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| Name | Class |
|---|---|
| Eli Lilly and Company | INDUSTRY |
The aim of this study is to monitor safety and efficacy of treatment with linagliptin in Korean patients with type 2 diabetes mellitus in routine clinical settings.
Study Design:
Post Marketing study- Observational study
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with Type 2 Diabetes Mellitus |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Trajenta tablet | Drug | Linagliptin |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Patients With Incidence of Adverse Events Who Had Taken at Least One Dose of Trajenta | Percentage of patients with incidence of any adverse events who had taken at least one dose of Trajenta. | Up to 26 weeks (long-term surveillance) |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline After 24 Weeks in Glycosylated Hemoglobin (HbA1c) | Change from baseline after 24 weeks in Glycosylated Hemoglobin (HbA1c). | Baseline and Week 24 |
| Percentage of Patients With Occurrence of Treat to Target Effectiveness Response, That is HbA1c Under Treatment of < 6.5% After 24 Weeks of Treatment |
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Inclusion criteria:
Patients who have been started on Trajenta in accordance with the approved label in Korea Patients who have signed on the data release consent form
Exclusion criteria:
Patients with previous exposure to Trajenta and current participation in clinical trials
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Korean patients with T2DM
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| Name | Affiliation | Role |
|---|---|---|
| Boehringer Ingelheim | Boehringer Ingelheim | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Multiple Locations | South Korea |
All patients were screened for eligibility to participate in the trial. Patients attended a specialist sites which ensured that they met all strictly implemented inclusion/exclusion criteria. Patients were not to be entered to trial if any one of the specific entry criteria was violated.
A regulatory requirement prospective, non-interventional, open-label, multi-centre national study to monitor the safety and effectiveness of Trajenta (Linagliptin, 5 milligram (mg), once daily) in Korean patients with type 2 diabetes mellitus
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| ID | Title | Description |
|---|---|---|
| FG000 | Trajenta (Linagliptin) 5 mg | Patients with type 2 diabetes mellitus were administered with Trajenta (Linagliptin) 5 mg once daily orally. |
| Title | Milestones | Reasons Not Completed | ||||
|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 21, 2017 | Jul 6, 2018 |
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Percentage of patients with occurrence of treat to target effectiveness response, that is HbA1c under treatment of < 6.5% after 24 weeks of treatment. |
| 24 Weeks |
| Percentage of Patients With Occurrence of Relative Effectiveness Response (HbA1c Lowering by at Least 0.5% After 24 Weeks of Treatment) | Percentage of patients with occurrence of relative effectiveness response (HbA1c lowering by at least 0.5% after 24 weeks of treatment). | 24 Weeks |
| Change From Baseline After 24 Weeks in Fasting Plasma Glucose (FPG) | Change from baseline after 24 weeks in fasting plasma glucose (FPG). | Baseline and Week 24 |
|
| COMPLETED | Number of patients in safety analysis set |
|
| NOT COMPLETED |
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|
Safety analysis set: This analysis set included all patients who were administrated Trajenta at least once, except patients violating inclusion/exclusion criteria, dosage administration or lost to follow up.
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| ID | Title | Description |
|---|---|---|
| BG000 | Trajenta (Linagliptin) 5 mg | Patients with type 2 diabetes mellitus were administered with Trajenta (Linagliptin) 5 mg once daily orally. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Number of patients in safety analysis set | Mean | Standard Deviation | Years |
| ||||||||||||||
| Sex: Female, Male | Number of patients in safety analysis set | Count of Participants | Participants |
| |||||||||||||||
| Race and Ethnicity Not Collected | All patients in the safety set were Korean because this was an inclusion criteria | Race and Ethnicity were not collected from any participant. | 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 | Percentage of Patients With Incidence of Adverse Events Who Had Taken at Least One Dose of Trajenta | Percentage of patients with incidence of any adverse events who had taken at least one dose of Trajenta. | Safety analysis set: This analysis set included all patients who were administrated Trajenta at least once, except patients violating inclusion/exclusion criteria, dosage administration or lost to follow up. | Posted | Number | Percentage of patients | Up to 26 weeks (long-term surveillance) |
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| ||||||||||||||||||||||||||
| Secondary | Change From Baseline After 24 Weeks in Glycosylated Hemoglobin (HbA1c) | Change from baseline after 24 weeks in Glycosylated Hemoglobin (HbA1c). | Effectiveness analysis set: This set includes all patients of the safety analysis set for whom HbA1c values were measured at both baseline and after drug administration. | Posted | Mean | Standard Deviation | Percentage of HbA1c | Baseline and Week 24 |
|
| ||||||||||||||||||||||||||
| Secondary | Percentage of Patients With Occurrence of Treat to Target Effectiveness Response, That is HbA1c Under Treatment of < 6.5% After 24 Weeks of Treatment | Percentage of patients with occurrence of treat to target effectiveness response, that is HbA1c under treatment of < 6.5% after 24 weeks of treatment. | Effectiveness analysis set | Posted | Number | Percentage of patients | 24 Weeks |
|
| |||||||||||||||||||||||||||
| Secondary | Percentage of Patients With Occurrence of Relative Effectiveness Response (HbA1c Lowering by at Least 0.5% After 24 Weeks of Treatment) | Percentage of patients with occurrence of relative effectiveness response (HbA1c lowering by at least 0.5% after 24 weeks of treatment). | Effectiveness analysis set | Posted | Number | Percentage of patients | 24 Weeks |
|
| |||||||||||||||||||||||||||
| Secondary | Change From Baseline After 24 Weeks in Fasting Plasma Glucose (FPG) | Change from baseline after 24 weeks in fasting plasma glucose (FPG). | Effectiveness analysis set: the patients with the data available for FPG | Posted | Mean | Standard Deviation | Milligrams per Deciliter | Baseline and Week 24 |
|
|
From the entire surveillance period until re-examination period, up to 6 years.
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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 | Trajenta (Linagliptin) 5 mg | Patients with type 2 diabetes mellitus were administered with Trajenta (Linagliptin) 5 mg once daily orally. | 2 | 3,119 | 49 | 3,119 | 0 | 3,119 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Constipation | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
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| Abdominal pain upper | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
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| Enterocolitis | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
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| Ileus | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
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| Gastroenteritis | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
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| Herpes zoster | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
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| Cystitis | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
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| Pyelonephritis acute | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
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| Bronchitis | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
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| Vestibular neuronitis | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
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| Sepsis | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
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| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 20.0 | Systematic Assessment |
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| Decreased appetite | Metabolism and nutrition disorders | MedDRA 20.0 | Systematic Assessment |
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| Dehydration | Metabolism and nutrition disorders | MedDRA 20.0 | Systematic Assessment |
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| Cerebral infarction | Nervous system disorders | MedDRA 20.0 | Systematic Assessment |
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| Dysarthria | Nervous system disorders | MedDRA 20.0 | Systematic Assessment |
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| Dementia Alzheimer's type | Nervous system disorders | MedDRA 20.0 | Systematic Assessment |
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| Chest pain | General disorders | MedDRA 20.0 | Systematic Assessment |
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| Pyrexia | General disorders | MedDRA 20.0 | Systematic Assessment |
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| Face oedema | General disorders | MedDRA 20.0 | Systematic Assessment |
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| Fatigue | General disorders | MedDRA 20.0 | Systematic Assessment |
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| Death | General disorders | MedDRA 20.0 | Systematic Assessment |
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| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Systematic Assessment |
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| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Systematic Assessment |
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| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Systematic Assessment |
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| Diabetic foot | Skin and subcutaneous tissue disorders | MedDRA 20.0 | Systematic Assessment |
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| Skin lesion | Skin and subcutaneous tissue disorders | MedDRA 20.0 | Systematic Assessment |
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| Metastases to liver | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.0 | Systematic Assessment |
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| Acute leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.0 | Systematic Assessment |
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| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.0 | Systematic Assessment |
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| Non-small cell lung cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.0 | Systematic Assessment |
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| Pericardial effusion malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.0 | Systematic Assessment |
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| Gastric cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.0 | Systematic Assessment |
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| Rectal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.0 | Systematic Assessment |
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| Pancreatic carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.0 | Systematic Assessment |
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| Meniscus injury | Injury, poisoning and procedural complications | MedDRA 20.0 | Systematic Assessment |
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| Pneumoconiosis | Injury, poisoning and procedural complications | MedDRA 20.0 | Systematic Assessment |
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| Cardiac failure congestive | Cardiac disorders | MedDRA 20.0 | Systematic Assessment |
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| Angina pectoris | Cardiac disorders | MedDRA 20.0 | Systematic Assessment |
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| Acute myocardial infarction | Cardiac disorders | MedDRA 20.0 | Systematic Assessment |
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| Angina unstable | Cardiac disorders | MedDRA 20.0 | Systematic Assessment |
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| Cardiac arrest | Cardiac disorders | MedDRA 20.0 | Systematic Assessment |
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| Diabetic retinopathy | Eye disorders | MedDRA 20.0 | Systematic Assessment |
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| Acute kidney injury | Renal and urinary disorders | MedDRA 20.0 | Systematic Assessment |
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| End stage renal disease | Renal and urinary disorders | MedDRA 20.0 | Systematic Assessment |
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| Cholecystitis acute | Hepatobiliary disorders | MedDRA 20.0 | Systematic Assessment |
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| Cholangitis | Hepatobiliary disorders | MedDRA 20.0 | Systematic Assessment |
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| Vertigo | Ear and labyrinth disorders | MedDRA 20.0 | Systematic Assessment |
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| Renal transplant failure | Immune system disorders | MedDRA 20.0 | 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 | 1-800-243-0127 | clintriage.rdg@boehringer-ingelheim.com |
| SAP_000.pdf |
| Prot | Yes | No | No | Study Protocol | Feb 22, 2017 | Jul 6, 2018 | Prot_001.pdf |
| 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 |
|---|---|
| D000069476 | Linagliptin |
| ID | Term |
|---|---|
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D011799 | Quinazolines |
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| Male |
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| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
| Before drug administration |
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| After drug administration |
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