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| ID | Type | Description | Link |
|---|---|---|---|
| 2013-002304-14 | EudraCT Number | EudraCT |
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| Name | Class |
|---|---|
| Eli Lilly and Company | INDUSTRY |
The aim of the study is to generate pharmacokinetic and pharmacodynamic data to identify the safe-effective dose of empagliflozin in children and adolescents aged 10 to less than 18 years with type 2 diabetes mellitus.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| empagliflozin high dose | Experimental | Patient to receive a high dose of empagliflozin |
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| empagliflozin medium dose | Experimental | Patient to receive a medium dose of empagliflozin |
|
| empagliflozin low dose | Experimental | Patient to receive a low dose of empagliflozin |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| empagliflozin medium dose | Drug |
| ||
| empagliflozin high dose |
| Measure | Description | Time Frame |
|---|---|---|
| AUC0-inf | Area under the concentration-time curve of analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-inf). | Before drug administration (-0:30 hours (h)) and 0:30h, 1:00h, 1:30h, 2:00h, 4:00h, 8:00h, 12:00 (Day 1), 24:00 (Day 2), 34:00 (Day 2), 48:00 (Day 3) after drug administration. |
| AUC0-tz | Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the time of the last quantifiable concentration (AUC0-tz). | Before drug administration (-0:30 hours (h)) and 0:30h, 1:00h, 1:30h, 2:00h, 4:00h, 8:00h, 12:00 (Day 1), 24:00 (Day 2), 34:00 (Day 2), 48:00 (Day 3) after drug administration. |
| Cmax | Maximum measured concentration in plasma (Cmax). | Before drug administration (-0:30 hours (h)) and 0:30h, 1:00h, 1:30h, 2:00h, 4:00h, 8:00h, 12:00 (Day 1), 24:00 (Day 2), 34:00 (Day 2), 48:00 (Day 3) after drug administration. |
| Tmax | Maximum measured concentration in plasma (tmax). | Before drug administration (-0:30 hours (h)) and 0:30h, 1:00h, 1:30h, 2:00h, 4:00h, 8:00h, 12:00 (Day 1), 24:00 (Day 2), 34:00 (Day 2), 48:00 (Day 3) after drug administration. |
| t1/2 | Terminal half-life in plasma (t1/2). | Before drug administration (-0:30 hours (h)) and 0:30h, 1:00h, 1:30h, 2:00h, 4:00h, 8:00h, 12:00 (Day 1), 24:00 (Day 2), 34:00 (Day 2), 48:00 (Day 3) after drug administration. |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Urinary Glucose Excretion (UGE) Over 24 h After Study Drug Intake | Change from baseline in Urinary Glucose Excretion (UGE) over 24 h after study drug intake. For the changes from baseline in UGE on Day 1 (0 to 24 h postdose) , adjusted means per treatment group were to be calculated based on an ANCOVA including 'treatment' as a fixed effect and 'UGE at baseline' and 'FPG at baseline' as continuous covariates. Means presented are the adjusted means. |
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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 |
|---|---|---|---|---|---|---|
| 1245.87.01013 Boehringer Ingelheim Investigational Site | New Haven | Connecticut | United States | |||
| 1245.87.01004 Boehringer Ingelheim Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29941496 | Derived | Bjornstad P, Laffel L, Tamborlane WV, Simons G, Hantel S, von Eynatten M, George J, Marquard J, Cherney DZI. Acute Effect of Empagliflozin on Fractional Excretion of Sodium and eGFR in Youth With Type 2 Diabetes. Diabetes Care. 2018 Aug;41(8):e129-e130. doi: 10.2337/dc18-0394. Epub 2018 Jun 25. No abstract available. | |
| 29655290 | Derived |
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| ID | Title | Description |
|---|---|---|
| FG000 | Empagliflozin 5mg | Single dose (1 tablet) of 5mg, empagliflozin, film-coated tablet administered orally. |
| FG001 | Empagliflozin 10mg | Single dose (1 tablet) of 10mg, empagliflozin, film-coated tablet administered orally. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Drug |
|
| empagliflozin low dose | Drug |
|
| baseline and 24 hours |
| Change From Baseline in Fasting Plasma Glucose (FPG) at 24 h After Study Drug Intake | Change from baseline in Fasting Plasma Glucose (FPG) at 24h after study drug intake. For the change from baseline in FPG at 24 h postdose (in the morning of Day 2), adjusted means per treatment group were to be calculated based on an ANCOVA including 'treatment' as a fixed effect and 'FPG at baseline' as continuous covariate. Means presented are the adjusted means. | baseline and 24 hours |
| Change From Baseline in 8-point Plasma Glucose Profile Over 24 h After Study Drug Intake | Change from baseline in 8-point plasma glucose profile over 24h after study drug intake (as defined by change from baseline in Mean Daily Glucose (MDG) calculated at Day 1). For the changes from baseline in MDG on Day 1, adjusted means per treatment group were to be calculated based on an ANCOVA including 'treatment' as fixed effect and 'MDG at baseline' as continuous covariate. Means presented are the adjusted means. | baseline and 24 hours |
| Boston |
| Massachusetts |
| United States |
| 1245.87.01002 Boehringer Ingelheim Investigational Site | Toledo | Ohio | United States |
| 1245.87.01012 Boehringer Ingelheim Investigational Site | Philadelphia | Pennsylvania | United States |
| 1245.87.01001 Boehringer Ingelheim Investigational Site | Pittsburgh | Pennsylvania | United States |
| 1245.87.33001 Boehringer Ingelheim Investigational Site | Lyon | France |
| 1245.87.97202 Boehringer Ingelheim Investigational Site | Beersheba | Israel |
| 1245.87.97203 Boehringer Ingelheim Investigational Site | Tel Litwinsky | Israel |
| 1245.87.52001 Boehringer Ingelheim Investigational Site | Chihuahua City | Mexico |
| 1245.87.27003 Boehringer Ingelheim Investigational Site | Bellville | South Africa |
| 1245.87.27002 Boehringer Ingelheim Investigational Site | Pretoria | South Africa |
| Laffel LMB, Tamborlane WV, Yver A, Simons G, Wu J, Nock V, Hobson D, Hughan KS, Kaspers S, Marquard J. Pharmacokinetic and pharmacodynamic profile of the sodium-glucose co-transporter-2 inhibitor empagliflozin in young people with Type 2 diabetes: a randomized trial. Diabet Med. 2018 Aug;35(8):1096-1104. doi: 10.1111/dme.13629. Epub 2018 May 6. |
| FG002 | Empagliflozin 25mg | Single dose (1 tablet) of 25mg, empagliflozin, film-coated tablet administered orally. |
| COMPLETED |
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| NOT COMPLETED |
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Treated Set (TS): The TS included all patients who were allocated trial medication and had received trial medication (empagliflozin).
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| ID | Title | Description |
|---|---|---|
| BG000 | Empagliflozin 5mg | Single dose (1 tablet) of 5mg, empagliflozin, film-coated tablet administered orally. |
| BG001 | Empagliflozin 10mg | Single dose (1 tablet) of 10mg, empagliflozin, film-coated tablet administered orally. |
| BG002 | Empagliflozin 25mg | Single dose (1 tablet) of 25mg, empagliflozin, film-coated tablet administered orally. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| 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 | AUC0-inf | Area under the concentration-time curve of analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-inf). | Pharmacokinetic Set (PKS): The PKS included all treated patients who provided at least 1 primary or secondary pharmacokinetic parameter for statistical assessment. | Posted | Geometric Mean | Geometric Coefficient of Variation | nmol*h/L | Before drug administration (-0:30 hours (h)) and 0:30h, 1:00h, 1:30h, 2:00h, 4:00h, 8:00h, 12:00 (Day 1), 24:00 (Day 2), 34:00 (Day 2), 48:00 (Day 3) after drug administration. |
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| Primary | AUC0-tz | Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the time of the last quantifiable concentration (AUC0-tz). | Pharmacokinetic Set (PKS): The PKS included all treated patients who provided at least 1 primary or secondary pharmacokinetic parameter for statistical assessment. | Posted | Geometric Mean | Geometric Coefficient of Variation | nmol*h/L | Before drug administration (-0:30 hours (h)) and 0:30h, 1:00h, 1:30h, 2:00h, 4:00h, 8:00h, 12:00 (Day 1), 24:00 (Day 2), 34:00 (Day 2), 48:00 (Day 3) after drug administration. |
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| Primary | Cmax | Maximum measured concentration in plasma (Cmax). | Pharmacokinetic Set (PKS): The PKS included all treated patients who provided at least 1 primary or secondary pharmacokinetic parameter for statistical assessment. | Posted | Geometric Mean | Geometric Coefficient of Variation | nmol/L | Before drug administration (-0:30 hours (h)) and 0:30h, 1:00h, 1:30h, 2:00h, 4:00h, 8:00h, 12:00 (Day 1), 24:00 (Day 2), 34:00 (Day 2), 48:00 (Day 3) after drug administration. |
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| Primary | Tmax | Maximum measured concentration in plasma (tmax). | Pharmacokinetic Set (PKS): The PKS included all treated patients who provided at least 1 primary or secondary pharmacokinetic parameter for statistical assessment. | Posted | Median | Full Range | hours | Before drug administration (-0:30 hours (h)) and 0:30h, 1:00h, 1:30h, 2:00h, 4:00h, 8:00h, 12:00 (Day 1), 24:00 (Day 2), 34:00 (Day 2), 48:00 (Day 3) after drug administration. |
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| Primary | t1/2 | Terminal half-life in plasma (t1/2). | Pharmacokinetic Set (PKS): The PKS included all treated patients who provided at least 1 primary or secondary pharmacokinetic parameter for statistical assessment. | Posted | Geometric Mean | Geometric Coefficient of Variation | hours | Before drug administration (-0:30 hours (h)) and 0:30h, 1:00h, 1:30h, 2:00h, 4:00h, 8:00h, 12:00 (Day 1), 24:00 (Day 2), 34:00 (Day 2), 48:00 (Day 3) after drug administration. |
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| Secondary | Change From Baseline in Urinary Glucose Excretion (UGE) Over 24 h After Study Drug Intake | Change from baseline in Urinary Glucose Excretion (UGE) over 24 h after study drug intake. For the changes from baseline in UGE on Day 1 (0 to 24 h postdose) , adjusted means per treatment group were to be calculated based on an ANCOVA including 'treatment' as a fixed effect and 'UGE at baseline' and 'FPG at baseline' as continuous covariates. Means presented are the adjusted means. | Treated Set (TS) including patients with UGE data on both visits | Posted | Mean | Standard Error | g/24h | baseline and 24 hours |
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| Secondary | Change From Baseline in Fasting Plasma Glucose (FPG) at 24 h After Study Drug Intake | Change from baseline in Fasting Plasma Glucose (FPG) at 24h after study drug intake. For the change from baseline in FPG at 24 h postdose (in the morning of Day 2), adjusted means per treatment group were to be calculated based on an ANCOVA including 'treatment' as a fixed effect and 'FPG at baseline' as continuous covariate. Means presented are the adjusted means. | Treated Set (TS) including patients with FPG data on both visits | Posted | Mean | Standard Error | mg/dL | baseline and 24 hours |
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| Secondary | Change From Baseline in 8-point Plasma Glucose Profile Over 24 h After Study Drug Intake | Change from baseline in 8-point plasma glucose profile over 24h after study drug intake (as defined by change from baseline in Mean Daily Glucose (MDG) calculated at Day 1). For the changes from baseline in MDG on Day 1, adjusted means per treatment group were to be calculated based on an ANCOVA including 'treatment' as fixed effect and 'MDG at baseline' as continuous covariate. Means presented are the adjusted means. | Treated Set (TS) including patients with plasma glucose profile data on both visits | Posted | Mean | Standard Error | mg/dL | baseline and 24 hours |
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All adverse events reported within 7 days following trial drug administration were considered on treatment, up to 8 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 | Empagliflozin 5mg | Single dose (1 tablet) of 5mg, empagliflozin, film-coated tablet administered orally. | 0 | 9 | 4 | 9 | ||
| EG001 | Empagliflozin 10mg | Single dose (1 tablet) of 10mg, empagliflozin, film-coated tablet administered orally. | 0 | 8 | 1 | 8 | ||
| EG002 | Empagliflozin 25mg | Single dose (1 tablet) of 25mg, empagliflozin, film-coated tablet administered orally. | 0 | 10 | 2 | 10 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
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| Anal pruritus | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
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| Ligament sprain | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
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| Dehydration | Metabolism and nutrition disorders | MedDRA 18.1 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
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Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Boehringer Ingelheim Call Center | Boehringer Ingelheim (BI) | 1800-243-0127 | clintriage.rdg@boehringer-ingelheim.com |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| C570240 | empagliflozin |
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