Diabetes Mellitus, Type 2Phase 1NCT02722239
An Open-label, Randomized, Crossover Study of Comparative Pharmacokinetics and Bioequivalence of Dapagliflozin + Metformin, 10 mg + 1000 mg Versus the Combined Use of Forxiga™, 10 mg and Two Glucophage® Long, ER Tablets, 500 mg Co-administered to Healthy Volunteers Under Standard Fed Conditions
A Phase 1 study testing Xigduo XR, Metformin ER (Glucophage® long) and Dapagliflozin (Forxiga) in people with Diabetes Mellitus, Type 2, run by AstraZeneca at 1 site in Russia.
Trial summary
The aim of this study is to demonstrate bioequivalence of fixed dose combination Dapagliflozin + Metformin modified -release, film-coated tablets, 10 mg + 1000 mg, (AstraZeneca AB, Sweden) versus Forxiga™ (Dapagliflozin), film-coated tablets, 10 mg (Bristol Myers Squibb Company, USA) and Glucophage® long (Metformin)… Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Xigduo XR, Metformin ER (Glucophage® long) and Dapagliflozin (Forxiga)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteRussia
- Study dates
- 30 Mar 2016to 5 May 2016
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- The volunteer is able to understand the requirements of the study, to sign the informed consent form, and agrees with all the restrictions imposed in the course of the study;
- Male and female subjects aged 18-45, inclusive;
- Caucasian race;
- Body-mass index (BMI) within the range dated 18.5 to 30 kg/m2;
- Verified diagnosis "healthy" as confirmed by the results of standard clinical, laboratory, and instrumental evaluations;
- A negative pregnancy test at the Screening Visit for female subjects of childbearing potential.
- Postmenopausal (no menses for at least 1 year) or surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy) females are exempted from the requirement. In case of using hormonal contraceptives, these should be withdrawn at least 2 months before the study;
- Volunteers' with preserved reproductive potential agree to use adequate contraception throughout the study and for 30 days thereafter
Who cannot join
- Known hypersensitivity or intolerance to dapagliflozin or metformin or any other excipient of the study drugs;
- History of allergy to Na+ glucose co-transport inhibitor;
- Complicated allergic history including food intolerance;
- Lactose intolerance, lactase deficiency, glucose-galactose malabsorption;
- Chronic diseases of the cardiovascular, bronchopulmonary, nervous, endocrine, or musculoskeletal systems, as well as diseases of the gastrointestinal tract, liver, kidneys, blood, immune system, mental disorders;
- Deviations from the normal parameters in clinical blood count analysis, biochemical blood analysis, urinalysis; vital signs;
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- Mental, physical and other reasons that do not allow the subjects according to investigator's opinion to assess their behavior adequately, to follow correctly the requirements of the clinical study protocol and to assess the expected risks and possible discomfort;
- Organic brain damage, history of increased seizure activity;
- Changes on ECG (clinically significant);
- Systolic blood pressure (AD) measured in a sitting position, less than 100 mmHg or above 130 mmHg and / or diastolic blood pressure below 70 mm Hg or above 90 mmHg at screening or any time during the study;
- Heart rate less than 60 or more than 80 beats per minute at screening or prior to administration of the drug in each period of the study;
- Scheduled radioisotope or radiological examinations using iodinated contrast agents during < 2 days before dosing;
- Rare hereditary diseases manifestating with fructose or sorbitol intolerance;
- Gastrointestinal tract surgery (except appendectomy);
- Acute infectious diseases less than 4 weeks before the start of the study;
- Regular medication (including dietary supplements and combination herbal medicinal products) and vitamins intake within 2 weeks (or 6 half-lives, whichever is longer) prior inclusion into the study and subject does not give agreement to refuse from this medication until the end of study;
- Administration of the medicines that have a significant effect on circulatory dynamics, liver function, etc. (barbiturates, omeprazol, zimetidin etc.) less than 30 days before the start of the study;
- Blood donation (450 ml and more of blood or plasma) less than 2 months before the start of the study;
- Participation in another clinical study within 3 months before the start of the study;
- Alcohol intake > 10 units of alcohol per week (1 unit of alcohol - 500 ml of beer, 200 ml of dry wine or 50 ml of strong alcoholic beverages) or history of alcohol abuse, narcomania or other drug abuse.
- Use of alcohol and/or caffeinated and xanthine containing substances (for example, coffee, tea, colas, energetic drinks), chocolate as well as citrus fruits and cranberry (including juices, fruit drinks, etc.) 72 hours prior and throughout the study.
- Smoker (>10 cigarettes per day) and/or inability to refrain from smoking on Period I and Period II
- Special diets (e.g. vegetarians or hypocaloric diet [ less than 1000 cal/day]) or lifestyle (including night work and extreme physical activities, such as sports or weight lifting), which may impede the study conduction and monitoring;
- Positive screening blood test for hepatitis B surface antigen (HBsAg), hepatitis C (HCV) antibody, human immunodeficiency virus (HIV-1or HIV-2 antibodies) and / or syphilis (RW);
- A positive drug urine screening (cocaine, opiates, cannabis, barbiturates, amphetamines);
- A positive alcohol breath test;
- Dehydration due to diarrhea, vomiting or another cause during the last 24 hours before the start of the study;
- There is any concern by the investigator regarding the safe participation of the subject in the study or for any other reason; the investigator considers the subject ineligible for the study.
- Breast-feeding period;
- For women - Use of hormonal contraceptives for 2 months before the study start;
- Female volunteers with childbearing potential, having unprotected sexual intercourse with any unsterilized male partner (i.e., a man that is not sterilized by vasectomy for at least 6 months) for 30 days before receiving study medication.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-label, Randomized, Crossover Study of Comparative Pharmacokinetics and Bioequivalence of Dapagliflozin + Metformin Modified Release Film-coated Tablets, 10 mg + 1000 mg (AstraZeneca AB, Sweden) Versus the Combined Use of Forxiga™ (Dapagliflozin), Film-coated Tablets, 10 mg (Bristol Myers Squibb Company, USA) and Two Glucophage® Long (Metformin), ER Tablets, 500 mg (Merck Santé S.A.S., France), Co-administered to Healthy Volunteers Under Standard Fed Conditions
The aim of this study is to demonstrate bioequivalence of fixed dose combination Dapagliflozin + Metformin modified -release, film-coated tablets, 10 mg + 1000 mg, (AstraZeneca AB, Sweden) versus Forxiga™ (Dapagliflozin), film-coated tablets, 10 mg (Bristol Myers Squibb Company, USA) and Glucophage® long (Metformin), ER tablets, 1000 mg (2 x 500 mg) (Merck Santé S.A.S., France) which are already registered in the Russian Federation.
Read the detailed description
Randomised open-label crossover comparative, single center, two periods, clinical study of investigational drug and reference drugs bioequivalence evaluation with a single administration of the study drug (1 modified - release film-coated tablets of Dapagliflozin + Metformin or 1 film-coated tablets of Forxiga™ + 2 tablets ER of Glucophage® long) under fed condition in healthy volunteers.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Xigduo XR, Metformin ER (Glucophage® long), Dapagliflozin (Forxiga)
- Keywords
- Xigduo;, bioequivalence;, crossover;, Russia
- 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.
Xigduo XRDrug
a single oral dose of modified release fixed dose combination film-coated tablet consisting of 10 mg dapagliflozin IR and 1000 mg metformin hydrochloride extended release
Metformin ER (Glucophage® long)Drug
co-administration of a single oral dose of 10 mg dapagliflozin film-coated tablet (Forxiga™) and two tablets 500 mg metformin hydrochloride extended release tablets (Glucophage® long).
Dapagliflozin (Forxiga)Drug
co-administration of a single oral dose of 10 mg dapagliflozin film-coated tablet (Forxiga™) and two tablets 500 mg metformin hydrochloride extended release tablets (Glucophage® long).
| Study group | Role | What they receive |
|---|---|---|
| T/R | Experimental | Test product (T): a single oral dose of modified release fixed dose combination film-coated tablet consisting of 10 mg dapagliflozin IR and 1000 mg metformin hydrochloride extended release. Volunteers enrolled to group 1, on the first study period will take the study test product (Т), and on the second study period after wash out period of 7 days the volunteers will be given the Reference product (R) Receives: Drug: Xigduo XR; Drug: Metformin ER (Glucophage® long); Drug: Dapagliflozin (Forxiga) |
| R/T | Experimental | Reference product (R): co-administration of a single oral dose of 10 mg dapagliflozin film-coated tablet (Forxiga™) and two tablets 500 mg metformin hydrochloride extended release tablets (Glucophage® long). Volunteers from group 2 will be administered with the study drug in reverse order. It means that group 1 will take the study products in sequence T-R and group 2 in the sequence R-T. Receives: Drug: Xigduo XR; Drug: Metformin ER (Glucophage® long); Drug: Dapagliflozin (Forxiga) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Concentration (Cmax).
Measured: Blood sampling 0 h, 30 min, 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 10 hours, 12 hours, 24 hours, 36 hours, 48 hours and 72 hours after the dosing. Time interval for sampling is provided with pharmacokinetic characteristics of the product.
Area Under the "Concentration - Time" Curve (AUC0-t)
Measured: Blood sampling 0 h, 30 min, 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 10 hours, 12 hours, 24 hours, 36 hours, 48 hours and 72 hours after the dosing. Time interval for sampling is provided with pharmacokinetic characteristics of the product.
Area Under the "Concentration - Time" Curve (AUC0-∞)
Measured: Blood sampling 0 h, 30 min, 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 10 hours, 12 hours, 24 hours, 36 hours, 48 hours and 72 hours after the dosing. Time interval for sampling is provided with pharmacokinetic characteristics of the product.
Bioequivalence Consideration: 90% Confidence Intervals for the Test:Reference Geometric Least Squares Mean Ratios
The drugs are considered bioequivalent if the 90% confidence intervals for the Test : Reference products geometric least squares mean ratios of AUC, Cmax и Cmax/AUC parameters are in the range of 80% - 125%.
Measured: Blood sampling 0 h, 30 min, 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 10 hours, 12 hours, 24 hours, 36 hours, 48 hours and 72 hours after the dosing. Time interval for sampling is provided with pharmacokinetic characteristics of the product.
Adverse Events
Adverse events data for Dapagliflozin + Metformin, modified-release film-coated tablets, 10 mg + 1000 mg (AstraZeneca AB, Sweden) and for co-administered Forxiga™ (Dapagliflozin), film-coated tablets, 10 mg, (Bristol Myers Squibb Company, USA) and Glucophage® long (Metformin), XR tablets, 500 mg/2 tablets (Merck Santé S.A.S, France)
Measured: AE information will be collected from the time of the first dosing to the last study procedure made in the hospital, approximately 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2016 (estimated)
- Study start30 Mar 2016
- Primary completion5 May 2016
- Study completion5 May 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- More trials run by AstraZenecaThe 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Biocard
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02722239
- Sponsor's protocol ID
- D1691C00012
- Other IDs
- D1691C00012
- Status last verified
- Aug 2017
- First submitted
- 15 Mar 2016
- Last updated
- 19 Feb 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Khomitskaya Y, Tikhonova N, Gudkov K, Erofeeva S, Holmes V, Dayton B, Davies N, Boulton DW, Tang W. Bioequivalence of Dapagliflozin/Metformin Extended-release Fixed-combination Drug Product and Single-component Dapagliflozin and Metformin Extended-release Tablets in Healthy Russian Subjects. Clin Ther. 2018 Apr;40(4):550-561.e3. doi: 10.1016/j.clinthera.2018.02.006. Epub 2018 Mar 14.
PubMed 29548719
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Randomized, Crossover Study of Comparative Pharmacokinetics and Bioequivalence of Dapagliflozin + Metformin Modified Release Film-coated Tablets, 10 mg + 1000 mg (AstraZeneca AB, Sweden) Versus the Combined Use of Forxiga™ (Dapagliflozin), Film-coated Tablets, 10 mg (Bristol Myers Squibb Company, USA) and Two Glucophage® Long (Metformin), ER Tablets, 500 mg (Merck Santé S.A.S., France), Co-administered to Healthy Volunteers Under Standard Fed Conditions
- ClinicalTrials.gov ID
- NCT02722239
- Acronym / sponsor ID
- D1691C00012
- Conditions
- Diabetes Mellitus, Type 2
- Keywords
- Xigduo;, bioequivalence;, crossover;, Russia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Collaborators
- Biocard
- Study start
- 30 Mar 2016 (actual)
- Primary completion
- 5 May 2016 (actual)
- Study completion
- 5 May 2016 (actual)
- First posted
- 29 Mar 2016 (estimated)
- Results
- Posted 19 Feb 2018
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 demonstrate bioequivalence of fixed dose combination Dapagliflozin + Metformin modified -release, film-coated tablets, 10 mg + 1000 mg, (AstraZeneca AB, Sweden) versus Forxiga™ (Dapagliflozin), film-coated tablets, 10 mg (Bristol Myers Squibb Company, USA) and Glucophage® long (Metformin), ER tablets, 1000 mg (2 x 500 mg) (Merck Santé S.A.S., France) which are already registered in the Russian Federation.
Detailed description
Randomised open-label crossover comparative, single center, two periods, clinical study of investigational drug and reference drugs bioequivalence evaluation with a single administration of the study drug (1 modified - release film-coated tablets of Dapagliflozin + Metformin or 1 film-coated tablets of Forxiga™ + 2 tablets ER of Glucophage® long) under fed condition in healthy volunteers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| T/R | Experimental | Drug: Xigduo XR, Drug: Metformin ER (Glucophage® long), Drug: Dapagliflozin (Forxiga)Test product (T): a single oral dose of modified release fixed dose combination film-coated tablet consisting of 10 mg dapagliflozin IR and 1000 mg metformin hydrochloride extended release. Volunteers enrolled to group 1, on the first study period will take the study test product (Т), and on the second study period after wash out period of 7 days the volunteers will be given the Reference product (R) |
| R/T | Experimental | Drug: Xigduo XR, Drug: Metformin ER (Glucophage® long), Drug: Dapagliflozin (Forxiga)Reference product (R): co-administration of a single oral dose of 10 mg dapagliflozin film-coated tablet (Forxiga™) and two tablets 500 mg metformin hydrochloride extended release tablets (Glucophage® long). Volunteers from group 2 will be administered with the study drug in reverse order. It means that group 1 will take the study products in sequence T-R and group 2 in the sequence R-T. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- The volunteer is able to understand the requirements of the study, to sign the informed consent form, and agrees with all the restrictions imposed in the course of the study;
- Male and female subjects aged 18-45, inclusive;
- Caucasian race;
- Body-mass index (BMI) within the range dated 18.5 to 30 kg/m2;
- Verified diagnosis "healthy" as confirmed by the results of standard clinical, laboratory, and instrumental evaluations;
Key exclusion criteria (31 listed)
- Known hypersensitivity or intolerance to dapagliflozin or metformin or any other excipient of the study drugs;
- History of allergy to Na+ glucose co-transport inhibitor;
- Complicated allergic history including food intolerance;
- Lactose intolerance, lactase deficiency, glucose-galactose malabsorption;
- Chronic diseases of the cardiovascular, bronchopulmonary, nervous, endocrine, or musculoskeletal systems, as well as diseases of the gastrointestinal tract, liver, kidneys, blood, immune system, mental disorders;
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 |
|---|---|---|
| Xigduo XRa single oral dose of modified release fixed dose combination film-coated tablet consisting of 10 mg dapagliflozin IR and 1000 mg metformin hydrochloride extended release | Drug | R/T, T/R |
| Metformin ER (Glucophage® long)co-administration of a single oral dose of 10 mg dapagliflozin film-coated tablet (Forxiga™) and two tablets 500 mg metformin hydrochloride extended release tablets (Glucophage® long). | Drug | R/T, T/R |
| Dapagliflozin (Forxiga)co-administration of a single oral dose of 10 mg dapagliflozin film-coated tablet (Forxiga™) and two tablets 500 mg metformin hydrochloride extended release tablets (Glucophage® long). | Drug | R/T, T/R |
Primary outcome
Maximum Concentration (Cmax).
Time frame: Blood sampling 0 h, 30 min, 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 10 hours, 12 hours, 24 hours, 36 hours, 48 hours and 72 hours after the dosing. Time interval for sampling is provided with pharmacokinetic characteristics of the product.
Area Under the "Concentration - Time" Curve (AUC0-t)
Time frame: Blood sampling 0 h, 30 min, 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 10 hours, 12 hours, 24 hours, 36 hours, 48 hours and 72 hours after the dosing. Time interval for sampling is provided with pharmacokinetic characteristics of the product.
Area Under the "Concentration - Time" Curve (AUC0-∞)
Time frame: Blood sampling 0 h, 30 min, 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 10 hours, 12 hours, 24 hours, 36 hours, 48 hours and 72 hours after the dosing. Time interval for sampling is provided with pharmacokinetic characteristics of the product.
Bioequivalence Consideration: 90% Confidence Intervals for the Test:Reference Geometric Least Squares Mean Ratios
Time frame: Blood sampling 0 h, 30 min, 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 10 hours, 12 hours, 24 hours, 36 hours, 48 hours and 72 hours after the dosing. Time interval for sampling is provided with pharmacokinetic characteristics of the product.
The drugs are considered bioequivalent if the 90% confidence intervals for the Test : Reference products geometric least squares mean ratios of AUC, Cmax и Cmax/AUC parameters are in the range of 80% - 125%.
Adverse Events
Time frame: AE information will be collected from the time of the first dosing to the last study procedure made in the hospital, approximately 1 month
Adverse events data for Dapagliflozin + Metformin, modified-release film-coated tablets, 10 mg + 1000 mg (AstraZeneca AB, Sweden) and for co-administered Forxiga™ (Dapagliflozin), film-coated tablets, 10 mg, (Bristol Myers Squibb Company, USA) and Glucophage® long (Metformin), XR tablets, 500 mg/2 tablets (Merck Santé S.A.S, France)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 29548719Khomitskaya Y, Tikhonova N, Gudkov K, Erofeeva S, Holmes V, Dayton B, Davies N, Boulton DW, Tang W. Bioequivalence of Dapagliflozin/Metformin Extended-release Fixed-combination Drug Product and Single-component Dapagliflozin and Metformin Extended-release Tablets in Healthy Russian Subjects. Clin Ther. 2018 Apr;40(4):550-561.e3. doi: 10.1016/j.clinthera.2018.02.006. Epub 2018 Mar 14.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Xigduo XR, Metformin ER (Glucophage® long) and Dapagliflozin (Forxiga) in people with Diabetes Mellitus, Type 2, run by AstraZeneca at 1 site in Russia.
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 8 inclusion and 31 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Feb 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 Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 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?
Yes. Results are posted in the registry (first posted 19 Feb 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum Concentration (Cmax). (time frame: Blood sampling 0 h, 30 min, 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 10 hours, 12 hours, 24 hours, 36 hours, 48 hours and 72 hours after the dosing. Time interval for sampling is provided with pharmacokinetic characteristics of the product.). The study lists 5 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 NCT02722239, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2018.