Type 2 Diabetes MellitusPhase 4NCT02471404

Efficacy and Safety of Dapagliflozin and Dapagliflozin Plus Saxagliptin in Combination With Metformin in Type 2 Diabetes Patients Compared With Sulphonylurea

A Phase 4 study testing Dapagliflozin, Saxagliptin and Glimepiride in people with Type 2 Diabetes Mellitus and Inadequate Glycaemic Control, run by AstraZeneca at 173 sites in 5 countries.

Completed

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

Official record

Search all trials

Trial summary

This study is being carried out to see if dapagliflozin and dapagliflozin plus saxagliptin as an addition to metformin is effective and safe in treating patients with type 2 diabetes when compared to glimepiride (sulphonylurea) as an addition to metformin treatment. Read more about this study

Who is it for?: Ages 18 to 74 years
Conditions the study is for: Type 2 Diabetes Mellitus, Inadequate Glycaemic Control
What is being tested?: Dapagliflozin, Saxagliptin and Glimepiride
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 939 participants
Where: 173 sitesin 5 countries
Study dates: 21 Sep 2015to 13 Mar 2017
Phase: Phase 4
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 74 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Is male or female and ≥18 and <75 years old at time of informed consent.
Has a HbA1c of ≥7.5% and ≤10.5% based on central laboratory results from Visit 1, with individual need for therapy escalation.
Currently treated with a stable maximum tolarated dose (MTD) (≥1500 mg/day) of metformin therapy for at least 8 weeks prior to Enrolment visit.
Has a BMI of ≤45 kg/m2 at Enrolment visit.
Has a C-peptide laboratory value of ≥1.0 ng/mL (0.33 nmol/L; 333.3 pmol/L) based on central laboratory results from Visit 1.
Main, Exclusion Criteria:

Show all 10Show fewer

Clinically diagnosed with Type I diabetes, known diagnosis of maturity onset diabetes of the young (MODY), or secondary diabetes mellitus or known presence of glutamate decarboxylase 65 (GAD65) antibodies.
Patients who, in the judgment of the Investigator, may be at risk for dehydration or volume depletion that may affect the patient's safety and/or the interpretation of efficacy or safety data.
Clinically significant cardiovascular disease or procedure within 3 months prior to Enrolment or expected to require coronary revascularization procedure during the course of the study.
Concomitant treatment with loop diuretics

Who cannot join

None listed.

Trial locations and contacts

173 sites in 5 countries.

Country

City, postcode or hospital

173 sites in 5 countries

Germany111 sites

Research Site
Aschaffenburg, 63739
Research Site
Bad Homburg, 61348
Research Site
Bad Mergentheim, 97980
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Bad Nauheim, 61231
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Bad Neuenahr-Ahrweiler, 53474
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Bad Oeynhausen, 32545
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Bad Reichenhall, 83435
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Berlin, 10115
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Berlin, 10409
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Berlin, 10629
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Berlin, 10787
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Berlin, 12627
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Berlin, 13125
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Berlin, 13597
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Bochum, 44787
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Bochum, 44869
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Bonn, 53179
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Bünde, 32257
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Cologne, 51069
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Daaden, 57567
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Darmstadt, 64295
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Datteln, 45711
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Deggingen, 73326
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Dippoldiswalde, 01744
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Dortmund, 44137
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Dresden, 01309
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Duisburg, 47179
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Erfurt, 99085
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Erlangen, 91052
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Eschweiler, 52249
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Essen, 45136
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Essen, 45355
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Essen, 45359
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Frankfurt, 60594
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Frankfurt, 60596
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Frankfurt am Main, 60594
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Freiburg im Breisgau, 79106
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Freiburg im Breisgau, 79110
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Freudenstadt, 72250
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Gelnhausen, 63571
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Giengen an der Brenz, 89537
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Goch, 47574
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Göttingen, 37073
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Grevesmühlen, 23936
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Großheirath, 96269
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Hamburg, 20246
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Hamburg, 21073
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Hamburg, 21109
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Hamburg, 22041
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Hamburg, 22391
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Hamburg, 22607
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Hamelin, 31785
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Hanover, 30625
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Heidelberg, 69115
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Herne, 44653
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Hildesheim, 31139
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Hof, 95030
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Höhenkirchen, 85635
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Hohenmölsen, 06679
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Jerichow, 39319
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Kallstadt, 67169
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Karlsruhe, 76199
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Kassel, 34117
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Kiel-Kronshagen, 24119
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Köthen, 06366
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Leipzig, 04103
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Leipzig, 04109
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Lichtenfels, 96215
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Lingen, 49808
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Löhne, 32584
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Ludwigshafen, 67059
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Magdeburg, 39120
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Mannheim, 68161
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Mannheim, 68163
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Marburg, 35037
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Marl, 45770
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Meine, 38527
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Meißen, 01662
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Mühldorf A. Inn, 84453
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München, 80339
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München, 80809
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München, 81477
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Münster, 48143
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Münster, 48153
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Neumünster, 24534
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Neuwied Am Rhein, 56564
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Oldenburg, 23758
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Papenburg, 26871
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Pirna, 01796
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Rehburg-Loccum, 31547
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Rehlingen-Siersburg, 66780
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Reinfeld, 23858
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Remagen, 53424
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Rhaunen, 55624
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Rodgau-Dudenhofen, 63110
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Saarlouis, 66740
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Schwabenheim, 55270
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Speyer, 67346
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Stadtbergen, 86391
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Stolberg, 52222
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Straubing, 94315
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Stuttgart, 70199
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Sulzbach, 92237
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Trier, 54290
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Villingen-Schwenningen, 78048
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Wahlstedt, 23812
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Wangen, 88239
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Weinheim, 69469
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Westerkappeln, 49492
Research Site
Wetzlar, 35584
Research Site
Witten, 58455

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Slovakia21 sites

Research Site
Banská Bystrica, 974 01
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Bratislava, 81108
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Bratislava, 833 01
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Košice, 040 01
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Košice, 04011
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Košice
Research Site
Levice, 934 01
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Levice, 934 05
Research Site
Lučenec, 984 01
Research Site
Malacky, 901 01
Research Site
Námestovo, 029 01
Research Site
Nové Zámky, 94001
Research Site
Považská Bystrica, 017 01
Research Site
Považská Bystrica, 017 26
Research Site
Prievidza, 971 01
Research Site
Púchov, 020 01
Research Site
Rimavská Sobota, 979 01
Research Site
Sabinov, 083 01
Research Site
Trenčín, 911 01
Research Site
Trnava, 917 01
Research Site
Vrútky, 038 61

Other trials in Slovakia

Hungary17 sites

Research Site
Ács, 2941
Research Site
Budapest, 1106
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Budapest, 1171
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Budapest, 1213
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Csongrád, 6640
Research Site
Debrecen, 4025
Research Site
Esztergom, 2500
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Hatvan, 3000
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Kisvárda, 4600
Research Site
Komárom, 2921
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Miskolc, 3529
Research Site
Mosonmagyaróvár, 9200
Research Site
Nyíregyháza, 4405
Research Site
Orosháza-Szentetornya, 5900
Research Site
Pécs, 7623
Research Site
Polgár, 4090
Research Site
Székesfehérvár, 8000

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Poland14 sites

Research Site
Bochnia, 32-700
Research Site
Bydgoszcz, 85-231
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Chrzanów, 32-500
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Gdansk, 80-286
Research Site
Koluszki, 95-040
Research Site
Krakow, 31-567
Research Site
Legnica, 59-220
Research Site
Lodz, 90-132
Research Site
Mrągowo, 11-700
Research Site
Ostrowiec Świętokrzyski, 27-400
Research Site
Poznan, 61655
Research Site
Sobótka, 55-050
Research Site
Wierzchosławice, 33-122
Research Site
Wroclaw, 54-144

Other trials in Poland

Czechia10 sites

Research Site
Hodonín, 695 01
Research Site
Hradec Králové, 500 05
Research Site
Jílové u Prahy, 254 01
Research Site
Ostrava - Belsky Les, 700 30
Research Site
Pardubice, 530 02
Research Site
Plzen - Severni Predmesti, 301 00
Research Site
Praha Klanovice, 190 14
Research Site
Přelouč, 535 01
Research Site
Uherské Hradiště, 686 01
Research Site
Zlín, 760 01

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About this study

Official title: A 52-Week, Multi-Centre, Randomised, Parallel-Group, Double-Blind, Active Controlled, Phase IV Study to Evaluate the Safety and Efficacy of Dapagliflozin or Dapagliflozin Plus Saxagliptin Compared With Sulphonylurea All Given as Add-on Therapy to Metformin in Adult Patients With Type 2 Diabetes Who Have Inadequate Glycaemic Control on Metformin Monotherapy

Conditions: Type 2 Diabetes Mellitus, Inadequate Glycaemic Control
Being tested: Dapagliflozin, Saxagliptin, Glimepiride, Placebo for dapagliflozin, Placebo for saxagliptin
Keywords: Diabetes Mellitus Type 2,, metformin,, saxagliptin,, dapagliflozin,, glimepiride,, inadequate glycaemic control
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.

DapagliflozinDrug
Also called Forxiga
10 mg, orally Green, plain, diamond-shaped, film-coated tablet
SaxagliptinDrug
Also called Onglyza™
5 mg, orally Plain, yellow, biconvex, round, film-coated tablet
GlimepirideDrug
Also called Amaryl
1, 2, or 4 mg, orally Opaque gray capsule
Placebo for dapagliflozinDrug
Does not contain active ingredient, orally Green, plain, diamond-shaped, film-coated tablet
Placebo for saxagliptinDrug
Does not contain active ingredient, orally Plain, yellow, biconvex, round, film-coated tablet
Placebo for glimepirideDrug
Does not contain active ingredient, orally. Opaque gray capsule

Study groups in NCT02471404
Study group	Role	What they receive
Dapagliflozin+metformin	Active comparator	Dapagliflozin + saxagliptin placebo + glimepiride placebo + metformin Receives: Drug: Dapagliflozin; Drug: Placebo for saxagliptin; Drug: Placebo for glimepiride
Dapagliflozin+saxagliptin+metformin	Active comparator	Dapagliflozin + saxagliptin + glimepiride placebo+ metformin Receives: Drug: Dapagliflozin; Drug: Saxagliptin; Drug: Placebo for glimepiride
Glimepiride+metformin	Active comparator	Glimepiride + dapagliflozin placebo + saxagliptin placebo + metformin Receives: Drug: Glimepiride; Drug: Placebo for dapagliflozin; Drug: Placebo for saxagliptin

What is being measured

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

Change in Haemoglobin A1c (HbA1c) From Baseline to Week 52
Change in HbA1c from baseline (week 0) to week 52.
Measured: Baseline, week 52. Values recorded after rescue treatment or collected more than 8 days after the last dose date were excluded from the analysis

Secondary outcomes (5)

Patients With at Least One Episode of Confirmed Hypoglycaemia
Percentage of patients reporting at least 1 episode of hypoglycaemia (symptomatic + blood glucose <=50 mg/dL) during the double-blind treatment period
Measured: Up to Week 52. Values recorded after rescue treatment or collected more than 8 days after the last dose date were excluded from the analysis
Change in Total Body Weight From Baseline at Week 52
Change in body weight from baseline (week 0) to week 52
Measured: Baseline, week 52. Values recorded after rescue treatment or collected more than 8 days after the last dose date were excluded from the analysis
Change in Fasting Plasma Glucose (FPG) From Baseline to Week 52
Change in FPG from baseline (week 0) to week 52
Measured: Baseline, week 52. Values recorded after rescue treatment or collected more than 8 days after the last dose date were excluded from the analysis
Time to Rescue
The time to rescue (from first dose date after randomisation to start of rescue medication or discontinuation due to lack of glycaemic control) during the 52 week double blind treatment period
Measured: Over the 52 week treatment period
Number of Patients Rescued
Number (%) of patients rescued.
Measured: Over the 52 week treatment period

Timeline

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

21 Sep 201513 Mar 2017

First posted15 Jun 2015 (estimated)
Study start21 Sep 2015
Primary completion13 Mar 2017
Study completion13 Mar 2017

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 Type 2 Diabetes MellitusStudies 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 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 939 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02471404
Sponsor's protocol ID: D1689C00014
Status last verified: Mar 2019
First submitted: 11 Jun 2015
Last updated: 26 Mar 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Muller-Wieland D, Kellerer M, Cypryk K, Skripova D, Rohwedder K, Johnsson E, Garcia-Sanchez R, Kurlyandskaya R, Sjostrom CD, Jacob S, Seufert J, Dronamraju N, Csomos K. Efficacy and safety of dapagliflozin or dapagliflozin plus saxagliptin versus glimepiride as add-on to metformin in patients with type 2 diabetes. Diabetes Obes Metab. 2018 Nov;20(11):2598-2607. doi: 10.1111/dom.13437. Epub 2018 Jul 16.
PubMed 29947099

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 26 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A 52-Week, Multi-Centre, Randomised, Parallel-Group, Double-Blind, Active Controlled, Phase IV Study to Evaluate the Safety and Efficacy of Dapagliflozin or Dapagliflozin Plus Saxagliptin Compared With Sulphonylurea All Given as Add-on Therapy to Metformin in Adult Patients With Type 2 Diabetes Who Have Inadequate Glycaemic Control on Metformin Monotherapy
ClinicalTrials.gov ID: NCT02471404
Acronym / sponsor ID: D1689C00014
Conditions: Type 2 Diabetes Mellitus, Inadequate Glycaemic Control
Keywords: Diabetes Mellitus Type 2,, metformin,, saxagliptin,, dapagliflozin,, glimepiride,, inadequate glycaemic control
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 939 participants (actual)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Study start: 21 Sep 2015 (actual)
Primary completion: 13 Mar 2017 (actual)
Study completion: 13 Mar 2017 (actual)
First posted: 15 Jun 2015 (estimated)
Results: Posted 26 Mar 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 3

Arm	Type	Receives
Dapagliflozin+metformin	Active comparator	Drug: Dapagliflozin, Drug: Placebo for saxagliptin, Drug: Placebo for glimepirideDapagliflozin + saxagliptin placebo + glimepiride placebo + metformin
Dapagliflozin+saxagliptin+metformin	Active comparator	Drug: Dapagliflozin, Drug: Saxagliptin, Drug: Placebo for glimepirideDapagliflozin + saxagliptin + glimepiride placebo+ metformin
Glimepiride+metformin	Active comparator	Drug: Glimepiride, Drug: Placebo for dapagliflozin, Drug: Placebo for saxagliptinGlimepiride + dapagliflozin placebo + saxagliptin placebo + metformin

Who may qualify

Ages: 18 to 74 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (10 listed)

Is male or female and ≥18 and <75 years old at time of informed consent.
Has a HbA1c of ≥7.5% and ≤10.5% based on central laboratory results from Visit 1, with individual need for therapy escalation.
Currently treated with a stable maximum tolarated dose (MTD) (≥1500 mg/day) of metformin therapy for at least 8 weeks prior to Enrolment visit.
Has a BMI of ≤45 kg/m2 at Enrolment visit.
Has a C-peptide laboratory value of ≥1.0 ng/mL (0.33 nmol/L; 333.3 pmol/L) based on central laboratory results from Visit 1.

Key exclusion criteria (0 listed)

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: Forxiga10 mg, orally Green, plain, diamond-shaped, film-coated tablet	Drug	Dapagliflozin+metformin, Dapagliflozin+saxagliptin+metformin
SaxagliptinAlso: Onglyza™5 mg, orally Plain, yellow, biconvex, round, film-coated tablet	Drug	Dapagliflozin+saxagliptin+metformin
GlimepirideAlso: Amaryl1, 2, or 4 mg, orally Opaque gray capsule	Drug	Glimepiride+metformin
Placebo for dapagliflozinDoes not contain active ingredient, orally Green, plain, diamond-shaped, film-coated tablet	Drug	Glimepiride+metformin
Placebo for saxagliptinDoes not contain active ingredient, orally Plain, yellow, biconvex, round, film-coated tablet	Drug	Dapagliflozin+metformin, Glimepiride+metformin
Placebo for glimepirideDoes not contain active ingredient, orally. Opaque gray capsule	Drug	Dapagliflozin+metformin, Dapagliflozin+saxagliptin+metformin

Primary outcome

Change in Haemoglobin A1c (HbA1c) From Baseline to Week 52
Time frame: Baseline, week 52. Values recorded after rescue treatment or collected more than 8 days after the last dose date were excluded from the analysis
Change in HbA1c from baseline (week 0) to week 52.

5 secondary outcomes

Patients With at Least One Episode of Confirmed Hypoglycaemia
Time frame: Up to Week 52. Values recorded after rescue treatment or collected more than 8 days after the last dose date were excluded from the analysis
Change in Total Body Weight From Baseline at Week 52
Time frame: Baseline, week 52. Values recorded after rescue treatment or collected more than 8 days after the last dose date were excluded from the analysis
Change in Fasting Plasma Glucose (FPG) From Baseline to Week 52
Time frame: Baseline, week 52. Values recorded after rescue treatment or collected more than 8 days after the last dose date were excluded from the analysis
Time to Rescue
Time frame: Over the 52 week treatment period
Number of Patients Rescued
Time frame: Over the 52 week treatment period

Results and safety

Results posted to the registry on 26 Mar 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Dapagliflozin 10mg	314	281
Saxagliptin 5mg and Dapagliflozin 10mg	312	298
Glimepiride 1mg/2mg/4mg	313	288

Primary outcome: Change in Haemoglobin A1c (HbA1c) From Baseline to Week 52

Time frame: Baseline, week 52. Values recorded after rescue treatment or collected more than 8 days after the last dose date were excluded from the analysis. Least squares mean (Standard Error). Unit: HbA1c %

Measure	Dapaglifozin 10mg n = 311	Saxagliptin 5mg and Dapagliflozin 10mg n = 312	Glimepiride 1mg/2mg/4mg n = 309
Value	-0.82 (0.049)	-1.2 (0.046)	-0.99 (0.048)

Dapaglifozin 10mg vs Glimepiride 1mg/2mg/4mg: Mean Difference (Final Values): 0.16 (95% CI 0.0294 to 0.2986), Mixed Models Analysis
Saxagliptin 5mg and Dapagliflozin 10mg vs Glimepiride 1mg/2mg/4mg: Mean Difference (Final Values): -0.21 (95% CI -0.3443 to -0.0825), p = 0.001, Mixed Models Analysis

Population analysed: Full Analysis Set

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse Events from signature of informed consent, enrolment, randomisation and throughout the 52 week treatment period and including the follow-up period. Serious Adverse Events from the time of informed consent.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Dapagliflozin 10mg	39 of 313 (12.5%)	29 of 313 (9.3%)	0 of 313
Saxagliptin 5mg and Dapagliflozin 10mg	22 of 312 (7.1%)	31 of 312 (9.9%)	0 of 312
Glimepiride 1mg/2mg/4mg	35 of 312 (11.2%)	37 of 312 (11.9%)	0 of 312

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 29947099Muller-Wieland D, Kellerer M, Cypryk K, Skripova D, Rohwedder K, Johnsson E, Garcia-Sanchez R, Kurlyandskaya R, Sjostrom CD, Jacob S, Seufert J, Dronamraju N, Csomos K. Efficacy and safety of dapagliflozin or dapagliflozin plus saxagliptin versus glimepiride as add-on to metformin in patients with type 2 diabetes. Diabetes Obes Metab. 2018 Nov;20(11):2598-2607. doi: 10.1111/dom.13437. Epub 2018 Jul 16.
d1689c00014\_SAP\_RedactedLink provided by the sponsor.
d1689c00014\_CSP\_RedactedLink provided by the sponsor.

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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.

173 sites in 5 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Dapagliflozin, Saxagliptin and Glimepiride in people with Type 2 Diabetes Mellitus and Inadequate Glycaemic Control, run by AstraZeneca at 173 sites in 5 countries.

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 10 inclusion and 0 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 26 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 173 sites in Germany, Slovakia, Hungary, Poland, Czechia. 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 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?

Yes. Results are posted in the registry (first posted 26 Mar 2019). 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?

Change in Haemoglobin A1c (HbA1c) From Baseline to Week 52 (time frame: Baseline, week 52. Values recorded after rescue treatment or collected more than 8 days after the last dose date were excluded from the analysis). 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 NCT02471404, 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 26 Mar 2019.