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Safety and Efficacy Study of Empagliflozin and Metformin for 24 Weeks in Treatment Naive Patients With Type 2 Diabetes

NCT ID: NCT01719003

Last Updated: 2016-02-19

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

1413 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-10-31

Study Completion Date

2014-12-31

Brief Summary

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This study will investigate the efficacy and safety of two doses (high and low) of empagliflozin in combination with metformin (500 mg and 1000 mg) administered twice daily in patients with type 2 diabetes mellitus (T2DM). Study will compare four dose combinations of empagliflozin + metformin versus each individual component after 24 weeks of treatment.

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Detailed Description

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Conditions

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Diabetes Mellitus, Type 2 Hyperglycemia

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 low dose qd

Empagliflozin low dose once daily

Group Type EXPERIMENTAL

Empagliflozin low dose qd

Intervention Type DRUG

Empagliflozin low dose once daily

Empagliflozin high dose qd

Empagliflozin high dose once daily

Group Type EXPERIMENTAL

Empagliflozin high dose qd

Intervention Type DRUG

Empagliflozin high dose once daily

OL empa high dose + met 1000 mg bid

Open label empagliflozin high dose split twice daily + metformin 1000 mg twice daily - Patients are no longer enrolled into this arm because of change in the inclusion criteria in protocol version 2.0 all patients are now enrolled into remaining double-blind arms. Patients already enrolled in the open-label arm according to protocol version 1.0 can complete the study.

Group Type EXPERIMENTAL

Metformin 1000 mg bid

Intervention Type DRUG

Metformin 1000 mg twice daily

Empagliflozin high dose bid

Intervention Type DRUG

Empagliflozin high dose split twice daily

Empagliflozin low dose + met 500 mg bid

Empagliflozin low dose split twice daily + metformin 500 mg twice daily

Group Type EXPERIMENTAL

Metformin 500 mg bid

Intervention Type DRUG

Metformin 500 mg twice daily

Empagliflozin low dose bid

Intervention Type DRUG

Empagliflozin low dose split twice daily

Empagliflozin low dose + met 1000 mg bid

Empagliflozin low dose split twice daily + metformin 1000 mg twice daily

Group Type EXPERIMENTAL

Empagliflozin low dose bid

Intervention Type DRUG

Empagliflozin low dose split twice daily

Metformin 1000 mg bid

Intervention Type DRUG

Metformin 1000 mg twice daily

Empagliflozin high dose + met 500 mg bid

Empagliflozin high dose split twice daily + metformin 500 mg twice daily

Group Type EXPERIMENTAL

Metformin 500 mg bid

Intervention Type DRUG

Metformin 500 mg twice daily

Empagliflozin high dose bid

Intervention Type DRUG

Empagliflozin high dose split twice daily

Empagliflozin high dose + met 1000mg bid

Empagliflozin high dose split twice daily + metformin 1000 mg twice daily

Group Type EXPERIMENTAL

Metformin 1000 mg bid

Intervention Type DRUG

Metformin 1000 mg twice daily

Empagliflozin high dose bid

Intervention Type DRUG

Empagliflozin high dose split twice daily

Metformin 500 mg bid

Metformin 500 mg twice daily

Group Type EXPERIMENTAL

Metformin 500 mg bid

Intervention Type DRUG

Metformin 500 mg twice daily

Metformin 1000 mg bid

Metformin 1000 mg twice daily

Group Type EXPERIMENTAL

Metformin 1000 mg bid

Intervention Type DRUG

Metformin 1000 mg twice daily

Interventions

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Metformin 500 mg bid

Metformin 500 mg twice daily

Intervention Type DRUG

Metformin 1000 mg bid

Metformin 1000 mg twice daily

Intervention Type DRUG

Empagliflozin low dose qd

Empagliflozin low dose once daily

Intervention Type DRUG

Empagliflozin high dose qd

Empagliflozin high dose once daily

Intervention Type DRUG

Empagliflozin low dose bid

Empagliflozin low dose split twice daily

Intervention Type DRUG

Metformin 500 mg bid

Metformin 500 mg twice daily

Intervention Type DRUG

Empagliflozin high dose bid

Empagliflozin high dose split twice daily

Intervention Type DRUG

Empagliflozin low dose bid

Empagliflozin low dose split twice daily

Intervention Type DRUG

Metformin 1000 mg bid

Metformin 1000 mg twice daily

Intervention Type DRUG

Metformin 500 mg bid

Metformin 500 mg twice daily

Intervention Type DRUG

Metformin 1000 mg bid

Metformin 1000 mg twice daily

Intervention Type DRUG

Empagliflozin high dose bid

Empagliflozin high dose split twice daily

Intervention Type DRUG

Metformin 1000 mg bid

Metformin 1000 mg twice daily

Intervention Type DRUG

Empagliflozin high dose bid

Empagliflozin high dose split twice daily

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Diagnosis of type 2 diabetes mellitus prior to informed consent
2. Male and female patients on diet and exercise regimen who are drug-naive, defined as absence of any oral antidiabetic therapy for 12 weeks prior to randomization
3. HbA1c \>=7.5% and \<= 12% (\>=58.5 mmol/mol and \<=107.7 mmol/mol)
4. Body Mass Index (BMI) \<= 45 kg/m2 at screening

Exclusion Criteria

1. Uncontrolled hyperglycemia with a glucose level \>240 mg/dl (\>13.3 mmol/L) after an overnight fast during placebo run-in and confirmed by a second laboratory measurement (not on the same day)
2. Any antidiabetic drug within 12 weeks prior to randomization
3. Impaired renal function, defined as estimated creatinine clearance rate (eCCr) \<60 ml/min (Cockcroft-Gault formula) as determined during screening and/or run-in period
4. Contraindications to metformin according to the local label
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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1276.1.10014 Boehringer Ingelheim Investigational Site

Birmingham, Alabama, United States

Site Status

1276.1.10019 Boehringer Ingelheim Investigational Site

Birmingham, Alabama, United States

Site Status

1276.1.10044 Boehringer Ingelheim Investigational Site

Manley Hot Springs, Alaska, United States

Site Status

1276.1.10010 Boehringer Ingelheim Investigational Site

Glendale, Arizona, United States

Site Status

1276.1.10035 Boehringer Ingelheim Investigational Site

Searcy, Arkansas, United States

Site Status

1276.1.10046 Boehringer Ingelheim Investigational Site

Chula Vista, California, United States

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1276.1.10006 Boehringer Ingelheim Investigational Site

Huntington Beach, California, United States

Site Status

1276.1.10043 Boehringer Ingelheim Investigational Site

La Mesa, California, United States

Site Status

1276.1.10009 Boehringer Ingelheim Investigational Site

Los Angeles, California, United States

Site Status

1276.1.10040 Boehringer Ingelheim Investigational Site

Los Angeles, California, United States

Site Status

1276.1.10045 Boehringer Ingelheim Investigational Site

Oceanside, California, United States

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1276.1.10042 Boehringer Ingelheim Investigational Site

Colorado Springs, Colorado, United States

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1276.1.10001 Boehringer Ingelheim Investigational Site

Denver, Colorado, United States

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1276.1.10003 Boehringer Ingelheim Investigational Site

Northglenn, Colorado, United States

Site Status

1276.1.10026 Boehringer Ingelheim Investigational Site

Fort Lauderdale, Florida, United States

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1276.1.10024 Boehringer Ingelheim Investigational Site

Oldsmar, Florida, United States

Site Status

1276.1.10027 Boehringer Ingelheim Investigational Site

Port Orange, Florida, United States

Site Status

1276.1.10023 Boehringer Ingelheim Investigational Site

Marietta, Georgia, United States

Site Status

1276.1.10034 Boehringer Ingelheim Investigational Site

Evansville, Indiana, United States

Site Status

1276.1.10032 Boehringer Ingelheim Investigational Site

Fall River, Massachusetts, United States

Site Status

1276.1.10036 Boehringer Ingelheim Investigational Site

Bridgman, Michigan, United States

Site Status

1276.1.10037 Boehringer Ingelheim Investigational Site

Hazelwood, Missouri, United States

Site Status

1276.1.10007 Boehringer Ingelheim Investigational Site

Las Vegas, Nevada, United States

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1276.1.10015 Boehringer Ingelheim Investigational Site

Union, New Jersey, United States

Site Status

1276.1.10033 Boehringer Ingelheim Investigational Site

Asheboro, North Carolina, United States

Site Status

1276.1.10022 Boehringer Ingelheim Investigational Site

Burlington, North Carolina, United States

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1276.1.10002 Boehringer Ingelheim Investigational Site

Lenoir, North Carolina, United States

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1276.1.10005 Boehringer Ingelheim Investigational Site

Cincinnati, Ohio, United States

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1276.1.10011 Boehringer Ingelheim Investigational Site

Gallipolis, Ohio, United States

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1276.1.10030 Boehringer Ingelheim Investigational Site

Columbia, South Carolina, United States

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1276.1.10008 Boehringer Ingelheim Investigational Site

Greer, South Carolina, United States

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1276.1.10013 Boehringer Ingelheim Investigational Site

Hodges, South Carolina, United States

Site Status

1276.1.10017 Boehringer Ingelheim Investigational Site

Humboldt, Tennessee, United States

Site Status

1276.1.10018 Boehringer Ingelheim Investigational Site

Houston, Texas, United States

Site Status

1276.1.10025 Boehringer Ingelheim Investigational Site

Houston, Texas, United States

Site Status

1276.1.10028 Boehringer Ingelheim Investigational Site

Houston, Texas, United States

Site Status

1276.1.10016 Boehringer Ingelheim Investigational Site

Kingwood, Texas, United States

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1276.1.10021 Boehringer Ingelheim Investigational Site

San Antonio, Texas, United States

Site Status

1276.1.10041 Boehringer Ingelheim Investigational Site

San Antonio, Texas, United States

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1276.1.10004 Boehringer Ingelheim Investigational Site

Manassas, Virginia, United States

Site Status

1276.1.10012 Boehringer Ingelheim Investigational Site

Wenatchee, Washington, United States

Site Status

1276.1.55008 Boehringer Ingelheim Investigational Site

Belém, , Brazil

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1276.1.55003 Boehringer Ingelheim Investigational Site

Brasília, , Brazil

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1276.1.55006 Boehringer Ingelheim Investigational Site

Fortaleza, , Brazil

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1276.1.55007 Boehringer Ingelheim Investigational Site

Fortaleza, , Brazil

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1276.1.55009 Boehringer Ingelheim Investigational Site

Fortaleza, , Brazil

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1276.1.55004 Boehringer Ingelheim Investigational Site

Goiânia, , Brazil

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1276.1.55002 Boehringer Ingelheim Investigational Site

Porto Alegre, , Brazil

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1276.1.55001 Boehringer Ingelheim Investigational Site

São Paulo, , Brazil

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1276.1.20003 Boehringer Ingelheim Investigational Site

Coquitlam, British Columbia, Canada

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1276.1.20012 Boehringer Ingelheim Investigational Site

Coquitlam, British Columbia, Canada

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1276.1.20008 Boehringer Ingelheim Investigational Site

Victoria, British Columbia, Canada

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1276.1.20004 Boehringer Ingelheim Investigational Site

Antigonish, Nova Scotia, Canada

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1276.1.20005 Boehringer Ingelheim Investigational Site

Hawkesbury, Ontario, Canada

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1276.1.20013 Boehringer Ingelheim Investigational Site

Sarnia, Ontario, Canada

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1276.1.20010 Boehringer Ingelheim Investigational Site

Strathroy, Ontario, Canada

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1276.1.20006 Boehringer Ingelheim Investigational Site

Thornhill, Ontario, Canada

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1276.1.20007 Boehringer Ingelheim Investigational Site

Mirabel, Quebec, Canada

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1276.1.20002 Boehringer Ingelheim Investigational Site

Québec, Quebec, Canada

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1276.1.20001 Boehringer Ingelheim Investigational Site

Saskatoon, Saskatchewan, Canada

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1276.1.42002 Boehringer Ingelheim Investigational Site

Benátky nad Jizerou, , Czechia

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1276.1.42008 Boehringer Ingelheim Investigational Site

Olomouc, , Czechia

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1276.1.42007 Boehringer Ingelheim Investigational Site

Ostrava, , Czechia

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1276.1.42009 Boehringer Ingelheim Investigational Site

Pilsen, , Czechia

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1276.1.42003 Boehringer Ingelheim Investigational Site

Prague, , Czechia

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1276.1.42004 Boehringer Ingelheim Investigational Site

Prague, , Czechia

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1276.1.42010 Boehringer Ingelheim Investigational Site

Prague, , Czechia

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1276.1.95001 Boehringer Ingelheim Investigational Site

Abbasia Cairo, Egypt, , Egypt

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1276.1.95003 Boehringer Ingelheim Investigational Site

Al Manial, Cairo, Egypt, , Egypt

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1276.1.95004 Boehringer Ingelheim Investigational Site

Alexandria, , Egypt

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1276.1.95002 Boehringer Ingelheim Investigational Site

El Darasa Cairo Egypt, , Egypt

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1276.1.33004 Boehringer Ingelheim Investigational Site

Behren-lès-Forbach, , France

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1276.1.33012 Boehringer Ingelheim Investigational Site

Bersée, , France

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1276.1.33005 Boehringer Ingelheim Investigational Site

Cournonterral, , France

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1276.1.33007 Boehringer Ingelheim Investigational Site

Hautmont, , France

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1276.1.33013 Boehringer Ingelheim Investigational Site

Paris, , France

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1276.1.33001 Boehringer Ingelheim Investigational Site

Poitiers, , France

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1276.1.33006 Boehringer Ingelheim Investigational Site

Saint-Génis-des-Fontaines, , France

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1276.1.33003 Boehringer Ingelheim Investigational Site

Savonnières, , France

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1276.1.33002 Boehringer Ingelheim Investigational Site

Thouars, , France

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1276.1.33011 Boehringer Ingelheim Investigational Site

Thun-Saint-Amand, , France

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1276.1.33010 Boehringer Ingelheim Investigational Site

Tours, , France

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1276.1.33009 Boehringer Ingelheim Investigational Site

Vandome, , France

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1276.1.33008 Boehringer Ingelheim Investigational Site

Vieux-Condé, , France

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1276.1.49005 Boehringer Ingelheim Investigational Site

Berlin, , Germany

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1276.1.49008 Boehringer Ingelheim Investigational Site

Celle, , Germany

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1276.1.49006 Boehringer Ingelheim Investigational Site

Dortmund, , Germany

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1276.1.49011 Boehringer Ingelheim Investigational Site

Dresden, , Germany

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1276.1.49003 Boehringer Ingelheim Investigational Site

Essen, , Germany

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1276.1.49007 Boehringer Ingelheim Investigational Site

Ingelheim, , Germany

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1276.1.49014 Boehringer Ingelheim Investigational Site

Neuwied, , Germany

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1276.1.49004 Boehringer Ingelheim Investigational Site

Offenbach, , Germany

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1276.1.49002 Boehringer Ingelheim Investigational Site

Stuhr-Brinkum, , Germany

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1276.1.49012 Boehringer Ingelheim Investigational Site

Teuchern, , Germany

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1276.1.50002 Boehringer Ingelheim Investigational Site

Barbena Santa Rosa, , Guatemala

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1276.1.50003 Boehringer Ingelheim Investigational Site

Guatemala City, , Guatemala

Site Status

1276.1.50005 Boehringer Ingelheim Investigational Site

Guatemala City, , Guatemala

Site Status

1276.1.50006 Boehringer Ingelheim Investigational Site

Guatemala City, , Guatemala

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1276.1.50001 Boehringer Ingelheim Investigational Site

Quetzaltenango, , Guatemala

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1276.1.96001 Boehringer Ingelheim Investigational Site

Beirut, , Lebanon

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1276.1.96002 Boehringer Ingelheim Investigational Site

El Chouf, , Lebanon

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1276.1.96003 Boehringer Ingelheim Investigational Site

Saida, , Lebanon

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1276.1.96004 Boehringer Ingelheim Investigational Site

Saida, , Lebanon

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1276.1.60002 Boehringer Ingelheim Investigational Site

Ipoh, Perak, , Malaysia

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1276.1.60001 Boehringer Ingelheim Investigational Site

Johor Bahru, , Malaysia

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1276.1.60003 Boehringer Ingelheim Investigational Site

Kubang Kerian, , Malaysia

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1276.1.52004 Boehringer Ingelheim Investigational Site

Aguascalientes, , Mexico

Site Status

1276.1.52007 Boehringer Ingelheim Investigational Site

Aguascalientes, , Mexico

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1276.1.52003 Boehringer Ingelheim Investigational Site

Guadalajara, , Mexico

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1276.1.52002 Boehringer Ingelheim Investigational Site

Mexico City, , Mexico

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1276.1.52001 Boehringer Ingelheim Investigational Site

Monterrey, , Mexico

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1276.1.52006 Boehringer Ingelheim Investigational Site

San Lucas Tepetlcalco, , Mexico

Site Status

1276.1.52005 Boehringer Ingelheim Investigational Site

Zapopan, , Mexico

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1276.1.51001 Boehringer Ingelheim Investigational Site

Lima, , Peru

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1276.1.51002 Boehringer Ingelheim Investigational Site

Lima, , Peru

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1276.1.51003 Boehringer Ingelheim Investigational Site

Lima, , Peru

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1276.1.51004 Boehringer Ingelheim Investigational Site

Lima, , Peru

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1276.1.51005 Boehringer Ingelheim Investigational Site

Lima, , Peru

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1276.1.63009 Boehringer Ingelheim Investigational Site

Cebu City, Cebu, , Philippines

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1276.1.63002 Boehringer Ingelheim Investigational Site

Cebu City, Philippines, , Philippines

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1276.1.63004 Boehringer Ingelheim Investigational Site

Davao City, , Philippines

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1276.1.63003 Boehringer Ingelheim Investigational Site

Iloilo City, , Philippines

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1276.1.63006 Boehringer Ingelheim Investigational Site

Manila, , Philippines

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1276.1.63001 Boehringer Ingelheim Investigational Site

Marikina City, , Philippines

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1276.1.63005 Boehringer Ingelheim Investigational Site

Maybunga, Pasig City, , Philippines

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1276.1.63007 Boehringer Ingelheim Investigational Site

San Juan City, , Philippines

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1276.1.63008 Boehringer Ingelheim Investigational Site

Tarlac City, , Philippines

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1276.1.70012 Boehringer Ingelheim Investigational Site

Barnaul, , Russia

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1276.1.70011 Boehringer Ingelheim Investigational Site

Kemerovo, , Russia

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1276.1.70015 Boehringer Ingelheim Investigational Site

Novosibirsk, , Russia

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1276.1.70016 Boehringer Ingelheim Investigational Site

Novosibirsk, , Russia

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1276.1.70018 Boehringer Ingelheim Investigational Site

Novosibirsk, , Russia

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1276.1.70007 Boehringer Ingelheim Investigational Site

Petrozavodsk, , Russia

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1276.1.70005 Boehringer Ingelheim Investigational Site

Saint Petersburg, , Russia

Site Status

1276.1.70006 Boehringer Ingelheim Investigational Site

Saint Petersburg, , Russia

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1276.1.70017 Boehringer Ingelheim Investigational Site

Saint Petersburg, , Russia

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1276.1.70009 Boehringer Ingelheim Investigational Site

Saratov, , Russia

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1276.1.70010 Boehringer Ingelheim Investigational Site

Smolensk, , Russia

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1276.1.70013 Boehringer Ingelheim Investigational Site

Yaroslavl, , Russia

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1276.1.38104 Boehringer Ingelheim Investigational Site

Belgrade, , Serbia

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1276.1.38105 Boehringer Ingelheim Investigational Site

Belgrade, , Serbia

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1276.1.38106 Boehringer Ingelheim Investigational Site

Belgrade, , Serbia

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1276.1.38107 Boehringer Ingelheim Investigational Site

Belgrade, , Serbia

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1276.1.38103 Boehringer Ingelheim Investigational Site

Kragujevac, , Serbia

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1276.1.38101 Boehringer Ingelheim Investigational Site

Niš, , Serbia

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1276.1.38108 Boehringer Ingelheim Investigational Site

Novi Sad, , Serbia

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1276.1.38102 Boehringer Ingelheim Investigational Site

Zaječar, , Serbia

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1276.1.82006 Boehringer Ingelheim Investigational Site

Deagu, , South Korea

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1276.1.82010 Boehringer Ingelheim Investigational Site

Goyang, , South Korea

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1276.1.82001 Boehringer Ingelheim Investigational Site

Incheon, , South Korea

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1276.1.82009 Boehringer Ingelheim Investigational Site

Pusan, , South Korea

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1276.1.82002 Boehringer Ingelheim Investigational Site

Seoul, , South Korea

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1276.1.82004 Boehringer Ingelheim Investigational Site

Seoul, , South Korea

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1276.1.82005 Boehringer Ingelheim Investigational Site

Seoul, , South Korea

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1276.1.82007 Boehringer Ingelheim Investigational Site

Seoul, , South Korea

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1276.1.82008 Boehringer Ingelheim Investigational Site

Seoul, , South Korea

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1276.1.82003 Boehringer Ingelheim Investigational Site

Wŏnju, , South Korea

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1276.1.34048 Boehringer Ingelheim Investigational Site

Alicante, , Spain

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1276.1.34050 Boehringer Ingelheim Investigational Site

Alzira, , Spain

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1276.1.34028 Boehringer Ingelheim Investigational Site

Madrid, , Spain

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1276.1.34045 Boehringer Ingelheim Investigational Site

Pozuelo de Alarcón, , Spain

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1276.1.34034 Boehringer Ingelheim Investigational Site

Sabadell (Barcelona), , Spain

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1276.1.34027 Boehringer Ingelheim Investigational Site

Salamanca, , Spain

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1276.1.34052 Boehringer Ingelheim Investigational Site

Tarragona, , Spain

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1276.1.34051 Boehringer Ingelheim Investigational Site

Zaragoza, , Spain

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1276.1.88005 Boehringer Ingelheim Investigational Site

Kaohsiung City, , Taiwan

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1276.1.88002 Boehringer Ingelheim Investigational Site

New Taipei City, , Taiwan

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1276.1.88001 Boehringer Ingelheim Investigational Site

Taichung, , Taiwan

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1276.1.88003 Boehringer Ingelheim Investigational Site

Taichung, , Taiwan

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1276.1.88004 Boehringer Ingelheim Investigational Site

Taichung, , Taiwan

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1276.1.88006 Boehringer Ingelheim Investigational Site

Taipei, , Taiwan

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1276.1.66001 Boehringer Ingelheim Investigational Site

Bangkok, Thailand, , Thailand

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1276.1.66003 Boehringer Ingelheim Investigational Site

Bangkok, Thailand, , Thailand

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1276.1.66002 Boehringer Ingelheim Investigational Site

Nakhon Ratchasima, , Thailand

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1276.1.90003 Boehringer Ingelheim Investigational Site

Ankara, , Turkey (Türkiye)

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1276.1.90004 Boehringer Ingelheim Investigational Site

Antalya, , Turkey (Türkiye)

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1276.1.90006 Boehringer Ingelheim Investigational Site

Denizli, , Turkey (Türkiye)

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1276.1.90002 Boehringer Ingelheim Investigational Site

Erzurum, , Turkey (Türkiye)

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1276.1.90005 Boehringer Ingelheim Investigational Site

Istanbul, , Turkey (Türkiye)

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1276.1.90001 Boehringer Ingelheim Investigational Site

Izmir, , Turkey (Türkiye)

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1276.1.44002 Boehringer Ingelheim Investigational Site

Bolton, , United Kingdom

Site Status

1276.1.44001 Boehringer Ingelheim Investigational Site

Bradford-on-Avon, , United Kingdom

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1276.1.44005 Boehringer Ingelheim Investigational Site

Chippenham, , United Kingdom

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1276.1.44006 Boehringer Ingelheim Investigational Site

Dagenham, , United Kingdom

Site Status

1276.1.44004 Boehringer Ingelheim Investigational Site

Doncaster, , United Kingdom

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1276.1.44008 Boehringer Ingelheim Investigational Site

Glasgow, , United Kingdom

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1276.1.44003 Boehringer Ingelheim Investigational Site

Leeds, , United Kingdom

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1276.1.44007 Boehringer Ingelheim Investigational Site

Manchester, , United Kingdom

Site Status

1276.1.44011 Boehringer Ingelheim Investigational Site

Mortimer, , United Kingdom

Site Status

1276.1.44009 Boehringer Ingelheim Investigational Site

Sandbach, , United Kingdom

Site Status

Countries

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United States Brazil Canada Czechia Egypt France Germany Guatemala Lebanon Malaysia Mexico Peru Philippines Russia Serbia South Korea Spain Taiwan Thailand Turkey (Türkiye) United Kingdom

References

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Hadjadj S, Rosenstock J, Meinicke T, Woerle HJ, Broedl UC. Initial Combination of Empagliflozin and Metformin in Patients With Type 2 Diabetes. Diabetes Care. 2016 Oct;39(10):1718-28. doi: 10.2337/dc16-0522. Epub 2016 Aug 4.

Reference Type DERIVED
PMID: 27493136 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2010-021375-92

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

1276.1

Identifier Type: -

Identifier Source: org_study_id

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