Diabetes Mellitus, Type 2Phase 3NCT01306214

Safety and Efficacy of BI 10773 as add-on to Insulin Regimen in Patients With Type 2 Diabetes Mellitus

A Phase 3 study testing BI 10773 in people with Diabetes Mellitus, Type 2 and Obesity, run by Boehringer Ingelheim at 103 sites in 14 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 trial will evaluate use of BI 10773 as add-on to insulin regimen alone or with metformin in patients with typr 2 diabetes. Both lowering glucose and HbA1c and reducing the use of insulin in this population would provide significant new information for the BI 10773 use and would offer a potential new therapeutic… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Diabetes Mellitus, Type 2, Obesity
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: 566 participants
Where: 103 sitesin 14 countries
Study dates: Feb 2011to Apr 2013
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 T2DM prior to informed consent
Male and female patients on diet and exercise regimen who are pre-treated with multiple daily injections (MDI) of insulin alone or in combination with immediate or extended release metformin
Stable metformin therapy: daily dose >=1500 mg/day or maximum tolerated dose
HbA1c >=7.5% and <=10% at screening

Who cannot join

Uncontrolled hyperglycemia with a glucose level >240 mg/dl (>13.3 mmol/L) after an overnight fast during placebo run-in
Any contraindications to metformin according to the local label
Acute coronary syndrome, stroke or TIA within 3 months prior to informed consent

Trial locations and contacts

103 sites in 14 countries.

Country

City, postcode or hospital

103 sites in 14 countries

United States26 sites

1245.49.10003 Boehringer Ingelheim Investigational Site
Austin, Texas
1245.49.10005 Boehringer Ingelheim Investigational Site
Birmingham, Alabama
1245.49.10021 Boehringer Ingelheim Investigational Site
Blue Ridge, Georgia
1245.49.10033 Boehringer Ingelheim Investigational Site
Bountiful, Utah
1245.49.10011 Boehringer Ingelheim Investigational Site
Chandler, Arizona
1245.49.10009 Boehringer Ingelheim Investigational Site
Chicago, Illinois
1245.49.10006 Boehringer Ingelheim Investigational Site
Columbus, Ohio
1245.49.10002 Boehringer Ingelheim Investigational Site
Corona, California
1245.49.10001 Boehringer Ingelheim Investigational Site
Dallas, Texas
1245.49.10024 Boehringer Ingelheim Investigational Site
Denver, Colorado
1245.49.10013 Boehringer Ingelheim Investigational Site
El Cajon, California
1245.49.10015 Boehringer Ingelheim Investigational Site
Evansville, Indiana
1245.49.10007 Boehringer Ingelheim Investigational Site
Fargo, North Dakota
1245.49.10023 Boehringer Ingelheim Investigational Site
Greenville, North Carolina
1245.49.10025 Boehringer Ingelheim Investigational Site
Greer, South Carolina
1245.49.10018 Boehringer Ingelheim Investigational Site
Hialeah, Florida
1245.49.10031 Boehringer Ingelheim Investigational Site
Houston, Texas
1245.49.10030 Boehringer Ingelheim Investigational Site
Lomita, California
1245.49.10022 Boehringer Ingelheim Investigational Site
Memphis, Tennessee
1245.49.10016 Boehringer Ingelheim Investigational Site
Miami, Florida
1245.49.10026 Boehringer Ingelheim Investigational Site
Norfolk, Virginia
1245.49.10020 Boehringer Ingelheim Investigational Site
Renton, Washington
1245.49.10032 Boehringer Ingelheim Investigational Site
Salt Lake City, Utah
1245.49.10014 Boehringer Ingelheim Investigational Site
Spring Valley, California
1245.49.10004 Boehringer Ingelheim Investigational Site
Tucson, Arizona
1245.49.10019 Boehringer Ingelheim Investigational Site
Westlake Village, California

Other trials in United States

Mexico11 sites

1245.49.52011 Boehringer Ingelheim Investigational Site
Aguascalientes
1245.49.52012 Boehringer Ingelheim Investigational Site
Cuautla
1245.49.52003 Boehringer Ingelheim Investigational Site
Durango
1245.49.52005 Boehringer Ingelheim Investigational Site
Durango
1245.49.52004 Boehringer Ingelheim Investigational Site
Guadalajara
1245.49.52006 Boehringer Ingelheim Investigational Site
Guadalajara
1245.49.52008 Boehringer Ingelheim Investigational Site
Guadalajara
1245.49.52001 Boehringer Ingelheim Investigational Site
México, D.F.
1245.49.52002 Boehringer Ingelheim Investigational Site
Monterrey
1245.49.52009 Boehringer Ingelheim Investigational Site
Monterrey
1245.49.52010 Boehringer Ingelheim Investigational Site
Monterrey

Other trials in Mexico

France9 sites

1245.49.33001 Boehringer Ingelheim Investigational Site
Grenoble
1245.49.33011 Boehringer Ingelheim Investigational Site
Le Creusot
1245.49.33012 Boehringer Ingelheim Investigational Site
Marseille
1245.49.33003 Boehringer Ingelheim Investigational Site
Nantes
1245.49.33010 Boehringer Ingelheim Investigational Site
Narbonne
1245.49.33004 Boehringer Ingelheim Investigational Site
Pierre-Bénite
1245.49.33007 Boehringer Ingelheim Investigational Site
Point-à-Pitre Cedex
1245.49.33008 Boehringer Ingelheim Investigational Site
Saint-Priest-en-Jarez
1245.49.33009 Boehringer Ingelheim Investigational Site
Vénissieux

Other trials in France

Spain8 sites

1245.49.34039 Boehringer Ingelheim Investigational Site
Ávila
1245.49.34038 Boehringer Ingelheim Investigational Site
Madrid
1245.49.34044 Boehringer Ingelheim Investigational Site
Madrid
1245.49.34043 Boehringer Ingelheim Investigational Site
MBoadilla Del Monte (Madrid)
1245.49.34047 Boehringer Ingelheim Investigational Site
Palma de Mallorca
1245.49.34045 Boehringer Ingelheim Investigational Site
Pozuelo de Alarcón
1245.49.34016 Boehringer Ingelheim Investigational Site
Santiago de Compostela (La Coruña)
1245.49.34041 Boehringer Ingelheim Investigational Site
Valencia

Other trials in Spain

Belgium6 sites

1245.49.32010 Boehringer Ingelheim Investigational Site
Bonheiden
1245.49.32002 Boehringer Ingelheim Investigational Site
Edegem
1245.49.32007 Boehringer Ingelheim Investigational Site
Huy
1245.49.32014 Boehringer Ingelheim Investigational Site
Jette
1245.49.32013 Boehringer Ingelheim Investigational Site
La Louvière
1245.49.32012 Boehringer Ingelheim Investigational Site
Leuven

Other trials in Belgium

Czechia6 sites

1245.49.42013 Boehringer Ingelheim Investigational Site
Břeclav
1245.49.42003 Boehringer Ingelheim Investigational Site
Brno
1245.49.42010 Boehringer Ingelheim Investigational Site
Brno
1245.49.42011 Boehringer Ingelheim Investigational Site
Chrudim
1245.49.42009 Boehringer Ingelheim Investigational Site
Hodonín
1245.49.42012 Boehringer Ingelheim Investigational Site
Svitavy56802

Other trials in Czechia

Germany6 sites

1245.49.49104 Boehringer Ingelheim Investigational Site
Bosenheim
1245.49.49013 Boehringer Ingelheim Investigational Site
Dresden
1245.49.49101 Boehringer Ingelheim Investigational Site
Mainz
1245.49.49002 Boehringer Ingelheim Investigational Site
Neuwied
1245.49.49005 Boehringer Ingelheim Investigational Site
Saarbrücken
1245.49.49102 Boehringer Ingelheim Investigational Site
Wangen

Other trials in Germany

Peru6 sites

1245.49.51002 Boehringer Ingelheim Investigational Site
Arequipa
1245.49.51006 Boehringer Ingelheim Investigational Site
Arequipa
1245.49.51010 Boehringer Ingelheim Investigational Site
Jesus Maria
1245.49.51001 Boehringer Ingelheim Investigational Site
Lima
1245.49.51008 Boehringer Ingelheim Investigational Site
Lima
1245.49.51009 Boehringer Ingelheim Investigational Site
Lima

Other trials in Peru

Colombia5 sites

1245.49.57003 Boehringer Ingelheim Investigational Site
Barranquilla
1245.49.57004 Boehringer Ingelheim Investigational Site
Bogotá
1245.49.57005 Boehringer Ingelheim Investigational Site
Bogotá
1245.49.57006 Boehringer Ingelheim Investigational Site
Bogotá
1245.49.57002 Boehringer Ingelheim Investigational Site
Medellín

Other trials in Colombia

Guatemala5 sites

1245.49.50201 Boehringer Ingelheim Investigational Site
Guatemala City
1245.49.50202 Boehringer Ingelheim Investigational Site
Guatemala City
1245.49.50203 Boehringer Ingelheim Investigational Site
Guatemala City
1245.49.50204 Boehringer Ingelheim Investigational Site
Guatemala City
1245.49.50205 Boehringer Ingelheim Investigational Site
Quetzaltenango

Other trials in Guatemala

Ukraine5 sites

1245.49.75016 Boehringer Ingelheim Investigational Site
Kharkiv
1245.49.75007 Boehringer Ingelheim Investigational Site
Kiev
1245.49.75014 Boehringer Ingelheim Investigational Site
Kiev
1245.49.75015 Boehringer Ingelheim Investigational Site
Kiev
1245.49.75013 Boehringer Ingelheim Investigational Site
Kyiv

Other trials in Ukraine

Russia4 sites

1245.49.70008 Boehringer Ingelheim Investigational Site
Moscow
1245.49.70009 Boehringer Ingelheim Investigational Site
Moscow
1245.49.70006 Boehringer Ingelheim Investigational Site
Saint Petersburg
1245.49.70010 Boehringer Ingelheim Investigational Site
Saint Petersburg

Other trials in Russia

Bulgaria3 sites

1245.49.59003 Boehringer Ingelheim Investigational Site
Pleven
1245.49.59004 Boehringer Ingelheim Investigational Site
Sofia
1245.49.59001 Boehringer Ingelheim Investigational Site
Stara Zagora

Other trials in Bulgaria

Finland3 sites

1245.49.72001 Boehringer Ingelheim Investigational Site
Kuopio
1245.49.72002 Boehringer Ingelheim Investigational Site
Oulu
1245.49.72003 Boehringer Ingelheim Investigational Site
Turku

Other trials in Finland

About this study

Official title: A Phase III, Randomized, Double-blind, Placebo-controlled, Parallel Group Safety and Efficacy Study of BI 10773 (10 mg and 25 mg Administered Orally Once Daily) During 52 Weeks in Patients With Type 2 Diabetes Mellitus and Insufficient Glycemic Control on MDI Insulin Regimen Alone or With Metformin

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

What participants receive

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

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

Study groups in NCT01306214
Study group	Role	What they receive
BI 10773 low dose	Experimental	BI 10773 low dose once daily Receives: Drug: Placebo; Drug: BI 10773
BI 10773 high dose	Experimental	BI 10733 high dose 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.

Change From Baseline in HbA1c After 18 Weeks of Treatment
The primary endpoint was the change from baseline in HbA1c after 18 weeks of treatment.
Measured: Baseline and 18 weeks

Secondary outcomes (3)

Change From Baseline in Insulin Dose After 52 Weeks of Treatment
The secondary endpoint is change from baseline in insulin dose after 52 weeks of treatment
Measured: Baseline and 52 weeks
Change From Baseline in Body Weight After 52 Weeks of Treatment
The secondary endpoint was the change from baseline in body weight after 52 weeks of treatment
Measured: Baseline and 52 weeks
Change From Baseline in HbA1c After 52 Weeks of Treatment
The secondary endpoint was the change from baseline in HbA1c after 52 weeks of treatment
Measured: Baseline and 52 weeks

Timeline

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

Feb 2011Apr 2013

First posted1 Mar 2011 (estimated)
Study startFeb 2011
Primary completionApr 2013
Study completionApr 2013

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)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: 566 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01306214
Sponsor's protocol ID: 1245.49
Other IDs: 2010-019968-37
Status last verified: May 2014
First submitted: 28 Feb 2011
Last updated: 17 Jun 2014
Results posted: Yes, on ClinicalTrials.gov

Publications

Tuttle KR, Levin A, Nangaku M, Kadowaki T, Agarwal R, Hauske SJ, Elsasser A, Ritter I, Steubl D, Wanner C, Wheeler DC. Safety of Empagliflozin in Patients With Type 2 Diabetes and Chronic Kidney Disease: Pooled Analysis of Placebo-Controlled Clinical Trials. Diabetes Care. 2022 Jun 2;45(6):1445-1452. doi: 10.2337/dc21-2034.
PubMed 35472672
Rosenstock J, Jelaska A, Frappin G, Salsali A, Kim G, Woerle HJ, Broedl UC; EMPA-REG MDI Trial Investigators. Improved glucose control with weight loss, lower insulin doses, and no increased hypoglycemia with empagliflozin added to titrated multiple daily injections of insulin in obese inadequately controlled type 2 diabetes. Diabetes Care. 2014 Jul;37(7):1815-23. doi: 10.2337/dc13-3055. Epub 2014 Jun 14.
PubMed 24929430

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 Phase III, Randomized, Double-blind, Placebo-controlled, Parallel Group Safety and Efficacy Study of BI 10773 (10 mg and 25 mg Administered Orally Once Daily) During 52 Weeks in Patients With Type 2 Diabetes Mellitus and Insufficient Glycemic Control on MDI Insulin Regimen Alone or With Metformin
ClinicalTrials.gov ID: NCT01306214
Acronym / sponsor ID: 1245.49
Conditions: Diabetes Mellitus, Type 2, Obesity
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 566 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Collaborators: Eli Lilly and Company
Study start: Feb 2011
Primary completion: Apr 2013 (actual)
Study completion: Apr 2013 (actual)
First posted: 1 Mar 2011 (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: Placebo, Drug: BI 10773BI 10773 low dose once daily
BI 10773 high dose	Experimental	Drug: Placebo, Drug: BI 10773BI 10733 high dose 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 (4 listed)

Diagnosis of T2DM prior to informed consent
Male and female patients on diet and exercise regimen who are pre-treated with multiple daily injections (MDI) of insulin alone or in combination with immediate or extended release metformin
Stable metformin therapy: daily dose >=1500 mg/day or maximum tolerated dose
HbA1c >=7.5% and <=10% at screening

Key exclusion criteria (3 listed)

Uncontrolled hyperglycemia with a glucose level >240 mg/dl (>13.3 mmol/L) after an overnight fast during placebo run-in
Any contraindications to metformin according to the local label
Acute coronary syndrome, stroke or TIA within 3 months prior to informed consent

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

Primary outcome

Change From Baseline in HbA1c After 18 Weeks of Treatment
Time frame: Baseline and 18 weeks
The primary endpoint was the change from baseline in HbA1c after 18 weeks of treatment.

3 secondary outcomes

Change From Baseline in Insulin Dose After 52 Weeks of Treatment
Time frame: Baseline and 52 weeks
Change From Baseline in Body Weight After 52 Weeks of Treatment
Time frame: Baseline and 52 weeks
Change From Baseline in HbA1c After 52 Weeks of Treatment
Time frame: Baseline and 52 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	189	161
Empagliflozin 10 mg	187	159
Empagliflozin 25 mg	190	168

Primary outcome: Change From Baseline in HbA1c After 18 Weeks of Treatment

Time frame: Baseline and 18 weeks. Least squares mean (Standard Error). Unit: percentage of HbA1c

Measure	Placebo n = 188	Empagliflozin 10 mg n = 186	Empagliflozin 25 mg n = 189
Value	-0.50 (0.05)	-0.94 (0.05)	-1.02 (0.05)

Placebo vs Empagliflozin 10 mg: Adjusted mean difference: -0.44 (97.5% CI -0.61 to -0.27), p <0.0001, ANCOVA
Placebo vs Empagliflozin 25 mg: Adjusted mean difference: -0.52 (97.5% CI -0.69 to -0.35), p <0.0001, ANCOVA

Population analysed: The analysis was conducted on the full analysis set (FAS) of patients. Values after start of antidiabetic rescue therapy (week 18 definition) were set to missing and last observation carried forward (LOCF-18) was used for imputation of missing values.

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: Up to 52 weeks. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	22 of 188 (11.7%)	146 of 188 (77.7%)	Not reported
Empagliflozin 10 mg	20 of 186 (10.8%)	135 of 186 (72.6%)	Not reported
Empagliflozin 25 mg	22 of 189 (11.6%)	140 of 189 (74.1%)	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 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 24929430Rosenstock J, Jelaska A, Frappin G, Salsali A, Kim G, Woerle HJ, Broedl UC; EMPA-REG MDI Trial Investigators. Improved glucose control with weight loss, lower insulin doses, and no increased hypoglycemia with empagliflozin added to titrated multiple daily injections of insulin in obese inadequately controlled type 2 diabetes. Diabetes Care. 2014 Jul;37(7):1815-23. doi: 10.2337/dc13-3055. Epub 2014 Jun 14.

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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

103 sites in 14 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 Obesity, run by Boehringer Ingelheim at 103 sites in 14 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 4 inclusion and 3 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 103 sites in United States, Mexico, France, Spain, Belgium and 9 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?

Change From Baseline in HbA1c After 18 Weeks of Treatment (time frame: Baseline and 18 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 NCT01306214, which also lists 2 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.