Diabetes Mellitus, Type 2Phase 3NCT01204294

Comprehensive Add on Study in Japan

A Phase 3 study testing Linagliptin and Metformin in people with Diabetes Mellitus, Type 2, run by Boehringer Ingelheim at 43 sites in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The objective of the current study is to investigate the safety and efficacy of linagliptin (5mg / once daily) given for 52 weeks as add-on therapy to patients with type 2 diabetes mellitus and insufficient glycaemic control despite diet, exercise, and treatment with one approved antidiabetic drug. 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?: Linagliptin and Metformin
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 574 participants
Where: 43 sitesJapan
Study dates: Sep 2010to Jan 2012
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
Male and female patients on diet and exercise regimen who are treated with one antidiabetic drug

Who cannot join

Myocardial infarction, stroke, transient ischemic attack, or pulmonary embolism
Impaired hepatic function
Glitazone, glinide, and sulfonylurea group: renal failure or renal impairment defined as estimated glomerular filtration rate <30 ml/min (severe renal impairment) at Visit 1, Biguanide group: renal failure or renal impairment defined as estimated glomerular filtration rate <60 ml/min (moderate renal impairment) at Visit 1
Treatment with anti-obesity drugs

Trial locations and contacts

43 sites in 1 country.

City, postcode or hospital

43 sites in 1 country

Japan43 sites

1218.78.008 Boehringer Ingelheim Investigational Site
Akishima, Tokyo
1218.78.030 Boehringer Ingelheim Investigational Site
Amagasaki, Hyogo
1218.78.017 Boehringer Ingelheim Investigational Site
Annaka, Gunma
1218.78.006 Boehringer Ingelheim Investigational Site
Aomori, Aomori
1218.78.007 Boehringer Ingelheim Investigational Site
Aomori, Aomori
1218.78.009 Boehringer Ingelheim Investigational Site
Chuo-ku, Tokyo
1218.78.013 Boehringer Ingelheim Investigational Site
Chuo-ku, Tokyo
1218.78.032 Boehringer Ingelheim Investigational Site
Fukuoka, Fukuoka
1218.78.040 Boehringer Ingelheim Investigational Site
Fukuoka, Fukuoka
1218.78.037 Boehringer Ingelheim Investigational Site
Higashi Osaka, Osaka
1218.78.043 Boehringer Ingelheim Investigational Site
Hitachinaka, Ibaraki
1218.78.019 Boehringer Ingelheim Investigational Site
Isesaki, Gunma
1218.78.036 Boehringer Ingelheim Investigational Site
Kashiwara, Osaka
1218.78.026 Boehringer Ingelheim Investigational Site
Kasugai, Aichi
1218.78.038 Boehringer Ingelheim Investigational Site
Kawachinagano, Osaka
1218.78.021 Boehringer Ingelheim Investigational Site
Kitaazumi-gun, Nagano
1218.78.022 Boehringer Ingelheim Investigational Site
Matsumoto, Nagano
1218.78.033 Boehringer Ingelheim Investigational Site
Matsumoto, Nagano
1218.78.012 Boehringer Ingelheim Investigational Site
Meguro-ku, Tokyo
1218.78.041 Boehringer Ingelheim Investigational Site
Meguro-ku, Tokyo
1218.78.034 Boehringer Ingelheim Investigational Site
Morioka, Iwate
1218.78.035 Boehringer Ingelheim Investigational Site
Morioka, Iwate
1218.78.018 Boehringer Ingelheim Investigational Site
Moriya, Ibaraki
1218.78.024 Boehringer Ingelheim Investigational Site
Nagoya, Aichi
1218.78.025 Boehringer Ingelheim Investigational Site
Nagoya, Aichi
1218.78.027 Boehringer Ingelheim Investigational Site
Nagoya, Aichi
1218.78.028 Boehringer Ingelheim Investigational Site
Nagoya, Aichi
1218.78.031 Boehringer Ingelheim Investigational Site
Nagoya, Aichi
1218.78.039 Boehringer Ingelheim Investigational Site
Oita, Oita
1218.78.004 Boehringer Ingelheim Investigational Site
Okinawa, Okinawa
1218.78.016 Boehringer Ingelheim Investigational Site
Sagae, Yamagata
1218.78.001 Boehringer Ingelheim Investigational Site
Sapporo, Hokkaido
1218.78.020 Boehringer Ingelheim Investigational Site
Sapporo, Hokkaido
1218.78.042 Boehringer Ingelheim Investigational Site
Sapporo, Hokkaido
1218.78.005 Boehringer Ingelheim Investigational Site
Shimajiri-gun, Okinawa
1218.78.014 Boehringer Ingelheim Investigational Site
Shinjuku-ku, Tokyo
1218.78.002 Boehringer Ingelheim Investigational Site
Shinjyuku-ku. Tokyo
1218.78.011 Boehringer Ingelheim Investigational Site
Shizuoka, Shizuoka
1218.78.003 Boehringer Ingelheim Investigational Site
Suita, Osaka
1218.78.023 Boehringer Ingelheim Investigational Site
Tokorozawa, Saitama
1218.78.029 Boehringer Ingelheim Investigational Site
Tokorozawa, Saitama
1218.78.010 Boehringer Ingelheim Investigational Site
Tsuchiura, Ibaraki
1218.78.015 Boehringer Ingelheim Investigational Site
Yamagata, Yamagata

Other trials in Japan

About this study

Official title: An Open Label, Randomised, Parallel Group Safety and Efficacy Study of Linagliptin (5 mg Administered Orally Once Daily) Over 52 Weeks in Patients With Type 2 Diabetes Mellitus and Insufficient Glycaemic Control Despite Background Mono-therapy With an Approved Antidiabetic Drug

Conditions: Diabetes Mellitus, Type 2
Being tested: Linagliptin, Metformin
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.

LinagliptinDrug
Linagliptin once daily
LinagliptinDrug
Linagliptin once daily
MetforminDrug
Metformin twice or three time per day
MetforminDrug
Metformin twice or three time per day
LinagliptinDrug
Linagliptin once daily
LinagliptinDrug
Linagliptin once daily
LinagliptinDrug
Linagliptin once daily

Study groups in NCT01204294
Study group	Role	What they receive
Bigu+Lina	Experimental	biguanide plus linagliptin Receives: Drug: Linagliptin
Glin+Lina	Experimental	glinide plus linagliptin Receives: Drug: Linagliptin
Glit+Lina	Experimental	glitazone plus linagliptin Receives: Drug: Linagliptin
SU+Lina	Experimental	sulfonylurea plus linagliptin Receives: Drug: Linagliptin
A-GI+Lina	Experimental	alpha-glucosidase inhibitor plus linagliptin Receives: Drug: Linagliptin
SU+Met	Active comparator	sulfonylurea plus metformin Receives: Drug: Metformin
A-GI+Met	Active comparator	alpha-glucosidase inhibitor plus metformin Receives: Drug: Metformin

What is being measured

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

Incidence of Adverse Events (AEs)
The number of patient with any AEs, patients with severe AE, patients with AEs leading to discontinuation of trial drug, and patients with Hypoglycaemic events
Measured: The first drug administration through 7 days after the last drug administration, up to 382 days

Secondary outcomes (1)

Glycosylated Haemoglobin A1c (HbA1c)
The change from baseline in HbA1c after 52 weeks of treatment. When the HbA1c after 52 weeks treatment was missing, the value from the measurements at the closest preceding visit replaced the missing value.
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.

Sep 2010Jan 2012

First posted17 Sep 2010 (estimated)
Study startSep 2010
Primary completionJan 2012
Study completionJan 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.
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: None (open label)
Enrolment: 574 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01204294
Sponsor's protocol ID: 1218.78
Status last verified: Feb 2014
First submitted: 16 Sep 2010
Last updated: 28 Mar 2014
Results posted: Yes, on ClinicalTrials.gov

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 28 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open Label, Randomised, Parallel Group Safety and Efficacy Study of Linagliptin (5 mg Administered Orally Once Daily) Over 52 Weeks in Patients With Type 2 Diabetes Mellitus and Insufficient Glycaemic Control Despite Background Mono-therapy With an Approved Antidiabetic Drug
ClinicalTrials.gov ID: NCT01204294
Acronym / sponsor ID: 1218.78
Conditions: Diabetes Mellitus, Type 2
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 574 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Collaborators: Eli Lilly and Company
Study start: Sep 2010
Primary completion: Jan 2012 (actual)
Study completion: Jan 2012 (actual)
First posted: 17 Sep 2010 (estimated)
Results: Posted 23 Jan 2013

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: None (open label)
Number of arms: 7

Arm	Type	Receives
Bigu+Lina	Experimental	Drug: Linagliptinbiguanide plus linagliptin
Glin+Lina	Experimental	Drug: Linagliptinglinide plus linagliptin
Glit+Lina	Experimental	Drug: Linagliptinglitazone plus linagliptin
SU+Lina	Experimental	Drug: Linagliptinsulfonylurea plus linagliptin
A-GI+Lina	Experimental	Drug: Linagliptinalpha-glucosidase inhibitor plus linagliptin
SU+Met	Active comparator	Drug: Metforminsulfonylurea plus metformin
A-GI+Met	Active comparator	Drug: Metforminalpha-glucosidase inhibitor plus metformin

Who may qualify

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

Key inclusion criteria (2 listed)

Diagnosis of type 2 diabetes mellitus
Male and female patients on diet and exercise regimen who are treated with one antidiabetic drug

Key exclusion criteria (4 listed)

Myocardial infarction, stroke, transient ischemic attack, or pulmonary embolism
Impaired hepatic function
Glitazone, glinide, and sulfonylurea group: renal failure or renal impairment defined as estimated glomerular filtration rate <30 ml/min (severe renal impairment) at Visit 1, Biguanide group: renal failure or renal impairment defined as estimated glomerular filtration rate <60 ml/min (moderate renal impairment) at Visit 1
Treatment with anti-obesity drugs

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
LinagliptinLinagliptin once daily	Drug	Glin+Lina
LinagliptinLinagliptin once daily	Drug	Glit+Lina
MetforminMetformin twice or three time per day	Drug	A-GI+Met
MetforminMetformin twice or three time per day	Drug	SU+Met
LinagliptinLinagliptin once daily	Drug	A-GI+Lina
LinagliptinLinagliptin once daily	Drug	Bigu+Lina
LinagliptinLinagliptin once daily	Drug	SU+Lina

Primary outcome

Incidence of Adverse Events (AEs)
Time frame: The first drug administration through 7 days after the last drug administration, up to 382 days
The number of patient with any AEs, patients with severe AE, patients with AEs leading to discontinuation of trial drug, and patients with Hypoglycaemic events

1 secondary outcome

Glycosylated Haemoglobin A1c (HbA1c)
Time frame: Baseline and 52 weeks

Results and safety

Results posted to the registry on 23 Jan 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
Bigu+Lina	82	79
Glin+Lina	66	58
Glit+Lina	74	69
SU+Lina	143	132
A-GI+Lina	85	83
SU+Met	63	58
A-GI+Met	61	59

Primary outcome: Incidence of Adverse Events (AEs)

Time frame: The first drug administration through 7 days after the last drug administration, up to 382 days. Number. Unit: Patients

Measure	Bigu+Lina n = 82	Glin+Lina n = 66	Glit+Lina n = 74	SU+Lina n = 143	A-GI+Lina n = 85	SU+Met n = 63	A-GI+Met n = 61
Patients with any AE	69	55	62	114	71	44	52
Patients with severe AE	1	1	0	2	1	1	0
Patients with AEs leading to discontinuation	2	5	0	8	1	4	0
Patients with Hypoglycaemic events	1	0	2	21	2	10	2

Population analysed: The treated set (TS) comprised all patients who received at least one dose of randomised study medication in the 52-week treatment period

1 secondary outcome is reported in the full results.

Adverse events

Time frame: The first drug administration through 7 days after the last drug administration, up to 382 days. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Bigu+Lina	8 of 82 (9.8%)	55 of 82 (67.1%)	Not reported
Glin+Lina	5 of 66 (7.6%)	41 of 66 (62.1%)	Not reported
Glit+Lina	2 of 74 (2.7%)	37 of 74 (50%)	Not reported
SU+Lina	7 of 143 (4.9%)	83 of 143 (58%)	Not reported
A-GI+Lina	7 of 85 (8.2%)	54 of 85 (63.5%)	Not reported
SU+Met	5 of 63 (7.9%)	31 of 63 (49.2%)	Not reported
A-GI+Met	3 of 61 (4.9%)	33 of 61 (54.1%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related InfoLink provided by the sponsor.
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

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

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Linagliptin and Metformin in people with Diabetes Mellitus, Type 2, run by Boehringer Ingelheim at 43 sites in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 4 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 28 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 43 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 23 Jan 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?

Incidence of Adverse Events (AEs) (time frame: The first drug administration through 7 days after the last drug administration, up to 382 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 NCT01204294.

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 28 Mar 2014.