Diabetes Mellitus, Type 2Phase 3NCT01167881

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

A Phase 3 study testing BI 10773 and Glimepiride in people with Diabetes Mellitus, Type 2, run by Boehringer Ingelheim at 182 sites in 23 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Diabetes Mellitus, Type 2
What is being tested?: BI 10773 and Glimepiride
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 1,549 participants
Where: 182 sitesin 23 countries
Study dates: Aug 2010to Aug 2015
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Show all 10Show fewer

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

Trial locations and contacts

182 sites in 23 countries.

Country

City, postcode or hospital

182 sites in 23 countries

United States25 sites

1245.28.10033 Boehringer Ingelheim Investigational Site
Blue Ridge, Georgia
1245.28.10026 Boehringer Ingelheim Investigational Site
Boise, Idaho
1245.28.10009 Boehringer Ingelheim Investigational Site
Bradednton, Florida
1245.28.10011 Boehringer Ingelheim Investigational Site
Cincinnati, Ohio
1245.28.10019 Boehringer Ingelheim Investigational Site
Cincinnati, Ohio
1245.28.10004 Boehringer Ingelheim Investigational Site
Columbus, Ohio
1245.28.10031 Boehringer Ingelheim Investigational Site
Dallas, Texas
1245.28.10030 Boehringer Ingelheim Investigational Site
Draper, Utah
1245.28.10027 Boehringer Ingelheim Investigational Site
Henderson, Nevada
1245.28.10016 Boehringer Ingelheim Investigational Site
Hot Springs, Arkansas
1245.28.10013 Boehringer Ingelheim Investigational Site
Kenosha, Wisconsin
1245.28.10032 Boehringer Ingelheim Investigational Site
Longview, Texas
1245.28.10020 Boehringer Ingelheim Investigational Site
Medford, Oregon
1245.28.10007 Boehringer Ingelheim Investigational Site
Omaha, Nebraska
1245.28.10008 Boehringer Ingelheim Investigational Site
Perrysburg, Ohio
1245.28.10005 Boehringer Ingelheim Investigational Site
Phoenix, Arizona
1245.28.10012 Boehringer Ingelheim Investigational Site
Phoenix, Arizona
1245.28.10017 Boehringer Ingelheim Investigational Site
Portland, Oregon
1245.28.10014 Boehringer Ingelheim Investigational Site
Rochester, New York
1245.28.10003 Boehringer Ingelheim Investigational Site
Sacramento, California
1245.28.10023 Boehringer Ingelheim Investigational Site
Salt Lake City, Utah
1245.28.10022 Boehringer Ingelheim Investigational Site
San Antonio, Texas
1245.28.10006 Boehringer Ingelheim Investigational Site
Shelby, North Carolina
1245.28.10015 Boehringer Ingelheim Investigational Site
Tampa, Florida
1245.28.10021 Boehringer Ingelheim Investigational Site
West Hills, California

Other trials in United States

Canada20 sites

1245.28.20074 Boehringer Ingelheim Investigational Site
Calgary, Alberta
1245.28.20077 Boehringer Ingelheim Investigational Site
Calgary, Alberta
1245.28.20072 Boehringer Ingelheim Investigational Site
Chicoutimi, Quebec
1245.28.20081 Boehringer Ingelheim Investigational Site
Chicoutimi, Quebec
1245.28.20080 Boehringer Ingelheim Investigational Site
Collingwood, Ontario
1245.28.20075 Boehringer Ingelheim Investigational Site
Edmonton, Alberta
1245.28.20085 Boehringer Ingelheim Investigational Site
Gatineau, Quebec
1245.28.20082 Boehringer Ingelheim Investigational Site
Grand Falls-Windsor, Newfoundland and Labrador
1245.28.20083 Boehringer Ingelheim Investigational Site
Greater Sudbury, Ontario
1245.28.20071 Boehringer Ingelheim Investigational Site
Halifax, Nova Scotia
1245.28.20084 Boehringer Ingelheim Investigational Site
Langley, British Columbia
1245.28.20043 Boehringer Ingelheim Investigational Site
Longueuil, Quebec
1245.28.20070 Boehringer Ingelheim Investigational Site
Montreal, Quebec
1245.28.20016 Boehringer Ingelheim Investigational Site
Mount Pearl, Newfoundland and Labrador
1245.28.20076 Boehringer Ingelheim Investigational Site
Québec, Quebec
1245.28.20073 Boehringer Ingelheim Investigational Site
Sherbrooke, Quebec
1245.28.20079 Boehringer Ingelheim Investigational Site
St. John's, Newfoundland and Labrador
1245.28.20078 Boehringer Ingelheim Investigational Site
Stayner, Ontario
1245.28.20005 Boehringer Ingelheim Investigational Site
Strathroy, Ontario
1245.28.20021 Boehringer Ingelheim Investigational Site
Trois-Rivières, Quebec

Other trials in Canada

United Kingdom16 sites

1245.28.44006 Boehringer Ingelheim Investigational Site
Addlestone
1245.28.44020 Boehringer Ingelheim Investigational Site
Ashford
1245.28.44008 Boehringer Ingelheim Investigational Site
Balham
1245.28.44035 Boehringer Ingelheim Investigational Site
Barnstable
1245.28.44016 Boehringer Ingelheim Investigational Site
Blackpool
1245.28.44021 Boehringer Ingelheim Investigational Site
Bradford on Avon
1245.28.44019 Boehringer Ingelheim Investigational Site
Burbage
1245.28.44027 Boehringer Ingelheim Investigational Site
Chestfield, Whitstable
1245.28.44011 Boehringer Ingelheim Investigational Site
Chippenham
1245.28.44022 Boehringer Ingelheim Investigational Site
Chippenham
1245.28.44043 Boehringer Ingelheim Investigational Site
Coventry
1245.28.44025 Boehringer Ingelheim Investigational Site
Doncaster
1245.28.44030 Boehringer Ingelheim Investigational Site
Ely
1245.28.44007 Boehringer Ingelheim Investigational Site
Midsomer Norton
1245.28.44023 Boehringer Ingelheim Investigational Site
Nantwich
1245.28.44017 Boehringer Ingelheim Investigational Site
Whitstable

Other trials in United Kingdom

India13 sites

1245.28.91206 Boehringer Ingelheim Investigational Site
Ahmedabad
1245.28.91202 Boehringer Ingelheim Investigational Site
Bangalore
1245.28.91204 Boehringer Ingelheim Investigational Site
Bangalore
1245.28.91205 Boehringer Ingelheim Investigational Site
Bangalore
1245.28.91208 Boehringer Ingelheim Investigational Site
Bangalore
1245.28.91201 Boehringer Ingelheim Investigational Site
Chennai
1245.28.91213 Boehringer Ingelheim Investigational Site
Chennai
1245.28.91203 Boehringer Ingelheim Investigational Site
Hyderabad
1245.28.91211 Boehringer Ingelheim Investigational Site
Kolkata
1245.28.91210 Boehringer Ingelheim Investigational Site
Mangalore
1245.28.91212 Boehringer Ingelheim Investigational Site
New Delhi
1245.28.91207 Boehringer Ingelheim Investigational Site
Pune
1245.28.91209 Boehringer Ingelheim Investigational Site
Uttar Pradesh

Other trials in India

Spain11 sites

1245.28.34004 Boehringer Ingelheim Investigational Site
Barcelona
1245.28.34011 Boehringer Ingelheim Investigational Site
Barcelona
1245.28.34002 Boehringer Ingelheim Investigational Site
Burjasot
1245.28.34003 Boehringer Ingelheim Investigational Site
Centelles
1245.28.34009 Boehringer Ingelheim Investigational Site
Granada
1245.28.34012 Boehringer Ingelheim Investigational Site
Madrid
1245.28.34013 Boehringer Ingelheim Investigational Site
Madrid
1245.28.34005 Boehringer Ingelheim Investigational Site
Mataró
1245.28.34001 Boehringer Ingelheim Investigational Site
Pineda de Mar
1245.28.34010 Boehringer Ingelheim Investigational Site
San Sebastián de los Reyes
1245.28.34006 Boehringer Ingelheim Investigational Site
Tarrega - Lleida

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South Africa10 sites

1245.28.76019 Boehringer Ingelheim Investigational Site
Boksburg North
1245.28.76018 Boehringer Ingelheim Investigational Site
Bryanston
1245.28.76016 Boehringer Ingelheim Investigational Site
Cape Town
1245.28.76017 Boehringer Ingelheim Investigational Site
Cape Town
1245.28.76012 Boehringer Ingelheim Investigational Site
Durban
1245.28.76015 Boehringer Ingelheim Investigational Site
Durban
1245.28.76013 Boehringer Ingelheim Investigational Site
Krugersdorp
1245.28.76024 Boehringer Ingelheim Investigational Site
Lenasia
1245.28.76023 Boehringer Ingelheim Investigational Site
Lenasia South
1245.28.76014 Boehringer Ingelheim Investigational Site
Pretoria

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Philippines9 sites

1245.28.63016 Boehringer Ingelheim Investigational Site
Cavite City
1245.28.63013 Boehringer Ingelheim Investigational Site
Cebu City
1245.28.63020 Boehringer Ingelheim Investigational Site
Jaro Iloilo City
1245.28.63004 Boehringer Ingelheim Investigational Site
Manila
1245.28.63015 Boehringer Ingelheim Investigational Site
Manila
1245.28.63012 Boehringer Ingelheim Investigational Site
Pasig
1245.28.63011 Boehringer Ingelheim Investigational Site
Quezon City
1245.28.63010 Boehringer Ingelheim Investigational Site
Tacloban City
1245.28.63014 Boehringer Ingelheim Investigational Site
Tagbilaran City, Bohol

Other trials in Philippines

Czechia8 sites

1245.28.42003 Boehringer Ingelheim Investigational Site
Brno
1245.28.42005 Boehringer Ingelheim Investigational Site
Holice
1245.28.42002 Boehringer Ingelheim Investigational Site
Mladá Boleslav
1245.28.42008 Boehringer Ingelheim Investigational Site
Prague
1245.28.42001 Boehringer Ingelheim Investigational Site
Slaný
1245.28.42007 Boehringer Ingelheim Investigational Site
Slaný
1245.28.42004 Boehringer Ingelheim Investigational Site
Uherské Hradiště
1245.28.42006 Boehringer Ingelheim Investigational Site
Zlín

Other trials in Czechia

Italy8 sites

1245.28.39021 Boehringer Ingelheim Investigational Site
Cagliari
1245.28.39022 Boehringer Ingelheim Investigational Site
Chieri (to)
1245.28.39016 Boehringer Ingelheim Investigational Site
Lucca
1245.28.39018 Boehringer Ingelheim Investigational Site
Milan
1245.28.39019 Boehringer Ingelheim Investigational Site
Milan
1245.28.39017 Boehringer Ingelheim Investigational Site
Monserrato (ca)
1245.28.39023 Boehringer Ingelheim Investigational Site
Rimini
1245.28.39020 Boehringer Ingelheim Investigational Site
Salerno

Other trials in Italy

Malaysia8 sites

1245.28.60003 Boehringer Ingelheim Investigational Site
Johor Bahru
1245.28.60006 Boehringer Ingelheim Investigational Site
Kelantan
1245.28.60005 Boehringer Ingelheim Investigational Site
Kuala Lumpur
1245.28.60009 Boehringer Ingelheim Investigational Site
Kuala Lumpur
1245.28.60004 Boehringer Ingelheim Investigational Site
Kuala Pahang
1245.28.60007 Boehringer Ingelheim Investigational Site
Perak
1245.28.60010 Boehringer Ingelheim Investigational Site
Pulau Pinang
1245.28.60001 Boehringer Ingelheim Investigational Site
Selangor Darul Ehsan

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Sweden8 sites

1245.28.46009 Boehringer Ingelheim Investigational Site
Borås
1245.28.46008 Boehringer Ingelheim Investigational Site
Lund
1245.28.46001 Boehringer Ingelheim Investigational Site
Malmö
1245.28.46005 Boehringer Ingelheim Investigational Site
Örebro
1245.28.46002 Boehringer Ingelheim Investigational Site
Stockholm
1245.28.46006 Boehringer Ingelheim Investigational Site
Stockholm
1245.28.46007 Boehringer Ingelheim Investigational Site
Stockholm
1245.28.46004 Boehringer Ingelheim Investigational Site
Uppsala

Other trials in Sweden

Austria6 sites

1245.28.43006 Boehringer Ingelheim Investigational Site
Graz
1245.28.43005 Boehringer Ingelheim Investigational Site
Salzburg
1245.28.43001 Boehringer Ingelheim Investigational Site
Vienna
1245.28.43002 Boehringer Ingelheim Investigational Site
Vienna
1245.28.43003 Boehringer Ingelheim Investigational Site
Vienna
1245.28.43004 Boehringer Ingelheim Investigational Site
Vienna

Other trials in Austria

Taiwan5 sites

1245.28.88004 Boehringer Ingelheim Investigational Site
Changhua
1245.28.88003 Boehringer Ingelheim Investigational Site
Taichung
1245.28.88005 Boehringer Ingelheim Investigational Site
Tainan Hsien
1245.28.88001 Boehringer Ingelheim Investigational Site
Taipei
1245.28.88002 Boehringer Ingelheim Investigational Site
Taipei Hsien

Other trials in Taiwan

Argentina4 sites

1245.28.54010 Boehringer Ingelheim Investigational Site
Buenos Aires
1245.28.54001 Boehringer Ingelheim Investigational Site
Capital Federal
1245.28.54002 Boehringer Ingelheim Investigational Site
Córdoba
1245.28.54003 Boehringer Ingelheim Investigational Site
Córdoba

Other trials in Argentina

Colombia4 sites

1245.28.57007 Boehringer Ingelheim Investigational Site
Barranquilla
1245.28.57003 Boehringer Ingelheim Investigational Site
Bogotá
1245.28.57005 Boehringer Ingelheim Investigational Site
Bogotá
1245.28.57006 Boehringer Ingelheim Investigational Site
Floridablanca

Other trials in Colombia

Finland4 sites

1245.28.72001 Boehringer Ingelheim Investigational Site
Helsinki
1245.28.72004 Boehringer Ingelheim Investigational Site
Joensuu
1245.28.72003 Boehringer Ingelheim Investigational Site
Oulu
1245.28.72002 Boehringer Ingelheim Investigational Site
Pori

Other trials in Finland

Mexico4 sites

1245.28.52006 Boehringer Ingelheim Investigational Site
Aguascalientes
1245.28.52008 Boehringer Ingelheim Investigational Site
Cuautla
1245.28.52009 Boehringer Ingelheim Investigational Site
Guadalajara
1245.28.52007 Boehringer Ingelheim Investigational Site
México

Other trials in Mexico

Portugal4 sites

1245.28.35006 Boehringer Ingelheim Investigational Site
Amadora
1245.28.35002 Boehringer Ingelheim Investigational Site
Lisbon
1245.28.35012 Boehringer Ingelheim Investigational Site
Porto
1245.28.35016 Boehringer Ingelheim Investigational Site
Vila Nova de Gaia

Other trials in Portugal

Thailand4 sites

1245.28.66006 Boehringer Ingelheim Investigational Site
Bangkok
1245.28.66007 Boehringer Ingelheim Investigational Site
Bangkok
1245.28.66004 Boehringer Ingelheim Investigational Site
Muang District
1245.28.66008 Boehringer Ingelheim Investigational Site
Nakhonratchasima

Other trials in Thailand

Hong Kong3 sites

1245.28.85201 Boehringer Ingelheim Investigational Site
Hong Kong
1245.28.85207 Boehringer Ingelheim Investigational Site
Hong Kong
1245.28.85202 Boehringer Ingelheim Investigational Site
Kowloon

Other trials in Hong Kong

Netherlands3 sites

1245.28.31008 Boehringer Ingelheim Investigational Site
's-Hertogenbosch
1245.28.31020 Boehringer Ingelheim Investigational Site
Losser
1245.28.31014 Boehringer Ingelheim Investigational Site
Rotterdam

Other trials in Netherlands

Norway3 sites

1245.28.47002 Boehringer Ingelheim Investigational Site
Hønefoss
1245.28.47001 Boehringer Ingelheim Investigational Site
Oslo
1245.28.47003 Boehringer Ingelheim Investigational Site
Sandefjord

Other trials in Norway

Switzerland2 sites

1245.28.41015 Boehringer Ingelheim Investigational Site
Ascona
1245.28.41017 Inselspital Bern
Bern

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About this study

Official title: A Phase III Randomised, Double-blind, Active-controlled Parallel Group Efficacy and Safety Study of BI 10773 Compared to Glimepiride Administered Orally During 104 Weeks With a 104 Week Extension Period in Patients With Type 2 Diabetes Mellitus and Insufficient Glycaemic Control Despite Metformin Treatment

Conditions: Diabetes Mellitus, Type 2
Being tested: BI 10773, Glimepiride, Placebo
Medical subject headings: Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

BI 10773Drug
Medium dose once daily
GlimepirideDrug
1-4 mg once daily
PlaceboDrug
Placebo matching BI 10773
PlaceboDrug
Placebo matching Glimepiride

Study groups in NCT01167881
Study group	Role	What they receive
BI 10773 dose plus metformin	Experimental	Patients receive one BI10773 tablet and one placebo Glimepiride capsule once daily Receives: Drug: BI 10773; Drug: Placebo
Glimepiride 1-4 mg plus metformin	Active comparator	Patients receive one glimepiride capsule and one placebo tablet Bi 10773 once daily. Receives: Drug: Glimepiride; Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

The Change From Baseline in Glycosylated Haemoglobin (HbA1c) After 104 Weeks of Treatment.
Measured: Baseline and 104 weeks

Secondary outcomes (9)

The Change in Body Weight From Baseline After 104 Weeks of Treatment.
Measured: baseline and 104 weeks
The Occurrence of Confirmed Hypoglycaemic Events During 104 Weeks of Treatment.
Measured: baseline and 104 weeks
The Change in Systolic Blood Pressure (SBP) From Baseline After 104 Weeks of Treatment.
Measured: baseline and 104 weeks
The Change in Diastolic Blood Pressure (DBP) From Baseline After 104 Weeks of Treatment.
Measured: baseline and 104 weeks
The Change From Baseline in HbA1c After 52 Weeks of Treatment.
Measured: baseline and 52 weeks
The Change in Body Weight From Baseline After 52 Weeks of Treatment.
Measured: baseline and 52 weeks
The Occurrence of Confirmed Hypoglycaemic Events During 52 Weeks of Treatment.
Measured: baseline and 52 weeks
The Change in Systolic Blood Pressure (SBP) From Baseline After 52 Weeks of Treatment.
Measured: baseline and 52 weeks
The Change in Diastolic Blood Pressure (DBP) From Baseline After 52 Weeks of Treatment.
Measured: baseline and 52 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Aug 2010Aug 2015

First posted22 Jul 2010 (estimated)
Study startAug 2010
Primary completionAug 2013
Study completionAug 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (5)Papers the sponsor has linked to this study.
Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
More trials run by Boehringer IngelheimThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Enrolment: 1,549 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01167881
Sponsor's protocol ID: 1245.28
Other IDs: 2009-016244-39, 2009
Status last verified: Jul 2016
First submitted: 15 Jul 2010
Last updated: 2 Sep 2016
Results posted: Yes, on ClinicalTrials.gov

Publications

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.
PubMed 40020703
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.
PubMed 38770818
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.
PubMed 33576249
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.
PubMed 24948511
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.
PubMed 24007456

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 2 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase III Randomised, Double-blind, Active-controlled Parallel Group Efficacy and Safety Study of BI 10773 Compared to Glimepiride Administered Orally During 104 Weeks With a 104 Week Extension Period in Patients With Type 2 Diabetes Mellitus and Insufficient Glycaemic Control Despite Metformin Treatment
ClinicalTrials.gov ID: NCT01167881
Acronym / sponsor ID: 1245.28
Conditions: Diabetes Mellitus, Type 2
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 1,549 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Collaborators: Eli Lilly and Company
Study start: Aug 2010
Primary completion: Aug 2013 (actual)
Study completion: Aug 2015 (actual)
First posted: 22 Jul 2010 (estimated)
Results: Posted 8 Aug 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Number of arms: 2

Arm	Type	Receives
BI 10773 dose plus metformin	Experimental	Drug: BI 10773, Drug: PlaceboPatients receive one BI10773 tablet and one placebo Glimepiride capsule once daily
Glimepiride 1-4 mg plus metformin	Active comparator	Drug: Glimepiride, Drug: PlaceboPatients receive one glimepiride capsule and one placebo tablet Bi 10773 once daily.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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

Key exclusion criteria (10 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
BI 10773Medium dose once daily	Drug	BI 10773 dose plus metformin
Glimepiride1-4 mg once daily	Drug	Glimepiride 1-4 mg plus metformin
PlaceboPlacebo matching BI 10773	Drug	Glimepiride 1-4 mg plus metformin
PlaceboPlacebo matching Glimepiride	Drug	BI 10773 dose plus metformin

Primary outcome

The Change From Baseline in Glycosylated Haemoglobin (HbA1c) After 104 Weeks of Treatment.
Time frame: Baseline and 104 weeks

9 secondary outcomes

The Change in Body Weight From Baseline After 104 Weeks of Treatment.
Time frame: baseline and 104 weeks
The Occurrence of Confirmed Hypoglycaemic Events During 104 Weeks of Treatment.
Time frame: baseline and 104 weeks
The Change in Systolic Blood Pressure (SBP) From Baseline After 104 Weeks of Treatment.
Time frame: baseline and 104 weeks
The Change in Diastolic Blood Pressure (DBP) From Baseline After 104 Weeks of Treatment.
Time frame: baseline and 104 weeks
The Change From Baseline in HbA1c After 52 Weeks of Treatment.
Time frame: baseline and 52 weeks
The Change in Body Weight From Baseline After 52 Weeks of Treatment.
Time frame: baseline and 52 weeks
The Occurrence of Confirmed Hypoglycaemic Events During 52 Weeks of Treatment.
Time frame: baseline and 52 weeks
The Change in Systolic Blood Pressure (SBP) From Baseline After 52 Weeks of Treatment.
Time frame: baseline and 52 weeks
The Change in Diastolic Blood Pressure (DBP) From Baseline After 52 Weeks of Treatment.
Time frame: baseline and 52 weeks

Results and safety

Results posted to the registry on 8 Aug 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Empaglifozin 25 mg	769	610
Glimepiride	780	589

Primary outcome: The Change From Baseline in Glycosylated Haemoglobin (HbA1c) After 104 Weeks of Treatment.

Time frame: Baseline and 104 weeks. Mean (Standard Error). Unit: percentage of HbA1c

Measure	Empaglifozin 25 mg n = 765	Glimepiride n = 780
Value	-0.66 (0.03)	-0.55 (0.03)

Empaglifozin 25 mg vs Glimepiride: Mean Difference (Net): -0.11 (97.5% CI -0.20 to -0.01), p <0.0001, ANCOVA
Empaglifozin 25 mg vs Glimepiride: Mean Difference (Net): -0.11 (97.5% CI -0.20 to -0.01), p = 0.0153, ANCOVA

Population analysed: FAS (LOCF) - Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF); Values after start of antidiabetic rescue therapy were set to missing and last observation carried forward (LOCF) was used for imputation of missing values. .

9 secondary outcomes are reported in the full results.

Adverse events

Time frame: Up to 4 years.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Empa 25mg	161 of 765 (21%)	580 of 765 (75.8%)	Not reported
Glimepiride	153 of 780 (19.6%)	637 of 780 (81.7%)	Not reported

Limitations and caveats (from the sponsor): It should be noted that not all patients were followed up for 4 years with regard to the frequencies of adverse events presented up to 4 years.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 40020703Dennis 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.
Derived from this study: PubMed 38770818Natale 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.
Derived from this study: PubMed 33576249Salem 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.
Derived from this study: PubMed 24948511Ridderstrale 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.
Derived from this study: PubMed 24007456Ridderstrale 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Boehringer Ingelheim study chair

Boehringer Ingelheim

182 sites in 23 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing BI 10773 and Glimepiride in people with Diabetes Mellitus, Type 2, run by Boehringer Ingelheim at 182 sites in 23 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 182 sites in United States, Canada, United Kingdom, India, Spain and 18 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 8 Aug 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The Change From Baseline in Glycosylated Haemoglobin (HbA1c) After 104 Weeks of Treatment. (time frame: Baseline and 104 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01167881, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2016.