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A 16 Weeks Study on Efficacy and Safety of Two Doses of Empagliflozin (BI 10773) (Once Daily Versus Twice Daily) in Patients With Type 2 Diabetes Mellitus and Preexisting Metformin Therapy

NCT ID: NCT01649297

Last Updated: 2015-07-23

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

983 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-10-31

Study Completion Date

2013-12-31

Brief Summary

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The aim of this study is to investigate the efficacy and safety of two doses (high and low) of empagliflozin as add-on therapy to metformin in patients with type 2 diabetes mellitus (T2DM) and insufficient glycaemic control. Both doses may be given once daily or split to a twice daily dosage. This results in 4 different dosage regimens of empagliflozin (high dose once daily or split vs. low dose once daily or split). This is done to evaluate whether a twice daily dose regimen of empagliflozin results in a loss of efficacy relative to once daily dosing when given on top of metformin background therapy.

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

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Efficacy and Safety of Empagliflozin (BI 10773) With Metformin in Patients With Type 2 Diabetes

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Efficacy and Safety of Empagliflozin (BI 10773) / Linagliptin (BI 1356) Fixed Dose Combination in Treatment naïve and Metformin Treated Type 2 Diabetes Patients

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Diabetes Mellitus, Type 2
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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 (high dose qd)

Patients receive Empagliflozin high dose once daily

Group Type EXPERIMENTAL

Placebo

Intervention Type DRUG

Patients receive placebo matching empagliflozin (low dose qd)

Placebo

Intervention Type DRUG

Patients receive placebo matching Empagliflozin (high dose bid)

Placebo

Intervention Type DRUG

Patients receive placebo matching empagliflozin (low dose bid)

Empagliflozin (high dose qd)

Intervention Type DRUG

Patients receive Empagliflozin high dose once daily

empagliflozin (high dose bid)

Patients receive Empagliflozin high dose split twice daily

Group Type EXPERIMENTAL

Placebo

Intervention Type DRUG

Patients receive placebo matching Empagliflozin (high dose qd)

Placebo

Intervention Type DRUG

Patients receive placebo matching empagliflozin (low dose qd)

Placebo

Intervention Type DRUG

Patients receive placebo matching empagliflozin (low dose bid)

empagliflozin (high dose bid)

Intervention Type DRUG

Patients receive Empagliflozin high dose split twice daily

empagliflozin (low dose qd)

Patients receive Empagliflozin low dose once daily

Group Type EXPERIMENTAL

empagliflozin (low dose qd)

Intervention Type DRUG

Patients receive Empagliflozin low dose once daily

Placebo

Intervention Type DRUG

Patients receive placebo matching empagliflozin (low dose bid)

Placebo

Intervention Type DRUG

Patients receive placebo matching Empagliflozin (high dose bid)

Placebo

Intervention Type DRUG

Patients receive placebo matching Empagliflozin (high dose qd)

empagliflozin (low dose bid)

Patients receive Empagliflozin low dose split twice daily

Group Type EXPERIMENTAL

Placebo

Intervention Type DRUG

Patients receive placebo matching Empagliflozin (high dose qd)

Placebo

Intervention Type DRUG

Patients receive placebo matching empagliflozin (low dose qd)

Placebo

Intervention Type DRUG

Patients receive placebo matching Empagliflozin (high dose bid)

empagliflozin (low dose bid)

Intervention Type DRUG

Patients receive Empagliflozin low dose split twice daily

Placebo

Patients receive placebo matching Empagliflozin

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Patients receive placebo matching empagliflozin (low dose bid)

Placebo

Intervention Type DRUG

Patients receive placebo matching Empagliflozin (high dose qd)

Placebo

Intervention Type DRUG

Patients receive placebo matching Empagliflozin (high dose bid)

Placebo

Intervention Type DRUG

Patients receive placebo matching empagliflozin (low dose qd)

Interventions

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Placebo

Patients receive placebo matching empagliflozin (low dose qd)

Intervention Type DRUG

Placebo

Patients receive placebo matching empagliflozin (low dose bid)

Intervention Type DRUG

Placebo

Patients receive placebo matching Empagliflozin (high dose qd)

Intervention Type DRUG

Placebo

Patients receive placebo matching Empagliflozin (high dose qd)

Intervention Type DRUG

Placebo

Patients receive placebo matching Empagliflozin (high dose qd)

Intervention Type DRUG

empagliflozin (low dose qd)

Patients receive Empagliflozin low dose once daily

Intervention Type DRUG

Placebo

Patients receive placebo matching empagliflozin (low dose qd)

Intervention Type DRUG

Placebo

Patients receive placebo matching empagliflozin (low dose bid)

Intervention Type DRUG

Placebo

Patients receive placebo matching Empagliflozin (high dose bid)

Intervention Type DRUG

Placebo

Patients receive placebo matching Empagliflozin (high dose bid)

Intervention Type DRUG

Placebo

Patients receive placebo matching empagliflozin (low dose qd)

Intervention Type DRUG

Placebo

Patients receive placebo matching empagliflozin (low dose bid)

Intervention Type DRUG

Placebo

Patients receive placebo matching Empagliflozin (high dose bid)

Intervention Type DRUG

Placebo

Patients receive placebo matching empagliflozin (low dose qd)

Intervention Type DRUG

Placebo

Patients receive placebo matching empagliflozin (low dose bid)

Intervention Type DRUG

Placebo

Patients receive placebo matching Empagliflozin (high dose bid)

Intervention Type DRUG

Empagliflozin (high dose qd)

Patients receive Empagliflozin high dose once daily

Intervention Type DRUG

empagliflozin (high dose bid)

Patients receive Empagliflozin high dose split twice daily

Intervention Type DRUG

Placebo

Patients receive placebo matching Empagliflozin (high dose qd)

Intervention Type DRUG

empagliflozin (low dose bid)

Patients receive Empagliflozin low dose split twice daily

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. confirmed diagnosis of T2DM
2. Glycated hemoglobin (HbA1c) \>=7.0 and \<=10/0% at Visit 1
3. Metformin therapy (at least 1500 mg/day, BID)
4. age\>=18 at Visit 1
5. body mass index \<=45 kg/m2

Exclusion Criteria

1. estimated creatinine clearance rate (eCCr) \<60 ml/min (Cockcroft-Gault formula) screening and/or run-in
2. a confirmed glucose level \>240 mg/dl (\>13.3 mmol/L) after an overnight fast during placebo run-in
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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1276.10.11036 Boehringer Ingelheim Investigational Site

Florence, Alabama, United States

Site Status

1276.10.11049 Boehringer Ingelheim Investigational Site

Jonesboro, Arkansas, United States

Site Status

1276.10.11040 Boehringer Ingelheim Investigational Site

Lomita, California, United States

Site Status

1276.10.11033 Boehringer Ingelheim Investigational Site

Los Angeles, California, United States

Site Status

1276.10.11002 Boehringer Ingelheim Investigational Site

Rancho Cucamonga, California, United States

Site Status

1276.10.11050 Boehringer Ingelheim Investigational Site

Sacramento, California, United States

Site Status

1276.10.11015 Boehringer Ingelheim Investigational Site

West Hills, California, United States

Site Status

1276.10.11012 Boehringer Ingelheim Investigational Site

Norwalk, Connecticut, United States

Site Status

1276.10.11047 Boehringer Ingelheim Investigational Site

Waterbury, Connecticut, United States

Site Status

1276.10.11010 Boehringer Ingelheim Investigational Site

Bradenton, Florida, United States

Site Status

1276.10.11005 Boehringer Ingelheim Investigational Site

Davie, Florida, United States

Site Status

1276.10.11004 Boehringer Ingelheim Investigational Site

Jacksonville, Florida, United States

Site Status

1276.10.11051 Boehringer Ingelheim Investigational Site

Miami, Florida, United States

Site Status

1276.10.11009 Boehringer Ingelheim Investigational Site

Oakland Park, Florida, United States

Site Status

1276.10.11044 Boehringer Ingelheim Investigational Site

Palm Harbor, Florida, United States

Site Status

1276.10.11030 Boehringer Ingelheim Investigational Site

Dunwoody, Georgia, United States

Site Status

1276.10.11027 Boehringer Ingelheim Investigational Site

Chicago, Illinois, United States

Site Status

1276.10.11020 Boehringer Ingelheim Investigational Site

Elwood, Indiana, United States

Site Status

1276.10.11001 Boehringer Ingelheim Investigational Site

Bangor, Maine, United States

Site Status

1276.10.11048 Boehringer Ingelheim Investigational Site

Sterling Heights, Michigan, United States

Site Status

1276.10.11058 Boehringer Ingelheim Investigational Site

Jackson, Mississippi, United States

Site Status

1276.10.11055 Boehringer Ingelheim Investigational Site

Edison, New Jersey, United States

Site Status

1276.10.11011 Boehringer Ingelheim Investigational Site

Brooklyn, New York, United States

Site Status

1276.10.11035 Boehringer Ingelheim Investigational Site

North Myrtle Beach, North Carolina, United States

Site Status

1276.10.11041 Boehringer Ingelheim Investigational Site

Winston-Salem, North Carolina, United States

Site Status

1276.10.11018 Boehringer Ingelheim Investigational Site

Cincinnati, Ohio, United States

Site Status

1276.10.11043 Boehringer Ingelheim Investigational Site

Dayton, Ohio, United States

Site Status

1276.10.11017 Boehringer Ingelheim Investigational Site

Kettering, Ohio, United States

Site Status

1276.10.11022 Boehringer Ingelheim Investigational Site

Fleetwood, Pennsylvania, United States

Site Status

1276.10.11003 Boehringer Ingelheim Investigational Site

Johnson City, Tennessee, United States

Site Status

1276.10.11042 Boehringer Ingelheim Investigational Site

Corpus Christi, Texas, United States

Site Status

1276.10.11013 Boehringer Ingelheim Investigational Site

Dallas, Texas, United States

Site Status

1276.10.11026 Boehringer Ingelheim Investigational Site

Houston, Texas, United States

Site Status

1276.10.11031 Boehringer Ingelheim Investigational Site

Houston, Texas, United States

Site Status

1276.10.11034 Boehringer Ingelheim Investigational Site

Houston, Texas, United States

Site Status

1276.10.11028 Boehringer Ingelheim Investigational Site

Pearland, Texas, United States

Site Status

1276.10.11029 Boehringer Ingelheim Investigational Site

San Antonio, Texas, United States

Site Status

1276.10.11016 Boehringer Ingelheim Investigational Site

Port Orchard, Washington, United States

Site Status

1276.10.11024 Boehringer Ingelheim Investigational Site

Spokane, Washington, United States

Site Status

1276.10.61002 Boehringer Ingelheim Investigational Site

Wollongong, New South Wales, Australia

Site Status

1276.10.61001 Boehringer Ingelheim Investigational Site

Box Hill, Victoria, Australia

Site Status

1276.10.20008 Boehringer Ingelheim Investigational Site

Calgary, Alberta, Canada

Site Status

1276.10.20005 Boehringer Ingelheim Investigational Site

Surrey, British Columbia, Canada

Site Status

1276.10.20010 Boehringer Ingelheim Investigational Site

Winnipeg, Manitoba, Canada

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1276.10.20002 Boehringer Ingelheim Investigational Site

Bathurst, New Brunswick, Canada

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1276.10.20001 Boehringer Ingelheim Investigational Site

Brampton, Ontario, Canada

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1276.10.20007 Boehringer Ingelheim Investigational Site

Corunna, Ontario, Canada

Site Status

1276.10.20006 Boehringer Ingelheim Investigational Site

Sarnia, Ontario, Canada

Site Status

1276.10.20004 Boehringer Ingelheim Investigational Site

Drummondville, Quebec, Canada

Site Status

1276.10.20003 Boehringer Ingelheim Investigational Site

Point Claire, Quebec, Canada

Site Status

1276.10.20009 Boehringer Ingelheim Investigational Site

Victoriaville, Quebec, Canada

Site Status

1276.10.37203 Boehringer Ingelheim Investigational Site

Pärnu, , Estonia

Site Status

1276.10.37201 Boehringer Ingelheim Investigational Site

Tallinn, , Estonia

Site Status

1276.10.37202 Boehringer Ingelheim Investigational Site

Tallinn, , Estonia

Site Status

1276.10.37204 Boehringer Ingelheim Investigational Site

Viljandi County, , Estonia

Site Status

1276.10.33002 Boehringer Ingelheim Investigational Site

Aire-sur-l'Adour, , France

Site Status

1276.10.33003 Boehringer Ingelheim Investigational Site

Bischheim, , France

Site Status

1276.10.33009 Boehringer Ingelheim Investigational Site

Bourg-des-Comptes, , France

Site Status

1276.10.33014 Boehringer Ingelheim Investigational Site

Bourges, , France

Site Status

1276.10.33007 Boehringer Ingelheim Investigational Site

Broglie, , France

Site Status

1276.10.33001 Boehringer Ingelheim Investigational Site

Mont-de-Marsan, , France

Site Status

1276.10.33008 Boehringer Ingelheim Investigational Site

Paris, , France

Site Status

1276.10.33006 Boehringer Ingelheim Investigational Site

Saint Vinecnt de Tyrosse, , France

Site Status

1276.10.33011 Boehringer Ingelheim Investigational Site

Segré, , France

Site Status

1276.10.33004 Boehringer Ingelheim Investigational Site

Strasbourg, , France

Site Status

1276.10.99501 Boehringer Ingelheim Investigational Site

Tbilisi, , Georgia

Site Status

1276.10.99502 Boehringer Ingelheim Investigational Site

Tbilisi, , Georgia

Site Status

1276.10.99503 Boehringer Ingelheim Investigational Site

Tbilisi, , Georgia

Site Status

1276.10.99504 Boehringer Ingelheim Investigational Site

Tbilisi, , Georgia

Site Status

1276.10.99505 Boehringer Ingelheim Investigational Site

Tbilisi, , Georgia

Site Status

1276.10.99506 Boehringer Ingelheim Investigational Site

Tbilisi, , Georgia

Site Status

1276.10.49001 Boehringer Ingelheim Investigational Site

Aschaffenburg, , Germany

Site Status

1276.10.49006 Boehringer Ingelheim Investigational Site

Berlin, , Germany

Site Status

1276.10.49007 Boehringer Ingelheim Investigational Site

Berlin, , Germany

Site Status

1276.10.49005 Boehringer Ingelheim Investigational Site

Essen, , Germany

Site Status

1276.10.49004 Boehringer Ingelheim Investigational Site

Frankfurt, , Germany

Site Status

1276.10.49002 Boehringer Ingelheim Investigational Site

Nuremberg, , Germany

Site Status

1276.10.49003 Boehringer Ingelheim Investigational Site

Rehlingen-Siersburg, , Germany

Site Status

1276.10.50201 Boehringer Ingelheim Investigational Site

Guatemala Ciudad, , Guatemala

Site Status

1276.10.50203 Boehringer Ingelheim Investigational Site

Guatemala Ciudad, , Guatemala

Site Status

1276.10.50204 Boehringer Ingelheim Investigational Site

Guatemala Ciudad, , Guatemala

Site Status

1276.10.50205 Boehringer Ingelheim Investigational Site

Guatemala Ciudad, , Guatemala

Site Status

1276.10.50202 Boehringer Ingelheim Investigational Site

Quetzaltenango Ciudad, , Guatemala

Site Status

1276.10.39004 Boehringer Ingelheim Investigational Site

Arenzano (GE), , Italy

Site Status

1276.10.39003 Boehringer Ingelheim Investigational Site

Bologna, , Italy

Site Status

1276.10.39007 Boehringer Ingelheim Investigational Site

Catanzaro, , Italy

Site Status

1276.10.39009 Boehringer Ingelheim Investigational Site

Catanzaro, , Italy

Site Status

1276.10.39002 Boehringer Ingelheim Investigational Site

Napoli, , Italy

Site Status

1276.10.39006 Boehringer Ingelheim Investigational Site

Palermo, , Italy

Site Status

1276.10.39001 Boehringer Ingelheim Investigational Site

Roma, , Italy

Site Status

1276.10.39008 Boehringer Ingelheim Investigational Site

Roma, , Italy

Site Status

1276.10.39005 Boehringer Ingelheim Investigational Site

Torino, , Italy

Site Status

1276.10.37102 Boehringer Ingelheim Investigational Site

Daugavpils, , Latvia

Site Status

1276.10.37104 Boehringer Ingelheim Investigational Site

Ogre, , Latvia

Site Status

1276.10.37101 Boehringer Ingelheim Investigational Site

Riga, , Latvia

Site Status

1276.10.37103 Boehringer Ingelheim Investigational Site

Tukums, , Latvia

Site Status

1276.10.37003 Boehringer Ingelheim Investigational Site

Kaunas, , Lithuania

Site Status

1276.10.37004 Boehringer Ingelheim Investigational Site

Kaunas, , Lithuania

Site Status

1276.10.37002 Boehringer Ingelheim Investigational Site

Klaipėda, , Lithuania

Site Status

1276.10.37001 Boehringer Ingelheim Investigational Site

Vilnius, , Lithuania

Site Status

1276.10.52003 Boehringer Ingelheim Investigational Site

Durango, , Mexico

Site Status

1276.10.52001 Boehringer Ingelheim Investigational Site

Mexico City, , Mexico

Site Status

1276.10.52002 Boehringer Ingelheim Investigational Site

Mexico City, , Mexico

Site Status

1276.10.52005 Boehringer Ingelheim Investigational Site

Pachuca, , Mexico

Site Status

1276.10.52004 Boehringer Ingelheim Investigational Site

Tijuana, , Mexico

Site Status

1276.10.64001 Boehringer Ingelheim Investigational Site

Christchurch, , New Zealand

Site Status

1276.10.64002 Boehringer Ingelheim Investigational Site

Greenlane East Auckland NZ, , New Zealand

Site Status

1276.10.48001 Boehringer Ingelheim Investigational Site

Bialystok, , Poland

Site Status

1276.10.48002 Boehringer Ingelheim Investigational Site

Bialystok, , Poland

Site Status

1276.10.48008 Boehringer Ingelheim Investigational Site

Giżycko, , Poland

Site Status

1276.10.48005 Boehringer Ingelheim Investigational Site

Katowice, , Poland

Site Status

1276.10.48006 Boehringer Ingelheim Investigational Site

Katowice, , Poland

Site Status

1276.10.48004 Boehringer Ingelheim Investigational Site

Krakow, , Poland

Site Status

1276.10.48003 Boehringer Ingelheim Investigational Site

Warsaw, , Poland

Site Status

1276.10.70001 Boehringer Ingelheim Investigational Site

Moscow, , Russia

Site Status

1276.10.70002 Boehringer Ingelheim Investigational Site

Moscow, , Russia

Site Status

1276.10.70003 Boehringer Ingelheim Investigational Site

Moscow, , Russia

Site Status

1276.10.70004 Boehringer Ingelheim Investigational Site

Moscow, , Russia

Site Status

1276.10.70005 Boehringer Ingelheim Investigational Site

Moscow, , Russia

Site Status

1276.10.70007 Boehringer Ingelheim Investigational Site

Moscow, , Russia

Site Status

1276.10.70008 Boehringer Ingelheim Investigational Site

Saint Petersburg, , Russia

Site Status

1276.10.70009 Boehringer Ingelheim Investigational Site

Saint Petersburg, , Russia

Site Status

1276.10.27004 Boehringer Ingelheim Investigational Site

Paarl, , South Africa

Site Status

1276.10.27003 Boehringer Ingelheim Investigational Site

Parow, , South Africa

Site Status

1276.10.27006 Boehringer Ingelheim Investigational Site

Plumstead, Cape Town, , South Africa

Site Status

1276.10.27001 Boehringer Ingelheim Investigational Site

Pretoria, , South Africa

Site Status

1276.10.27005 Boehringer Ingelheim Investigational Site

Pretoria, , South Africa

Site Status

1276.10.27002 Boehringer Ingelheim Investigational Site

Somerset West, , South Africa

Site Status

1276.10.34005 Boehringer Ingelheim Investigational Site

Barcelona, , Spain

Site Status

1276.10.34001 Boehringer Ingelheim Investigational Site

L'Hospitalet de Llobregat, , Spain

Site Status

1276.10.34003 Boehringer Ingelheim Investigational Site

L'Hospitalet de Llobregat, , Spain

Site Status

1276.10.34002 Boehringer Ingelheim Investigational Site

les Borges del Camp, , Spain

Site Status

1276.10.34004 Boehringer Ingelheim Investigational Site

Sant Adria Del Besos, , Spain

Site Status

1276.10.34006 Boehringer Ingelheim Investigational Site

Vic, , Spain

Site Status

1276.10.38002 Boehringer Ingelheim Investigational Site

Kharkiv, , Ukraine

Site Status

1276.10.38007 Boehringer Ingelheim Investigational Site

Kharkiv, , Ukraine

Site Status

1276.10.38001 Boehringer Ingelheim Investigational Site

Kiev, , Ukraine

Site Status

1276.10.38004 Boehringer Ingelheim Investigational Site

Kiev, , Ukraine

Site Status

1276.10.38005 Boehringer Ingelheim Investigational Site

Kyiv, , Ukraine

Site Status

Countries

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United States Australia Canada Estonia France Georgia Germany Guatemala Italy Latvia Lithuania Mexico New Zealand Poland Russia South Africa Spain Ukraine

References

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Tuttle KR, Levin A, Nangaku M, Kadowaki T, Agarwal R, Hauske SJ, Elsasser A, Ritter I, Steubl D, Wanner C, Wheeler DC. Safety of Empagliflozin in Patients With Type 2 Diabetes and Chronic Kidney Disease: Pooled Analysis of Placebo-Controlled Clinical Trials. Diabetes Care. 2022 Jun 2;45(6):1445-1452. doi: 10.2337/dc21-2034.

Reference Type DERIVED
PMID: 35472672 (View on PubMed)

Other Identifiers

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2012-000905-53

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

1276.10

Identifier Type: -

Identifier Source: org_study_id

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An Efficacy, Safety, and Tolerability Study of Canagliflozin in the Treatment of Patients With Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Metformin Monotherapy
NCT01340664 COMPLETED PHASE2
Bioequivalence of a Fixed Dose Combination Tablet of Empagliflozin/Metformin Extended Release Compared With Mono Compound Tablets in Healthy Subjects
NCT02230995 COMPLETED PHASE1
Bioequivalence of a 2.5 mg Linagliptin / 850 mg Metformin Fixed Dose Combination Tablet Compared With Single Linagliptin 2.5 mg and Metformin 850 mg Tablets in Healthy Volunteers
NCT02220647 COMPLETED PHASE1
Efficacy and Safety of BI 1356 BS (Linagliptin) in Combination With Metformin in Patients With type2 Diabetes
NCT00309608 COMPLETED PHASE2