Diabetes Mellitus, Type 2Phase 2NCT01193218

Empagliflozin (BI 10773) Dose Finder Study in Japanese Patients With Type 2 Diabetes Mellitus

A Phase 2 study testing BI 10773 in people with Diabetes Mellitus, Type 2, run by Boehringer Ingelheim at 32 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 study is conducted to determine the most appropriate therapeutic doses of BI 10773 in Japanese patients with T2DM at first treatment period. The second treatment period is required to obtain sufficient safety data (one-year exposure to BI 10773) in Japanese patients with T2DM according to the ICH E1 guideline. Read more about this study

Who is it for?: Ages 20 to 80 years
Conditions the study is for: Diabetes Mellitus, Type 2
What is being tested?: BI 10773
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 547 participants
Where: 32 sitesJapan
Study dates: Sep 2010to Jun 2012
Phase: Phase 2
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 to 80 years
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:
drug-naïve, defined as no antidiabetic drugs for 10 weeks prior to informed consent.
pre-treated with one oral antidiabetic drug; the present antidiabetic therapy has to be unchanged for 10 weeks prior to informed consent.
HbA1c at Visit 1a:
for patients who are drug naïve: HbA1c >=7.0 to =<10.0%
for patients treated with one oral antidiabetic drug: HbA1c >=6.5 to =<9.0%
HbA1c of >=7.0% and =<10% at Visit 2 (start of run-in)

Who cannot join

Uncontrolled hyperglycaemia with a glucose level >240 mg/dL (>13.3 mmol/L) after an overnight fast during wash-out/placebo run-in period and confirmed by a second measurement (not on the same day).
Acute coronary syndromes, stroke or transient ischaemic attack within 12 weeks prior to informed consent
Impaired renal function, defined as calculated eGFR <60 ml/min (MDRD formula) during screening and/or wash-out period and/or run-in phase.
Bariatric surgery within the past 2 years and other gastrointestinal surgeries that induce chronic malabsorption
Blood dyscrasias or any disorders causing hemolysis or unstable Red Blood Cell (e.g. malaria, babesiosis, haemolytic anemia)
Treatment with anti-obesity drugs (e.g. sibutramine, mazindol) 12 weeks prior to informed consent or any other treatment at the time of screening (i.e. surgery, aggressive diet regimen, etc.) leading to unstable body weight

Trial locations and contacts

32 sites in 1 country.

City, postcode or hospital

32 sites in 1 country

Japan32 sites

1245.38.016 Boehringer Ingelheim Investigational Site
Chiyoda-ku, Tokyo
1245.38.001 Boehringer Ingelheim Investigational Site
Chuo-ku, Tokyo
1245.38.003 Boehringer Ingelheim Investigational Site
Chuo-ku, Tokyo
1245.38.002 Boehringer Ingelheim Investigational Site
Hachioji, Tokyo
1245.38.010 Boehringer Ingelheim Investigational Site
Hanamaki, Iwate
1245.38.005 Boehringer Ingelheim Investigational Site
Kamakura, Kanagawa
1245.38.020 Boehringer Ingelheim Investigational Site
Kanazawa, Ishikawa
1245.38.013 Boehringer Ingelheim Investigational Site
Kashiwa, Chiba
1245.38.019 Boehringer Ingelheim Investigational Site
Katsushika-ku, Tokyo
1245.38.021 Boehringer Ingelheim Investigational Site
Kyoto, Kyoto
1245.38.024 Boehringer Ingelheim Investigational Site
Matsuyama, Ehime
1245.38.004 Boehringer Ingelheim Investigational Site
Minato-ku, Tokyo
1245.38.011 Boehringer Ingelheim Investigational Site
Moriya, Ibaraki
1245.38.030 Boehringer Ingelheim Investigational Site
Naha, Okinawa
1245.38.032 Boehringer Ingelheim Investigational Site
Okawa, Fukuoka
1245.38.031 Boehringer Ingelheim Investigational Site
Okinawa, Okinawa
1245.38.025 Boehringer Ingelheim Investigational Site
Saga, Saga
1245.38.014 Boehringer Ingelheim Investigational Site
Saitama, Saitama
1245.38.006 Boehringer Ingelheim Investigational Site
Sapporo, Hokkaido
1245.38.007 Boehringer Ingelheim Investigational Site
Sapporo, Hokkaido
1245.38.008 Boehringer Ingelheim Investigational Site
Sapporo, Hokkaido
1245.38.009 Boehringer Ingelheim Investigational Site
Sapporo, Hokkaido
1245.38.012 Boehringer Ingelheim Investigational Site
Sasima-gun, Ibaraki
1245.38.015 Boehringer Ingelheim Investigational Site
Shinjuku-ku, Tokyo
1245.38.018 Boehringer Ingelheim Investigational Site
Shinjuku-ku, Tokyo
1245.38.017 Boehringer Ingelheim Investigational Site
Suginami-ku, Tokyo
1245.38.022 Boehringer Ingelheim Investigational Site
Suita, Osaka
1245.38.023 Boehringer Ingelheim Investigational Site
Ube, Yamaguchi
1245.38.026 Boehringer Ingelheim Investigational Site
Urasoe, Okinawa
1245.38.027 Boehringer Ingelheim Investigational Site
Urasoe, Okinawa
1245.38.028 Boehringer Ingelheim Investigational Site
Urasoe, Okinawa
1245.38.029 Boehringer Ingelheim Investigational Site
Urasoe, Okinawa

Other trials in Japan

About this study

Official title: A Double-blind, Randomised, Parallel Group Efficacy and Safety Study of BI 10773 (5 mg, 10 mg, 25 mg, and 50 mg) Compared to Placebo When Administered Orally Once Daily Over 12 Weeks, as Monotherapy, in Patients With Type 2 Diabetes and Insufficient Glycaemic Control Despite Diet and Exercise, Followed by a 40 Week Randomised Extension Study to Assess Long Term Safety of BI 10773 (10 mg and 25 mg)

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

Placebo (low dose)Drug
Placebo tablets once a day
Placebo (low dose)Drug
Placebo tablets once a day
Placebo (mid dose)Drug
Placebo tablets once a day
Placebo (high dose)Drug
Placebo tablets once a day
BI 10773Drug
BI 10773 tablets low dose once a day
Placebo (mid dose)Drug
Placebo tablets once a day
Placebo (high dose)Drug
Placebo tablets once a day
Placebo (high dose)Drug
Placebo tablets once a day
BI 10773Drug
BI 10773 tablets mid-high dose once a day
BI 10773Drug
BI 10773 tablets high dose once a day
Placebo (mid dose)Drug
Placebo tablets once a day
Placebo (high dose)Drug
Placebo tablets once a day
Placebo (low dose)Drug
Placebo tablets once a day
Placebo (low dose)Drug
Placebo tablets once a day
BI 10773Drug
BI 10773 tablets mid-low dose once a day
Placebo (mid dose)Drug
Placebo tablets once a day

Study groups in NCT01193218
Study group	Role	What they receive
BI 10773 low dose QD	Experimental	BI 10773 tablets low dose once a day Receives: Drug: Placebo (mid dose); Drug: Placebo (high dose); Drug: BI 10773
BI 10773 mid-low dose QD	Experimental	BI 10773 tablets mid-low dose once a day Receives: Drug: Placebo (high dose); Drug: Placebo (low dose); Drug: BI 10773
BI 10773 mid-high dose QD	Experimental	BI 10773 tablets mid-high dose once a day Receives: Drug: BI 10773; Drug: Placebo (high dose); Drug: Placebo (low dose); Drug: Placebo (mid dose)
BI 10773 high dose QD	Experimental	BI 10773 tablets high dose once a day Receives: Drug: Placebo (low dose); Drug: Placebo (mid dose); Drug: BI 10773
Placebo	Placebo comparator	Placebo tablets once a day Receives: Drug: Placebo (low dose); Drug: Placebo (high dose); Drug: Placebo (mid dose)

What is being measured

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

Change From Baseline in HbA1c After 12 Weeks of Treatment.
The primary endpoint in this study is the change from baseline in HbA1c after 12 weeks of treatment.
Measured: baseline and 12 weeks

Secondary outcomes (2)

Occurrence of Treat to Target Efficacy Response
Occurrence of treat to target efficacy response, that is an HbA1c of <7.0% after 12 weeks of treatment
Measured: baseline and 12 weeks
Change From Baseline in FPG
Change from baseline in FPG after 12 weeks of treatment
Measured: baseline and 12 weeks

Timeline

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

Sep 2010Jun 2012

First posted1 Sep 2010 (estimated)
Study startSep 2010
Primary completionJun 2012
Study completionJun 2012

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 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 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Enrolment: 547 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01193218
Sponsor's protocol ID: 1245.38
Status last verified: May 2014
First submitted: 31 Aug 2010
Last updated: 17 Jun 2014
Results posted: Yes, on ClinicalTrials.gov

Publications

Natale P, Tunnicliffe DJ, Toyama T, Palmer SC, Saglimbene VM, Ruospo M, Gargano L, Stallone G, Gesualdo L, Strippoli GF. Sodium-glucose co-transporter protein 2 (SGLT2) inhibitors for people with chronic kidney disease and diabetes. Cochrane Database Syst Rev. 2024 May 21;5(5):CD015588. doi: 10.1002/14651858.CD015588.pub2.
PubMed 38770818
Tuttle KR, Levin A, Nangaku M, Kadowaki T, Agarwal R, Hauske SJ, Elsasser A, Ritter I, Steubl D, Wanner C, Wheeler DC. Safety of Empagliflozin in Patients With Type 2 Diabetes and Chronic Kidney Disease: Pooled Analysis of Placebo-Controlled Clinical Trials. Diabetes Care. 2022 Jun 2;45(6):1445-1452. doi: 10.2337/dc21-2034.
PubMed 35472672
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
Kadowaki T, Haneda M, Inagaki N, Terauchi Y, Taniguchi A, Koiwai K, Rattunde H, Woerle HJ, Broedl UC. Efficacy and safety of empagliflozin monotherapy for 52 weeks in Japanese patients with type 2 diabetes: a randomized, double-blind, parallel-group study. Adv Ther. 2015 Apr;32(4):306-18. doi: 10.1007/s12325-015-0198-0. Epub 2015 Apr 7.
PubMed 25845768

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 Double-blind, Randomised, Parallel Group Efficacy and Safety Study of BI 10773 (5 mg, 10 mg, 25 mg, and 50 mg) Compared to Placebo When Administered Orally Once Daily Over 12 Weeks, as Monotherapy, in Patients With Type 2 Diabetes and Insufficient Glycaemic Control Despite Diet and Exercise, Followed by a 40 Week Randomised Extension Study to Assess Long Term Safety of BI 10773 (10 mg and 25 mg)
ClinicalTrials.gov ID: NCT01193218
Acronym / sponsor ID: 1245.38
Conditions: Diabetes Mellitus, Type 2
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 547 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Collaborators: Eli Lilly and Company
Study start: Sep 2010
Primary completion: Jun 2012 (actual)
Study completion: Jun 2012 (actual)
First posted: 1 Sep 2010 (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: 5

Arm	Type	Receives
BI 10773 low dose QD	Experimental	Drug: Placebo (mid dose), Drug: Placebo (high dose), Drug: BI 10773BI 10773 tablets low dose once a day
BI 10773 mid-low dose QD	Experimental	Drug: Placebo (high dose), Drug: Placebo (low dose), Drug: BI 10773BI 10773 tablets mid-low dose once a day
BI 10773 mid-high dose QD	Experimental	Drug: BI 10773, Drug: Placebo (high dose), Drug: Placebo (low dose), Drug: Placebo (mid dose)BI 10773 tablets mid-high dose once a day
BI 10773 high dose QD	Experimental	Drug: Placebo (low dose), Drug: Placebo (mid dose), Drug: BI 10773BI 10773 tablets high dose once a day
Placebo	Placebo comparator	Drug: Placebo (low dose), Drug: Placebo (high dose), Drug: Placebo (mid dose)Placebo tablets once a day

Who may qualify

Ages: 20 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

Diagnosis of type 2 diabetes mellitus prior to informed consent
Male and female patients on diet and exercise regimen who are:
HbA1c at Visit 1a:
HbA1c of >=7.0% and =<10% at Visit 2 (start of run-in)

Key exclusion criteria (6 listed)

Uncontrolled hyperglycaemia with a glucose level >240 mg/dL (>13.3 mmol/L) after an overnight fast during wash-out/placebo run-in period and confirmed by a second measurement (not on the same day).
Acute coronary syndromes, stroke or transient ischaemic attack within 12 weeks prior to informed consent
Impaired renal function, defined as calculated eGFR <60 ml/min (MDRD formula) during screening and/or wash-out period and/or run-in phase.
Bariatric surgery within the past 2 years and other gastrointestinal surgeries that induce chronic malabsorption
Blood dyscrasias or any disorders causing hemolysis or unstable Red Blood Cell (e.g. malaria, babesiosis, haemolytic anemia)

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
Placebo (low dose)Placebo tablets once a day	Drug	Placebo
Placebo (low dose)Placebo tablets once a day	Drug	BI 10773 high dose QD
Placebo (mid dose)Placebo tablets once a day	Drug	BI 10773 low dose QD
Placebo (high dose)Placebo tablets once a day	Drug	BI 10773 low dose QD
BI 10773BI 10773 tablets low dose once a day	Drug	BI 10773 low dose QD
Placebo (mid dose)Placebo tablets once a day	Drug	BI 10773 high dose QD
Placebo (high dose)Placebo tablets once a day	Drug	Placebo
Placebo (high dose)Placebo tablets once a day	Drug	BI 10773 mid-low dose QD
BI 10773BI 10773 tablets mid-high dose once a day	Drug	BI 10773 mid-high dose QD
BI 10773BI 10773 tablets high dose once a day	Drug	BI 10773 high dose QD
Placebo (mid dose)Placebo tablets once a day	Drug	Placebo
Placebo (high dose)Placebo tablets once a day	Drug	BI 10773 mid-high dose QD
Placebo (low dose)Placebo tablets once a day	Drug	BI 10773 mid-low dose QD
Placebo (low dose)Placebo tablets once a day	Drug	BI 10773 mid-high dose QD
BI 10773BI 10773 tablets mid-low dose once a day	Drug	BI 10773 mid-low dose QD
Placebo (mid dose)Placebo tablets once a day	Drug	BI 10773 mid-high dose QD

Primary outcome

Change From Baseline in HbA1c After 12 Weeks of Treatment.
Time frame: baseline and 12 weeks
The primary endpoint in this study is the change from baseline in HbA1c after 12 weeks of treatment.

2 secondary outcomes

Occurrence of Treat to Target Efficacy Response
Time frame: baseline and 12 weeks
Change From Baseline in FPG
Time frame: baseline and 12 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
Placebo/Empa 10mg	109	100
Placebo/Empa 25 mg	0	0
Empa 5mg/10mg	110	107
Empa 5 mg/25 mg	0	0
Empa 10mg	109	108
Empa 25mg	109	106
Empa 50mg\10mg	110	107
Empa 50 mg/25 mg	0	0

Primary outcome: Change From Baseline in HbA1c After 12 Weeks of Treatment.

Time frame: baseline and 12 weeks. Least squares mean (Standard Error). Unit: percentage of HbA1c

Measure	Placebo (12 Week) n = 109	Empa 5mg (12 Week) n = 110	Empa 10mg (12 Week) n = 109	Empa 25mg (12 Week) n = 109	Empa 50mg (12 Week) n = 110
Value	0.30 (0.09)	-0.42 (0.09)	-0.40 (0.09)	-0.65 (0.09)	-0.61 (0.09)

Placebo (12 Week) vs Empa 5mg (12 Week): Mean Difference (Final Values): -0.72 (95% CI -0.87 to -0.57), p <0.0001, ANCOVA
Placebo (12 Week) vs Empa 10mg (12 Week): Mean Difference (Final Values): -0.70 (95% CI -0.85 to -0.55), p <0.0001, ANCOVA
Placebo (12 Week) vs Empa 25mg (12 Week): Mean Difference (Final Values): -0.95 (95% CI -1.10 to -0.80), p <0.0001, ANCOVA

Population analysed: Full analysis set (FAS)

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: between first drug intake of study medication up to a period of 7 days (inclusive) after the last drug intake of study medication, up to 392 days. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo (12 Week)	3 of 109 (2.8%)	15 of 109 (13.8%)	Not reported
Empa 5mg (12 Week)	0 of 110 (0%)	19 of 110 (17.3%)	Not reported
Empa 10mg (12 Week)	0 of 109 (0%)	16 of 109 (14.7%)	Not reported
Empa 25mg (12 Week)	3 of 109 (2.8%)	26 of 109 (23.9%)	Not reported
Empa 50mg (12 Week)	1 of 110 (0.9%)	20 of 110 (18.2%)	Not reported
Empa 10mg (Randomized, 52 Week)	3 of 109 (2.8%)	39 of 109 (35.8%)	Not reported
Empa 25mg (Randomized, 52 Week)	8 of 109 (7.3%)	49 of 109 (45%)	Not reported
Empa 10mg (With at Least One Dose, 52 Week)	8 of 267 (3%)	83 of 267 (31.1%)	Not reported
Empa 25mg (With at Least One Dose, 52 Week)	15 of 265 (5.7%)	93 of 265 (35.1%)	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 38770818Natale P, Tunnicliffe DJ, Toyama T, Palmer SC, Saglimbene VM, Ruospo M, Gargano L, Stallone G, Gesualdo L, Strippoli GF. Sodium-glucose co-transporter protein 2 (SGLT2) inhibitors for people with chronic kidney disease and diabetes. Cochrane Database Syst Rev. 2024 May 21;5(5):CD015588. doi: 10.1002/14651858.CD015588.pub2.
Derived from this study: PubMed 35472672Tuttle KR, Levin A, Nangaku M, Kadowaki T, Agarwal R, Hauske SJ, Elsasser A, Ritter I, Steubl D, Wanner C, Wheeler DC. Safety of Empagliflozin in Patients With Type 2 Diabetes and Chronic Kidney Disease: Pooled Analysis of Placebo-Controlled Clinical Trials. Diabetes Care. 2022 Jun 2;45(6):1445-1452. doi: 10.2337/dc21-2034.
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 25845768Kadowaki T, Haneda M, Inagaki N, Terauchi Y, Taniguchi A, Koiwai K, Rattunde H, Woerle HJ, Broedl UC. Efficacy and safety of empagliflozin monotherapy for 52 weeks in Japanese patients with type 2 diabetes: a randomized, double-blind, parallel-group study. Adv Ther. 2015 Apr;32(4):306-18. doi: 10.1007/s12325-015-0198-0. Epub 2015 Apr 7.
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

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

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing BI 10773 in people with Diabetes Mellitus, Type 2, run by Boehringer Ingelheim at 32 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 8 inclusion and 6 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 32 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

Change From Baseline in HbA1c After 12 Weeks of Treatment. (time frame: baseline and 12 weeks). 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 NCT01193218, 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 17 Jun 2014.