Diabetes Mellitus, Type 2Phase 3NCT00654381

Japanese P III vs Voglibose and Placebo

A Phase 3 study testing BI 1356 and voglibose in people with Diabetes Mellitus, Type 2, run by Boehringer Ingelheim at 47 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 current study is to investigate the efficacy, safety and tolerability of Linagliptin (BI 1356) (5 mg or 10 mg / once daily) compared to placebo given for 12 weeks and voglibose for 26 weeks as mono therapy in patients with type 2 diabetes mellitus with insufficient glycaemic control. 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 1356 and voglibose
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 561 participants
Where: 47 sitesJapan
Study dates: Apr 2008to Jan 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 20 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Japanese patients with a diagnosis of type 2 diabetes mellitus. Antidiabetic therapy has to be stable for at least 10 weeks before Visit 1.
Glycosylated haemoglobin A1 (HbA1c) 7.0 - 10.0% at Visit 3 (beginning of the 2-week placebo run-in phase)
Age: >= 20 and <= 80
Body Mass Index (BMI) <= 40 kg/m2

Who cannot join

Myocardial infarction, stroke or transient ischemic attack (TIA) within 6 months before Visit 1
Impaired hepatic function
History of severe allergy/hypersensitivity
Treatment with anti-diabetic, anti obesity drugs, etc 3 months before Visit 1
Fasting blood glucose >240 mg/dl (=13.3 mmol/L) at Visits 2 or 3

Trial locations and contacts

47 sites in 1 country.

City, postcode or hospital

47 sites in 1 country

Japan47 sites

1218.23.05 Boehringer Ingelheim Investigational Site
Asahi, Chiba
1218.23.06 Boehringer Ingelheim Investigational Site
Funabashi, Chiba
1218.23.21 Boehringer Ingelheim Investigational Site
Hitachinaka, Ibaraki
1218.23.44 Boehringer Ingelheim Investigational Site
Hitachiota, Ibaraki
1218.23.09 Boehringer Ingelheim Investigational Site
Imizu, Toyama
1218.23.45 Boehringer Ingelheim Investigational Site
Inashiki-gun, Ibaraki
1218.23.13 Boehringer Ingelheim Investigational Site
Izumisano, Osaka
1218.23.27 Boehringer Ingelheim Investigational Site
Kariya, Aichi
1218.23.47 Boehringer Ingelheim Investigational Site
Kitakatsushika-gun, Saitama
1218.23.39 Boehringer Ingelheim Investigational Site
Kitakyuushuu, Fukuoka
1218.23.02 Boehringer Ingelheim Investigational Site
Koriyama, Fukushima
1218.23.03 Boehringer Ingelheim Investigational Site
Koriyama, Fukushima
1218.23.10 Boehringer Ingelheim Investigational Site
Kyoto, Kyoto
1218.23.37 Boehringer Ingelheim Investigational Site
Marugame, Kagawa
1218.23.38 Boehringer Ingelheim Investigational Site
Marugame, Kagawa
1218.23.23 Boehringer Ingelheim Investigational Site
Matsumoto, Nagano
1218.23.07 Boehringer Ingelheim Investigational Site
Meguro-ku, Tokyo
1218.23.25 Boehringer Ingelheim Investigational Site
Nagoya, Aichi
1218.23.26 Boehringer Ingelheim Investigational Site
Nagoya, Aichi
1218.23.28 Boehringer Ingelheim Investigational Site
Nagoya, Aichi
1218.23.29 Boehringer Ingelheim Investigational Site
Nagoya, Aichi
1218.23.30 Boehringer Ingelheim Investigational Site
Nagoya, Aichi
1218.23.04 Boehringer Ingelheim Investigational Site
Naka, Ibaraki
1218.23.15 Boehringer Ingelheim Investigational Site
Nishi-ku, Hiroshima, Hiroshima
1218.23.34 Boehringer Ingelheim Investigational Site
Nishi-ku, Sakai, Osaka
1218.23.22 Boehringer Ingelheim Investigational Site
Nishishinjyuku, Shinjyuku-ku, Tokyo
1218.23.16 Boehringer Ingelheim Investigational Site
Oita, Oita
1218.23.40 Boehringer Ingelheim Investigational Site
Oita, Oita
1218.23.36 Boehringer Ingelheim Investigational Site
Okayama, Okayama
1218.23.11 Boehringer Ingelheim Investigational Site
Osaka, Osaka
1218.23.12 Boehringer Ingelheim Investigational Site
Osaka, Osaka
1218.23.32 Boehringer Ingelheim Investigational Site
Osaka, Osaka
1218.23.33 Boehringer Ingelheim Investigational Site
Osaka, Osaka
1218.23.35 Boehringer Ingelheim Investigational Site
Osaka, Osaka
1218.23.17 Boehringer Ingelheim Investigational Site
Sapporo, Hokkaido
1218.23.18 Boehringer Ingelheim Investigational Site
Sapporo, Hokkaido
1218.23.19 Boehringer Ingelheim Investigational Site
Sapporo, Hokkaido
1218.23.41 Boehringer Ingelheim Investigational Site
Sapporo, Hokkaido
1218.23.42 Boehringer Ingelheim Investigational Site
Sapporo, Hokkaido
1218.23.43 Boehringer Ingelheim Investigational Site
Sapporo, Hokkaido
1218.23.01 Boehringer Ingelheim Investigational Site
Sendai, Miyagi
1218.23.20 Boehringer Ingelheim Investigational Site
Sendai, Miyagi
1218.23.46 Boehringer Ingelheim Investigational Site
Shinjuku-ku, Tokyo
1218.23.08 Boehringer Ingelheim Investigational Site
Shinjyuku-ku,Tokyo
1218.23.14 Boehringer Ingelheim Investigational Site
Suita, Osaka
1218.23.31 Boehringer Ingelheim Investigational Site
Takatsuki, Osaka
1218.23.48 Boehringer Ingelheim Investigational Site
Yokohama, Kanagawa

Other trials in Japan

About this study

Official title: A Double-blind Phase III Study to Evaluate the Efficacy of BI 1356 5 mg and 10 mg vs. Placebo for 12 Weeks and vs. Voglibose 0.6 mg for 26 Weeks in Patients With Type 2 Diabetes Mellitus and Insufficient Glycaemic Control, Followed by an Extension Study to 52 Weeks to Evaluate Long-term Safety

Conditions: Diabetes Mellitus, Type 2
Being tested: BI 1356, voglibose placebo, BI 1356 placebo, voglibose
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.

BI 1356Drug
5 mg/daily
BI 1356Drug
10 mg/daily
voglibose placeboDrug
three times daily
BI 1356 placeboDrug
once daily
vogliboseDrug
0.6 mg/daily

Study groups in NCT00654381
Study group	Role	What they receive
voglibose 0.2 mg three times a day (TID)	Active comparator	patient to receive a tablet containing 0.2 mg voglibose TID plus 2 placebo tablets matching BI 1356 Receives: Drug: voglibose
BI 1356 low dose	Experimental	patient to receive a tablet containing BI 1356 and matching placebo plus 3 placebo tablets matching voglibose Receives: Drug: BI 1356
BI 1356 high dose	Experimental	patient to receive 2 tablets containing BI 1356 plus 3 placebo tablets matching voglibose Receives: Drug: BI 1356
placebo	Placebo comparator	patient to receive 2 placebo tablets matching BI 1356 plus 3 placebo tablets matching voglibose Receives: Drug: voglibose placebo; Drug: BI 1356 placebo

What is being measured

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

Change From Baseline in HbA1c at Week 12
Change from the baseline measurement, where the baseline measurement was obtained at randomization (0 week) before receiving study medication
Measured: 12 weeks
Change From Baseline in HbA1c at Week 26
Change from the baseline measurement, where the baseline measurement was obtained at randomization (0 week) before receiving study medication
Measured: 26 weeks
Examination of Long-term Safety of Linagliptin (52-week Treatment)
The incidence of AEs (Preferred Terms) with a frequency of 5% or more in the patients with type 2 diabetes mellitus who received linagliptin (5 mg or 10 mg) once daily for 52 weeks
Measured: 52 weeks

Secondary outcomes (6)

Relative Efficacy Response of HbA1c at Week 12
HbA1c value decreased below 7.0%, below 6.5% and reduction from baseline ≥0.5% at Week 12
Measured: 12 weeks
Relative Efficacy Response of HbA1c at Week 26
HbA1c value decreased below 7.0%, below 6.5% and reduction from baseline ≥0.5% at Week 26
Measured: 26 weeks
Relative Efficacy Response of HbA1c at Week 52
HbA1c value decreased below 7.0%, below 6.5% and reduction from baseline ≥0.5% at Week 52
Measured: 52 weeks
Change From Baseline in Fasting Plasma Glucose (FPG) at Week 12
Change from the baseline measurement, where the baseline measurement was obtained at randomization (0 week) before receiving study medication
Measured: 12 weeks
Change From Baseline in Fasting Plasma Glucose (FPG) at Week 26
Change from the baseline measurement, where the baseline measurement was obtained at randomization (0 week) before receiving study medication
Measured: 26 weeks
Change From Baseline in Fasting Plasma Glucose (FPG) at Week 52
Change from the baseline measurement, where the baseline measurement was obtained at randomization (0 week) before receiving study medication
Measured: 52 weeks

Timeline

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

Apr 2008Jan 2010

First posted8 Apr 2008 (estimated)
Study startApr 2008
Primary completionJan 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 (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: 561 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00654381
Sponsor's protocol ID: 1218.23
Status last verified: Dec 2013
First submitted: 3 Apr 2008
Last updated: 27 Jan 2014
Results posted: Yes, on ClinicalTrials.gov

Publications

Johansen OE, Neubacher D, von Eynatten M, Patel S, Woerle HJ. Cardiovascular safety with linagliptin in patients with type 2 diabetes mellitus: a pre-specified, prospective, and adjudicated meta-analysis of a phase 3 programme. Cardiovasc Diabetol. 2012 Jan 10;11:3. doi: 10.1186/1475-2840-11-3.
PubMed 22234149
Horie Y, Hayashi N, Dugi K, Takeuchi M. Design, statistical analysis and sample size calculation of a phase IIb/III study of linagliptin versus voglibose and placebo. Trials. 2009 Sep 5;10:82. doi: 10.1186/1745-6215-10-82.
PubMed 19732457

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 Diabetes Mellitus, Type 2 trials

Study at a glance

From the registry record, last updated by the sponsor on 27 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Double-blind Phase III Study to Evaluate the Efficacy of BI 1356 5 mg and 10 mg vs. Placebo for 12 Weeks and vs. Voglibose 0.6 mg for 26 Weeks in Patients With Type 2 Diabetes Mellitus and Insufficient Glycaemic Control, Followed by an Extension Study to 52 Weeks to Evaluate Long-term Safety
ClinicalTrials.gov ID: NCT00654381
Acronym / sponsor ID: 1218.23
Conditions: Diabetes Mellitus, Type 2
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 561 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: Apr 2008
Primary completion: Jan 2010 (actual)
First posted: 8 Apr 2008 (estimated)
Results: Posted 2 Aug 2011

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: 4

Arm	Type	Receives
voglibose 0.2 mg three times a day (TID)	Active comparator	Drug: voglibosepatient to receive a tablet containing 0.2 mg voglibose TID plus 2 placebo tablets matching BI 1356
BI 1356 low dose	Experimental	Drug: BI 1356patient to receive a tablet containing BI 1356 and matching placebo plus 3 placebo tablets matching voglibose
BI 1356 high dose	Experimental	Drug: BI 1356patient to receive 2 tablets containing BI 1356 plus 3 placebo tablets matching voglibose
placebo	Placebo comparator	Drug: voglibose placebo, Drug: BI 1356 placebopatient to receive 2 placebo tablets matching BI 1356 plus 3 placebo tablets matching voglibose

Who may qualify

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

Key inclusion criteria (4 listed)

Japanese patients with a diagnosis of type 2 diabetes mellitus. Antidiabetic therapy has to be stable for at least 10 weeks before Visit 1.
Glycosylated haemoglobin A1 (HbA1c) 7.0 - 10.0% at Visit 3 (beginning of the 2-week placebo run-in phase)
Age: >= 20 and <= 80
Body Mass Index (BMI) <= 40 kg/m2

Key exclusion criteria (5 listed)

Myocardial infarction, stroke or transient ischemic attack (TIA) within 6 months before Visit 1
Impaired hepatic function
History of severe allergy/hypersensitivity
Treatment with anti-diabetic, anti obesity drugs, etc 3 months before Visit 1
Fasting blood glucose >240 mg/dl (=13.3 mmol/L) at Visits 2 or 3

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
BI 13565 mg/daily	Drug	BI 1356 low dose
BI 135610 mg/daily	Drug	BI 1356 high dose
voglibose placebothree times daily	Drug	placebo
BI 1356 placeboonce daily	Drug	placebo
voglibose0.6 mg/daily	Drug	voglibose 0.2 mg three times a day (TID)

Primary outcome

Change From Baseline in HbA1c at Week 12
Time frame: 12 weeks
Change from the baseline measurement, where the baseline measurement was obtained at randomization (0 week) before receiving study medication
Change From Baseline in HbA1c at Week 26
Time frame: 26 weeks
Change from the baseline measurement, where the baseline measurement was obtained at randomization (0 week) before receiving study medication
Examination of Long-term Safety of Linagliptin (52-week Treatment)
Time frame: 52 weeks
The incidence of AEs (Preferred Terms) with a frequency of 5% or more in the patients with type 2 diabetes mellitus who received linagliptin (5 mg or 10 mg) once daily for 52 weeks

6 secondary outcomes

Relative Efficacy Response of HbA1c at Week 12
Time frame: 12 weeks
Relative Efficacy Response of HbA1c at Week 26
Time frame: 26 weeks
Relative Efficacy Response of HbA1c at Week 52
Time frame: 52 weeks
Change From Baseline in Fasting Plasma Glucose (FPG) at Week 12
Time frame: 12 weeks
Change From Baseline in Fasting Plasma Glucose (FPG) at Week 26
Time frame: 26 weeks
Change From Baseline in Fasting Plasma Glucose (FPG) at Week 52
Time frame: 52 weeks

Results and safety

Results posted to the registry on 2 Aug 2011, 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 - BI1356 (Linagliptin) 5mg - Linagliptin 5mg	39	36
Placebo - Linagliptin 5mg - Linagliptin 10mg	41	38
Linagliptin 5mg - Linagliptin 5mg - Linagliptin 5mg	159	156
Linagliptin 10 mg - Linagliptin 10 mg - Linagliptin 10 mg	160	155
Voglibose - Voglibose - Linagliptin 5mg	81	79
Voglibose - Voglibose - Linagliptin 10mg	81	79

Primary outcome: Change From Baseline in HbA1c at Week 12

Time frame: 12 weeks. Least squares mean (Standard Error). Unit: Percent

Measure	Placebo n = 80	Linagliptin 5mg n = 159	Linagliptin 10 mg n = 157
Value	0.63 (0.08)	-0.24 (0.06)	-0.25 (0.06)

Placebo vs Linagliptin 5mg: Least Squares Mean Difference: -0.87 (95% CI -1.04 to -0.7), p <0.0001, ANCOVA
Placebo vs Linagliptin 10 mg: Least Squares Mean Difference: -0.88 (95% CI -1.05 to -0.71), p <0.0001, ANCOVA

Population analysed: For the 12-week analysis, it was planed the comparison between Linagliptin and placebo. Then the patients with voglibose were excluded in this analysis.Full analysis set for 12-week treatment period with Last Observation Carried Forward.

Primary outcome: Change From Baseline in HbA1c at Week 26

Time frame: 26 weeks. Least squares mean (Standard Error). Unit: Percent

Measure	Linagliptin 5mg n = 159	Linagliptin 10 mg n = 157	Voglibose n = 162
Value	-0.13 (0.07)	-0.19 (0.07)	0.19 (0.07)

Linagliptin 5mg vs Voglibose: Least Squares Mean Difference: -0.32 (95% CI -0.49 to -0.15), p = 0.0003, ANCOVA
Linagliptin 10 mg vs Voglibose: Least Squares Mean Difference: -0.39 (95% CI -0.56 to -0.21), p <0.0001, ANCOVA

Population analysed: For the 26-week analysis, it was planed the comparison between Linagliptin and Voglibose. Then the patients with placebo were excluded in this analysis.Full analysis set for 26-week treatment period with Last Observation Carried Forward.

Primary outcome: Examination of Long-term Safety of Linagliptin (52-week Treatment)

Time frame: 52 weeks. Number. Unit: participants

Measure	Linagliptin 5mg n = 266	Linagliptin 10 mg n = 274
Nasopharyngitis	84	81
Back pain	15	21
Constipation	12	19

Population analysed: The patients who received at least one dose of linagliptin 5 mg or linagliptin 10 mg during the randomised treatment period

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: 52 weeks. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo (1st Stage)	1 of 80 (1.3%)	23 of 80 (28.8%)	Not reported
Linagliptin 5mg (2nd-Extension Stage After Placebo)	3 of 36 (8.3%)	19 of 36 (52.8%)	Not reported
Linagliptin 10mg (2nd-Extension Stage After Placebo)	1 of 38 (2.6%)	21 of 38 (55.3%)	Not reported
Linagliptin 5mg (1st-2nd-Extension Stage)	14 of 159 (8.8%)	101 of 159 (63.5%)	Not reported
Linagliptin 10mg (1st-2nd-Extension Stage)	10 of 160 (6.3%)	107 of 160 (66.9%)	Not reported
Voglibose (1st-2nd Stage)	7 of 162 (4.3%)	83 of 162 (51.2%)	Not reported
Linagliptin 5mg (Extension Stage After Voglibose)	3 of 71 (4.2%)	28 of 71 (39.4%)	Not reported
Linagliptin 10mg (Extension Stage After Voglibose)	3 of 76 (3.9%)	31 of 76 (40.8%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 22234149Johansen OE, Neubacher D, von Eynatten M, Patel S, Woerle HJ. Cardiovascular safety with linagliptin in patients with type 2 diabetes mellitus: a pre-specified, prospective, and adjudicated meta-analysis of a phase 3 programme. Cardiovasc Diabetol. 2012 Jan 10;11:3. doi: 10.1186/1475-2840-11-3.
Derived from this study: PubMed 19732457Horie Y, Hayashi N, Dugi K, Takeuchi M. Design, statistical analysis and sample size calculation of a phase IIb/III study of linagliptin versus voglibose and placebo. Trials. 2009 Sep 5;10:82. doi: 10.1186/1745-6215-10-82.

Related trials for Diabetes Mellitus, Type 2

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.

Boehringer Ingelheim study chair

Boehringer Ingelheim

47 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 BI 1356 and voglibose in people with Diabetes Mellitus, Type 2, run by Boehringer Ingelheim at 47 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 4 inclusion and 5 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 27 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 47 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 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 2 Aug 2011). 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 at Week 12 (time frame: 12 weeks). The study lists 3 primary outcomes in all. 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 NCT00654381, 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 27 Jan 2014.