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The objective of this trial is to investigate the pharmacokinetics and pharmacodynamics of linagliptin (BI 1356) 5 mg administered orally in patients with Type 2 diabetes mellitus of African American origin.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| linagliptin | Experimental | Pharmacokinetic (PK)/Pharmacodynamic (PD) investigation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| linagliptin QD (once daily) for 7 days | Drug | dipeptidyl peptidase IV (DPP-4) activity will be measured as PD response to drug administration |
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| Measure | Description | Time Frame |
|---|---|---|
| Linagliptin: AUC_τ,ss | area under the concentration time curve (AUC_τ) of linagliptin in plasma at steady state over a uniform dosing interval | 24 hours |
| Linagliptin: C_max,ss | maximum concentration of linagliptin in plasma at steady state | 24 hours |
| DPP-4 Inhibition: E_24,ss | Plasma DPP-4 inhibition at trough under steady state conditions. Plasma DPP-4 inhibition is derived by calculating (1-(activity in presence of linagliptin)/baseline activity))*100%, where 'activity' is the activity of the DPP-IV enzyme. | One single measurement 24 h after drug administration under steady state conditions |
| Measure | Description | Time Frame |
|---|---|---|
| Treatment Emergent Adverse Events | Frequency of patients with AEs | 21 days |
| Electrocardiogram (ECG), Vital Signs, Physical Finding or Laboratory Finding Abnormalities | 12-lead-Electrocardiogram (ECG), vital sign (blood pressure and pulse rate), physical finding and laboratory abnormalities |
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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 |
|---|---|---|---|---|---|---|
| 1218.55.0006 Boehringer Ingelheim Investigational Site | Cypress | California | United States | |||
| 1218.55.0008 Boehringer Ingelheim Investigational Site |
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| ID | Title | Description |
|---|---|---|
| FG000 | Linagliptin 5mg | Linagliptin 5mg once daily |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| 21 days |
| Patients With Electrocardiogram (ECG), Vital Signs, Physical Finding or Laboratory Finding Abnormalities Reported as an Adverse Event | Patients with Electrocardiogram (ECG), vital signs, physical finding reported as an adverse event | 21 days |
| Linagliptin: AUC_0-24 | area under the concentration time curve of linagliptin in plasma over the time interval from 0 to 24h after administration of the first dose | 24 hours |
| Linagliptin: C_max | maximum concentration of linagliptin in plasma on Day 1 | 24h |
| DPP-4 Inhibition: E_24 | Plasma DPP-4 inhibition 24 hours after first dose. Plasma DPP-4 inhibition is derived by calculating (1-(activity in presence of linagliptin)/baseline activity))*100%, where 'activity' is the activity of the DPP-IV enzyme. | One single measurement 24 h after drug administration |
| DeLand |
| Florida |
| United States |
| 1218.55.0004 Boehringer Ingelheim Investigational Site | Miami | Florida | United States |
| 1218.55.0005 Boehringer Ingelheim Investigational Site | Baltimore | Maryland | United States |
| 1218.55.0003 Boehringer Ingelheim Investigational Site | New York | New York | United States |
| 1218.55.0001 Boehringer Ingelheim Investigational Site | Dallas | Texas | United States |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Linagliptin 5mg | Linagliptin 5mg once daily |
| Units | Counts |
|---|---|
| Participants |
|
| 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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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Number | Participants |
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| Body mass index (BMI) continuous | Mean | Standard Deviation | kg/m^2 |
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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 | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Secondary | Treatment Emergent Adverse Events | Frequency of patients with AEs | All treated patients | Posted | Number | Participants | 21 days |
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| Secondary | Electrocardiogram (ECG), Vital Signs, Physical Finding or Laboratory Finding Abnormalities | 12-lead-Electrocardiogram (ECG), vital sign (blood pressure and pulse rate), physical finding and laboratory abnormalities | All treated patients | Posted | Number | Participants | 21 days |
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| Primary | Linagliptin: AUC_τ,ss | area under the concentration time curve (AUC_τ) of linagliptin in plasma at steady state over a uniform dosing interval | Treated set | Posted | Geometric Mean | Geometric Coefficient of Variation | nmol*h/L | 24 hours |
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| Primary | Linagliptin: C_max,ss | maximum concentration of linagliptin in plasma at steady state | Treated set | Posted | Geometric Mean | Geometric Coefficient of Variation | nmol/L | 24 hours |
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| Secondary | Patients With Electrocardiogram (ECG), Vital Signs, Physical Finding or Laboratory Finding Abnormalities Reported as an Adverse Event | Patients with Electrocardiogram (ECG), vital signs, physical finding reported as an adverse event | All treated patients | Posted | Number | Participants | 21 days |
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| Secondary | Linagliptin: AUC_0-24 | area under the concentration time curve of linagliptin in plasma over the time interval from 0 to 24h after administration of the first dose | Treated set- All patients with values for the area under the concentration time curve of the analyte in plasma over the time interval from 0 to 24 h after administration of the first dose (AUC_0-24) for Linagliptin | Posted | Geometric Mean | Geometric Coefficient of Variation | nmol*h/L | 24 hours |
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| Primary | DPP-4 Inhibition: E_24,ss | Plasma DPP-4 inhibition at trough under steady state conditions. Plasma DPP-4 inhibition is derived by calculating (1-(activity in presence of linagliptin)/baseline activity))*100%, where 'activity' is the activity of the DPP-IV enzyme. | Treated set | Posted | Median | Full Range | Percent (of inhibition) | One single measurement 24 h after drug administration under steady state conditions |
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| Secondary | Linagliptin: C_max | maximum concentration of linagliptin in plasma on Day 1 | Treated set - All patients with values for the maximum measured concentration of linagliptin in plasma (C_max) | Posted | Geometric Mean | Geometric Coefficient of Variation | nmol/L | 24h |
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| Secondary | DPP-4 Inhibition: E_24 | Plasma DPP-4 inhibition 24 hours after first dose. Plasma DPP-4 inhibition is derived by calculating (1-(activity in presence of linagliptin)/baseline activity))*100%, where 'activity' is the activity of the DPP-IV enzyme. | Treated set | Posted | Median | Full Range | Percent (of inhibition) | One single measurement 24 h after drug administration |
|
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7 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 | Linagliptin 5mg | Linagliptin 5mg once daily | 0 | 41 | 5 | 41 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | MedDra (13,0) | Systematic Assessment |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Boehringer Ingelheim Call Center | Boehringer Ingelheim Pharmaceuticals | 1-800-243-0127 | 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 |
|---|---|
| D000074584 | WW Domain-Containing Oxidoreductase |
| ID | Term |
|---|---|
| D000074583 | Short Chain Dehydrogenase-Reductases |
| D064430 | NAD (+) and NADP (+) Dependent Alcohol Oxidoreductases |
| D000429 | Alcohol Oxidoreductases |
| D010088 | Oxidoreductases |
| D004798 | Enzymes |
| D045762 | Enzymes and Coenzymes |
| D025521 | Tumor Suppressor Proteins |
| D009363 | Neoplasm Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
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| Unknown or Not Reported |
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| Title | Measurements |
|---|---|
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| Discontinuation due to AEs |
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| Title | Denominators | Categories |
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| ECG abnormalities |
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| Vital signs abnormalities |
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| Physical finding abnormalities |
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| Laboratory finding abnormalities |
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