Diabetes Mellitus, Type 2Phase 3NCT00602472

BI 1356 (Linagliptin) in Combination With Metformin and a Sulphonylurea in Type 2 Diabetes

A Phase 3 study testing linagliptin in people with Diabetes Mellitus, Type 2, run by Boehringer Ingelheim at 100 sites in 11 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

The objective of the current study is to investigate the efficacy, safety and tolerability of BI 1356 (5 mg once daily) compared to placebo given for 24 weeks as add-on therapy to metformin in combination with a sulphonylurea in patients with type 2 diabetes mellitus with insufficient glycaemic control. Read more about this study

Who is it for?: Ages 18 to 80 years
Conditions the study is for: Diabetes Mellitus, Type 2
What is being tested?: linagliptin
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 1,058 participants
Where: 100 sitesin 11 countries
Study dates: Feb 2008to May 2009
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 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Male and female patients with a diagnosis of type 2 diabetes mellitus, currently treated only with a stable total daily dose of preferably* >/= 1500 mg metformin and a dose of a sulphonylurea drug that has been documented, by the Investigator, to be the individual maximum tolerated dose of that sulphonylurea drug. Both the dose and dosing regimen of metformin and the sulphonylurea must be stable (i.e. unchanged) for 10 weeks prior to informed consent, and must not be changed for the duration of the trial
Glycosylated haemoglobin A1 (HbA1c) >/= 7.0 and </= 10.0% at the screening Visit 1a and at Visit 2 (start of placebo run-in phase)
Age >/= 18 and </= 80 years at Visit 1a (screening)
BMI (Body Mass Index) </= 40 kg/m2 at Visit 1a (screening)
Signed and dated written informed consent, at the latest by the date of Visit 1a, in accordance with GCP and local legislation *Patients currently treated with a total daily dose of less than 1500 mg metformin can be included in the trial if the Investigator has documented that the dose is the maximum tolerated dose of metformin for that patient.

Who cannot join

Myocardial infarction, stroke or TIA (transient ischaemic attack) within 6 months prior to the date of informed consent
Impaired hepatic function, defined by serum levels of either alanine transaminase (ALT/SGPT), aspartase transaminase (AST/SGOT), or alkaline phosphatase (ALP) above 3 times the upper limit of normal (ULN), as determined at Visit 1a
Renal failure or renal impairment (serum creatinine >/= 1.5 mg/dl) as determined at Visit 1a
Treatment with rosiglitazone or pioglitazone within 3 months prior to the date of informed consent
Treatment with GLP-1 analogues (e.g. exenatide) within 3 months prior to the date of informed consent
Treatment with insulin within 3 months prior to the date of informed consent

Show all 14Show fewer

Treatment with anti-obesity drugs (e.g. sibutramine, rimonabant, orlistat) within 3 months prior to the date of informed consent
Current treatment with systemic steroids (i.e. at the time of informed consent) or a change in the dosage of thyroid hormones within 6 weeks prior to the date of informed consent
Pre-menopausal women (last menstruation </= 1 year prior to the date of informed consent) who:
are nursing or pregnant
or are of child-bearing potential and are not practicing an acceptable method of birth control, or do not plan to continue using this method throughout the study and do not agree to periodic pregnancy testing during their participation in the trial. Acceptable methods of birth control include transdermal patch, intra uterine devices/systems (IUDs/IUSs), oral, implantable or injectable contraceptives, sexual abstinence and vasectomised partner. No exception will be made.
Known hypersensitivity or allergy to the investigational product or its excipients or to the trial background therapy (i.e. metformin in combination with a sulphonylurea) or sulphonamides
Dehydration (as confirmed by the Investigators clinical opinion)
Current acute or chronic metabolic acidosis

Trial locations and contacts

100 sites in 11 countries.

Country

City, postcode or hospital

100 sites in 11 countries

China15 sites

1218.18.86001 Boehringer Ingelheim Investigational Site
Beijing
1218.18.86002 Boehringer Ingelheim Investigational Site
Beijing
1218.18.86004 Boehringer Ingelheim Investigational Site
Beijing
1218.18.86013 Boehringer Ingelheim Investigational Site
Chengdu, Sichuan Province
1218.18.86009 Boehringer Ingelheim Investigational Site
Dalian
1218.18.86011 Boehringer Ingelheim Investigational Site
Guangzhou
1218.18.86014 Boehringer Ingelheim Investigational Site
Haerbin
1218.18.86005 Boehringer Ingelheim Investigational Site
Nanjing, Jiangsu Province
1218.18.86008 Boehringer Ingelheim Investigational Site
Qingdao
1218.18.86015 Boehringer Ingelheim Investigational Site
Shanghai
1218.18.86010 Boehringer Ingelheim Investigational Site
Shenyang
1218.18.86003 Boehringer Ingelheim Investigational Site
Weizikeng
1218.18.86007 Boehringer Ingelheim Investigational Site
Wuhan
1218.18.86012 Boehringer Ingelheim Investigational Site
Wuhan, Hubei Province
1218.18.86006 Boehringer Ingelheim Investigational Site
Xian, Shanxi Province

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Argentina14 sites

1218.18.54001 Boehringer Ingelheim Investigational Site
Capital Federal
1218.18.54002 Boehringer Ingelheim Investigational Site
Capital Federal
1218.18.54004 Boehringer Ingelheim Investigational Site
Capital Federal
1218.18.54005 Boehringer Ingelheim Investigational Site
Capital Federal
1218.18.54010 Boehringer Ingelheim Investigational Site
Capital Federal
1218.18.54009 Boehringer Ingelheim Investigational Site
Córdoba
1218.18.54013 Boehringer Ingelheim Investigational Site
Córdoba
1218.18.54014 Boehringer Ingelheim Investigational Site
Corrientes
1218.18.54003 Boehringer Ingelheim Investigational Site
Mar del Plata
1218.18.54012 Boehringer Ingelheim Investigational Site
Mar del Plata
1218.18.54011 Boehringer Ingelheim Investigational Site
Mendoza
1218.18.54015 Boehringer Ingelheim Investigational Site
Parque Velez Sarfield
1218.18.54006 Boehringer Ingelheim Investigational Site
Rosario
1218.18.54007 Boehringer Ingelheim Investigational Site
Salta

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Canada12 sites

1218.18.01005 Boehringer Ingelheim Investigational Site
Calgary, Alberta
1218.18.01010 Boehringer Ingelheim Investigational Site
Calgary, Alberta
1218.18.01006 Boehringer Ingelheim Investigational Site
Etobicoke, Ontario
1218.18.01009 Boehringer Ingelheim Investigational Site
Hamilton, Ontario
1218.18.01002 Boehringer Ingelheim Investigational Site
London, Ontario
1218.18.01004 Boehringer Ingelheim Investigational Site
Montague, Prince Edward Island
1218.18.01012 Boehringer Ingelheim Investigational Site
Oakville, Ontario
1218.18.01008 Boehringer Ingelheim Investigational Site
Sarnia, Ontario
1218.18.01007 Boehringer Ingelheim Investigational Site
Saskatoon, Saskatchewan
1218.18.01001 Boehringer Ingelheim Investigational Site
Toronto, Ontario
1218.18.01003 Boehringer Ingelheim Investigational Site
Vancouver, British Columbia
1218.18.01011 Boehringer Ingelheim Investigational Site
Vancouver, British Columbia

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South Korea11 sites

1218.18.82004 Boehringer Ingelheim Investigational Site
Busan
1218.18.82011 Boehringer Ingelheim Investigational Site
Daegu
1218.18.82008 Boehringer Ingelheim Investigational Site
Incheon
1218.18.82010 Boehringer Ingelheim Investigational Site
Jeonju
1218.18.82002 Boehringer Ingelheim Investigational Site
Pusan
1218.18.82001 Boehringer Ingelheim Investigational Site
Seoul
1218.18.82005 Boehringer Ingelheim Investigational Site
Seoul
1218.18.82006 Boehringer Ingelheim Investigational Site
Seoul
1218.18.82007 Boehringer Ingelheim Investigational Site
Seoul
1218.18.82009 Boehringer Ingelheim Investigational Site
Seoul
1218.18.82003 Boehringer Ingelheim Investigational Site
Suwon

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United Kingdom10 sites

1218.18.44005 Boehringer Ingelheim Investigational Site
Ashford
1218.18.44004 Boehringer Ingelheim Investigational Site
Baillieston, Glasgow
1218.18.44001 Boehringer Ingelheim Investigational Site
Bath
1218.18.44003 Boehringer Ingelheim Investigational Site
Burbage
1218.18.44010 Boehringer Ingelheim Investigational Site
Bury Saint Edmonds
1218.18.44009 Boehringer Ingelheim Investigational Site
Cardiff
1218.18.44008 Boehringer Ingelheim Investigational Site
Glasgow
1218.18.44002 Boehringer Ingelheim Investigational Site
Penarth
1218.18.44006 Boehringer Ingelheim Investigational Site
Reading
1218.18.44007 Boehringer Ingelheim Investigational Site
Waterloo, Liverpool

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Germany9 sites

1218.18.49004 Boehringer Ingelheim Investigational Site
Aschaffenburg
1218.18.49028 Boehringer Ingelheim Investigational Site
Bad Mergentheim
1218.18.49022 Boehringer Ingelheim Investigational Site
Berlin
1218.18.49024 Boehringer Ingelheim Investigational Site
Bosenheim
1218.18.49020 Boehringer Ingelheim Investigational Site
Dresden
1218.18.49101 Boehringer Ingelheim Investigational Site
Mainz
1218.18.49003 Boehringer Ingelheim Investigational Site
Neuwied
1218.18.49007 Boehringer Ingelheim Investigational Site
Nuremberg
1218.18.49014 Boehringer Ingelheim Investigational Site
Saarbrücken

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Taiwan8 sites

1218.18.88605 Boehringer Ingelheim Investigational Site
Changhua
1218.18.88604 Boehringer Ingelheim Investigational Site
Taichung
1218.18.88606 Boehringer Ingelheim Investigational Site
Tainan
1218.18.88601 Boehringer Ingelheim Investigational Site
Taipei
1218.18.88602 Boehringer Ingelheim Investigational Site
Taipei
1218.18.88603 Boehringer Ingelheim Investigational Site
Taipei
1218.18.88607 Boehringer Ingelheim Investigational Site
Taipei
1218.18.88608 Boehringer Ingelheim Investigational Site
Taoyuan

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Belgium7 sites

1218.18.32005 Boehringer Ingelheim Investigational Site
Bruges
1218.18.32007 Boehringer Ingelheim Investigational Site
Brussels
1218.18.32006 Boehringer Ingelheim Investigational Site
Edegem
1218.18.32004 Boehringer Ingelheim Investigational Site
Genk
1218.18.32003 Boehringer Ingelheim Investigational Site
Ghent
1218.18.32002 Boehringer Ingelheim Investigational Site
Huy
1218.18.32001 Boehringer Ingelheim Investigational Site
Liège

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Philippines5 sites

1218.18.63005 Boehringer Ingelheim Investigational Site
Manila
1218.18.63002 Boehringer Ingelheim Investigational Site
Marikina City
1218.18.63001 Boehringer Ingelheim Investigational Site
Pasig
1218.18.63004 Boehringer Ingelheim Investigational Site
Quezon City
1218.18.63003 Boehringer Ingelheim Investigational Site
San Juan City

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Russia5 sites

1218.18.70014 Boehringer Ingelheim Investigational Site
Arkhangelsk
1218.18.70012 Boehringer Ingelheim Investigational Site
Moscow
1218.18.70013 Boehringer Ingelheim Investigational Site
Rostov-on-Don
1218.18.70015 Boehringer Ingelheim Investigational Site
Saint Petersburg
1218.18.70016 Boehringer Ingelheim Investigational Site
Samara

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Turkey (Türkiye)4 sites

1218.18.90003 Boehringer Ingelheim Investigational Site
Erzurum
1218.18.90005 Boehringer Ingelheim Investigational Site
Istanbul
1218.18.90001 Boehringer Ingelheim Investigational Site
Izmir
1218.18.90004 Boehringer Ingelheim Investigational Site
Konya

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About this study

Official title: A Randomised, Double-blind, Placebo-controlled Parallel Group Efficacy and Safety Study of BI 1356 (5 mg) Administered Orally Once Daily Over 24 Weeks, With an Open-label Extension to One Year (Placebo Patients Switched to BI 1356), in Type 2 Diabetic Patients With Insufficient Glycaemic Control Despite a Therapy of Metformin in Combination With a Sulphonylurea

Conditions: Diabetes Mellitus, Type 2
Being tested: linagliptin, placebo
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
active
placeboDrug
placebo to linagliptin 5 mg

Study groups in NCT00602472
Study group	Role	What they receive
linagliptin 5 mg	Experimental	linagliptin 5 mg once daily Receives: Drug: linagliptin
placebo	Placebo comparator	placebo matching linagliptin 5 mg tablets Receives: Drug: placebo

What is being measured

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

HbA1c Change From Baseline to Week 24
HbA1c is measured as a percentage. Thus, this change from baseline reflects the Week 24 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for baseline HbA1c and previous anti-diabetic medication.
Measured: Baseline and week 24

Secondary outcomes (12)

HbA1c Change From Baseline to Week 6
HbA1c is measured as a percentage. Thus, this change from baseline reflects the Week 6 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for baseline HbA1c and previous anti-diabetic medication.
Measured: Baseline and week 6
HbA1c Change From Baseline to Week 12
HbA1c is measured as a percentage. Thus, this change from baseline reflects the Week 12 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for baseline HbA1c and previous anti-diabetic medication.
Measured: Baseline and week 12
HbA1c Change From Baseline to Week 18
HbA1c is measured as a percentage. Thus, this change from baseline reflects the Week 18 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for baseline HbA1c and previous anti-diabetic medication.
Measured: Baseline and week 18
FPG Change From Baseline to Week 24
This change from baseline reflects the Week 24 FPG minus the baseline FPG. Means are treatment-adjusted for baseline HbA1c, baseline FPG and previous anti-diabetic medication.
Measured: Baseline and week 24
FPG Change From Baseline to Week 6
This change from baseline reflects the Week 6 FPG minus the baseline FPG. Means are treatment-adjusted for baseline HbA1c, baseline FPG and previous anti-diabetic medication.
Measured: Baseline and week 6
FPG Change From Baseline to Week 12
This change from baseline reflects the Week 12 FPG minus the baseline FPG. Means are treatment adjusted for baseline HbA1c, baseline FPG and previous anti-diabetic medication.
Measured: Baseline and week 12
FPG Change From Baseline to Week 18
This change from baseline reflects the Week 18 FPG minus the Week 0 FPG. Means are treatment-adjusted for baseline HbA1c, baseline FPG and previous anti-diabetic medication
Measured: Baseline and week 18
Percentage of Patients With HbA1c <7.0% at Week 24
The percentage of patients with an HbA1c value below 7% at week 24 was calculated for each treatment arm. If a patient did not have an HbA1c value at week 24 they were considered a failure, so HbA1c above 7%. Only patients with baseline HbA1c >= 7%
Measured: Baseline and week 24
Percentage of Patients With HbA1c < 7.0% at Week 24
The percentage of patients with an HbA1c value below 7% at week 24 was calculated for each treatment arm. If a patient did not have an HbA1c value at week 24 they were considered a failure, so HbA1c above 7%.
Measured: Baseline and week 24
Percentage of Patients With HbA1c <6.5% at Week 24
The percentage of patients with an HbA1c value below 6.5% at week 24 was calculated for each treatment arm. If a patient did not have an HbA1c value at week 24 they were considered a failure, so HbA1c above 6.5%. Only patients with baseline HbA1c >= 6.5%
Measured: Baseline and week 24
Percentage of Patients With HbA1c<6.5% at Week 24
The percentage of patients with an HbA1c value below 6.5% at week 24 was calculated for each treatment arm. If a patient did not have an HbA1c value at week 24 they were considered a failure, so HbA1c above 6.5%
Measured: Baseline and week 24
Percentage of Patients Who Have a HbA1c Lowering by 0.5% at Week 24
The percentage of patients with an HbA1c reduction greater than 0.5% at week 24 from baseline was calculated for each treatment arm. If a patient did not have an HbA1c value at week 24 they were considered a failure, so HbA1c reduction less than 0.5%
Measured: Baseline and week 24

Timeline

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

Feb 2008May 2009

First posted28 Jan 2008 (estimated)
Study startFeb 2008
Primary completionMay 2009

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 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Enrolment: 1,058 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00602472
Sponsor's protocol ID: 1218.18
Other IDs: 2007-002450-28
Status last verified: Feb 2014
First submitted: 15 Jan 2008
Last updated: 28 Mar 2014
Results posted: Yes, on ClinicalTrials.gov

Publications

Del Prato S, Patel S, Crowe S, von Eynatten M. Efficacy and safety of linagliptin according to patient baseline characteristics: A pooled analysis of three phase 3 trials. Nutr Metab Cardiovasc Dis. 2016 Oct;26(10):886-92. doi: 10.1016/j.numecd.2016.06.015. Epub 2016 Jul 1.
PubMed 27484756
Zeng Z, Yang JK, Tong N, Yan S, Zhang X, Gong Y, Woerle HJ. Efficacy and safety of linagliptin added to metformin and sulphonylurea in Chinese patients with type 2 diabetes: a sub-analysis of data from a randomised clinical trial. Curr Med Res Opin. 2013 Aug;29(8):921-9. doi: 10.1185/03007995.2013.805123. Epub 2013 Jun 4.
PubMed 23672632
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
Owens DR, Swallow R, Dugi KA, Woerle HJ. Efficacy and safety of linagliptin in persons with type 2 diabetes inadequately controlled by a combination of metformin and sulphonylurea: a 24-week randomized study. Diabet Med. 2011 Nov;28(11):1352-61. doi: 10.1111/j.1464-5491.2011.03387.x.
PubMed 21781152

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: A Randomised, Double-blind, Placebo-controlled Parallel Group Efficacy and Safety Study of BI 1356 (5 mg) Administered Orally Once Daily Over 24 Weeks, With an Open-label Extension to One Year (Placebo Patients Switched to BI 1356), in Type 2 Diabetic Patients With Insufficient Glycaemic Control Despite a Therapy of Metformin in Combination With a Sulphonylurea
ClinicalTrials.gov ID: NCT00602472
Acronym / sponsor ID: 1218.18
Conditions: Diabetes Mellitus, Type 2
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 1,058 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: Feb 2008
Primary completion: May 2009 (actual)
First posted: 28 Jan 2008 (estimated)
Results: Posted 15 Jun 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: 2

Arm	Type	Receives
linagliptin 5 mg	Experimental	Drug: linagliptinlinagliptin 5 mg once daily
placebo	Placebo comparator	Drug: placeboplacebo matching linagliptin 5 mg tablets

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Male and female patients with a diagnosis of type 2 diabetes mellitus, currently treated only with a stable total daily dose of preferably* >/= 1500 mg metformin and a dose of a sulphonylurea drug that has been documented, by the Investigator, to be the individual maximum tolerated dose of that sulphonylurea drug. Both the dose and dosing regimen of metformin and the sulphonylurea must be stable (i.e. unchanged) for 10 weeks prior to informed consent, and must not be changed for the duration of the trial
Glycosylated haemoglobin A1 (HbA1c) >/= 7.0 and </= 10.0% at the screening Visit 1a and at Visit 2 (start of placebo run-in phase)
Age >/= 18 and </= 80 years at Visit 1a (screening)
BMI (Body Mass Index) </= 40 kg/m2 at Visit 1a (screening)
Signed and dated written informed consent, at the latest by the date of Visit 1a, in accordance with GCP and local legislation *Patients currently treated with a total daily dose of less than 1500 mg metformin can be included in the trial if the Investigator has documented that the dose is the maximum tolerated dose of metformin for that patient.

Key exclusion criteria (14 listed)

Myocardial infarction, stroke or TIA (transient ischaemic attack) within 6 months prior to the date of informed consent
Impaired hepatic function, defined by serum levels of either alanine transaminase (ALT/SGPT), aspartase transaminase (AST/SGOT), or alkaline phosphatase (ALP) above 3 times the upper limit of normal (ULN), as determined at Visit 1a
Renal failure or renal impairment (serum creatinine >/= 1.5 mg/dl) as determined at Visit 1a
Treatment with rosiglitazone or pioglitazone within 3 months prior to the date of informed consent
Treatment with GLP-1 analogues (e.g. exenatide) within 3 months prior to the date of informed consent

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
linagliptinactive	Drug	linagliptin 5 mg
placeboplacebo to linagliptin 5 mg	Drug	placebo

Primary outcome

HbA1c Change From Baseline to Week 24
Time frame: Baseline and week 24
HbA1c is measured as a percentage. Thus, this change from baseline reflects the Week 24 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for baseline HbA1c and previous anti-diabetic medication.

12 secondary outcomes

HbA1c Change From Baseline to Week 6
Time frame: Baseline and week 6
HbA1c Change From Baseline to Week 12
Time frame: Baseline and week 12
HbA1c Change From Baseline to Week 18
Time frame: Baseline and week 18
FPG Change From Baseline to Week 24
Time frame: Baseline and week 24
FPG Change From Baseline to Week 6
Time frame: Baseline and week 6
FPG Change From Baseline to Week 12
Time frame: Baseline and week 12
FPG Change From Baseline to Week 18
Time frame: Baseline and week 18
Percentage of Patients With HbA1c <7.0% at Week 24
Time frame: Baseline and week 24
Percentage of Patients With HbA1c < 7.0% at Week 24
Time frame: Baseline and week 24
Percentage of Patients With HbA1c <6.5% at Week 24
Time frame: Baseline and week 24
Percentage of Patients With HbA1c<6.5% at Week 24
Time frame: Baseline and week 24
Percentage of Patients Who Have a HbA1c Lowering by 0.5% at Week 24
Time frame: Baseline and week 24

Results and safety

Results posted to the registry on 15 Jun 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	263	242
Linagliptin	792	734

Primary outcome: HbA1c Change From Baseline to Week 24

Time frame: Baseline and week 24. Mean (Standard Error). Unit: Percent

Measure	Placebo n = 262	Linagliptin n = 778
Value	-0.10 (0.05)	-0.72 (0.03)

Placebo vs Linagliptin: Mean Difference (Final Values): -0.62 (95% CI -0.73 to -0.50), p <0.0001, ANCOVA

Population analysed: The Full Analysis Set (FAS) included all treated and randomised patients with a baseline and at least one on treatment HbA1c measurement available. Last observation carried forward (LOCF) was used as the imputation rule.

12 secondary outcomes are reported in the full results.

Adverse events

Time frame: From day of first drug dose until 7 days after last dose, with an average of 166 days. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	10 of 263 (3.8%)	94 of 263 (35.7%)	Not reported
Linagliptin	25 of 792 (3.2%)	273 of 792 (34.5%)	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.
Derived from this study: PubMed 27484756Del Prato S, Patel S, Crowe S, von Eynatten M. Efficacy and safety of linagliptin according to patient baseline characteristics: A pooled analysis of three phase 3 trials. Nutr Metab Cardiovasc Dis. 2016 Oct;26(10):886-92. doi: 10.1016/j.numecd.2016.06.015. Epub 2016 Jul 1.
Derived from this study: PubMed 23672632Zeng Z, Yang JK, Tong N, Yan S, Zhang X, Gong Y, Woerle HJ. Efficacy and safety of linagliptin added to metformin and sulphonylurea in Chinese patients with type 2 diabetes: a sub-analysis of data from a randomised clinical trial. Curr Med Res Opin. 2013 Aug;29(8):921-9. doi: 10.1185/03007995.2013.805123. Epub 2013 Jun 4.
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 21781152Owens DR, Swallow R, Dugi KA, Woerle HJ. Efficacy and safety of linagliptin in persons with type 2 diabetes inadequately controlled by a combination of metformin and sulphonylurea: a 24-week randomized study. Diabet Med. 2011 Nov;28(11):1352-61. doi: 10.1111/j.1464-5491.2011.03387.x.
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

100 sites in 11 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing linagliptin in people with Diabetes Mellitus, Type 2, run by Boehringer Ingelheim at 100 sites in 11 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 5 inclusion and 14 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 100 sites in China, Argentina, Canada, South Korea, United Kingdom and 6 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 15 Jun 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?

HbA1c Change From Baseline to Week 24 (time frame: Baseline and 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 NCT00602472, 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 28 Mar 2014.