Diabetes Mellitus, Type 2Phase 1NCT00558571

4 Week Treatment With Three Oral Doses of BI 10773 in Patients With Type 2 Diabetes

A Phase 1 study testing BI 10773 low dose, BI 10773 medium dose and BI 10773 high dose in people with Diabetes Mellitus, Type 2, run by Boehringer Ingelheim at 3 sites in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Primary objective: safety and tolerability of BI 10773 in male and female patients with type 2 diabetes Secondary objective: pharmacokinetics and pharmacodynamics of BI 10773 Read more about this study

Who is it for?: Ages 18 to 70 years
Conditions the study is for: Diabetes Mellitus, Type 2
What is being tested?: BI 10773 low dose, BI 10773 medium dose and BI 10773 high dose
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 78 participants
Where: 3 sitesGermany
Study dates: Jan 2008to Apr 2008
Phase: Phase 1
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 70 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Male and postmenopausal or hysterectomised female patients with type 2 diabetes
Age >18 and < 70 years
BMI >18.5 and <40 kg/m2

Who cannot join

Antidiabetic treatment with insulin or glitazones or with more than one oral hypoglycaemic agent;
Fasted blood glucose > 240 mg/dl (>13.3 mmol/L) or a blood glucose level above 400 mg/dl (22.2 mmol/L) postprandially;
HbA1c > 8.5 %

Trial locations and contacts

3 sites in 1 country.

Germany3 sites

1245.4.49003 Boehringer Ingelheim Investigational Site
Berlin
1245.4.49002 Boehringer Ingelheim Investigational Site
Mainz
1245.4.49001 Boehringer Ingelheim Investigational Site
Neuss

Other trials in Germany

About this study

Official title: Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of 4 Weeks Treatment With Three Oral Doses of BI 10773 as Tablets in Female and Male Patients With Type 2 Diabetes

Primary objective: safety and tolerability of BI 10773 in male and female patients with type 2 diabetes Secondary objective: pharmacokinetics and pharmacodynamics of BI 10773

Conditions: Diabetes Mellitus, Type 2
Being tested: BI 10773 low dose, placebo to BI 10773, BI 10773 medium dose, BI 10773 high dose
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 10773 low doseDrug
placebo to BI 10773Drug
BI 10773 medium doseDrug
BI 10773 high doseDrug

Study groups in NCT00558571
Study group	Role	What they receive
Placebo	Placebo comparator	Not described Receives: Drug: placebo to BI 10773
BI 10773 low dose	Experimental	Not described Receives: Drug: BI 10773 low dose
BI 10773 medium dose	Experimental	Not described Receives: Drug: BI 10773 medium dose
BI 10773 high dose	Experimental	Not described Receives: Drug: BI 10773 high dose

What is being measured

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

Number of Subjects With Drug Related Adverse Events
number of subjects with investigator-defined drug-related adverse events.
Measured: from drug administration up to 6 weeks
Clinical Relevant Abnormalities for Vital Signs, Blood Chemistry, Haematology, Urinanalysis and ECG
Clinical Relevant Abnormalities for Vital Signs, Blood Chemistry, Haematology, Urinanalysis and ECG. New abnormal findings or worsening of baseline conditions were reported as Adverse Events.
Measured: from drug administration up to 6 weeks

Secondary outcomes (17)

Cmax of Empagliflozin
maximum concentration of the analyte in plasma after first dose (Cmax, Day 1 ) and at steady state over a uniform dosing interval (Cmax,ss, Day 28).
Measured: 0:05 before drug administration and 0:15 0:30 0:45 1:00 1:30 2:00 2:30 3:00 4:00 6:00 8:00 10:00 12:00 16:00 24:00 hours(h) after drug administration on day 1 and 28
Tmax of Empagliflozin
time from last dosing to maximum concentration of the analyte in plasma after first dose (Day 1), denoted by tmax; and at steady state (Day 28), denoted by tmax,ss.
Measured: 0:05 before drug administration and 0:15 0:30 0:45 1:00 1:30 2:00 2:30 3:00 4:00 6:00 8:00 10:00 12:00 16:00 24:00 h after drug administration on day 1 and 28
t1/2 of Empagliflozin
terminal half-life of the analyte in plasma after first dose (Day 1), denoted by t1/2; and at steady state (Day 28), denoted by t1/2,ss.
Measured: 0:05 before drug administration and 0:15 0:30 0:45 1:00 1:30 2:00 2:30 3:00 4:00 6:00 8:00 10:00 12:00 16:00 24:00 h after drug administration on day 1 and 28
AUC0-∞ of Empagliflozin
Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞) and over a uniform dosing interval τ at steady state (AUCτ,ss)
Measured: 0:05 before drug administration and 0:15 0:30 0:45 1:00 1:30 2:00 2:30 3:00 4:00 6:00 8:00 10:00 12:00 16:00 24:00 h after drug administration on day 1
CL/F of Empaglifozin
apparent clearance of the analyte in plasma after first dose (CL/F) and at steady state (CL/F,ss)
Measured: 0:05 before drug administration and 0:15 0:30 0:45 1:00 1:30 2:00 2:30 3:00 4:00 6:00 8:00 10:00 12:00 16:00 24:00 h after drug administration on day 1 and 28
fe0-24 of Empagliflozin
Fraction of analyte eliminated in urine from time point 0 to 24h after first dose (fe0-24) and at steady state (fe0-24,ss)
Measured: 0:05 before drug administration and 0:15 0:30 0:45 1:00 1:30 2:00 2:30 3:00 4:00 6:00 8:00 10:00 12:00 16:00 24:00 h after drug administration on day 1 and 28
LI (Linearity Index).
The linearity index is defined as AUC0-τ divided by AUC0-∞ both at steady state.
Measured: 0:05 before drug administration and 0:15 0:30 0:45 1:00 1:30 2:00 2:30 3:00 4:00 6:00 8:00 10:00 12:00 16:00 after drug administration on day 1 and 28
Ae0-24 of Glucose
Amount of glucose eliminated in urine over the time interval 0 to 24h on day -2, -1, 1, 27 and 28. (Urinary Glucose Excretion)
Measured: Day -2 and 27: -2 to 0, 0 to 5, 5 to 12 and 12 to 24h; Day -1 and 1: 0 to 5, 5 to 12 and 12 to 24; Day 28: 0 to 5, 5 to 12, 12 to 24, 24 to 36, 36 to 48 and 48 to 72h
Fasting Plasma Glucose (FPG)
fasting plasma glucose on day -1 (baseline) and change from baseline to day 28
Measured: in the morning of days -1 and 28
Mean Daily Glucose (MDG) Measured in Blood
change from baseline in MDG on the days 1, 7, 14, 21 and 27. Baseline is defined as day -2.
Measured: 0:00, 2:30, 5:00, 7:00, 10:00, 12:00, 13:30, 24:00 h after drug administration on day -2. 0:05 h before drug administration and 2:30, 5:00, 7:00, 10:00, 12:00, 13:30, 24:00 h after drug administration on day 1, 7, 14, 21 and 27
Insulin AUEC0-5
change in AUEC0-5 from baseline on day 28. Baseline is defined as day -1.
Measured: 0:00, 2:30, 5:00, 7:00, 10:00, 12:00 after drug administration on day -1. 0:05 before drug administration and 2:30, 5:00, 7:00, 10:00, 12:00 after drug administration on day 28.
Insulin Emax (Maximum Measured Effect)
change in Emax from baseline on day 28. Baseline is defined as day -1
Measured: 0:00, 2:30, 5:00, 7:00, 10:00, 12:00 after drug administration on day -1. 0:05 before drug administration and 2:30, 5:00, 7:00, 10:00, 12:00 after drug administration on day 28.
Fasting Insulin
Change from baseline to the days 1, 7, 14, 21 and 28. Baseline is defined as day -1.
Measured: in the morning of days -1( baseline), 1, 7, 14, 21 and 28
Glucagon Emax (Maximum Measured Effect)
Change from baseline (day -1) in Emax on day 28.
Measured: 0:00, 2:30, 5:00, 7:00, 10:00, 12:00, 24:00 h after drug administration on day -1. 0:05 before drug administration and 2:30, 5:00, 7:00, 10:00, 12:00 after drug administration on day 28.
Glucagon AUEC0-5
Change from baseline (day -1) in AUEC0-5 on day 28.
Measured: 0:00, 2:30, 5:00, 7:00, 10:00, 12:00 after drug administration on day -1. 0:05 before drug administration and 2:30, 5:00, 7:00, 10:00, 12:00 after drug administration on day 28.
Fructosamine
change from baseline to days 14 and 18. Baseline is defined as day -1.
Measured: day -1 (baseline), 14 and 28
HbA1c
change from baseline on day 28. Baseline is defined as day -1.
Measured: in the morning of days -1 and 28

Timeline

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

Jan 2008Apr 2008

First posted15 Nov 2007 (estimated)
Study startJan 2008
Primary completionApr 2008

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 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 78 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00558571
Sponsor's protocol ID: 1245.4
Other IDs: EudraCT No 2007-002685-36
Status last verified: Jul 2014
First submitted: 14 Nov 2007
Last updated: 7 Aug 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 7 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of 4 Weeks Treatment With Three Oral Doses of BI 10773 as Tablets in Female and Male Patients With Type 2 Diabetes
ClinicalTrials.gov ID: NCT00558571
Acronym / sponsor ID: 1245.4
Conditions: Diabetes Mellitus, Type 2
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 78 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: Jan 2008
Primary completion: Apr 2008 (actual)
First posted: 15 Nov 2007 (estimated)
Results: Posted 7 Aug 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Primary objective: safety and tolerability of BI 10773 in male and female patients with type 2 diabetes Secondary objective: pharmacokinetics and pharmacodynamics of BI 10773

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 4

Arm	Type	Receives
Placebo	Placebo comparator	Drug: placebo to BI 10773
BI 10773 low dose	Experimental	Drug: BI 10773 low dose
BI 10773 medium dose	Experimental	Drug: BI 10773 medium dose
BI 10773 high dose	Experimental	Drug: BI 10773 high dose

Who may qualify

Ages: 18 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Male and postmenopausal or hysterectomised female patients with type 2 diabetes
Age >18 and < 70 years
BMI >18.5 and <40 kg/m2

Key exclusion criteria (3 listed)

Antidiabetic treatment with insulin or glitazones or with more than one oral hypoglycaemic agent;
Fasted blood glucose > 240 mg/dl (>13.3 mmol/L) or a blood glucose level above 400 mg/dl (22.2 mmol/L) postprandially;
HbA1c > 8.5 %

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 low dose	Drug	BI 10773 low dose
placebo to BI 10773	Drug	Placebo
BI 10773 medium dose	Drug	BI 10773 medium dose
BI 10773 high dose	Drug	BI 10773 high dose

Primary outcome

Number of Subjects With Drug Related Adverse Events
Time frame: from drug administration up to 6 weeks
number of subjects with investigator-defined drug-related adverse events.
Clinical Relevant Abnormalities for Vital Signs, Blood Chemistry, Haematology, Urinanalysis and ECG
Time frame: from drug administration up to 6 weeks
Clinical Relevant Abnormalities for Vital Signs, Blood Chemistry, Haematology, Urinanalysis and ECG. New abnormal findings or worsening of baseline conditions were reported as Adverse Events.

17 secondary outcomes

Cmax of Empagliflozin
Time frame: 0:05 before drug administration and 0:15 0:30 0:45 1:00 1:30 2:00 2:30 3:00 4:00 6:00 8:00 10:00 12:00 16:00 24:00 hours(h) after drug administration on day 1 and 28
Tmax of Empagliflozin
Time frame: 0:05 before drug administration and 0:15 0:30 0:45 1:00 1:30 2:00 2:30 3:00 4:00 6:00 8:00 10:00 12:00 16:00 24:00 h after drug administration on day 1 and 28
t1/2 of Empagliflozin
Time frame: 0:05 before drug administration and 0:15 0:30 0:45 1:00 1:30 2:00 2:30 3:00 4:00 6:00 8:00 10:00 12:00 16:00 24:00 h after drug administration on day 1 and 28
AUC0-∞ of Empagliflozin
Time frame: 0:05 before drug administration and 0:15 0:30 0:45 1:00 1:30 2:00 2:30 3:00 4:00 6:00 8:00 10:00 12:00 16:00 24:00 h after drug administration on day 1
CL/F of Empaglifozin
Time frame: 0:05 before drug administration and 0:15 0:30 0:45 1:00 1:30 2:00 2:30 3:00 4:00 6:00 8:00 10:00 12:00 16:00 24:00 h after drug administration on day 1 and 28
fe0-24 of Empagliflozin
Time frame: 0:05 before drug administration and 0:15 0:30 0:45 1:00 1:30 2:00 2:30 3:00 4:00 6:00 8:00 10:00 12:00 16:00 24:00 h after drug administration on day 1 and 28
LI (Linearity Index).
Time frame: 0:05 before drug administration and 0:15 0:30 0:45 1:00 1:30 2:00 2:30 3:00 4:00 6:00 8:00 10:00 12:00 16:00 after drug administration on day 1 and 28
Ae0-24 of Glucose
Time frame: Day -2 and 27: -2 to 0, 0 to 5, 5 to 12 and 12 to 24h; Day -1 and 1: 0 to 5, 5 to 12 and 12 to 24; Day 28: 0 to 5, 5 to 12, 12 to 24, 24 to 36, 36 to 48 and 48 to 72h
Fasting Plasma Glucose (FPG)
Time frame: in the morning of days -1 and 28
Mean Daily Glucose (MDG) Measured in Blood
Time frame: 0:00, 2:30, 5:00, 7:00, 10:00, 12:00, 13:30, 24:00 h after drug administration on day -2. 0:05 h before drug administration and 2:30, 5:00, 7:00, 10:00, 12:00, 13:30, 24:00 h after drug administration on day 1, 7, 14, 21 and 27
Insulin AUEC0-5
Time frame: 0:00, 2:30, 5:00, 7:00, 10:00, 12:00 after drug administration on day -1. 0:05 before drug administration and 2:30, 5:00, 7:00, 10:00, 12:00 after drug administration on day 28.
Insulin Emax (Maximum Measured Effect)
Time frame: 0:00, 2:30, 5:00, 7:00, 10:00, 12:00 after drug administration on day -1. 0:05 before drug administration and 2:30, 5:00, 7:00, 10:00, 12:00 after drug administration on day 28.
Fasting Insulin
Time frame: in the morning of days -1( baseline), 1, 7, 14, 21 and 28
Glucagon Emax (Maximum Measured Effect)
Time frame: 0:00, 2:30, 5:00, 7:00, 10:00, 12:00, 24:00 h after drug administration on day -1. 0:05 before drug administration and 2:30, 5:00, 7:00, 10:00, 12:00 after drug administration on day 28.
Glucagon AUEC0-5
Time frame: 0:00, 2:30, 5:00, 7:00, 10:00, 12:00 after drug administration on day -1. 0:05 before drug administration and 2:30, 5:00, 7:00, 10:00, 12:00 after drug administration on day 28.
Fructosamine
Time frame: day -1 (baseline), 14 and 28
HbA1c
Time frame: in the morning of days -1 and 28

Results and safety

Results posted to the registry on 7 Aug 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	16	16
10mg Empagliflozin	16	16
25mg Empagliflozin	16	16
100mg Empagliflozin	30	30

Primary outcome: Number of Subjects With Drug Related Adverse Events

Time frame: from drug administration up to 6 weeks. Number. Unit: participants

Measure	Placebo n = 16	10mg Empagliflozin n = 16	25mg Empagliflozin n = 16	100mg Empagliflozin n = 30
Value	7	3	4	14

Population analysed: treated set: comprised all 78 patients who received at least one dose of study medication

Primary outcome: Clinical Relevant Abnormalities for Vital Signs, Blood Chemistry, Haematology, Urinanalysis and ECG

Time frame: from drug administration up to 6 weeks. Number. Unit: participants

Measure	10mg Empagliflozin n = 16	25mg Empagliflozin n = 16	100mg Empagliflozin n = 30
Lipase increased	0	1	2
Blood triglycerides increased	1	0	0
Blood creatine phosphokinase increased	0	0	1
Ventricular extrasystoles	1	0	0

Population analysed: treated set

17 secondary outcomes are reported in the full results.

Adverse events

Time frame: From screening (35 to 15 days before treatment administration) until the end of study examination (35 to 41 days after treatment administration). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	0 of 16 (0%)	10 of 16 (62.5%)	Not reported
10mg Empagliflozin	0 of 16 (0%)	8 of 16 (50%)	Not reported
25mg Empagliflozin	0 of 16 (0%)	9 of 16 (56.3%)	Not reported
100mg Empagliflozin	0 of 30 (0%)	18 of 30 (60%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 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

3 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing BI 10773 low dose, BI 10773 medium dose and BI 10773 high dose in people with Diabetes Mellitus, Type 2, run by Boehringer Ingelheim at 3 sites in Germany.

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 3 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 7 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Germany. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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 7 Aug 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?

Number of Subjects With Drug Related Adverse Events (time frame: from drug administration up to 6 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00558571, 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 7 Aug 2014.