Diabetes Mellitus, Type 2Phase 2NCT00881530

Empagliflozin (BI 10773) in Type Two Diabetes (T2D) Patients, Open Label Extension

A Phase 2 study testing BI 10773, Metformin and Sitagliptin in people with Diabetes Mellitus, Type 2, run by Boehringer Ingelheim at 137 sites in 21 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

The objective of the current study is to investigate the safety and efficacy of BI 10773 in 2 different doses compared to Metformin or to Sitagliptin given for 78 weeks in different modalities of treatment in patients with type 2 diabetes mellitus. 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, Metformin and Sitagliptin
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 660 participants
Where: 137 sitesin 21 countries
Study dates: Mar 2009to May 2011
Phase: Phase 2
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

patients completing one of double blind phase II trials 1245.9 or 1245.10
informed consent

Who cannot join

patients meeting withdrawal criteria of preceding trial
significant hepatic impairment
significant renal impairment with creatinine clearance < 50 ml/min
contraindication to Metformin for all patients treated with Metformin
premenopausal women that are nursing or pregnant or not practicing acceptable methods of birth control
drug or alcohol abuse

Trial locations and contacts

137 sites in 21 countries.

Country

City, postcode or hospital

137 sites in 21 countries

France13 sites

1245.24.3302A Boehringer Ingelheim Investigational Site
Bondy
1245.24.3302B Boehringer Ingelheim Investigational Site
Bondy
1245.24.3310A Boehringer Ingelheim Investigational Site
Caen
1245.24.3310C Boehringer Ingelheim Investigational Site
Caen
1245.24.3301A Boehringer Ingelheim Investigational Site
Corbeil-Essonnes
1245.24.3303A Boehringer Ingelheim Investigational Site
La Rochelle
1245.24.3303B Boehringer Ingelheim Investigational Site
La Rochelle
1245.24.3309A Boehringer Ingelheim Investigational Site
Nanterre
1245.24.3306A Boehringer Ingelheim Investigational Site
Narbonne
1245.24.3304A Boehringer Ingelheim Investigational Site
Reims
1245.24.3311B Boehringer Ingelheim Investigational Site
Saint-Mandé
1245.24.3305A Boehringer Ingelheim Investigational Site
Valenciennes
1245.24.3305B Boehringer Ingelheim Investigational Site
Valenciennes

Other trials in France

United States12 sites

1245.24.101004 Boehringer Ingelheim Investigational Site
Clearwarter, Florida
1245.24.101015 Boehringer Ingelheim Investigational Site
Dallas, Texas
1245.24.101025 Boehringer Ingelheim Investigational Site
Federal Way, Washington
1245.24.101005 Boehringer Ingelheim Investigational Site
Miami, Florida
1245.24.101001 Boehringer Ingelheim Investigational Site
Mission Viejo, California
1245.24.101023 Boehringer Ingelheim Investigational Site
Norristown, Pennsylvania
1245.24.101014 Boehringer Ingelheim Investigational Site
Roswell, Georgia
1245.24.101024 Boehringer Ingelheim Investigational Site
Saint Cloud, Florida
1245.24.101028 Boehringer Ingelheim Investigational Site
Spring Valley, California
1245.24.101016 Boehringer Ingelheim Investigational Site
Staten Island, New York
1245.24.101006 Boehringer Ingelheim Investigational Site
Wadsworth, Ohio
1245.24.101027 Boehringer Ingelheim Investigational Site
Walnut Creek, California

Other trials in United States

Russia12 sites

1245.24.701002 Boehringer Ingelheim Investigational Site
Kazan'
1245.24.701008 Boehringer Ingelheim Investigational Site
Moscow
1245.24.701009 Boehringer Ingelheim Investigational Site
Moscow
1245.24.701010 Boehringer Ingelheim Investigational Site
Moscow
1245.24.701004 Boehringer Ingelheim Investigational Site
Petrozavodsk
1245.24.701012 Boehringer Ingelheim Investigational Site
Saint Petersburg
1245.24.701013 Boehringer Ingelheim Investigational Site
Saint Petersburg
1245.24.701014 Boehringer Ingelheim Investigational Site
Saratov
1245.24.701005 Boehringer Ingelheim Investigational Site
Smolensk
1245.24.701006 Boehringer Ingelheim Investigational Site
Yaroslavl
1245.24.701007 Boehringer Ingelheim Investigational Site
Yaroslavl
1245.24.701001 Boehringer Ingelheim Investigational Site
Yekaterinburg

Other trials in Russia

Germany9 sites

1245.24.491011 Boehringer Ingelheim Investigational Site
Aschaffenburg
1245.24.491007 Boehringer Ingelheim Investigational Site
Frankfurt am Main
1245.24.491004 Boehringer Ingelheim Investigational Site
Hamburg
1245.24.491005 Boehringer Ingelheim Investigational Site
Hamburg
1245.24.491002 Boehringer Ingelheim Investigational Site
Melsungen
1245.24.491012 Boehringer Ingelheim Investigational Site
Nuremberg
1245.24.491008 Boehringer Ingelheim Investigational Site
Rehlingen-Siersburg
1245.24.491003 Boehringer Ingelheim Investigational Site
Saint Ingbert/Oberwürzbach
1245.24.491010 Boehringer Ingelheim Investigational Site
Sulzbach-Rosenberg

Other trials in Germany

Ukraine9 sites

1245.24.381007 Boehringer Ingelheim Investigational Site
Dnipro
1245.24.381003 Boehringer Ingelheim Investigational Site
Kharkiv
1245.24.381009 Boehringer Ingelheim Investigational Site
Kharkiv
1245.24.381010 Boehringer Ingelheim Investigational Site
Kharkiv
1245.24.381008 Boehringer Ingelheim Investigational Site
Kiev
1245.24.381002 Boehringer Ingelheim Investigational Site
Odesa
1245.24.381006 Boehringer Ingelheim Investigational Site
Vinnitsa
1245.24.381001 Boehringer Ingelheim Investigational Site
Vinnytsia
1245.24.381005 Boehringer Ingelheim Investigational Site
Vinnytsia

Other trials in Ukraine

Romania8 sites

1245.24.401005 Boehringer Ingelheim Investigational Site
Alba Iulia
1245.24.401006 Boehringer Ingelheim Investigational Site
Baia Mare Maramures
1245.24.401002 Boehringer Ingelheim Investigational Site
Brasov
1245.24.401001 Boehringer Ingelheim Investigational Site
Bucharest
1245.24.401008 Boehringer Ingelheim Investigational Site
Bucharest
1245.24.401003 Boehringer Ingelheim Investigational Site
Galati
1245.24.401007 Boehringer Ingelheim Investigational Site
Satu Mare
1245.24.401004 Boehringer Ingelheim Investigational Site
Târgu Mureş

Other trials in Romania

Slovakia8 sites

1245.24.421102 Boehringer Ingelheim Investigational Site
Bratislava
1245.24.421107 Boehringer Ingelheim Investigational Site
Bratislava
1245.24.421103 Boehringer Ingelheim Investigational Site
Lučenec
1245.24.421105 Boehringer Ingelheim Investigational Site
Nitra
1245.24.421106 Boehringer Ingelheim Investigational Site
Nitra
1245.24.421104 Boehringer Ingelheim Investigational Site
Nové Mesto nad Váhom
1245.24.421108 Boehringer Ingelheim Investigational Site
Prešov
1245.24.421101 Boehringer Ingelheim Investigational Site
Prievidza

Other trials in Slovakia

South Korea8 sites

1245.24.821006 Boehringer Ingelheim Investigational Site
Goyang
1245.24.821008 Boehringer Ingelheim Investigational Site
Goyang
1245.24.821007 Boehringer Ingelheim Investigational Site
Incheon
1245.24.821002 Boehringer Ingelheim Investigational Site
Pucheon
1245.24.821001 Boehringer Ingelheim Investigational Site
Seoul
1245.24.821004 Boehringer Ingelheim Investigational Site
Seoul
1245.24.821009 Boehringer Ingelheim Investigational Site
Suwon
1245.24.821003 Boehringer Ingelheim Investigational Site
Uijeongbu-si

Other trials in South Korea

Latvia7 sites

1245.24.371101 Boehringer Ingelheim Investigational Site
Daugavpils
1245.24.371105 Boehringer Ingelheim Investigational Site
Kuldīga
1245.24.371106 Boehringer Ingelheim Investigational Site
Ogre
1245.24.371103 Boehringer Ingelheim Investigational Site
Riga
1245.24.371107 Boehringer Ingelheim Investigational Site
Riga
1245.24.371102 Boehringer Ingelheim Investigational Site
Talsi
1245.24.371104 Boehringer Ingelheim Investigational Site
Valmiera

Other trials in Latvia

Spain7 sites

1245.24.341002 Boehringer Ingelheim Investigational Site
Barcelona
1245.24.341001 Boehringer Ingelheim Investigational Site
Girona
1245.24.341010 Boehringer Ingelheim Investigational Site
L'Hospitalet de Llobregat (Barcelona)
1245.24.341004 Boehringer Ingelheim Investigational Site
Málaga
1245.24.341005 Boehringer Ingelheim Investigational Site
Palma Mallorca
1245.24.341006 Boehringer Ingelheim Investigational Site
Palma Mallorca
1245.24.341008 Boehringer Ingelheim Investigational Site
Santander

Other trials in Spain

Taiwan7 sites

1245.24.886105 Boehringer Ingelheim Investigational Site
Changhua
1245.24.886107 Boehringer Ingelheim Investigational Site
Kaohsiung City
1245.24.886104 Boehringer Ingelheim Investigational Site
Taichun
1245.24.886106 Boehringer Ingelheim Investigational Site
Tainan
1245.24.886101 Boehringer Ingelheim Investigational Site
Taipei
1245.24.886103 Boehringer Ingelheim Investigational Site
Taipei
1245.24.886102 Boehringer Ingelheim Investigational Site
Taoyuan

Other trials in Taiwan

Estonia5 sites

1245.24.372101 Boehringer Ingelheim Investigational Site
Tallinn
1245.24.372102 Boehringer Ingelheim Investigational Site
Tallinn
1245.24.372103 Boehringer Ingelheim Investigational Site
Tallinn
1245.24.372104 Boehringer Ingelheim Investigational Site
Tallinn
1245.24.372105 Boehringer Ingelheim Investigational Site
Tartu

Other trials in Estonia

Hungary5 sites

1245.24.361001 Boehringer Ingelheim Investigational Site
Budapest
1245.24.361003 Boehringer Ingelheim Investigational Site
Budapest
1245.24.361004 Boehringer Ingelheim Investigational Site
Budapest
1245.24.361005 Boehringer Ingelheim Investigational Site
Győr
1245.24.361002 Boehringer Ingelheim Investigational Site
Szombathely

Other trials in Hungary

Croatia4 sites

1245.24.385104 Boehringer Ingelheim Investigational Site
Karlovac
1245.24.385103 Boehringer Ingelheim Investigational Site
Krapinske Toplice
1245.24.385106 Boehringer Ingelheim Investigational Site
Osijek
1245.24.385101 Boehringer Ingelheim Investigational Site
Zagreb

Other trials in Croatia

Czechia4 sites

1245.24.420101 Boehringer Ingelheim Investigational Site
Břeclav
1245.24.420103 Boehringer Ingelheim Investigational Site
Brno
1245.24.420105 Boehringer Ingelheim Investigational Site
Brno
1245.24.420102 Boehringer Ingelheim Investigational Site
Hodonín

Other trials in Czechia

Finland4 sites

1245.24.581006 Boehringer Ingelheim Investigational Site
Kerava
1245.24.581003 Boehringer Ingelheim Investigational Site
Oulu
1245.24.581004 Boehringer Ingelheim Investigational Site
Tampere
1245.24.581001 Boehringer Ingelheim Investigational Site
Turku

Other trials in Finland

Norway4 sites

1245.24.471004 Boehringer Ingelheim Investigational Site
Ålesund
1245.24.471003 Boehringer Ingelheim Investigational Site
Hamar
1245.24.471005 Boehringer Ingelheim Investigational Site
Oslo
1245.24.471001 Boehringer Ingelheim Investigational Site
Stavanger

Other trials in Norway

Austria3 sites

1245.24.431002 Boehringer Ingelheim Investigational Site
Graz
1245.24.431001 Boehringer Ingelheim Investigational Site
Vienna
1245.24.431003 Boehringer Ingelheim Investigational Site
Vienna

Other trials in Austria

Italy3 sites

1245.24.391006 Boehringer Ingelheim Investigational Site
Genova
1245.24.391003 Boehringer Ingelheim Investigational Site
Pisa
1245.24.391005 Boehringer Ingelheim Investigational Site
Treviso

Other trials in Italy

Sweden3 sites

1245.24.461004 Boehringer Ingelheim Investigational Site
Härnösand
1245.24.461005 Boehringer Ingelheim Investigational Site
Lund
1245.24.461001 Boehringer Ingelheim Investigational Site
Stockholm

Other trials in Sweden

Lithuania2 sites

1245.24.370102 Boehringer Ingelheim Investigational Site
Klaipėda
1245.24.370101 Boehringer Ingelheim Investigational Site
Vilnius

Other trials in Lithuania

About this study

Official title: A 78 Week Open Label Extension to Trials Assessing the Safety and Efficacy of BI 10773 as Monotherapy or in Combination With Metformin in Type 2 Diabetic Patients

Conditions: Diabetes Mellitus, Type 2
Being tested: BI 10773, Metformin, Sitagliptin
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.

BI 10773Drug
BI 10773 high dose once daily
MetforminDrug
open label comparator
BI 10773Drug
BI 10773 low dose once daily
SitagliptinDrug
open label comparator

Study groups in NCT00881530
Study group	Role	What they receive
Sitagliptin	Active comparator	100 mg Receives: Drug: Sitagliptin
Metformin	Active comparator	2000 mg Receives: Drug: Metformin
BI 10773 X mg	Experimental	lower dose Receives: Drug: BI 10773
BI 10773 Y mg	Experimental	higher dose Receives: Drug: BI 10773

What is being measured

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

Hypoglycaemic Events
Investigator defined Hypoglycaemic events. For documentation of hypoglycemic events, the following criteria were taken into consideration:
- Asymptomatic hypoglycemia: the event was not accompanied by typical symptoms of hypoglycemia but with a measured plasma glucose of ≤70 mg/dL (≤3.9 mmol/L)
- Documented symptomatic hypoglycemia with glucose of ≥54 mg/dL and ≤70 mg/dL (≥3.0 mmol/L and ≤3.9 mmol/L)
- Documented symptomatic hypoglycemia with glucose of <54 mg/dL (<3.0 mmol/L): the event was accompanied by typical symptoms of hypoglycemia but in no need for external assistance
- Severe hypoglycemic episode: the event required the assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions
Measured: 78 weeks plus 1 week of follow-up
Change From Baseline to Week 78 in Lipid Parameters
Change from baseline to week 78 in lipid parameters (Total cholesterol, High-density lipoprotein (HDL), Low-density lipoprotein (LDL) and Triglyceride)
Measured: Weeks 1 and 78
Clinical Relevant Abnormalities for Physical Examination, Vital Signs, ECG and Laboratory Measurements
Clinical Relevant Abnormalities for Physical Examination, Vital Signs, ECG and Laboratory Measurements. New abnormal findings or worsening of baseline conditions were reported as treatment related Adverse Events.
Measured: 78 weeks plus 1 week of follow-up

Secondary outcomes (5)

Change From Baseline in HbA1c Over Time
Baseline source: before first intake of active treatment (preceding trial or Open label extension)
Measured: Weeks 1, 6, 18, 30, 42, 54, 66 and 78
Occurence of a Treat-to-target Response (HbA1c < 7.0%)
Occurence of a treat-to-target response, defined as HbA1c < 7.0% over time
Measured: Weeks 1, 6, 18, 30, 42, 54, 66 and 78
Occurrence of a Treat-to-target Response (HbA1c < 6.5%)
Occurrence of a Treat-to-target Response, defined as HbA1c < 6.5% over time
Measured: Weeks 1, 6, 18, 30, 42, 54, 66 and 78
Occurrence of a Relative Efficacy Response
Occurrence of a Relative Efficacy Response (HbA1c Lowered by at least >=0.5% over time)
Measured: Weeks 1, 6, 18, 30, 42, 54, 66 and 78
Change From Baseline in Fasting Plasma Glucose (FPG) Over Time
Baseline source: before first intake of active treatment (preceding trial or Open label extension)
Measured: Weeks 1, 6, 18, 30, 42, 54, 66 and 78

Timeline

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

Mar 2009May 2011

First posted15 Apr 2009 (estimated)
Study startMar 2009
Primary completionMay 2011

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 (1)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 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 660 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00881530
Sponsor's protocol ID: 1245.24
Other IDs: 2008-007938-21, 2008
Status last verified: May 2014
First submitted: 14 Apr 2009
Last updated: 16 Jun 2014
Results posted: Yes, on ClinicalTrials.gov

Publications

Ferrannini E, Berk A, Hantel S, Pinnetti S, Hach T, Woerle HJ, Broedl UC. Long-term safety and efficacy of empagliflozin, sitagliptin, and metformin: an active-controlled, parallel-group, randomized, 78-week open-label extension study in patients with type 2 diabetes. Diabetes Care. 2013 Dec;36(12):4015-21. doi: 10.2337/dc13-0663. Epub 2013 Nov 1.
PubMed 24186878

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

Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruitingPhase 3
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)

All Diabetes Mellitus, Type 2 trials

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 78 Week Open Label Extension to Trials Assessing the Safety and Efficacy of BI 10773 as Monotherapy or in Combination With Metformin in Type 2 Diabetic Patients
ClinicalTrials.gov ID: NCT00881530
Acronym / sponsor ID: 1245.24
Conditions: Diabetes Mellitus, Type 2
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 660 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: Mar 2009
Primary completion: May 2011 (actual)
First posted: 15 Apr 2009 (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: None (open label)
Number of arms: 4

Arm	Type	Receives
Sitagliptin	Active comparator	Drug: Sitagliptin100 mg
Metformin	Active comparator	Drug: Metformin2000 mg
BI 10773 X mg	Experimental	Drug: BI 10773lower dose
BI 10773 Y mg	Experimental	Drug: BI 10773higher dose

Who may qualify

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

Key inclusion criteria (2 listed)

patients completing one of double blind phase II trials 1245.9 or 1245.10
informed consent

Key exclusion criteria (6 listed)

patients meeting withdrawal criteria of preceding trial
significant hepatic impairment
significant renal impairment with creatinine clearance < 50 ml/min
contraindication to Metformin for all patients treated with Metformin
premenopausal women that are nursing or pregnant or not practicing acceptable methods of birth control

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 high dose once daily	Drug	BI 10773 Y mg
Metforminopen label comparator	Drug	Metformin
BI 10773BI 10773 low dose once daily	Drug	BI 10773 X mg
Sitagliptinopen label comparator	Drug	Sitagliptin

Primary outcome

Hypoglycaemic Events
Time frame: 78 weeks plus 1 week of follow-up
Investigator defined Hypoglycaemic events. For documentation of hypoglycemic events, the following criteria were taken into consideration: * Asymptomatic hypoglycemia: the event was not accompanied by typical symptoms of hypoglycemia but with a measured plasma glucose of ≤70 mg/dL (≤3.9 mmol/L) * Documented symptomatic hypoglycemia with glucose of ≥54 mg/dL and ≤70 mg/dL (≥3.0 mmol/L and ≤3.9 mmol/L) * Documented symptomatic hypoglycemia with glucose of <54 mg/dL (<3.0 mmol/L): the event was accompanied by typical symptoms of hypoglycemia but in no need for external assistance * Severe hypoglycemic episode: the event required the assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions
Change From Baseline to Week 78 in Lipid Parameters
Time frame: Weeks 1 and 78
Change from baseline to week 78 in lipid parameters (Total cholesterol, High-density lipoprotein (HDL), Low-density lipoprotein (LDL) and Triglyceride)
Clinical Relevant Abnormalities for Physical Examination, Vital Signs, ECG and Laboratory Measurements
Time frame: 78 weeks plus 1 week of follow-up
Clinical Relevant Abnormalities for Physical Examination, Vital Signs, ECG and Laboratory Measurements. New abnormal findings or worsening of baseline conditions were reported as treatment related Adverse Events.

5 secondary outcomes

Change From Baseline in HbA1c Over Time
Time frame: Weeks 1, 6, 18, 30, 42, 54, 66 and 78
Occurence of a Treat-to-target Response (HbA1c < 7.0%)
Time frame: Weeks 1, 6, 18, 30, 42, 54, 66 and 78
Occurrence of a Treat-to-target Response (HbA1c < 6.5%)
Time frame: Weeks 1, 6, 18, 30, 42, 54, 66 and 78
Occurrence of a Relative Efficacy Response
Time frame: Weeks 1, 6, 18, 30, 42, 54, 66 and 78
Change From Baseline in Fasting Plasma Glucose (FPG) Over Time
Time frame: Weeks 1, 6, 18, 30, 42, 54, 66 and 78

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
Empagliflozin 10 mg	106	92
Empagliflozin 25 mg	109	104
Metformin	56	51
Empagliflozin 10 mg + Metformin	166	157
Empagliflozin 25 mg + Metformin	166	152
Sitaglipin + Metformin	56	51

Primary outcome: Hypoglycaemic Events

Time frame: 78 weeks plus 1 week of follow-up. Number. Unit: percentage of participants

Measure	Empagliflozin 10 mg n = 106	Empagliflozin 25 mg n = 109	Metformin n = 56	Empagliflozin 10 mg + Metformin n = 166	Empagliflozin 25 mg + Metformin n = 166	Sitaglipin + Metformin n = 56
Value	0.9	1.8	7.1	2.4	3.6	5.4

Population analysed: Treated set

Primary outcome: Change From Baseline to Week 78 in Lipid Parameters

Time frame: Weeks 1 and 78. Mean (Standard Deviation). Unit: mmol/L

Measure	Empagliflozin 10 mg n = 105	Empagliflozin 25 mg n = 109	Metformin n = 56	Empagliflozin 10 mg + Metformin n = 164	Empagliflozin 25 mg + Metformin n = 162	Sitaglipin + Metformin n = 56
Total Cholesterol	-0.13 (1.17)	0.09 (0.88)	-0.24 (0.77)	0.19 (0.81)	0.13 (0.75)	-0.05 (0.91)
HDL	0.08 (0.11)	0.07 (0.10)	0.06 (0.10)	0.06 (0.09)	0.07 (0.10)	0.03 (0.08)
LDL (N=102, 108, 52, 161, 159, 55)	-0.02 (0.83)	0.05 (0.83)	-0.13 (0.74)	0.13 (0.71)	0.07 (0.69)	0.00 (0.79)
Triglyceride	-0.5 (2.3)	-0.0 (0.6)	-0.5 (1.2)	0.1 (0.9)	-0.1 (0.8)	-0.2 (0.9)

Population analysed: Treated set

Primary outcome: Clinical Relevant Abnormalities for Physical Examination, Vital Signs, ECG and Laboratory Measurements

Time frame: 78 weeks plus 1 week of follow-up. Number. Unit: percentage of participants

Measure	Empagliflozin 10 mg n = 106	Empagliflozin 25 mg n = 109	Metformin n = 56	Empagliflozin 10 mg + Metformin n = 166	Empagliflozin 25 mg + Metformin n = 166	Sitaglipin + Metformin n = 56
Alanine aminotransferase increased	0.9	0.9	3.6	0.6	0.6	1.8
Aspartate aminotransferase increased	1.9	0.0	1.8	0.0	0.6	0.0
Gamma-glutamyltransferase increased	0.9	0.0	1.8	0.0	1.2	0.0
Blood alkaline phosphatase increased	0.9	0.0	0.0	0.0	0.0	0.0
Blood creatine phosphokinase increased	0.9	0.0	0.0	0.0	0.0	0.0
Granulocyte count decreased	0.9	0.0	0.0	0.0	0.0	0.0
Hepatic enzyme increased	0.0	0.9	0.0	0.6	0.0	0.0
Blood creatinine increased	0.9	0.9	0.0	0.0	0.6	0.0

Population analysed: Treated set

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: From drug administration until 7 days after the last intake of study drug, up to 582 days. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Empagliflozin 10 mg	10 of 106 (9.4%)	34 of 106 (32.1%)	Not reported
Empagliflozin 25 mg	7 of 109 (6.4%)	46 of 109 (42.2%)	Not reported
Metformin	3 of 56 (5.4%)	27 of 56 (48.2%)	Not reported
Empagliflozin 10 mg + Metformin	10 of 166 (6%)	74 of 166 (44.6%)	Not reported
Empagliflozin 25 mg + Metformin	13 of 166 (7.8%)	79 of 166 (47.6%)	Not reported
Sitaglipin + Metformin	9 of 56 (16.1%)	26 of 56 (46.4%)	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 24186878Ferrannini E, Berk A, Hantel S, Pinnetti S, Hach T, Woerle HJ, Broedl UC. Long-term safety and efficacy of empagliflozin, sitagliptin, and metformin: an active-controlled, parallel-group, randomized, 78-week open-label extension study in patients with type 2 diabetes. Diabetes Care. 2013 Dec;36(12):4015-21. doi: 10.2337/dc13-0663. Epub 2013 Nov 1.

Related trials for Diabetes Mellitus, Type 2

Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruitingPhase 3
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

137 sites in 21 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing BI 10773, Metformin and Sitagliptin in people with Diabetes Mellitus, Type 2, run by Boehringer Ingelheim at 137 sites in 21 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 2 inclusion and 6 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 137 sites in France, United States, Russia, Germany, Ukraine and 16 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

Hypoglycaemic Events (time frame: 78 weeks plus 1 week of follow-up). 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 NCT00881530, which also lists 1 linked publication.

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.