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Linagliptin as Add on Therapy to Empagliflozin 10 mg or 25 mg With Background Metformin in Patient With Type 2 Diabetes

NCT ID: NCT01778049

Last Updated: 2016-04-04

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

708 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-01-31

Study Completion Date

2015-03-31

Brief Summary

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The objective of the study is to investigate the efficacy, safety and tolerability of linagliptin 5 mg qd compared to placebo given for 24 weeks in inadequately controlled T2DM patients on empagliflozin 10 mg or 25 mg and maximum tolerated dose of metformin. The primary objective of efficacy evaluation is planned after 24 weeks of treatment. The study is designed to show superiority of the combination of empagliflozin and linagliptin over empagliflozin alone.

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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

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Study Groups

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Empagliflozin 10 mg dose

Empagliflozin open label treatment period

Group Type EXPERIMENTAL

BI 10773

Intervention Type DRUG

Empagliflozin active

Placebo add on 10 mg dose

Empagliflozin / Linagliptin 10/5 mg Dose FDC placebo add on run-in

Group Type EXPERIMENTAL

BI 10773 / BI 1356 Placebo

Intervention Type DRUG

Empagliflozin / Linagliptin 10/5 mg Dose placebo FDC

BI 10773

Intervention Type DRUG

Empagliflozin active

Empagliflozin/Linagliptin 25/5 mg Dose

Empagliflozin / Linagliptin 25/5 mg Dose FDC active

Group Type EXPERIMENTAL

BI 10773 / BI 1356

Intervention Type DRUG

Empagliflozin / Linagliptin 25/5 mg Dose FDC active

BI 10773 Placebo

Intervention Type DRUG

Empagliflozin placebo

Empagliflozin/Linagliptin 10/5 mg Dose.

Empagliflozin / Linagliptin 10/5 mg Dose FDC placebo

Group Type EXPERIMENTAL

BI 10773 / BI 1356 Placebo

Intervention Type DRUG

Empagliflozin / Linagliptin 10/5 mg Dose FDC placebo

BI 10773

Intervention Type DRUG

Empagliflozin active

Empagliflozin/Linagliptin 10/5 mg Dose

Empagliflozin / Linagliptin 10/5 mg Dose FDC active

Group Type EXPERIMENTAL

BI 10773 Placebo

Intervention Type DRUG

Empagliflozin placebo

BI 10773 / BI 1356

Intervention Type DRUG

Empagliflozin / Linagliptin 10/5 mg Dose FDC active

Empagliflozin 25 mg dose

Empagliflozin open label treatment period

Group Type EXPERIMENTAL

BI 10773

Intervention Type DRUG

Empagliflozin active

Empagliflozin/Linagliptin 25/5 mg Dose.

Empagliflozin / Linagliptin 25/5 mg Dose FDC placebo

Group Type EXPERIMENTAL

BI 10773

Intervention Type DRUG

Empagliflozin active

BI 10773 / BI 1356 Placebo

Intervention Type DRUG

Empagliflozin / Linagliptin 25/5 mg Dose FDC placebo

Placebo add on 25 mg dose

Empagliflozin / Linagliptin 25/5 mg Dose FDC placebo add on run-in

Group Type EXPERIMENTAL

BI 10773

Intervention Type DRUG

Empagliflozin active

BI 10773 / BI 1356 Placebo

Intervention Type DRUG

Empagliflozin / Linagliptin 25/5 mg Dose FDC placebo

Interventions

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BI 10773

Empagliflozin active

Intervention Type DRUG

BI 10773 Placebo

Empagliflozin placebo

Intervention Type DRUG

BI 10773 / BI 1356

Empagliflozin / Linagliptin 25/5 mg Dose FDC active

Intervention Type DRUG

BI 10773

Empagliflozin active

Intervention Type DRUG

BI 10773 / BI 1356

Empagliflozin / Linagliptin 10/5 mg Dose FDC active

Intervention Type DRUG

BI 10773 / BI 1356 Placebo

Empagliflozin / Linagliptin 10/5 mg Dose placebo FDC

Intervention Type DRUG

BI 10773

Empagliflozin active

Intervention Type DRUG

BI 10773

Empagliflozin active

Intervention Type DRUG

BI 10773

Empagliflozin active

Intervention Type DRUG

BI 10773 / BI 1356 Placebo

Empagliflozin / Linagliptin 25/5 mg Dose FDC placebo

Intervention Type DRUG

BI 10773 Placebo

Empagliflozin placebo

Intervention Type DRUG

BI 10773 / BI 1356 Placebo

Empagliflozin / Linagliptin 10/5 mg Dose FDC placebo

Intervention Type DRUG

BI 10773

Empagliflozin active

Intervention Type DRUG

BI 10773 / BI 1356 Placebo

Empagliflozin / Linagliptin 25/5 mg Dose FDC placebo

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Signed and dated ICF (Informed Consent Form)
2. Male or female on diet and exercise regime and on stable background metformin \> or equal to 1500 mg or maximun dose according to local label
3. HBA1c (Glicoslated Hemoglobin) \> or equal to 8% and \< or equal to 10.5 % at Visit 1
4. HbA1c \> or equal to 7 and \< or equal to 10.5 at Visit 4
5. Age \> or equal to 18 years
6. BMI (Body Mass Index) \< or equal to 45

Exclusion Criteria

1. Uncontrolled hyperglycemia during open label period and placebo add on "run-in" period
2. Use of any other antidiabetic
3. Renal function below 60 ml/min/1.73 m2
4. Antiobesity drugs or aggresive diets
5. Gastorintestinal surgeries
6. Current systemic steroids or uncontrolled endocrine disorders other than Diabetes Type 2
7. Acute coronary syndrome and stroke within 3 months of informed consent
8. Known allergies to DPP-IV (Dypeptidil Peptidase IV) or SGLT-2 (Sodium Glucose Transporter 2) inhibitors
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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1275.10.01019 Boehringer Ingelheim Investigational Site

Chino, California, United States

Site Status

1275.10.01008 Boehringer Ingelheim Investigational Site

Huntington Beach, California, United States

Site Status

1275.10.01003 Boehringer Ingelheim Investigational Site

San Diego, California, United States

Site Status

1275.10.01024 Boehringer Ingelheim Investigational Site

San Diego, California, United States

Site Status

1275.10.01002 Boehringer Ingelheim Investigational Site

Sylmar, California, United States

Site Status

1275.10.01011 Boehringer Ingelheim Investigational Site

Miami, Florida, United States

Site Status

1275.10.01009 Boehringer Ingelheim Investigational Site

Orlando, Florida, United States

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1275.10.01023 Boehringer Ingelheim Investigational Site

Oviedo, Florida, United States

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1275.10.01006 Boehringer Ingelheim Investigational Site

Tamarac, Florida, United States

Site Status

1275.10.01017 Boehringer Ingelheim Investigational Site

Conyers, Georgia, United States

Site Status

1275.10.01016 Boehringer Ingelheim Investigational Site

Snellville, Georgia, United States

Site Status

1275.10.01012 Boehringer Ingelheim Investigational Site

Avon, Indiana, United States

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1275.10.01013 Boehringer Ingelheim Investigational Site

Muncie, Indiana, United States

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1275.10.01010 Boehringer Ingelheim Investigational Site

Elkton, Maryland, United States

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1275.10.01001 Boehringer Ingelheim Investigational Site

Stevensville, Michigan, United States

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1275.10.01007 Boehringer Ingelheim Investigational Site

Salisbury, North Carolina, United States

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1275.10.01005 Boehringer Ingelheim Investigational Site

Bismarck, North Dakota, United States

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1275.10.01020 Boehringer Ingelheim Investigational Site

Oklahoma City, Oklahoma, United States

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1275.10.01022 Boehringer Ingelheim Investigational Site

Pittsburgh, Pennsylvania, United States

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1275.10.01021 Boehringer Ingelheim Investigational Site

Union, South Carolina, United States

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1275.10.01014 Boehringer Ingelheim Investigational Site

North Richland Hills, Texas, United States

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1275.10.01018 Boehringer Ingelheim Investigational Site

Draper, Utah, United States

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1275.10.01015 Boehringer Ingelheim Investigational Site

Richmond, Virginia, United States

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1275.10.01025 Boehringer Ingelheim Investigational Site

Virginia Beach, Virginia, United States

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1275.10.54005 Boehringer Ingelheim Investigational Site

Caba, , Argentina

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1275.10.54012 Boehringer Ingelheim Investigational Site

Caba, , Argentina

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1275.10.54002 Boehringer Ingelheim Investigational Site

Capital Federal, , Argentina

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1275.10.54007 Boehringer Ingelheim Investigational Site

Capital Federal, , Argentina

Site Status

1275.10.54013 Boehringer Ingelheim Investigational Site

Capital Federal, , Argentina

Site Status

1275.10.54006 Boehringer Ingelheim Investigational Site

Córdoba, , Argentina

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1275.10.54008 Boehringer Ingelheim Investigational Site

Córdoba, , Argentina

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1275.10.54011 Boehringer Ingelheim Investigational Site

Córdoba, , Argentina

Site Status

1275.10.54003 Boehringer Ingelheim Investigational Site

Godoy Cruz, Mendoza, , Argentina

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1275.10.54009 Boehringer Ingelheim Investigational Site

Mar del Plata, , Argentina

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1275.10.54004 Boehringer Ingelheim Investigational Site

Salta, , Argentina

Site Status

1275.10.54001 Boehringer Ingelheim Investigational Site

San Isidro, , Argentina

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1275.10.54010 Boehringer Ingelheim Investigational Site

Zárate, , Argentina

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1275.10.61008 Boehringer Ingelheim Investigational Site

Cardiff, New South Wales, Australia

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1275.10.61002 Boehringer Ingelheim Investigational Site

East Ringwood, Victoria, Australia

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1275.10.61001 Boehringer Ingelheim Investigational Site

Heidelberg Heights, Victoria, Australia

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1275.10.61009 Boehringer Ingelheim Investigational Site

Mirrabooka, Western Australia, Australia

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1275.10.02004 Boehringer Ingelheim Investigational Site

Edmonton, Alberta, Canada

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1275.10.02001 Boehringer Ingelheim Investigational Site

Red Deer, Alberta, Canada

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1275.10.02003 Boehringer Ingelheim Investigational Site

Chilliwack, British Columbia, Canada

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1275.10.02009 Boehringer Ingelheim Investigational Site

Coquitlam, British Columbia, Canada

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1275.10.02012 Boehringer Ingelheim Investigational Site

Vancouver, British Columbia, Canada

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1275.10.02006 Boehringer Ingelheim Investigational Site

Winnipeg, Manitoba, Canada

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1275.10.02008 Boehringer Ingelheim Investigational Site

Winnipeg, Manitoba, Canada

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1275.10.02005 Boehringer Ingelheim Investigational Site

Moncton, New Brunswick, Canada

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1275.10.02013 Boehringer Ingelheim Investigational Site

Burlington, Ontario, Canada

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1275.10.02007 Boehringer Ingelheim Investigational Site

Greater Sudbury, Ontario, Canada

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1275.10.02002 Boehringer Ingelheim Investigational Site

Strathroy, Ontario, Canada

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1275.10.02011 Boehringer Ingelheim Investigational Site

Drummondville, Quebec, Canada

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1275.10.02010 Boehringer Ingelheim Investigational Site

Montreal, Quebec, Canada

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1275.10.34014 Boehringer Ingelheim Investigational Site

Ávila, , El Salvador

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1275.10.49007 Boehringer Ingelheim Investigational Site

Aßlar, , Germany

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1275.10.49014 Boehringer Ingelheim Investigational Site

Berlin, , Germany

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1275.10.49004 Boehringer Ingelheim Investigational Site

Cologne, , Germany

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1275.10.49016 Boehringer Ingelheim Investigational Site

Elsterwerda, , Germany

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1275.10.49012 Boehringer Ingelheim Investigational Site

Hamburg, , Germany

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1275.10.49005 Boehringer Ingelheim Investigational Site

Hatten, , Germany

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1275.10.49008 Boehringer Ingelheim Investigational Site

Kiel Kronshagen, , Germany

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1275.10.49010 Boehringer Ingelheim Investigational Site

Lübeck, , Germany

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1275.10.49003 Boehringer Ingelheim Investigational Site

Münster, , Germany

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1275.10.49006 Boehringer Ingelheim Investigational Site

Pirna, , Germany

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1275.10.49013 Boehringer Ingelheim Investigational Site

Saint Ingbert/Oberwürzbach, , Germany

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1275.10.49001 Boehringer Ingelheim Investigational Site

Unterschneidheim, , Germany

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1275.10.49015 Boehringer Ingelheim Investigational Site

Wangen, , Germany

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1275.10.39005 Boehringer Ingelheim Investigational Site

Ancona, , Italy

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1275.10.39006 Boehringer Ingelheim Investigational Site

Catania, , Italy

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1275.10.39009 Boehringer Ingelheim Investigational Site

Catania, , Italy

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1275.10.39014 Boehringer Ingelheim Investigational Site

Catania, , Italy

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1275.10.39007 Boehringer Ingelheim Investigational Site

Latina, , Italy

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1275.10.39012 Boehringer Ingelheim Investigational Site

Milan, , Italy

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1275.10.39013 Boehringer Ingelheim Investigational Site

Milan, , Italy

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1275.10.39015 Boehringer Ingelheim Investigational Site

Olbia (OT), , Italy

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1275.10.39016 Boehringer Ingelheim Investigational Site

Orbassano (TO), , Italy

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1275.10.39004 Boehringer Ingelheim Investigational Site

Palermo, , Italy

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1275.10.39003 Boehringer Ingelheim Investigational Site

Pistoia, , Italy

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1275.10.39008 Boehringer Ingelheim Investigational Site

Roma, , Italy

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1275.10.39001 Boehringer Ingelheim Investigational Site

Sesto San Giovanni (MI), , Italy

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1275.10.39010 Boehringer Ingelheim Investigational Site

Siena, , Italy

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1275.10.39011 Boehringer Ingelheim Investigational Site

Terni, , Italy

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1275.10.35104 Boehringer Ingelheim Investigational Site

Cantanhede, , Portugal

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1275.10.35112 Boehringer Ingelheim Investigational Site

Porto, , Portugal

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1275.10.35103 Boehringer Ingelheim Investigational Site

Sandim, , Portugal

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1275.10.35105 Boehringer Ingelheim Investigational Site

Tornada, , Portugal

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1275.10.35108 Boehringer Ingelheim Investigational Site

Valadares, , Portugal

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1275.10.35101 Boehringer Ingelheim Investigational Site

Vila Nova de Gaia, , Portugal

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1275.10.07004 Boehringer Ingelheim Investigational Site

Chelyabinsk, , Russia

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1275.10.07003 Boehringer Ingelheim Investigational Site

Saint Petersburg, , Russia

Site Status

1275.10.07006 Boehringer Ingelheim Investigational Site

Saint Petersburg, , Russia

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1275.10.07001 Boehringer Ingelheim Investigational Site

Saratov, , Russia

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1275.10.07005 Boehringer Ingelheim Investigational Site

Saratov, , Russia

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1275.10.07002 Boehringer Ingelheim Investigational Site

Yaroslavl, , Russia

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1275.10.34003 Boehringer Ingelheim Investigational Site

Barcelona, , Spain

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1275.10.34004 Boehringer Ingelheim Investigational Site

Canet de Mar, , Spain

Site Status

1275.10.34008 Boehringer Ingelheim Investigational Site

Centelles, , Spain

Site Status

1275.10.34009 Boehringer Ingelheim Investigational Site

L'Hospitalet de Llobregat (Barcelona), , Spain

Site Status

1275.10.34012 Boehringer Ingelheim Investigational Site

La Roca del Vallès, , Spain

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1275.10.34006 Boehringer Ingelheim Investigational Site

Madrid, , Spain

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1275.10.34011 Boehringer Ingelheim Investigational Site

Mataró, , Spain

Site Status

1275.10.34001 Boehringer Ingelheim Investigational Site

Málaga, , Spain

Site Status

1275.10.34010 Boehringer Ingelheim Investigational Site

Málaga, , Spain

Site Status

1275.10.34013 Boehringer Ingelheim Investigational Site

Pineda de Mar, , Spain

Site Status

1275.10.34002 Boehringer Ingelheim Investigational Site

Sabadell, , Spain

Site Status

1275.10.34005 Boehringer Ingelheim Investigational Site

Tarragona, , Spain

Site Status

1275.10.38006 Boehringer Ingelheim Investigational Site

Chernivtsi, , Ukraine

Site Status

1275.10.38007 Boehringer Ingelheim Investigational Site

Dnipro, , Ukraine

Site Status

1275.10.38002 Boehringer Ingelheim Investigational Site

Kiev, , Ukraine

Site Status

1275.10.38003 Boehringer Ingelheim Investigational Site

Kiev, , Ukraine

Site Status

1275.10.38004 Boehringer Ingelheim Investigational Site

Lviv, , Ukraine

Site Status

1275.10.38001 Boehringer Ingelheim Investigational Site

Vinnitsa, , Ukraine

Site Status

1275.10.38005 Boehringer Ingelheim Investigational Site

Zhytomyr, , Ukraine

Site Status

Countries

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United States Argentina Australia Canada El Salvador Germany Italy Portugal Russia Spain Ukraine

References

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Tinahones FJ, Gallwitz B, Nordaby M, Gotz S, Maldonado-Lutomirsky M, Woerle HJ, Broedl UC. Linagliptin as add-on to empagliflozin and metformin in patients with type 2 diabetes: Two 24-week randomized, double-blind, double-dummy, parallel-group trials. Diabetes Obes Metab. 2017 Feb;19(2):266-274. doi: 10.1111/dom.12814. Epub 2016 Nov 24.

Reference Type DERIVED
PMID: 27762093 (View on PubMed)

Other Identifiers

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2012-002271-34

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

1275.10

Identifier Type: -

Identifier Source: org_study_id

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