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| Name | Class |
|---|---|
| Eli Lilly and Company | INDUSTRY |
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Study objectives is to investigate the safety of long-term daily use of TRADIANCE® Combination Tablets AP and BP in Japanese patients with Type 2 Diabetes mellitus (T2DM) used in routine care.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Subjects with type 2 Diabetes Mellitus |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TRADIANCE® Combination Tablets AP | Drug | Fixed dose combination |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Adverse Drug Reactions (ADRs) | The number of participants with adverse drug reactions is reported. | From first dose of study medication until last dose + 7 days, up to 102.1 weeks. |
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Inclusion Criteria:
Exclusion Criteria:
None
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Patients with type 2 Diabetes Mellitus
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| Name | Affiliation | Role |
|---|---|---|
| Rie Ikeda, 81364172200 | zzCDMJP_PV_PMS@boehringer-ingelheim.com | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nippon Boehringer Ingelheim Co., Ltd | Tokyo | 1416017 | Japan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35946927 | Derived | Inagaki N, Nishimoto T, Nishiya Y, Nitta D. Safety and effectiveness of empagliflozin and linagliptin fixed-dose combination therapy in Japanese patients with type 2 diabetes: final results of a one-year post-marketing surveillance study. Expert Opin Drug Saf. 2023 Feb;22(2):153-163. doi: 10.1080/14740338.2022.2107200. Epub 2022 Aug 16. |
| Label | URL |
|---|---|
| Related Info | View source |
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After the study is completed and the primary manuscript is accepted for publishing, researchers can use this following link https:// trials.boehringer-ingelheim.com/trial_results/ clinical_submission_documents.html to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement". Also, Researchers can use the following link http://trials.boehringeringelheim. com/ to find information in order to request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website. The data shared are the raw clinical study data sets.
After all regulatory activities are completed in the US and EU for the product and indication, and after the primary manuscript has been accepted for publication.
For study documents - upon signing of a 'Document Sharing Agreement'. For study data - 1. after the submission and approval of the research proposal (checks will be performed by both the independent review panel and the sponsor, including checking that the planned analysis does not compete with sponsor's publication plan); 2. and upon signing of a 'Data Sharing Agreement'.
All subjects were screened for eligibility prior to participation in the trial. Subjects attended a specialist site which ensured that they (the subjects) strictly met all inclusion and none of the exclusion criteria.
Subjects were not to be allocated to a treatment group if any of the entry criteria were violated.
This was a non-interventional study based on newly collect data of patients under routine care to confirm safety of TRADIANCE® Combination Tablets AP and BP in real-world setting in Japanese patients with Type 2 Diabetes mellitus (T2DM).
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| ID | Title | Description |
|---|---|---|
| FG000 | All Patients With Type 2 Diabetes Mellitus | TRADIANCE® Combination Tablet AP or BP (fixed dose combination of empagliflozin and linagliptin) were administered orally once daily for patients with type 2 Diabetes Mellitus (T2DM). The TRADIANCE® Combination Tablet AP contains 10 milligrams (mg) empagliflozin and 5 mg linagliptin, while Tablet BP contains 25 mg empagliflozin and 5 mg linagliptin. Patients were followed up to 52 weeks. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Safety set: The safety set included all patients who had no invalid registration, who were documented to have taken at least one dose of TRADIANCE® Combination Tablets AP or BP.
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| ID | Title | Description |
|---|---|---|
| BG000 | All Patients With Type 2 Diabetes Mellitus | TRADIANCE® Combination Tablet AP or BP (fixed dose combination of empagliflozin and linagliptin) were administered orally once daily for patients with type 2 Diabetes Mellitus (T2DM). The TRADIANCE® Combination Tablet AP contains 10 milligrams (mg) empagliflozin and 5 mg linagliptin, while Tablet BP contains 25 mg empagliflozin and 5 mg linagliptin. Patients were followed up to 52 weeks. |
| 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 | Number of Participants With Adverse Drug Reactions (ADRs) | The number of participants with adverse drug reactions is reported. | Safety set: The safety set included all patients who had no invalid registration, who were documented to have taken at least one dose of TRADIANCE® Combination Tablets AP or BP. | Posted | Count of Participants | Participants | From first dose of study medication until last dose + 7 days, up to 102.1 weeks. |
|
From first dose of study medication until last dose + 7 days, up to 102.1 weeks.
Safety set: The safety set included all patients who had no invalid registration, who were documented to have taken at least one dose of TRADIANCE® Combination Tablets AP or BP.
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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 | All Patients With Type 2 Diabetes Mellitus | TRADIANCE® Combination Tablet AP or BP (fixed dose combination of empagliflozin and linagliptin) were administered orally once daily for patients with type 2 Diabetes Mellitus (T2DM). The TRADIANCE® Combination Tablet AP contains 10 milligrams (mg) empagliflozin and 5 mg linagliptin, while Tablet BP contains 25 mg empagliflozin and 5 mg linagliptin. Patients were followed up to 52 weeks. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Infective spondylitis | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Boehringer Ingelheim Call Center | Boehringer Ingelheim | 1-800-243-0127 | clintriage.rdg@boehringer-ingelheim.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Nov 20, 2018 | Jan 10, 2022 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 24, 2021 | Jan 10, 2022 | SAP_001.pdf |
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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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| TRADIANCE® Combination Tablets BP |
| Drug |
Fixed dose combination |
|
| Lost to Follow-up |
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| Adverse Event |
|
| Case report form (CRF) not collected |
|
| No patient visit after entry |
|
| Switch to other diabetes medication |
|
| Prevention for recurrence of cystitis |
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| Postoperative therapy of esophageal cancer |
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| Insufficient effectives |
|
| Excessive alcohol intake |
|
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
|
|
| 5 |
| 1,146 |
| 40 |
| 1,146 |
| 0 |
| 1,146 |
| Influenza | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
|
| Pyelonephritis | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
|
| Pyoderma | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
|
| Blood loss anaemia | Blood and lymphatic system disorders | MedDRA 24.0 | Systematic Assessment |
|
| Diabetes mellitus inadequate control | Metabolism and nutrition disorders | MedDRA 24.0 | Systematic Assessment |
|
| Carotid artery occlusion | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
|
| Subarachnoid haemorrhage | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
|
| Atrioventricular block second degree | Cardiac disorders | MedDRA 24.0 | Systematic Assessment |
|
| Myocardial infarction | Cardiac disorders | MedDRA 24.0 | Systematic Assessment |
|
| Idiopathic interstitial pneumonia | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
|
| Colitis ischaemic | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
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| Gastric ulcer haemorrhage | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
|
| Intestinal obstruction | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
|
| Cholangitis acute | Hepatobiliary disorders | MedDRA 24.0 | Systematic Assessment |
|
| Death | General disorders | MedDRA 24.0 | Systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
|
| Pneumonia bacterial | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
|
| Viral infection | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
|
| Cerebral infarction | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
|
| Thalamic infarction | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
|
| Acute myocardial infarction | Cardiac disorders | MedDRA 24.0 | Systematic Assessment |
|
| Angina pectoris | Cardiac disorders | MedDRA 24.0 | Systematic Assessment |
|
| Angina unstable | Cardiac disorders | MedDRA 24.0 | Systematic Assessment |
|
| Cardiac failure | Cardiac disorders | MedDRA 24.0 | Systematic Assessment |
|
| Myocarditis | Cardiac disorders | MedDRA 24.0 | Systematic Assessment |
|
| Bile duct stone | Hepatobiliary disorders | MedDRA 24.0 | Systematic Assessment |
|
| Spinal compression fracture | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
|
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.0 | Systematic Assessment |
|
| Cholangiocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.0 | Systematic Assessment |
|
| Colon cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.0 | Systematic Assessment |
|
| Hepatocellular carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.0 | Systematic Assessment |
|
| Lung neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.0 | Systematic Assessment |
|
| Oesophageal adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.0 | Systematic Assessment |
|
| Pancreatic carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.0 | Systematic Assessment |
|
| Parathyroid tumour | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.0 | Systematic Assessment |
|
| Scrotal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.0 | Systematic Assessment |
|
| Skin cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.0 | Systematic Assessment |
|
| Uterine cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.0 | Systematic Assessment |
|
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| D004700 | Endocrine System Diseases |