Diabetes Mellitus, Type 2Phase 2NCT01649297

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

A Phase 2 study testing empagliflozin (low dose qd), Empagliflozin (high dose qd) and empagliflozin (high dose bid) in people with Diabetes Mellitus, Type 2, run by Boehringer Ingelheim at 139 sites in 18 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

Who is it for?: Ages 18 years and older
Conditions the study is for: Diabetes Mellitus, Type 2
What is being tested?: empagliflozin (low dose qd), Empagliflozin (high dose qd) and empagliflozin (high dose bid)
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 983 participants
Where: 139 sitesin 18 countries
Study dates: Oct 2012to Dec 2013
Phase: Phase 2
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

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

Who cannot join

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

Trial locations and contacts

139 sites in 18 countries.

Country

City, postcode or hospital

139 sites in 18 countries

United States39 sites

1276.10.11001 Boehringer Ingelheim Investigational Site
Bangor, Maine
1276.10.11010 Boehringer Ingelheim Investigational Site
Bradenton, Florida
1276.10.11011 Boehringer Ingelheim Investigational Site
Brooklyn, New York
1276.10.11027 Boehringer Ingelheim Investigational Site
Chicago, Illinois
1276.10.11018 Boehringer Ingelheim Investigational Site
Cincinnati, Ohio
1276.10.11042 Boehringer Ingelheim Investigational Site
Corpus Christi, Texas
1276.10.11013 Boehringer Ingelheim Investigational Site
Dallas, Texas
1276.10.11005 Boehringer Ingelheim Investigational Site
Davie, Florida
1276.10.11043 Boehringer Ingelheim Investigational Site
Dayton, Ohio
1276.10.11030 Boehringer Ingelheim Investigational Site
Dunwoody, Georgia
1276.10.11055 Boehringer Ingelheim Investigational Site
Edison, New Jersey
1276.10.11020 Boehringer Ingelheim Investigational Site
Elwood, Indiana
1276.10.11022 Boehringer Ingelheim Investigational Site
Fleetwood, Pennsylvania
1276.10.11036 Boehringer Ingelheim Investigational Site
Florence, Alabama
1276.10.11026 Boehringer Ingelheim Investigational Site
Houston, Texas
1276.10.11031 Boehringer Ingelheim Investigational Site
Houston, Texas
1276.10.11034 Boehringer Ingelheim Investigational Site
Houston, Texas
1276.10.11058 Boehringer Ingelheim Investigational Site
Jackson, Mississippi
1276.10.11004 Boehringer Ingelheim Investigational Site
Jacksonville, Florida
1276.10.11003 Boehringer Ingelheim Investigational Site
Johnson City, Tennessee
1276.10.11049 Boehringer Ingelheim Investigational Site
Jonesboro, Arkansas
1276.10.11017 Boehringer Ingelheim Investigational Site
Kettering, Ohio
1276.10.11040 Boehringer Ingelheim Investigational Site
Lomita, California
1276.10.11033 Boehringer Ingelheim Investigational Site
Los Angeles, California
1276.10.11051 Boehringer Ingelheim Investigational Site
Miami, Florida
1276.10.11035 Boehringer Ingelheim Investigational Site
North Myrtle Beach, North Carolina
1276.10.11012 Boehringer Ingelheim Investigational Site
Norwalk, Connecticut
1276.10.11009 Boehringer Ingelheim Investigational Site
Oakland Park, Florida
1276.10.11044 Boehringer Ingelheim Investigational Site
Palm Harbor, Florida
1276.10.11028 Boehringer Ingelheim Investigational Site
Pearland, Texas
1276.10.11016 Boehringer Ingelheim Investigational Site
Port Orchard, Washington
1276.10.11002 Boehringer Ingelheim Investigational Site
Rancho Cucamonga, California
1276.10.11050 Boehringer Ingelheim Investigational Site
Sacramento, California
1276.10.11029 Boehringer Ingelheim Investigational Site
San Antonio, Texas
1276.10.11024 Boehringer Ingelheim Investigational Site
Spokane, Washington
1276.10.11048 Boehringer Ingelheim Investigational Site
Sterling Heights, Michigan
1276.10.11047 Boehringer Ingelheim Investigational Site
Waterbury, Connecticut
1276.10.11015 Boehringer Ingelheim Investigational Site
West Hills, California
1276.10.11041 Boehringer Ingelheim Investigational Site
Winston-Salem, North Carolina

Other trials in United States

Canada10 sites

1276.10.20002 Boehringer Ingelheim Investigational Site
Bathurst, New Brunswick
1276.10.20001 Boehringer Ingelheim Investigational Site
Brampton, Ontario
1276.10.20008 Boehringer Ingelheim Investigational Site
Calgary, Alberta
1276.10.20007 Boehringer Ingelheim Investigational Site
Corunna, Ontario
1276.10.20004 Boehringer Ingelheim Investigational Site
Drummondville, Quebec
1276.10.20003 Boehringer Ingelheim Investigational Site
Point Claire, Quebec
1276.10.20006 Boehringer Ingelheim Investigational Site
Sarnia, Ontario
1276.10.20005 Boehringer Ingelheim Investigational Site
Surrey, British Columbia
1276.10.20009 Boehringer Ingelheim Investigational Site
Victoriaville, Quebec
1276.10.20010 Boehringer Ingelheim Investigational Site
Winnipeg, Manitoba

Other trials in Canada

France10 sites

1276.10.33002 Boehringer Ingelheim Investigational Site
Aire-sur-l'Adour
1276.10.33003 Boehringer Ingelheim Investigational Site
Bischheim
1276.10.33009 Boehringer Ingelheim Investigational Site
Bourg-des-Comptes
1276.10.33014 Boehringer Ingelheim Investigational Site
Bourges
1276.10.33007 Boehringer Ingelheim Investigational Site
Broglie
1276.10.33001 Boehringer Ingelheim Investigational Site
Mont-de-Marsan
1276.10.33008 Boehringer Ingelheim Investigational Site
Paris
1276.10.33006 Boehringer Ingelheim Investigational Site
Saint Vinecnt de Tyrosse
1276.10.33011 Boehringer Ingelheim Investigational Site
Segré
1276.10.33004 Boehringer Ingelheim Investigational Site
Strasbourg

Other trials in France

Italy9 sites

1276.10.39004 Boehringer Ingelheim Investigational Site
Arenzano (GE)
1276.10.39003 Boehringer Ingelheim Investigational Site
Bologna
1276.10.39007 Boehringer Ingelheim Investigational Site
Catanzaro
1276.10.39009 Boehringer Ingelheim Investigational Site
Catanzaro
1276.10.39002 Boehringer Ingelheim Investigational Site
Naples
1276.10.39006 Boehringer Ingelheim Investigational Site
Palermo
1276.10.39001 Boehringer Ingelheim Investigational Site
Roma
1276.10.39008 Boehringer Ingelheim Investigational Site
Roma
1276.10.39005 Boehringer Ingelheim Investigational Site
Torino

Other trials in Italy

Russia8 sites

1276.10.70001 Boehringer Ingelheim Investigational Site
Moscow
1276.10.70002 Boehringer Ingelheim Investigational Site
Moscow
1276.10.70003 Boehringer Ingelheim Investigational Site
Moscow
1276.10.70004 Boehringer Ingelheim Investigational Site
Moscow
1276.10.70005 Boehringer Ingelheim Investigational Site
Moscow
1276.10.70007 Boehringer Ingelheim Investigational Site
Moscow
1276.10.70008 Boehringer Ingelheim Investigational Site
Saint Petersburg
1276.10.70009 Boehringer Ingelheim Investigational Site
Saint Petersburg

Other trials in Russia

Germany7 sites

1276.10.49001 Boehringer Ingelheim Investigational Site
Aschaffenburg
1276.10.49006 Boehringer Ingelheim Investigational Site
Berlin
1276.10.49007 Boehringer Ingelheim Investigational Site
Berlin
1276.10.49005 Boehringer Ingelheim Investigational Site
Essen
1276.10.49004 Boehringer Ingelheim Investigational Site
Frankfurt
1276.10.49002 Boehringer Ingelheim Investigational Site
Nuremberg
1276.10.49003 Boehringer Ingelheim Investigational Site
Rehlingen-Siersburg

Other trials in Germany

Poland7 sites

1276.10.48001 Boehringer Ingelheim Investigational Site
Bialystok
1276.10.48002 Boehringer Ingelheim Investigational Site
Bialystok
1276.10.48008 Boehringer Ingelheim Investigational Site
Giżycko
1276.10.48005 Boehringer Ingelheim Investigational Site
Katowice
1276.10.48006 Boehringer Ingelheim Investigational Site
Katowice
1276.10.48004 Boehringer Ingelheim Investigational Site
Krakow
1276.10.48003 Boehringer Ingelheim Investigational Site
Warsaw

Other trials in Poland

Georgia6 sites

1276.10.99501 Boehringer Ingelheim Investigational Site
Tbilisi
1276.10.99502 Boehringer Ingelheim Investigational Site
Tbilisi
1276.10.99503 Boehringer Ingelheim Investigational Site
Tbilisi
1276.10.99504 Boehringer Ingelheim Investigational Site
Tbilisi
1276.10.99505 Boehringer Ingelheim Investigational Site
Tbilisi
1276.10.99506 Boehringer Ingelheim Investigational Site
Tbilisi

Other trials in Georgia

South Africa6 sites

1276.10.27004 Boehringer Ingelheim Investigational Site
Paarl
1276.10.27003 Boehringer Ingelheim Investigational Site
Parow
1276.10.27006 Boehringer Ingelheim Investigational Site
Plumstead, Cape Town
1276.10.27001 Boehringer Ingelheim Investigational Site
Pretoria
1276.10.27005 Boehringer Ingelheim Investigational Site
Pretoria
1276.10.27002 Boehringer Ingelheim Investigational Site
Somerset West

Other trials in South Africa

Spain6 sites

1276.10.34005 Boehringer Ingelheim Investigational Site
Barcelona
1276.10.34001 Boehringer Ingelheim Investigational Site
L'Hospitalet de Llobregat
1276.10.34003 Boehringer Ingelheim Investigational Site
L'Hospitalet de Llobregat
1276.10.34002 Boehringer Ingelheim Investigational Site
les Borges del Camp
1276.10.34004 Boehringer Ingelheim Investigational Site
Sant Adria Del Besos
1276.10.34006 Boehringer Ingelheim Investigational Site
Vic

Other trials in Spain

Guatemala5 sites

1276.10.50201 Boehringer Ingelheim Investigational Site
Guatemala Ciudad
1276.10.50203 Boehringer Ingelheim Investigational Site
Guatemala Ciudad
1276.10.50204 Boehringer Ingelheim Investigational Site
Guatemala Ciudad
1276.10.50205 Boehringer Ingelheim Investigational Site
Guatemala Ciudad
1276.10.50202 Boehringer Ingelheim Investigational Site
Quetzaltenango Ciudad

Other trials in Guatemala

Mexico5 sites

1276.10.52003 Boehringer Ingelheim Investigational Site
Durango
1276.10.52001 Boehringer Ingelheim Investigational Site
Mexico City
1276.10.52002 Boehringer Ingelheim Investigational Site
Mexico City
1276.10.52005 Boehringer Ingelheim Investigational Site
Pachuca
1276.10.52004 Boehringer Ingelheim Investigational Site
Tijuana

Other trials in Mexico

Ukraine5 sites

1276.10.38002 Boehringer Ingelheim Investigational Site
Kharkiv
1276.10.38007 Boehringer Ingelheim Investigational Site
Kharkiv
1276.10.38001 Boehringer Ingelheim Investigational Site
Kiev
1276.10.38004 Boehringer Ingelheim Investigational Site
Kiev
1276.10.38005 Boehringer Ingelheim Investigational Site
Kyiv

Other trials in Ukraine

Estonia4 sites

1276.10.37203 Boehringer Ingelheim Investigational Site
Pärnu
1276.10.37201 Boehringer Ingelheim Investigational Site
Tallinn
1276.10.37202 Boehringer Ingelheim Investigational Site
Tallinn
1276.10.37204 Boehringer Ingelheim Investigational Site
Viljandi County

Other trials in Estonia

Latvia4 sites

1276.10.37102 Boehringer Ingelheim Investigational Site
Daugavpils
1276.10.37104 Boehringer Ingelheim Investigational Site
Ogre
1276.10.37101 Boehringer Ingelheim Investigational Site
Riga
1276.10.37103 Boehringer Ingelheim Investigational Site
Tukums

Other trials in Latvia

Lithuania4 sites

1276.10.37003 Boehringer Ingelheim Investigational Site
Kaunas
1276.10.37004 Boehringer Ingelheim Investigational Site
Kaunas
1276.10.37002 Boehringer Ingelheim Investigational Site
Klaipėda
1276.10.37001 Boehringer Ingelheim Investigational Site
Vilnius

Other trials in Lithuania

Australia2 sites

1276.10.61001 Boehringer Ingelheim Investigational Site
Box Hill, Victoria
1276.10.61002 Boehringer Ingelheim Investigational Site
Wollongong, New South Wales

Other trials in Australia

New Zealand2 sites

1276.10.64001 Boehringer Ingelheim Investigational Site
Christchurch
1276.10.64002 Boehringer Ingelheim Investigational Site
Greenlane East Auckland NZ

Other trials in New Zealand

About this study

Official title: A Randomised, Double Blind, Placebo Controlled, Parallel Group Efficacy and Safety Study of Oral Administration of Empagliflozin Twice Daily Versus Once Daily in Two Different Daily Doses Over 16 Weeks as add-on Therapy to a Twice Daily Dosing Regimen of Metformin in Patients With Type 2 Diabetes Mellitus and Insufficient Glycaemic Control

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.

Conditions: Diabetes Mellitus, Type 2
Being tested: Placebo, empagliflozin (low dose qd), Empagliflozin (high dose qd), empagliflozin (high dose bid), empagliflozin (low dose bid)
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.

PlaceboDrug
Patients receive placebo matching empagliflozin (low dose qd)
PlaceboDrug
Patients receive placebo matching empagliflozin (low dose bid)
PlaceboDrug
Patients receive placebo matching Empagliflozin (high dose qd)
PlaceboDrug
Patients receive placebo matching Empagliflozin (high dose qd)
PlaceboDrug
Patients receive placebo matching Empagliflozin (high dose qd)
empagliflozin (low dose qd)Drug
Patients receive Empagliflozin low dose once daily
PlaceboDrug
Patients receive placebo matching empagliflozin (low dose qd)
PlaceboDrug
Patients receive placebo matching empagliflozin (low dose bid)
PlaceboDrug
Patients receive placebo matching Empagliflozin (high dose bid)
PlaceboDrug
Patients receive placebo matching Empagliflozin (high dose bid)
PlaceboDrug
Patients receive placebo matching empagliflozin (low dose qd)
PlaceboDrug
Patients receive placebo matching empagliflozin (low dose bid)
PlaceboDrug
Patients receive placebo matching Empagliflozin (high dose bid)
PlaceboDrug
Patients receive placebo matching empagliflozin (low dose qd)
PlaceboDrug
Patients receive placebo matching empagliflozin (low dose bid)
PlaceboDrug
Patients receive placebo matching Empagliflozin (high dose bid)
Empagliflozin (high dose qd)Drug
Patients receive Empagliflozin high dose once daily
empagliflozin (high dose bid)Drug
Patients receive Empagliflozin high dose split twice daily
PlaceboDrug
Patients receive placebo matching Empagliflozin (high dose qd)
empagliflozin (low dose bid)Drug
Patients receive Empagliflozin low dose split twice daily

Study groups in NCT01649297
Study group	Role	What they receive
empagliflozin (high dose qd)	Experimental	Patients receive Empagliflozin high dose once daily Receives: Drug: Placebo; Drug: Empagliflozin (high dose qd)
empagliflozin (high dose bid)	Experimental	Patients receive Empagliflozin high dose split twice daily Receives: Drug: Placebo; Drug: empagliflozin (high dose bid)
empagliflozin (low dose qd)	Experimental	Patients receive Empagliflozin low dose once daily Receives: Drug: empagliflozin (low dose qd); Drug: Placebo
empagliflozin (low dose bid)	Experimental	Patients receive Empagliflozin low dose split twice daily Receives: Drug: Placebo; Drug: empagliflozin (low dose bid)
Placebo	Placebo comparator	Patients receive placebo matching Empagliflozin Receives: Drug: Placebo

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 16
Change from baseline in HbA1c (%) after 16 weeks of treatment. The term 'baseline' refers to the last observation prior to the first intake of any randomised study medication.
Means provided are the adjusted means.
Measured: Baseline and 16 weeks

Secondary outcomes (1)

Fasting Plasma Glucose (FPG) Change From Baseline at Week 16
Change from baseline in FPG (mg/dL) after 16 weeks of treatment. The term 'baseline' refers to the last observation prior to the first intake of any randomised study medication.
Means provided are the adjusted means.
Measured: Baseline and 16 weeks

Timeline

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

Oct 2012Dec 2013

First posted25 Jul 2012 (estimated)
Study startOct 2012
Primary completionDec 2013
Study completionDec 2013

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 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Enrolment: 983 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01649297
Sponsor's protocol ID: 1276.10
Other IDs: 2012-000905-53
Status last verified: Jun 2015
First submitted: 23 Jul 2012
Last updated: 23 Jul 2015
Results posted: Yes, on ClinicalTrials.gov

Publications

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.
PubMed 35472672

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 23 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomised, Double Blind, Placebo Controlled, Parallel Group Efficacy and Safety Study of Oral Administration of Empagliflozin Twice Daily Versus Once Daily in Two Different Daily Doses Over 16 Weeks as add-on Therapy to a Twice Daily Dosing Regimen of Metformin in Patients With Type 2 Diabetes Mellitus and Insufficient Glycaemic Control
ClinicalTrials.gov ID: NCT01649297
Acronym / sponsor ID: 1276.10
Conditions: Diabetes Mellitus, Type 2
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 983 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Collaborators: Eli Lilly and Company
Study start: Oct 2012
Primary completion: Dec 2013 (actual)
Study completion: Dec 2013 (actual)
First posted: 25 Jul 2012 (estimated)
Results: Posted 23 Jul 2015

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: 5

Arm	Type	Receives
empagliflozin (high dose qd)	Experimental	Drug: Placebo, Drug: Empagliflozin (high dose qd)Patients receive Empagliflozin high dose once daily
empagliflozin (high dose bid)	Experimental	Drug: Placebo, Drug: empagliflozin (high dose bid)Patients receive Empagliflozin high dose split twice daily
empagliflozin (low dose qd)	Experimental	Drug: empagliflozin (low dose qd), Drug: PlaceboPatients receive Empagliflozin low dose once daily
empagliflozin (low dose bid)	Experimental	Drug: Placebo, Drug: empagliflozin (low dose bid)Patients receive Empagliflozin low dose split twice daily
Placebo	Placebo comparator	Drug: PlaceboPatients receive placebo matching Empagliflozin

Who may qualify

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

Key inclusion criteria (5 listed)

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

Key exclusion criteria (2 listed)

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

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
PlaceboPatients receive placebo matching empagliflozin (low dose qd)	Drug	empagliflozin (high dose qd)
PlaceboPatients receive placebo matching empagliflozin (low dose bid)	Drug	Placebo
PlaceboPatients receive placebo matching Empagliflozin (high dose qd)	Drug	empagliflozin (high dose bid)
PlaceboPatients receive placebo matching Empagliflozin (high dose qd)	Drug	empagliflozin (low dose bid)
PlaceboPatients receive placebo matching Empagliflozin (high dose qd)	Drug	Placebo
empagliflozin (low dose qd)Patients receive Empagliflozin low dose once daily	Drug	empagliflozin (low dose qd)
PlaceboPatients receive placebo matching empagliflozin (low dose qd)	Drug	empagliflozin (low dose bid)
PlaceboPatients receive placebo matching empagliflozin (low dose bid)	Drug	empagliflozin (low dose qd)
PlaceboPatients receive placebo matching Empagliflozin (high dose bid)	Drug	empagliflozin (high dose qd)
PlaceboPatients receive placebo matching Empagliflozin (high dose bid)	Drug	Placebo
PlaceboPatients receive placebo matching empagliflozin (low dose qd)	Drug	empagliflozin (high dose bid)
PlaceboPatients receive placebo matching empagliflozin (low dose bid)	Drug	empagliflozin (high dose qd)
PlaceboPatients receive placebo matching Empagliflozin (high dose bid)	Drug	empagliflozin (low dose bid)
PlaceboPatients receive placebo matching empagliflozin (low dose qd)	Drug	Placebo
PlaceboPatients receive placebo matching empagliflozin (low dose bid)	Drug	empagliflozin (high dose bid)
PlaceboPatients receive placebo matching Empagliflozin (high dose bid)	Drug	empagliflozin (low dose qd)
Empagliflozin (high dose qd)Patients receive Empagliflozin high dose once daily	Drug	empagliflozin (high dose qd)
empagliflozin (high dose bid)Patients receive Empagliflozin high dose split twice daily	Drug	empagliflozin (high dose bid)
PlaceboPatients receive placebo matching Empagliflozin (high dose qd)	Drug	empagliflozin (low dose qd)
empagliflozin (low dose bid)Patients receive Empagliflozin low dose split twice daily	Drug	empagliflozin (low dose bid)

Primary outcome

HbA1c (Glycosylated Haemoglobin) Change From Baseline at Week 16
Time frame: Baseline and 16 weeks
Change from baseline in HbA1c (%) after 16 weeks of treatment. The term 'baseline' refers to the last observation prior to the first intake of any randomised study medication. Means provided are the adjusted means.

1 secondary outcome

Fasting Plasma Glucose (FPG) Change From Baseline at Week 16
Time frame: Baseline and 16 weeks

Results and safety

Results posted to the registry on 23 Jul 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Empa 12.5mg BID	219	205
Empa 25mg QD	218	205
Empa 5mg BID	219	202
Empa 10mg QD	220	201
Placebo	107	103

Primary outcome: HbA1c (Glycosylated Haemoglobin) Change From Baseline at Week 16

Time frame: Baseline and 16 weeks. Mean (Standard Error). Unit: percentage of HbA1c

Measure	Empa 12.5mg BID n = 215	Empa 25mg QD n = 214	Empa 5mg BID n = 215	Empa 10mg QD n = 213	Placebo n = 107
Value	-0.83 (0.05)	-0.72 (0.05)	-0.66 (0.05)	-0.64 (0.05)	-0.22 (0.07)

Empa 5mg BID vs Empa 10mg QD: Adjusted mean difference: -0.02 (95% CI -0.16 to 0.13), p <0.0001, ANCOVA
Empa 12.5mg BID vs Empa 25mg QD: Adjusted mean difference: -0.11 (95% CI -0.26 to 0.03), p <0.0001, ANCOVA
Empa 12.5mg BID vs Placebo: Adjusted mean difference: -0.61 (95% CI -0.79 to -0.44), p <0.0001, ANCOVA

Population analysed: Full Analysis Set (FAS) is the basis for the intention-to-treat analysis. FAS with last observation carried forward (LOCF) imputation is used as the primary method of accounting for missing data. Values after the patient started rescue medication were excluded from analysis (and imputed with an LOCF procedure).

1 secondary outcome is reported in the full results.

Adverse events

Time frame: 16 weeks + 1 week follow-up. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Empa 12.5mg BID	5 of 219 (2.3%)	10 of 219 (4.6%)	Not reported
Empa 25mg QD	2 of 218 (0.9%)	10 of 218 (4.6%)	Not reported
Empa 5mg BID	7 of 219 (3.2%)	8 of 219 (3.7%)	Not reported
Empa 10mg QD	5 of 220 (2.3%)	15 of 220 (6.8%)	Not reported
Placebo	1 of 107 (0.9%)	4 of 107 (3.7%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 35472672Tuttle 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.
Related InfoLink provided by the sponsor.

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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

139 sites in 18 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 5 inclusion and 2 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 23 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 139 sites in United States, Canada, France, Italy, Russia and 13 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 23 Jul 2015). 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 16 (time frame: Baseline and 16 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 NCT01649297, 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 23 Jul 2015.