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

NCT ID: NCT00915772

Last Updated: 2014-05-14

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

567 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-06-30

Brief Summary

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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 type 2 diabetic patients previously completing the double-blind part of study 1218.46

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Detailed Description

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Conditions

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Diabetes Mellitus, Type 2

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Study Groups

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Linagliptin + metformin bid

Linagliptin low dose + metformin 500 mg, bid

Group Type EXPERIMENTAL

Linagliptin + metformin

Intervention Type DRUG

Linagliptin tablet low dose + metformin tablet 500 mg bid

Linagliptin+ metformin bid

Linagliptin low dose + metformin 1000 mg bid

Group Type EXPERIMENTAL

Linagliptin+metformin

Intervention Type DRUG

Linagliptin low dose tablet + metformin 1000 mg tablet bid

Metformin bid

Metformin 1000 mg bid

Group Type ACTIVE_COMPARATOR

Metformin

Intervention Type DRUG

Metformin 1000 mg tablet bid

Interventions

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Linagliptin + metformin

Linagliptin tablet low dose + metformin tablet 500 mg bid

Intervention Type DRUG

Linagliptin+metformin

Linagliptin low dose tablet + metformin 1000 mg tablet bid

Intervention Type DRUG

Metformin

Metformin 1000 mg tablet bid

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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)

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Boehringer Ingelheim

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Boehringer Ingelheim

Role: STUDY_CHAIR

Boehringer Ingelheim

Locations

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1218.52.11005 Boehringer Ingelheim Investigational Site

Calgary, Alberta, Canada

Site Status

1218.52.11003 Boehringer Ingelheim Investigational Site

Edmonton, Alberta, Canada

Site Status

1218.52.11002 Boehringer Ingelheim Investigational Site

Red Deer, Alberta, Canada

Site Status

1218.52.11006 Boehringer Ingelheim Investigational Site

Vancouver, British Columbia, Canada

Site Status

1218.52.11008 Boehringer Ingelheim Investigational Site

Winnipeg, Manitoba, Canada

Site Status

1218.52.11004 Boehringer Ingelheim Investigational Site

Hamilton, Ontario, Canada

Site Status

1218.52.11007 Boehringer Ingelheim Investigational Site

Oakville, Ontario, Canada

Site Status

1218.52.11010 Boehringer Ingelheim Investigational Site

Toronto, Ontario, Canada

Site Status

1218.52.38502 Boehringer Ingelheim Investigational Site

Karlovac, , Croatia

Site Status

1218.52.38503 Boehringer Ingelheim Investigational Site

Krapinske Toplice, , Croatia

Site Status

1218.52.38504 Boehringer Ingelheim Investigational Site

Osijek, , Croatia

Site Status

1218.52.38505 Boehringer Ingelheim Investigational Site

Rijeka, , Croatia

Site Status

1218.52.38501 Boehringer Ingelheim Investigational Site

Sisak, , Croatia

Site Status

1218.52.37202 Boehringer Ingelheim Investigational Site

Pärnu, , Estonia

Site Status

1218.52.37201 Boehringer Ingelheim Investigational Site

Tallinn, , Estonia

Site Status

1218.52.37203 Boehringer Ingelheim Investigational Site

Tallinn, , Estonia

Site Status

1218.52.3303D Boehringer Ingelheim Investigational Site

Aire Sur l'Aadour, , France

Site Status

1218.52.3308B Boehringer Ingelheim Investigational Site

Bischheim, , France

Site Status

1218.52.3305A Boehringer Ingelheim Investigational Site

Bourges, , France

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1218.52.3304F Boehringer Ingelheim Investigational Site

Bousse, , France

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1218.52.3308C Boehringer Ingelheim Investigational Site

Gambsheim, , France

Site Status

1218.52.3301A Boehringer Ingelheim Investigational Site

Grenoble Cédex, , France

Site Status

1218.52.3305B Boehringer Ingelheim Investigational Site

Guérigny, , France

Site Status

1218.52.3304A Boehringer Ingelheim Investigational Site

Jarny, , France

Site Status

1218.52.3302D Boehringer Ingelheim Investigational Site

La Riche, , France

Site Status

1218.52.9999 Boehringer Ingelheim Investigational Site

La Riche, , France

Site Status

1218.52.3307A Boehringer Ingelheim Investigational Site

La Seyne-sur-Mer, , France

Site Status

1218.52.3307E Boehringer Ingelheim Investigational Site

La Seyne-sur-Mer, , France

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1218.52.3305G Boehringer Ingelheim Investigational Site

Lury-sur-Arnon, , France

Site Status

1218.52.3303A Boehringer Ingelheim Investigational Site

Mont-de-Marsan, , France

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1218.52.3308F Boehringer Ingelheim Investigational Site

Mundolsheim, , France

Site Status

1218.52.3305E Boehringer Ingelheim Investigational Site

Nevers, , France

Site Status

1218.52.3306A Boehringer Ingelheim Investigational Site

Orthez, , France

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1218.52.3306C Boehringer Ingelheim Investigational Site

Orthez, , France

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1218.52.3303B Boehringer Ingelheim Investigational Site

Saint-Martin-d'Oney, , France

Site Status

1218.52.3302E Boehringer Ingelheim Investigational Site

Savonnières, , France

Site Status

1218.52.3308A Boehringer Ingelheim Investigational Site

Strasbourg, , France

Site Status

1218.52.3308D Boehringer Ingelheim Investigational Site

Strasbourg, , France

Site Status

1218.52.3308E Boehringer Ingelheim Investigational Site

Strasbourg, , France

Site Status

1218.52.3307D Boehringer Ingelheim Investigational Site

Toulon, , France

Site Status

1218.52.3302A Boehringer Ingelheim Investigational Site

Tours, , France

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1218.52.49002 Boehringer Ingelheim Investigational Site

Bad Dürrheim-Sunthausen, , Germany

Site Status

1218.52.49006 Boehringer Ingelheim Investigational Site

Cologne, , Germany

Site Status

1218.52.49003 Boehringer Ingelheim Investigational Site

München, , Germany

Site Status

1218.52.49007 Boehringer Ingelheim Investigational Site

Schauenburg, , Germany

Site Status

1218.52.91009 Boehringer Ingelheim Investigational Site

Aurangabad, , India

Site Status

1218.52.91001 Boehringer Ingelheim Investigational Site

Bangalore, , India

Site Status

1218.52.91004 Boehringer Ingelheim Investigational Site

Bangalore, , India

Site Status

1218.52.91012 Boehringer Ingelheim Investigational Site

Bangalore, , India

Site Status

1218.52.91011 Boehringer Ingelheim Investigational Site

Bhopal, , India

Site Status

1218.52.91003 Boehringer Ingelheim Investigational Site

Chennai, , India

Site Status

1218.52.91020 Boehringer Ingelheim Investigational Site

Chennai, , India

Site Status

1218.52.91018 Boehringer Ingelheim Investigational Site

Hyderadad, , India

Site Status

1218.52.91008 Boehringer Ingelheim Investigational Site

Jaipur, , India

Site Status

1218.52.91002 Boehringer Ingelheim Investigational Site

Karnataka, , India

Site Status

1218.52.91007 Boehringer Ingelheim Investigational Site

Karnataka, , India

Site Status

1218.52.91019 Boehringer Ingelheim Investigational Site

Madurai, , India

Site Status

1218.52.91013 Boehringer Ingelheim Investigational Site

Maharashtra, , India

Site Status

1218.52.91015 Boehringer Ingelheim Investigational Site

Mumbai, , India

Site Status

1218.52.91014 Boehringer Ingelheim Investigational Site

Nagpru, , India

Site Status

1218.52.91016 Boehringer Ingelheim Investigational Site

P.O.Trivandrum, , India

Site Status

1218.52.91010 Boehringer Ingelheim Investigational Site

Pune, , India

Site Status

1218.52.91006 Boehringer Ingelheim Investigational Site

West Bengal, , India

Site Status

1218.52.37001 Boehringer Ingelheim Investigational Site

Kaunas, , Lithuania

Site Status

1218.52.37004 Boehringer Ingelheim Investigational Site

Kaunas, , Lithuania

Site Status

1218.52.37003 Boehringer Ingelheim Investigational Site

Vilnius, , Lithuania

Site Status

1218.52.52006 Boehringer Ingelheim Investigational Site

Aguascalientes, , Mexico

Site Status

1218.52.52002 Boehringer Ingelheim Investigational Site

Cuernavaca, , Mexico

Site Status

1218.52.52004 Boehringer Ingelheim Investigational Site

Guadalajara, , Mexico

Site Status

1218.52.52007 Boehringer Ingelheim Investigational Site

México, , Mexico

Site Status

1218.52.52008 Boehringer Ingelheim Investigational Site

México, , Mexico

Site Status

1218.52.52010 Boehringer Ingelheim Investigational Site

Tijuana, , Mexico

Site Status

1218.52.52009 Boehringer Ingelheim Investigational Site

Veracruz, , Mexico

Site Status

1218.52.31004 Boehringer Ingelheim Investigational Site

's-Hertogenbosch, , Netherlands

Site Status

1218.52.31005 Boehringer Ingelheim Investigational Site

's-Hertogenbosch, , Netherlands

Site Status

1218.52.31001 Boehringer Ingelheim Investigational Site

Almere Stad, , Netherlands

Site Status

1218.52.31002 Boehringer Ingelheim Investigational Site

Beek en Donk, , Netherlands

Site Status

1218.52.31010 Boehringer Ingelheim Investigational Site

Breda, , Netherlands

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1218.52.31013 Boehringer Ingelheim Investigational Site

Groningen, , Netherlands

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1218.52.31014 Boehringer Ingelheim Investigational Site

Velp, , Netherlands

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1218.52.31015 Boehringer Ingelheim Investigational Site

Zoetermeer, , Netherlands

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1218.52.40001 Boehringer Ingelheim Investigational Site

Alba Iulia, , Romania

Site Status

1218.52.40005 Boehringer Ingelheim Investigational Site

Galati, , Romania

Site Status

1218.52.40003 Boehringer Ingelheim Investigational Site

Oradea, , Romania

Site Status

1218.52.40002 Boehringer Ingelheim Investigational Site

Ploieşti, , Romania

Site Status

1218.52.40004 Boehringer Ingelheim Investigational Site

Satu Mare, , Romania

Site Status

1218.52.70001 Boehringer Ingelheim Investigational Site

Moscow, , Russia

Site Status

1218.52.70002 Boehringer Ingelheim Investigational Site

Moscow, , Russia

Site Status

1218.52.70003 Boehringer Ingelheim Investigational Site

Moscow, , Russia

Site Status

1218.52.70004 Boehringer Ingelheim Investigational Site

Moscow, , Russia

Site Status

1218.52.70006 Boehringer Ingelheim Investigational Site

Moscow, , Russia

Site Status

1218.52.70005 Boehringer Ingelheim Investigational Site

Saint Petersburg, , Russia

Site Status

1218.52.70007 Boehringer Ingelheim Investigational Site

Saint Petersburg, , Russia

Site Status

1218.52.46002 Boehringer Ingelheim Investigational Site

Gothenburg, , Sweden

Site Status

1218.52.46003 Boehringer Ingelheim Investigational Site

Malmo, , Sweden

Site Status

1218.52.46005 Boehringer Ingelheim Investigational Site

Stockholm, , Sweden

Site Status

1218.52.46001 Boehringer Ingelheim Investigational Site

Uppsala, , Sweden

Site Status

1218.52.2162A Boehringer Ingelheim Investigational Site

Bab Saâdoun Tunis, , Tunisia

Site Status

1218.52.2162B Boehringer Ingelheim Investigational Site

Bab Sâadoun Tunis, , Tunisia

Site Status

1218.52.9992 Boehringer Ingelheim Investigational Site

Bab Sâadoun Tunis, , Tunisia

Site Status

1218.52.2161A Boehringer Ingelheim Investigational Site

Tunis, , Tunisia

Site Status

1218.52.2161B Boehringer Ingelheim Investigational Site

Tunis, , Tunisia

Site Status

1218.52.2163A Boehringer Ingelheim Investigational Site

Tunis, , Tunisia

Site Status

1218.52.2163B Boehringer Ingelheim Investigational Site

Tunis, , Tunisia

Site Status

1218.52.9991 Boehringer Ingelheim Investigational Site

Tunis, , Tunisia

Site Status

1218.52.9993 Boehringer Ingelheim Investigational Site

Tunis, , Tunisia

Site Status

1218.52.38003 Boehringer Ingelheim Investigational Site

Kiev, , Ukraine

Site Status

1218.52.38001 Boehringer Ingelheim Investigational Site

Lviv, , Ukraine

Site Status

1218.52.38005 Boehringer Ingelheim Investigational Site

Lviv, , Ukraine

Site Status

1218.52.38002 Boehringer Ingelheim Investigational Site

Odesa, , Ukraine

Site Status

1218.52.38004 Boehringer Ingelheim Investigational Site

Odesa, , Ukraine

Site Status

1218.52.38006 Boehringer Ingelheim Investigational Site

Vinnitsa, , Ukraine

Site Status

Countries

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Canada Croatia Estonia France Germany India Lithuania Mexico Netherlands Romania Russia Sweden Tunisia Ukraine

Related Links

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http://trials.boehringer-ingelheim.com/content/dam/internet/opu/clinicaltrial/com_EN/results/1218/1218.52_Literature.pdf

List of publications

Other Identifiers

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2008-008494-59

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

1218.52

Identifier Type: -

Identifier Source: org_study_id

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