Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Eli Lilly and Company | INDUSTRY |
Study to investigate the safety and efficacy of long-term daily use of Trazenta® Tablets as monotherapy in patients with type 2 diabetes mellitus and to assess baseline characteristics of patients with type 2 diabetes mellitus starting Trazenta® Tablets or any other oral antidiabetic monotherapy (naïve or switched from prior therapy of different oral antidiabetic drug).
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oral antidiabetic drug (OAD) |
| ||
| Trazenta |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| OAD | Drug | OAD except Trazenta tablets |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Adverse Drug Reactions (ADRs) | An adverse drug reactions (ADR) was defined as an adverse event (AE) if either the investigator or the sponsor (or both) assessed the causal relationship of Trazenta® Tablets either as "Yes", "Probably yes" or "Can't be denied". | From start of the treatment until the end of this PMS, i.e. up to week 156 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in HbA1c at the Last Observation During the Observation Period. | Change from baseline in Haemoglobin A1c (HbA1c) at the last observation during the observation period is presented as mean change from baseline and standard deviation (SD). | Baseline and 156 week or last observation |
Not provided
Inclusion criteria:
Exclusion criteria:
None
Not provided
Not provided
Not provided
Not provided
3300
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Boehringer Ingelheim | Boehringer Ingelheim | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| One Or Multiple Locations | Japan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35418260 | Derived | Yabe D, Yamamoto F, Lund SS, Okamura T, Kadowaki T. Long-term safety and effectiveness of linagliptin by baseline body mass index in Japanese patients with type 2 diabetes: a 3-year post-marketing surveillance study. Expert Opin Drug Saf. 2022 Oct;21(10):1303-1313. doi: 10.1080/14740338.2022.2057948. Epub 2022 May 3. | |
| 31933070 | Derived |
Not provided
Not provided
Non-interventional,observational prospective study based on newly collected data under routine medical practice with 1 grp of Pts. treated with long-term daily use of Trazenta® Tablets for evaluation of baseline,safety& efficacy data & another grp of Pts. treated with any other oral antidiabetic monotherapy for collection of baseline data only.
In this post marketing surveillance (PMS) study 4876 patients were registered: 2513 patients (Pts.) in Trazenta® Tablets group & 2363 patients in other Oral Antidiabetic Drug (OAD) group (grp). 2414 out of 2513 patients were treated (trt) with Trazenta® Tablets. For other OAD group only baseline data & no observation period.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Trazenta® Tablets | Patients with type 2 diabetes mellitus were administered orally with 5 milligram (mg) of Trazenta® tablets for 156 weeks or until discontinuation. |
| FG001 | Other OAD | Patients with type 2 diabetes mellitus who were treated with any other oral antidiabetic monotherapy except Trazenta® tablets |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Baseline (bl) set: This set included all pts. of safety set for Trazenta tablets grp excluding pts. who were not diagnosed as type 2 diabetes mellitus or had important protocol violations (PV) with respect to treatments at bl. Pts. in other OAD grp were evaluated only for patient demographic & bl characteristics, excluding pts had important PV.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Trazenta® Tablets | Patients with type 2 diabetes mellitus were administered orally with 5 milligram (mg) of Trazenta® tablets for 156 weeks or until discontinuation. |
| BG001 | Other OAD |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Age at the time of start taking Trazenta® Tablets or other OAD is presented |
| 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 Participants With Adverse Drug Reactions (ADRs) | An adverse drug reactions (ADR) was defined as an adverse event (AE) if either the investigator or the sponsor (or both) assessed the causal relationship of Trazenta® Tablets either as "Yes", "Probably yes" or "Can't be denied". | Safety Set (SS): SS includes all patients who had received treatment of Trazenta® Tablets as mono therapy except those who were found to have no observation after enrolment, invalid registration, or invalid contract. | Posted | Number | Percentage of Participants | From start of the treatment until the end of this PMS, i.e. up to week 156 |
|
From first drug administration patient was observed until 156 weeks, up to 241 weeks.
Safety Set (SS) (SS includes all patients who had received treatment of Trazenta® Tablets as mono therapy except those who were found to have no observation after enrolment, invalid registration, or invalid contract.) was used for adverse event reporting.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Trazenta® Tablets | Patients with type 2 diabetes mellitus were administered orally with 5 milligram (mg) of Trazenta® tablets for 156 weeks or until discontinuation. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pneumonia | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
Not provided
The study was conducted in an unblinded manner and without controls. The explanatory power of the study results was limited and the study results should be interpreted with the necessary caution.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Boehringer Ingelheim, Call Centre | Boehringer Ingelheim | 1-800-243-0127 | clintriage.rdg@boehringer-ingelheim.com |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 4, 2013 | Aug 17, 2018 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 14, 2017 | Aug 17, 2018 | SAP_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 |
Not provided
Not provided
Not provided
Not provided
Not provided
| Trazenta |
| Drug |
Linagliptin |
|
| Yamamoto F, Ikeda R, Ochiai K, Hirase T, Hayashi N, Okamura T. Long-Term Safety and Effectiveness of Linagliptin in Japanese Patients with Type 2 Diabetes and Renal Dysfunction: a Post-Marketing Surveillance Study. Diabetes Ther. 2020 Feb;11(2):523-533. doi: 10.1007/s13300-019-00754-4. Epub 2020 Jan 13. |
| 31713160 | Derived | Yamamoto F, Unno Y, Okamura T, Ikeda R, Ochiai K, Hayashi N. Long-Term Safety and Effectiveness of Linagliptin in Japanese Patients with Type 2 Diabetes Mellitus: A 3-Year Post-Marketing Surveillance Study. Diabetes Ther. 2020 Jan;11(1):107-117. doi: 10.1007/s13300-019-00723-x. Epub 2019 Nov 11. |
| Lack of Efficacy |
|
| Lost to Follow-up |
|
| Patients had no visit after entry |
|
| CRF not collected |
|
| Not treated |
|
| Other than listed |
|
Patients with type 2 diabetes mellitus who were treated with any other oral antidiabetic monotherapy except Trazenta® tablets
| BG002 | Total | Total of all reporting groups |
SS
| Mean |
| Standard Deviation |
| Years |
|
| Sex: Female, Male | Number of patients is categorized as Male or Female. | SS | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected in this trial. | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | Change From Baseline in HbA1c at the Last Observation During the Observation Period. | Change from baseline in Haemoglobin A1c (HbA1c) at the last observation during the observation period is presented as mean change from baseline and standard deviation (SD). | Efficacy Set: A subset of the safety set, which includes all patients in the "safety set" except those who had no available efficacy data and/or who did not suffer from type 2 diabetes mellitus from the safety set. | Posted | Mean | Standard Deviation | percentage of HbA1c | Baseline and 156 week or last observation |
|
|
|
| 34 |
| 2,235 |
| 116 |
| 2,235 |
| 0 |
| 2,235 |
| Herpes zoster | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
|
| Bacterial infection | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
|
| Gangrene | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
|
| Colon cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.1 | Systematic Assessment |
|
| Pancreatic carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.1 | Systematic Assessment |
|
| Gastric cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.1 | Systematic Assessment |
|
| Lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.1 | Systematic Assessment |
|
| Rectosigmoid cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.1 | Systematic Assessment |
|
| Bladder cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.1 | Systematic Assessment |
|
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.1 | Systematic Assessment |
|
| Gastric cancer recurrent | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.1 | Systematic Assessment |
|
| Hepatic cancer recurrent | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.1 | Systematic Assessment |
|
| Lung neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.1 | Systematic Assessment |
|
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.1 | Systematic Assessment |
|
| Renal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.1 | Systematic Assessment |
|
| Tongue neoplasm malignant stage unspecified | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.1 | Systematic Assessment |
|
| Polycythaemia | Blood and lymphatic system disorders | MedDRA 20.1 | Systematic Assessment |
|
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA 20.1 | Systematic Assessment |
|
| Diabetes mellitus inadequate control | Metabolism and nutrition disorders | MedDRA 20.1 | Systematic Assessment |
|
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA 20.1 | Systematic Assessment |
|
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 20.1 | Systematic Assessment |
|
| Alcoholism | Psychiatric disorders | MedDRA 20.1 | Systematic Assessment |
|
| Cerebral infarction | Nervous system disorders | MedDRA 20.1 | Systematic Assessment |
|
| Dementia | Nervous system disorders | MedDRA 20.1 | Systematic Assessment |
|
| Altered state of consciousness | Nervous system disorders | MedDRA 20.1 | Systematic Assessment |
|
| Carotid artery occlusion | Nervous system disorders | MedDRA 20.1 | Systematic Assessment |
|
| Dementia Alzheimer's type | Nervous system disorders | MedDRA 20.1 | Systematic Assessment |
|
| Loss of consciousness | Nervous system disorders | MedDRA 20.1 | Systematic Assessment |
|
| Parkinson's disease | Nervous system disorders | MedDRA 20.1 | Systematic Assessment |
|
| Syncope | Nervous system disorders | MedDRA 20.1 | Systematic Assessment |
|
| Cataract | Eye disorders | MedDRA 20.1 | Systematic Assessment |
|
| Cardiac failure | Cardiac disorders | MedDRA 20.1 | Systematic Assessment |
|
| Myocardial infarction | Cardiac disorders | MedDRA 20.1 | Systematic Assessment |
|
| Angina pectoris | Cardiac disorders | MedDRA 20.1 | Systematic Assessment |
|
| Angina unstable | Cardiac disorders | MedDRA 20.1 | Systematic Assessment |
|
| Acute myocardial infarction | Cardiac disorders | MedDRA 20.1 | Systematic Assessment |
|
| Cardiac failure congestive | Cardiac disorders | MedDRA 20.1 | Systematic Assessment |
|
| Atrial fibrillation | Cardiac disorders | MedDRA 20.1 | Systematic Assessment |
|
| Atrial flutter | Cardiac disorders | MedDRA 20.1 | Systematic Assessment |
|
| Prinzmetal angina | Cardiac disorders | MedDRA 20.1 | Systematic Assessment |
|
| Aortic dissection | Vascular disorders | MedDRA 20.1 | Systematic Assessment |
|
| Circulatory collapse | Vascular disorders | MedDRA 20.1 | Systematic Assessment |
|
| Deep vein thrombosis | Vascular disorders | MedDRA 20.1 | Systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA 20.1 | Systematic Assessment |
|
| Peripheral arterial occlusive disease | Vascular disorders | MedDRA 20.1 | Systematic Assessment |
|
| Peripheral artery occlusion | Vascular disorders | MedDRA 20.1 | Systematic Assessment |
|
| Shock | Vascular disorders | MedDRA 20.1 | Systematic Assessment |
|
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Systematic Assessment |
|
| Asphyxia | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Systematic Assessment |
|
| Aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Systematic Assessment |
|
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Systematic Assessment |
|
| Interstitial lung disease | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Systematic Assessment |
|
| Organising pneumonia | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Systematic Assessment |
|
| Pneumonia aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Systematic Assessment |
|
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Systematic Assessment |
|
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Systematic Assessment |
|
| Ileus | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
|
| Enterocolitis | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
|
| Haematemesis | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
|
| Ileus paralytic | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
|
| Intestinal obstruction | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
|
| Intestinal perforation | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
|
| Large intestine polyp | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
|
| Mechanical ileus | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
|
| Bile duct stenosis | Hepatobiliary disorders | MedDRA 20.1 | Systematic Assessment |
|
| Hepatic cirrhosis | Hepatobiliary disorders | MedDRA 20.1 | Systematic Assessment |
|
| Hepatitis acute | Hepatobiliary disorders | MedDRA 20.1 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 20.1 | Systematic Assessment |
|
| Spinal column stenosis | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | Systematic Assessment |
|
| Still's disease | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | Systematic Assessment |
|
| Chronic kidney disease | Renal and urinary disorders | MedDRA 20.1 | Systematic Assessment |
|
| Acute kidney injury | Renal and urinary disorders | MedDRA 20.1 | Systematic Assessment |
|
| Renal impairment | Renal and urinary disorders | MedDRA 20.1 | Systematic Assessment |
|
| Death | General disorders | MedDRA 20.1 | Systematic Assessment |
|
| Sudden death | General disorders | MedDRA 20.1 | Systematic Assessment |
|
| Sudden cardiac death | General disorders | MedDRA 20.1 | Systematic Assessment |
|
| Biopsy liver | Investigations | MedDRA 20.1 | Systematic Assessment |
|
| Blood creatinine increased | Investigations | MedDRA 20.1 | Systematic Assessment |
|
| Blood urea increased | Investigations | MedDRA 20.1 | Systematic Assessment |
|
| Blood uric acid increased | Investigations | MedDRA 20.1 | Systematic Assessment |
|
| White blood cell count decreased | Investigations | MedDRA 20.1 | Systematic Assessment |
|
| Femur fracture | Injury, poisoning and procedural complications | MedDRA 20.1 | Systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | MedDRA 20.1 | Systematic Assessment |
|
| Subdural haematoma | Injury, poisoning and procedural complications | MedDRA 20.1 | Systematic Assessment |
|
| Clavicle fracture | Injury, poisoning and procedural complications | MedDRA 20.1 | Systematic Assessment |
|
| Femoral neck fracture | Injury, poisoning and procedural complications | MedDRA 20.1 | Systematic Assessment |
|
| Patella fracture | Injury, poisoning and procedural complications | MedDRA 20.1 | Systematic Assessment |
|
| Road traffic accident | Injury, poisoning and procedural complications | MedDRA 20.1 | Systematic Assessment |
|
| Spinal compression fracture | Injury, poisoning and procedural complications | MedDRA 20.1 | Systematic Assessment |
|
| Subarachnoid haemorrhage | Injury, poisoning and procedural complications | MedDRA 20.1 | Systematic Assessment |
|
Not provided
Not provided
| D004700 | Endocrine System Diseases |