Diabetes Mellitus, Type 2Phase 3NCT01159600

Efficacy and Safety Study With Empagliflozin (BI 10773) vs. Placebo as add-on to Metformin or Metformin Plus Sulfonylurea Over 24 Weeks in Patients With Type 2 Diabetes

A Phase 3 study testing BI 10773 in people with Diabetes Mellitus, Type 2, run by Boehringer Ingelheim at 148 sites in 12 countries.

Completed

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

Official record

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Trial summary

The objective of the current study is to investigate the efficacy, safety and tolerability of two doses of BI 10773 compared to placebo given for 24 weeks as add-on therapy to metformin or metformin plus sulfonylurea in patients with Typ 2 Diabetes Mellitus with 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
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 1,504 participants
Where: 148 sitesin 12 countries
Study dates: Jul 2010to Feb 2012
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 a diet and exercise regimen who are pre-treated with immediate release metformin or immediate release metformin plus sulfonylurea (see below for minimum doses). The treatment regimen has to be unchanged for 12 weeks prior to randomisation.
Minimum dose for metformin: > or = 1500 mg/day or maximum tolerated dose or maximum dose according to local label Minimum dose for sulfonylurea: > or = half of the maximal recommended dose or maximum tolerated dose or maximum dose according to local label
HbA1c of > or = 7.0% and < or = 11% at Visit 1 (screening) in order to be eligible for randomised treatment HbA1c of > 11% at Visit 1 (screening) in order to be eligible for the open-label treatment arm (25 mg BI 10773)
Age> or = 18
Body Mass Index (BM)I < or = 45 kg/m2 (Body Mass Index) at Visit 1 (Screening)
Signed and dated written informed consent by date of Visit 1 in accordance with Good Clinical Practice (GCP) and local legislation

Who cannot join

Uncontrolled hyperglycaemia with a glucose level > 240 mg/dl (>13.3 mmol/L) after an overnight fast during placebo run-in and confirmed by a second measurement (not on the same day)
Any other antidiabetic drug within 12 weeks prior to randomisation except those mentioned in inclusion criterion 2
Myocardial infarction, stroke or transient ischemic attack (TIA) within 3 months prior to informed consent
Indication of liver disease, defined by serum levels of either ALT (SGPT), AST (SGOT), or alkaline phosphatase above 3 x upper limit of normal (ULN) as determined during screening and/or run-in phase
Impaired renal function, defined as eGFR<30 ml/min (severe renal impairment) as determined during screening and/or run-in phase
Bariatric surgery within the past two years and other gastrointestinal surgeries that induce chronic malabsorption

Show all 17Show fewer

Medical history of cancer (except for basal cell carcinoma) and/or treatment for cancer within the last 5 years
Contraindications to metformin and/or sulfonylurea according to the local label for those patients that enter the study with the respective background therapy
Blood dyscrasias or any disorders causing haemolysis or unstable Red Blood Cell (e.g. malaria, babesiosis, haemolytic anaemia)
Treatment with anti-obesity drugs (e.g. sibutramine, orlistat) 3 months prior to informed consent or any other treatment at the time of screening (i.e. surgery, aggressive diet regimen, etc.) leading to unstable body weight
Current treatment with systemic steroids at time of informed consent or change in dosage of thyroid hormones within 6 weeks prior to informed consent or any other uncontrolled endocrine disorder except Typ 2 Diabetes
Pre-menopausal women (last menstruation ¿ 1 year prior to informed consent) who:
are nursing or pregnant or
are of child-bearing potential and are not practicing an acceptable method of birth control, or do not plan to continue using this method throughout the study and do not agree to submit to periodic pregnancy testing during participation in the trial. Acceptable methods of birth control include tubal ligation, transdermal patch, intra uterine devices/systems (IUDs/IUSs), oral, implantable or injectable contraceptives, sexual abstinence (if acceptable by local authorities), double barrier method and vasectomised partner
Alcohol or drug abuse within the 3 months prior to informed consent that would interfere with trial participation or any ongoing condition leading to a decreased compliance to study procedures or study drug intake
Participation in another trial with an investigational drug within 30 days prior to informed consent
Any other clinical condition that would jeopardize patients safety while participating in this clinical trial

Trial locations and contacts

148 sites in 12 countries.

Country

City, postcode or hospital

148 sites in 12 countries

China26 sites

1245.23.86031 Boehringer Ingelheim Investigational Site
Beijing
1245.23.86032 Boehringer Ingelheim Investigational Site
Beijing
1245.23.86033 Boehringer Ingelheim Investigational Site
Beijing
1245.23.86034 Boehringer Ingelheim Investigational Site
Beijing
1245.23.86035 Boehringer Ingelheim Investigational Site
Beijing
1245.23.86048 Boehringer Ingelheim Investigational Site
Chengdu
1245.23.86058 Boehringer Ingelheim Investigational Site
Chongqing
1245.23.86038 Boehringer Ingelheim Investigational Site
Dalian
1245.23.86002 Boehringer Ingelheim Investigational Site
Guangzhou
1245.23.86052 Boehringer Ingelheim Investigational Site
Guangzhou
1245.23.86037 Boehringer Ingelheim Investigational Site
Haerbin
1245.23.86049 Boehringer Ingelheim Investigational Site
Jinan
1245.23.86053 Boehringer Ingelheim Investigational Site
Jinan
1245.23.86042 Boehringer Ingelheim Investigational Site
Nanjing
1245.23.86043 Boehringer Ingelheim Investigational Site
Nanjing
1245.23.86055 Boehringer Ingelheim Investigational Site
Nanning
1245.23.86056 Boehringer Ingelheim Investigational Site
Nanning
1245.23.86039 Boehringer Ingelheim Investigational Site
Shanghai
1245.23.86040 Boehringer Ingelheim Investigational Site
Shanghai
1245.23.86054 Boehringer Ingelheim Investigational Site
Shantou
1245.23.86057 Boehringer Ingelheim Investigational Site
Shenyang
1245.23.86045 Boehringer Ingelheim Investigational Site
Shijiazhuang
1245.23.86013 Boehringer Ingelheim Investigational Site
Suzhou
1245.23.86036 Boehringer Ingelheim Investigational Site
Tianjin
1245.23.86041 Boehringer Ingelheim Investigational Site
Xi'an
1245.23.86051 Boehringer Ingelheim Investigational Site
Zhenjiang

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United States25 sites

1245.23.10117 Boehringer Ingelheim Investigational Site
Arkansas City, Kansas
1245.23.10145 Boehringer Ingelheim Investigational Site
Birmingham, Alabama
1245.23.10001 Boehringer Ingelheim Investigational Site
Chicago, Illinois
1245.23.10120 Boehringer Ingelheim Investigational Site
Columbus, Ohio
1245.23.10080 Boehringer Ingelheim Investigational Site
Decatur, Georgia
1245.23.10159 Boehringer Ingelheim Investigational Site
Des Moines, Iowa
1245.23.10042 Boehringer Ingelheim Investigational Site
Fort Lauderdale, Florida
1245.23.10156 Boehringer Ingelheim Investigational Site
Houston, Texas
1245.23.10095 Boehringer Ingelheim Investigational Site
Huntington Park, California
1245.23.10109 Boehringer Ingelheim Investigational Site
Huntington Park, California
1245.23.10153 Boehringer Ingelheim Investigational Site
Hurst, Texas
1245.23.10133 Boehringer Ingelheim Investigational Site
Jupiter, Florida
1245.23.10143 Boehringer Ingelheim Investigational Site
Killeen, Texas
1245.23.10148 Boehringer Ingelheim Investigational Site
Lexington, Kentucky
1245.23.10074 Boehringer Ingelheim Investigational Site
Los Angeles, California
1245.23.10158 Boehringer Ingelheim Investigational Site
Mt. Pleasant, South Carolina
1245.23.10157 Boehringer Ingelheim Investigational Site
Newton, Kansas
1245.23.10031 Boehringer Ingelheim Investigational Site
Oklahoma City, Oklahoma
1245.23.10149 Boehringer Ingelheim Investigational Site
Rancho Cucamonga, California
1245.23.10034 Boehringer Ingelheim Investigational Site
Rochester, New York
1245.23.10106 Boehringer Ingelheim Investigational Site
San Antonio, Texas
1245.23.10015 Boehringer Ingelheim Investigational Site
Simpsonville, South Carolina
1245.23.10123 Boehringer Ingelheim Investigational Site
Smithtown, New York
1245.23.10046 Boehringer Ingelheim Investigational Site
Tempe, Arizona
1245.23.10127 Boehringer Ingelheim Investigational Site
Waterbury, Connecticut

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Canada21 sites

1245.23.20001 Boehringer Ingelheim Investigational Site
Barrie, Ontario
1245.23.20022 Boehringer Ingelheim Investigational Site
Brampton, Ontario
1245.23.20032 Boehringer Ingelheim Investigational Site
Calgary, Alberta
1245.23.20035 Boehringer Ingelheim Investigational Site
Corunna, Ontario
1245.23.20023 Boehringer Ingelheim Investigational Site
Edmonton, Alberta
1245.23.20030 Boehringer Ingelheim Investigational Site
Etobicoke, Ontario
1245.23.20026 Boehringer Ingelheim Investigational Site
Halifax, Nova Scotia
1245.23.20037 Boehringer Ingelheim Investigational Site
Hamilton, Ontario
1245.23.20027 Boehringer Ingelheim Investigational Site
Laval, Quebec
1245.23.20029 Boehringer Ingelheim Investigational Site
London, Ontario
1245.23.20003 Boehringer Ingelheim Investigational Site
Markham, Ontario
1245.23.20025 Boehringer Ingelheim Investigational Site
Montreal, Quebec
1245.23.20040 Boehringer Ingelheim Investigational Site
Oakville, Ontario
1245.23.20024 Boehringer Ingelheim Investigational Site
Paradise, Newfoundland and Labrador
1245.23.20038 Boehringer Ingelheim Investigational Site
Saint-Laurent, Quebec
1245.23.20034 Boehringer Ingelheim Investigational Site
Sarnia, Ontario
1245.23.20036 Boehringer Ingelheim Investigational Site
Sherbrooke, Quebec
1245.23.20031 Boehringer Ingelheim Investigational Site
St. John's, Newfoundland and Labrador
1245.23.20039 Boehringer Ingelheim Investigational Site
Toronto, Ontario
1245.23.20028 Boehringer Ingelheim Investigational Site
Vancouver, British Columbia
1245.23.20033 Boehringer Ingelheim Investigational Site
Victoria, British Columbia

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France17 sites

1245.23.33015 Boehringer Ingelheim Investigational Site
Arras
1245.23.33008 Boehringer Ingelheim Investigational Site
Bersée
1245.23.33020 Boehringer Ingelheim Investigational Site
Bischheim
1245.23.33002 Boehringer Ingelheim Investigational Site
Bondy
1245.23.33016 Boehringer Ingelheim Investigational Site
Bruay-la-Buissière
1245.23.33001 Boehringer Ingelheim Investigational Site
Corbeil-Essonnes
1245.23.33010 Boehringer Ingelheim Investigational Site
Croix
1245.23.33009 Boehringer Ingelheim Investigational Site
Hautmont
1245.23.33003 Boehringer Ingelheim Investigational Site
La Rochelle
1245.23.33045 Boehringer Ingelheim Investigational Site
Marseille
1245.23.33014 Boehringer Ingelheim Investigational Site
Mundolsheim
1245.23.33004 Boehringer Ingelheim Investigational Site
Narbonne
1245.23.33012 Boehringer Ingelheim Investigational Site
Schiltigheim
1245.23.33013 Boehringer Ingelheim Investigational Site
Strasbourg
1245.23.33019 Boehringer Ingelheim Investigational Site
Strasbourg
1245.23.33007 Boehringer Ingelheim Investigational Site
Vieux-Condé
1245.23.33018 Boehringer Ingelheim Investigational Site
Wattrelos

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South Korea13 sites

1245.23.82012 Boehringer Ingelheim Investigational Site
Anyang
1245.23.82004 Boehringer Ingelheim Investigational Site
Busan
1245.23.82011 Boehringer Ingelheim Investigational Site
Goyang
1245.23.82009 Boehringer Ingelheim Investigational Site
Ilsan
1245.23.82001 Boehringer Ingelheim Investigational Site
Incheon
1245.23.82006 Boehringer Ingelheim Investigational Site
Jeonju
1245.23.82005 Boehringer Ingelheim Investigational Site
Seoul
1245.23.82007 Boehringer Ingelheim Investigational Site
Seoul
1245.23.82008 Boehringer Ingelheim Investigational Site
Seoul
1245.23.82010 Boehringer Ingelheim Investigational Site
Seoul
1245.23.82014 Boehringer Ingelheim Investigational Site
Seoul
1245.23.82002 Boehringer Ingelheim Investigational Site
Suwon
1245.23.82003 Boehringer Ingelheim Investigational Site
Wŏnju

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Germany11 sites

1245.23.49001 Boehringer Ingelheim Investigational Site
Dormagen
1245.23.49009 Boehringer Ingelheim Investigational Site
Flörsheim
1245.23.49004 Boehringer Ingelheim Investigational Site
Hatten
1245.23.49007 Boehringer Ingelheim Investigational Site
Künzing
1245.23.49002 Boehringer Ingelheim Investigational Site
Neuwied
1245.23.49008 Boehringer Ingelheim Investigational Site
Nuremberg
1245.23.49010 Boehringer Ingelheim Investigational Site
Rednitzhembach
1245.23.49006 Boehringer Ingelheim Investigational Site
Rehburg-Loccum
1245.23.49011 Boehringer Ingelheim Investigational Site
Rehlingen-Siersburg
1245.23.49005 Boehringer Ingelheim Investigational Site
Saarbrücken
1245.23.49003 Boehringer Ingelheim Investigational Site
Unterschneidheim

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Taiwan10 sites

1245.23.88010 Boehringer Ingelheim Investigational Site
Kaohsiung City
1245.23.88011 Boehringer Ingelheim Investigational Site
Kaohsiung City
1245.23.88012 Boehringer Ingelheim Investigational Site
Kaohsiung City
1245.23.88013 Boehringer Ingelheim Investigational Site
Kaohsiung City
1245.23.88009 Boehringer Ingelheim Investigational Site
Taichung
1245.23.88014 Boehringer Ingelheim Investigational Site
Tainan
1245.23.88006 Boehringer Ingelheim Investigational Site
Taipei
1245.23.88007 Boehringer Ingelheim Investigational Site
Taipei
1245.23.88021 Boehringer Ingelheim Investigational Site
Taipei
1245.23.88008 Boehringer Ingelheim Investigational Site
Taoyuan County

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Slovakia7 sites

1245.23.74005 Boehringer Ingelheim Investigational Site
Bratislava
1245.23.74002 Boehringer Ingelheim Investigational Site
Lučenec
1245.23.74006 Boehringer Ingelheim Investigational Site
Nitra
1245.23.74014 Boehringer Ingelheim Investigational Site
Nové Zámky
1245.23.74001 Boehringer Ingelheim Investigational Site
Považská Bystrica
1245.23.74004 Boehringer Ingelheim Investigational Site
Prešov
1245.23.74003 Boehringer Ingelheim Investigational Site
Trebišov

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Turkey (Türkiye)6 sites

1245.23.90003 Boehringer Ingelheim Investigational Site
Erzurum
1245.23.90001 Boehringer Ingelheim Investigational Site
Gaziantep
1245.23.90002 Boehringer Ingelheim Investigational Site
Istanbul
1245.23.90006 Boehringer Ingelheim Investigational Site
Istanbul
1245.23.90007 Boehringer Ingelheim Investigational Site
Istanbul
1245.23.90004 Boehringer Ingelheim Investigational Site
Izmir

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India5 sites

1245.23.91101 Boehringer Ingelheim Investigational Site
Coimbatore
1245.23.91104 Boehringer Ingelheim Investigational Site
Indore
1245.23.91103 Boehringer Ingelheim Investigational Site
Maharashtra
1245.23.91102 Boehringer Ingelheim Investigational Site
Nagpur
1245.23.91105 Boehringer Ingelheim Investigational Site
Pune

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Mexico4 sites

1245.23.52003 Boehringer Ingelheim Investigational Site
Guadalajara
1245.23.52004 Boehringer Ingelheim Investigational Site
Guadalajara
1245.23.52001 Boehringer Ingelheim Investigational Site
Monterrey
1245.23.52002 Boehringer Ingelheim Investigational Site
Monterrey

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Slovenia3 sites

1245.23.38003 Boehringer Ingelheim Investigational Site
Celje
1245.23.38002 Boehringer Ingelheim Investigational Site
Koper
1245.23.38001 Boehringer Ingelheim Investigational Site
Maribor

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About this study

Official title: A Phase III Randomised, Double-blind, Placebo-controlled, Parallel Group, Efficacy and Safety Study of BI 10773 (10 mg, 25 mg) Administered Orally, Once Daily Over 24 Weeks in Patients With Type 2 Diabetes Mellitus With Insufficient Glycaemic Control Despite Treatment With Metformin Alone or Metformin in Combination With a Sulfonylurea

Conditions: Diabetes Mellitus, Type 2
Being tested: Placebo identical to BI 10773 high dose, Placebo identical to BI 10773 low dose, BI 10773
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.

Placebo identical to BI 10773 high doseDrug
Placebo tablets matching BI 10773 high dose
Placebo identical to BI 10773 low doseDrug
Placebo tablets matching BI 10773 low dose
BI 10773Drug
BI 10773 tablets once daily high dose open label
BI 10773Drug
BI 10773 tablets once daily high dose
Placebo identical to BI 10773 low doseDrug
Placebo tablets matching BI 10773 low dose
BI 10773Drug
BI 10773 tablets once daily low dose
Placebo identical to BI 10773 high doseDrug
Placebo tablets matching BI 10773 high dose

Study groups in NCT01159600
Study group	Role	What they receive
BI 10773 Arm 2	Experimental	BI 10773 once daily high dose Receives: Drug: BI 10773; Drug: Placebo identical to BI 10773 low dose
Placebo	Placebo comparator	Placebo matching BI 10773 Receives: Drug: Placebo identical to BI 10773 low dose; Drug: Placebo identical to BI 10773 high dose
BI 10773 open-label	Experimental	BI 10773 once daily high dose open label Receives: Drug: BI 10773
BI 10773 Arm 1	Experimental	BI 10773 once daily low dose Receives: Drug: Placebo identical to BI 10773 high dose; Drug: BI 10773

What is being measured

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

HbA1c Change From Baseline
Change from baseline in HbA1c after 24 weeks.
For open-label groups the descriptive mean is provided, for randomised groups adjusted means are provided. The means are adjusted separately for metformin alone and metformin plus sulphonylurea background medication.
Measured: Baseline and 24 weeks

Secondary outcomes (2)

Body Weight Change From Baseline
Body weight change from baseline after 24 weeks.
For open-label groups the descriptive mean is provided, for randomised groups adjusted means are provided. The means are adjusted separately for metformin alone and metformin plus sulphonylurea background medication.
Measured: Baseline and 24 weeks
Mean Daily Plasma Glucose (MDG) Change From Baseline
Change from baseline in mean daily glucose (MDG) using the 8-point blood glucose profile, after 24 weeks of treatment.
For open-label groups the descriptive mean is provided, for randomised groups adjusted means are provided. The means are adjusted separately for metformin alone and metformin plus sulphonylurea background medication.
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.

Jul 2010Feb 2012

First posted9 Jul 2010 (estimated)
Study startJul 2010
Primary completionFeb 2012

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: 1,504 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01159600
Sponsor's protocol ID: 1245.23
Other IDs: 2009-016258-41, 2009
Status last verified: May 2014
First submitted: 8 Jul 2010
Last updated: 17 Jun 2014
Results posted: Yes, on ClinicalTrials.gov

Publications

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
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
Inzucchi SE, Davies MJ, Khunti K, Trivedi P, George JT, Zwiener I, Johansen OE, Sattar N. Empagliflozin treatment effects across categories of baseline HbA1c, body weight and blood pressure as an add-on to metformin in patients with type 2 diabetes. Diabetes Obes Metab. 2021 Feb;23(2):425-433. doi: 10.1111/dom.14234. Epub 2020 Nov 20.
PubMed 33084149
Cherney D, Lund SS, Perkins BA, Groop PH, Cooper ME, Kaspers S, Pfarr E, Woerle HJ, von Eynatten M. The effect of sodium glucose cotransporter 2 inhibition with empagliflozin on microalbuminuria and macroalbuminuria in patients with type 2 diabetes. Diabetologia. 2016 Sep;59(9):1860-70. doi: 10.1007/s00125-016-4008-2. Epub 2016 Jun 17.
PubMed 27316632
Haring HU, Merker L, Seewaldt-Becker E, Weimer M, Meinicke T, Woerle HJ, Broedl UC; EMPA-REG METSU Trial Investigators. Empagliflozin as add-on to metformin plus sulfonylurea in patients with type 2 diabetes: a 24-week, randomized, double-blind, placebo-controlled trial. Diabetes Care. 2013 Nov;36(11):3396-404. doi: 10.2337/dc12-2673. Epub 2013 Aug 20.
PubMed 23963895

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 17 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase III Randomised, Double-blind, Placebo-controlled, Parallel Group, Efficacy and Safety Study of BI 10773 (10 mg, 25 mg) Administered Orally, Once Daily Over 24 Weeks in Patients With Type 2 Diabetes Mellitus With Insufficient Glycaemic Control Despite Treatment With Metformin Alone or Metformin in Combination With a Sulfonylurea
ClinicalTrials.gov ID: NCT01159600
Acronym / sponsor ID: 1245.23
Conditions: Diabetes Mellitus, Type 2
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 1,504 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Collaborators: Eli Lilly and Company
Study start: Jul 2010
Primary completion: Feb 2012 (actual)
First posted: 9 Jul 2010 (estimated)
Results: Posted 17 Jun 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: 4

Arm	Type	Receives
BI 10773 Arm 2	Experimental	Drug: BI 10773, Drug: Placebo identical to BI 10773 low doseBI 10773 once daily high dose
Placebo	Placebo comparator	Drug: Placebo identical to BI 10773 low dose, Drug: Placebo identical to BI 10773 high dosePlacebo matching BI 10773
BI 10773 open-label	Experimental	Drug: BI 10773BI 10773 once daily high dose open label
BI 10773 Arm 1	Experimental	Drug: Placebo identical to BI 10773 high dose, Drug: BI 10773BI 10773 once daily low dose

Who may qualify

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

Key inclusion criteria (7 listed)

Diagnosis of type 2 diabetes mellitus prior to informed consent
Male and female patients on a diet and exercise regimen who are pre-treated with immediate release metformin or immediate release metformin plus sulfonylurea (see below for minimum doses). The treatment regimen has to be unchanged for 12 weeks prior to randomisation.
Minimum dose for metformin: > or = 1500 mg/day or maximum tolerated dose or maximum dose according to local label Minimum dose for sulfonylurea: > or = half of the maximal recommended dose or maximum tolerated dose or maximum dose according to local label
HbA1c of > or = 7.0% and < or = 11% at Visit 1 (screening) in order to be eligible for randomised treatment HbA1c of > 11% at Visit 1 (screening) in order to be eligible for the open-label treatment arm (25 mg BI 10773)
Age> or = 18

Key exclusion criteria (17 listed)

Uncontrolled hyperglycaemia with a glucose level > 240 mg/dl (>13.3 mmol/L) after an overnight fast during placebo run-in and confirmed by a second measurement (not on the same day)
Any other antidiabetic drug within 12 weeks prior to randomisation except those mentioned in inclusion criterion 2
Myocardial infarction, stroke or transient ischemic attack (TIA) within 3 months prior to informed consent
Indication of liver disease, defined by serum levels of either ALT (SGPT), AST (SGOT), or alkaline phosphatase above 3 x upper limit of normal (ULN) as determined during screening and/or run-in phase
Impaired renal function, defined as eGFR<30 ml/min (severe renal impairment) as determined during screening and/or run-in phase

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
Placebo identical to BI 10773 high dosePlacebo tablets matching BI 10773 high dose	Drug	BI 10773 Arm 1
Placebo identical to BI 10773 low dosePlacebo tablets matching BI 10773 low dose	Drug	Placebo
BI 10773BI 10773 tablets once daily high dose open label	Drug	BI 10773 open-label
BI 10773BI 10773 tablets once daily high dose	Drug	BI 10773 Arm 2
Placebo identical to BI 10773 low dosePlacebo tablets matching BI 10773 low dose	Drug	BI 10773 Arm 2
BI 10773BI 10773 tablets once daily low dose	Drug	BI 10773 Arm 1
Placebo identical to BI 10773 high dosePlacebo tablets matching BI 10773 high dose	Drug	Placebo

Primary outcome

HbA1c Change From Baseline
Time frame: Baseline and 24 weeks
Change from baseline in HbA1c after 24 weeks. For open-label groups the descriptive mean is provided, for randomised groups adjusted means are provided. The means are adjusted separately for metformin alone and metformin plus sulphonylurea background medication.

2 secondary outcomes

Body Weight Change From Baseline
Time frame: Baseline and 24 weeks
Mean Daily Plasma Glucose (MDG) Change From Baseline
Time frame: Baseline and 24 weeks

Results and safety

Results posted to the registry on 17 Jun 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
Met: Placebo	207	186
Met: Empa 10mg	217	209
Met: Empa 25mg	214	196
Met: Empa 25mg Open Label	69	58
Met+SU: Placebo	225	201
Met+SU: Empa 10mg	226	208
Met+SU: Empa 25mg	218	199
Met+SU: Empa 25mg Open Label	103	85

Primary outcome: HbA1c Change From Baseline

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

Measure	Met: Placebo n = 207	Met: Empa 10mg n = 217	Met: Empa 25mg n = 213	Met: Empa 25mg Open Label n = 69	Met+SU: Placebo n = 225	Met+SU: Empa 10mg n = 225	Met+SU: Empa 25mg n = 216	Met+SU: Empa 25mg Open Label n = 101
Value	-0.13 (0.05)	-0.70 (0.05)	-0.77 (0.05)	-2.78 (0.21)	-0.17 (0.05)	-0.82 (0.05)	-0.77 (0.05)	-2.53 (0.15)

Met: Placebo vs Met: Empa 10mg: Mean difference: -0.57 (97.5% CI -0.72 to -0.42), p <0.0001, ANCOVA
Met: Placebo vs Met: Empa 25mg: Mean difference: -0.64 (97.5% CI -0.79 to -0.48), p <0.0001, ANCOVA
Met+SU: Placebo vs Met+SU: Empa 10mg: Mean difference: -0.64 (97.5% CI -0.79 to -0.49), p <0.0001, ANCOVA

Population analysed: Full analysis set. Treatment assignment as randomised. Open-label analysis: Open-label set which included all patients entered in the empa 25mg open-label treatment arm. Values after start of antidiabetic rescue therapy were set to missing and last observation carried forward (LOCF) was used for imputation of missing values.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Met: Placebo	7 of 206 (3.4%)	56 of 206 (27.2%)	Not reported
Met: Empa 10mg	7 of 217 (3.2%)	29 of 217 (13.4%)	Not reported
Met: Empa 25mg	5 of 214 (2.3%)	38 of 214 (17.8%)	Not reported
Met: Empa 25mg Open Label	1 of 69 (1.4%)	18 of 69 (26.1%)	Not reported
Met+SU: Placebo	14 of 225 (6.2%)	76 of 225 (33.8%)	Not reported
Met+SU: Empa 10mg	11 of 224 (4.9%)	77 of 224 (34.4%)	Not reported
Met+SU: Empa 25mg	1 of 217 (0.5%)	67 of 217 (30.9%)	Not reported
Met+SU: Empa 25mg Open Label	5 of 101 (5%)	28 of 101 (27.7%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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 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.
Derived from this study: PubMed 33084149Inzucchi SE, Davies MJ, Khunti K, Trivedi P, George JT, Zwiener I, Johansen OE, Sattar N. Empagliflozin treatment effects across categories of baseline HbA1c, body weight and blood pressure as an add-on to metformin in patients with type 2 diabetes. Diabetes Obes Metab. 2021 Feb;23(2):425-433. doi: 10.1111/dom.14234. Epub 2020 Nov 20.
Derived from this study: PubMed 27316632Cherney D, Lund SS, Perkins BA, Groop PH, Cooper ME, Kaspers S, Pfarr E, Woerle HJ, von Eynatten M. The effect of sodium glucose cotransporter 2 inhibition with empagliflozin on microalbuminuria and macroalbuminuria in patients with type 2 diabetes. Diabetologia. 2016 Sep;59(9):1860-70. doi: 10.1007/s00125-016-4008-2. Epub 2016 Jun 17.
Derived from this study: PubMed 23963895Haring HU, Merker L, Seewaldt-Becker E, Weimer M, Meinicke T, Woerle HJ, Broedl UC; EMPA-REG METSU Trial Investigators. Empagliflozin as add-on to metformin plus sulfonylurea in patients with type 2 diabetes: a 24-week, randomized, double-blind, placebo-controlled trial. Diabetes Care. 2013 Nov;36(11):3396-404. doi: 10.2337/dc12-2673. Epub 2013 Aug 20.
Related InfoLink provided by the sponsor.
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

148 sites in 12 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing BI 10773 in people with Diabetes Mellitus, Type 2, run by Boehringer Ingelheim at 148 sites in 12 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 7 inclusion and 17 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 17 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 148 sites in China, United States, Canada, France, South Korea and 7 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 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 17 Jun 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?

HbA1c Change From Baseline (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 NCT01159600, 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 17 Jun 2014.