Diabetes Mellitus, Type 2Phase 3NCT01164501

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

A Phase 3 study testing BI 10773 in people with Diabetes Mellitus, Type 2 and Renal Insufficiency, run by Boehringer Ingelheim at 127 sites in 15 countries.

Completed

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

Official record

Search all trials

Trial summary

This study will investigate the efficacy and safety of the BI 10773 in type 2 diabetic patients with renal impairment in order to provide these data for approval for BI 10773 as an antidiabetic agent by regulatory authorities. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Diabetes Mellitus, Type 2, Renal Insufficiency
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: 741 participants
Where: 127 sitesin 15 countries
Study dates: Jul 2010to Jul 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 and an estimated glomerular filtration rate of <90 ml/min.
Male and female patients on diet and exercise regimen who are pre-treated with any antidiabetic therapy and are on the maximum tolerated dose which has been unchanged for 12 weeks prior to randomisation.
HbA1c greater than or equal to 7.0% and less than or equal to 10.0% .
Aged 18 years or above.
Body Mass Index less than or equal to 45 kg/m2

Who cannot join

Uncontrolled hyperglycaemia defined as >13.3 mmol/L after an overnight fast during placebo run-in.
Impaired renal function, defined as an estimated glomerular filtration rate <15 ml/min.
Renal impairment requiring any form of chronic dialysis.
Requiring acute dialysis within three months prior to informed consent.
Renal transplant recipient.
Myocardial infarction, stroke or Transient Ischemic Attack within three months prior to informed consent.

Show all 14Show fewer

Indication of liver disease.
Bariatric surgery within the past two years.
Medical history of cancer.
Blood dyscrasias or any disorders causing hemolysis or unstable red blood cell.
Contraindications to pre-existing background antidiabetic therapy.
Treatment with anti-obesity drugs.
Current treatment with systemic steroids or change in dosage of thyroid hormones within six weeks prior to informed consent or any other uncontrolled endocrine disorder except Type 2 Diabetes.
Pre-menopausal women who are nursing or pregnant or are of child-bearing potential and are not practising an acceptable method of birth control.

Trial locations and contacts

127 sites in 15 countries.

Country

City, postcode or hospital

127 sites in 15 countries

United States18 sites

1245.36.10014 Boehringer Ingelheim Investigational Site
Anaheim, California
1245.36.10005 Boehringer Ingelheim Investigational Site
Bethlehem, Pennsylvania
1245.36.10012 Boehringer Ingelheim Investigational Site
Corpus Christi, Texas
1245.36.10013 Boehringer Ingelheim Investigational Site
Dallas, Texas
1245.36.10021 Boehringer Ingelheim Investigational Site
Endwell, New York
1245.36.10008 Boehringer Ingelheim Investigational Site
Greenville, North Carolina
1245.36.10004 Boehringer Ingelheim Investigational Site
Greer, South Carolina
1245.36.10018 Boehringer Ingelheim Investigational Site
Honolulu, Hawaii
1245.36.10002 Boehringer Ingelheim Investigational Site
Houston, Texas
1245.36.10019 Boehringer Ingelheim Investigational Site
Lomita, California
1245.36.10003 Boehringer Ingelheim Investigational Site
Melrose Park, Pennsylvania
1245.36.10017 Boehringer Ingelheim Investigational Site
Plantation, Florida
1245.36.10023 Boehringer Ingelheim Investigational Site
Renton, Washington
1245.36.10007 Boehringer Ingelheim Investigational Site
San Antonio, Texas
1245.36.10015 Boehringer Ingelheim Investigational Site
Shreveport, Louisiana
1245.36.10011 Boehringer Ingelheim Investigational Site
Spokane, Washington
1245.36.10006 Boehringer Ingelheim Investigational Site
Tacoma, Washington
1245.36.10009 Boehringer Ingelheim Investigational Site
West Palm Beach, Florida

Other trials in United States

India15 sites

1245.36.91209 Boehringer Ingelheim Investigational Site
Aligarh, Uttar Pradesh
1245.36.91202 Boehringer Ingelheim Investigational Site
Bangalore
1245.36.91204 Boehringer Ingelheim Investigational Site
Bangalore
1245.36.91205 Boehringer Ingelheim Investigational Site
Bangalore
1245.36.91208 Boehringer Ingelheim Investigational Site
Bangalore
1245.36.91201 Boehringer Ingelheim Investigational Site
Chennai
1245.36.91214 Boehringer Ingelheim Investigational Site
Chennai
1245.36.91213 Boehringer Ingelheim Investigational Site
Gūrgaon
1245.36.91203 Boehringer Ingelheim Investigational Site
Hyderabad
1245.36.91211 Boehringer Ingelheim Investigational Site
Kolkata
1245.36.91210 Boehringer Ingelheim Investigational Site
Mangalore
1245.36.91215 Boehringer Ingelheim Investigational Site
Mumbai, Maharastra
1245.36.91216 Boehringer Ingelheim Investigational Site
Nashik
1245.36.91212 Boehringer Ingelheim Investigational Site
New Delhi
1245.36.91207 Boehringer Ingelheim Investigational Site
Pune

Other trials in India

United Kingdom12 sites

1245.36.44018 Boehringer Ingelheim Investigational Site
Bath
1245.36.44010 Boehringer Ingelheim Investigational Site
Birmingham
1245.36.44013 Boehringer Ingelheim Investigational Site
Blackpool
1245.36.44016 Boehringer Ingelheim Investigational Site
Blackpool
1245.36.44026 Boehringer Ingelheim Investigational Site
Chester
1245.36.44012 Boehringer Ingelheim Investigational Site
Chesterfield
1245.36.44025 Boehringer Ingelheim Investigational Site
Doncaster
1245.36.44036 Boehringer Ingelheim Investigational Site
Epsom
1245.36.44001 Boehringer Ingelheim Investigational Site
Frome
1245.36.44007 Boehringer Ingelheim Investigational Site
Midsomer Norton
1245.36.44023 Boehringer Ingelheim Investigational Site
Nantwich
1245.36.44024 Boehringer Ingelheim Investigational Site
Welwyn Garden City

Other trials in United Kingdom

Malaysia10 sites

1245.36.60003 Boehringer Ingelheim Investigational Site
Johor Baru
1245.36.60006 Boehringer Ingelheim Investigational Site
Kelantan Kota Bahru
1245.36.60005 Boehringer Ingelheim Investigational Site
Kuala Lumpur
1245.36.60009 Boehringer Ingelheim Investigational Site
Kuala Lumpur
1245.36.60004 Boehringer Ingelheim Investigational Site
Kuala Pahang
1245.36.60007 Boehringer Ingelheim Investigational Site
Perak
1245.36.60011 Boehringer Ingelheim Investigational Site
Perak
1245.36.60010 Boehringer Ingelheim Investigational Site
Pulau Piang
1245.36.60008 Boehringer Ingelheim Investigational Site
Sabak Bernam
1245.36.60001 Boehringer Ingelheim Investigational Site
Selangor Darul Ehsan

Other trials in Malaysia

Spain10 sites

1245.36.34015 Boehringer Ingelheim Investigational Site
Barcelona
1245.36.34009 Boehringer Ingelheim Investigational Site
Granada
1245.36.34014 Boehringer Ingelheim Investigational Site
L'Hospitalet de Llobregat
1245.36.34012 Boehringer Ingelheim Investigational Site
Madrid
1245.36.34013 Boehringer Ingelheim Investigational Site
Madrid
1245.36.34020 Boehringer Ingelheim Investigational Site
Manresa
1245.36.34021 Boehringer Ingelheim Investigational Site
San Sebastián de los Reyes
1245.36.34016 Boehringer Ingelheim Investigational Site
Santiago de Compostela
1245.36.34017 Boehringer Ingelheim Investigational Site
Valencia
1245.36.34019 Boehringer Ingelheim Investigational Site
Valencia

Other trials in Spain

Canada9 sites

1245.36.20052 Boehringer Ingelheim Investigational Site
Calgary, Alberta
1245.36.20054 Boehringer Ingelheim Investigational Site
Calgary, Alberta
1245.36.20023 Boehringer Ingelheim Investigational Site
Edmonton, Alberta
1245.36.20055 Boehringer Ingelheim Investigational Site
Edmonton, Alberta
1245.36.20051 Boehringer Ingelheim Investigational Site
Mississauga, Ontario
1245.36.20056 Boehringer Ingelheim Investigational Site
Montreal, Quebec
1245.36.20086 Boehringer Ingelheim Investigational Site
Thornhill, Ontario
1245.36.20053 Boehringer Ingelheim Investigational Site
Toronto, Ontario
1245.36.20048 Boehringer Ingelheim Investigational Site
Winnipeg, Manitoba

Other trials in Canada

France9 sites

1245.36.33001 Boehringer Ingelheim Investigational Site
Corbeil-Essonnes
1245.36.33042 Boehringer Ingelheim Investigational Site
Nanterre
1245.36.33041 Boehringer Ingelheim Investigational Site
Nice
1245.36.33036 Boehringer Ingelheim Investigational Site
Paris
1245.36.33040 Boehringer Ingelheim Investigational Site
Poitiers
1245.36.33037 Boehringer Ingelheim Investigational Site
Reims
1245.36.33038 Boehringer Ingelheim Investigational Site
Reims
1245.36.33043 Boehringer Ingelheim Investigational Site
Rennes
1245.36.33044 Boehringer Ingelheim Investigational Site
Saint-Mandé

Other trials in France

Netherlands7 sites

1245.36.31015 Boehringer Ingelheim Investigational Site
Amersfoort
1245.36.31012 Boehringer Ingelheim Investigational Site
Geleen
1245.36.31017 Boehringer Ingelheim Investigational Site
Hardenberg
1245.36.31009 Boehringer Ingelheim Investigational Site
Maastricht
1245.36.31004 Boehringer Ingelheim Investigational Site
The Hague
1245.36.31002 Boehringer Ingelheim Investigational Site
Utrecht
1245.36.31003 Boehringer Ingelheim Investigational Site
Zaandam

Other trials in Netherlands

Poland7 sites

1245.36.48006 Boehringer Ingelheim Investigational Site
Gdansk
1245.36.48003 Boehringer Ingelheim Investigational Site
Lodz
1245.36.48004 Boehringer Ingelheim Investigational Site
Lodz
1245.36.48001 Boehringer Ingelheim Investigational Site
Lublin
1245.36.48002 Boehringer Ingelheim Investigational Site
Poznan
1245.36.48007 Boehringer Ingelheim Investigational Site
Ruda Śląska
1245.36.48005 Boehringer Ingelheim Investigational Site
Torun

Other trials in Poland

Philippines6 sites

1245.36.63008 Boehringer Ingelheim Investigational Site
Cavite City
1245.36.63006 Boehringer Ingelheim Investigational Site
Cebu
1245.36.63005 Boehringer Ingelheim Investigational Site
Manila
1245.36.63007 Boehringer Ingelheim Investigational Site
Manila
1245.36.63009 Boehringer Ingelheim Investigational Site
Marikina City
1245.36.63010 Boehringer Ingelheim Investigational Site
Tacloban City

Other trials in Philippines

Russia6 sites

1245.36.70008 Boehringer Ingelheim Investigational Site
Moscow
1245.36.70009 Boehringer Ingelheim Investigational Site
Moscow
1245.36.70011 Boehringer Ingelheim Investigational Site
Moscow
1245.36.70004 Boehringer Ingelheim Investigational Site
Saint Petersburg
1245.36.70006 Boehringer Ingelheim Investigational Site
Saint Petersburg
1245.36.70002 Boehringer Ingelheim Investigational Site
Vsevolozhsk

Other trials in Russia

Slovakia6 sites

1245.36.74011 Boehringer Ingelheim Investigational Site
Moldava nad Bodvou
1245.36.74013 Boehringer Ingelheim Investigational Site
Nitra
1245.36.74008 Boehringer Ingelheim Investigational Site
Nové Mesto nad Váhom
1245.36.74012 Boehringer Ingelheim Investigational Site
Prešov
1245.36.74007 Boehringer Ingelheim Investigational Site
Trenčín
1245.36.74009 Boehringer Ingelheim Investigational Site
Žilina

Other trials in Slovakia

Hong Kong5 sites

1245.36.85201 Boehringer Ingelheim Investigational Site
Hong Kong
1245.36.85204 Boehringer Ingelheim Investigational Site
Hong Kong
1245.36.85205 Boehringer Ingelheim Investigational Site
Hong Kong
1245.36.85206 Boehringer Ingelheim Investigational Site
Hong Kong
1245.36.85202 Boehringer Ingelheim Investigational Site
Kowloon

Other trials in Hong Kong

Portugal4 sites

1245.36.35003 Boehringer Ingelheim Investigational Site
Faro
1245.36.35002 Boehringer Ingelheim Investigational Site
Lisbon
1245.36.35004 Boehringer Ingelheim Investigational Site
Lisbon
1245.36.35001 Boehringer Ingelheim Investigational Site
Vila Nova de Gaia

Other trials in Portugal

South Africa3 sites

1245.36.76021 Boehringer Ingelheim Investigational Site
Plumstead
1245.36.76020 Boehringer Ingelheim Investigational Site
Somerset West
1245.36.76022 Boehringer Ingelheim Investigational Site
Somerset West

Other trials in South Africa

About this study

Official title: A Phase III, Randomised, Double-blind, Placebo-controlled, Parallel Group, Efficacy and Safety Study of BI 10773 (10 mg and 25 mg Administered Once Daily) as Add on to Pre-existing Antidiabetic Therapy Over 52 Weeks in Patients With Type 2 Diabetes Mellitus and Renal Impairment and Insufficient Glycaemic Control

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

What participants receive

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

BI 10773Drug
BI 10773 tablets once daily
PlaceboDrug
Placebo tablets identical to BI 10773 low dose
PlaceboDrug
Placebo tablets identical to BI 10773 high dose
BI 10773Drug
BI 10773 tablets once daily
PlaceboDrug
Placebo tablets identical to BI 10773 low dose
PlaceboDrug
Placebo tablets identical to BI 10773 high dose

Study groups in NCT01164501
Study group	Role	What they receive
BI 10773 low dose	Experimental	BI 10773 tablets once daily Receives: Drug: BI 10773; Drug: Placebo
BI 10773 high dose	Experimental	BI 10773 tablets once daily Receives: Drug: Placebo; Drug: BI 10773
Placebo	Placebo comparator	Placebo tablets matching BI 10773 Receives: Drug: Placebo

What is being measured

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

HbA1c Change From Baseline in Patients With Mild or Moderate Renal Impairment
Change from baseline in HbA1c after 24 weeks, for patients with mild or moderate renal impairment.
Note adjusted means are provided.
Measured: Baseline and 24 weeks
HbA1c Change From Baseline in Patients With Mild Renal Impairment
Change from baseline in HbA1c after 24 weeks, for patients with mild renal impairment.
Note adjusted means are provided.
Measured: Baseline and 24 weeks
HbA1c Change From Baseline in Patients With Moderate Renal Impairment
Change from baseline in HbA1c after 24 weeks, for patients with moderate renal impairment.
Note adjusted means are provided.
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 2010Jul 2012

First posted16 Jul 2010 (estimated)
Study startJul 2010
Primary completionJul 2012
Study completionJul 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: 741 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01164501
Sponsor's protocol ID: 1245.36
Other IDs: 2009-016179-31, 2009
Status last verified: May 2014
First submitted: 15 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
Barnett AH, Mithal A, Manassie J, Jones R, Rattunde H, Woerle HJ, Broedl UC; EMPA-REG RENAL trial investigators. Efficacy and safety of empagliflozin added to existing antidiabetes treatment in patients with type 2 diabetes and chronic kidney disease: a randomised, double-blind, placebo-controlled trial. Lancet Diabetes Endocrinol. 2014 May;2(5):369-84. doi: 10.1016/S2213-8587(13)70208-0. Epub 2014 Jan 24.
PubMed 24795251

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 (10 mg and 25 mg Administered Once Daily) as Add on to Pre-existing Antidiabetic Therapy Over 52 Weeks in Patients With Type 2 Diabetes Mellitus and Renal Impairment and Insufficient Glycaemic Control
ClinicalTrials.gov ID: NCT01164501
Acronym / sponsor ID: 1245.36
Conditions: Diabetes Mellitus, Type 2, Renal Insufficiency
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 741 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Collaborators: Eli Lilly and Company
Study start: Jul 2010
Primary completion: Jul 2012 (actual)
Study completion: Jul 2012 (actual)
First posted: 16 Jul 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: 3

Arm	Type	Receives
BI 10773 low dose	Experimental	Drug: BI 10773, Drug: PlaceboBI 10773 tablets once daily
BI 10773 high dose	Experimental	Drug: Placebo, Drug: BI 10773BI 10773 tablets once daily
Placebo	Placebo comparator	Drug: PlaceboPlacebo tablets matching BI 10773

Who may qualify

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

Key inclusion criteria (5 listed)

Diagnosis of type 2 diabetes mellitus prior to informed consent and an estimated glomerular filtration rate of <90 ml/min.
Male and female patients on diet and exercise regimen who are pre-treated with any antidiabetic therapy and are on the maximum tolerated dose which has been unchanged for 12 weeks prior to randomisation.
HbA1c greater than or equal to 7.0% and less than or equal to 10.0% .
Aged 18 years or above.
Body Mass Index less than or equal to 45 kg/m2

Key exclusion criteria (14 listed)

Uncontrolled hyperglycaemia defined as >13.3 mmol/L after an overnight fast during placebo run-in.
Impaired renal function, defined as an estimated glomerular filtration rate <15 ml/min.
Renal impairment requiring any form of chronic dialysis.
Requiring acute dialysis within three months prior to informed consent.
Renal transplant recipient.

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

Interventions

Intervention	Type	Arms
BI 10773BI 10773 tablets once daily	Drug	BI 10773 low dose
PlaceboPlacebo tablets identical to BI 10773 low dose	Drug	BI 10773 high dose
PlaceboPlacebo tablets identical to BI 10773 high dose	Drug	Placebo
BI 10773BI 10773 tablets once daily	Drug	BI 10773 high dose
PlaceboPlacebo tablets identical to BI 10773 low dose	Drug	Placebo
PlaceboPlacebo tablets identical to BI 10773 high dose	Drug	BI 10773 low dose

Primary outcome

HbA1c Change From Baseline in Patients With Mild or Moderate Renal Impairment
Time frame: Baseline and 24 weeks
Change from baseline in HbA1c after 24 weeks, for patients with mild or moderate renal impairment. Note adjusted means are provided.
HbA1c Change From Baseline in Patients With Mild Renal Impairment
Time frame: Baseline and 24 weeks
Change from baseline in HbA1c after 24 weeks, for patients with mild renal impairment. Note adjusted means are provided.
HbA1c Change From Baseline in Patients With Moderate Renal Impairment
Time frame: Baseline and 24 weeks
Change from baseline in HbA1c after 24 weeks, for patients with moderate renal impairment. Note adjusted means are provided.

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	321	278
Empa 10mg	98	88
Empa 25mg	322	280

Primary outcome: HbA1c Change From Baseline in Patients With Mild or Moderate Renal Impairment

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

Measure	Placebo n = 282	Empa 25mg n = 284
Value	0.05 (0.04)	-0.46 (0.04)

Placebo vs Empa 25mg: Mean Difference (Final Values): -0.51 (95% CI -0.62 to -0.39), p <0.0001, ANCOVA

Population analysed: Full analysis set (FAS) which included all randomised patients, treated with at least one dose of trial medication, who had a baseline HbA1c value. Values after start of antidiabetic rescue therapy were set to missing and last observation carried forward (LOCF) was used for imputation of missing values.

Primary outcome: HbA1c Change From Baseline in Patients With Mild Renal Impairment

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

Measure	Placebo n = 95	Empa 10mg n = 98	Empa 25mg n = 97
Value	0.06 (0.07)	-0.46 (0.07)	-0.63 (0.07)

Placebo vs Empa 10mg: Mean Difference (Final Values): -0.52 (95% CI -0.72 to -0.32), p <0.0001, ANCOVA
Placebo vs Empa 25mg: Mean Difference (Final Values): -0.68 (95% CI -0.88 to -0.49), p <0.0001, ANCOVA

Primary outcome: HbA1c Change From Baseline in Patients With Moderate Renal Impairment

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

Measure	Placebo n = 187	Empa 25mg n = 187
Value	0.05 (0.05)	-0.37 (0.05)

Placebo vs Empa 25mg: Mean Difference (Final Values): -0.42 (95% CI -0.56 to -0.28), p <0.0001, ANCOVA

Adverse events

Time frame: From first drug administration until 7 days after last trial medication intake, up to 458 days. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	44 of 319 (13.8%)	207 of 319 (64.9%)	Not reported
Empa 10mg	6 of 98 (6.1%)	64 of 98 (65.3%)	Not reported
Empa 25mg	40 of 321 (12.5%)	187 of 321 (58.3%)	Not reported

Limitations and caveats (from the sponsor): In this trial, only patients with mild or moderate renal impairment were analysed. Patients with severe or no renal impairment were not analysed.

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 24795251Barnett AH, Mithal A, Manassie J, Jones R, Rattunde H, Woerle HJ, Broedl UC; EMPA-REG RENAL trial investigators. Efficacy and safety of empagliflozin added to existing antidiabetes treatment in patients with type 2 diabetes and chronic kidney disease: a randomised, double-blind, placebo-controlled trial. Lancet Diabetes Endocrinol. 2014 May;2(5):369-84. doi: 10.1016/S2213-8587(13)70208-0. Epub 2014 Jan 24.
Related InfoLink provided by the sponsor.

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Chronic Kidney Disease, Hypertension (HTN)
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A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
Not yet recruiting
Impact of Endoscopic Sleeve Gastroplasty (ESG) in Obese Adults With Type 2 Diabetes (T2D)
Type 2 Diabetes Mellitus (T2D), Obesity (BMI>30)

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

127 sites in 15 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 and Renal Insufficiency, run by Boehringer Ingelheim at 127 sites in 15 countries.

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

Who may be eligible to take part?

The sponsor lists 5 inclusion and 14 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 127 sites in United States, India, United Kingdom, Malaysia, Spain and 10 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?

HbA1c Change From Baseline in Patients With Mild or Moderate Renal Impairment (time frame: Baseline and 24 weeks). The study lists 3 primary outcomes in all. 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 NCT01164501, 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.