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| ID | Type | Description | Link |
|---|---|---|---|
| 2010-018609-13 | EudraCT Number | EudraCT |
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The objective of this study is to demonstrate that BI 10773 does not prolong the QT(c) interval more than placebo
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BI 10773 | Experimental | single oral (high and low) dose per subject |
|
| Placebo | Placebo Comparator | 2 single oral doses per subject |
|
| Moxifloxacin | Active Comparator | single oral dose per subject |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BI 10773 (low) | Drug | single oral dose |
| |
| Moxifloxacin |
| Measure | Description | Time Frame |
|---|---|---|
| Empa 25mg: Mean QTcN Change From Baseline Between 1 and 4 Hours After Dosing | Mean QTcN (heart rate-corrected QT interval, using a study population-based approach) from the ECGs obtained between 1h to 4h following drug administration minus the mean QTcN from the baseline electrocardiogram (ECGs) obtained pre-dose at each visit, for empa 25mg. Note, the treatment means presented are actually adjusted means. | 60 minutes (min), 50min and 40 min before the first dose and 1 hour (h), 1.5h, 2h, 2.5h, 3h and 4h after the first dose |
| Empa 200mg: Mean QTcN Change From Baseline Between 1 and 4 Hours After Dosing | Mean QTcN (heart rate-corrected QT interval, using a study population-based approach) from the ECGs obtained between 1h to 4h following drug administration minus the mean QTcN from the baseline ECGs obtained pre-dose at each visit, for empa 200mg. Note, the treatment means presented are actually adjusted means. | 60 minutes (min), 50min and 40 min before the first dose and 1 hour (h), 1.5h, 2h, 2.5h, 3h and 4h after the first dose |
| Measure | Description | Time Frame |
|---|---|---|
| Empa 25 mg: Mean QTcN Change From Baseline Between 30 Minutes and 24 Hours After Dosing | Mean changes from baseline in QTcN from all ECGs taken between 30 minutes and 24 hours after dosings, for empa 25 mg. Note, presented means are actually adjusted means. | 60 minutes (min), 50min and 40 min before the first dose and 30min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h and 24h after the first dose |
| Measure | Description | Time Frame |
|---|---|---|
| Time-matched Change From Placebo in QTcN Between 30 Minutes and 24 Hours After Dosing. | The time-matched change from placebo is defined per time point as the difference of the ECG measurement following administration of empa or moxifloxacin minus the average of the measurements obtained following the two administrations of placebo. The clinically relevant information (and endpoint resulting from ICH E14) is shown by the maximum mean value of all measurements. Results are presented for the greatest change, for empa 25mg the greatest change was seen at the 24 hour time point, for empa 200 mg and moxifloxacin the greatest change was seen at the 2.5 hour time point. |
Inclusion criteria:
healthy female and male subjects
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| Name | Affiliation | Role |
|---|---|---|
| Boehringer Ingelheim | Boehringer Ingelheim | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 1245.16.1 Boehringer Ingelheim Investigational Site | Biberach | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23617452 | Derived | Ring A, Brand T, Macha S, Breithaupt-Groegler K, Simons G, Walter B, Woerle HJ, Broedl UC. The sodium glucose cotransporter 2 inhibitor empagliflozin does not prolong QT interval in a thorough QT (TQT) study. Cardiovasc Diabetol. 2013 Apr 24;12:70. doi: 10.1186/1475-2840-12-70. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Study Overall | Total number of patients randomised and treated in the study. This was a randomised, placebo controlled, 5-period crossover trial, participants were randomised to one of ten possible treatment sequences. The treatments administered were
The trial was double-blind for the placebo and Empagliflozin (Empa) treatments, but open-label for the moxifloxacin treatment. A washout period of at least 1 week was respected between drug administrations. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Study Overall | Total number of patients randomised and treated in the study. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Empa 25mg: Mean QTcN Change From Baseline Between 1 and 4 Hours After Dosing | Mean QTcN (heart rate-corrected QT interval, using a study population-based approach) from the ECGs obtained between 1h to 4h following drug administration minus the mean QTcN from the baseline electrocardiogram (ECGs) obtained pre-dose at each visit, for empa 25mg. Note, the treatment means presented are actually adjusted means. | Full analysis set (FAS): all treated subjects who had at least one baseline assessment and at least one post-baseline assessment for at least one ECG endpoint. | Posted | Mean | Standard Error | ms | 60 minutes (min), 50min and 40 min before the first dose and 1 hour (h), 1.5h, 2h, 2.5h, 3h and 4h after the first dose | Observations | Participants |
|
Drug administration until beginning of next sequence/end of trial, up to 48 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Single oral dose of placebo (8 tablets). |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Road traffic accident | Injury, poisoning and procedural complications | MEDDRA 13.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations | MEDDRA 13.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Boehringer Ingelheim Call Center | Boehringer Ingelheim Pharmaceuticals | 1-800-243-0127 | clintriage.rdg@boehringer-ingelheim.com |
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| ID | Term |
|---|---|
| C570240 | empagliflozin |
| D000077266 | Moxifloxacin |
| ID | Term |
|---|---|
| D024841 | Fluoroquinolones |
| D042462 | 4-Quinolones |
| D015363 | Quinolones |
| D011804 | Quinolines |
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| Drug |
single oral dose |
|
| BI 10773 Placebo | Drug | 2 times single dose |
|
| BI 10773 (high) | Drug | single oral dose |
|
| Empa 200 mg: Mean QTcN Change From Baseline Between 30 Minutes and 24 Hours After Dosing | Mean changes from baseline in QTcN from all ECGs taken between 30 minutes and 24 hours after dosings, for empa 200 mg. Note, presented means are actually adjusted means. | 60 minutes (min), 50min and 40 min before the first dose and 30min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h and 24h after the first dose |
| Mean QTcN Change From Baseline Between 2 and 4 Hours After Dosing | Mean changes from baseline in QTcN from all ECGs taken between 2 hours and 4 hours after dosings Note, the means presented are actually adjusted means. | 60 minutes (min), 50min and 40 min before the first dose and 2 hour (h), 2.5h, 3h and 4h after the first dose |
| Empa 25mg: Change From Mean Baseline in QTcN at Each Time Point Between 30 Minutes and 24 Hours After Dosings | Change from mean baseline in QTcN at each time point between 30 minutes and 24 hours after dosings for empa 25mg. The clinically relevant information (and endpoint resulting from ICH E14) is shown by the maximum upper confidence limit value over time. For this outcome results are presented for the 24 hour timepoint as this was when the maximum value was seen. Note, the presented means are actually adjusted means. | 60 minutes (min), 50min and 40 min before the first dose and 0.5 hour (h), 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h and 24h after the first dose |
| Empa 200mg: Change From Mean Baseline in QTcN at Each Time Point Between 30 Minutes and 24 Hours After Dosings | Change from mean baseline in QTcN at each time point between 30 minutes and 24 hours after dosings for empa 200mg. The clinically relevant information (and endpoint resulting from ICH E14) is shown by the maximum upper confidence limit value over time. For this outcome results are presented for the 2.5 hour timepoint as this was when the maximum value was seen. Note, the presented means are actually adjusted means. | 60 minutes (min), 50min and 40 min before the first dose and 0.5 hour (h), 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h and 24h after the first dose |
| 60 minutes (min), 50min and 40 min before the first dose and 30min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h and 24h after the first dose |
| Placebo Corrected Change From Mean Baseline at Any Time Point Between 30 Minutes and 24 Hours After Dosings. | The placebo corrected change from mean baseline is defined per time point as the difference of the change from baseline for empa or moxifloxacin minus the average change from baseline obtained for the two administrations of placebo. The clinically relevant information (and endpoint resulting from ICH E14) is shown by the maximum mean value of all measurements. Results are presented for the greatest change, for empa 25mg the greatest change was seen at the 24 hour time point, for empa 200 mg and moxifloxacin the greatest change was seen at the 2.5 hour time point. | 60 minutes (min), 50min and 40 min before the first dose and 30min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h and 24h after the first dose |
| Clinically Relevant Abnormalities for Physical Examination, Vital Signs, ECG, Blood Chemistry and Assessment of Tolerability by the Investigator | Clinically relevant abnormalities for physical examination, vital signs, ECG, blood chemistry, haematology, urinanalysis and assessment of tolerability by the investigator. New abnormal findings or worsening of baseline conditions were reported as adverse events (AEs). Time frame for AE reporting includes the period of first drug administration until end of study. A more detailed definition of the used time frame and MedDRA Version can be found in the AE section. | Drug administration until beginning of next sequence/end of trial, up to 48 days |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG001 |
| Empa 25 mg |
Single oral dose of Empagliflozin (Empa) 25mg (1 tablet with strength 25mg) plus 7 tablets of placebo. |
|
|
|
| Secondary | Empa 25 mg: Mean QTcN Change From Baseline Between 30 Minutes and 24 Hours After Dosing | Mean changes from baseline in QTcN from all ECGs taken between 30 minutes and 24 hours after dosings, for empa 25 mg. Note, presented means are actually adjusted means. | Full analysis set (FAS): all treated subjects who had at least one baseline assessment and at least one post-baseline assessment for at least one ECG endpoint. | Posted | Mean | Standard Error | ms | 60 minutes (min), 50min and 40 min before the first dose and 30min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h and 24h after the first dose | Observations | Participants |
|
|
|
|
| Secondary | Empa 200 mg: Mean QTcN Change From Baseline Between 30 Minutes and 24 Hours After Dosing | Mean changes from baseline in QTcN from all ECGs taken between 30 minutes and 24 hours after dosings, for empa 200 mg. Note, presented means are actually adjusted means. | Full analysis set (FAS): all treated subjects who had at least one baseline assessment and at least one post-baseline assessment for at least one ECG endpoint. | Posted | Mean | Standard Deviation | ms | 60 minutes (min), 50min and 40 min before the first dose and 30min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h and 24h after the first dose | Observations | Participants |
|
|
|
|
| Secondary | Mean QTcN Change From Baseline Between 2 and 4 Hours After Dosing | Mean changes from baseline in QTcN from all ECGs taken between 2 hours and 4 hours after dosings Note, the means presented are actually adjusted means. | Full analysis set (FAS): all treated subjects who had at least one baseline assessment and at least one post-baseline assessment for at least one ECG endpoint. | Posted | Mean | Standard Error | ms | 60 minutes (min), 50min and 40 min before the first dose and 2 hour (h), 2.5h, 3h and 4h after the first dose | Observations | Participants |
|
|
|
|
| Secondary | Empa 25mg: Change From Mean Baseline in QTcN at Each Time Point Between 30 Minutes and 24 Hours After Dosings | Change from mean baseline in QTcN at each time point between 30 minutes and 24 hours after dosings for empa 25mg. The clinically relevant information (and endpoint resulting from ICH E14) is shown by the maximum upper confidence limit value over time. For this outcome results are presented for the 24 hour timepoint as this was when the maximum value was seen. Note, the presented means are actually adjusted means. | Full analysis set (FAS): all treated subjects who had at least one baseline assessment and at least one post-baseline assessment for at least one ECG endpoint. | Posted | Mean | Standard Error | ms | 60 minutes (min), 50min and 40 min before the first dose and 0.5 hour (h), 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h and 24h after the first dose | Observations | Participants |
|
|
|
|
| Secondary | Empa 200mg: Change From Mean Baseline in QTcN at Each Time Point Between 30 Minutes and 24 Hours After Dosings | Change from mean baseline in QTcN at each time point between 30 minutes and 24 hours after dosings for empa 200mg. The clinically relevant information (and endpoint resulting from ICH E14) is shown by the maximum upper confidence limit value over time. For this outcome results are presented for the 2.5 hour timepoint as this was when the maximum value was seen. Note, the presented means are actually adjusted means. | Full analysis set (FAS): all treated subjects who had at least one baseline assessment and at least one post-baseline assessment for at least one ECG endpoint. | Posted | Mean | Standard Error | ms | 60 minutes (min), 50min and 40 min before the first dose and 0.5 hour (h), 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h and 24h after the first dose | Observations | Participants |
|
|
|
|
| Primary | Empa 200mg: Mean QTcN Change From Baseline Between 1 and 4 Hours After Dosing | Mean QTcN (heart rate-corrected QT interval, using a study population-based approach) from the ECGs obtained between 1h to 4h following drug administration minus the mean QTcN from the baseline ECGs obtained pre-dose at each visit, for empa 200mg. Note, the treatment means presented are actually adjusted means. | Full analysis set (FAS): all treated subjects who had at least one baseline assessment and at least one post-baseline assessment for at least one ECG endpoint. | Posted | Mean | Standard Deviation | ms | 60 minutes (min), 50min and 40 min before the first dose and 1 hour (h), 1.5h, 2h, 2.5h, 3h and 4h after the first dose | Observations | Participants |
|
|
|
|
| Other Pre-specified | Time-matched Change From Placebo in QTcN Between 30 Minutes and 24 Hours After Dosing. | The time-matched change from placebo is defined per time point as the difference of the ECG measurement following administration of empa or moxifloxacin minus the average of the measurements obtained following the two administrations of placebo. The clinically relevant information (and endpoint resulting from ICH E14) is shown by the maximum mean value of all measurements. Results are presented for the greatest change, for empa 25mg the greatest change was seen at the 24 hour time point, for empa 200 mg and moxifloxacin the greatest change was seen at the 2.5 hour time point. | Full analysis set (FAS): all treated subjects who had at least one baseline assessment and at least one post-baseline assessment for at least one ECG endpoint. | Posted | Mean | Standard Deviation | ms | 60 minutes (min), 50min and 40 min before the first dose and 30min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h and 24h after the first dose |
|
|
|
| Other Pre-specified | Placebo Corrected Change From Mean Baseline at Any Time Point Between 30 Minutes and 24 Hours After Dosings. | The placebo corrected change from mean baseline is defined per time point as the difference of the change from baseline for empa or moxifloxacin minus the average change from baseline obtained for the two administrations of placebo. The clinically relevant information (and endpoint resulting from ICH E14) is shown by the maximum mean value of all measurements. Results are presented for the greatest change, for empa 25mg the greatest change was seen at the 24 hour time point, for empa 200 mg and moxifloxacin the greatest change was seen at the 2.5 hour time point. | Full analysis set (FAS): all treated subjects who had at least one baseline assessment and at least one post-baseline assessment for at least one ECG endpoint. | Posted | Mean | Standard Deviation | ms | 60 minutes (min), 50min and 40 min before the first dose and 30min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h and 24h after the first dose |
|
|
|
| Other Pre-specified | Clinically Relevant Abnormalities for Physical Examination, Vital Signs, ECG, Blood Chemistry and Assessment of Tolerability by the Investigator | Clinically relevant abnormalities for physical examination, vital signs, ECG, blood chemistry, haematology, urinanalysis and assessment of tolerability by the investigator. New abnormal findings or worsening of baseline conditions were reported as adverse events (AEs). Time frame for AE reporting includes the period of first drug administration until end of study. A more detailed definition of the used time frame and MedDRA Version can be found in the AE section. | Treated set (TS): All subjects who were dispensed trial medication and were documented to have taken at least one dose of investigational treatment. | Posted | Number | participants | Drug administration until beginning of next sequence/end of trial, up to 48 days |
|
|
|
| 0 |
| 29 |
| 6 |
| 29 |
| EG001 | Empa 25 mg | Single oral dose of Empagliflozin (Empa) 25mg (1 tablet) plus 7 tablets of placebo. | 0 | 28 | 3 | 28 |
| EG002 | Empa 200 mg | Single oral dose of Empagliflozin (Empa) 200 mg (8 tablets of 25 mg) | 0 | 30 | 2 | 30 |
| EG003 | Moxifloxacin | Single oral dose of moxifloxacin 400 mg (1 tablet) | 1 | 29 | 0 | 29 |
| Headache | Nervous system disorders | MEDDRA 13.1 | Systematic Assessment |
|
Other - Any publication of the result of this trial must be consistent with the Boehringer Ingelheim publication policy. The rights of the investigator and of the sponsor with regard to publication of the results of this trial are described in the investigator contract.
| D006574 |
| Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |