Type1diabetesPhase 1DapaDreamNCT02987738
Pilot Study to Explore the Efficacy of DAPAglifozin as add-on to Closed-loop Control in Patients With Type 1 Diabetes
A Phase 1 study testing Dapagliflozin in people with Type1diabetes, run by Kinderkrankenhaus auf der Bult at 1 site in Germany.
Trial summary
Dapagliflozin has a unique mechanism of action that does not directly affect either insulin resistance or insulin secretion, but rather improves glycemia by reduction of glucose re-absorption from proximal renal tubules. Read more about this study
- Who is it for?
- Ages 12 to 21 years
- Conditions the study is for
- Type1diabetes
- What is being tested?
- Dapagliflozin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteGermany
- Study dates
- 9 Feb 2017to 19 Dec 2017
- Phase
- Phase 1
- 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 12 to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Male or female aged 12-21 years (both inclusive)
- Type 1 diabetes mellitus (as diagnosed clinically) ≥ 12 months
- No DKA 12 weeks prior to the study
- On CSII (insulin pump therapy) since at least 3 months
- Average daily dose of Insulin between 0.6 - 2.0 U/kg
- Body mass index 18 to 35 kg/m2 or the 10th to 99th centile for BMI according to age and gender with a minimum weight of 50kg
- A1c range 6,5% - 11% (inclusive)
Who cannot join
- History of drug or alcohol abuse within the last five years prior to screening
- Anamnestic history of hypersensitivity to the study drugs (or any component of the study drug) or to drugs with similar chemical structures
- History of severe or multiple allergies
- Treatment with any other investigational drug within 3 months prior to screening
- Progressive fatal disease
- History of significant cardiovascular, respiratory, gastrointestinal, hepatic (ALAT and/or ASAT > 3 times the normal reference range), renal (creatinine > 1.1 mg/dl in women and > 1.5 mg/dl in men), neurological, psychiatric and/or hematological disease as judged by the investigator
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- Pregnant or lactating women
- Sexually active women of childbearing potential not consistently and correctly practicing birth control by implants, injectables, combined oral contraceptives, hormonal intrauterine devices (IUDs), sexual abstinence or vasectomized partner
- Lack of compliance or other similar reason that, according to investigator, precludes satisfactory participation in the study
- Target Disease Exclusions
- History of Type 2 diabetes, maturity onset diabetes of young (MODY), pancreatic surgery or chronic pancreatitis
- Any use of oral hypoglycemic agents within 12 months prior to the screening visit
- History of diabetes ketoacidosis (DKA) within 12 weeks prior to prior to the screening visit
- History of diabetes insipidus
- History of hospital admission for glycemic control (either hyperglycemia or hypoglycemia) within 3 months prior to prior to the screening visit
- Frequent episodes of hypoglycemia as defined by more than one episode requiring assistance, emergency care (paramedics or emergency room care) or glucagon therapy, or more than 2 unexplained episodes of symptomatic hypoglycemia within 3 months prior to the screening visit. An unexplained event is defined as an event that cannot be explained by circumstances such as dietary (e.g. missed meal), strenuous exercise, error in insulin dosing, etc.
- Hypoglycemic unawareness
- History of Addison's disease or chronic adrenal insufficiency
- Physical and Laboratory Test Findings
- Aspartate aminotransferase (AST) > 2x Upper limit of normal (ULN)
- Alanine aminotransferase (ALT) > 2x ULN
- Serum total bilirubin > 2x ULN
- Estimated GFR (eGFR) by the Modification of Diet in Renal Disease (MDRD) formula ≤ 60 ml/min/1.73m2. The renal function, eGFR will be estimated by the abbreviated MDRD, using laboratory measurements of serum creatinine collected at screening [eGFR (ml/min/1.73m2) = 175 x (standardized Scr)-1.154 x (Age)-0.203 x (0.742 if female) x (1.212 if Black)].
- Hemoglobin ≤ 11.0 g/dl (110 g/l) for boys / men; hemoglobin ≤10.0 g/dl (100 g/L) for girls / women.
- Creatine kinase (CK) > 3x ULN
- Positive for hepatitis B surface antigen or anti-hepatitis C virus antibody.
- Abnormal Free T4 Note: abnormal TSH value at screening will be further evaluated for free T4. Subjects with abnormal free T4 values will be excluded. A one-time retest may be allowed, as determined by the Investigator, after a minimum of 6 weeks following the adjustment of thyroid hormone replacement therapy in subject who have had a prior diagnosis of a thyroid disorder and who are currently receiving thyroid replacement therapy. Such cases should be discussed with the Investigator prior to retesting. The subject must have all screening procedures and laboratory assessments performed as part of this re-test, and all of these must meet enrolment eligibility criteria. The subject's number will, however, remain the same as initially assigned.
- Allergies and Adverse Drug Reaction
- Allergies or contraindication to the contents of dapagliflozin tablets or insulin
- Renal, Hepatic, Hematological/Oncological Diseases/Conditions
- History of unstable or rapidly progressing renal disease
- Conditions of congenital renal glucosuria
- Renal allograft
- Significant hepatic disease, including but not limited to, chronic active hepatitis and/or severe hepatic insufficiency
- Documented history of hepatotoxicity with any medication
- Documented history of severe hepatobiliary disease
- History of hemoglobinopathy, with the exception of sickle cell trait (SA) or
- thalassemia minor; or chronic or recurrent hemolysis
- Donation of blood or blood products to a blood bank, blood transfusion, or
- participation in a clinical study requiring withdrawal of > 400 mL of blood during the 6 weeks prior to the enrolment visit
- Known immunocompromised status, including but not limited to, individuals who have
- undergone organ transplantation or who are positive for the human immunodeficiency virus
- Malignancy within 5 years of the screening visit (with the exception of treated basal cell or treated squamous cell carcinoma of the skin) Other Exclusion Criteria
- Prisoners or subjects who are involuntarily incarcerated
- Subjects who are compulsorily detained for treatment of either a psychiatric or physical (eg, infectious disease) illness
- Replacement or chronic systemic corticosteroid therapy, defined as any dose of systemic corticosteroid taken for > 4 weeks within 3 months prior to Day -3 visit.
- NOTE: Topical or inhaled corticosteroids are allowed.
- Any unstable endocrine, psychiatric, rheumatic disorders as judged by the Investigator.
- Subject is, in the judgment of the Investigator, unlikely to comply with the protocol or has any severe concurrent medical or psychological condition that may affect the interpretation of efficacy or safety data.
- Subject with any condition which, in the judgment of the Investigator, may render the subject unable to complete the study or which may pose a significant risk to the subject.
- Subject is currently abusing alcohol or other drugs or has done so within the last 6 months.
- Subject is a participating investigator, study coordinator, employee of an investigator or immediate family member of any of the aforementioned.
- Administration of any other investigational drug within 30 days of planned enrolment to this study.
- No clinical conditions or clinically significant abnormalities, in any laboratory value(s) collected after screening and prior to randomization which, in the Investigator's judgment, should preclude entry into the treatment period.
- Dosing day exclusion criteria
- Subjects who meet one or more of the dosing day exclusion criteria will be excluded from the dosing visit or withdrawn from the trial as specified below:
- Non-fasting, ie, consumption of food or beverages other than water, later than at 23:00 hours the evening before dosing.
- Clinically significant illness with onset within 4 weeks prior to dosing
- Presence of clinically significant acute gastrointestinal symptoms (eg nausea, vomiting, heartburn or diarrhoea), as judged by the investigator
- Consumption of alcohol within 24 hours prior to dosing
- Episode of severe hypoglycemia occurring within the last 24 hours prior to dosing
- Any medical condition that, in the opinion of the Investigator, could interfere with insulin pharmacokinetics and/or glucose metabolism.
- Use of the following: systemic (oral or i.v.) corticosteroids, monoamine oxidase (MAO) inhibitors, systemic non-selective beta-blockers, growth hormone, non-routine vitamins or herbal products. Furthermore, thyroid hormones are not allowed unless the subject has used stable medication during the past 3 months.
- Non-adherence to pre-dosing insulin regimen consisting of CSII
- Subjects who meet one or more of dosing day exclusion criteria will be excluded from the dosing visit. In case a subject is excluded from the dosing visit, the dosing visit can be rescheduled 1-7 days later. Each of the dosing visits can only be rescheduled once.
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Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-Blind, Placebo-controlled, Single-center, Phase 1 Inpatient Pilot Study to Explore the Safety and Efficacy of DAPAglifozin as Add-on to Day and Night Closed-loop Control in Patients Type 1 Diabetes (T1D)
Dapagliflozin has a unique mechanism of action that does not directly affect either insulin resistance or insulin secretion, but rather improves glycemia by reduction of glucose re-absorption from proximal renal tubules. Dapagliflozin is expected to reduce mean daily glucose, improve glycemic control and reduce overall insulin requirements. Improved glycemic control with reduced variability may also lead to reduced frequency of hypoglycemia.
In youth with T1D, Dapagliflozin led to a significant reduction of insulin needed to achieve target glucose irrespective of preexisting HbA1c levels.
Read more
In this pilot study data will be collected to investigate the effect on glucose of two doses of 10mg (each) dapagliflozin within range for the ensuing 24 hours during the DreaMed automated insulin delivery in patients with type 1 diabetes dosing with dapagliflozin in an in-patient setting combined with an automated sensor based CE marked insulin delivery system to data if dapagliflozin is a suitable add-on therapy. This will provide optimal monitoring of subject safety and assessment of the effects of dapagliflozin in a structured setting.
If this inpatient study shows evidence that Dapagliflozin is a suitable add on therapy and leads to an increase of time within the target glucose range when using a sensor based insulin pump therapy (closed-loop) further outpatient studies are planned to be conducted.
Read the detailed description
The purpose of this pilot study is to collect clinical data of two doses of 10mg (each) dapagliflozin as add-on to night and day closed-loop control using the DreaMed automated insulin delivery on the time [%] within glucose range 70-180 mg/dl (3.9-10mmol/l) for the ensuing 24 hours with two oral mixed-meals.
The study aimed to patients who have different degrees of inadequate glycemic control despite insulin use.
A maximum of 45 patients will be screened until 30 Type 1 Diabetes mellitus patient (15 adults, 15 adolescents) will completed the study.
The trial will consist of six visits: a screening visit (Visit 1), two dosing visits (Visit 2 and Visit 4), two phone visits (Visit 3 and Visit 5) and a follow-up visit (Visit 6). Furthermore, an information visit will take place prior to the screening visit in order to obtain patient's informed consent. Screening will take place 2-21 days prior to Visit 2 and the follow-up visit will take place 5-21 days after the end of Visit 4. The dosing visits will be separated by a wash-out period (5-30 days between the end of Visit 2 and begin of Visit 4) during which the subjects will resume their normal insulin treatment. Each phone visit (Visit 3 and Visit 5) will take place 3-5 days after the end of dosing Visits 2 and 4. The planned total duration of the trial is 18-78 days per subject (rescheduled visits excluded). Each subject will be randomised to a treatment sequence consisting of two treatment periods in which the subjects will receive 2 times 10mg dapagliflozin and placebo on two separate dosing visits.
Subjects metabolic control will be achieved by using the DreaMed system (closed loop). The procedure will be used in order to aim and maintain blood glucose levels between 70 and 180 mg/dl thereby.
Two standardized mixed-meals will be given 12 hours and 18 hours after dosing. Blood glucose measurements will be performed every 30min for 120min after the mixed-meal.
Blood samples for determination of dapagliflozin concentration in serum will be taken 14times in 24hours as well as ß-Hydroxybutyrate and every urine sample will be collected for 24 hours after first dosing for the determination of 24hour urinary glucose and creatinine for efficacy measurement.
In addition a full blood gas analysis will be drawn if an elevated β-hydroxybutyrate of >1.0 mmol/L will be detected.
24 hours after first dosing with dapagliflozin/ placebo of each dosing visit the subjects will resume their usual insulin treatment and can leave the hospital.
After conclusion of the trial the documented insulin doses over time will be summed up for calculation of the total insulin dose and the insulin dose per kg body weight per 24 hours.
- Conditions
- Type1diabetes
- Being tested
- Dapagliflozin, Placebo Oral Tablet
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DapagliflozinDrug
Also called Forxiga
two administrations in the evening and 12 hours later
Placebo Oral TabletDrug
Also called Control
two administrations in the evening and 12 hours later
| Study group | Role | What they receive |
|---|---|---|
| dapagliflozin | Experimental | two administrations of 10 mg dapagliflozin as tablet Receives: Drug: Dapagliflozin |
| Placebo Oral Tablets | Placebo comparator | two administrations identical to the experimental drug Receives: Drug: Placebo Oral Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time in Range 70-180%
Collection of clinical data regarding the treatment of two doses of 10mg dapagliflozin as add-on to night and day closed-loop control using the DreaMed Algorithm and the time within glucose range 70-180 mg/dl (3.9-10mmol/l) [%]
Measured: 24 hours
Secondary outcomes (4)
urinary glucose excretion
effect on urinary glucose excretion after a treatment with two doses of 10mg dapagliflozin (1x10 mg before bedtime and 1x10mg in the morning) in patients with type 1 diabetes
Measured: 24 hours
postprandial insulin need
effect of postprandial insulin need after Treatment with dapagliflozin
Measured: 24 hours
ß-hydroxybutyrate
association between Treatment of dapagliflozin and ß-hydroxybutyrate levels
Measured: 24 hours
Reduction of Insulin dose
effect of insulin dose reduction during the DreaMed automated insulin delivery 24 hours after two doses of 10mg dapagliflozin in patients with type 1 diabetes
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2016 (estimated)
- Study start9 Feb 2017
- Primary completion19 Dec 2017
- Study completion19 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type1diabetesStudies 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kinderkrankenhaus auf der Bult
- Sponsor type
- University, hospital or other
- Collaborators
- AstraZeneca, Alcedis GmbH
- Responsible party
- Sponsor
- Investigators
- Thomas Danne, MD, Principal investigator, Kinder- und Jugendkrankenhaus AUF DER BULT
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02987738
- Sponsor's protocol ID
- ESR-15-11453
- Acronym
- DapaDream
- Status last verified
- Oct 2024
- First submitted
- 6 Dec 2016
- Last updated
- 15 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-controlled, Single-center, Phase 1 Inpatient Pilot Study to Explore the Safety and Efficacy of DAPAglifozin as Add-on to Day and Night Closed-loop Control in Patients Type 1 Diabetes (T1D)
- ClinicalTrials.gov ID
- NCT02987738
- Acronym / sponsor ID
- DapaDream / ESR-15-11453
- Conditions
- Type1diabetes
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Kinderkrankenhaus auf der BultUniversity, hospital or other
- Collaborators
- AstraZeneca, Alcedis GmbH
- Study start
- 9 Feb 2017 (actual)
- Primary completion
- 19 Dec 2017 (actual)
- Study completion
- 19 Dec 2017 (actual)
- First posted
- 9 Dec 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.
Dapagliflozin has a unique mechanism of action that does not directly affect either insulin resistance or insulin secretion, but rather improves glycemia by reduction of glucose re-absorption from proximal renal tubules. Dapagliflozin is expected to reduce mean daily glucose, improve glycemic control and reduce overall insulin requirements. Improved glycemic control with reduced variability may also lead to reduced frequency of hypoglycemia.
In youth with T1D, Dapagliflozin led to a significant reduction of insulin needed to achieve target glucose irrespective of preexisting HbA1c levels.
In this pilot study data will be collected to investigate the effect on glucose of two doses of 10mg (each) dapagliflozin within range for the ensuing 24 hours during the DreaMed automated insulin delivery in patients with type 1 diabetes dosing with dapagliflozin in an in-patient setting combined with an automated sensor based CE marked insulin delivery system to data if dapagliflozin is a suitable add-on therapy. This will provide optimal monitoring of subject safety and assessment of the effects of dapagliflozin in a structured setting.
If this inpatient study shows evidence that Dapagliflozin is a suitable add on therapy and leads to an increase of time within the target glucose range when using a sensor based insulin pump therapy (closed-loop) further outpatient studies are planned to be conducted.
Detailed description
The purpose of this pilot study is to collect clinical data of two doses of 10mg (each) dapagliflozin as add-on to night and day closed-loop control using the DreaMed automated insulin delivery on the time [%] within glucose range 70-180 mg/dl (3.9-10mmol/l) for the ensuing 24 hours with two oral mixed-meals.
The study aimed to patients who have different degrees of inadequate glycemic control despite insulin use.
A maximum of 45 patients will be screened until 30 Type 1 Diabetes mellitus patient (15 adults, 15 adolescents) will completed the study.
The trial will consist of six visits: a screening visit (Visit 1), two dosing visits (Visit 2 and Visit 4), two phone visits (Visit 3 and Visit 5) and a follow-up visit (Visit 6). Furthermore, an information visit will take place prior to the screening visit in order to obtain patient's informed consent. Screening will take place 2-21 days prior to Visit 2 and the follow-up visit will take place 5-21 days after the end of Visit 4. The dosing visits will be separated by a wash-out period (5-30 days between the end of Visit 2 and begin of Visit 4) during which the subjects will resume their normal insulin treatment. Each phone visit (Visit 3 and Visit 5) will take place 3-5 days after the end of dosing Visits 2 and 4. The planned total duration of the trial is 18-78 days per subject (rescheduled visits excluded). Each subject will be randomised to a treatment sequence consisting of two treatment periods in which the subjects will receive 2 times 10mg dapagliflozin and placebo on two separate dosing visits.
Subjects metabolic control will be achieved by using the DreaMed system (closed loop). The procedure will be used in order to aim and maintain blood glucose levels between 70 and 180 mg/dl thereby.
Two standardized mixed-meals will be given 12 hours and 18 hours after dosing. Blood glucose measurements will be performed every 30min for 120min after the mixed-meal.
Blood samples for determination of dapagliflozin concentration in serum will be taken 14times in 24hours as well as ß-Hydroxybutyrate and every urine sample will be collected for 24 hours after first dosing for the determination of 24hour urinary glucose and creatinine for efficacy measurement.
In addition a full blood gas analysis will be drawn if an elevated β-hydroxybutyrate of >1.0 mmol/L will be detected.
24 hours after first dosing with dapagliflozin/ placebo of each dosing visit the subjects will resume their usual insulin treatment and can leave the hospital.
After conclusion of the trial the documented insulin doses over time will be summed up for calculation of the total insulin dose and the insulin dose per kg body weight per 24 hours.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| dapagliflozin | Experimental | Drug: Dapagliflozintwo administrations of 10 mg dapagliflozin as tablet |
| Placebo Oral Tablets | Placebo comparator | Drug: Placebo Oral Tablettwo administrations identical to the experimental drug |
Who may qualify
- Ages
- 12 to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- Male or female aged 12-21 years (both inclusive)
- Type 1 diabetes mellitus (as diagnosed clinically) ≥ 12 months
- No DKA 12 weeks prior to the study
- On CSII (insulin pump therapy) since at least 3 months
- Average daily dose of Insulin between 0.6 - 2.0 U/kg
Key exclusion criteria (66 listed)
- History of drug or alcohol abuse within the last five years prior to screening
- Anamnestic history of hypersensitivity to the study drugs (or any component of the study drug) or to drugs with similar chemical structures
- History of severe or multiple allergies
- Treatment with any other investigational drug within 3 months prior to screening
- Progressive fatal disease
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 |
|---|---|---|
| DapagliflozinAlso: Forxigatwo administrations in the evening and 12 hours later | Drug | dapagliflozin |
| Placebo Oral TabletAlso: Controltwo administrations in the evening and 12 hours later | Drug | Placebo Oral Tablets |
Primary outcome
Time in Range 70-180%
Time frame: 24 hours
Collection of clinical data regarding the treatment of two doses of 10mg dapagliflozin as add-on to night and day closed-loop control using the DreaMed Algorithm and the time within glucose range 70-180 mg/dl (3.9-10mmol/l) [%]
4 secondary outcomes
urinary glucose excretion
Time frame: 24 hours
postprandial insulin need
Time frame: 24 hours
ß-hydroxybutyrate
Time frame: 24 hours
Reduction of Insulin dose
Time frame: 24 hours
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 15 Oct 2024.
- Individual participant dataSharing planned: No
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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.
Thomas Danne, MD principal investigator
Kinder- und Jugendkrankenhaus AUF DER BULT
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Dapagliflozin in people with Type1diabetes, run by Kinderkrankenhaus auf der Bult at 1 site in Germany.
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 7 inclusion and 66 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 15 Oct 2024. 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 Germany. 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 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.
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?
Time in Range 70-180% (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Oct 2024.