22, 2015
- Status last verified
- Jan 2021
- First submitted
- 12 Jan 2016
- Last updated
- 14 Jan 2021
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Kannel WB, Hjortland M, Castelli WP. Role of diabetes in congestive heart failure: the Framingham study. Am J Cardiol. 1974 Jul;34(1):29-34. doi: 10.1016/0002-9149(74)90089-7. No abstract available.
PubMed 4835750Factor SM, Okun EM, Minase T. Capillary microaneurysms in the human diabetic heart. N Engl J Med. 1980 Feb 14;302(7):384-8. doi: 10.1056/NEJM198002143020706. No abstract available.
PubMed 7351930Nitenberg A, Paycha F, Ledoux S, Sachs R, Attali JR, Valensi P. Coronary artery responses to physiological stimuli are improved by deferoxamine but not by L-arginine in non-insulin-dependent diabetic patients with angiographically normal coronary arteries and no other risk factors. Circulation. 1998 Mar 3;97(8):736-43. doi: 10.1161/01.cir.97.8.736.
PubMed 9498536Rodrigues B, McNeill JH. The diabetic heart: metabolic causes for the development of a cardiomyopathy. Cardiovasc Res. 1992 Oct;26(10):913-22. doi: 10.1093/cvr/26.10.913. No abstract available.
PubMed 1486584van Heerebeek L, Hamdani N, Handoko ML, Falcao-Pires I, Musters RJ, Kupreishvili K, Ijsselmuiden AJ, Schalkwijk CG, Bronzwaer JG, Diamant M, Borbely A, van der Velden J, Stienen GJ, Laarman GJ, Niessen HW, Paulus WJ. Diastolic stiffness of the failing diabetic heart: importance of fibrosis, advanced glycation end products, and myocyte resting tension. Circulation. 2008 Jan 1;117(1):43-51. doi: 10.1161/CIRCULATIONAHA.107.728550. Epub 2007 Dec 10.
PubMed 18071071From AM, Scott CG, Chen HH. The development of heart failure in patients with diabetes mellitus and pre-clinical diastolic dysfunction a population-based study. J Am Coll Cardiol. 2010 Jan 26;55(4):300-5. doi: 10.1016/j.jacc.2009.12.003.
PubMed 20117433Yancy CW, Lopatin M, Stevenson LW, De Marco T, Fonarow GC; ADHERE Scientific Advisory Committee and Investigators. Clinical presentation, management, and in-hospital outcomes of patients admitted with acute decompensated heart failure with preserved systolic function: a report from the Acute Decompensated Heart Failure National Registry (ADHERE) Database. J Am Coll Cardiol. 2006 Jan 3;47(1):76-84. doi: 10.1016/j.jacc.2005.09.022. Epub 2005 Dec 15.
PubMed 16386668Bhashyam S, Fields AV, Patterson B, Testani JM, Chen L, Shen YT, Shannon RP. Glucagon-like peptide-1 increases myocardial glucose uptake via p38alpha MAP kinase-mediated, nitric oxide-dependent mechanisms in conscious dogs with dilated cardiomyopathy. Circ Heart Fail. 2010 Jul;3(4):512-21. doi: 10.1161/CIRCHEARTFAILURE.109.900282. Epub 2010 May 13.
PubMed 20466848Thrainsdottir I, Malmberg K, Olsson A, Gutniak M, Ryden L. Initial experience with GLP-1 treatment on metabolic control and myocardial function in patients with type 2 diabetes mellitus and heart failure. Diab Vasc Dis Res. 2004 May;1(1):40-3. doi: 10.3132/dvdr.2004.005.
PubMed 16305055Nathanson D, Ullman B, Lofstrom U, Hedman A, Frick M, Sjoholm A, Nystrom T. Effects of intravenous exenatide in type 2 diabetic patients with congestive heart failure: a double-blind, randomised controlled clinical trial of efficacy and safety. Diabetologia. 2012 Apr;55(4):926-35. doi: 10.1007/s00125-011-2440-x. Epub 2012 Jan 13.
PubMed 22246377
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Liraglutide on Diastolic Cardiac Function and Myocardial Perfusion as Determined by Magnetic Resonance Imaging in Patients With Type 2 Diabetes: a Double-blind Randomized Parallel-group Trial
- ClinicalTrials.gov ID
- NCT02655770
- Acronym / sponsor ID
- 2015-000410-22
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Collaborators
- Slagelse Hospital, Novo Nordisk A/S
- Study start
- Feb 2016 (actual)
- Primary completion
- Dec 2019 (actual)
- Study completion
- Dec 2019 (actual)
- First posted
- 14 Jan 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine whether liraglutide a GLP-1 analogue are effective in the treatment of diastolic dysfunction in type 2 diabetes patients analyzed by cardiac MRI. Secondary if the treatment has any effect on the perfusion of the heart on a cardiac-MRI.
Detailed description
Aim: To test if treatment with liraglutide a GLP-1 analogue in 18 weeks improves diastolic performance in type 2 diabetes (DM2) patients with diastolic dysfunction, compared to placebo. Furthermore, analyzing cardiac MRI indices of fibrosis and the effect on myocardial perfusion.
The investigators find that especially diastolic dysfunction is of interest, because it is highly overrepresented in DM2 patients and no treatment exists. Glucagon-like peptide 1 analogue could be a possible treatment agent, by increasing the energy level in the myocardium. No previous study has tested the effect of treatment with a glucagon-like peptide 1 analogue on diastolic dysfunction.
Design: A randomised double-blinded placebo-controlled clinical trial. Sample size: 40 patients, 20 in each group. The superior inter-study reproducibility results in considerably lower calculated sample sizes (reductions of 55% to 93%) required by cardiac MR compared with echocardiography to show clinically relevant changes. Power calculations show that only 30 patients are needed form our primary outcome, to allow for dropouts the investigators have chosen to include 40 patients.
Intervention: After randomization, patients will be treated with placebo or liraglutide (up to 1.8 mg s.c. once daily). Total treatment period will be 18 weeks. A cardiac MRI scan and an echocardiography will be preformed at baseline and after 18 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Liraglutide arm | Active comparator | Drug: LiraglutidePatients will be treated with liraglutide (up to 1.8 mg s.c. once daily). Total treatment period will be 18 weeks. |
| Placebo arm | Placebo comparator | Drug: PlaceboPatients will be treated with placebo (up to equal to 1.8 mg drug dose s.c. once daily). Total treatment period will be 18 weeks. The study will be placebo-controlled with placebo as an add-on to conventional diabetes treatment. Thus, no patient will receive a sub-standard treatment. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Male or female patient fully capable of informed consent
- Informed consent
- Age 18-80 years (both years inclusive)
- T2DM diagnosed at least 3 months prior to visit 0
- NYHA class I-III at visit 0
Key exclusion criteria (36 listed)
- Lack of consent.
- NYHA class IV
- Type 1 diabetes mellitus
- Incretin-based therapy (GLP-1 receptor agonists; exenatide, liraglutide or other and DPP-IV inhibitors) within 30 days prior to randomisation (visit 1)
- Glitazon therapy within 30 days prior to randomisation (visit 1)
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 |
|---|---|---|
| LiraglutideAlso: Victoza | Drug | Liraglutide arm |
| Placebo | Drug | Placebo arm |
Primary outcome
Change in diastolic properties as assessed by CMR.
Time frame: Measured in week 18 and compared to baseline.
LA passive emptying fraction (%) (before and after glycopyrolate)
Change in diastolic properties as assessed by CMR.
Time frame: Measured in week 18 and compared to baseline.
LV peak filling rate (ml/s) (before and after glycopyrolate)
2 secondary outcomes
MRI indices of myocardial perfusion
Time frame: Measured in week 18 and compared to baseline.
Echocardiographic indices of diastolic dysfunction
Time frame: Measured in week 18 and compared to baseline.
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 14 Jan 2021.
- Background: PubMed 4835750Kannel WB, Hjortland M, Castelli WP. Role of diabetes in congestive heart failure: the Framingham study. Am J Cardiol. 1974 Jul;34(1):29-34. doi: 10.1016/0002-9149(74)90089-7. No abstract available.
- Background: PubMed 7351930Factor SM, Okun EM, Minase T. Capillary microaneurysms in the human diabetic heart. N Engl J Med. 1980 Feb 14;302(7):384-8. doi: 10.1056/NEJM198002143020706. No abstract available.
- Background: PubMed 9498536Nitenberg A, Paycha F, Ledoux S, Sachs R, Attali JR, Valensi P. Coronary artery responses to physiological stimuli are improved by deferoxamine but not by L-arginine in non-insulin-dependent diabetic patients with angiographically normal coronary arteries and no other risk factors. Circulation. 1998 Mar 3;97(8):736-43. doi: 10.1161/01.cir.97.8.736.
- Background: PubMed 1486584Rodrigues B, McNeill JH. The diabetic heart: metabolic causes for the development of a cardiomyopathy. Cardiovasc Res. 1992 Oct;26(10):913-22. doi: 10.1093/cvr/26.10.913. No abstract available.
- Background: PubMed 18071071van Heerebeek L, Hamdani N, Handoko ML, Falcao-Pires I, Musters RJ, Kupreishvili K, Ijsselmuiden AJ, Schalkwijk CG, Bronzwaer JG, Diamant M, Borbely A, van der Velden J, Stienen GJ, Laarman GJ, Niessen HW, Paulus WJ. Diastolic stiffness of the failing diabetic heart: importance of fibrosis, advanced glycation end products, and myocyte resting tension. Circulation. 2008 Jan 1;117(1):43-51. doi: 10.1161/CIRCULATIONAHA.107.728550. Epub 2007 Dec 10.
- Background: PubMed 20117433From AM, Scott CG, Chen HH. The development of heart failure in patients with diabetes mellitus and pre-clinical diastolic dysfunction a population-based study. J Am Coll Cardiol. 2010 Jan 26;55(4):300-5. doi: 10.1016/j.jacc.2009.12.003.
- Background: PubMed 16386668Yancy CW, Lopatin M, Stevenson LW, De Marco T, Fonarow GC; ADHERE Scientific Advisory Committee and Investigators. Clinical presentation, management, and in-hospital outcomes of patients admitted with acute decompensated heart failure with preserved systolic function: a report from the Acute Decompensated Heart Failure National Registry (ADHERE) Database. J Am Coll Cardiol. 2006 Jan 3;47(1):76-84. doi: 10.1016/j.jacc.2005.09.022. Epub 2005 Dec 15.
- Background: PubMed 20466848Bhashyam S, Fields AV, Patterson B, Testani JM, Chen L, Shen YT, Shannon RP. Glucagon-like peptide-1 increases myocardial glucose uptake via p38alpha MAP kinase-mediated, nitric oxide-dependent mechanisms in conscious dogs with dilated cardiomyopathy. Circ Heart Fail. 2010 Jul;3(4):512-21. doi: 10.1161/CIRCHEARTFAILURE.109.900282. Epub 2010 May 13.
- Background: PubMed 16305055Thrainsdottir I, Malmberg K, Olsson A, Gutniak M, Ryden L. Initial experience with GLP-1 treatment on metabolic control and myocardial function in patients with type 2 diabetes mellitus and heart failure. Diab Vasc Dis Res. 2004 May;1(1):40-3. doi: 10.3132/dvdr.2004.005.
- Background: PubMed 22246377Nathanson D, Ullman B, Lofstrom U, Hedman A, Frick M, Sjoholm A, Nystrom T. Effects of intravenous exenatide in type 2 diabetic patients with congestive heart failure: a double-blind, randomised controlled clinical trial of efficacy and safety. Diabetologia. 2012 Apr;55(4):926-35. doi: 10.1007/s00125-011-2440-x. Epub 2012 Jan 13.
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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.
Niels Vejlstrup, MD, Med.Sc.D study director
Copenhagen University Hospital, Rigshospitalet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Liraglutide in people with Diabetes Mellitus Type 2 and Diastolic Dysfunction, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
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 11 inclusion and 36 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 14 Jan 2021. 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 Denmark. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Change in diastolic properties as assessed by CMR. (time frame: Measured in week 18 and compared to baseline.). 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 NCT02655770, which also lists 10 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 Jan 2021.