Diabetes Mellitus, Type 2Phase 2NCT00789035

12 Weeks Treatment With 3 Different Doses of BI 10773 in Type 2 Diabetic Patients

A Phase 2 study testing BI 10773 and metformin in people with Diabetes Mellitus, Type 2, run by Boehringer Ingelheim at 74 sites in 13 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 is to investigate the efficacy, safety and pharmacokinetics of three different doses of BI 10773 compared to placebo given for 12 weeks in patients with type 2 diabetes mellitus with insufficient glycemic control. In addition an open-label metformin arm will be assessed Read more about this study

Who is it for?: Ages 18 to 80 years
Conditions the study is for: Diabetes Mellitus, Type 2
What is being tested?: BI 10773 and metformin
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 408 participants
Where: 74 sitesin 13 countries
Study dates: Oct 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 80 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
either treatment-naïve or on a maximum of 1 oral antidiabetic therapy on a stable dose for the10 weeks prior to screening
HbA1c ≥6.5 to ≤9.0% and for treatment-naïve patients:HbA1c >7.0 to ≤10.0%
HbA1c >7.0 to ≤10.0% at Visit 2 (start of run-in) for all patients
Age between 18 and 80 years
BMI less than 40 kg/m2
Signed and dated informed consent prior to admission to the study in accordance with GCP and local legislation

Who cannot join

Myocardial infarction, stroke or TIA within 6 months prior to informed consent
Impaired hepatic function
Renal insufficiency or impaired renal function
Disease of central nervous system, or psychiatric disorders or clinically relevant neurologic disorders that may interfere with trial participation
Chronic or clinically relevant acute infections
Current or chronic urogenital tract infection determined by medical history

Show all 18Show fewer

History of clinically relevant allergy/hypersensitivity
Treatment with glitazones, GLP-1 analogues or insulin within 3 months prior to informed consent
Treatment with anti obesity drugs
Current treatment with systemic steroids
Alcohol abuse
Treatment with an investigational drug within 2 months prior to informed consent
known intolerance to metformin
Dehydration
Unstable or acute CHF
Acute or chronic acidosis
Hereditary galactose intolerance
Woman of child bearing potential who are nursing or pregnant or not practicing an acceptable method of birth control

Trial locations and contacts

74 sites in 13 countries.

Country

City, postcode or hospital

74 sites in 13 countries

Argentina10 sites

1245.9.54001 Boehringer Ingelheim Investigational Site
Capital Federal
1245.9.54002 Boehringer Ingelheim Investigational Site
Capital Federal
1245.9.54007 Boehringer Ingelheim Investigational Site
Capital Federal
1245.9.54008 Boehringer Ingelheim Investigational Site
Capital Federal
1245.9.54009 Boehringer Ingelheim Investigational Site
Capital Federal
1245.9.54010 Boehringer Ingelheim Investigational Site
Capital Federal
1245.9.54004 Boehringer Ingelheim Investigational Site
Mar del Plata
1245.9.54003 Boehringer Ingelheim Investigational Site
Mendoza
1245.9.54005 Boehringer Ingelheim Investigational Site
Salta
1245.9.54006 Boehringer Ingelheim Investigational Site
Salta

Other trials in Argentina

South Korea9 sites

1245.9.82006 Boehringer Ingelheim Investigational Site
Goyang
1245.9.82008 Boehringer Ingelheim Investigational Site
Goyang
1245.9.82007 Boehringer Ingelheim Investigational Site
Incheon
1245.9.82002 Boehringer Ingelheim Investigational Site
Pucheon
1245.9.82001 Boehringer Ingelheim Investigational Site
Seoul
1245.9.82004 Boehringer Ingelheim Investigational Site
Seoul
1245.9.82005 Boehringer Ingelheim Investigational Site
Seoul
1245.9.82009 Boehringer Ingelheim Investigational Site
Suwon
1245.9.82003 Boehringer Ingelheim Investigational Site
Uijeongbu-si

Other trials in South Korea

Germany8 sites

1245.9.49007 Boehringer Ingelheim Investigational Site
Aschaffenburg
1245.9.49001 Boehringer Ingelheim Investigational Site
Erlangen
1245.9.49004 Boehringer Ingelheim Investigational Site
Hamburg
1245.9.49005 Boehringer Ingelheim Investigational Site
Hamburg
1245.9.49002 Boehringer Ingelheim Investigational Site
Melsungen
1245.9.49008 Boehringer Ingelheim Investigational Site
Nuremberg
1245.9.49003 Boehringer Ingelheim Investigational Site
Saint Ingbert/Oberwürzbach
1245.9.49006 Boehringer Ingelheim Investigational Site
Sulzbach-Rosenberg

Other trials in Germany

Russia7 sites

1245.9.70002 Boehringer Ingelheim Investigational Site
Kazan'
1245.9.70003 Boehringer Ingelheim Investigational Site
Nizhny Novgorod
1245.9.70004 Boehringer Ingelheim Investigational Site
Petrozavodsk
1245.9.70005 Boehringer Ingelheim Investigational Site
Smolensk
1245.9.70006 Boehringer Ingelheim Investigational Site
Yaroslavl
1245.9.70007 Boehringer Ingelheim Investigational Site
Yaroslavl
1245.9.70001 Boehringer Ingelheim Investigational Site
Yekaterinburg

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Taiwan7 sites

1245.9.88605 Boehringer Ingelheim Investigational Site
Changhua
1245.9.88607 Boehringer Ingelheim Investigational Site
Kaohsiung City
1245.9.88604 Boehringer Ingelheim Investigational Site
Taichung
1245.9.88606 Boehringer Ingelheim Investigational Site
Tainan
1245.9.88601 Boehringer Ingelheim Investigational Site
Taipei
1245.9.88603 Boehringer Ingelheim Investigational Site
Taipei
1245.9.88602 Boehringer Ingelheim Investigational Site
Taoyuan

Other trials in Taiwan

Croatia5 sites

1245.9.38504 Boehringer Ingelheim Investigational Site
Karlovac
1245.9.38503 Boehringer Ingelheim Investigational Site
Krapinske Toplice
1245.9.38506 Boehringer Ingelheim Investigational Site
Osijek
1245.9.38505 Boehringer Ingelheim Investigational Site
Varaždin
1245.9.38501 Boehringer Ingelheim Investigational Site
Zagreb

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Italy5 sites

1245.9.39006 Boehringer Ingelheim Investigational Site
Genova
1245.9.39001 Boehringer Ingelheim Investigational Site
Pisa
1245.9.39003 Boehringer Ingelheim Investigational Site
Pisa
1245.9.39004 Boehringer Ingelheim Investigational Site
Siena
1245.9.39005 Boehringer Ingelheim Investigational Site
Treviso

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Sweden5 sites

1245.9.46003 Boehringer Ingelheim Investigational Site
Gothenburg
1245.9.46004 Boehringer Ingelheim Investigational Site
Härnösand
1245.9.46005 Boehringer Ingelheim Investigational Site
Lund
1245.9.46001 Boehringer Ingelheim Investigational Site
Stockholm
1245.9.46002 Boehringer Ingelheim Investigational Site
Västerås

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Ukraine5 sites

1245.9.38003 Boehringer Ingelheim Investigational Site
Kharkiv
1245.9.38004 Boehringer Ingelheim Investigational Site
Kiev
1245.9.38002 Boehringer Ingelheim Investigational Site
Odesa
1245.9.38001 Boehringer Ingelheim Investigational Site
Vinnytsia
1245.9.38005 Boehringer Ingelheim Investigational Site
Vinnytsia

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Romania4 sites

1245.9.40003 Boehringer Ingelheim Investigational Site
Brasov
1245.9.40002 Boehringer Ingelheim Investigational Site
Bucharest
1245.9.40004 Boehringer Ingelheim Investigational Site
Galati
1245.9.40005 Boehringer Ingelheim Investigational Site
Târgu Mureş

Other trials in Romania

Slovakia4 sites

1245.9.62002 Boehringer Ingelheim Investigational Site
Bratislava
1245.9.62003 Boehringer Ingelheim Investigational Site
Lučenec
1245.9.62004 Boehringer Ingelheim Investigational Site
Nové Mesto nad Váhom
1245.9.62001 Boehringer Ingelheim Investigational Site
Prievidza

Other trials in Slovakia

Estonia3 sites

1245.9.37201 Boehringer Ingelheim Investigational Site
Tallinn
1245.9.37202 Boehringer Ingelheim Investigational Site
Tallinn
1245.9.37203 Boehringer Ingelheim Investigational Site
Tallinn

Other trials in Estonia

Lithuania2 sites

1245.9.37002 Boehringer Ingelheim Investigational Site
Klaipėda
1245.9.37001 Boehringer Ingelheim Investigational Site
Vilnius

Other trials in Lithuania

About this study

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

Conditions: Diabetes Mellitus, Type 2
Being tested: BI 10773, placebo, metformin
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
metforminDrug

What is being measured

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

Change of Glycosilated Haemoglobin A1c (HbA1c) From Baseline After 12 Weeks of Treatment
Change of HbA1c from baseline after 12 weeks of treatment.
Note, adjusted means are presented. For the placebo and empa groups, measured values presented are for the model including only these treatment groups, for the metformin group the measured values presented are for the model including only placebo and metformin groups.
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.
Note, adjusted means are presented. For the placebo and empa groups, measured values presented are for the model including only these treatment groups, for the metformin group the measured values presented are for the model including only placebo and metformin groups.
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%).
Measured: 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%).
Measured: 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). 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 (within 30 minutes before dosing) trough concentrations of Empagliflozin in plasma
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.

Oct 2008Oct 2009

First posted11 Nov 2008 (estimated)
Study startOct 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: 408 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00789035
Sponsor's protocol ID: 1245.9
Other IDs: EudraCT No 2008-000640-14
Status last verified: May 2014
First submitted: 13 Oct 2008
Last updated: 18 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?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 18 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase IIb, Randomized, Parallel Group Safety, Efficacy, and Pharmacokinetics Study of BI 10773 (5 mg, 10 mg and 25 mg) Administered Orally Once Daily Over 12 Weeks Compared Double Blind to Placebo, as Monotherapy, With an Additional Open-label Metformin Arm in Type 2 Diabetic Patients With Insufficient Glycemic Control
ClinicalTrials.gov ID: NCT00789035
Acronym / sponsor ID: 1245.9
Conditions: Diabetes Mellitus, Type 2
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 408 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: Oct 2008
Primary completion: Oct 2009 (actual)
First posted: 11 Nov 2008 (estimated)
Results: Posted 18 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 80 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
either treatment-naïve or on a maximum of 1 oral antidiabetic therapy on a stable dose for the10 weeks prior to screening
HbA1c ≥6.5 to ≤9.0% and for treatment-naïve patients:HbA1c >7.0 to ≤10.0%
HbA1c >7.0 to ≤10.0% at Visit 2 (start of run-in) for all patients
Age between 18 and 80 years

Key exclusion criteria (18 listed)

Myocardial infarction, stroke or TIA within 6 months prior to informed consent
Impaired hepatic function
Renal insufficiency or impaired renal function
Disease of central nervous system, or psychiatric disorders or clinically relevant neurologic disorders that may interfere with trial participation
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	–
metformin	Drug	–

Primary outcome

Change of Glycosilated Haemoglobin A1c (HbA1c) From Baseline After 12 Weeks of Treatment
Time frame: Baseline and 12 weeks
Change of HbA1c from baseline after 12 weeks of treatment. Note, adjusted means are presented. For the placebo and empa groups, measured values presented are for the model including only these treatment groups, for the metformin group the measured values presented are for the model including only placebo and metformin groups.

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: 12 weeks
Proportion of Patients Who Achieve an HbA1c Lowering of at Least 0.5% After 12 Weeks of Treatment
Time frame: 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 18 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	82	76
Empagliflozin 5 mg	81	74
Empagliflozin 10 mg	81	80
Empagliflozin 25 mg	82	81
Metformin OL	80	74

Primary outcome: Change of Glycosilated Haemoglobin A1c (HbA1c) From Baseline After 12 Weeks of Treatment

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

Measure	Placebo n = 82	Empagliflozin 5 mg n = 81	Empagliflozin 10 mg n = 81	Empagliflozin 25 mg n = 82	Metformin OL n = 80
Value	0.09 (0.09)	-0.43 (0.09)	-0.48 (0.09)	-0.63 (0.09)	-0.75 (0.09)

Placebo vs Empagliflozin 5 mg: Mean Difference (Final Values): -0.52 (95% CI -0.74 to -0.29), p <0.0001, ANCOVA
Placebo vs Empagliflozin 10 mg: Mean Difference (Final Values): -0.57 (95% CI -0.80 to -0.35), p <0.0001, ANCOVA
Placebo vs Empagliflozin 25 mg: Mean Difference (Final Values): -0.72 (95% CI -0.94 to -0.50), p <0.0001, ANCOVA

Population analysed: The full analysis set (FAS) consists of all randomised patients who were treated with at least 1 dose of study drug and had a baseline measurement of the primary endpoint. Modified last observation carried forward was used as the imputation method (LOCF).

9 secondary outcomes are reported in the full results.

Adverse events

Time frame: From first drug administration until 7 days after last intake of study medication, up to 121 days. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	0 of 82 (0%)	1 of 82 (1.2%)	Not reported
Empagliflozin 5 mg	2 of 81 (2.5%)	3 of 81 (3.7%)	Not reported
Empagliflozin 10 mg qd	0 of 81 (0%)	5 of 81 (6.2%)	Not reported
Empagliflozin 25 mg qd	1 of 82 (1.2%)	1 of 82 (1.2%)	Not reported
Metformin OL	3 of 80 (3.8%)	7 of 80 (8.8%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 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.

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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

74 sites in 13 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 metformin in people with Diabetes Mellitus, Type 2, run by Boehringer Ingelheim at 74 sites in 13 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 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 18 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 74 sites in Argentina, South Korea, Germany, Russia, Taiwan and 8 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 18 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 of Glycosilated Haemoglobin A1c (HbA1c) From Baseline 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 NCT00789035, 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 18 Jun 2014.