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

NCT ID: NCT01167881

Last Updated: 2016-09-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 1549 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-08-31
• Study Completion Date: 2015-08-31

Brief Summary

This is a pivotal phase III study, mandatory to seek approval by regulatory authorities for BI 10773 as an anti-diabetic agent compared to an active comparator in patients with type 2 diabetes mellitus and insufficient glycaemic control.

Conditions

Diabetes Mellitus, Type 2

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

BI 10773 dose plus metformin

Patients receive one BI10773 tablet and one placebo Glimepiride capsule once daily

Group Type: EXPERIMENTAL

BI 10773

Intervention Type: DRUG

Medium dose once daily

Placebo

Intervention Type: DRUG

Placebo matching Glimepiride

Glimepiride 1-4 mg plus metformin

Patients receive one glimepiride capsule and one placebo tablet Bi 10773 once daily.

Group Type: ACTIVE_COMPARATOR

Glimepiride

Intervention Type: DRUG

1-4 mg once daily

Placebo

Intervention Type: DRUG

Placebo matching BI 10773

Interventions

BI 10773

Medium dose once daily

Intervention Type: DRUG

Glimepiride

1-4 mg once daily

Intervention Type: DRUG

Placebo

Placebo matching BI 10773

Intervention Type: DRUG

Placebo

Placebo matching Glimepiride

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Diagnosis typ 2 diabetes mellitus
• Male and female on diet and exercise regimen, pre-treated with metformin 12 weeks prior to randomisation
• HbA1c equal or greater than 7.0% and less than or equal to 10% at visit 1
• 18 years or more
• BMI equal or less than 45Kg/m2

Exclusion Criteria

• Uncontrolled hyperglycemia defined as glucose more that 13.3 mmol/L after overnight fast during placebo run-in
• Any other antidiabetic drug within 12 weeks prior to randomisation except metformin
• Acute coronary syndrome (non-STEMI, STEMI unstable angina pectoris), stroke or transient ischemic attack within 12 weeks of informed consent
• Indication of liver disease
• Moderate to severe renal impairment
• Bariatric surgery within past 2 years
• Medical history of cancer or treatment for cancer within last 5 years
• Blood dyscrasias or any disorders causing haemolysis or unstable red blood cell
• Contraindications hypersensitivity to concomitant drugs
• Treatment with anti-obesity drugs

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Eli Lilly and Company

INDUSTRY

Sponsor Role: collaborator

Boehringer Ingelheim

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Boehringer Ingelheim

Role: STUDY_CHAIR

Boehringer Ingelheim

Locations

1245.28.10005 Boehringer Ingelheim Investigational Site

Phoenix, Arizona, United States

1245.28.10012 Boehringer Ingelheim Investigational Site

Phoenix, Arizona, United States

1245.28.10016 Boehringer Ingelheim Investigational Site

Hot Springs, Arkansas, United States

1245.28.10003 Boehringer Ingelheim Investigational Site

Sacramento, California, United States

1245.28.10021 Boehringer Ingelheim Investigational Site

West Hills, California, United States

1245.28.10009 Boehringer Ingelheim Investigational Site

Bradednton, Florida, United States

1245.28.10015 Boehringer Ingelheim Investigational Site

Tampa, Florida, United States

1245.28.10033 Boehringer Ingelheim Investigational Site

Blue Ridge, Georgia, United States

1245.28.10026 Boehringer Ingelheim Investigational Site

Boise, Idaho, United States

1245.28.10007 Boehringer Ingelheim Investigational Site

Omaha, Nebraska, United States

1245.28.10027 Boehringer Ingelheim Investigational Site

Henderson, Nevada, United States

1245.28.10014 Boehringer Ingelheim Investigational Site

Rochester, New York, United States

1245.28.10006 Boehringer Ingelheim Investigational Site

Shelby, North Carolina, United States

1245.28.10011 Boehringer Ingelheim Investigational Site

Cincinnati, Ohio, United States

1245.28.10019 Boehringer Ingelheim Investigational Site

Cincinnati, Ohio, United States

1245.28.10004 Boehringer Ingelheim Investigational Site

Columbus, Ohio, United States

1245.28.10008 Boehringer Ingelheim Investigational Site

Perrysburg, Ohio, United States

1245.28.10020 Boehringer Ingelheim Investigational Site

Medford, Oregon, United States

1245.28.10017 Boehringer Ingelheim Investigational Site

Portland, Oregon, United States

1245.28.10031 Boehringer Ingelheim Investigational Site

Dallas, Texas, United States

1245.28.10032 Boehringer Ingelheim Investigational Site

Longview, Texas, United States

1245.28.10022 Boehringer Ingelheim Investigational Site

San Antonio, Texas, United States

1245.28.10030 Boehringer Ingelheim Investigational Site

Draper, Utah, United States

1245.28.10023 Boehringer Ingelheim Investigational Site

Salt Lake City, Utah, United States

1245.28.10013 Boehringer Ingelheim Investigational Site

Kenosha, Wisconsin, United States

1245.28.54010 Boehringer Ingelheim Investigational Site

Buenos Aires, , Argentina

1245.28.54001 Boehringer Ingelheim Investigational Site

Capital Federal, , Argentina

1245.28.54002 Boehringer Ingelheim Investigational Site

Córdoba, , Argentina

1245.28.54003 Boehringer Ingelheim Investigational Site

Córdoba, , Argentina

1245.28.43006 Boehringer Ingelheim Investigational Site

Graz, , Austria

1245.28.43005 Boehringer Ingelheim Investigational Site

Salzburg, , Austria

1245.28.43001 Boehringer Ingelheim Investigational Site

Vienna, , Austria

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Vienna, , Austria

1245.28.43003 Boehringer Ingelheim Investigational Site

Vienna, , Austria

1245.28.43004 Boehringer Ingelheim Investigational Site

Vienna, , Austria

1245.28.20074 Boehringer Ingelheim Investigational Site

Calgary, Alberta, Canada

1245.28.20077 Boehringer Ingelheim Investigational Site

Calgary, Alberta, Canada

1245.28.20075 Boehringer Ingelheim Investigational Site

Edmonton, Alberta, Canada

1245.28.20084 Boehringer Ingelheim Investigational Site

Langley, British Columbia, Canada

1245.28.20082 Boehringer Ingelheim Investigational Site

Grand Falls-Windsor, Newfoundland and Labrador, Canada

1245.28.20016 Boehringer Ingelheim Investigational Site

Mount Pearl, Newfoundland and Labrador, Canada

1245.28.20079 Boehringer Ingelheim Investigational Site

St. John's, Newfoundland and Labrador, Canada

1245.28.20071 Boehringer Ingelheim Investigational Site

Halifax, Nova Scotia, Canada

1245.28.20080 Boehringer Ingelheim Investigational Site

Collingwood, Ontario, Canada

1245.28.20083 Boehringer Ingelheim Investigational Site

Greater Sudbury, Ontario, Canada

1245.28.20078 Boehringer Ingelheim Investigational Site

Stayner, Ontario, Canada

1245.28.20005 Boehringer Ingelheim Investigational Site

Strathroy, Ontario, Canada

1245.28.20072 Boehringer Ingelheim Investigational Site

Chicoutimi, Quebec, Canada

1245.28.20081 Boehringer Ingelheim Investigational Site

Chicoutimi, Quebec, Canada

1245.28.20085 Boehringer Ingelheim Investigational Site

Gatineau, Quebec, Canada

1245.28.20043 Boehringer Ingelheim Investigational Site

Longueuil, Quebec, Canada

1245.28.20070 Boehringer Ingelheim Investigational Site

Montreal, Quebec, Canada

1245.28.20076 Boehringer Ingelheim Investigational Site

Québec, Quebec, Canada

1245.28.20073 Boehringer Ingelheim Investigational Site

Sherbrooke, Quebec, Canada

1245.28.20021 Boehringer Ingelheim Investigational Site

Trois-Rivières, Quebec, Canada

1245.28.57007 Boehringer Ingelheim Investigational Site

Barranquilla, , Colombia

1245.28.57003 Boehringer Ingelheim Investigational Site

Bogotá, , Colombia

1245.28.57005 Boehringer Ingelheim Investigational Site

Bogotá, , Colombia

1245.28.57006 Boehringer Ingelheim Investigational Site

Floridablanca, , Colombia

1245.28.42003 Boehringer Ingelheim Investigational Site

Brno, , Czechia

1245.28.42005 Boehringer Ingelheim Investigational Site

Holice, , Czechia

1245.28.42002 Boehringer Ingelheim Investigational Site

Mladá Boleslav, , Czechia

1245.28.42008 Boehringer Ingelheim Investigational Site

Prague, , Czechia

1245.28.42001 Boehringer Ingelheim Investigational Site

Slaný, , Czechia

1245.28.42007 Boehringer Ingelheim Investigational Site

Slaný, , Czechia

1245.28.42004 Boehringer Ingelheim Investigational Site

Uherské Hradiště, , Czechia

1245.28.42006 Boehringer Ingelheim Investigational Site

Zlín, , Czechia

1245.28.72001 Boehringer Ingelheim Investigational Site

Helsinki, , Finland

1245.28.72004 Boehringer Ingelheim Investigational Site

Joensuu, , Finland

1245.28.72003 Boehringer Ingelheim Investigational Site

Oulu, , Finland

1245.28.72002 Boehringer Ingelheim Investigational Site

Pori, , Finland

1245.28.85201 Boehringer Ingelheim Investigational Site

Hong Kong, , Hong Kong

1245.28.85207 Boehringer Ingelheim Investigational Site

Hong Kong, , Hong Kong

1245.28.85202 Boehringer Ingelheim Investigational Site

Kowloon, , Hong Kong

1245.28.91206 Boehringer Ingelheim Investigational Site

Ahmedabad, , India

1245.28.91202 Boehringer Ingelheim Investigational Site

Bangalore, , India

1245.28.91204 Boehringer Ingelheim Investigational Site

Bangalore, , India

1245.28.91205 Boehringer Ingelheim Investigational Site

Bangalore, , India

1245.28.91208 Boehringer Ingelheim Investigational Site

Bangalore, , India

1245.28.91201 Boehringer Ingelheim Investigational Site

Chennai, , India

1245.28.91213 Boehringer Ingelheim Investigational Site

Chennai, , India

1245.28.91203 Boehringer Ingelheim Investigational Site

Hyderabad, , India

1245.28.91211 Boehringer Ingelheim Investigational Site

Kolkata, , India

1245.28.91210 Boehringer Ingelheim Investigational Site

Mangalore, , India

1245.28.91212 Boehringer Ingelheim Investigational Site

New Delhi, , India

1245.28.91207 Boehringer Ingelheim Investigational Site

Pune, , India

1245.28.91209 Boehringer Ingelheim Investigational Site

Uttar Pradesh, , India

1245.28.39021 Boehringer Ingelheim Investigational Site

Cagliari, , Italy

1245.28.39022 Boehringer Ingelheim Investigational Site

Chieri (to), , Italy

1245.28.39016 Boehringer Ingelheim Investigational Site

Lucca, , Italy

1245.28.39018 Boehringer Ingelheim Investigational Site

Milan, , Italy

1245.28.39019 Boehringer Ingelheim Investigational Site

Milan, , Italy

1245.28.39017 Boehringer Ingelheim Investigational Site

Monserrato (ca), , Italy

1245.28.39023 Boehringer Ingelheim Investigational Site

Rimini, , Italy

1245.28.39020 Boehringer Ingelheim Investigational Site

Salerno, , Italy

1245.28.60003 Boehringer Ingelheim Investigational Site

Johor Bahru, , Malaysia

1245.28.60006 Boehringer Ingelheim Investigational Site

Kelantan, , Malaysia

1245.28.60005 Boehringer Ingelheim Investigational Site

Kuala Lumpur, , Malaysia

1245.28.60009 Boehringer Ingelheim Investigational Site

Kuala Lumpur, , Malaysia

1245.28.60004 Boehringer Ingelheim Investigational Site

Kuala Pahang, , Malaysia

1245.28.60007 Boehringer Ingelheim Investigational Site

Perak, , Malaysia

1245.28.60010 Boehringer Ingelheim Investigational Site

Pulau Pinang, , Malaysia

1245.28.60001 Boehringer Ingelheim Investigational Site

Selangor Darul Ehsan, , Malaysia

1245.28.52006 Boehringer Ingelheim Investigational Site

Aguascalientes, , Mexico

1245.28.52008 Boehringer Ingelheim Investigational Site

Cuautla, , Mexico

1245.28.52009 Boehringer Ingelheim Investigational Site

Guadalajara, , Mexico

1245.28.52007 Boehringer Ingelheim Investigational Site

México, , Mexico

1245.28.31008 Boehringer Ingelheim Investigational Site

's-Hertogenbosch, , Netherlands

1245.28.31020 Boehringer Ingelheim Investigational Site

Losser, , Netherlands

1245.28.31014 Boehringer Ingelheim Investigational Site

Rotterdam, , Netherlands

1245.28.47002 Boehringer Ingelheim Investigational Site

Hønefoss, , Norway

1245.28.47001 Boehringer Ingelheim Investigational Site

Oslo, , Norway

1245.28.47003 Boehringer Ingelheim Investigational Site

Sandefjord, , Norway

1245.28.63016 Boehringer Ingelheim Investigational Site

Cavite City, , Philippines

1245.28.63013 Boehringer Ingelheim Investigational Site

Cebu City, , Philippines

1245.28.63020 Boehringer Ingelheim Investigational Site

Jaro Iloilo City, , Philippines

1245.28.63004 Boehringer Ingelheim Investigational Site

Manila, , Philippines

1245.28.63015 Boehringer Ingelheim Investigational Site

Manila, , Philippines

1245.28.63012 Boehringer Ingelheim Investigational Site

Pasig, , Philippines

1245.28.63011 Boehringer Ingelheim Investigational Site

Quezon City, , Philippines

1245.28.63010 Boehringer Ingelheim Investigational Site

Tacloban City, , Philippines

1245.28.63014 Boehringer Ingelheim Investigational Site

Tagbilaran City, Bohol, , Philippines

1245.28.35006 Boehringer Ingelheim Investigational Site

Amadora, , Portugal

1245.28.35002 Boehringer Ingelheim Investigational Site

Lisbon, , Portugal

1245.28.35012 Boehringer Ingelheim Investigational Site

Porto, , Portugal

1245.28.35016 Boehringer Ingelheim Investigational Site

Vila Nova de Gaia, , Portugal

1245.28.76019 Boehringer Ingelheim Investigational Site

Boksburg North, , South Africa

1245.28.76018 Boehringer Ingelheim Investigational Site

Bryanston, , South Africa

1245.28.76016 Boehringer Ingelheim Investigational Site

Cape Town, , South Africa

1245.28.76017 Boehringer Ingelheim Investigational Site

Cape Town, , South Africa

1245.28.76012 Boehringer Ingelheim Investigational Site

Durban, , South Africa

1245.28.76015 Boehringer Ingelheim Investigational Site

Durban, , South Africa

1245.28.76013 Boehringer Ingelheim Investigational Site

Krugersdorp, , South Africa

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Lenasia, , South Africa

1245.28.76023 Boehringer Ingelheim Investigational Site

Lenasia South, , South Africa

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Pretoria, , South Africa

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Barcelona, , Spain

1245.28.34011 Boehringer Ingelheim Investigational Site

Barcelona, , Spain

1245.28.34002 Boehringer Ingelheim Investigational Site

Burjasot, , Spain

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Centelles, , Spain

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Granada, , Spain

1245.28.34012 Boehringer Ingelheim Investigational Site

Madrid, , Spain

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Madrid, , Spain

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Mataró, , Spain

1245.28.34001 Boehringer Ingelheim Investigational Site

Pineda de Mar, , Spain

1245.28.34010 Boehringer Ingelheim Investigational Site

San Sebastián de los Reyes, , Spain

1245.28.34006 Boehringer Ingelheim Investigational Site

Tarrega - Lleida, , Spain

1245.28.46009 Boehringer Ingelheim Investigational Site

Borås, , Sweden

1245.28.46008 Boehringer Ingelheim Investigational Site

Lund, , Sweden

1245.28.46001 Boehringer Ingelheim Investigational Site

Malmo, , Sweden

1245.28.46005 Boehringer Ingelheim Investigational Site

Örebro, , Sweden

1245.28.46002 Boehringer Ingelheim Investigational Site

Stockholm, , Sweden

1245.28.46006 Boehringer Ingelheim Investigational Site

Stockholm, , Sweden

1245.28.46007 Boehringer Ingelheim Investigational Site

Stockholm, , Sweden

1245.28.46004 Boehringer Ingelheim Investigational Site

Uppsala, , Sweden

1245.28.41015 Boehringer Ingelheim Investigational Site

Ascona, , Switzerland

1245.28.41017 Inselspital Bern

Bern, , Switzerland

1245.28.88004 Boehringer Ingelheim Investigational Site

Changhua, , Taiwan

1245.28.88003 Boehringer Ingelheim Investigational Site

Taichung, , Taiwan

1245.28.88005 Boehringer Ingelheim Investigational Site

Tainan Hsien, , Taiwan

1245.28.88001 Boehringer Ingelheim Investigational Site

Taipei, , Taiwan

1245.28.88002 Boehringer Ingelheim Investigational Site

Taipei Hsien, , Taiwan

1245.28.66006 Boehringer Ingelheim Investigational Site

Bangkok, , Thailand

1245.28.66007 Boehringer Ingelheim Investigational Site

Bangkok, , Thailand

1245.28.66004 Boehringer Ingelheim Investigational Site

Muang District, , Thailand

1245.28.66008 Boehringer Ingelheim Investigational Site

Nakhonratchasima, , Thailand

1245.28.44006 Boehringer Ingelheim Investigational Site

Addlestone, , United Kingdom

1245.28.44020 Boehringer Ingelheim Investigational Site

Ashford, , United Kingdom

1245.28.44008 Boehringer Ingelheim Investigational Site

Balham, , United Kingdom

1245.28.44035 Boehringer Ingelheim Investigational Site

Barnstable, , United Kingdom

1245.28.44016 Boehringer Ingelheim Investigational Site

Blackpool, , United Kingdom

1245.28.44021 Boehringer Ingelheim Investigational Site

Bradford-on-Avon, , United Kingdom

1245.28.44019 Boehringer Ingelheim Investigational Site

Burbage, , United Kingdom

1245.28.44027 Boehringer Ingelheim Investigational Site

Chestfield, Whitstable, , United Kingdom

1245.28.44011 Boehringer Ingelheim Investigational Site

Chippenham, , United Kingdom

1245.28.44022 Boehringer Ingelheim Investigational Site

Chippenham, , United Kingdom

1245.28.44043 Boehringer Ingelheim Investigational Site

Coventry, , United Kingdom

1245.28.44025 Boehringer Ingelheim Investigational Site

Doncaster, , United Kingdom

1245.28.44030 Boehringer Ingelheim Investigational Site

Ely, , United Kingdom

1245.28.44007 Boehringer Ingelheim Investigational Site

Midsomer Norton, , United Kingdom

1245.28.44023 Boehringer Ingelheim Investigational Site

Nantwich, , United Kingdom

1245.28.44017 Boehringer Ingelheim Investigational Site

Whitstable, , United Kingdom

Countries

United States; Argentina; Austria; Canada; Colombia; Czechia; Finland; Hong Kong; India; Italy; Malaysia; Mexico; Netherlands; Norway; Philippines; Portugal; South Africa; Spain; Sweden; Switzerland; Taiwan; Thailand; United Kingdom

References

Dennis JM, Young KG, Cardoso P, Gudemann LM, McGovern AP, Farmer A, Holman RR, Sattar N, McKinley TJ, Pearson ER, Jones AG, Shields BM, Hattersley AT; MASTERMIND Consortium. A five-drug class model using routinely available clinical features to optimise prescribing in type 2 diabetes: a prediction model development and validation study. Lancet. 2025 Mar 1;405(10480):701-714. doi: 10.1016/S0140-6736(24)02617-5. Epub 2025 Feb 25.

Reference Type: DERIVED

PMID: 40020703 (View on PubMed)

Natale P, Tunnicliffe DJ, Toyama T, Palmer SC, Saglimbene VM, Ruospo M, Gargano L, Stallone G, Gesualdo L, Strippoli GF. Sodium-glucose co-transporter protein 2 (SGLT2) inhibitors for people with chronic kidney disease and diabetes. Cochrane Database Syst Rev. 2024 May 21;5(5):CD015588. doi: 10.1002/14651858.CD015588.pub2.

Reference Type: DERIVED

PMID: 38770818 (View on PubMed)

Salem A, Men P, Ramos M, Zhang YJ, Ustyugova A, Lamotte M. Cost-effectiveness analysis of empagliflozin compared with glimepiride in patients with Type 2 diabetes in China. J Comp Eff Res. 2021 Apr;10(6):469-480. doi: 10.2217/cer-2020-0284. Epub 2021 Feb 12.

Reference Type: DERIVED

PMID: 33576249 (View on PubMed)

Ridderstrale M, Andersen KR, Zeller C, Kim G, Woerle HJ, Broedl UC; EMPA-REG H2H-SU trial investigators. Comparison of empagliflozin and glimepiride as add-on to metformin in patients with type 2 diabetes: a 104-week randomised, active-controlled, double-blind, phase 3 trial. Lancet Diabetes Endocrinol. 2014 Sep;2(9):691-700. doi: 10.1016/S2213-8587(14)70120-2. Epub 2014 Jun 16.

Reference Type: DERIVED

PMID: 24948511 (View on PubMed)

Ridderstrale M, Svaerd R, Zeller C, Kim G, Woerle HJ, Broedl UC; EMPA-REG H2H-SU trial investigators. Rationale, design and baseline characteristics of a 4-year (208-week) phase III trial of empagliflozin, an SGLT2 inhibitor, versus glimepiride as add-on to metformin in patients with type 2 diabetes mellitus with insufficient glycemic control. Cardiovasc Diabetol. 2013 Sep 5;12:129. doi: 10.1186/1475-2840-12-129.

Reference Type: DERIVED

PMID: 24007456 (View on PubMed)

Other Identifiers

2009-016244-39

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

1245.28

Identifier Type: -

Identifier Source: org_study_id