Diabetes Mellitus, Type 2Phase 3NCT01368081

Empagliflozin (BI 10773) Comprehensive add-on Study in Japanese Subjects With Type 2 Diabetes Mellitus

A Phase 3 study testing Metformin and BI 10773 in people with Diabetes Mellitus, Type 2, run by Boehringer Ingelheim at 87 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

The objective of the study is to investigate the long-term safety and efficacy of BI 10773 given for 52 weeks as add-on therapy to one oral antidiabetic drug in patients with type 2 diabetes mellitus with insufficient glycaemic control. Read more about this study

Who is it for?: Ages 20 years and older
Conditions the study is for: Diabetes Mellitus, Type 2
What is being tested?: Metformin and BI 10773
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 1,162 participants
Where: 87 sitesJapan
Study dates: May 2011to Apr 2013
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

.Diagnosis of type 2 diabetes mellitus prior to informed consent
Male and female patients, on diet and exercise regimen, who are pre-treated with one of the following oral antidiabetic drugs: sulfonylurea, glinide, biguanide, Alpha-glucosidase inhibitor (a-GI), dipeptidyl peptidase-IV (DPP-IV) inhibitor or thiazolidinedione
glycosylated haemoglobin (HbA1c) at Visit 1: >=7.0 to =<10.0% (national glycohemoglobin standardization program)

Who cannot join

Uncontrolled hyperglycaemia with a glucose level >240 mg/dL (>13.3 mmol/L)
Acute coronary syndrome, stroke or transient ischemic attack (TIA) within 12 weeks prior to informed consent
Indication of liver disease, defined by serum levels of either alanine transaminase (ALT), aspartate transaminase (AST), or alkaline phosphatase (ALP) above 3 x upper limit of normal (ULN)

Trial locations and contacts

87 sites in 1 country.

City, postcode or hospital

87 sites in 1 country

Japan87 sites

1245.52.023 Boehringer Ingelheim Investigational Site
Adachi-ku, Tokyo
1245.52.048 Boehringer Ingelheim Investigational Site
Aki-gun, Hiroshima
1245.52.012 Boehringer Ingelheim Investigational Site
Annaka, Gunma
1245.52.087 Boehringer Ingelheim Investigational Site
Atami, Shizuoka
1245.52.008 Boehringer Ingelheim Investigational Site
Beppu, Oita
1245.52.073 Boehringer Ingelheim Investigational Site
Chiyoda-ku, Tokyo
1245.52.002 Boehringer Ingelheim Investigational Site
Chuo-ku, Tokyo
1245.52.020 Boehringer Ingelheim Investigational Site
Chuo-ku, Tokyo
1245.52.021 Boehringer Ingelheim Investigational Site
Chuo-ku, Tokyo
1245.52.031 Boehringer Ingelheim Investigational Site
Fujisawa, Kanagawa
1245.52.077 Boehringer Ingelheim Investigational Site
Fukuoka, Fukuoka
1245.52.086 Boehringer Ingelheim Investigational Site
Hadano, Kanagawa
1245.52.037 Boehringer Ingelheim Investigational Site
Hamamatsu, Shizuoka
1245.52.046 Boehringer Ingelheim Investigational Site
Himeji, Hyogo
1245.52.047 Boehringer Ingelheim Investigational Site
Hiroshima, Hiroshima
1245.52.051 Boehringer Ingelheim Investigational Site
Imabari, Ehime
1245.52.016 Boehringer Ingelheim Investigational Site
Iruma,Saitama
1245.52.033 Boehringer Ingelheim Investigational Site
Isehara, Kanagawa
1245.52.011 Boehringer Ingelheim Investigational Site
Isesaki, Gunma
1245.52.045 Boehringer Ingelheim Investigational Site
Izumisano,Osaka
1245.52.088 Boehringer Ingelheim Investigational Site
Kamakura, Kanagawa
1245.52.072 Boehringer Ingelheim Investigational Site
Kamakura,Kanagawa
1245.52.034 Boehringer Ingelheim Investigational Site
Kanazawa, Ishikawa
1245.52.058 Boehringer Ingelheim Investigational Site
Kanoya, Kagoshima
1245.52.019 Boehringer Ingelheim Investigational Site
Kashiwa, Chiba
1245.52.039 Boehringer Ingelheim Investigational Site
Kasugai, Aichi
1245.52.027 Boehringer Ingelheim Investigational Site
Kawasaki, Kanagawa
1245.52.018 Boehringer Ingelheim Investigational Site
Kita-adachi-gun, Saitama
1245.52.022 Boehringer Ingelheim Investigational Site
Kita-ku, Tokyo
1245.52.052 Boehringer Ingelheim Investigational Site
Kitakyushu, Fukuoka
1245.52.076 Boehringer Ingelheim Investigational Site
Kobe, Hyogo
1245.52.026 Boehringer Ingelheim Investigational Site
Kodaira, Tokyo
1245.52.069 Boehringer Ingelheim Investigational Site
Koriyama, Fukushima
1245.52.071 Boehringer Ingelheim Investigational Site
Koriyama, Fukushima
1245.52.014 Boehringer Ingelheim Investigational Site
Koshigaya, Saitama
1245.52.074 Boehringer Ingelheim Investigational Site
Kuki, Saitama
1245.52.055 Boehringer Ingelheim Investigational Site
Kumamoto, Kumamoto
1245.52.049 Boehringer Ingelheim Investigational Site
Kure, Hiroshima
1245.52.040 Boehringer Ingelheim Investigational Site
Kyoto, Kyoto
1245.52.010 Boehringer Ingelheim Investigational Site
Maebashi, Gunma
1245.52.080 Boehringer Ingelheim Investigational Site
Maebashi, Gunma
1245.52.050 Boehringer Ingelheim Investigational Site
Matsuyama, Ehime
1245.52.075 Boehringer Ingelheim Investigational Site
Meguro-ku, Tokyo
1245.52.056 Boehringer Ingelheim Investigational Site
Miyazaki, Miyazaki
1245.52.057 Boehringer Ingelheim Investigational Site
Miyazaki, Miyazaki
1245.52.079 Boehringer Ingelheim Investigational Site
Morioka, Iwate
1245.52.003 Boehringer Ingelheim Investigational Site
Nagoya, Aichi
1245.52.004 Boehringer Ingelheim Investigational Site
Nagoya, Aichi
1245.52.005 Boehringer Ingelheim Investigational Site
Nagoya, Aichi
1245.52.038 Boehringer Ingelheim Investigational Site
Nagoya, Aichi
1245.52.059 Boehringer Ingelheim Investigational Site
Naha, Okinawa
1245.52.066 Boehringer Ingelheim Investigational Site
Naha, Okinawa
1245.52.065 Boehringer Ingelheim Investigational Site
Nanjyo, Okinawa
1245.52.007 Boehringer Ingelheim Investigational Site
Oita, Oita
1245.52.053 Boehringer Ingelheim Investigational Site
Okawa, Fukuoka
1245.52.068 Boehringer Ingelheim Investigational Site
Okinawa, Okinawa
1245.52.042 Boehringer Ingelheim Investigational Site
Osaka,Osaka
1245.52.089 Boehringer Ingelheim Investigational Site
Osaki, Miyagi
1245.52.024 Boehringer Ingelheim Investigational Site
Ota-ku, Tokyo
1245.52.054 Boehringer Ingelheim Investigational Site
Saga, Saga
1245.52.032 Boehringer Ingelheim Investigational Site
Sagamihara, Kanagawa
1245.52.085 Boehringer Ingelheim Investigational Site
Sagamihara, Kanagawa
1245.52.013 Boehringer Ingelheim Investigational Site
Saitama, Saitama
1245.52.015 Boehringer Ingelheim Investigational Site
Sakado, Saitama
1245.52.044 Boehringer Ingelheim Investigational Site
Sakai, Osaka
1245.52.035 Boehringer Ingelheim Investigational Site
Saku, Nagano
1245.52.009 Boehringer Ingelheim Investigational Site
Sapporo, Hokkaido
1245.52.025 Boehringer Ingelheim Investigational Site
Setagaya-ku, Tokyo
1245.52.063 Boehringer Ingelheim Investigational Site
Shimajiri-gun, Okinawa
1245.52.064 Boehringer Ingelheim Investigational Site
Shimajiri-gun, Okinawa
1245.52.001 Boehringer Ingelheim Investigational Site
Shinjuku-ku. Tokyo
1245.52.036 Boehringer Ingelheim Investigational Site
Shizuoka, Shizuoka
1245.52.006 Boehringer Ingelheim Investigational Site
Suita, Osaka
1245.52.043 Boehringer Ingelheim Investigational Site
Takatsuki, Osaka
1245.52.017 Boehringer Ingelheim Investigational Site
Tokorozawa, Saitama
1245.52.070 Boehringer Ingelheim Investigational Site
Tokorozawa, Saitama
1245.52.061 Boehringer Ingelheim Investigational Site
Tomigusuku, Okinawa
1245.52.062 Boehringer Ingelheim Investigational Site
Tomigusuku, Okinawa
1245.52.041 Boehringer Ingelheim Investigational Site
Uji, Kyoto
1245.52.067 Boehringer Ingelheim Investigational Site
Uruma, Okinawa
1245.52.028 Boehringer Ingelheim Investigational Site
Yokohama, Kanagawa
1245.52.029 Boehringer Ingelheim Investigational Site
Yokohama, Kanagawa
1245.52.030 Boehringer Ingelheim Investigational Site
Yokohama, Kanagawa
1245.52.081 Boehringer Ingelheim Investigational Site
Yokohama, Kanagawa
1245.52.082 Boehringer Ingelheim Investigational Site
Yokohama, Kanagawa
1245.52.083 Boehringer Ingelheim Investigational Site
Yokohama, Kanagawa
1245.52.084 Boehringer Ingelheim Investigational Site
Yokohama, Kanagawa

Other trials in Japan

About this study

Official title: A 52-week, Randomised, Multi-centre, Parallel Group Study to Investigate the Safety and Efficacy of BI 10773 (10 mg or 25 mg Administered Orally Once Daily) as add-on Therapy to an Oral Antidiabetic Drug (Sulfonylurea, Biguanide, Thiazolidinedione, Alpha Glucosidase Inhibitor, DPP-IV Inhibitor, or Glinide) in Patients With Type 2 Diabetes Mellitus With Insufficient Glycaemic Control

Conditions: Diabetes Mellitus, Type 2
Being tested: Metformin, BI 10773, Placebo (low dose), Placebo (high dose)
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.

MetforminDrug
Metformin tablets 500-2250 mg a day (twice or three times per day)
BI 10773Drug
BI 10773 low dose tablet once daily
Placebo (low dose)Drug
Placebo tablets once daily
BI 10773Drug
BI 10773 high dose tablet once daily
Placebo (high dose)Drug
Placebo tablets once daily

Study groups in NCT01368081
Study group	Role	What they receive
BI 10773 low dose	Experimental	BI 10773 low dose tablet once daily Receives: Drug: BI 10773; Drug: Placebo (high dose)
BI 10773 high dose	Experimental	BI 10773 high dose tablet once daily Receives: Drug: Placebo (low dose); Drug: BI 10773
Metformin	Active comparator	Metformin tablets 500-2250 mg a day (twice or three times per day) Receives: Drug: Metformin

What is being measured

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

Number of Patients With Drug Related Adverse Events
Number of Patients With Drug Related Adverse Events after the first drug intake until 7 days after the last treatment administration, up to 383 days
Measured: After the first drug intake until 7 days after the last treatment administration, up to 383 days

Secondary outcomes (1)

Change From Baseline in HbA1c
Change from baseline in HbA1c after 52 weeks of treatment
Measured: Baseline and 52 weeks

Timeline

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

May 2011Apr 2013

First posted7 Jun 2011 (estimated)
Study startMay 2011
Primary completionApr 2013
Study completionApr 2013

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 (2)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 Boehringer IngelheimThe 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: Double blind
Enrolment: 1,162 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01368081
Sponsor's protocol ID: 1245.52
Status last verified: May 2014
First submitted: 19 May 2011
Last updated: 17 Jun 2014
Results posted: Yes, on ClinicalTrials.gov

Publications

Shiba T, Ishii S, Okamura T, Mitsuyoshi R, Pfarr E, Koiwai K. Efficacy and safety of empagliflozin in Japanese patients with type 2 diabetes mellitus: A sub-analysis by body mass index and age of pooled data from three clinical trials. Diabetes Res Clin Pract. 2017 Sep;131:169-178. doi: 10.1016/j.diabres.2017.07.004. Epub 2017 Jul 8.
PubMed 28753486
Araki E, Tanizawa Y, Tanaka Y, Taniguchi A, Koiwai K, Kim G, Salsali A, Woerle HJ, Broedl UC. Long-term treatment with empagliflozin as add-on to oral antidiabetes therapy in Japanese patients with type 2 diabetes mellitus. Diabetes Obes Metab. 2015 Jul;17(7):665-74. doi: 10.1111/dom.12464. Epub 2015 Apr 15.
PubMed 25772548

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 17 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A 52-week, Randomised, Multi-centre, Parallel Group Study to Investigate the Safety and Efficacy of BI 10773 (10 mg or 25 mg Administered Orally Once Daily) as add-on Therapy to an Oral Antidiabetic Drug (Sulfonylurea, Biguanide, Thiazolidinedione, Alpha Glucosidase Inhibitor, DPP-IV Inhibitor, or Glinide) in Patients With Type 2 Diabetes Mellitus With Insufficient Glycaemic Control
ClinicalTrials.gov ID: NCT01368081
Acronym / sponsor ID: 1245.52
Conditions: Diabetes Mellitus, Type 2
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 1,162 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Collaborators: Eli Lilly and Company
Study start: May 2011
Primary completion: Apr 2013 (actual)
Study completion: Apr 2013 (actual)
First posted: 7 Jun 2011 (estimated)
Results: Posted 17 Jun 2014

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: Double blind
Number of arms: 3

Arm	Type	Receives
BI 10773 low dose	Experimental	Drug: BI 10773, Drug: Placebo (high dose)BI 10773 low dose tablet once daily
BI 10773 high dose	Experimental	Drug: Placebo (low dose), Drug: BI 10773BI 10773 high dose tablet once daily
Metformin	Active comparator	Drug: MetforminMetformin tablets 500-2250 mg a day (twice or three times per day)

Who may qualify

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

Key inclusion criteria (3 listed)

.Diagnosis of type 2 diabetes mellitus prior to informed consent
Male and female patients, on diet and exercise regimen, who are pre-treated with one of the following oral antidiabetic drugs: sulfonylurea, glinide, biguanide, Alpha-glucosidase inhibitor (a-GI), dipeptidyl peptidase-IV (DPP-IV) inhibitor or thiazolidinedione
glycosylated haemoglobin (HbA1c) at Visit 1: >=7.0 to =<10.0% (national glycohemoglobin standardization program)

Key exclusion criteria (3 listed)

Uncontrolled hyperglycaemia with a glucose level >240 mg/dL (>13.3 mmol/L)
Acute coronary syndrome, stroke or transient ischemic attack (TIA) within 12 weeks prior to informed consent
Indication of liver disease, defined by serum levels of either alanine transaminase (ALT), aspartate transaminase (AST), or alkaline phosphatase (ALP) above 3 x upper limit of normal (ULN)

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
MetforminMetformin tablets 500-2250 mg a day (twice or three times per day)	Drug	Metformin
BI 10773BI 10773 low dose tablet once daily	Drug	BI 10773 low dose
Placebo (low dose)Placebo tablets once daily	Drug	BI 10773 high dose
BI 10773BI 10773 high dose tablet once daily	Drug	BI 10773 high dose
Placebo (high dose)Placebo tablets once daily	Drug	BI 10773 low dose

Primary outcome

Number of Patients With Drug Related Adverse Events
Time frame: After the first drug intake until 7 days after the last treatment administration, up to 383 days
Number of Patients With Drug Related Adverse Events after the first drug intake until 7 days after the last treatment administration, up to 383 days

1 secondary outcome

Change From Baseline in HbA1c
Time frame: Baseline and 52 weeks

Results and safety

Results posted to the registry on 17 Jun 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Sulfonylurea: Empa 10mg	136	126
Sulfonylurea: Empa 25mg	137	128
Sulfonylurea: Metformin	63	59
Biguanide: Empa 10mg	68	63
Biguanide: Empa 25mg	65	63
Thiazolidinedione: Empa 10mg	137	127
Thiazolidinedione: Empa 25mg	136	124
Alpha Glucosidase Inhibitor: Empa 10mg	69	62
Alpha Glucosidase Inhibitor: Empa 25mg	70	62
DPP-IV Inhibitor: Empa 10mg	68	58
DPP-IV Inhibitor: Empa 25mg	71	62
Glinide: Empa 10mg	70	67
Glinide: Empa 25mg	70	63

Primary outcome: Number of Patients With Drug Related Adverse Events

Time frame: After the first drug intake until 7 days after the last treatment administration, up to 383 days. Number. Unit: participants

Measure	Sulfonylurea: Empa 10mg n = 136	Sulfonylurea: Empa 25mg n = 137	Sulfonylurea: Metformin n = 63	Biguanide: Empa 10mg n = 68	Biguanide: Empa 25mg n = 65	Thiazolidinedione: Empa 10mg n = 137	Thiazolidinedione: Empa 25mg n = 136	Alpha Glucosidase Inhibitor: Empa 10mg n = 69	Alpha Glucosidase Inhibitor: Empa 25mg n = 70	DPP-IV Inhibitor: Empa 10mg n = 68	DPP-IV Inhibitor: Empa 25mg n = 71	Glinide: Empa 10mg n = 70	Glinide: Empa 25mg n = 70
Value	19	25	13	13	9	20	19	7	5	9	18	9	9

Population analysed: Treated patients

1 secondary outcome is reported in the full results.

Adverse events

Time frame: After the first drug intake until 7 days after the last treatment administration, up to 383 days. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Sulfonylurea: Empa 10mg	10 of 136 (7.4%)	73 of 136 (53.7%)	Not reported
Sulfonylurea: Empa 25mg	7 of 137 (5.1%)	74 of 137 (54%)	Not reported
Sulfonylurea: Metformin	3 of 63 (4.8%)	44 of 63 (69.8%)	Not reported
Biguanide: Empa 10mg	7 of 68 (10.3%)	32 of 68 (47.1%)	Not reported
Biguanide: Empa 25mg	2 of 65 (3.1%)	35 of 65 (53.8%)	Not reported
Thiazolidinedione: Empa 10mg	12 of 137 (8.8%)	77 of 137 (56.2%)	Not reported
Thiazolidinedione: Empa 25mg	12 of 136 (8.8%)	74 of 136 (54.4%)	Not reported
Alpha-GI: Empa 10mg	2 of 69 (2.9%)	40 of 69 (58%)	Not reported
Alpha-GI: Empa 25mg	5 of 70 (7.1%)	34 of 70 (48.6%)	Not reported
DPP-4 Inhibitor: Empa 10mg	7 of 68 (10.3%)	37 of 68 (54.4%)	Not reported
DPP-4 Inhibitor: Empa 25mg	5 of 71 (7%)	36 of 71 (50.7%)	Not reported
Glinide: Empa 10mg	1 of 70 (1.4%)	30 of 70 (42.9%)	Not reported
Glinide: Empa 25mg	4 of 70 (5.7%)	38 of 70 (54.3%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 28753486Shiba T, Ishii S, Okamura T, Mitsuyoshi R, Pfarr E, Koiwai K. Efficacy and safety of empagliflozin in Japanese patients with type 2 diabetes mellitus: A sub-analysis by body mass index and age of pooled data from three clinical trials. Diabetes Res Clin Pract. 2017 Sep;131:169-178. doi: 10.1016/j.diabres.2017.07.004. Epub 2017 Jul 8.
Derived from this study: PubMed 25772548Araki E, Tanizawa Y, Tanaka Y, Taniguchi A, Koiwai K, Kim G, Salsali A, Woerle HJ, Broedl UC. Long-term treatment with empagliflozin as add-on to oral antidiabetes therapy in Japanese patients with type 2 diabetes mellitus. Diabetes Obes Metab. 2015 Jul;17(7):665-74. doi: 10.1111/dom.12464. Epub 2015 Apr 15.
Related InfoLink 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.

Boehringer Ingelheim study chair

Boehringer Ingelheim

87 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 Metformin and BI 10773 in people with Diabetes Mellitus, Type 2, run by Boehringer Ingelheim at 87 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 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 17 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 87 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 17 Jun 2014). 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 Patients With Drug Related Adverse Events (time frame: After the first drug intake until 7 days after the last treatment administration, up to 383 days). 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 NCT01368081, which also lists 2 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 17 Jun 2014.