Diabetes Mellitus, Type 2Phase 2NCT00749190

BI 10773 add-on to Metformin in Patients With Type 2 Diabetes

A Phase 2 study testing BI 10773 and sitagliptin in people with Diabetes Mellitus, Type 2, run by Boehringer Ingelheim at 116 sites in 16 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 efficacy, safety and pharmacokinetics of five doses of BI 10773 compared to placebo given for 12 weeks as add-on therapy to on going metformin therapy in patients with T2DM with insufficient glycemic control. Read more about this study

Who is it for?: Ages 18 to 79 years
Conditions the study is for: Diabetes Mellitus, Type 2
What is being tested?: BI 10773 and sitagliptin
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 495 participants
Where: 116 sitesin 16 countries
Study dates: Aug 2008to Oct 2009
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 to 79 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Male and female patients with a diagnosis of type 2 diabetes mellitus and previously treated with metformin alone or with metformin and one other oral antidiabetic drug
Stable metformin therapy of at least 1500 mg/day, or less if that is a maximum tolerated dose.
HbA1c at screening 6.5% to 9.0% for patients on metformin and one other antidiabetic drug, and HbA1c >7.0% to 10% for patients on metformin only
HbA1c >7.0% to 10.0% at Visit 2 (Start of Run-in)
Age >=18 and <80years
Body Mass Index (BMI) <=40 kg/m2
Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice (GCP) and local legislation

Who cannot join

Myocardial infarction, stroke or transient ischemic attack (TIA) within 6 months prior to informed consent
Impaired hepatic function
Renal insufficiency or impaired renal function
Diseases of the central nervous system or psychiatric disorders or clinically relevant neurological disorders that may interfere with participation in the trial
Chronic or clinically relevant acute infections
Current or chronic urogenital tract infection

Show all 13Show fewer

History of clinically relevant allergy/hypersensitivity
Treatment with glitazones (e.g., rosiglitazone, pioglitazone), glucagon-like peptide (GLP-1) analogues, or insulin within 3 months prior to informed consent
Treatment with anti-obesity drugs within 3 months prior to informed consent
Treatment with systemic steroids or change in dosage of thyroid hormones within 6 weeks prior to informed consent
Alcohol abuse or drug abuse
Treatment with an investigational drug within 2 months prior to informed consent
Women of child-bearing potential who are nursing or pregnant, or who are not practicing an acceptable method of birth control, or do not plan to continue using this method throughout the study and do not agree to periodic pregnancy testing during participation in the trial

Trial locations and contacts

116 sites in 16 countries.

Country

City, postcode or hospital

116 sites in 16 countries

France28 sites

1245.10.3302A Boehringer Ingelheim Investigational Site
Bondy
1245.10.3302B Boehringer Ingelheim Investigational Site
Bondy
1245.10.3310A Boehringer Ingelheim Investigational Site
Caen
1245.10.3310B Boehringer Ingelheim Investigational Site
Caen
1245.10.3310C Boehringer Ingelheim Investigational Site
Caen
1245.10.3301A Boehringer Ingelheim Investigational Site
Corbeil-Essonnes
1245.10.3301B Boehringer Ingelheim Investigational Site
Corbeil-Essonnes
1245.10.3303A Boehringer Ingelheim Investigational Site
La Rochelle
1245.10.3303B Boehringer Ingelheim Investigational Site
La Rochelle
1245.10.3303C Boehringer Ingelheim Investigational Site
La Rochelle
1245.10.3303D Boehringer Ingelheim Investigational Site
La Rochelle
1245.10.3308A Boehringer Ingelheim Investigational Site
Le Grau-du-Roi
1245.10.3308B Boehringer Ingelheim Investigational Site
Le Grau-du-Roi
1245.10.3309A Boehringer Ingelheim Investigational Site
Nanterre
1245.10.3306A Boehringer Ingelheim Investigational Site
Narbonne
1245.10.3306B Boehringer Ingelheim Investigational Site
Narbonne
1245.10.3307A Boehringer Ingelheim Investigational Site
Quimper
1245.10.3304A Boehringer Ingelheim Investigational Site
Reims
1245.10.3304B Boehringer Ingelheim Investigational Site
Reims
1245.10.3304C Boehringer Ingelheim Investigational Site
Reims
1245.10.3311A Boehringer Ingelheim Investigational Site
Saint-Mandé
1245.10.3311B Boehringer Ingelheim Investigational Site
Saint-Mandé
1245.10.3311C Boehringer Ingelheim Investigational Site
Saint-Mandé
1245.10.3311D Boehringer Ingelheim Investigational Site
Saint-Mandé
1245.10.3305A Boehringer Ingelheim Investigational Site
Valenciennes
1245.10.3305B Boehringer Ingelheim Investigational Site
Valenciennes
1245.10.3305C Boehringer Ingelheim Investigational Site
Valenciennes
1245.10.3305D Boehringer Ingelheim Investigational Site
Valenciennes

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United States19 sites

1245.10.10026 Boehringer Ingelheim Investigational Site
Chula Vista, California
1245.10.10004 Boehringer Ingelheim Investigational Site
Clearwarter, Florida
1245.10.10010 Boehringer Ingelheim Investigational Site
Clemson, South Carolina
1245.10.10015 Boehringer Ingelheim Investigational Site
Dallas, Texas
1245.10.10025 Boehringer Ingelheim Investigational Site
Federal Way, Washington
1245.10.10021 Boehringer Ingelheim Investigational Site
Melbourne, Florida
1245.10.10005 Boehringer Ingelheim Investigational Site
Miami, Florida
1245.10.10019 Boehringer Ingelheim Investigational Site
Miami, Florida
1245.10.10001 Boehringer Ingelheim Investigational Site
Mission Viejo, California
1245.10.10023 Boehringer Ingelheim Investigational Site
Norristown, Pennsylvania
1245.10.10011 Boehringer Ingelheim Investigational Site
Pasadena, California
1245.10.10014 Boehringer Ingelheim Investigational Site
Roswell, Georgia
1245.10.10024 Boehringer Ingelheim Investigational Site
Saint Cloud, Florida
1245.10.10009 Boehringer Ingelheim Investigational Site
Shelby, North Carolina
1245.10.10028 Boehringer Ingelheim Investigational Site
Spring Valley, California
1245.10.10016 Boehringer Ingelheim Investigational Site
Staten Island, New York
1245.10.10012 Boehringer Ingelheim Investigational Site
Temple, Texas
1245.10.10006 Boehringer Ingelheim Investigational Site
Wadsworth, Ohio
1245.10.10027 Boehringer Ingelheim Investigational Site
Walnut Creek, California

Other trials in United States

Latvia7 sites

1245.10.37101 Boehringer Ingelheim Investigational Site
Daugavpils
1245.10.37105 Boehringer Ingelheim Investigational Site
Kuldīga
1245.10.37106 Boehringer Ingelheim Investigational Site
Ogre
1245.10.37103 Boehringer Ingelheim Investigational Site
Riga
1245.10.37107 Boehringer Ingelheim Investigational Site
Riga
1245.10.37102 Boehringer Ingelheim Investigational Site
Talsi
1245.10.37104 Boehringer Ingelheim Investigational Site
Valmiera

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Romania7 sites

1245.10.40001 Boehringer Ingelheim Investigational Site
Alba Iulia
1245.10.40005 Boehringer Ingelheim Investigational Site
Baia Mare Maramures
1245.10.40003 Boehringer Ingelheim Investigational Site
Brasov
1245.10.40002 Boehringer Ingelheim Investigational Site
Bucharest
1245.10.40007 Boehringer Ingelheim Investigational Site
Bucharest
1245.10.40004 Boehringer Ingelheim Investigational Site
Galati
1245.10.40006 Boehringer Ingelheim Investigational Site
Satu Mare

Other trials in Romania

Russia7 sites

1245.10.70001 Boehringer Ingelheim Investigational Site
Moscow
1245.10.70002 Boehringer Ingelheim Investigational Site
Moscow
1245.10.70003 Boehringer Ingelheim Investigational Site
Moscow
1245.10.70004 Boehringer Ingelheim Investigational Site
Saint Petersburg
1245.10.70005 Boehringer Ingelheim Investigational Site
Saint Petersburg
1245.10.70006 Boehringer Ingelheim Investigational Site
Saint Petersburg
1245.10.70007 Boehringer Ingelheim Investigational Site
Saratov

Other trials in Russia

Spain7 sites

1245.10.34002 Boehringer Ingelheim Investigational Site
Barcelona
1245.10.34001 Boehringer Ingelheim Investigational Site
Girona
1245.10.34010 Boehringer Ingelheim Investigational Site
L'Hospitalet de Llobregat (Barcelona)
1245.10.34004 Boehringer Ingelheim Investigational Site
Málaga
1245.10.34005 Boehringer Ingelheim Investigational Site
Palma (Mallorca)
1245.10.34006 Boehringer Ingelheim Investigational Site
Palma de Mallorca
1245.10.34008 Boehringer Ingelheim Investigational Site
Santander

Other trials in Spain

Argentina5 sites

1245.10.54002 Boehringer Ingelheim Investigational Site
Capital Federal
1245.10.54004 Boehringer Ingelheim Investigational Site
Capital Federal
1245.10.54008 Boehringer Ingelheim Investigational Site
Capital Federal
1245.10.54006 Boehringer Ingelheim Investigational Site
Mar del Plata
1245.10.54005 Boehringer Ingelheim Investigational Site
Mendoza

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Hungary5 sites

1245.10.36001 Boehringer Ingelheim Investigational Site
Budapest
1245.10.36003 Boehringer Ingelheim Investigational Site
Budapest
1245.10.36004 Boehringer Ingelheim Investigational Site
Budapest
1245.10.36005 Boehringer Ingelheim Investigational Site
Győr
1245.10.36002 Boehringer Ingelheim Investigational Site
Szombathely

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Ukraine5 sites

1245.10.38002 Boehringer Ingelheim Investigational Site
Dnipro
1245.10.38004 Boehringer Ingelheim Investigational Site
Kharkiv
1245.10.38005 Boehringer Ingelheim Investigational Site
Kharkiv
1245.10.38003 Boehringer Ingelheim Investigational Site
Kiev
1245.10.38001 Boehringer Ingelheim Investigational Site
Vinnitsa

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Austria4 sites

1245.10.43002 Boehringer Ingelheim Investigational Site
Graz
1245.10.43004 Boehringer Ingelheim Investigational Site
Innsbruck
1245.10.43001 Boehringer Ingelheim Investigational Site
Vienna
1245.10.43003 Boehringer Ingelheim Investigational Site
Vienna

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Czechia4 sites

1245.10.42001 Boehringer Ingelheim Investigational Site
Břeclav
1245.10.42003 Boehringer Ingelheim Investigational Site
Brno
1245.10.42005 Boehringer Ingelheim Investigational Site
Brno
1245.10.42002 Boehringer Ingelheim Investigational Site
Hodonín

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Finland4 sites

1245.10.58006 Boehringer Ingelheim Investigational Site
Kerava
1245.10.58003 Boehringer Ingelheim Investigational Site
Oulu
1245.10.58004 Boehringer Ingelheim Investigational Site
Tampere
1245.10.58001 Boehringer Ingelheim Investigational Site
Turku

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Germany4 sites

1245.10.49001 Boehringer Ingelheim Investigational Site
Erlangen
1245.10.49003 Boehringer Ingelheim Investigational Site
Frankfurt
1245.10.49002 Boehringer Ingelheim Investigational Site
Hamburg
1245.10.49004 Boehringer Ingelheim Investigational Site
Rehlingen-Siersburg

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Norway4 sites

1245.10.47004 Boehringer Ingelheim Investigational Site
Ålesund
1245.10.47003 Boehringer Ingelheim Investigational Site
Hamar
1245.10.47005 Boehringer Ingelheim Investigational Site
Oslo
1245.10.47001 Boehringer Ingelheim Investigational Site
Stavanger

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Slovakia4 sites

1245.10.62003 Boehringer Ingelheim Investigational Site
Bratislava
1245.10.62001 Boehringer Ingelheim Investigational Site
Nitra
1245.10.62002 Boehringer Ingelheim Investigational Site
Nitra
1245.10.62004 Boehringer Ingelheim Investigational Site
Prešov

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Estonia2 sites

1245.10.37201 Boehringer Ingelheim Investigational Site
Tallinn
1245.10.37202 Boehringer Ingelheim Investigational Site
Tartu

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About this study

Official title: A Phase II, Randomized, Parallel Group Safety, Efficacy, and Pharmacokinetics Study of BI 10773 (1 mg, 5 mg, 10 mg, 25 mg, and 50 mg) Administered Orally Once Daily Over 12 Weeks Compared Double Blind to Placebo With an Additional Open-label Sitagliptin Arm in Type 2 Diabetic Patients With Insufficient Glycemic Control Despite Metformin Therapy

Conditions: Diabetes Mellitus, Type 2
Being tested: BI 10773, placebo, 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
placeboDrug
sitagliptinDrug

What is being measured

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

Change From Baseline in HbA1c After 12 Weeks of Treatment
Change from baseline in HbA1c after 12 weeks of treatment.
In the measured values adjusted means are displayed. For means for the placebo and empagliflozin arms are from the model excluding the sitagliptin open label (OL) arm. The mean for the sitagliptin OL arm is from the model with just this treatment group and the placebo group.
Measured: Baseline and 12 weeks

Secondary outcomes (9)

Change of FPG From Baseline After 12 Weeks of Treatment
Change of Fasting Plasma Glucose (FPG) from baseline after 12 weeks of treatment. Results presented stem from a repeated measures analysis.
In the measured values adjusted means are displayed. For means for the placebo and empagliflozin arms are from the model excluding the sitagliptin open label (OL) arm. The mean for the sitagliptin OL arm is from the model with just this treatment group and the placebo group.
Measured: Baseline and 12 weeks
Change of HbA1c From Baseline Over Time
Change of HbA1c from baseline over time. Results presented stem from a repeated measures analysis.
Measured: Baseline and weeks 4, 8 and 12
Proportion of Patients Who Achieve an HbA1c ≤7.0% After 12 Weeks of Treatment
Results for HbA1c categories at week 12 (Proportion of patients with HbA1c less than equal to 7%) based on logistic regression
Measured: Baseline and 12 weeks
Proportion of Patients Who Achieve an HbA1c Lowering of at Least 0.5% After 12 Weeks of Treatment
Results for HbA1c categories at week 12 (Proportion of patients with HbA1c lowered at least 0.5%) based on logistic regression
Measured: Baseline and 12 weeks
Change From Baseline to Week 12 in Fasting Plasma Insulin (FPI)
Results for change of FPI from baseline at week 12 based on ANCOVA
Measured: Baseline and 12 weeks
Change in Homeostasis Model Assessment Index for Insulin Resistance (HOMA-IR)
HOMA-IR (to assess insulin resistance) is defined as (FPI x FPG)/22.5. Results based on ANCOVA.
Measured: Baseline and 12 weeks
Change in Homeostasis Model Assessment Index for Beta Cell Function (HOMA-%B)
HOMA-%B (to assess insulin beta cell function) is defined as (20 x FPI)/(FPG-3.5), FPG in mg/dl. Results are based on ANCOVA.
Measured: Baseline and 12 weeks
Change of Body Weight After 12 Weeks of Treatment
Results for change of body weight after 12 weeks of treatment based on ANCOVA.
Measured: Baseline and 12 weeks
Trough Concentrations of Empagliflozin in Plasma
(Pre-dose) trough concentrations of Empagliflozin in plasma, within 30 minutes of dosing.
Measured: Days 28, 56 and 84

Timeline

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

Aug 2008Oct 2009

First posted9 Sep 2008 (estimated)
Study startAug 2008
Primary completionOct 2009

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 2
Primary purpose: Treatment
Intervention model: Parallel groups
Enrolment: 495 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00749190
Sponsor's protocol ID: 1245.10
Other IDs: EudraCT 2008-000641-54
Status last verified: May 2014
First submitted: 8 Sep 2008
Last updated: 13 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
Riggs MM, Staab A, Seman L, MacGregor TR, Bergsma TT, Gastonguay MR, Macha S. Population pharmacokinetics of empagliflozin, a sodium glucose cotransporter 2 inhibitor, in patients with type 2 diabetes. J Clin Pharmacol. 2013 Oct;53(10):1028-38. doi: 10.1002/jcph.147. Epub 2013 Aug 13.
PubMed 23940010

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 13 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase II, Randomized, Parallel Group Safety, Efficacy, and Pharmacokinetics Study of BI 10773 (1 mg, 5 mg, 10 mg, 25 mg, and 50 mg) Administered Orally Once Daily Over 12 Weeks Compared Double Blind to Placebo With an Additional Open-label Sitagliptin Arm in Type 2 Diabetic Patients With Insufficient Glycemic Control Despite Metformin Therapy
ClinicalTrials.gov ID: NCT00749190
Acronym / sponsor ID: 1245.10
Conditions: Diabetes Mellitus, Type 2
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 495 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: Aug 2008
Primary completion: Oct 2009 (actual)
First posted: 9 Sep 2008 (estimated)
Results: Posted 13 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
Intervention model: Parallel groups

Who may qualify

Ages: 18 to 79 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

Male and female patients with a diagnosis of type 2 diabetes mellitus and previously treated with metformin alone or with metformin and one other oral antidiabetic drug
Stable metformin therapy of at least 1500 mg/day, or less if that is a maximum tolerated dose.
HbA1c at screening 6.5% to 9.0% for patients on metformin and one other antidiabetic drug, and HbA1c >7.0% to 10% for patients on metformin only
HbA1c >7.0% to 10.0% at Visit 2 (Start of Run-in)
Age >=18 and <80years

Key exclusion criteria (13 listed)

Myocardial infarction, stroke or transient ischemic attack (TIA) within 6 months prior to informed consent
Impaired hepatic function
Renal insufficiency or impaired renal function
Diseases of the central nervous system or psychiatric disorders or clinically relevant neurological disorders that may interfere with participation in the trial
Chronic or clinically relevant acute infections

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 10773	Drug	–
placebo	Drug	–
sitagliptin	Drug	–

Primary outcome

Change From Baseline in HbA1c After 12 Weeks of Treatment
Time frame: Baseline and 12 weeks
Change from baseline in HbA1c after 12 weeks of treatment. In the measured values adjusted means are displayed. For means for the placebo and empagliflozin arms are from the model excluding the sitagliptin open label (OL) arm. The mean for the sitagliptin OL arm is from the model with just this treatment group and the placebo group.

9 secondary outcomes

Change of FPG From Baseline After 12 Weeks of Treatment
Time frame: Baseline and 12 weeks
Change of HbA1c From Baseline Over Time
Time frame: Baseline and weeks 4, 8 and 12
Proportion of Patients Who Achieve an HbA1c ≤7.0% After 12 Weeks of Treatment
Time frame: Baseline and 12 weeks
Proportion of Patients Who Achieve an HbA1c Lowering of at Least 0.5% After 12 Weeks of Treatment
Time frame: Baseline and 12 weeks
Change From Baseline to Week 12 in Fasting Plasma Insulin (FPI)
Time frame: Baseline and 12 weeks
Change in Homeostasis Model Assessment Index for Insulin Resistance (HOMA-IR)
Time frame: Baseline and 12 weeks
Change in Homeostasis Model Assessment Index for Beta Cell Function (HOMA-%B)
Time frame: Baseline and 12 weeks
Change of Body Weight After 12 Weeks of Treatment
Time frame: Baseline and 12 weeks
Trough Concentrations of Empagliflozin in Plasma
Time frame: Days 28, 56 and 84

Results and safety

Results posted to the registry on 13 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	71	66
Empagliflozin 1 mg	71	66
Empagliflozin 5 mg	71	70
Empagliflozin 10 mg	71	66
Empagliflozin 25 mg	70	70
Empagliflozin 50 mg	70	65
Sitagliptin OL	71	70

Primary outcome: Change From Baseline in HbA1c After 12 Weeks of Treatment

Time frame: Baseline and 12 weeks. Mean (Standard Error). Unit: percentage of HbA1c

Measure	Placebo n = 71	Empagliflozin 1 mg n = 71	Empagliflozin 5 mg n = 71	Empagliflozin 10 mg n = 71	Empagliflozin 25 mg n = 70	Empagliflozin 50 mg n = 70	Sitagliptin OL n = 71
Value	0.15 (0.08)	-0.09 (0.08)	-0.23 (0.08)	-0.56 (0.08)	-0.55 (0.08)	-0.49 (0.08)	-0.45 (0.10)

Placebo vs Empagliflozin 1 mg: Mean Difference (Final Values): -0.24 (95% CI -0.44 to -0.03), p = 0.0226, ANCOVA
Placebo vs Empagliflozin 5 mg: Mean Difference (Final Values): -0.39 (95% CI -0.59 to -0.18), p = 0.0002, ANCOVA
Placebo vs Empagliflozin 10 mg: Mean Difference (Final Values): -0.71 (95% CI -0.91 to -0.51), p <0.0001, ANCOVA

Population analysed: Full analysis set (FAS) consisting of all randomized patients who were treated with at least one dose of study drug and has a baseline measurement of the primary endpoint. The imputation method used was a modified last observation carried forward (LOCF) approach which used linear interpolation, LOCF and worst observation carried forward (WOCF).

9 secondary outcomes are reported in the full results.

Adverse events

Time frame: From first dose of study medication until 7 days following the last intake of study medication, up to 100 days. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	2 of 71 (2.8%)	4 of 71 (5.6%)	Not reported
Empagliflozin 1 mg	0 of 71 (0%)	2 of 71 (2.8%)	Not reported
Empagliflozin 5 mg	3 of 71 (4.2%)	2 of 71 (2.8%)	Not reported
Empagliflozin 10 mg	1 of 71 (1.4%)	7 of 71 (9.9%)	Not reported
Empagliflozin 25 mg	2 of 70 (2.9%)	4 of 70 (5.7%)	Not reported
Empagliflozin 50 mg	3 of 70 (4.3%)	3 of 70 (4.3%)	Not reported
Sitagliptin OL	0 of 71 (0%)	4 of 71 (5.6%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 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 23940010Riggs MM, Staab A, Seman L, MacGregor TR, Bergsma TT, Gastonguay MR, Macha S. Population pharmacokinetics of empagliflozin, a sodium glucose cotransporter 2 inhibitor, in patients with type 2 diabetes. J Clin Pharmacol. 2013 Oct;53(10):1028-38. doi: 10.1002/jcph.147. Epub 2013 Aug 13.
Related InfoLink provided by the sponsor.
Related InfoLink provided by the sponsor.

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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

116 sites in 16 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing BI 10773 and sitagliptin in people with Diabetes Mellitus, Type 2, run by Boehringer Ingelheim at 116 sites in 16 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 7 inclusion and 13 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 13 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 116 sites in France, United States, Latvia, Romania, Russia and 11 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 13 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 12 Weeks of Treatment (time frame: Baseline and 12 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 NCT00749190, 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 13 Jun 2014.