Diabetes Mellitus, Type 2Phase 3NCT01210001

Efficacy and Safety of Empagliflozin (BI 10773) in Type 2 Diabetes Patients on a Background of Pioglitazone Alone or With Metformin

A Phase 3 study testing BI 10773 in people with Diabetes Mellitus, Type 2, run by Boehringer Ingelheim at 68 sites in 7 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 BI 10773 in type 2 diabetic patients in order to provide these data for approval for BI 10773 by regulatory authorities as an antidiabetic agent as add-on therapy to pioglitazone alone or in combination with metformin. 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: 499 participants
Where: 68 sitesin 7 countries
Study dates: Sep 2010to Apr 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 pre-treated with pioglitazone alone or in combination with metformin. The treatment regimen should be unchanged for 12 weeks prior to randomisation.
HbA1c of >/= 7.0% and </= 10.0% at Visit 1 (screening).
Age >/= 18.
BMI </= 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 medication within 12 weeks prior to randomisation, except those defined as the permitted background therapy via inclusion criteria no. 2.
Myocardial infarction, stroke or transient ischaemic attack (TIA) within 3 months prior to informed consent.
Indication of liver disease, defined by serum levels of either alanine transaminase (ALT/SGPT), aspartate transaminase (AST/SGOT), or alkaline phosphatase above 3 x upper limit of normal (ULN) as determined during screening or during the placebo run-in period (i.e. at a visit prior to the randomisation visit, Visit 3).
Impaired renal function, defined as eGFR (estimated Glomerular Filtration Rate) < 30 ml/min (severe renal impairment, MDRD [Modification of Diet in Renal Disease] formula) as determined during screening or during the placebo run-in period (i.e. at a visit prior to the randomisation visit, Visit 3).
Bariatric surgery within the past two years and other gastrointestinal surgeries that induce chronic malabsorption.

Show all 18Show fewer

Medical history of cancer (except for basal cell carcinoma) and/or treatment for cancer within the last 5 years .
Blood dyscrasias or any disorders causing haemolysis or unstable red blood cells (e.g. malaria, babesiosis, haemolytic anaemia).
Contraindications to pioglitazone according to the local label.
Contraindication to pioglitazone and/or metformin (relevant only for those patients who enter the study with both these background therapies) according to the local labels.
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 T2D.
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 trial 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 to 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 jeopardise patient safety while participating in this clinical trial.

Trial locations and contacts

68 sites in 7 countries.

Country

City, postcode or hospital

68 sites in 7 countries

United States24 sites

1245.19.10071 Boehringer Ingelheim Investigational Site
Asheboro, North Carolina
1245.19.10033 Boehringer Ingelheim Investigational Site
Chattanooga, Tennessee
1245.19.10003 Boehringer Ingelheim Investigational Site
Dearborn, Michigan
1245.19.10014 Boehringer Ingelheim Investigational Site
Dubuque, Iowa
1245.19.10160 Boehringer Ingelheim Investigational Site
Essex, Maryland
1245.19.10162 Boehringer Ingelheim Investigational Site
Glendale, Arizona
1245.19.10070 Boehringer Ingelheim Investigational Site
Irvine, California
1245.19.10133 Boehringer Ingelheim Investigational Site
Jupiter, Florida
1245.19.10047 Boehringer Ingelheim Investigational Site
La Mesa, California
1245.19.10008 Boehringer Ingelheim Investigational Site
Marion, Ohio
1245.19.10112 Boehringer Ingelheim Investigational Site
Memphis, Tennessee
1245.19.10141 Boehringer Ingelheim Investigational Site
Milford, Connecticut
1245.19.10056 Boehringer Ingelheim Investigational Site
Muscle Shoals, Alabama
1245.19.10059 Boehringer Ingelheim Investigational Site
New Hyde Park, New York
1245.19.10002 Boehringer Ingelheim Investigational Site
Norfolk, Virginia
1245.19.10077 Boehringer Ingelheim Investigational Site
Perry, Georgia
1245.19.10161 Boehringer Ingelheim Investigational Site
Phoenix, Arizona
1245.19.10085 Boehringer Ingelheim Investigational Site
Plantation, Florida
1245.19.10149 Boehringer Ingelheim Investigational Site
Rancho Cucamonga, California
1245.19.10163 Boehringer Ingelheim Investigational Site
Riverside, California
1245.19.10086 Boehringer Ingelheim Investigational Site
Salisbury, North Carolina
1245.19.10123 Boehringer Ingelheim Investigational Site
Smithtown, New York
1245.19.10046 Boehringer Ingelheim Investigational Site
Tempe, Arizona
1245.19.10131 Boehringer Ingelheim Investigational Site
West Hills, California

Other trials in United States

India17 sites

1245.19.91005 Boehringer Ingelheim Investigational Site
Bangalore
1245.19.91006 Boehringer Ingelheim Investigational Site
Bangalore
1245.19.91008 Boehringer Ingelheim Investigational Site
Bangalore
1245.19.91003 Boehringer Ingelheim Investigational Site
Belagavi
1245.19.91004 Boehringer Ingelheim Investigational Site
Chennai
1245.19.91009 Boehringer Ingelheim Investigational Site
Chennai
1245.19.91001 Boehringer Ingelheim Investigational Site
Coimbatore
1245.19.91015 Boehringer Ingelheim Investigational Site
Kalaburagi
1245.19.91011 Boehringer Ingelheim Investigational Site
Kartanaka
1245.19.91002 Boehringer Ingelheim Investigational Site
Mumbai
1245.19.91007 Boehringer Ingelheim Investigational Site
Mumbai, Maharastra
1245.19.91017 Boehringer Ingelheim Investigational Site
Mysore
1245.19.91010 Boehringer Ingelheim Investigational Site
Nagpur
1245.19.91012 Boehringer Ingelheim Investigational Site
New Delhi
1245.19.91013 Boehringer Ingelheim Investigational Site
Patna
1245.19.91014 Boehringer Ingelheim Investigational Site
Pune
1245.19.91016 Boehringer Ingelheim Investigational Site
Pune

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Canada11 sites

1245.19.20057 Boehringer Ingelheim Investigational Site
Brampton, Ontario
1245.19.20059 Boehringer Ingelheim Investigational Site
Fort Erie, Ontario
1245.19.20060 Boehringer Ingelheim Investigational Site
London, Ontario
1245.19.20012 G.A. Research Associates Ltd.
Moncton, New Brunswick
1245.19.20009 Boehringer Ingelheim Investigational Site
Newmarket, Ontario
1245.19.20058 Boehringer Ingelheim Investigational Site
Saint Romuald, Quebec
1245.19.20034 Boehringer Ingelheim Investigational Site
Sarnia, Ontario
1245.19.20041 Boehringer Ingelheim Investigational Site
Saskatoon, Saskatchewan
1245.19.20031 Boehringer Ingelheim Investigational Site
St. John's, Newfoundland and Labrador
1245.19.20047 Boehringer Ingelheim Investigational Site
Vancouver, British Columbia
1245.19.20062 Boehringer Ingelheim Investigational Site
Vancouver, British Columbia

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Ukraine6 sites

1245.19.75002 Boehringer Ingelheim Investigational Site
Dnipro
1245.19.75001 Boehringer Ingelheim Investigational Site
Kharkiv
1245.19.75005 Boehringer Ingelheim Investigational Site
Kiev
1245.19.75006 Boehringer Ingelheim Investigational Site
Lviv
1245.19.75004 Boehringer Ingelheim Investigational Site
Vinnitsa
1245.19.75003 Boehringer Ingelheim Investigational Site
Vinnytsia

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Philippines5 sites

1245.19.63002 Boehringer Ingelheim Investigational Site
Cebu City, N/A, Philippines
1245.19.63003 Boehringer Ingelheim Investigational Site
Davao City, N/A, Philippines
1245.19.63004 Boehringer Ingelheim Investigational Site
Manila, Philippines
1245.19.63005 Boehringer Ingelheim Investigational Site
Pasig City, Philippines
1245.19.63001 Boehringer Ingelheim Investigational Site
San Juan City, Philippines

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Greece3 sites

1245.19.30002 Boehringer Ingelheim Investigational Site
Athens
1245.19.30001 Boehringer Ingelheim Investigational Site
Nikaia
1245.19.30004 Boehringer Ingelheim Investigational Site
Thessaloniki

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Thailand2 sites

1245.19.66003 Boehringer Ingelheim Investigational Site
Saimai
1245.19.66004 Boehringer Ingelheim Investigational Site
Udon Thani, Thailand

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About this study

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

Conditions: Diabetes Mellitus, Type 2
Being tested: Placebo, 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.

PlaceboDrug
Placebo tablets matching BI 10773 low dose
BI 10773Drug
BI 10773 tablets once daily
PlaceboDrug
Placebo tablets matching BI 10773 high dose
PlaceboDrug
Placebo tablets matching BI 10773 high dose
PlaceboDrug
Placebo tablets matching BI 10773 high dose
BI 10773Drug
BI 10773 tablets once daily

Study groups in NCT01210001
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
Change From Baseline in HbA1c after 24 weeks.
Note that adjusted means are provided.
Measured: Baseline and 24 weeks
HbA1c Change From Baseline for Pio and Met Background Medication Patients
Change From Baseline in HbA1c after 24 weeks for patients with pioglitazone (pio) and metformin (met) background medication only.
Note that adjusted means are provided.
Measured: Baseline and 24 weeks

Secondary outcomes (2)

Fasting Plasma Glucose (FPG) Change From Baseline
Change from baseline in fasting plasma glucose (FPG) after 24 weeks of treatment.
Note that adjusted means are provided.
Measured: Baseline and 24 weeks
Body Weight Change From Baseline
Change from baseline in body weight after 24 weeks.
Note that 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.

Sep 2010Apr 2012

First posted28 Sep 2010 (estimated)
Study startSep 2010
Primary completionApr 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: 499 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01210001
Sponsor's protocol ID: 1245.19
Other IDs: 2009-016154-40, 2009
Status last verified: May 2014
First submitted: 27 Sep 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
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
Kovacs CS, Seshiah V, Merker L, Christiansen AV, Roux F, Salsali A, Kim G, Stella P, Woerle HJ, Broedl UC; EMPA-REG EXTEND PIO investigators. Empagliflozin as Add-on Therapy to Pioglitazone With or Without Metformin in Patients With Type 2 Diabetes Mellitus. Clin Ther. 2015 Aug;37(8):1773-88.e1. doi: 10.1016/j.clinthera.2015.05.511. Epub 2015 Jun 29.
PubMed 26138864

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?

See locations

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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 Randomised, Double-blind, Placebo-controlled Parallel Group Efficacy and Safety Trial of BI 10773 (10 and 25 mg Administered Orally Once Daily) Over 24 Weeks in Patients With Type 2 Diabetes Mellitus With Insufficient Glycaemic Control Despite a Background Therapy of Pioglitazone Alone or in Combination With Metformin
ClinicalTrials.gov ID: NCT01210001
Acronym / sponsor ID: 1245.19
Conditions: Diabetes Mellitus, Type 2
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 499 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Collaborators: Eli Lilly and Company
Study start: Sep 2010
Primary completion: Apr 2012 (actual)
First posted: 28 Sep 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: 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 (6 listed)

Diagnosis of type 2 diabetes mellitus prior to informed consent.
Male and female patients on diet and exercise regimen who are pre-treated with pioglitazone alone or in combination with metformin. The treatment regimen should be unchanged for 12 weeks prior to randomisation.
HbA1c of >/= 7.0% and </= 10.0% at Visit 1 (screening).
Age >/= 18.
BMI </= 45 kg/m2 (Body Mass Index) at Visit 1 (screening).

Key exclusion criteria (18 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 medication within 12 weeks prior to randomisation, except those defined as the permitted background therapy via inclusion criteria no. 2.
Myocardial infarction, stroke or transient ischaemic attack (TIA) within 3 months prior to informed consent.
Indication of liver disease, defined by serum levels of either alanine transaminase (ALT/SGPT), aspartate transaminase (AST/SGOT), or alkaline phosphatase above 3 x upper limit of normal (ULN) as determined during screening or during the placebo run-in period (i.e. at a visit prior to the randomisation visit, Visit 3).
Impaired renal function, defined as eGFR (estimated Glomerular Filtration Rate) < 30 ml/min (severe renal impairment, MDRD [Modification of Diet in Renal Disease] formula) as determined during screening or during the placebo run-in period (i.e. at a visit prior to the randomisation visit, Visit 3).

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
PlaceboPlacebo tablets matching BI 10773 low dose	Drug	Placebo
BI 10773BI 10773 tablets once daily	Drug	BI 10773 low dose
PlaceboPlacebo tablets matching BI 10773 high dose	Drug	BI 10773 high dose
PlaceboPlacebo tablets matching BI 10773 high dose	Drug	BI 10773 low dose
PlaceboPlacebo tablets matching BI 10773 high dose	Drug	Placebo
BI 10773BI 10773 tablets once daily	Drug	BI 10773 high dose

Primary outcome

HbA1c Change From Baseline
Time frame: Baseline and 24 weeks
Change From Baseline in HbA1c after 24 weeks. Note that adjusted means are provided.
HbA1c Change From Baseline for Pio and Met Background Medication Patients
Time frame: Baseline and 24 weeks
Change From Baseline in HbA1c after 24 weeks for patients with pioglitazone (pio) and metformin (met) background medication only. Note that adjusted means are provided.

2 secondary outcomes

Fasting Plasma Glucose (FPG) Change From Baseline
Time frame: Baseline and 24 weeks
Body Weight 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
Placebo	166	147
Empa 10mg	165	154
Empa 25mg	168	156

Primary outcome: HbA1c Change From Baseline

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

Measure	Placebo n = 165	Empa 10mg n = 165	Empa 25mg n = 168
Value	-0.11 (0.07)	-0.59 (0.07)	-0.72 (0.07)

Placebo vs Empa 10mg: Mean Difference (Final Values): -0.48 (97.5% CI -0.69 to -0.27), p <0.0001, ANCOVA
Placebo vs Empa 25mg: Mean Difference (Final Values): -0.61 (97.5% CI -0.82 to -0.40), p <0.0001, ANCOVA

Population analysed: Full analysis set (FAS) which included all randomised and treated patients 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 for Pio and Met Background Medication Patients

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

Measure	Placebo n = 124	Empa 10mg n = 125	Empa 25mg n = 127
Value	-0.11 (0.08)	-0.55 (0.08)	-0.70 (0.07)

Placebo vs Empa 10mg: Mean Difference (Final Values): -0.45 (97.5% CI -0.69 to -0.21), p <0.0001, ANCOVA
Placebo vs Empa 25mg: Mean Difference (Final Values): -0.60 (97.5% CI -0.83 to -0.36), p <0.0001, ANCOVA

Population analysed: Full analysis set (FAS) which included all randomised and treated patients who had a baseline HbA1c value for patients on pioglitazone and metformin background medication. 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 dose of randomised study medication until 7 days after the last dose, up to 256 days. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	7 of 165 (4.2%)	56 of 165 (33.9%)	Not reported
Empa 10mg	7 of 165 (4.2%)	50 of 165 (30.3%)	Not reported
Empa 25mg	6 of 168 (3.6%)	34 of 168 (20.2%)	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 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 26138864Kovacs CS, Seshiah V, Merker L, Christiansen AV, Roux F, Salsali A, Kim G, Stella P, Woerle HJ, Broedl UC; EMPA-REG EXTEND PIO investigators. Empagliflozin as Add-on Therapy to Pioglitazone With or Without Metformin in Patients With Type 2 Diabetes Mellitus. Clin Ther. 2015 Aug;37(8):1773-88.e1. doi: 10.1016/j.clinthera.2015.05.511. Epub 2015 Jun 29.

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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

68 sites in 7 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 68 sites in 7 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 18 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 68 sites in United States, India, Canada, Ukraine, Philippines and 2 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). The study lists 2 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 NCT01210001, 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 17 Jun 2014.