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The aim of the trial is to assess the relative bioavailability of fixed dose combination tablets of linagliptin and metformin compared to the administration of two single tablets (linagliptin and metformin ) in Chinese subjects. The availability of a fixed dose combination tablet is expected to significantly enhance patients' compliance with antidiabetic treatment., in particular with concern to the frequent polypharmacy in diabetic patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| linagliptin/metformin(high dose) | Experimental | 24 subjects (12 male and 12 female) will be assigned to 2 treatment sequences. cross-over design was adopted to ensure each patient would take fixed dose combination tablets of linagliptin /metformin (high dose) and single linagliptin and metformin (high dose) tablets single dose in randomized order |
|
| linagliptin/metformin(low dose) | Experimental | 24 subjects (12 male and 12 female) will be assigned to 2 treatment sequences. cross-over design was adopted to ensure each patient would take fixed dose combination tablets of linagliptin /metformin (low dose) and single linagliptin and metformin (low dose) tablets single dose in randomized order |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| linagliptin/metformin(high dose) | Drug | patient would take fixed dose combination tablets of linagliptin /metformin (high dose) and single linagliptin and metformin (High dose) tablets single dose in random order, and each dosage will be separated in 42 days interval. |
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Concentration-time Curve of Linagliptin in Plasma Over the Time Interval 0 to 72 Hours (AUC0-72) | 1 hour (h) prior to drug administration, 20 minutes (min), 40 min, 1 h, 1 h 30 min, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 24 h, 34 h, 48 h and 72 h thereafter. | |
| Maximum Measured Concentration (Cmax) of Linagliptin. | 1 hour (h) prior to drug administration, 20 minutes (min), 40 min, 1 h, 1 h 30 min, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 24 h, 34 h, 48 h and 72 h thereafter. | |
| Area Under the Concentration-time Curve of Metformin in Plasma Over the Time Interval 0 to the Last Quantifiable Concentration (AUC0-tz) | 1 hour (h) prior to drug administration, 20 minutes (min), 40 min, 1 h, 1 h 30 min, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 24 h, 34 h, 48 h and 72 h thereafter. | |
| Maximum Measured Concentration (Cmax) of Metformin | 1 hour (h) prior to drug administration, 20 minutes (min), 40 min, 1 h, 1 h 30 min, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 24 h, 34 h, 48 h and 72 h thereafter. |
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Concentration Time Curve of the Analyte in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-infinity) for Linagliptin | AUC0-infinity is based on predicted last concentration values. | 1 hour (h) prior to drug administration, 20 minutes (min), 40 min, 1 h, 1 h 30 min, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 24 h, 34 h, 48 h and 72 h thereafter. |
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Inclusion criteria:
1. Healthy male and female subjects
Exclusion criteria:
1. Any relevant deviation from healthy conditions
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| Name | Affiliation | Role |
|---|---|---|
| Boehringer Ingelheim | Boehringer Ingelheim | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 1288.5.86001 Boehringer Ingelheim Investigational Site | Beijing | China |
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| ID | Title | Description |
|---|---|---|
| FG000 | Lina 2.5mg, Metformin 850mg | All patients receiving Linagliptin 2.5mg and Metformin 850mg. |
| FG001 | Lina 2.5mg, Metformin 500mg | All patients receiving Linagliptin 2.5mg and Metformin 500mg. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Lina 2.5mg, Metformin 850mg | All patients receiving Linagliptin 2.5mg and Metformin 850mg. |
| BG001 | Lina 2.5mg, Metformin 500mg | All patients receiving Linagliptin 2.5mg and Metformin 500mg. |
| 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 | Area Under the Concentration-time Curve of Linagliptin in Plasma Over the Time Interval 0 to 72 Hours (AUC0-72) | Treated Set. | Posted | Geometric Mean | Geometric Coefficient of Variation | nmol*h/L | 1 hour (h) prior to drug administration, 20 minutes (min), 40 min, 1 h, 1 h 30 min, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 24 h, 34 h, 48 h and 72 h thereafter. |
|
First treatment with study drug until End-of-Study (which was 7 to 14 days after study drug treatment in Visit 3), i.e. 7 weeks plus 4 to 11 days after first treatment with study drug
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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 2.5 mg, Metformin 850 mg as FDC Tablet | Patients receiving 2.5 mg Linagliptin and 850 mg Metformin as a fixed dose combination (FDC) tablet. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | 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 |
|---|---|
| D000069476 | Linagliptin |
| D008687 | Metformin |
| ID | Term |
|---|---|
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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| Linagliptin/metformin(low dose) | Drug | patient would take fixed dose combination tablets of linagliptin /metformin (low dose) and single linagliptin and metformin (Low dose) tablets single dose in random order, and each dosage will be separated in 42 days interval. |
|
| AUC(0-infinity) for Metformin | AUC0-infinity is based on predicted last concentration values. | 1 hour (h) prior to drug administration, 20 minutes (min), 40 min, 1 h, 1 h 30 min, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 24 h, 34 h, 48 h and 72 h thereafter. |
| AUC0-tz for Linagliptin | 1 hour (h) prior to drug administration, 20 minutes (min), 40 min, 1 h, 1 h 30 min, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 24 h, 34 h, 48 h and 72 h thereafter. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG002 | Linagliptin 2.5 mg, Metformin 500 mg as FDC Tablet | Patients receiving 2.5 mg Linagliptin and 500 mg Metformin as a fixed dose combination (FDC) tablet. |
| OG003 | Linagliptin 2.5 mg, Metformin 500 mg as Single Tablets | Patients receiving 2.5 mg Linagliptin and 500 mg Metformin as single tablets. |
|
|
|
| Primary | Maximum Measured Concentration (Cmax) of Linagliptin. | Treated Set. | Posted | Geometric Mean | Geometric Coefficient of Variation | nmol/L | 1 hour (h) prior to drug administration, 20 minutes (min), 40 min, 1 h, 1 h 30 min, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 24 h, 34 h, 48 h and 72 h thereafter. |
|
|
|
|
| Primary | Area Under the Concentration-time Curve of Metformin in Plasma Over the Time Interval 0 to the Last Quantifiable Concentration (AUC0-tz) | Posted | Geometric Mean | Geometric Coefficient of Variation | ng*h/mL | 1 hour (h) prior to drug administration, 20 minutes (min), 40 min, 1 h, 1 h 30 min, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 24 h, 34 h, 48 h and 72 h thereafter. |
|
|
|
|
| Primary | Maximum Measured Concentration (Cmax) of Metformin | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | 1 hour (h) prior to drug administration, 20 minutes (min), 40 min, 1 h, 1 h 30 min, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 24 h, 34 h, 48 h and 72 h thereafter. |
|
|
|
|
| Secondary | Area Under the Concentration Time Curve of the Analyte in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-infinity) for Linagliptin | AUC0-infinity is based on predicted last concentration values. | Posted | Geometric Mean | Geometric Coefficient of Variation | nmol*h/L | 1 hour (h) prior to drug administration, 20 minutes (min), 40 min, 1 h, 1 h 30 min, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 24 h, 34 h, 48 h and 72 h thereafter. |
|
|
|
|
| Secondary | AUC(0-infinity) for Metformin | AUC0-infinity is based on predicted last concentration values. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng*h/mL | 1 hour (h) prior to drug administration, 20 minutes (min), 40 min, 1 h, 1 h 30 min, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 24 h, 34 h, 48 h and 72 h thereafter. |
|
|
|
|
| Secondary | AUC0-tz for Linagliptin | Treated Set | Posted | Geometric Mean | Geometric Coefficient of Variation | nmol*h/L | 1 hour (h) prior to drug administration, 20 minutes (min), 40 min, 1 h, 1 h 30 min, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 24 h, 34 h, 48 h and 72 h thereafter. |
|
|
|
|
| 0 |
| 23 |
| 0 |
| 23 |
| EG001 | Linagliptin 2.5 mg, Metformin 850 mg as Single Tablets | Patients receiving 2.5 mg Linagliptin and 850 mg Metformin as single tablets. | 0 | 24 | 2 | 24 |
| EG002 | Linagliptin 2.5 mg, Metformin 500 mg as FDC Tablet | Patients receiving 2.5 mg Linagliptin and 500 mg Metformin as a fixed dose combination (FDC) tablet. | 0 | 24 | 0 | 24 |
| EG003 | Linagliptin 2.5 mg, Metformin 500 mg as Single Tablets | Patients receiving 2.5 mg Linagliptin and 500 mg Metformin as single tablets. | 0 | 24 | 2 | 24 |
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.
| D011799 | Quinazolines |
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
| adjusted gMean ratio |
| 111.4 |
| 2-Sided |
| 90 |
| 100.4 |
| 123.5 |
| No |
| Superiority or Other |
| adjusteg gMean ratio |
| 103.0 |
| 2-Sided |
| 90 |
| 96.2 |
| 110.1 |
| No |
| Superiority or Other |
| adjusted gMean ratio |
| 102.5 |
| 2-Sided |
| 90 |
| 92.2 |
| 113.9 |
| No |
| Superiority or Other |
| adjusted gMean ratio |
| 89.3 |
| 2-Sided |
| 90 |
| 80.2 |
| 99.3 |
| No |
| Superiority or Other |
| adjusted gMean ratio |
| 102.8 |
| 2-Sided |
| 90 |
| 97.0 |
| 109.0 |
| No |
| Superiority or Other |
| adjusted gMean ratio |
| 100.8 |
| 2-Sided |
| 90 |
| 95.1 |
| 106.8 |
| No |
| Superiority or Other |