Type 2 DiabetesPhase 3NCT00680745

Efficacy and Safety of Dapagliflozin in Combination With Glimepiride (a Sulphonylurea) in Type 2 Diabetes Patients

A Phase 3 study testing dapagliflozin, Glimepiride and metformin hydrochloride in people with Type 2 Diabetes, run by AstraZeneca at 66 sites in 7 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 in addition to glimepiride (sulphonylurea) is effective and safe in treating patients with type 2 diabetes when compared to glimepiride alone. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Type 2 Diabetes
What is being tested?: dapagliflozin, Glimepiride and metformin hydrochloride
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 597 participants
Where: 66 sitesin 7 countries
Study dates: Apr 2008to May 2010
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 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Type 2 Diabetes
Treatment with a stable sulphonylurea monotherapy dose that is at least half the maximal recommended dose for a minimum of 8 weeks prior to study
Inadequate glycaemic control, defined as A1C ≥ 7.0 % and ≤ 10%

Who cannot join

Type 1 Diabetes
Hepatic (liver) impairment
Renal (kidney) failure or dysfunction

Trial locations and contacts

66 sites in 7 countries.

Country

City, postcode or hospital

66 sites in 7 countries

Poland22 sites

Research Site
Bielsko-Biala
Research Site
Bydgoszcz
Research Site
Chojnice
Research Site
Chrzanów
Research Site
Ciechocinek
Research Site
Czechowice-Dziedzice
Research Site
Elblag
Research Site
Gdansk
Research Site
Gniewkowo
Research Site
Grudziądz
Research Site
Iława
Research Site
Krakow
Research Site
Mrągowo
Research Site
Płock
Research Site
Poznan
Research Site
Ruda Śląska
Research Site
Sopot
Research Site
Torun
Research Site
Wroclaw
Research Site
Zabrze
Research Site
Zielona Góra
Research Site
Żory

Other trials in Poland

Hungary14 sites

Research Site
Balatonfüred
Research Site
Békéscsaba
Research Site
Budapest
Research Site
Csongrád
Research Site
Eger
Research Site
Gyöngyös
Research Site
Kecskemét
Research Site
Makó
Research Site
Miskolc
Research Site
Mosonmagyaróvár
Research Site
Siófok
Research Site
Szentes
Research Site
Tát
Research Site
Zalaegerszeg

Other trials in Hungary

Czechia10 sites

Research Site
Blansko
Research Site
Břeclav
Research Site
Bruntál
Research Site
Hodonín
Research Site
Ostrava - Belsky Les
Research Site
Pilsen
Research Site
Prague
Research Site
Pribram VIII
Research Site
Rakovník
Research Site
Semily

Other trials in Czechia

South Korea8 sites

Research Site
Bucheon-si
Research Site
Incheon
Research Site
Jeonju, Jeollabuk-do
Research Site
Seongnam
Research Site
Seoul
Research Site
Suwon, Gyeonggi-do
Research Site
Uljeongbu
Research Site
Wŏnju, Gangwon-do

Other trials in South Korea

Ukraine6 sites

Research Site
Dnipropetrov'sk
Research Site
Donetsk
Research Site
Kharkiv
Research Site
Kiev
Research Site
Vinnytsia
Research Site
Zaporizhzhya

Other trials in Ukraine

Philippines4 sites

Research Site
Cebu City
Research Site
Manila
Research Site
Marikina City
Research Site
Pasig

Other trials in Philippines

Thailand2 sites

Research Site
Bangkok
Research Site
Chiang Mai

Other trials in Thailand

About this study

Official title: A 24-Week,Int.,Rand.,Double-blind,Parallel-group,Multi-centre, Plac.-Controlled Phase III Study With a 24-Wk Ext.Per.to Eval.the Efficacy and Safety of Dapagliflozin in Comb.With Glimepiride (a Sulphonylurea) in Subjects With Type2 Diab.Who Have Inadeq. Glycaemic Control on Glimepiride Therapy Alone

This study is being carried out to see if dapagliflozin in addition to glimepiride (sulphonylurea) is effective and safe in treating patients with type 2 diabetes when compared to glimepiride alone.

Conditions: Type 2 Diabetes
Being tested: dapagliflozin, Glimepiride, metformin hydrochloride, pioglitazone hydrochloride, Rosiglitazone
Keywords: Dapagliflozin, efficacy, safety, sulphonylurea, Type 2 diabetes
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
tablet oral 2.5, 5, or 10 mg total daily dose once daily 48 weeks
GlimepirideDrug
Also called Amaryl
tablet oral 2.5, 5, or 10 mg total daily dose once daily 48 weeks
metformin hydrochlorideDrug
Also called Glucophage
rescue medication oral dosing in accordance with the manufacturer's recommendations and clinical practice
pioglitazone hydrochlorideDrug
Also called Actos
rescue medication oral dosing in accordance with the manufacturer's recommendations and clinical practice
RosiglitazoneDrug
Also called Avandia
rescue medication oral dosing in accordance with the manufacturer's recommendations and clinical practice

Study groups in NCT00680745
Study group	Role	What they receive
1	Experimental	dapagliflozin 2.5mg + Glimepiride Receives: Drug: dapagliflozin; Drug: Glimepiride; Drug: metformin hydrochloride; Drug: pioglitazone hydrochloride; Drug: Rosiglitazone
2	Experimental	dapagliflozin 5mg + Glimepiride Receives: Drug: dapagliflozin; Drug: Glimepiride; Drug: metformin hydrochloride; Drug: pioglitazone hydrochloride; Drug: Rosiglitazone
3	Experimental	dapagliflozin 10mg + Glimepiride Receives: Drug: dapagliflozin; Drug: Glimepiride; Drug: metformin hydrochloride; Drug: pioglitazone hydrochloride; Drug: Rosiglitazone
4	Placebo comparator	Placebo + Glimepiride Receives: Drug: Glimepiride; Drug: metformin hydrochloride; Drug: pioglitazone hydrochloride; Drug: Rosiglitazone

What is being measured

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

Adjusted Mean Change in HbA1c Levels
To assess the efficacy of dapagliflozin compared to placebo as add-on therapy to glimepiride in improving glycemic control in participants with type 2 diabetes, as determined by the change in HbA1C levels from baseline to the end of the 24-week double-blind treatment period.
Measured: Baseline to Week 24

Secondary outcomes (5)

Adjusted Mean Change in Body Weight
To show that dapagliflozin plus glimepiride results in greater reduction in body weight or less weight gain after 24 weeks of treatment when compared to placebo plus glimepiride.
Measured: Baseline to Week 24
Adjusted Mean Change in 2-h Post-challenge Plasma Glucose Rise
To show that dapagliflozin plus glimepiride results in greater reductions in the 2-h post-challenge plasma glucose rise as a response to an oral glucose tolerance test (OGTT) from baseline to Week 24.
Measured: Baseline to Week 24
Proportion of Participants Achieving Glycemic Response Defined as HbA1c <7%
To show that dapagliflozin plus glimepiride results in a larger proportion of participants achieving a therapeutic glycemic response, defined as HbA1c < 7% after 24 weeks of treatment, compared to placebo plus glimepiride.
Measured: At Week 24
Adjusted Mean Change in Body Weight for Participants With Baseline Body Mass Index (BMI)≥27 kg/m2
To show that dapagliflozin plus glimepiride results in greater reductions in body weight or less weight gain in participants with baseline BMI ≥27 kg/m2 after 24 weeks of treatment when compared to placebo plus glimepiride.
Measured: Baseline to Week 24
Adjusted Mean Change in Fasting Plasma Glucose (FPG)
To show that dapagliflozin plus glimepiride leads to greater reductions in FPG after 24 weeks of treatment compared to placebo plus glimepiride.
Measured: Baseline to Week 24

Timeline

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

Apr 2008May 2010

First posted20 May 2008 (estimated)
Study startApr 2008
Primary completionNov 2009
Study completionMay 2010

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 (3)Papers the sponsor has linked to this study.
Other trials for Type 2 DiabetesStudies 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 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 597 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00680745
Sponsor's protocol ID: D1690C00005
Status last verified: Aug 2013
First submitted: 16 May 2008
Last updated: 14 Oct 2013
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Shah M, Stolbov L, Yakovleva T, Tang W, Sokolov V, Penland RC, Boulton D, Parkinson J. A model-based approach to investigating the relationship between glucose-insulin dynamics and dapagliflozin treatment effect in patients with type 2 diabetes. Diabetes Obes Metab. 2021 Apr;23(4):991-1000. doi: 10.1111/dom.14305. Epub 2021 Jan 25.
PubMed 33368935
Strojek K, Yoon KH, Hruba V, Elze M, Langkilde AM, Parikh S. [Effect of dapagliflozin in patients with type 2 diabetes who have inadequate glycaemic control with glimepiride]. Dtsch Med Wochenschr. 2013 Apr;138 Suppl 1:S16-26. doi: 10.1055/s-0032-1305277. Epub 2013 Mar 25. German.
PubMed 23529567
Strojek K, Yoon KH, Hruba V, Elze M, Langkilde AM, Parikh S. Effect of dapagliflozin in patients with type 2 diabetes who have inadequate glycaemic control with glimepiride: a randomized, 24-week, double-blind, placebo-controlled trial. Diabetes Obes Metab. 2011 Oct;13(10):928-38. doi: 10.1111/j.1463-1326.2011.01434.x.
PubMed 21672123

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

Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
Not yet recruiting
Impact of Endoscopic Sleeve Gastroplasty (ESG) in Obese Adults With Type 2 Diabetes (T2D)
Type 2 Diabetes Mellitus (T2D), Obesity (BMI>30)

All Type 2 Diabetes trials

Study at a glance

From the registry record, last updated by the sponsor on 14 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A 24-Week,Int.,Rand.,Double-blind,Parallel-group,Multi-centre, Plac.-Controlled Phase III Study With a 24-Wk Ext.Per.to Eval.the Efficacy and Safety of Dapagliflozin in Comb.With Glimepiride (a Sulphonylurea) in Subjects With Type2 Diab.Who Have Inadeq. Glycaemic Control on Glimepiride Therapy Alone
ClinicalTrials.gov ID: NCT00680745
Acronym / sponsor ID: D1690C00005
Conditions: Type 2 Diabetes
Keywords: Dapagliflozin, efficacy, safety, sulphonylurea, Type 2 diabetes
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 597 participants (actual)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Collaborators: Bristol-Myers Squibb
Study start: Apr 2008
Primary completion: Nov 2009 (actual)
Study completion: May 2010 (actual)
First posted: 20 May 2008 (estimated)
Results: Posted 14 Oct 2013

Clinical summary

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

This study is being carried out to see if dapagliflozin in addition to glimepiride (sulphonylurea) is effective and safe in treating patients with type 2 diabetes when compared to glimepiride alone.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 4

Arm	Type	Receives
1	Experimental	Drug: dapagliflozin, Drug: Glimepiride, Drug: metformin hydrochloride, Drug: pioglitazone hydrochloride, Drug: Rosiglitazonedapagliflozin 2.5mg + Glimepiride
2	Experimental	Drug: dapagliflozin, Drug: Glimepiride, Drug: metformin hydrochloride, Drug: pioglitazone hydrochloride, Drug: Rosiglitazonedapagliflozin 5mg + Glimepiride
3	Experimental	Drug: dapagliflozin, Drug: Glimepiride, Drug: metformin hydrochloride, Drug: pioglitazone hydrochloride, Drug: Rosiglitazonedapagliflozin 10mg + Glimepiride
4	Placebo comparator	Drug: Glimepiride, Drug: metformin hydrochloride, Drug: pioglitazone hydrochloride, Drug: RosiglitazonePlacebo + Glimepiride

Who may qualify

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

Key inclusion criteria (3 listed)

Type 2 Diabetes
Treatment with a stable sulphonylurea monotherapy dose that is at least half the maximal recommended dose for a minimum of 8 weeks prior to study
Inadequate glycaemic control, defined as A1C ≥ 7.0 % and ≤ 10%

Key exclusion criteria (3 listed)

Type 1 Diabetes
Hepatic (liver) impairment
Renal (kidney) failure or dysfunction

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
dapagliflozintablet oral 2.5, 5, or 10 mg total daily dose once daily 48 weeks	Drug	1, 2, 3
GlimepirideAlso: Amaryltablet oral 2.5, 5, or 10 mg total daily dose once daily 48 weeks	Drug	1, 2, 3, 4
metformin hydrochlorideAlso: Glucophagerescue medication oral dosing in accordance with the manufacturer's recommendations and clinical practice	Drug	1, 2, 3, 4
pioglitazone hydrochlorideAlso: Actosrescue medication oral dosing in accordance with the manufacturer's recommendations and clinical practice	Drug	1, 2, 3, 4
RosiglitazoneAlso: Avandiarescue medication oral dosing in accordance with the manufacturer's recommendations and clinical practice	Drug	1, 2, 3, 4

Primary outcome

Adjusted Mean Change in HbA1c Levels
Time frame: Baseline to Week 24
To assess the efficacy of dapagliflozin compared to placebo as add-on therapy to glimepiride in improving glycemic control in participants with type 2 diabetes, as determined by the change in HbA1C levels from baseline to the end of the 24-week double-blind treatment period.

5 secondary outcomes

Adjusted Mean Change in Body Weight
Time frame: Baseline to Week 24
Adjusted Mean Change in 2-h Post-challenge Plasma Glucose Rise
Time frame: Baseline to Week 24
Proportion of Participants Achieving Glycemic Response Defined as HbA1c <7%
Time frame: At Week 24
Adjusted Mean Change in Body Weight for Participants With Baseline Body Mass Index (BMI)≥27 kg/m2
Time frame: Baseline to Week 24
Adjusted Mean Change in Fasting Plasma Glucose (FPG)
Time frame: Baseline to Week 24

Results and safety

Results posted to the registry on 14 Oct 2013, 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 2.5mg + Glimepiride	154	140
Dapagliflozin 5mg + Glimepiride	145	132
Dapagliflozin 10mg + Glimepiride	151	141
Placebo + Glimepiride	146	133

Primary outcome: Adjusted Mean Change in HbA1c Levels

Time frame: Baseline to Week 24. Least squares mean (95% Confidence Interval). Unit: Percent

Measure	Dapagliflozin 2.5mg + Glimepiride n = 154	Dapagliflozin 5mg + Glimepiride n = 142	Dapagliflozin 10mg + Glimepiride n = 150	Placebo + Glimepiride n = 143
Value	-0.58 (-0.69 to -0.46)	-0.63 (-0.75 to -0.50)	-0.82 (-0.94 to -0.70)	-0.13 (-0.26 to -0.01)

Dapagliflozin 2.5mg + Glimepiride vs Placebo + Glimepiride: Mean Difference (Final Values): -0.44 (95% CI -0.61 to -0.27), p <0.0001, ANCOVA
Dapagliflozin 5mg + Glimepiride vs Placebo + Glimepiride: Mean Difference (Final Values): -0.49 (95% CI -0.67 to -0.32), p <0.0001, ANCOVA
Dapagliflozin 10mg + Glimepiride vs Placebo + Glimepiride: Mean Difference (Final Values): -0.68 (95% CI -0.86 to -0.51), p <0.0001, ANCOVA

Population analysed: Full Analysis Set, participants with non-missing baseline and Week 24 (LOCF) values

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: Non-serious/serious adverse events on or after the first day and on or prior to the last day of the 24-week double-blind treatment period plus 4/30 days or up to follow-up visit if earlier, or up to and incl the start date of extension period if earlier.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Dapagliflozin 2.5mg + Glimepiride	11 of 154 (7.1%)	22 of 154 (14.3%)	Not reported
Dapagliflozin 5mg + Glimepiride	10 of 145 (6.9%)	19 of 145 (13.1%)	Not reported
Dapagliflozin 10mg + Glimepiride	9 of 151 (6%)	18 of 151 (11.9%)	Not reported
Placebo + Glimepiride	7 of 146 (4.8%)	15 of 146 (10.3%)	Not reported

Limitations and caveats (from the sponsor): For participants who did not complete 24 weeks LOCF (last observation carried forward) was used. Only values prior to rescue medication were used.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2013.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 33368935Shah M, Stolbov L, Yakovleva T, Tang W, Sokolov V, Penland RC, Boulton D, Parkinson J. A model-based approach to investigating the relationship between glucose-insulin dynamics and dapagliflozin treatment effect in patients with type 2 diabetes. Diabetes Obes Metab. 2021 Apr;23(4):991-1000. doi: 10.1111/dom.14305. Epub 2021 Jan 25.
Derived from this study: PubMed 23529567Strojek K, Yoon KH, Hruba V, Elze M, Langkilde AM, Parikh S. [Effect of dapagliflozin in patients with type 2 diabetes who have inadequate glycaemic control with glimepiride]. Dtsch Med Wochenschr. 2013 Apr;138 Suppl 1:S16-26. doi: 10.1055/s-0032-1305277. Epub 2013 Mar 25. German.
Derived from this study: PubMed 21672123Strojek K, Yoon KH, Hruba V, Elze M, Langkilde AM, Parikh S. Effect of dapagliflozin in patients with type 2 diabetes who have inadequate glycaemic control with glimepiride: a randomized, 24-week, double-blind, placebo-controlled trial. Diabetes Obes Metab. 2011 Oct;13(10):928-38. doi: 10.1111/j.1463-1326.2011.01434.x.

Related trials for Type 2 Diabetes

Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
Not yet recruiting
Impact of Endoscopic Sleeve Gastroplasty (ESG) in Obese Adults With Type 2 Diabetes (T2D)
Type 2 Diabetes Mellitus (T2D), Obesity (BMI>30)

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.

Krzysztof Strojek, Prof. Dr. principal investigator

Silesian Medical University3-Maja 13/15, 41-800 Zabrze; Poland

66 sites in 7 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing dapagliflozin, Glimepiride and metformin hydrochloride in people with Type 2 Diabetes, run by AstraZeneca at 66 sites in 7 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 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Oct 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 66 sites in Poland, Hungary, Czechia, South Korea, Ukraine and 2 more countries. 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 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 14 Oct 2013). 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?

Adjusted Mean Change in HbA1c Levels (time frame: Baseline to Week 24). 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 NCT00680745, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2013.