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| Name | Class |
|---|---|
| Eli Lilly and Company | INDUSTRY |
The primary objective of this study is to monitor the safety profile of Trajenta Duo in Korean patients with type 2 diabetes mellitus (T2DM) in a routine clinical setting.
Study Design:
Post Marketed Study- Observational study
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with T2DM |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Trajenta duo | Drug | Linagliptin and Metformin |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence Rate of Adverse Events (AE) | The incidence rate is the number of new cases per population at risk in a given time period. The incidence rate was calculated in patients who take at least one Trajenta Duo | Up to 26 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Hemoglobin A1c (HbA1c) After 24 Weeks of Treatment. | This outcome has measured difference between HbA1c values from baseline to 24 weeks post treatment. The term 'baseline' refers to the last observation prior to the administration of any study medication. HbA1c is a form of hemoglobin, a blood pigment that carries oxygen, which is bound to glucose. The term HbA1c also refers to glycated hemoglobin. High levels of HbA1c (Normal range is less than 6%) indicate poorer control of diabetes than level in normal range. |
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Inclusion criteria:
Potential subjets must meet all of the following inclusion criteria to enter this trial:
Exclusion criteria:
Individuals with any of the following characteristics will not be able to enter this study:
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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. Subjects attended specialist sites which would then ensure that all subjects met all inclusion/exclusion criteria. Subjects were not to be enrolled in the study if any one of the specific entry criteria were violated.
This is an observational study in patients with type 2 diabetes mellitus who had been administered with TrajentaDuo® Tablets. The Case Report Forms of 724 subjects investigated by 15 investigators at 14 hospitals were retrieved from November 15, 2012 up to September 13, 2017.
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| ID | Title | Description |
|---|---|---|
| FG000 | TrajentaDuo® Tablet | Patients with type 2 diabetes mellitus (T2DM) were administered with oral dose of TrajentaDuo® (Linagliptin/Metformin hydrochloride (HCl) fixed dose combination, 2.5 mg/500 mg, 2.5 mg/850 mg or 2.5 mg/1000 mg, twice daily) Tablet |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Safety Analysis Set: This analysis set included all subjects except subjects violating inclusion/exclusion criteria, dosage adminstration or were lost to follow up.
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| ID | Title | Description |
|---|---|---|
| BG000 | TrajentaDuo® Tablet | Patients with type 2 diabetes mellitus (T2DM) were administered with oral dose of TrajentaDuo® (Linagliptin/Metformin hydrochloride (HCl) fixed dose combination, 2.5 mg/500 mg, 2.5 mg/850 mg or 2.5 mg/1000 mg, twice daily) Tablet |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Age of all patients enrolled in the study |
| 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 | Change From Baseline in Hemoglobin A1c (HbA1c) After 24 Weeks of Treatment. | This outcome has measured difference between HbA1c values from baseline to 24 weeks post treatment. The term 'baseline' refers to the last observation prior to the administration of any study medication. HbA1c is a form of hemoglobin, a blood pigment that carries oxygen, which is bound to glucose. The term HbA1c also refers to glycated hemoglobin. High levels of HbA1c (Normal range is less than 6%) indicate poorer control of diabetes than level in normal range. | Effectiveness Analysis Set: This analysis set included all subjects from safety analysis set for whom HbA1c was recorded before administration of treatment and at least once after treatment for at least 10 weeks. | Posted | Mean | Standard Deviation | Percentage (%) of HbA1c | Baseline and Week 24 |
|
From first drug administration until 24 weeks of treatment administration, up to approximately 252 weeks after last visit.
An adverse event (AE) is defined as any untoward medical occurrence, including an exacerbation of a pre-existing condition, in a patient in a clinical investigation who received a pharmaceutical product. The event does not necessarily have to have a causal relationship with this treatment. All reported adverse events including hypoglycemic events in patients who take at least one dose of Trajenta Duo® were noted.
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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 | TrajentaDuo® Tablet | Patients with type 2 diabetes mellitus (T2DM) were administered with oral dose of TrajentaDuo® (Linagliptin/Metformin hydrochloride (HCl) fixed dose combination, 2.5 mg/500 mg, 2.5 mg/850 mg or 2.5 mg/1000 mg, twice daily) Tablet |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Angina pectoris | Cardiac disorders | 20.0 | 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_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 22, 2017 | Jun 5, 2018 | Prot_SAP_000.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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| Baseline and Week 24 |
| Target Effectiveness Response Rate | Occurrence of treatment to target effectiveness response is an HbA1c under treatment of < 6.5% after 24 weeks of treatment. This outcome measures percentage of patients achieving HbA1c < 6.5% after 24 weeks. | 24 Weeks |
| Relative Effectiveness Response Rate | Occurrence of relative effectiveness response. This outcome measures percentage of patients for which HbA1c has reduced by at least 0.5% after 24 weeks. | 24 Weeks |
| Change From Baseline in Fasting Plasma Glucose (FPG) After 24 Weeks of Treatment. | This outcome has measured difference between Fasting Plasma Glucose (FPG) values from baseline to 24 weeks post treatment. The term 'baseline' refers to the last observation prior to the administration of any study medication. | 24 Weeks |
Safety Analysis Set: This analysis set included all subjects except subjects violating inclusion/exclusion criteria, dosage adminstration or were lost to follow up.
| Mean |
| Standard Deviation |
| Years |
|
| Sex: Female, Male | Gender distribution of all patients enrolled in the study | Safety Analysis Set: This analysis set included all subjects except subjects violating inclusion/exclusion criteria, dosage adminstration or were lost to follow up. | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Hemoglobin A1c (HbA1c) at baseline | HbA1c values measured at baseline in percent. HbA1c is a form of hemoglobin, a blood pigment that carries oxygen, which is bound to glucose. The term HbA1c also refers to glycated hemoglobin. High levels of HbA1c (Normal range is less than 6%) indicate poorer control of diabetes than level in normal range. | Effectiveness Analysis Set: This analysis set included all subjects from safety analysis set for whom HbA1c was recorded before administration of treatment and at least once after treatment for at least 10 weeks. | Mean | Standard Deviation | Percentage of HbA1c (%) |
|
|
|
|
| Secondary | Target Effectiveness Response Rate | Occurrence of treatment to target effectiveness response is an HbA1c under treatment of < 6.5% after 24 weeks of treatment. This outcome measures percentage of patients achieving HbA1c < 6.5% after 24 weeks. | Effectiveness Analysis Set: This analysis set included all subjects from safety analysis set for whom HbA1c was recorded before administration of treatment and at least once after treatment for at least 10 weeks. | Posted | Number | Percentage of Patients (%) | 24 Weeks |
|
|
|
| Secondary | Relative Effectiveness Response Rate | Occurrence of relative effectiveness response. This outcome measures percentage of patients for which HbA1c has reduced by at least 0.5% after 24 weeks. | Effectiveness Analysis Set: This analysis set included all subjects from safety analysis set for whom HbA1c was recorded before administration of treatment and at least once after treatment for at least 10 weeks. | Posted | Number | Percentage of patients (%) | 24 Weeks |
|
|
|
| Secondary | Change From Baseline in Fasting Plasma Glucose (FPG) After 24 Weeks of Treatment. | This outcome has measured difference between Fasting Plasma Glucose (FPG) values from baseline to 24 weeks post treatment. The term 'baseline' refers to the last observation prior to the administration of any study medication. | Effectiveness Analysis Set: This analysis set included all subjects from safety analysis set for whom HbA1c was recorded before administration of treatment and at least once after treatment for at least 10 weeks. | Posted | Mean | Standard Deviation | Milligram/deciLitre (mg/dL) | 24 Weeks |
|
|
|
|
| Primary | Incidence Rate of Adverse Events (AE) | The incidence rate is the number of new cases per population at risk in a given time period. The incidence rate was calculated in patients who take at least one Trajenta Duo | Safety Analysis Set: This analysis set included all subjects except subjects violating inclusion/exclusion criteria, dosage adminstration or were lost to follow up. | Posted | Number | Percentage of patients (%) | Up to 26 weeks |
|
|
|
| 0 |
| 709 |
| 15 |
| 709 |
| 0 |
| 709 |
| Acute myocardial infarction | Cardiac disorders | 20.0 | Systematic Assessment |
|
| Angina unstable | Cardiac disorders | 20.0 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | 20.0 | Systematic Assessment |
|
| Pancreatitis | Gastrointestinal disorders | 20.0 | Systematic Assessment |
|
| Stomatitis | Gastrointestinal disorders | 20.0 | Systematic Assessment |
|
| Mediastinitis | Infections and infestations | 20.0 | Systematic Assessment |
|
| Pneumonia | Infections and infestations | 20.0 | Systematic Assessment |
|
| Rhinitis | Infections and infestations | 20.0 | Systematic Assessment |
|
| Vitreous haemorrhage | Eye disorders | 20.0 | Systematic Assessment |
|
| Pyrexia | General disorders | 20.0 | Systematic Assessment |
|
| Ligament sprain | Injury, poisoning and procedural complications | 20.0 | Systematic Assessment |
|
| Flank pain | Musculoskeletal and connective tissue disorders | 20.0 | Systematic Assessment |
|
| Vocal cord polyp | Respiratory, thoracic and mediastinal disorders | 20.0 | Systematic Assessment |
|
| Myelodysplastic syndrome | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 20.0 | Systematic Assessment |
|
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.
| D004700 | Endocrine System Diseases |