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| Name | Class |
|---|---|
| Eli Lilly and Company | INDUSTRY |
The objective of this study is to assess the effect of the different degrees of renal impairment on the pharmacokinetics, pharmacodynamics and safety of BI10773 following oral administration of high dose BI10773 as a single dose in Japanese patients with type 2 diabetes mellitus.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BI10773 medium dose group 1 | Experimental | BI10773 medium dose tablet single dose group 1 |
|
| BI10773 medium dose group 2 | Experimental | BI10773 medium dose tablet single dose group 2 |
|
| BI10773 Medium dose group 3 | Experimental | BI10773 medium dose tablet single dose group 3 |
|
| BI10773 Medium dose group 4 | Experimental | BI10773 medium dose tablet single dose group 4 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BI10773 | Drug | BI10773 medium dose tablet single dose |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Total Urinary Glucose Excretion (UGE) | change from baseline in total urinary glucose excretion (UGE) to 24 hours | baseline and 24 hours |
| Area Under the Concentration Time Curve of the Analyte in Plasma | Area under the concentration time curve of the analyte in plasma over the time interval from 0 to infinity | Predose and 20 minutes (min), 40min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 14h, 24h, 36h 48h, 72h and 96h after drug administration |
| Maximum Concentration | Maximum concentration of the analyte in plasma | Predose and 20 minutes (min), 40min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 14h, 24h, 36h 48h, 72h and 96h after drug administration |
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Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Boehringer Ingelheim | Boehringer Ingelheim | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 1245.53.001 Boehringer Ingelheim Investigational Site | Kurume, Fukuoka | Japan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25199997 | Derived | Sarashina A, Ueki K, Sasaki T, Tanaka Y, Koiwai K, Sakamoto W, Woerle HJ, Salsali A, Broedl UC, Macha S. Effect of renal impairment on the pharmacokinetics, pharmacodynamics, and safety of empagliflozin, a sodium glucose cotransporter 2 inhibitor, in Japanese patients with type 2 diabetes mellitus. Clin Ther. 2014 Nov 1;36(11):1606-15. doi: 10.1016/j.clinthera.2014.08.001. Epub 2014 Sep 5. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Normal Renal Function | 25 mg empagliflozin taken as a single dose for patients with normal renal function |
| FG001 | Mild Renal Impairment | 25 mg empagliflozin taken as a single dose for patients with mild renal impairment |
| FG002 | Moderate Renal Impairment | 25 mg empagliflozin taken as a single dose for patients with moderate renal impairment |
| FG003 | Severe Renal Impairment | 25 mg empagliflozin taken as a single dose for patients with severe renal impairment |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Normal Renal Function | 25 mg empagliflozin taken as a single dose for patients with normal renal function |
| BG001 | Mild Renal Impairment | 25 mg empagliflozin taken as a single dose for patients with mild renal impairment |
| 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 | Change From Baseline in Total Urinary Glucose Excretion (UGE) | change from baseline in total urinary glucose excretion (UGE) to 24 hours | Treated patients who had complete urine sample (baseline and 24 hours) for analyses. | Posted | Least Squares Mean | 95% Confidence Interval | mg | baseline and 24 hours |
|
From trial drug intake until the end-of-study examination visit, up to 12 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 | Normal Renal Function | 25 mg empagliflozin taken as a single dose for patients with normal renal function |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal distension | Gastrointestinal disorders | MEDDRA 15.1 | 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 |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C570240 | empagliflozin |
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| BI10773 |
| Drug |
BI10773 medium dose tablet single dose |
|
| BI10773 | Drug | BI10773 medium dose tablet single dose |
|
| BI10773 | Drug | BI10773 medium dose tablet single dose |
|
| BG002 | Moderate Renal Impairment | 25 mg empagliflozin taken as a single dose for patients with moderate renal impairment |
| BG003 | Severe Renal Impairment | 25 mg empagliflozin taken as a single dose for patients with severe renal impairment |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG002 |
| Moderate Renal Impairment |
25 mg empagliflozin taken as a single dose for patients with moderate renal impairment |
| OG003 | Severe Renal Impairment | 25 mg empagliflozin taken as a single dose for patients with severe renal impairment |
|
|
| Primary | Area Under the Concentration Time Curve of the Analyte in Plasma | Area under the concentration time curve of the analyte in plasma over the time interval from 0 to infinity | Treated patients | Posted | Geometric Mean | Geometric Coefficient of Variation | nmol*h/L | Predose and 20 minutes (min), 40min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 14h, 24h, 36h 48h, 72h and 96h after drug administration |
|
|
|
|
| Primary | Maximum Concentration | Maximum concentration of the analyte in plasma | Treated patients | Posted | Geometric Mean | Geometric Coefficient of Variation | nmol/L | Predose and 20 minutes (min), 40min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 14h, 24h, 36h 48h, 72h and 96h after drug administration |
|
|
|
|
| 0 |
| 8 |
| 0 |
| 8 |
| EG001 | Mild Renal Impairment | 25 mg empagliflozin taken as a single dose for patients with mild renal impairment | 0 | 8 | 0 | 8 |
| EG002 | Moderate Renal Impairment | 25 mg empagliflozin taken as a single dose for patients with moderate renal impairment | 0 | 8 | 2 | 8 |
| EG003 | Severe Renal Impairment | 25 mg empagliflozin taken as a single dose for patients with severe renal impairment | 0 | 8 | 0 | 8 |
| Decreased appetite | Metabolism and nutrition disorders | MEDDRA 15.1 | Systematic Assessment |
|
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.
| D004700 | Endocrine System Diseases |
The model includes fixed effect for the renal function group
| Geometric mean ratio |
| 143.82 |
| 2-Sided |
| 90 |
| 118.306 |
| 174.848 |
| Superiority or Other |
| ANOVA | The model includes fixed effect for the renal function group | Geometric mean ratio | 152.31 | 2-Sided | 90 | 125.287 | 185.166 | Superiority or Other |
The model includes fixed effect for the renal function group
| Geometric mean ratio |
| 92.18 |
| 2-Sided |
| 90 |
| 71.216 |
| 119.305 |
| Superiority or Other |
| ANOVA | The model includes fixed effect for the renal function group | Geometric mean ratio | 94.01 | 2-Sided | 90 | 72.630 | 121.674 | Superiority or Other |