Diabetes Mellitus, Type 2Phase 3NCT01719003

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

A Phase 3 study testing Metformin 500 mg bid, Metformin 1000 mg bid and Empagliflozin low dose qd in people with Diabetes Mellitus, Type 2 and Hyperglycemia, run by Boehringer Ingelheim at 190 sites in 21 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 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). Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Diabetes Mellitus, Type 2, Hyperglycemia
What is being tested?: Metformin 500 mg bid, Metformin 1000 mg bid and Empagliflozin low dose qd
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 1,413 participants
Where: 190 sitesin 21 countries
Study dates: Oct 2012to Dec 2014
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 of type 2 diabetes mellitus prior to informed consent
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
HbA1c >=7.5% and <= 12% (>=58.5 mmol/mol and <=107.7 mmol/mol)
Body Mass Index (BMI) <= 45 kg/m2 at screening

Who cannot join

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)
Any antidiabetic drug within 12 weeks prior to randomization
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
Contraindications to metformin according to the local label

Trial locations and contacts

190 sites in 21 countries.

Country

City, postcode or hospital

190 sites in 21 countries

United States41 sites

1276.1.10033 Boehringer Ingelheim Investigational Site
Asheboro, North Carolina
1276.1.10014 Boehringer Ingelheim Investigational Site
Birmingham, Alabama
1276.1.10019 Boehringer Ingelheim Investigational Site
Birmingham, Alabama
1276.1.10036 Boehringer Ingelheim Investigational Site
Bridgman, Michigan
1276.1.10022 Boehringer Ingelheim Investigational Site
Burlington, North Carolina
1276.1.10046 Boehringer Ingelheim Investigational Site
Chula Vista, California
1276.1.10005 Boehringer Ingelheim Investigational Site
Cincinnati, Ohio
1276.1.10042 Boehringer Ingelheim Investigational Site
Colorado Springs, Colorado
1276.1.10030 Boehringer Ingelheim Investigational Site
Columbia, South Carolina
1276.1.10001 Boehringer Ingelheim Investigational Site
Denver, Colorado
1276.1.10034 Boehringer Ingelheim Investigational Site
Evansville, Indiana
1276.1.10032 Boehringer Ingelheim Investigational Site
Fall River, Massachusetts
1276.1.10026 Boehringer Ingelheim Investigational Site
Fort Lauderdale, Florida
1276.1.10011 Boehringer Ingelheim Investigational Site
Gallipolis, Ohio
1276.1.10010 Boehringer Ingelheim Investigational Site
Glendale, Arizona
1276.1.10008 Boehringer Ingelheim Investigational Site
Greer, South Carolina
1276.1.10037 Boehringer Ingelheim Investigational Site
Hazelwood, Missouri
1276.1.10013 Boehringer Ingelheim Investigational Site
Hodges, South Carolina
1276.1.10018 Boehringer Ingelheim Investigational Site
Houston, Texas
1276.1.10025 Boehringer Ingelheim Investigational Site
Houston, Texas
1276.1.10028 Boehringer Ingelheim Investigational Site
Houston, Texas
1276.1.10017 Boehringer Ingelheim Investigational Site
Humboldt, Tennessee
1276.1.10006 Boehringer Ingelheim Investigational Site
Huntington Beach, California
1276.1.10016 Boehringer Ingelheim Investigational Site
Kingwood, Texas
1276.1.10043 Boehringer Ingelheim Investigational Site
La Mesa, California
1276.1.10007 Boehringer Ingelheim Investigational Site
Las Vegas, Nevada
1276.1.10002 Boehringer Ingelheim Investigational Site
Lenoir, North Carolina
1276.1.10009 Boehringer Ingelheim Investigational Site
Los Angeles, California
1276.1.10040 Boehringer Ingelheim Investigational Site
Los Angeles, California
1276.1.10004 Boehringer Ingelheim Investigational Site
Manassas, Virginia
1276.1.10044 Boehringer Ingelheim Investigational Site
Manley Hot Springs, Alaska
1276.1.10023 Boehringer Ingelheim Investigational Site
Marietta, Georgia
1276.1.10003 Boehringer Ingelheim Investigational Site
Northglenn, Colorado
1276.1.10045 Boehringer Ingelheim Investigational Site
Oceanside, California
1276.1.10024 Boehringer Ingelheim Investigational Site
Oldsmar, Florida
1276.1.10027 Boehringer Ingelheim Investigational Site
Port Orange, Florida
1276.1.10021 Boehringer Ingelheim Investigational Site
San Antonio, Texas
1276.1.10041 Boehringer Ingelheim Investigational Site
San Antonio, Texas
1276.1.10035 Boehringer Ingelheim Investigational Site
Searcy, Arkansas
1276.1.10015 Boehringer Ingelheim Investigational Site
Union, New Jersey
1276.1.10012 Boehringer Ingelheim Investigational Site
Wenatchee, Washington

Other trials in United States

France13 sites

1276.1.33004 Boehringer Ingelheim Investigational Site
Behren-lès-Forbach
1276.1.33012 Boehringer Ingelheim Investigational Site
Bersée
1276.1.33005 Boehringer Ingelheim Investigational Site
Cournonterral
1276.1.33007 Boehringer Ingelheim Investigational Site
Hautmont
1276.1.33013 Boehringer Ingelheim Investigational Site
Paris
1276.1.33001 Boehringer Ingelheim Investigational Site
Poitiers
1276.1.33006 Boehringer Ingelheim Investigational Site
Saint-Génis-des-Fontaines
1276.1.33003 Boehringer Ingelheim Investigational Site
Savonnières
1276.1.33002 Boehringer Ingelheim Investigational Site
Thouars
1276.1.33011 Boehringer Ingelheim Investigational Site
Thun-Saint-Amand
1276.1.33010 Boehringer Ingelheim Investigational Site
Tours
1276.1.33009 Boehringer Ingelheim Investigational Site
Vandome
1276.1.33008 Boehringer Ingelheim Investigational Site
Vieux-Condé

Other trials in France

Russia12 sites

1276.1.70012 Boehringer Ingelheim Investigational Site
Barnaul
1276.1.70011 Boehringer Ingelheim Investigational Site
Kemerovo
1276.1.70015 Boehringer Ingelheim Investigational Site
Novosibirsk
1276.1.70016 Boehringer Ingelheim Investigational Site
Novosibirsk
1276.1.70018 Boehringer Ingelheim Investigational Site
Novosibirsk
1276.1.70007 Boehringer Ingelheim Investigational Site
Petrozavodsk
1276.1.70005 Boehringer Ingelheim Investigational Site
Saint Petersburg
1276.1.70006 Boehringer Ingelheim Investigational Site
Saint Petersburg
1276.1.70017 Boehringer Ingelheim Investigational Site
Saint Petersburg
1276.1.70009 Boehringer Ingelheim Investigational Site
Saratov
1276.1.70010 Boehringer Ingelheim Investigational Site
Smolensk
1276.1.70013 Boehringer Ingelheim Investigational Site
Yaroslavl

Other trials in Russia

Canada11 sites

1276.1.20004 Boehringer Ingelheim Investigational Site
Antigonish Nova Scotia, Nova Scotia
1276.1.20003 Boehringer Ingelheim Investigational Site
Coquitlam, British Columbia
1276.1.20012 Boehringer Ingelheim Investigational Site
Coquitlam, British Columbia
1276.1.20005 Boehringer Ingelheim Investigational Site
Hawkesbury, Ontario
1276.1.20007 Boehringer Ingelheim Investigational Site
Mirabel, Quebec
1276.1.20002 Boehringer Ingelheim Investigational Site
Québec, Quebec
1276.1.20013 Boehringer Ingelheim Investigational Site
Sarnia, Ontario
1276.1.20001 Boehringer Ingelheim Investigational Site
Saskatoon, Saskatchewan
1276.1.20010 Boehringer Ingelheim Investigational Site
Strathroy, Ontario
1276.1.20006 Boehringer Ingelheim Investigational Site
Thornhill, Ontario
1276.1.20008 Boehringer Ingelheim Investigational Site
Victoria, British Columbia

Other trials in Canada

Germany10 sites

1276.1.49005 Boehringer Ingelheim Investigational Site
Berlin
1276.1.49008 Boehringer Ingelheim Investigational Site
Celle
1276.1.49006 Boehringer Ingelheim Investigational Site
Dortmund
1276.1.49011 Boehringer Ingelheim Investigational Site
Dresden
1276.1.49003 Boehringer Ingelheim Investigational Site
Essen
1276.1.49007 Boehringer Ingelheim Investigational Site
Ingelheim
1276.1.49014 Boehringer Ingelheim Investigational Site
Neuwied
1276.1.49004 Boehringer Ingelheim Investigational Site
Offenbach
1276.1.49002 Boehringer Ingelheim Investigational Site
Stuhr-Brinkum
1276.1.49012 Boehringer Ingelheim Investigational Site
Teuchern

Other trials in Germany

South Korea10 sites

1276.1.82006 Boehringer Ingelheim Investigational Site
Deagu
1276.1.82010 Boehringer Ingelheim Investigational Site
Goyang
1276.1.82001 Boehringer Ingelheim Investigational Site
Incheon
1276.1.82009 Boehringer Ingelheim Investigational Site
Pusan
1276.1.82002 Boehringer Ingelheim Investigational Site
Seoul
1276.1.82004 Boehringer Ingelheim Investigational Site
Seoul
1276.1.82005 Boehringer Ingelheim Investigational Site
Seoul
1276.1.82007 Boehringer Ingelheim Investigational Site
Seoul
1276.1.82008 Boehringer Ingelheim Investigational Site
Seoul
1276.1.82003 Boehringer Ingelheim Investigational Site
Wŏnju

Other trials in South Korea

United Kingdom10 sites

1276.1.44002 Boehringer Ingelheim Investigational Site
Bolton
1276.1.44001 Boehringer Ingelheim Investigational Site
Bradford on Avon
1276.1.44005 Boehringer Ingelheim Investigational Site
Chippenham
1276.1.44006 Boehringer Ingelheim Investigational Site
Dagenham
1276.1.44004 Boehringer Ingelheim Investigational Site
Doncaster
1276.1.44008 Boehringer Ingelheim Investigational Site
Glasgow
1276.1.44003 Boehringer Ingelheim Investigational Site
Leeds
1276.1.44007 Boehringer Ingelheim Investigational Site
Manchester
1276.1.44011 Boehringer Ingelheim Investigational Site
Mortimer
1276.1.44009 Boehringer Ingelheim Investigational Site
Sandbach

Other trials in United Kingdom

Philippines9 sites

1276.1.63009 Boehringer Ingelheim Investigational Site
Cebu City, Cebu
1276.1.63002 Boehringer Ingelheim Investigational Site
Cebu City, Philippines
1276.1.63004 Boehringer Ingelheim Investigational Site
Davao City
1276.1.63003 Boehringer Ingelheim Investigational Site
Iloilo City
1276.1.63006 Boehringer Ingelheim Investigational Site
Manila
1276.1.63001 Boehringer Ingelheim Investigational Site
Marikina City
1276.1.63005 Boehringer Ingelheim Investigational Site
Maybunga, Pasig City
1276.1.63007 Boehringer Ingelheim Investigational Site
San Juan City
1276.1.63008 Boehringer Ingelheim Investigational Site
Tarlac City

Other trials in Philippines

Brazil8 sites

1276.1.55008 Boehringer Ingelheim Investigational Site
Belém
1276.1.55003 Boehringer Ingelheim Investigational Site
Brasília
1276.1.55006 Boehringer Ingelheim Investigational Site
Fortaleza
1276.1.55007 Boehringer Ingelheim Investigational Site
Fortaleza
1276.1.55009 Boehringer Ingelheim Investigational Site
Fortaleza
1276.1.55004 Boehringer Ingelheim Investigational Site
Goiânia
1276.1.55002 Boehringer Ingelheim Investigational Site
Porto Alegre
1276.1.55001 Boehringer Ingelheim Investigational Site
São Paulo

Other trials in Brazil

Serbia8 sites

1276.1.38104 Boehringer Ingelheim Investigational Site
Belgrade
1276.1.38105 Boehringer Ingelheim Investigational Site
Belgrade
1276.1.38106 Boehringer Ingelheim Investigational Site
Belgrade
1276.1.38107 Boehringer Ingelheim Investigational Site
Belgrade
1276.1.38103 Boehringer Ingelheim Investigational Site
Kragujevac
1276.1.38101 Boehringer Ingelheim Investigational Site
Niš
1276.1.38108 Boehringer Ingelheim Investigational Site
Novi Sad
1276.1.38102 Boehringer Ingelheim Investigational Site
Zaječar

Other trials in Serbia

Spain8 sites

1276.1.34048 Boehringer Ingelheim Investigational Site
Alicante
1276.1.34050 Boehringer Ingelheim Investigational Site
Alzira
1276.1.34028 Boehringer Ingelheim Investigational Site
Madrid
1276.1.34045 Boehringer Ingelheim Investigational Site
Pozuelo de Alarcón
1276.1.34034 Boehringer Ingelheim Investigational Site
Sabadell (Barcelona)
1276.1.34027 Boehringer Ingelheim Investigational Site
Salamanca
1276.1.34052 Boehringer Ingelheim Investigational Site
Tarragona
1276.1.34051 Boehringer Ingelheim Investigational Site
Zaragoza

Other trials in Spain

Czechia7 sites

1276.1.42002 Boehringer Ingelheim Investigational Site
Benátky nad Jizerou
1276.1.42008 Boehringer Ingelheim Investigational Site
Olomouc
1276.1.42007 Boehringer Ingelheim Investigational Site
Ostrava
1276.1.42009 Boehringer Ingelheim Investigational Site
Pilsen
1276.1.42003 Boehringer Ingelheim Investigational Site
Prague
1276.1.42004 Boehringer Ingelheim Investigational Site
Prague
1276.1.42010 Boehringer Ingelheim Investigational Site
Prague

Other trials in Czechia

Mexico7 sites

1276.1.52004 Boehringer Ingelheim Investigational Site
Aguascalientes
1276.1.52007 Boehringer Ingelheim Investigational Site
Aguascalientes
1276.1.52003 Boehringer Ingelheim Investigational Site
Guadalajara
1276.1.52002 Boehringer Ingelheim Investigational Site
Mexico City
1276.1.52001 Boehringer Ingelheim Investigational Site
Monterrey
1276.1.52006 Boehringer Ingelheim Investigational Site
San Lucas Tepetlcalco
1276.1.52005 Boehringer Ingelheim Investigational Site
Zapopan

Other trials in Mexico

Taiwan6 sites

1276.1.88005 Boehringer Ingelheim Investigational Site
Kaohsiung City
1276.1.88002 Boehringer Ingelheim Investigational Site
New Taipei City
1276.1.88001 Boehringer Ingelheim Investigational Site
Taichung
1276.1.88003 Boehringer Ingelheim Investigational Site
Taichung
1276.1.88004 Boehringer Ingelheim Investigational Site
Taichung
1276.1.88006 Boehringer Ingelheim Investigational Site
Taipei

Other trials in Taiwan

Turkey (Türkiye)6 sites

1276.1.90003 Boehringer Ingelheim Investigational Site
Ankara
1276.1.90004 Boehringer Ingelheim Investigational Site
Antalya
1276.1.90006 Boehringer Ingelheim Investigational Site
Denizli
1276.1.90002 Boehringer Ingelheim Investigational Site
Erzurum
1276.1.90005 Boehringer Ingelheim Investigational Site
Istanbul
1276.1.90001 Boehringer Ingelheim Investigational Site
Izmir

Other trials in Turkey (Türkiye)

Guatemala5 sites

1276.1.50002 Boehringer Ingelheim Investigational Site
Barbena Santa Rosa
1276.1.50003 Boehringer Ingelheim Investigational Site
Guatemala City
1276.1.50005 Boehringer Ingelheim Investigational Site
Guatemala City
1276.1.50006 Boehringer Ingelheim Investigational Site
Guatemala City
1276.1.50001 Boehringer Ingelheim Investigational Site
Quetzaltenango

Other trials in Guatemala

Peru5 sites

1276.1.51001 Boehringer Ingelheim Investigational Site
Lima
1276.1.51002 Boehringer Ingelheim Investigational Site
Lima
1276.1.51003 Boehringer Ingelheim Investigational Site
Lima
1276.1.51004 Boehringer Ingelheim Investigational Site
Lima
1276.1.51005 Boehringer Ingelheim Investigational Site
Lima

Other trials in Peru

Egypt4 sites

1276.1.95001 Boehringer Ingelheim Investigational Site
Abbasia Cairo, Egypt
1276.1.95003 Boehringer Ingelheim Investigational Site
Al Manial, Cairo, Egypt
1276.1.95004 Boehringer Ingelheim Investigational Site
Alexandria
1276.1.95002 Boehringer Ingelheim Investigational Site
El Darasa Cairo Egypt

Other trials in Egypt

Lebanon4 sites

1276.1.96001 Boehringer Ingelheim Investigational Site
Beirut
1276.1.96002 Boehringer Ingelheim Investigational Site
El Chouf
1276.1.96003 Boehringer Ingelheim Investigational Site
Saida
1276.1.96004 Boehringer Ingelheim Investigational Site
Saida

Other trials in Lebanon

Malaysia3 sites

1276.1.60002 Boehringer Ingelheim Investigational Site
Ipoh, Perak
1276.1.60001 Boehringer Ingelheim Investigational Site
Johor Bahru
1276.1.60003 Boehringer Ingelheim Investigational Site
Kubang Kerian

Other trials in Malaysia

Thailand3 sites

1276.1.66001 Boehringer Ingelheim Investigational Site
Bangkok, Thailand
1276.1.66003 Boehringer Ingelheim Investigational Site
Bangkok, Thailand
1276.1.66002 Boehringer Ingelheim Investigational Site
Nakhon Ratchasima

Other trials in Thailand

About this study

Official title: A 24-week Phase III Randomized, Double-blind, Parallel Group Study to Evaluate the Efficacy and Safety of Twice Daily Oral Administration of Empagliflozin + Metformin Compared With the Individual Components of Empagliflozin or Metformin in Drug Naive Patients With Type 2 Diabetes Mellitus

Conditions: Diabetes Mellitus, Type 2, Hyperglycemia
Being tested: Metformin 500 mg bid, Metformin 1000 mg bid, Empagliflozin low dose qd, Empagliflozin high dose qd, Empagliflozin low dose bid
Medical subject headings: Diabetes Mellitus, Type 2, Hyperglycemia

What participants receive

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

Metformin 500 mg bidDrug
Metformin 500 mg twice daily
Metformin 1000 mg bidDrug
Metformin 1000 mg twice daily
Empagliflozin low dose qdDrug
Empagliflozin low dose once daily
Empagliflozin high dose qdDrug
Empagliflozin high dose once daily
Empagliflozin low dose bidDrug
Empagliflozin low dose split twice daily
Metformin 500 mg bidDrug
Metformin 500 mg twice daily
Empagliflozin high dose bidDrug
Empagliflozin high dose split twice daily
Empagliflozin low dose bidDrug
Empagliflozin low dose split twice daily
Metformin 1000 mg bidDrug
Metformin 1000 mg twice daily
Metformin 500 mg bidDrug
Metformin 500 mg twice daily
Metformin 1000 mg bidDrug
Metformin 1000 mg twice daily
Empagliflozin high dose bidDrug
Empagliflozin high dose split twice daily
Metformin 1000 mg bidDrug
Metformin 1000 mg twice daily
Empagliflozin high dose bidDrug
Empagliflozin high dose split twice daily

Study groups in NCT01719003
Study group	Role	What they receive
Empagliflozin low dose qd	Experimental	Empagliflozin low dose once daily Receives: Drug: Empagliflozin low dose qd
Empagliflozin high dose qd	Experimental	Empagliflozin high dose once daily Receives: Drug: Empagliflozin high dose qd
OL empa high dose + met 1000 mg bid	Experimental	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. Receives: Drug: Metformin 1000 mg bid; Drug: Empagliflozin high dose bid
Empagliflozin low dose + met 500 mg bid	Experimental	Empagliflozin low dose split twice daily + metformin 500 mg twice daily Receives: Drug: Metformin 500 mg bid; Drug: Empagliflozin low dose bid
Empagliflozin low dose + met 1000 mg bid	Experimental	Empagliflozin low dose split twice daily + metformin 1000 mg twice daily Receives: Drug: Empagliflozin low dose bid; Drug: Metformin 1000 mg bid
Empagliflozin high dose + met 500 mg bid	Experimental	Empagliflozin high dose split twice daily + metformin 500 mg twice daily Receives: Drug: Metformin 500 mg bid; Drug: Empagliflozin high dose bid
Empagliflozin high dose + met 1000mg bid	Experimental	Empagliflozin high dose split twice daily + metformin 1000 mg twice daily Receives: Drug: Metformin 1000 mg bid; Drug: Empagliflozin high dose bid
Metformin 500 mg bid	Experimental	Metformin 500 mg twice daily Receives: Drug: Metformin 500 mg bid
Metformin 1000 mg bid	Experimental	Metformin 1000 mg twice daily Receives: Drug: Metformin 1000 mg bid

What is being measured

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

HbA1c (Glycosylated Haemoglobin) Change From Baseline at Week 24
Change from baseline in HbA1c (%) after 24 weeks of treatment. "Baseline" refers to the last observation before the start of any randomised trial treatment medication. Means presented are the adjusted means
Measured: baseline and 24 weeks

Secondary outcomes (2)

FPG (Fasting Plasma Glucose) Change From Baseline at Week 24
Change from baseline in FPG (mg/dL) after 24 weeks of treatment. "Baseline" refers to the last observation before the start of any randomised trial treatment medication. Means presented are the adjusted means.
Measured: baseline and 24 weeks
Body Weight Change From Baseline at Week 24
Change from baseline in body weight (kg) after 24 weeks of treatment. "Baseline" refers to the last observation before the start of any randomised trial treatment. medication. Means presented are the adjusted means.
Measured: baseline and 24 weeks

Timeline

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

Oct 2012Dec 2014

First posted1 Nov 2012 (estimated)
Study startOct 2012
Primary completionNov 2014
Study completionDec 2014

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 (1)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: 1,413 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01719003
Sponsor's protocol ID: 1276.1
Other IDs: 2010-021375-92
Status last verified: Jan 2016
First submitted: 30 Oct 2012
Last updated: 19 Feb 2016
Results posted: Yes, on ClinicalTrials.gov

Publications

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.
PubMed 27493136

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 19 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A 24-week Phase III Randomized, Double-blind, Parallel Group Study to Evaluate the Efficacy and Safety of Twice Daily Oral Administration of Empagliflozin + Metformin Compared With the Individual Components of Empagliflozin or Metformin in Drug Naive Patients With Type 2 Diabetes Mellitus
ClinicalTrials.gov ID: NCT01719003
Acronym / sponsor ID: 1276.1
Conditions: Diabetes Mellitus, Type 2, Hyperglycemia
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 1,413 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Collaborators: Eli Lilly and Company
Study start: Oct 2012
Primary completion: Nov 2014 (actual)
Study completion: Dec 2014 (actual)
First posted: 1 Nov 2012 (estimated)
Results: Posted 19 Feb 2016

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: 9

Arm	Type	Receives
Empagliflozin low dose qd	Experimental	Drug: Empagliflozin low dose qdEmpagliflozin low dose once daily
Empagliflozin high dose qd	Experimental	Drug: Empagliflozin high dose qdEmpagliflozin high dose once daily
OL empa high dose + met 1000 mg bid	Experimental	Drug: Metformin 1000 mg bid, Drug: Empagliflozin high dose bidOpen 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.
Empagliflozin low dose + met 500 mg bid	Experimental	Drug: Metformin 500 mg bid, Drug: Empagliflozin low dose bidEmpagliflozin low dose split twice daily + metformin 500 mg twice daily
Empagliflozin low dose + met 1000 mg bid	Experimental	Drug: Empagliflozin low dose bid, Drug: Metformin 1000 mg bidEmpagliflozin low dose split twice daily + metformin 1000 mg twice daily
Empagliflozin high dose + met 500 mg bid	Experimental	Drug: Metformin 500 mg bid, Drug: Empagliflozin high dose bidEmpagliflozin high dose split twice daily + metformin 500 mg twice daily
Empagliflozin high dose + met 1000mg bid	Experimental	Drug: Metformin 1000 mg bid, Drug: Empagliflozin high dose bidEmpagliflozin high dose split twice daily + metformin 1000 mg twice daily
Metformin 500 mg bid	Experimental	Drug: Metformin 500 mg bidMetformin 500 mg twice daily
Metformin 1000 mg bid	Experimental	Drug: Metformin 1000 mg bidMetformin 1000 mg twice daily

Who may qualify

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

Key inclusion criteria (4 listed)

Diagnosis of type 2 diabetes mellitus prior to informed consent
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
HbA1c >=7.5% and <= 12% (>=58.5 mmol/mol and <=107.7 mmol/mol)
Body Mass Index (BMI) <= 45 kg/m2 at screening

Key exclusion criteria (4 listed)

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)
Any antidiabetic drug within 12 weeks prior to randomization
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
Contraindications to metformin according to the local label

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
Metformin 500 mg bidMetformin 500 mg twice daily	Drug	Empagliflozin low dose + met 500 mg bid
Metformin 1000 mg bidMetformin 1000 mg twice daily	Drug	OL empa high dose + met 1000 mg bid
Empagliflozin low dose qdEmpagliflozin low dose once daily	Drug	Empagliflozin low dose qd
Empagliflozin high dose qdEmpagliflozin high dose once daily	Drug	Empagliflozin high dose qd
Empagliflozin low dose bidEmpagliflozin low dose split twice daily	Drug	Empagliflozin low dose + met 500 mg bid
Metformin 500 mg bidMetformin 500 mg twice daily	Drug	Empagliflozin high dose + met 500 mg bid
Empagliflozin high dose bidEmpagliflozin high dose split twice daily	Drug	OL empa high dose + met 1000 mg bid
Empagliflozin low dose bidEmpagliflozin low dose split twice daily	Drug	Empagliflozin low dose + met 1000 mg bid
Metformin 1000 mg bidMetformin 1000 mg twice daily	Drug	Empagliflozin high dose + met 1000mg bid
Metformin 500 mg bidMetformin 500 mg twice daily	Drug	Metformin 500 mg bid
Metformin 1000 mg bidMetformin 1000 mg twice daily	Drug	Metformin 1000 mg bid
Empagliflozin high dose bidEmpagliflozin high dose split twice daily	Drug	Empagliflozin high dose + met 1000mg bid
Metformin 1000 mg bidMetformin 1000 mg twice daily	Drug	Empagliflozin low dose + met 1000 mg bid
Empagliflozin high dose bidEmpagliflozin high dose split twice daily	Drug	Empagliflozin high dose + met 500 mg bid

Primary outcome

HbA1c (Glycosylated Haemoglobin) Change From Baseline at Week 24
Time frame: baseline and 24 weeks
Change from baseline in HbA1c (%) after 24 weeks of treatment. "Baseline" refers to the last observation before the start of any randomised trial treatment medication. Means presented are the adjusted means

2 secondary outcomes

FPG (Fasting Plasma Glucose) Change From Baseline at Week 24
Time frame: baseline and 24 weeks
Body Weight Change From Baseline at Week 24
Time frame: baseline and 24 weeks

Results and safety

Results posted to the registry on 19 Feb 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Empagliflozin 12.5 mg Bid+ Metformin 1000 mg Bid	170	161
Empagliflozin 12.5 mg Bid+ Metformin 500 mg Bid	170	153
Empagliflozin 5 mg Bid + Metformin 1000 mg Bid	171	154
Empagliflozin 5 mg Bid + Metformin 500 mg Bid	169	156
Empagliflozin 25 mg qd	167	150
Empagliflozin 10 mg qd	172	160
Metformin 1000 mg Bid	170	150
Metformin 500 mg Bid	171	151
Empagliflozin 12.5 mg Bid + Metformin 1000 mg Bid OL	53	49

Primary outcome: HbA1c (Glycosylated Haemoglobin) Change From Baseline at Week 24

Time frame: baseline and 24 weeks. Mean (Standard Error). Unit: percentage of HbA1c

Measure	Empagliflozin 12.5 mg Bid+ Metformin 1000 mg Bid n = 159	Empagliflozin 12.5 mg Bid+ Metformin 500 mg Bid n = 149	Empagliflozin 5 mg Bid + Metformin 1000 mg Bid n = 151	Empagliflozin 5 mg Bid + Metformin 500 mg Bid n = 153	Empagliflozin 25 mg qd n = 143	Empagliflozin 10 mg qd n = 156	Metformin 1000 mg Bid n = 146	Metformin 500 mg Bid n = 142
Value	-2.08 (0.08)	-1.93 (0.08)	-2.07 (0.08)	-1.98 (0.08)	-1.36 (0.08)	-1.35 (0.08)	-1.75 (0.09)	-1.18 (0.08)

Empagliflozin 12.5 mg Bid+ Metformin 1000 mg Bid vs Metformin 1000 mg Bid: Adjusted mean: -0.33 (95% CI -0.56 to -0.10), p = 0.0056, Mixed Models Analysis
Empagliflozin 12.5 mg Bid+ Metformin 1000 mg Bid vs Empagliflozin 25 mg qd: Adjusted mean: -0.72 (95% CI -0.95 to -0.48), p <0.0001, Mixed Models Analysis
Empagliflozin 12.5 mg Bid+ Metformin 500 mg Bid vs Metformin 500 mg Bid: Adjusted Mean: -0.75 (95% CI -0.98 to -0.51), p <0.0001, Mixed Models Analysis

Population analysed: FAS observed cases (OC) (Only patients with available data are analysed)

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events with an onset after the first dose of randomised trial medication up to a period of 7 days after the last dose (Up to 237 days). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Empagliflozin 12.5 mg Bid+ Metformin 1000 mg Bid	2 of 170 (1.2%)	48 of 170 (28.2%)	Not reported
Empagliflozin 12.5 mg Bid+ Metformin 500 mg Bid	6 of 170 (3.5%)	40 of 170 (23.5%)	Not reported
Empagliflozin 5 mg Bid + Metformin 1000 mg Bid	3 of 171 (1.8%)	35 of 171 (20.5%)	Not reported
Empagliflozin 5 mg Bid + Metformin 500 mg Bid	2 of 169 (1.2%)	42 of 169 (24.9%)	Not reported
Empagliflozin 25 mg qd	3 of 167 (1.8%)	41 of 167 (24.6%)	Not reported
Empagliflozin 10 mg qd	1 of 172 (0.6%)	36 of 172 (20.9%)	Not reported
Metformin 1000 mg Bid	3 of 170 (1.8%)	53 of 170 (31.2%)	Not reported
Metformin 500 mg Bid	3 of 171 (1.8%)	38 of 171 (22.2%)	Not reported
Empagliflozin 12.5 mg Bid + Metformin 1000 mg Bid OL	2 of 53 (3.8%)	16 of 53 (30.2%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 27493136Hadjadj 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.

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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

190 sites in 21 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 4 inclusion and 4 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 19 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 190 sites in United States, France, Russia, Canada, Germany and 16 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 19 Feb 2016). 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?

HbA1c (Glycosylated Haemoglobin) Change From Baseline at Week 24 (time frame: baseline and 24 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 NCT01719003, which also lists 1 linked publication.

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 19 Feb 2016.