DiabetesPhase 3SUSTAIN™NCT02207374

A Trial Comparing the Safety and Efficacy of Semaglutide Once Weekly in Monotherapy or in Combination With One OAD in Japanese Subjects With Type 2 Diabetes

A Phase 3 study testing semaglutide and DPP-4 inhibitor in people with Diabetes and Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 43 sites in Japan.

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 trial is conducted in Asia. The aim of the trial is to investigate safety and efficacy of semaglutide once weekly in monotherapy or in combination with one OAD (oral anti-diabetic drug) in Japanese subjects with type 2 diabetes who are insufficiently controlled on diet/exercise therapy or OAD monotherapy. Read more about this study

Who is it for?: Ages 20 years and older
Conditions the study is for: Diabetes, Diabetes Mellitus, Type 2
What is being tested?: semaglutide and DPP-4 inhibitor
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 601 participants
Where: 43 sitesJapan
Study dates: 4 Aug 2014to 27 Feb 2016
Phase: Phase 3
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 20 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Male or female, age at least 20 years at the time of signing informed consent
HbA1c (glycosylated haemoglobin A1c) between 7.0% and 10.5% (53-91 mmol/mol) (both inclusive)
Japanese subjects with type 2 diabetes mellitus (diagnosed clinically) and on stable treatment (defined as unchanged medication and unchanged dose) who are: a) on diet and exercise therapy for at least 30 days before Visit 1 (week -2). or b) on OAD monotherapy (either of SU (sulfonylurea), glinide, a-GI (a-glucosidase inhibitor) or TZD (thiazolidinediones)) within approved Japanese labelling in addition to diet and exercise therapy for at least 60 days before Visit 1 (week -2)

Who cannot join

Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using an adequate contraceptive method (e.g., abstinence [not having sex], diaphragm, condom [by the partner], intrauterine device, sponge, spermicide or oral contraceptives) throughout the trial including the 5 week follow-up period
Treatment with glucose lowering agent(s) other than stated in the inclusion criteria within 60 days before Visit 1 (week -2) and treatment with once weekly glucagon-like peptide-1 (GLP-1) receptor agonists within 90 days before Visit 1 (week -2). An exception is short-term treatment (below or equal to 7 days in total) with insulin in connection with inter-current illness
Any disorder which, in the opinion of the investigator, might jeopardise subject's safety or compliance with the protocol
History of chronic or idiopathic acute pancreatitis
Screening calcitonin value above or equal to 50 ng/L (pg/mL)
Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN2)

Show all 9Show fewer

Impaired renal function defined as estimated glomerular filtration rate (eGFR) below 30 mL/min/1.73 m^2 per modification of diet in renal disease (MDRD) formula (4 variable version)
Acute coronary or cerebrovascular event within 90 days before randomisation (Visit 2 [week 0])
Heart failure, New York Heart Association (NYHA) class IV

Trial locations and contacts

43 sites in 1 country.

City, postcode or hospital

43 sites in 1 country

Japan43 sites

Novo Nordisk Investigational Site
Akita-shi, Akita, 010 8543
Novo Nordisk Investigational Site
Annaka-shi, Gunma, 379 0116
Novo Nordisk Investigational Site
Asahikawa-shi, Hokkaido, 070 0002
Novo Nordisk Investigational Site
Asahikawa-shi, Hokkaido, 078 8510
Novo Nordisk Investigational Site
Bunkyo-ku, Tokyo, 113 8431
Novo Nordisk Investigational Site
Chuo-ku Tokyo, 103-0027
Novo Nordisk Investigational Site
Chuo-ku Tokyo, 104-0031
Novo Nordisk Investigational Site
Chuo-ku, Tokyo, 103 0002
Novo Nordisk Investigational Site
Chuo-ku, Tokyo, 103 0027
Novo Nordisk Investigational Site
Chuo-ku, Tokyo, 104-0061
Novo Nordisk Investigational Site
Fukuoka, 812 0025
Novo Nordisk Investigational Site
Higashiosaka-shi, Osaka
Novo Nordisk Investigational Site
Izumisano, 598 0048
Novo Nordisk Investigational Site
Kashiwara-shi, Osaka, 582 0005
Novo Nordisk Investigational Site
Katsushika-ku, Tokyo, 125 0054
Novo Nordisk Investigational Site
Kitakyushu-shi, Fukuoka, 800 0252
Novo Nordisk Investigational Site
Koriyama-shi, Fukushima, 963 8851
Novo Nordisk Investigational Site
Kumamoto-shi,Kumamoto, 862 0976
Novo Nordisk Investigational Site
Kyoto-shi, Kyoto, 615 8125
Novo Nordisk Investigational Site
Mito-shi, Ibaraki
Novo Nordisk Investigational Site
Miyazaki, 880 0034
Novo Nordisk Investigational Site
Naka-shi, Ibaraki, 311 0113
Novo Nordisk Investigational Site
Nishinomiya-shi, Hygo, 662 0971
Novo Nordisk Investigational Site
Nishinomiya-shi, Hyogo, 663-8501
Novo Nordisk Investigational Site
Okawa-shi, Fukuoka, 831 0016
Novo Nordisk Investigational Site
Okayama-shi, Okayama, 700 8505
Novo Nordisk Investigational Site
Osaka-shi, Osaka, 532 0003
Novo Nordisk Investigational Site
Ota-ku, Tokyo, 144 0035
Novo Nordisk Investigational Site
Ota-ku, Tokyo
Novo Nordisk Investigational Site
Oyama-shi, Tochigi, 323 0022
Novo Nordisk Investigational Site
Saga-shi,Saga, 849 0937
Novo Nordisk Investigational Site
Sapporo-shi, Hokkaido, 060 0062
Novo Nordisk Investigational Site
Sapporo-shi, Hokkaido, 062 0007
Novo Nordisk Investigational Site
Sendai, 980 0021
Novo Nordisk Investigational Site
Shimotsuke-shi, Tochigi, 329 0433
Novo Nordisk Investigational Site
Shinjuku-ku, Tokyo, 160-0008
Novo Nordisk Investigational Site
Shizuoka, 424 0853
Novo Nordisk Investigational Site
Suita-shi, Osaka, 565-0853
Novo Nordisk Investigational Site
Takatsuki-shi, Osaka, 569 1096
Novo Nordisk Investigational Site
Tokyo, 103-0028
Novo Nordisk Investigational Site
Tokyo, 123-0845
Novo Nordisk Investigational Site
Ube-shi, Yamaguchi
Novo Nordisk Investigational Site
Yokohama, 235 0045

Other trials in Japan

About this study

Official title: Safety and Efficacy of Semaglutide Once Weekly in Monotherapy or in Combination With One OAD in Japanese Subjects With Type 2 Diabetes Who Are Insufficiently Controlled on Diet/Exercise Therapy or OAD Monotherapy

All subjects will continue their pre-trial treatment (diet and exercise therapy or OAD monotherapy in addition to diet and exercise therapy) during the trial.

Conditions: Diabetes, Diabetes Mellitus, Type 2
Being tested: semaglutide, DPP-4 inhibitor
Medical subject headings: Diabetes Mellitus, Diabetes Mellitus, Type 2

What participants receive

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

semaglutideDrug
Subject will receive either a dose of 0.5 or 1.0 mg of semaglutide once weekly (subcutaneous (s.c.) injection).Treatment duration 56 weeks.
DPP-4 inhibitorDrug
Subjects will receive one DPP-4 inhibitor in addition to pre-trial OAD monotherapy, if any, for 56 weeks.

Study groups in NCT02207374
Study group	Role	What they receive
Semaglutide 0.5 mg	Experimental	Not described Receives: Drug: semaglutide
Semaglutide 1.0 mg	Experimental	Not described Receives: Drug: semaglutide
One additional OAD + pre-trial treatment	Active comparator	The type and dosage of the additional OAD will be selected by the investigators according to the approved Japanese labelling including drug combinations and contraindications. One of DPP-4 inhibitor (dipeptidyl peptidase-4), SU (sulfonylurea), glinide, biguanide, α-GI (α-glucosidase inhibitor)or TZD (thiazolidinediones) will be selected as the additional OAD. For the subjects treated with OAD monotherapy as pre-trial treatment, the type and dosage of the additional OAD with a different mechanism of action from the pre-trial OAD should be chosen. Receives: Drug: DPP-4 inhibitor

What is being measured

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

Number of Treatment Emergent Adverse Events (TEAEs)
An adverse event (AEs) was defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom or disease temporally associated with the use of a product, whether or not considered related to the product. All AEs mentioned here are treatment emergent adverse events (TEAE) defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment (week 0-56 treatment period) and no later than the follow-up visit during the on-treatment observation period (date of last dose + 42 days).
Measured: Weeks 0-56

Secondary outcomes (2)

Number of Severe or Blood Glucose (BG) Confirmed Symptomatic Hypoglycaemic Episodes
Severe or blood glucose (BG) confirmed symptomatic hypoglycaemic episodes were defined as episodes that were severe and/or BG confirmed by a plasma glucose value of <56 mg/dL (3.1 mmol/L), with symptoms consistent with hypoglycaemia. Severe hypoglycaemia: was an episode requiring assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions. The episodes mentioned here are treatment emergent hypoglycaemic episodes and defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment (week 0-56 treatment period) and no later than the follow-up visit during the on-treatment observation period (date of last dose + 42 days).
Measured: Weeks 0-56
Change in Glycosylated Haemoglobin A1c (HbA1c)
The observed mean change in HbA1c values from baseline after 56 weeks of treatment. Changes in HbA1c were analysed using a mixed model for repeated measurements (MMRM) with treatment and pre-trial treatment at screening as fixed factors and baseline value as covariate. The data were analysed for the "on-treatment without rescue medication" observation period which includes observations noted at or after the date of first dose of randomised treatment and not after the last dose of the trial product (+ a 7-day visit window) or initiation of rescue medication.
Measured: Week 0, week 56

Timeline

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

4 Aug 201427 Feb 2016

First posted4 Aug 2014 (estimated)
Study start4 Aug 2014
Primary completion27 Feb 2016
Study completion27 Feb 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 (4)Papers the sponsor has linked to this study.
Other trials for DiabetesStudies of the same condition, open and under way.
More trials run by Novo Nordisk A/SThe 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 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 601 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02207374
Sponsor's protocol ID: NN9535-4091
Other IDs: U1111-1140-3081, JapicCTI-142640
Acronym: SUSTAIN™
Status last verified: Jun 2018
First submitted: 1 Aug 2014
Last updated: 7 Jan 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Kaku K, Yamada Y, Watada H, Abiko A, Nishida T, Zacho J, Kiyosue A. Safety and efficacy of once-weekly semaglutide vs additional oral antidiabetic drugs in Japanese people with inadequately controlled type 2 diabetes: A randomized trial. Diabetes Obes Metab. 2018 May;20(5):1202-1212. doi: 10.1111/dom.13218. Epub 2018 Feb 21.
PubMed 29322610
Petri KCC, Ingwersen SH, Flint A, Zacho J, Overgaard RV. Exposure-response analysis for evaluation of semaglutide dose levels in type 2 diabetes. Diabetes Obes Metab. 2018 Sep;20(9):2238-2245. doi: 10.1111/dom.13358. Epub 2018 Jun 15.
PubMed 29748996
Carlsson Petri KC, Ingwersen SH, Flint A, Zacho J, Overgaard RV. Semaglutide s.c. Once-Weekly in Type 2 Diabetes: A Population Pharmacokinetic Analysis. Diabetes Ther. 2018 Aug;9(4):1533-1547. doi: 10.1007/s13300-018-0458-5. Epub 2018 Jun 15.
PubMed 29907893
Husain M, Bain SC, Holst AG, Mark T, Rasmussen S, Lingvay I. Effects of semaglutide on risk of cardiovascular events across a continuum of cardiovascular risk: combined post hoc analysis of the SUSTAIN and PIONEER trials. Cardiovasc Diabetol. 2020 Sep 30;19(1):156. doi: 10.1186/s12933-020-01106-4.
PubMed 32998732

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?

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Study at a glance

From the registry record, last updated by the sponsor on 7 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Safety and Efficacy of Semaglutide Once Weekly in Monotherapy or in Combination With One OAD in Japanese Subjects With Type 2 Diabetes Who Are Insufficiently Controlled on Diet/Exercise Therapy or OAD Monotherapy
ClinicalTrials.gov ID: NCT02207374
Acronym / sponsor ID: SUSTAIN™ / NN9535-4091
Conditions: Diabetes, Diabetes Mellitus, Type 2
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 601 participants (actual)
Lead sponsor: Novo Nordisk A/SIndustry (pharma, biotech, devices)
Study start: 4 Aug 2014 (actual)
Primary completion: 27 Feb 2016 (actual)
Study completion: 27 Feb 2016 (actual)
First posted: 4 Aug 2014 (estimated)
Results: Posted 7 Jan 2019

Clinical summary

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

All subjects will continue their pre-trial treatment (diet and exercise therapy or OAD monotherapy in addition to diet and exercise therapy) during the trial.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
Semaglutide 0.5 mg	Experimental	Drug: semaglutide
Semaglutide 1.0 mg	Experimental	Drug: semaglutide
One additional OAD + pre-trial treatment	Active comparator	Drug: DPP-4 inhibitorThe type and dosage of the additional OAD will be selected by the investigators according to the approved Japanese labelling including drug combinations and contraindications. One of DPP-4 inhibitor (dipeptidyl peptidase-4), SU (sulfonylurea), glinide, biguanide, α-GI (α-glucosidase inhibitor)or TZD (thiazolidinediones) will be selected as the additional OAD. For the subjects treated with OAD monotherapy as pre-trial treatment, the type and dosage of the additional OAD with a different mechanism of action from the pre-trial OAD should be chosen.

Who may qualify

Ages: 20 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Male or female, age at least 20 years at the time of signing informed consent
HbA1c (glycosylated haemoglobin A1c) between 7.0% and 10.5% (53-91 mmol/mol) (both inclusive)
Japanese subjects with type 2 diabetes mellitus (diagnosed clinically) and on stable treatment (defined as unchanged medication and unchanged dose) who are: a) on diet and exercise therapy for at least 30 days before Visit 1 (week -2). or b) on OAD monotherapy (either of SU (sulfonylurea), glinide, a-GI (a-glucosidase inhibitor) or TZD (thiazolidinediones)) within approved Japanese labelling in addition to diet and exercise therapy for at least 60 days before Visit 1 (week -2)

Key exclusion criteria (9 listed)

Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using an adequate contraceptive method (e.g., abstinence [not having sex], diaphragm, condom [by the partner], intrauterine device, sponge, spermicide or oral contraceptives) throughout the trial including the 5 week follow-up period
Treatment with glucose lowering agent(s) other than stated in the inclusion criteria within 60 days before Visit 1 (week -2) and treatment with once weekly glucagon-like peptide-1 (GLP-1) receptor agonists within 90 days before Visit 1 (week -2). An exception is short-term treatment (below or equal to 7 days in total) with insulin in connection with inter-current illness
Any disorder which, in the opinion of the investigator, might jeopardise subject's safety or compliance with the protocol
History of chronic or idiopathic acute pancreatitis
Screening calcitonin value above or equal to 50 ng/L (pg/mL)

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
semaglutideSubject will receive either a dose of 0.5 or 1.0 mg of semaglutide once weekly (subcutaneous (s.c.) injection).Treatment duration 56 weeks.	Drug	Semaglutide 0.5 mg, Semaglutide 1.0 mg
DPP-4 inhibitorSubjects will receive one DPP-4 inhibitor in addition to pre-trial OAD monotherapy, if any, for 56 weeks.	Drug	One additional OAD + pre-trial treatment

Primary outcome

Number of Treatment Emergent Adverse Events (TEAEs)
Time frame: Weeks 0-56
An adverse event (AEs) was defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom or disease temporally associated with the use of a product, whether or not considered related to the product. All AEs mentioned here are treatment emergent adverse events (TEAE) defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment (week 0-56 treatment period) and no later than the follow-up visit during the on-treatment observation period (date of last dose + 42 days).

2 secondary outcomes

Number of Severe or Blood Glucose (BG) Confirmed Symptomatic Hypoglycaemic Episodes
Time frame: Weeks 0-56
Change in Glycosylated Haemoglobin A1c (HbA1c)
Time frame: Week 0, week 56

Results and safety

Results posted to the registry on 7 Jan 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
Semaglutide 0.5 mg	239	233
Semaglutide 1.0 mg	241	231
Additional OAD	121	115

Primary outcome: Number of Treatment Emergent Adverse Events (TEAEs)

Time frame: Weeks 0-56. Number. Unit: Number of events

Measure	Semaglutide 0.5 mg n = 239	Semaglutide 1.0 mg n = 241	Additional OAD n = 120
Value	909	954	269

Population analysed: The safety analysis set (SAS) included all randomised subjects who had received at least one dose of semaglutide 0.5 mg (s.c.), semaglutide 1.0 mg (s.c.) or one additional OAD. Subjects in the SAS contributed to the evaluation "as treated".

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: All AEs mentioned here are treatment emergent adverse events (TEAE), defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment (week 0-56 treatment period) and no later than the follow-up visit during the on-treatment observation period (date of last dose + 42 days).. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Semaglutide 0.5 mg	19 of 239 (7.9%)	160 of 239 (66.9%)	Not reported
Semaglutide 1.0 mg	12 of 241 (5%)	169 of 241 (70.1%)	Not reported
Additional OAD	8 of 120 (6.7%)	61 of 120 (50.8%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 29322610Kaku K, Yamada Y, Watada H, Abiko A, Nishida T, Zacho J, Kiyosue A. Safety and efficacy of once-weekly semaglutide vs additional oral antidiabetic drugs in Japanese people with inadequately controlled type 2 diabetes: A randomized trial. Diabetes Obes Metab. 2018 May;20(5):1202-1212. doi: 10.1111/dom.13218. Epub 2018 Feb 21.
Results publication: PubMed 29748996Petri KCC, Ingwersen SH, Flint A, Zacho J, Overgaard RV. Exposure-response analysis for evaluation of semaglutide dose levels in type 2 diabetes. Diabetes Obes Metab. 2018 Sep;20(9):2238-2245. doi: 10.1111/dom.13358. Epub 2018 Jun 15.
Results publication: PubMed 29907893Carlsson Petri KC, Ingwersen SH, Flint A, Zacho J, Overgaard RV. Semaglutide s.c. Once-Weekly in Type 2 Diabetes: A Population Pharmacokinetic Analysis. Diabetes Ther. 2018 Aug;9(4):1533-1547. doi: 10.1007/s13300-018-0458-5. Epub 2018 Jun 15.
Derived from this study: PubMed 32998732Husain M, Bain SC, Holst AG, Mark T, Rasmussen S, Lingvay I. Effects of semaglutide on risk of cardiovascular events across a continuum of cardiovascular risk: combined post hoc analysis of the SUSTAIN and PIONEER trials. Cardiovasc Diabetol. 2020 Sep 30;19(1):156. doi: 10.1186/s12933-020-01106-4.
Clinical Trials at Novo NordiskLink 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.

Global Clinical Registry (GCR, 1452) study director

Novo Nordisk A/S

43 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing semaglutide and DPP-4 inhibitor in people with Diabetes and Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 43 sites in Japan.

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 3 inclusion and 9 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 7 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 43 sites in Japan. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 7 Jan 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?

Number of Treatment Emergent Adverse Events (TEAEs) (time frame: Weeks 0-56). 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 NCT02207374, which also lists 4 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 7 Jan 2019.