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Efficacy and Safety of Linagliptin in Combination With Insulin in Patients With Type 2 Diabetes

NCT ID: NCT00954447

Last Updated: 2013-12-30

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

1263 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-08-31

Brief Summary

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The objective of the current study is to investigate the efficacy, safety and tolerability of linagliptin (5 mg / once daily) compared to Placebo during long term treatment (52 weeks and longer) in combination with basal insulin in patients with type 2 diabetes mellitus with insufficient glycaemic control.

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

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Study Groups

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Linagliptin

patient receives a tablet with intended final marketed dose

Group Type EXPERIMENTAL

Linagliptin

Intervention Type DRUG

intended final marketed dose

Placebo

patient receives a tablet identical to those containing Linagliptin

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo, identical to Linagliptin tablet

Interventions

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Placebo

Placebo, identical to Linagliptin tablet

Intervention Type DRUG

Linagliptin

intended final marketed dose

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Diabetes type 2, detectable C-peptide, HbA1c 7-10%
2. Pretreatment with basal insulin +/- Metformin or/and +/- Pioglitazone 3 Age \> 18 years, BMI \<= 45 kg/m2

Exclusion Criteria

1. Uncontrolled hyperglycemia during Run-in
2. Myocardial infarction, stroke or TIA within 3 months prior to informed consent
3. Liver impairment; gastric surgery; medical history of cancer in last 5 years
4. Other antidiabetic drugs, antiobesity drugs, systemic steroids, other investigational drug before randomisation
5. Unsufficient birth control, pregnancy and nursing
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Eli Lilly and Company

INDUSTRY

Sponsor Role collaborator

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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1218.36.01043 Boehringer Ingelheim Investigational Site

Escondido, California, United States

Site Status

1218.36.01051 Boehringer Ingelheim Investigational Site

Escondido, California, United States

Site Status

1218.36.01065 Boehringer Ingelheim Investigational Site

Fresno, California, United States

Site Status

1218.36.01021 Boehringer Ingelheim Investigational Site

Greenbrae, California, United States

Site Status

1218.36.01013 Boehringer Ingelheim Investigational Site

Los Angeles, California, United States

Site Status

1218.36.01048 Boehringer Ingelheim Investigational Site

Los Angeles, California, United States

Site Status

1218.36.01058 Boehringer Ingelheim Investigational Site

San Diego, California, United States

Site Status

1218.36.01008 Boehringer Ingelheim Investigational Site

Santa Ana, California, United States

Site Status

1218.36.01056 Boehringer Ingelheim Investigational Site

Waterbury, Connecticut, United States

Site Status

1218.36.01054 Boehringer Ingelheim Investigational Site

Clearwater, Florida, United States

Site Status

1218.36.01035 Boehringer Ingelheim Investigational Site

Inverness, Florida, United States

Site Status

1218.36.01010 Boehringer Ingelheim Investigational Site

Miami, Florida, United States

Site Status

1218.36.01042 Boehringer Ingelheim Investigational Site

New Port Richey, Florida, United States

Site Status

1218.36.01063 Boehringer Ingelheim Investigational Site

Pembroke Pines, Florida, United States

Site Status

1218.36.01037 Boehringer Ingelheim Investigational Site

Ponte Vedra, Florida, United States

Site Status

1218.36.01032 Boehringer Ingelheim Investigational Site

Saint Cloud, Florida, United States

Site Status

1218.36.01049 Boehringer Ingelheim Investigational Site

St. Petersburg, Florida, United States

Site Status

1218.36.01036 Boehringer Ingelheim Investigational Site

Atlanta, Georgia, United States

Site Status

1218.36.01047 Boehringer Ingelheim Investigational Site

Decatur, Georgia, United States

Site Status

1218.36.01009 Boehringer Ingelheim Investigational Site

Roswell, Georgia, United States

Site Status

1218.36.01055 Boehringer Ingelheim Investigational Site

Honolulu, Hawaii, United States

Site Status

1218.36.01014 Boehringer Ingelheim Investigational Site

Chicago, Illinois, United States

Site Status

1218.36.01011 Boehringer Ingelheim Investigational Site

Paducah, Kentucky, United States

Site Status

1218.36.01034 Boehringer Ingelheim Investigational Site

City of Saint Peters, Missouri, United States

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1218.36.01040 Boehringer Ingelheim Investigational Site

Kansas City, Missouri, United States

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1218.36.01029 Boehringer Ingelheim Investigational Site

St Louis, Missouri, United States

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1218.36.01018 Boehringer Ingelheim Investigational Site

Omaha, Nebraska, United States

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1218.36.01053 Boehringer Ingelheim Investigational Site

New Hartford, New York, United States

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1218.36.01006 Boehringer Ingelheim Investigational Site

Burlington, North Carolina, United States

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1218.36.01025 Boehringer Ingelheim Investigational Site

Hickory, North Carolina, United States

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1218.36.01005 Boehringer Ingelheim Investigational Site

Statesville, North Carolina, United States

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1218.36.01015 Boehringer Ingelheim Investigational Site

Cincinnati, Ohio, United States

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1218.36.01039 Boehringer Ingelheim Investigational Site

Tulsa, Oklahoma, United States

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1218.36.01019 Boehringer Ingelheim Investigational Site

Altoona, Pennsylvania, United States

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1218.36.01012 Boehringer Ingelheim Investigational Site

Norristown, Pennsylvania, United States

Site Status

1218.36.01004 Boehringer Ingelheim Investigational Site

Greer, South Carolina, United States

Site Status

1218.36.01020 Boehringer Ingelheim Investigational Site

Simpsonville, South Carolina, United States

Site Status

1218.36.01003 Boehringer Ingelheim Investigational Site

Kingsport, Tennessee, United States

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1218.36.01038 Boehringer Ingelheim Investigational Site

Dallas, Texas, United States

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1218.36.01016 Boehringer Ingelheim Investigational Site

Houston, Texas, United States

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1218.36.01026 Boehringer Ingelheim Investigational Site

Salt Lake City, Utah, United States

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1218.36.01041 Boehringer Ingelheim Investigational Site

Bennington, Vermont, United States

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1218.36.01064 Boehringer Ingelheim Investigational Site

Richmond, Virginia, United States

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1218.36.01024 Boehringer Ingelheim Investigational Site

Lakewood, Washington, United States

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1218.36.01007 Boehringer Ingelheim Investigational Site

Renton, Washington, United States

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1218.36.01027 Boehringer Ingelheim Investigational Site

Spokane, Washington, United States

Site Status

1218.36.01062 Boehringer Ingelheim Investigational Site

Tacoma, Washington, United States

Site Status

1218.36.54001 Boehringer Ingelheim Investigational Site

Capital Federal, , Argentina

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1218.36.54002 Boehringer Ingelheim Investigational Site

Capital Federal, , Argentina

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1218.36.54003 Boehringer Ingelheim Investigational Site

Capital Federal, , Argentina

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1218.36.54005 Boehringer Ingelheim Investigational Site

Capital Federal, , Argentina

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1218.36.54004 Boehringer Ingelheim Investigational Site

Córdoba, , Argentina

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1218.36.32002 Boehringer Ingelheim Investigational Site

Edegem, , Belgium

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1218.36.320099 Boehringer Ingelheim Investigational Site

Edegem, , Belgium

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1218.36.32006 Boehringer Ingelheim Investigational Site

Sint-Gillis-Waas, , Belgium

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1218.36.55003 Boehringer Ingelheim Investigational Site

Belém, , Brazil

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1218.36.55004 Boehringer Ingelheim Investigational Site

Porto Alegre, , Brazil

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1218.36.55001 Boehringer Ingelheim Investigational Site

São Paulo, , Brazil

Site Status

1218.36.55002 Boehringer Ingelheim Investigational Site

São Paulo, , Brazil

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1218.36.02010 Boehringer Ingelheim Investigational Site

Calgary, Alberta, Canada

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1218.36.02004 Boehringer Ingelheim Investigational Site

Vancouver, British Columbia, Canada

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1218.36.02011 Boehringer Ingelheim Investigational Site

Victoria, British Columbia, Canada

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1218.36.02006 Boehringer Ingelheim Investigational Site

St. John's, Newfoundland and Labrador, Canada

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1218.36.02002 Boehringer Ingelheim Investigational Site

Halifax, Nova Scotia, Canada

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1218.36.02009 Boehringer Ingelheim Investigational Site

Hamilton, Ontario, Canada

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1218.36.02005 Boehringer Ingelheim Investigational Site

Kingston, Ontario, Canada

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1218.36.02008 Boehringer Ingelheim Investigational Site

Sarnia, Ontario, Canada

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1218.36.02007 Boehringer Ingelheim Investigational Site

Toronto, Ontario, Canada

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1218.36.02001 Boehringer Ingelheim Investigational Site

Laval, Quebec, Canada

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1218.36.02003 Boehringer Ingelheim Investigational Site

Montreal, Quebec, Canada

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1218.36.42004 Boehringer Ingelheim Investigational Site

Brno, , Czechia

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1218.36.42006 Boehringer Ingelheim Investigational Site

Břeclav, , Czechia

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1218.36.42005 Boehringer Ingelheim Investigational Site

Hodonín, , Czechia

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1218.36.42002 Boehringer Ingelheim Investigational Site

Mladá Boleslav, , Czechia

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1218.36.42001 Boehringer Ingelheim Investigational Site

Neratovice, , Czechia

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1218.36.42007 Boehringer Ingelheim Investigational Site

Zlín, , Czechia

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1218.36.35807 Boehringer Ingelheim Investigational Site

Joensuu, , Finland

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1218.36.35802 Boehringer Ingelheim Investigational Site

Kuopio, , Finland

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1218.36.35803 Boehringer Ingelheim Investigational Site

Oulu, , Finland

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1218.36.35805 Boehringer Ingelheim Investigational Site

Tampere, , Finland

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1218.36.35804 Boehringer Ingelheim Investigational Site

Turku, , Finland

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1218.36.35806 Boehringer Ingelheim Investigational Site

Vantaa, , Finland

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1218.36.49001 Boehringer Ingelheim Investigational Site

Berlin, , Germany

Site Status

1218.36.49002 Boehringer Ingelheim Investigational Site

Berlin, , Germany

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1218.36.49010 Boehringer Ingelheim Investigational Site

Berlin, , Germany

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1218.36.49009 Boehringer Ingelheim Investigational Site

Bosenheim, , Germany

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1218.36.49017 Boehringer Ingelheim Investigational Site

Cologne, , Germany

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1218.36.49004 Boehringer Ingelheim Investigational Site

Dortmund, , Germany

Site Status

1218.36.49006 Boehringer Ingelheim Investigational Site

Dresden, , Germany

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1218.36.49012 Boehringer Ingelheim Investigational Site

Magdeburg, , Germany

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1218.36.49005 Boehringer Ingelheim Investigational Site

Mainz, , Germany

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1218.36.49018 Boehringer Ingelheim Investigational Site

Neuwied, , Germany

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1218.36.49008 Boehringer Ingelheim Investigational Site

Pirna, , Germany

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1218.36.49019 Boehringer Ingelheim Investigational Site

Sulzbach-Rosenberg, , Germany

Site Status

1218.36.49003 Boehringer Ingelheim Investigational Site

Unterschneidheim, , Germany

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1218.36.49011 Boehringer Ingelheim Investigational Site

Wangen, , Germany

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1218.36.49014 Boehringer Ingelheim Investigational Site

Wangen, , Germany

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1218.36.49015 Boehringer Ingelheim Investigational Site

Westerkappeln, , Germany

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1218.36.30003 Boehringer Ingelheim Investigational Site

Athens, , Greece

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1218.36.30007 Boehringer Ingelheim Investigational Site

Athens, , Greece

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1218.36.30010 Boehringer Ingelheim Investigational Site

Athens, , Greece

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1218.36.30011 Boehringer Ingelheim Investigational Site

Larissa, , Greece

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1218.36.30002 Boehringer Ingelheim Investigational Site

Nikaia, , Greece

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1218.36.30005 Boehringer Ingelheim Investigational Site

Thessaloniki, , Greece

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1218.36.39002 Boehringer Ingelheim Investigational Site

Ferrara, , Italy

Site Status

1218.36.39003 Boehringer Ingelheim Investigational Site

Ferrara, , Italy

Site Status

1218.36.39004 Boehringer Ingelheim Investigational Site

Genova, , Italy

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1218.36.39005 Boehringer Ingelheim Investigational Site

Milan, , Italy

Site Status

1218.36.39001 Boehringer Ingelheim Investigational Site

Pordenone, , Italy

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1218.36.39007 Boehringer Ingelheim Investigational Site

Siena, , Italy

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1218.36.39006 Boehringer Ingelheim Investigational Site

Syracuse, , Italy

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1218.36.52002 Boehringer Ingelheim Investigational Site

Pachuca, , Mexico

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1218.36.52004 Boehringer Ingelheim Investigational Site

San Luis Potosí City, , Mexico

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1218.36.52005 Boehringer Ingelheim Investigational Site

Tijuana, , Mexico

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1218.36.31008 Boehringer Ingelheim Investigational Site

's-Hertogenbosch, , Netherlands

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1218.36.31001 Boehringer Ingelheim Investigational Site

Almere Stad, , Netherlands

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1218.36.31006 Boehringer Ingelheim Investigational Site

Beek, , Netherlands

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1218.36.31002 Boehringer Ingelheim Investigational Site

Ewijk, , Netherlands

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1218.36.31004 Boehringer Ingelheim Investigational Site

Oude Pekela, , Netherlands

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1218.36.31007 Boehringer Ingelheim Investigational Site

Roelofarendsveen, , Netherlands

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1218.36.31005 Boehringer Ingelheim Investigational Site

Wildervank, , Netherlands

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1218.36.47002 Boehringer Ingelheim Investigational Site

Bergen, , Norway

Site Status

1218.36.47006 Boehringer Ingelheim Investigational Site

Elverum, , Norway

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1218.36.47005 Boehringer Ingelheim Investigational Site

Hamar, , Norway

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1218.36.47004 Boehringer Ingelheim Investigational Site

Oslo, , Norway

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1218.36.47001 Boehringer Ingelheim Investigational Site

Stavanger, , Norway

Site Status

1218.36.51003 Boehringer Ingelheim Investigational Site

Lima, , Peru

Site Status

1218.36.70002 Boehringer Ingelheim Investigational Site

Moscow, , Russia

Site Status

1218.36.70003 Boehringer Ingelheim Investigational Site

Moscow, , Russia

Site Status

1218.36.70005 Boehringer Ingelheim Investigational Site

Saint Petersburg, , Russia

Site Status

1218.36.70001 Boehringer Ingelheim Investigational Site

Samara, , Russia

Site Status

1218.36.70007 Boehringer Ingelheim Investigational Site

Smolensk, , Russia

Site Status

1218.36.70006 Boehringer Ingelheim Investigational Site

Yaroslavl, , Russia

Site Status

1218.36.42103 Boehringer Ingelheim Investigational Site

Banská Bystrica, , Slovakia

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1218.36.42101 Boehringer Ingelheim Investigational Site

Bratislava, , Slovakia

Site Status

1218.36.42102 Boehringer Ingelheim Investigational Site

Bratislava, , Slovakia

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1218.36.42104 Boehringer Ingelheim Investigational Site

Bratislava, , Slovakia

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1218.36.42105 Boehringer Ingelheim Investigational Site

Prešov, , Slovakia

Site Status

1218.36.42106 Boehringer Ingelheim Investigational Site

Trebišov, , Slovakia

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1218.36.82004 Boehringer Ingelheim Investigational Site

Daegu, , South Korea

Site Status

1218.36.82009 Boehringer Ingelheim Investigational Site

Daegu, , South Korea

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1218.36.82008 Boehringer Ingelheim Investigational Site

Incheon, , South Korea

Site Status

1218.36.82007 Boehringer Ingelheim Investigational Site

Jeonju, , South Korea

Site Status

1218.36.82001 Boehringer Ingelheim Investigational Site

Pusan, , South Korea

Site Status

1218.36.82002 Boehringer Ingelheim Investigational Site

Seoul, , South Korea

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1218.36.82003 Boehringer Ingelheim Investigational Site

Seoul, , South Korea

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1218.36.82005 Boehringer Ingelheim Investigational Site

Seoul, , South Korea

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1218.36.82006 Boehringer Ingelheim Investigational Site

Seoul, , South Korea

Site Status

1218.36.82010 Boehringer Ingelheim Investigational Site

Suwon, , South Korea

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1218.36.34002 Boehringer Ingelheim Investigational Site

Badia Del Vallés (Barcelona), , Spain

Site Status

1218.36.34005 Boehringer Ingelheim Investigational Site

Barcelona, , Spain

Site Status

1218.36.34010 Boehringer Ingelheim Investigational Site

Barcelona, , Spain

Site Status

1218.36.34001 Boehringer Ingelheim Investigational Site

Bercelona, , Spain

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1218.36.34007 Boehringer Ingelheim Investigational Site

Borges Del Camp (Tarragona), , Spain

Site Status

1218.36.34003 Boehringer Ingelheim Investigational Site

Centelles (Barcelona), , Spain

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1218.36.34004 Boehringer Ingelheim Investigational Site

L'Hospitalet de Llobregat (Barcelona), , Spain

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1218.36.34011 Boehringer Ingelheim Investigational Site

Seville, , Spain

Site Status

1218.36.34009 Boehringer Ingelheim Investigational Site

Tàrrega (Lleida), , Spain

Site Status

1218.36.34006 Boehringer Ingelheim Investigational Site

Vic (Barcelona), , Spain

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1218.36.88610 Boehringer Ingelheim Investigational Site

Changhua, , Taiwan

Site Status

1218.36.88607 Boehringer Ingelheim Investigational Site

Kaohsiung City, , Taiwan

Site Status

1218.36.88601 Boehringer Ingelheim Investigational Site

Taichung, , Taiwan

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1218.36.88603 Boehringer Ingelheim Investigational Site

Taichung, , Taiwan

Site Status

1218.36.88606 Boehringer Ingelheim Investigational Site

Tainan City, , Taiwan

Site Status

1218.36.88602 Boehringer Ingelheim Investigational Site

Taipei, , Taiwan

Site Status

1218.36.88604 Boehringer Ingelheim Investigational Site

Taipei, , Taiwan

Site Status

1218.36.88605 Boehringer Ingelheim Investigational Site

Taipei, , Taiwan

Site Status

1218.36.88608 Boehringer Ingelheim Investigational Site

Taipei, , Taiwan

Site Status

1218.36.88609 Boehringer Ingelheim Investigational Site

Taipei, , Taiwan

Site Status

Countries

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Chile Sweden United States Argentina Belgium Brazil Canada Czechia Finland Germany Greece Italy Mexico Netherlands Norway Peru Russia Slovakia South Korea Spain Taiwan

References

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Sheu WH, Park SW, Gong Y, Pinnetti S, Bhattacharya S, Patel S, Seck T, Woerle HJ. Linagliptin improves glycemic control after 1 year as add-on therapy to basal insulin in Asian patients with type 2 diabetes mellitus. Curr Med Res Opin. 2015 Mar;31(3):503-12. doi: 10.1185/03007995.2015.1010638. Epub 2015 Feb 13.

Reference Type DERIVED
PMID: 25629790 (View on PubMed)

Yki-Jarvinen H, Rosenstock J, Duran-Garcia S, Pinnetti S, Bhattacharya S, Thiemann S, Patel S, Woerle HJ. Effects of adding linagliptin to basal insulin regimen for inadequately controlled type 2 diabetes: a >/=52-week randomized, double-blind study. Diabetes Care. 2013 Dec;36(12):3875-81. doi: 10.2337/dc12-2718. Epub 2013 Sep 23.

Reference Type DERIVED
PMID: 24062327 (View on PubMed)

Other Identifiers

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2008-008296-33

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

1218.36

Identifier Type: -

Identifier Source: org_study_id