Diabetes Mellitus, Type 2Phase 3NCT00915772

Treatment of Type 2 Diabetes With Linagliptin 2.5 mg Bid + Metformin 500 or 1000 mg Bid and Metformin 1000 mg Bid

A Phase 3 study testing Linagliptin + metformin, Linagliptin+metformin and Metformin in people with Diabetes Mellitus, Type 2, run by Boehringer Ingelheim at 112 sites in 14 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

A phase III randomised, double-blind parallel group extension study to investigate the efficacy and safety of twice daily administration of the free combination of linagliptin 2.5 mg + metformin 500 mg or of linagliptin 2.5 mg + metformin 1000 mg versus monotherapy with metformin 1000 mg twice daily over 54 weeks in… 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 + metformin, Linagliptin+metformin and Metformin
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 567 participants
Where: 112 sitesin 14 countries
Study dates: Jun 2009to Jun 2011
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

Signed and dated written informed consent, at the latest by the date of Visit 1
Patients completing the entire treatment period of the double-blind study 1218.46, who are not treated with rescue medication (Visit 7)

Who cannot join

Patients who meet one or more of the withdrawal criteria of the treatment period of the previous study 1218.46
Pre-menopausal women (last menstruation equal or less than 1 year prior to signing 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 submit to periodic pregnancy testing during 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 and in addition for male partners a barrier method, such as the use of condom with spermicide. No exception will be made.
Alcohol abuse within the 3 months prior to informed consent that would interfere with study participation
Drug abuse that in the opinion of the investigator would interfere with trial participation
Any other clinical condition which, in the opinion of the investigator, would not allow safe completion of the protocol and safe administration of the study medication

Trial locations and contacts

112 sites in 14 countries.

Country

City, postcode or hospital

112 sites in 14 countries

France25 sites

1218.52.3303D Boehringer Ingelheim Investigational Site
Aire Sur l'Aadour
1218.52.3308B Boehringer Ingelheim Investigational Site
Bischheim
1218.52.3305A Boehringer Ingelheim Investigational Site
Bourges
1218.52.3304F Boehringer Ingelheim Investigational Site
Bousse
1218.52.3308C Boehringer Ingelheim Investigational Site
Gambsheim
1218.52.3301A Boehringer Ingelheim Investigational Site
Grenoble Cédex
1218.52.3305B Boehringer Ingelheim Investigational Site
Guérigny
1218.52.3304A Boehringer Ingelheim Investigational Site
Jarny
1218.52.3302D Boehringer Ingelheim Investigational Site
La Riche
1218.52.9999 Boehringer Ingelheim Investigational Site
La Riche
1218.52.3307A Boehringer Ingelheim Investigational Site
La Seyne-sur-Mer
1218.52.3307E Boehringer Ingelheim Investigational Site
La Seyne-sur-Mer
1218.52.3305G Boehringer Ingelheim Investigational Site
Lury-sur-Arnon
1218.52.3303A Boehringer Ingelheim Investigational Site
Mont-de-Marsan
1218.52.3308F Boehringer Ingelheim Investigational Site
Mundolsheim
1218.52.3305E Boehringer Ingelheim Investigational Site
Nevers
1218.52.3306A Boehringer Ingelheim Investigational Site
Orthez
1218.52.3306C Boehringer Ingelheim Investigational Site
Orthez
1218.52.3303B Boehringer Ingelheim Investigational Site
Saint-Martin-d'Oney
1218.52.3302E Boehringer Ingelheim Investigational Site
Savonnières
1218.52.3308A Boehringer Ingelheim Investigational Site
Strasbourg
1218.52.3308D Boehringer Ingelheim Investigational Site
Strasbourg
1218.52.3308E Boehringer Ingelheim Investigational Site
Strasbourg
1218.52.3307D Boehringer Ingelheim Investigational Site
Toulon
1218.52.3302A Boehringer Ingelheim Investigational Site
Tours

Other trials in France

India18 sites

1218.52.91001 Boehringer Ingelheim Investigational Site
Bangalore
1218.52.91004 Boehringer Ingelheim Investigational Site
Bangalore
1218.52.91012 Boehringer Ingelheim Investigational Site
Bangalore
1218.52.91011 Boehringer Ingelheim Investigational Site
Bhopal
1218.52.91003 Boehringer Ingelheim Investigational Site
Chennai
1218.52.91020 Boehringer Ingelheim Investigational Site
Chennai
1218.52.91009 Boehringer Ingelheim Investigational Site
Chhatrapati Sambhajinagar
1218.52.91018 Boehringer Ingelheim Investigational Site
Hyderadad
1218.52.91008 Boehringer Ingelheim Investigational Site
Jaipur
1218.52.91002 Boehringer Ingelheim Investigational Site
Karnataka
1218.52.91007 Boehringer Ingelheim Investigational Site
Karnataka
1218.52.91019 Boehringer Ingelheim Investigational Site
Madurai
1218.52.91013 Boehringer Ingelheim Investigational Site
Maharashtra
1218.52.91015 Boehringer Ingelheim Investigational Site
Mumbai
1218.52.91014 Boehringer Ingelheim Investigational Site
Nagpru
1218.52.91016 Boehringer Ingelheim Investigational Site
P.O.Trivandrum
1218.52.91010 Boehringer Ingelheim Investigational Site
Pune
1218.52.91006 Boehringer Ingelheim Investigational Site
West Bengal

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Tunisia9 sites

1218.52.2162A Boehringer Ingelheim Investigational Site
Bab Saâdoun Tunis
1218.52.2162B Boehringer Ingelheim Investigational Site
Bab Sâadoun Tunis
1218.52.9992 Boehringer Ingelheim Investigational Site
Bab Sâadoun Tunis
1218.52.2161A Boehringer Ingelheim Investigational Site
Tunis
1218.52.2161B Boehringer Ingelheim Investigational Site
Tunis
1218.52.2163A Boehringer Ingelheim Investigational Site
Tunis
1218.52.2163B Boehringer Ingelheim Investigational Site
Tunis
1218.52.9991 Boehringer Ingelheim Investigational Site
Tunis
1218.52.9993 Boehringer Ingelheim Investigational Site
Tunis

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Canada8 sites

1218.52.11005 Boehringer Ingelheim Investigational Site
Calgary, Alberta
1218.52.11003 Boehringer Ingelheim Investigational Site
Edmonton, Alberta
1218.52.11004 Boehringer Ingelheim Investigational Site
Hamilton, Ontario
1218.52.11007 Boehringer Ingelheim Investigational Site
Oakville, Ontario
1218.52.11002 Boehringer Ingelheim Investigational Site
Red Deer, Alberta
1218.52.11010 Boehringer Ingelheim Investigational Site
Toronto, Ontario
1218.52.11006 Boehringer Ingelheim Investigational Site
Vancouver, British Columbia
1218.52.11008 Boehringer Ingelheim Investigational Site
Winnipeg, Manitoba

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Netherlands8 sites

1218.52.31004 Boehringer Ingelheim Investigational Site
's-Hertogenbosch
1218.52.31005 Boehringer Ingelheim Investigational Site
's-Hertogenbosch
1218.52.31001 Boehringer Ingelheim Investigational Site
Almere Stad
1218.52.31002 Boehringer Ingelheim Investigational Site
Beek en Donk
1218.52.31010 Boehringer Ingelheim Investigational Site
Breda
1218.52.31013 Boehringer Ingelheim Investigational Site
Groningen
1218.52.31014 Boehringer Ingelheim Investigational Site
Velp
1218.52.31015 Boehringer Ingelheim Investigational Site
Zoetermeer

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Mexico7 sites

1218.52.52006 Boehringer Ingelheim Investigational Site
Aguascalientes
1218.52.52002 Boehringer Ingelheim Investigational Site
Cuernavaca
1218.52.52004 Boehringer Ingelheim Investigational Site
Guadalajara
1218.52.52007 Boehringer Ingelheim Investigational Site
México
1218.52.52008 Boehringer Ingelheim Investigational Site
México
1218.52.52010 Boehringer Ingelheim Investigational Site
Tijuana
1218.52.52009 Boehringer Ingelheim Investigational Site
Veracruz

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Russia7 sites

1218.52.70001 Boehringer Ingelheim Investigational Site
Moscow
1218.52.70002 Boehringer Ingelheim Investigational Site
Moscow
1218.52.70003 Boehringer Ingelheim Investigational Site
Moscow
1218.52.70004 Boehringer Ingelheim Investigational Site
Moscow
1218.52.70006 Boehringer Ingelheim Investigational Site
Moscow
1218.52.70005 Boehringer Ingelheim Investigational Site
Saint Petersburg
1218.52.70007 Boehringer Ingelheim Investigational Site
Saint Petersburg

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Ukraine6 sites

1218.52.38003 Boehringer Ingelheim Investigational Site
Kiev
1218.52.38001 Boehringer Ingelheim Investigational Site
Lviv
1218.52.38005 Boehringer Ingelheim Investigational Site
Lviv
1218.52.38002 Boehringer Ingelheim Investigational Site
Odesa
1218.52.38004 Boehringer Ingelheim Investigational Site
Odesa
1218.52.38006 Boehringer Ingelheim Investigational Site
Vinnitsa

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Croatia5 sites

1218.52.38502 Boehringer Ingelheim Investigational Site
Karlovac
1218.52.38503 Boehringer Ingelheim Investigational Site
Krapinske Toplice
1218.52.38504 Boehringer Ingelheim Investigational Site
Osijek
1218.52.38505 Boehringer Ingelheim Investigational Site
Rijeka
1218.52.38501 Boehringer Ingelheim Investigational Site
Sisak

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Romania5 sites

1218.52.40001 Boehringer Ingelheim Investigational Site
Alba Iulia
1218.52.40005 Boehringer Ingelheim Investigational Site
Galati
1218.52.40003 Boehringer Ingelheim Investigational Site
Oradea
1218.52.40002 Boehringer Ingelheim Investigational Site
Ploieşti
1218.52.40004 Boehringer Ingelheim Investigational Site
Satu Mare

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Germany4 sites

1218.52.49002 Boehringer Ingelheim Investigational Site
Bad Dürrheim-Sunthausen
1218.52.49006 Boehringer Ingelheim Investigational Site
Cologne
1218.52.49003 Boehringer Ingelheim Investigational Site
München
1218.52.49007 Boehringer Ingelheim Investigational Site
Schauenburg

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Sweden4 sites

1218.52.46002 Boehringer Ingelheim Investigational Site
Gothenburg
1218.52.46003 Boehringer Ingelheim Investigational Site
Malmö
1218.52.46005 Boehringer Ingelheim Investigational Site
Stockholm
1218.52.46001 Boehringer Ingelheim Investigational Site
Uppsala

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Estonia3 sites

1218.52.37202 Boehringer Ingelheim Investigational Site
Pärnu
1218.52.37201 Boehringer Ingelheim Investigational Site
Tallinn
1218.52.37203 Boehringer Ingelheim Investigational Site
Tallinn

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Lithuania3 sites

1218.52.37001 Boehringer Ingelheim Investigational Site
Kaunas
1218.52.37004 Boehringer Ingelheim Investigational Site
Kaunas
1218.52.37003 Boehringer Ingelheim Investigational Site
Vilnius

Other trials in Lithuania

About this study

Official title: Extension Study Linagliptin 2.5 mg Bid + Metformin 500 or 1000 mg Bid Versus Metformin 1000 mg Bid

Conditions: Diabetes Mellitus, Type 2
Being tested: Linagliptin + metformin, Linagliptin+metformin, 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.

Linagliptin + metforminDrug
Linagliptin tablet low dose + metformin tablet 500 mg bid
Linagliptin+metforminDrug
Linagliptin low dose tablet + metformin 1000 mg tablet bid
MetforminDrug
Metformin 1000 mg tablet bid

Study groups in NCT00915772
Study group	Role	What they receive
Linagliptin + metformin bid	Experimental	Linagliptin low dose + metformin 500 mg, bid Receives: Drug: Linagliptin + metformin
Linagliptin+ metformin bid	Experimental	Linagliptin low dose + metformin 1000 mg bid Receives: Drug: Linagliptin+metformin
Metformin bid	Active comparator	Metformin 1000 mg bid Receives: Drug: Metformin

What is being measured

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

Frequency of Patients With Adverse Events (AEs)
This includes any AEs detected during routine physical examination and electrocardiogram (ECG) procedures.
Measured: 54 weeks
Change From Baseline at Week 54 in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
Baseline is defined as Visit 1 of 1218.52.
Measured: 54 weeks
Change From Baseline at Week 54 in Pulse Rate
Baseline is defined as Visit 1 of 1218.52.
Measured: 54 weeks
Frequency of Patients With Possibly Clinically Significant Abnormal Laboratory Parameters: Haematology
Measured: 54 weeks
Possibly Clinically Significant Abnormal Laboratory Parameters: Clinical Chemistry
ULN means upper limit of normal
Measured: 54 weeks
Clinical Relevant Drug-related Abnormal Findings in Physical Examination and ECG as Reported as AE
Frequency of patients with adverse events by treatment, primary system organ class and preferred term
Measured: Baseline and drug stop (up to 54 weeks) + 7 days

Secondary outcomes (7)

Change in HbA1c From Baseline Over Time
HbA1c is measured as a percentage. Thus, this change from baseline reflects the visit HbA1c percent minus the baseline HbA1c percent. Baseline is defined as visit 1 of 1218.52.
Measured: 54 weeks
Number of Patients With HbA1c <7.0% After 54 Weeks
Measured: 54 weeks
Number of Patients With HbA1c <6.5% Over Time
Measured: 54 weeks
Number of Patients With HbA1c of at Least <0.5% Over Time
Measured: 54 weeks
Change in FPG From Baseline Over Time
Baseline is defined as visit 1 of 1218.52.
Measured: 54 weeks
Number of Patients With Rescue Therapy
Measured: 54 weeks
Change in HbA1c From Baseline Over Time
HbA1c is measured as a percentage. Thus, this change from baseline reflects the visit HbA1c percent minus the baseline HbA1c percent. Baseline is defined as visit 3 from study 1218.46 (NCT00915772).
Measured: 78 weeks

Timeline

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

Jun 2009Jun 2011

First posted8 Jun 2009 (estimated)
Study startJun 2009
Primary completionJun 2011

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: Single group
Masking: Double blind
Enrolment: 567 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00915772
Sponsor's protocol ID: 1218.52
Other IDs: 2008-008494-59, 2008
Status last verified: Apr 2014
First submitted: 2 Jun 2009
Last updated: 14 May 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?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 14 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Extension Study Linagliptin 2.5 mg Bid + Metformin 500 or 1000 mg Bid Versus Metformin 1000 mg Bid
ClinicalTrials.gov ID: NCT00915772
Acronym / sponsor ID: 1218.52
Conditions: Diabetes Mellitus, Type 2
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 567 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: Jun 2009
Primary completion: Jun 2011 (actual)
First posted: 8 Jun 2009 (estimated)
Results: Posted 18 Jul 2012

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: Single group
Masking: Double blind
Number of arms: 3

Arm	Type	Receives
Linagliptin + metformin bid	Experimental	Drug: Linagliptin + metforminLinagliptin low dose + metformin 500 mg, bid
Linagliptin+ metformin bid	Experimental	Drug: Linagliptin+metforminLinagliptin low dose + metformin 1000 mg bid
Metformin bid	Active comparator	Drug: MetforminMetformin 1000 mg bid

Who may qualify

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

Key inclusion criteria (2 listed)

Signed and dated written informed consent, at the latest by the date of Visit 1
Patients completing the entire treatment period of the double-blind study 1218.46, who are not treated with rescue medication (Visit 7)

Key exclusion criteria (7 listed)

Patients who meet one or more of the withdrawal criteria of the treatment period of the previous study 1218.46
Pre-menopausal women (last menstruation equal or less than 1 year prior to signing 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 submit to periodic pregnancy testing during 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 and in addition for male partners a barrier method, such as the use of condom with spermicide. No exception will be made.
Alcohol abuse within the 3 months prior to informed consent that would interfere with study participation

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
Linagliptin + metforminLinagliptin tablet low dose + metformin tablet 500 mg bid	Drug	Linagliptin + metformin bid
Linagliptin+metforminLinagliptin low dose tablet + metformin 1000 mg tablet bid	Drug	Linagliptin+ metformin bid
MetforminMetformin 1000 mg tablet bid	Drug	Metformin bid

Primary outcome

Frequency of Patients With Adverse Events (AEs)
Time frame: 54 weeks
This includes any AEs detected during routine physical examination and electrocardiogram (ECG) procedures.
Change From Baseline at Week 54 in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
Time frame: 54 weeks
Baseline is defined as Visit 1 of 1218.52.
Change From Baseline at Week 54 in Pulse Rate
Time frame: 54 weeks
Baseline is defined as Visit 1 of 1218.52.
Frequency of Patients With Possibly Clinically Significant Abnormal Laboratory Parameters: Haematology
Time frame: 54 weeks
Possibly Clinically Significant Abnormal Laboratory Parameters: Clinical Chemistry
Time frame: 54 weeks
ULN means upper limit of normal
Clinical Relevant Drug-related Abnormal Findings in Physical Examination and ECG as Reported as AE
Time frame: Baseline and drug stop (up to 54 weeks) + 7 days
Frequency of patients with adverse events by treatment, primary system organ class and preferred term

7 secondary outcomes

Change in HbA1c From Baseline Over Time
Time frame: 54 weeks
Number of Patients With HbA1c <7.0% After 54 Weeks
Time frame: 54 weeks
Number of Patients With HbA1c <6.5% Over Time
Time frame: 54 weeks
Number of Patients With HbA1c of at Least <0.5% Over Time
Time frame: 54 weeks
Change in FPG From Baseline Over Time
Time frame: 54 weeks
Number of Patients With Rescue Therapy
Time frame: 54 weeks
Change in HbA1c From Baseline Over Time
Time frame: 78 weeks

Results and safety

Results posted to the registry on 18 Jul 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
M1000	170	134
L2.5+M500	225	179
L2.5+M1000	171	142

Primary outcome: Frequency of Patients With Adverse Events (AEs)

Time frame: 54 weeks. Number. Unit: participant

Measure	M1000 n = 170	L2.5+M500 n = 225	L2.5+M1000 n = 171
Patients with any AEs	124	149	132
Patients with severe AEs	4	7	5
Patients with withdrawal due to AEs (from AE page)	10	11	9

Population analysed: Treated Set (TS): all screened patients who were documented to have taken at lease 1 dose of study drug.

Primary outcome: Change From Baseline at Week 54 in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)

Time frame: 54 weeks. Mean (Standard Deviation). Unit: mmHg

Measure	M1000 n = 164	L2.5+M500 n = 214	L2.5+M1000 n = 165
DBP change from baseline	-0.3 (8.5)	-0.1 (7.4)	0.3 (8.8)
SBP change from baseline	0.6 (12.2)	-0.2 (13.2)	2.2 (13.6)

Population analysed: TS and observed cases (OC)

Primary outcome: Change From Baseline at Week 54 in Pulse Rate

Time frame: 54 weeks. Mean (Standard Deviation). Unit: beats per minute (bpm)

Measure	M1000 n = 164	L2.5+M500 n = 214	L2.5+M1000 n = 164
Value	0.0 (7.7)	0.6 (8.3)	0.1 (8.3)

Population analysed: TS and observed cases (OC)

Primary outcome: Frequency of Patients With Possibly Clinically Significant Abnormal Laboratory Parameters: Haematology

Time frame: 54 weeks. Number. Unit: participants

Measure	M1000 n = 168	L2.5+M500 n = 225	L2.5+M1000 n = 170
Haematocrit abnormality: <=32%	2	2	0
Haemoglobin abnormality:Female ≤9.5;Male ≤11.5g/dL	7	4	2
Red Blood Cells abnormality: < 3* 10^12/L	0	0	0
White Blood Cells abnormal decrease: < 3 * 10^9/L	0	3	1
White Blood Cells abnormal increase: <20.1*10^9/L	0	1	0
Platelets abnormal decrease: <= 75* 10^9/L	0	0	1
Platelets abnormal increase: >= 700* 10^9/L	0	0	0

Population analysed: TS and observed cases (OC)

7 secondary outcomes are reported in the full results.

Adverse events

Time frame: 54 weeks. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
M1000	7 of 170 (4.1%)	63 of 170 (37.1%)	Not reported
L2.5+M500	12 of 225 (5.3%)	87 of 225 (38.7%)	Not reported
L2.5+M1000	14 of 171 (8.2%)	77 of 171 (45%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
List of publicationsLink 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

112 sites in 14 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Linagliptin + metformin, Linagliptin+metformin and Metformin in people with Diabetes Mellitus, Type 2, run by Boehringer Ingelheim at 112 sites in 14 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 2 inclusion and 7 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 14 May 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 112 sites in France, India, Tunisia, Canada, Netherlands and 9 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. 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 18 Jul 2012). 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?

Frequency of Patients With Adverse Events (AEs) (time frame: 54 weeks). The study lists 6 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 NCT00915772.

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 14 May 2014.