Diabetes Mellitus, Type 2Phase 3NCT01177813

Efficacy and Safety of Empagliflozin (BI 10773) Versus Placebo and Sitagliptin Over 24 Weeks in Patients With Type 2 Diabetes

A Phase 3 study testing BI 10773 and BI 10773 open label in people with Diabetes Mellitus, Type 2, run by Boehringer Ingelheim at 124 sites in 9 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

Who is it for?: Ages 18 years and older
Conditions the study is for: Diabetes Mellitus, Type 2
What is being tested?: BI 10773 and BI 10773 open label
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 986 participants
Where: 124 sitesin 9 countries
Study dates: Jul 2010to Mar 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 diet and exercise regimen who are drug-naïve;
HbA1c >= 7.0% and <= 10.0% at Visit 1 (screening) for randomised treatment; HbA1c > 10.0% at visit 1 (screening) for the open-label BI 10773 arm;
Age >= 20 (Japan); Age >= 18 (countries other than Japan);
BMI <= 45 kg/m2 at Visit 1 (screening);
Signed and dated written informed consent by date of Visit 1

Who cannot join

Uncontrolled hyperglycaemia;
Acute coronary syndrome (non-STEMI, STEMI and unstable angina pectoris), stroke or TIA within 3 months prior to informed consent;
Indication of liver disease, either ALT, AST, or alkaline phosphatase above 3 x ULN;
Impaired renal function (eGFR<50 ml/min);
Bariatric surgery within the past two years or other GI surgeries;
Medical history of cancer;

Show all 15Show fewer

Contraindications to sitagliptin;
Blood dyscrasias or any disorders causing haemolysis or unstable red blood cell;
Treatment with any anti-diabetes drug within 12 weeks prior to randomisation;
Treatment with anti-obesity drugs or any other treatment leading to unstable body weight;
Current treatment with systemic steroids or change in dosage of thyroid hormones within 6 weeks prior to informed consent or any other uncontrolled endocrine disorder except T2DM;
Pre-menopausal women who are nursing or pregnant or are of child-bearing potential and not practicing an acceptable method of birth control;
Alcohol or drug abuse;
Intake of an investigational drug in another trial within 30 days prior to intake of study medication in this trial;
Any other clinical condition that would jeopardize patients safety while participating in this clinical trial

Trial locations and contacts

124 sites in 9 countries.

Country

City, postcode or hospital

124 sites in 9 countries

United States27 sites

1245.20.10117 Boehringer Ingelheim Investigational Site
Arkansas City, Kansas
1245.20.10128 Boehringer Ingelheim Investigational Site
Avon, Indiana
1245.20.10115 Boehringer Ingelheim Investigational Site
Brick, New Jersey
1245.20.10129 Boehringer Ingelheim Investigational Site
Carlisle, Ohio
1245.20.10154 Boehringer Ingelheim Investigational Site
Chino, California
1245.20.10045 Boehringer Ingelheim Investigational Site
Cincinnati, Ohio
1245.20.10119 Boehringer Ingelheim Investigational Site
Cincinnati, Ohio
1245.20.10137 Boehringer Ingelheim Investigational Site
Clearwater, Florida
1245.20.10080 Boehringer Ingelheim Investigational Site
Decatur, Georgia
1245.20.10060 Boehringer Ingelheim Investigational Site
Fishers, Indiana
1245.20.10130 Boehringer Ingelheim Investigational Site
Gallipolis, Ohio
1245.20.10150 Boehringer Ingelheim Investigational Site
Hot Springs, Arkansas
1245.20.10089 Boehringer Ingelheim Investigational Site
Houston, Texas
1245.20.10151 Boehringer Ingelheim Investigational Site
Hurst, Texas
1245.20.10065 Boehringer Ingelheim Investigational Site
Indianapolis, Indiana
1245.20.10146 Boehringer Ingelheim Investigational Site
Louisville, Kentucky
1245.20.10124 Boehringer Ingelheim Investigational Site
Mesa, Arizona
1245.20.10006 Boehringer Ingelheim Investigational Site
Miami, Florida
1245.20.10038 Boehringer Ingelheim Investigational Site
Northglenn, Colorado
1245.20.10108 Boehringer Ingelheim Investigational Site
Phoenix, Arizona
1245.20.10085 Boehringer Ingelheim Investigational Site
Plantation, Florida
1245.20.10155 Boehringer Ingelheim Investigational Site
San Antonio, Texas
1245.20.10009 Boehringer Ingelheim Investigational Site
Santa Ana, California
1245.20.10078 Boehringer Ingelheim Investigational Site
Tampa, Florida
1245.20.10144 Boehringer Ingelheim Investigational Site
Watertown, Massachusetts
1245.20.10131 Boehringer Ingelheim Investigational Site
West Hills, California
1245.20.10039 Boehringer Ingelheim Investigational Site
Wichita, Kansas

Other trials in United States

China23 sites

1245.20.86007 Boehringer Ingelheim Investigational Site
Beijing
1245.20.86008 Boehringer Ingelheim Investigational Site
Beijing
1245.20.86001 Boehringer Ingelheim Investigational Site
Guangzhou
1245.20.86002 Boehringer Ingelheim Investigational Site
Guangzhou
1245.20.86003 Boehringer Ingelheim Investigational Site
Guangzhou
1245.20.86012 Boehringer Ingelheim Investigational Site
Guiyang
1245.20.86020 Boehringer Ingelheim Investigational Site
Hangzhou
1245.20.86049 Boehringer Ingelheim Investigational Site
Jinan
1245.20.86018 Boehringer Ingelheim Investigational Site
Jingzhou
1245.20.86019 Boehringer Ingelheim Investigational Site
Nanchang
1245.20.86010 Boehringer Ingelheim Investigational Site
Nanjing
1245.20.86043 Boehringer Ingelheim Investigational Site
Nanjing
1245.20.86016 Boehringer Ingelheim Investigational Site
Qingdao
1245.20.86004 Boehringer Ingelheim Investigational Site
Shanghai
1245.20.86005 Boehringer Ingelheim Investigational Site
Shanghai
1245.20.86006 Boehringer Ingelheim Investigational Site
Shanghai
1245.20.86057 Boehringer Ingelheim Investigational Site
Shenyang
1245.20.86017 Boehringer Ingelheim Investigational Site
Shiyan
1245.20.86013 Boehringer Ingelheim Investigational Site
Suzhou
1245.20.86015 Boehringer Ingelheim Investigational Site
Taiyuan
1245.20.86009 Boehringer Ingelheim Investigational Site
Wuhan
1245.20.86011 Boehringer Ingelheim Investigational Site
Xi'an
1245.20.86014 Boehringer Ingelheim Investigational Site
Xiamen

Other trials in China

Canada19 sites

1245.20.20001 Boehringer Ingelheim Investigational Site
Barrie, Ontario
1245.20.20014 Boehringer Ingelheim Investigational Site
Charlottetown, Prince Edward Island
1245.20.20011 Boehringer Ingelheim Investigational Site
Chilliwack, British Columbia
1245.20.20019 Boehringer Ingelheim Investigational Site
Hamilton, Ontario
1245.20.20010 Boehringer Ingelheim Investigational Site
London, Ontario
1245.20.20017 Boehringer Ingelheim Investigational Site
London, Ontario
1245.20.20003 Boehringer Ingelheim Investigational Site
Markham, Ontario
1245.20.20012 Boehringer Ingelheim Investigational Site
Moncton, New Brunswick
1245.20.20007 Boehringer Ingelheim Investigational Site
Montague, Prince Edward Island
1245.20.20016 Boehringer Ingelheim Investigational Site
Mount Pearl, Newfoundland and Labrador
1245.20.20009 Boehringer Ingelheim Investigational Site
Newmarket, Ontario
1245.20.20013 Boehringer Ingelheim Investigational Site
Ottawa, Ontario
1245.20.20008 Boehringer Ingelheim Investigational Site
St. John's, Newfoundland and Labrador
1245.20.20005 Boehringer Ingelheim Investigational Site
Strathroy, Ontario
1245.20.20002 Boehringer Ingelheim Investigational Site
Toronto, Ontario
1245.20.20006 Boehringer Ingelheim Investigational Site
Toronto, Ontario
1245.20.20021 Boehringer Ingelheim Investigational Site
Trois-Rivières, Quebec
1245.20.20018 Boehringer Ingelheim Investigational Site
Victoria, British Columbia
1245.20.20015 Boehringer Ingelheim Investigational Site
Winnipeg, Manitoba

Other trials in Canada

Belgium15 sites

1245.20.32008 Boehringer Ingelheim Investigational Site
Brussels
1245.20.32011 Boehringer Ingelheim Investigational Site
Brussels
1245.20.32023 Boehringer Ingelheim Investigational Site
Brussels
1245.20.32003 Boehringer Ingelheim Investigational Site
De Pinte
1245.20.32015 Boehringer Ingelheim Investigational Site
Deurne
1245.20.32016 Boehringer Ingelheim Investigational Site
Deurne
1245.20.32025 Boehringer Ingelheim Investigational Site
Gozée
1245.20.32022 Boehringer Ingelheim Investigational Site
Landen
1245.20.32019 Boehringer Ingelheim Investigational Site
Leopoldsburg
1245.20.32024 Boehringer Ingelheim Investigational Site
Linkebeek
1245.20.32021 Boehringer Ingelheim Investigational Site
Mouscron
1245.20.32027 Boehringer Ingelheim Investigational Site
Retie
1245.20.32020 Boehringer Ingelheim Investigational Site
Sint-Gillis-Waas
1245.20.32018 Boehringer Ingelheim Investigational Site
Tielt
1245.20.32026 Boehringer Ingelheim Investigational Site
Tremelo

Other trials in Belgium

Japan12 sites

1245.20.81007 Boehringer Ingelheim Investigational Site
Chiyoda-ku, Tokyo
1245.20.81001 Boehringer Ingelheim Investigational Site
Chuo-ku, Tokyo
1245.20.81002 Boehringer Ingelheim Investigational Site
Chuo-ku, Tokyo
1245.20.81005 Boehringer Ingelheim Investigational Site
Ebetsu, Hokkaido
1245.20.81004 Boehringer Ingelheim Investigational Site
Kamakura, Kanagawa
1245.20.81003 Boehringer Ingelheim Investigational Site
Minato-ku, Tokyo
1245.20.81006 Boehringer Ingelheim Investigational Site
Shinjuku-ku, Tokyo
1245.20.81008 Boehringer Ingelheim Investigational Site
Shinjuku-ku, Tokyo
1245.20.81009 Boehringer Ingelheim Investigational Site
Suita, Osaka
1245.20.81010 Boehringer Ingelheim Investigational Site
Ube, Yamaguchi
1245.20.81012 Boehringer Ingelheim Investigational Site
Urasoe, Okinawa
1245.20.81013 Boehringer Ingelheim Investigational Site
Urasoe, Okinawa

Other trials in Japan

Germany11 sites

1245.20.49013 Boehringer Ingelheim Investigational Site
Dresden
1245.20.49016 Boehringer Ingelheim Investigational Site
Düsseldorf
1245.20.49015 Boehringer Ingelheim Investigational Site
Frankfurt
1245.20.49019 Boehringer Ingelheim Investigational Site
Haag
1245.20.49020 Boehringer Ingelheim Investigational Site
Hohenmölsen
1245.20.49014 Boehringer Ingelheim Investigational Site
Köthen
1245.20.49002 Boehringer Ingelheim Investigational Site
Neuwied
1245.20.49008 Boehringer Ingelheim Investigational Site
Nuremberg
1245.20.49017 Boehringer Ingelheim Investigational Site
Saint Ingbert/Oberwürzbach
1245.20.49022 Boehringer Ingelheim Investigational Site
Schauenburg
1245.20.49003 Boehringer Ingelheim Investigational Site
Unterschneidheim

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India10 sites

1245.20.91005 Boehringer Ingelheim Investigational Site
Bangalore
1245.20.91006 Boehringer Ingelheim Investigational Site
Bangalore
1245.20.91008 Boehringer Ingelheim Investigational Site
Bangalore
1245.20.91003 Boehringer Ingelheim Investigational Site
Belagavi
1245.20.91004 Boehringer Ingelheim Investigational Site
Chennai
1245.20.91009 Boehringer Ingelheim Investigational Site
Chennai
1245.20.91002 Boehringer Ingelheim Investigational Site
Mumbai
1245.20.91007 Boehringer Ingelheim Investigational Site
Mumbai, Maharastra
1245.20.91010 Boehringer Ingelheim Investigational Site
Nagpur
1245.20.91001 Boehringer Ingelheim Investigational Site
Tamil Nadu

Other trials in India

Ireland5 sites

1245.20.35302 Boehringer Ingelheim Investigational Site
Co. Cork
1245.20.35305 Boehringer Ingelheim Investigational Site
Co. Galway
1245.20.35303 Boehringer Ingelheim Investigational Site
Co. Wexford
1245.20.35304 Boehringer Ingelheim Investigational Site
Offaly
1245.20.35306 Boehringer Ingelheim Investigational Site
Wexford

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Switzerland2 sites

1245.20.41004 Boehringer Ingelheim Investigational Site
Lugano
1245.20.41003 Boehringer Ingelheim Investigational Site
Rorschach

Other trials in Switzerland

About this study

Official title: A Phase III Randomised, Double-blind, Placebo-controlled Parallel Group Efficacy and Safety Study of BI 10773 and Sitagliptin Administered Orally Over 24 Weeks, in Drug naïve Patients With Type 2 Diabetes Mellitus and Insufficient Glycaemic Control Despite Diet and Exercise

The aim of this study is to investigate the efficacy, safety and tolerability of BI 10773 compared to placebo and sitagliptin given for 24 weeks as monotherapy in patients with T2DM with insufficient glycaemic control. For the open-label part of the study the objective is to estimate the efficacy and safety of BI 10773 when given for 24 weeks in patients with T2DM with very poor glycaemic control.

Conditions: Diabetes Mellitus, Type 2
Being tested: Placebo identical to BI10773 high dose, BI 10773, BI 10773 open label, Placebo identical to BI10773 low dose, Placebo identical to Sitagliptin 100mg
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 BI10773 high doseDrug
placebo tablets once daily
BI 10773Drug
BI 10773 low dose tablet once daily
BI 10773 open labelDrug
Patients receive BI 10773 high dose tablets open label once daily
Placebo identical to BI10773 low doseDrug
placebo tablets once daily
Placebo identical to BI10773 low doseDrug
placebo tablets once daily
Placebo identical to BI10773 high doseDrug
placebo tablets once daily
Placebo identical to Sitagliptin 100mgDrug
placebo tablets once daily
Placebo identical to Sitagliptin 100mgDrug
placebo tablets once daily
BI10773Drug
BI 10773 high dose tablets once daily
SitagliptinDrug
Sitagliptin tablets 100 mg once daily
Placebo identical to Sitagliptin 100mgDrug
placebo tablets once daily
Placebo identical to BI10773 low doseDrug
placebo tablets once daily
Placebo identical to BI10773 high doseDrug
placebo tablets once daily

Study groups in NCT01177813
Study group	Role	What they receive
BI 10773 low dose	Experimental	Patients receive BI 10773 low dose tablets once daily Receives: Drug: Placebo identical to BI10773 high dose; Drug: BI 10773; Drug: Placebo identical to Sitagliptin 100mg
BI 10773 high dose	Experimental	Patients receive BI 10773 high dose tablets once daily Receives: Drug: Placebo identical to BI10773 low dose; Drug: BI10773; Drug: Placebo identical to Sitagliptin 100mg
Placebo	Placebo comparator	Patients receive tablets identical to those containing BI 10773 low dose and high dose and to Sitagliptin Receives: Drug: Placebo identical to BI10773 low dose; Drug: Placebo identical to Sitagliptin 100mg; Drug: Placebo identical to BI10773 high dose
Sitagliptin 100 mg	Active comparator	Patients receive Sitagliptin 100 mg tablets once daily Receives: Drug: Placebo identical to BI10773 high dose; Drug: Sitagliptin; Drug: Placebo identical to BI10773 low dose
BI 10773 high dose open label	Experimental	Patients receive BI 10773 high dose tablets open label once daily Receives: Drug: BI 10773 open label

What is being measured

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

Change From Baseline in Glycosylated Haemoglobin (HbA1c) After 24 Weeks
The term "baseline" refers to the last observation before the start of randomised trial treatment (or of open-label treatment for the open-label arm).
In this endpoint, the "measured values" show unadjusted values, whereas the statistical analyses show adjusted values. Statistics for open-label group are descriptive.
Measured: Baseline and day 169

Secondary outcomes (2)

Change From Baseline to Week 24 in Body Weight
The term "baseline" refers to the last observation before the start of randomised trial treatment (or of open-label treatment for the open-label arm).
In this endpoint, the "measured values" show unadjusted values, whereas the statistical analyses show adjusted values. Statistics for open-label group are descriptive.
Measured: Baseline and day 169
Change From Baseline to Week 24 in Systolic and Diastolic Blood Pressure (SBP and DBP)
The term "baseline" refers to the last observation before the start of randomised trial treatment (or of open-label treatment for the open-label arm).
In this endpoint, the "measured values" show unadjusted values, whereas the statistical analyses show adjusted values. Statistics for open-label group are descriptive.
For blood pressure, data following changes in antihypertensive therapy is censored, in the same way that data following initiation of rescue medication is censored.
Measured: Baseline and week 24

Timeline

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

Jul 2010Mar 2012

First posted9 Aug 2010 (estimated)
Study startJul 2010
Primary completionMar 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 (4)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: 986 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01177813
Sponsor's protocol ID: 1245.20
Other IDs: 2009-016243-20, 2009
Status last verified: May 2014
First submitted: 29 Jul 2010
Last updated: 16 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
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
Roden M, Weng J, Eilbracht J, Delafont B, Kim G, Woerle HJ, Broedl UC; EMPA-REG MONO trial investigators. Empagliflozin monotherapy with sitagliptin as an active comparator in patients with type 2 diabetes: a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Diabetes Endocrinol. 2013 Nov;1(3):208-19. doi: 10.1016/S2213-8587(13)70084-6. Epub 2013 Sep 9.
PubMed 24622369

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 16 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 and Sitagliptin Administered Orally Over 24 Weeks, in Drug naïve Patients With Type 2 Diabetes Mellitus and Insufficient Glycaemic Control Despite Diet and Exercise
ClinicalTrials.gov ID: NCT01177813
Acronym / sponsor ID: 1245.20
Conditions: Diabetes Mellitus, Type 2
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 986 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Collaborators: Eli Lilly and Company
Study start: Jul 2010
Primary completion: Mar 2012 (actual)
First posted: 9 Aug 2010 (estimated)
Results: Posted 16 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: 5

Arm	Type	Receives
BI 10773 low dose	Experimental	Drug: Placebo identical to BI10773 high dose, Drug: BI 10773, Drug: Placebo identical to Sitagliptin 100mgPatients receive BI 10773 low dose tablets once daily
BI 10773 high dose	Experimental	Drug: Placebo identical to BI10773 low dose, Drug: BI10773, Drug: Placebo identical to Sitagliptin 100mgPatients receive BI 10773 high dose tablets once daily
Placebo	Placebo comparator	Drug: Placebo identical to BI10773 low dose, Drug: Placebo identical to Sitagliptin 100mg, Drug: Placebo identical to BI10773 high dosePatients receive tablets identical to those containing BI 10773 low dose and high dose and to Sitagliptin
Sitagliptin 100 mg	Active comparator	Drug: Placebo identical to BI10773 high dose, Drug: Sitagliptin, Drug: Placebo identical to BI10773 low dosePatients receive Sitagliptin 100 mg tablets once daily
BI 10773 high dose open label	Experimental	Drug: BI 10773 open labelPatients receive BI 10773 high dose tablets open label once daily

Who may qualify

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

Key inclusion criteria (6 listed)

Diagnosis of type 2 diabetes mellitus prior to informed consent;
Male and female patients on diet and exercise regimen who are drug-naïve;
HbA1c >= 7.0% and <= 10.0% at Visit 1 (screening) for randomised treatment; HbA1c > 10.0% at visit 1 (screening) for the open-label BI 10773 arm;
Age >= 20 (Japan); Age >= 18 (countries other than Japan);
BMI <= 45 kg/m2 at Visit 1 (screening);

Key exclusion criteria (15 listed)

Uncontrolled hyperglycaemia;
Acute coronary syndrome (non-STEMI, STEMI and unstable angina pectoris), stroke or TIA within 3 months prior to informed consent;
Indication of liver disease, either ALT, AST, or alkaline phosphatase above 3 x ULN;
Impaired renal function (eGFR<50 ml/min);
Bariatric surgery within the past two years or other GI surgeries;

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 BI10773 high doseplacebo tablets once daily	Drug	BI 10773 low dose
BI 10773BI 10773 low dose tablet once daily	Drug	BI 10773 low dose
BI 10773 open labelPatients receive BI 10773 high dose tablets open label once daily	Drug	BI 10773 high dose open label
Placebo identical to BI10773 low doseplacebo tablets once daily	Drug	BI 10773 high dose
Placebo identical to BI10773 low doseplacebo tablets once daily	Drug	Placebo
Placebo identical to BI10773 high doseplacebo tablets once daily	Drug	Sitagliptin 100 mg
Placebo identical to Sitagliptin 100mgplacebo tablets once daily	Drug	Placebo
Placebo identical to Sitagliptin 100mgplacebo tablets once daily	Drug	BI 10773 low dose
BI10773BI 10773 high dose tablets once daily	Drug	BI 10773 high dose
SitagliptinSitagliptin tablets 100 mg once daily	Drug	Sitagliptin 100 mg
Placebo identical to Sitagliptin 100mgplacebo tablets once daily	Drug	BI 10773 high dose
Placebo identical to BI10773 low doseplacebo tablets once daily	Drug	Sitagliptin 100 mg
Placebo identical to BI10773 high doseplacebo tablets once daily	Drug	Placebo

Primary outcome

Change From Baseline in Glycosylated Haemoglobin (HbA1c) After 24 Weeks
Time frame: Baseline and day 169
The term "baseline" refers to the last observation before the start of randomised trial treatment (or of open-label treatment for the open-label arm). In this endpoint, the "measured values" show unadjusted values, whereas the statistical analyses show adjusted values. Statistics for open-label group are descriptive.

2 secondary outcomes

Change From Baseline to Week 24 in Body Weight
Time frame: Baseline and day 169
Change From Baseline to Week 24 in Systolic and Diastolic Blood Pressure (SBP and DBP)
Time frame: Baseline and week 24

Results and safety

Results posted to the registry on 16 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
Placebo	228	187
Empagliflozin10 mg	224	206
Empagliflozin 25 mg	224	204
Sitagliptin 100 mg	223	206
Empagliflozin 25 mg OL	87	78

Primary outcome: Change From Baseline in Glycosylated Haemoglobin (HbA1c) After 24 Weeks

Time frame: Baseline and day 169. Mean (Standard Error). Unit: percent of HbA1c

Measure	Placebo n = 228	Empagliflozin10 mg n = 224	Empagliflozin 25 mg n = 224	Sitagliptin 100 mg n = 223	Empagliflozin 25 mg OL n = 87
Value	0.06 (0.05)	-0.66 (0.06)	-0.77 (0.06)	-0.65 (0.05)	-3.10 (0.22)

Placebo vs Empagliflozin10 mg: Mean Difference (Final Values): -0.74 (97.5% CI -0.90 to -0.57), p <0.0001, ANCOVA
Placebo vs Empagliflozin 25 mg: Mean Difference (Final Values): -0.85 (97.5% CI -1.01 to -0.69), p <0.0001, ANCOVA

Population analysed: FAS and open-label set, last observation carried forward (LOCF) was used as the imputation rule for both sets

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: From first drug administration until seven days after last trial medication intake, up to 219 days. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	6 of 229 (2.6%)	63 of 229 (27.5%)	Not reported
Empagliflozin10 mg	8 of 224 (3.6%)	45 of 224 (20.1%)	Not reported
Empagliflozin 25 mg	5 of 223 (2.2%)	36 of 223 (16.1%)	Not reported
Sitagliptin 100 mg	6 of 223 (2.7%)	44 of 223 (19.7%)	Not reported
Empagliflozin 25 mg OL	3 of 87 (3.4%)	27 of 87 (31%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 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 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 24622369Roden M, Weng J, Eilbracht J, Delafont B, Kim G, Woerle HJ, Broedl UC; EMPA-REG MONO trial investigators. Empagliflozin monotherapy with sitagliptin as an active comparator in patients with type 2 diabetes: a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Diabetes Endocrinol. 2013 Nov;1(3):208-19. doi: 10.1016/S2213-8587(13)70084-6. Epub 2013 Sep 9.

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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

124 sites in 9 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing BI 10773 and BI 10773 open label in people with Diabetes Mellitus, Type 2, run by Boehringer Ingelheim at 124 sites in 9 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 6 inclusion and 15 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 16 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 124 sites in United States, China, Canada, Belgium, Japan and 4 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 16 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?

Change From Baseline in Glycosylated Haemoglobin (HbA1c) After 24 Weeks (time frame: Baseline and day 169). 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 NCT01177813, which also lists 4 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 16 Jun 2014.