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| ID | Type | Description | Link |
|---|---|---|---|
| JapicCTI-142609 | Registry Identifier | JapicCTI |
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The purpose of this survey is to evaluate the safety and efficacy of long-term use of alogliptin tablets (Nesina Tablets) in type 2 diabetic patients who have had an inadequate response to hypoglycemic agents (e.g., insulin preparations or rapid-acting insulin secretagogues)* in addition to dietary/exercise therapy. Participants will receive alogliptin as part of routine medical care.
* Patients receiving these hypoglycemic agents (excluding α-glucosidase inhibitors, thiazolidines, sulfonylureas, and biguanides) were excluded from existing specified drug-use surveys for alogliptin tablets.
This survey was designed to evaluate the safety and efficacy of long-term use of alogliptin tablets (Nesina Tablets) in type 2 diabetic patients who have had an inadequate response to hypoglycemic agents (e.g., insulin preparations or rapid-acting insulin secretagogues) in addition to dietary/exercise therapy. Participants will receive alogliptin as part of routine medical care.
For adults, 25 mg of alogliptin is usually administered orally once daily.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Alogliptin | Alogliptin 25 milligram (mg), tablets, orally, once daily, up to 12 months, along with an insulin preparations, with a rapid-acting insulin secretagogue (Glinide), with a SGLT-2 inhibitor, or the other diabetic drugs within 3 months prior to the start of alogliptin treatment or during the alogliptin treatment period in routine medical care. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Alogliptin | Drug | Alogliptin tablets |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Who Had One or More Adverse Reactions | Adverse drug reactions are defined as adverse events (AEs) which are in the investigator's opinion of causal relationship to the study treatment. AEs are defined as any unfavorable and unintended signs, symptoms or diseases temporally associated with the use of a medicinal product reported from the first dose of study drug to the last dose of study drug. | Up to Month 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Glycosylated Hemoglobin (HbA1c) | The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at final assessment point (up to Month 12) relative to baseline. | Baseline, and final assessment point (up to Month 12) |
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Inclusion Criteria:
-Type 2 diabetic patients meeting the following criteria are included in this survey:
Patients who have had an inadequate response to the following medications/therapies:
• Use of one hypoglycemic agent such as insulin preparations and rapid-acting insulin secretagogues, excluding other types of hypoglycemic agents (e.g., α-glucosidase inhibitors, thiazolidines, sulfonylureas, and biguanides)*, in addition to dietary/exercise therapy
* For use of alogliptin tablets in combination with these agents, a specified drug-use survey is currently ongoing.
Exclusion Criteria:
-Type 2 diabetic patients who meet any of the following criteria are excluded from this survey: Patients with contraindications for alogliptin tablets
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Type 2 diabetes mellitus
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| Name | Affiliation | Role |
|---|---|---|
| Study Director | Takeda | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Osaka | Japan | |||||
Takeda makes patient-level, de-identified data sets and associated documents available for all interventional studies after applicable marketing approvals and commercial availability have been received (or program is completely terminated), an opportunity for the primary publication of the research and final report development has been allowed, and other criteria have been met as set forth in Takeda's Data Sharing Policy (see www.TakedaClinicalTrials.com for details). To obtain access, researchers must submit a legitimate academic research proposal for adjudication by an independent review panel, who will review the scientific merit of the research and the requestor's qualifications and conflict of interest that can result in potential bias. Once approved, qualified researchers who sign a data sharing agreement are provided access to these data in a secure research environment.
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Enrolled participants had a diagnosis of type 2 diabetic mellitus and an inadequate response to hypoglycemic agents in addition to dietary/exercise therapy. Participants received interventions as part of routine medical care. Data reports overall population, since data not collected separately per arm as specified in protocol.
Participants took part in the study at 196 investigative sites in Japan, from 30 June 2014 to 30 June 2017. Data reports overall population, since data not collected separately per arm as specified in protocol.
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| ID | Title | Description |
|---|---|---|
| FG000 | Overall Population | Alogliptin 25 milligram (mg), tablets, orally, once daily, up to 12 months, along with an insulin preparations, with a rapid-acting insulin secretagogue (Glinide), with a SGLT-2 inhibitor, or the other diabetic drugs within 3 months prior to the start of alogliptin treatment or during the alogliptin treatment period in routine medical care. |
| 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 |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 2, 2017 | Feb 5, 2019 |
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| Number of Participants Achieving Specified HbA1c Level (< 7.0% and <6.0%) | The reported data were number of participants who achieved specified HbA1c Level (< 7.0% and <6.0%) during this study. | Baseline, and final assessment point (up to Month 12) |
| Change From Baseline in Laboratory Test Values (Fasting Blood Glucose Level) | The reported data were change from baseline in fasting blood glucose level. | Baseline, and final assessment point (up to Month 12) |
| Change From Baseline in Laboratory Test Values (Fasting Insulin Level) | The reported data were change from baseline in fasting insulin level. | Baseline, and final assessment point (up to Month 12) |
| Change From Baseline in Laboratory Test Values (Homeostasis Model Assessment Ratio [HOMA-R]) | The reported data were change from baseline in HOMA-R. HOMA-R measures insulin resistance, calculated by fasting insulin (μU/mL) multiplied by fasting glucose (mg/dL), and divided by a constant (405). A higher score indicates higher insulin resistance. | Baseline, and final assessment point (up to Month 12) |
| Change From Baseline in Laboratory Test Values (Homeostasis Model Assessment of Beta-cell Function [HOMA-β]) | The reported data were change from baseline in HOMA-β. HOMA-β measures as following; HOMA-β = fasting insulin (μU/mL) ×360/{fasting glucose (mg/dL) - 63}. | Baseline, and final assessment point (up to Month 12) |
| Tokyo |
| Japan |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Safety Analysis Set; The safety analysis set was defined as all participants who completed the study.
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| ID | Title | Description |
|---|---|---|
| BG000 | Alogliptin + Insulin | Alogliptin 25 mg, tablets, orally, once daily for up to 12 months, along with insulin preparation within 3 months prior to the start of alogliptin treatment or during the alogliptin treatment period. Participants received interventions as part of routine medical care. |
| BG001 | Alogliptin + Glinide | Alogliptin 25 mg, tablets, orally, once daily for up to 12 months, along with rapid-acting insulin secretagogue (Glinide) within 3 months prior to the start of alogliptin treatment or during the alogliptin treatment period. Participants received interventions as part of routine medical care. |
| BG002 | Alogliptin + SGLT-2 Inhibitor | Alogliptin 25 mg, tablets, orally, once daily for up to 12 months, along with SGLT-2 inhibitor within 3 months prior to the start of alogliptin treatment or during the alogliptin treatment period. Participants received interventions as part of routine medical care. |
| BG003 | Alogliptin + Other | Alogliptin 25 mg, tablets, orally, once daily for up to 12 months, along without insulin preparations, glinide, or SGLT-2 inhibitor within 3 months prior to the start of alogliptin treatment or during the alogliptin treatment period. Participants received interventions as part of routine medical care. |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | 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 |
| ||||||||||
| Region of Enrollment | Number | Participants |
| |||||||||||
| Duration of Diagnosis of Type-2 Diabetes Mellitus (Years) | Mean duration between start of study and first time of diagnosis of type 2 diabetes mellitus was reported. | The number analyzed is the number of participants with data available for analysis. | Mean | Standard Deviation | Years |
| ||||||||
| Height | The number analyzed is the number of participants with data available for analysis. | Mean | Standard Deviation | Centimeters (cm) |
| |||||||||
| Weight | The number analyzed is the number of participants with data available for analysis. | Mean | Standard Deviation | Kilograms (kg) |
| |||||||||
| BMI | Body Mass Index = weight (kg)/[height (m)^2] | The number analyzed is the number of participants with data available for analysis. | Median | Standard Deviation | kg/meter (m)^2 |
| ||||||||
| Waist Circumference (Male) | This baseline characteristic was analyzed only in male participants. | Count of Participants | Participants |
| ||||||||||
| Waist Circumference (Female) | This baseline characteristic was analyzed only in female participants. | Count of Participants | Participants |
| ||||||||||
| Healthcare Category | Participants were categorized as outpatient and inpatient. | Count of Participants | Participants |
| ||||||||||
| Medical Complications | Complications defined as a disease or a health condition for each participant at the start of study. Complications were classified as congenital anomalies, endocrine disorders, hematologic disorders, psychiatric and nervous system disorders, cardiovascular disorders, respiratory disorders, gastrointestinal (GI) disorders, renal disease and other complications. Other complications included all complications except for those mentioned above. | Count of Participants | Participants |
| ||||||||||
| Concomitant Diabetes Mellitus | Count of Participants | Participants |
| |||||||||||
| Concomitant Hypertension | Count of Participants | Participants |
| |||||||||||
| Concomitant Hyperlipidemia | Count of Participants | Participants |
| |||||||||||
| Concomitant Hyperuricaemia | Count of Participants | Participants |
| |||||||||||
| Concomitant Hepatic Disorder | Count of Participants | Participants |
| |||||||||||
| Degree of Hepatic Dysfunction | Severity was determined using aspartate aminotransferase (AST) or alanine transaminase (ALT) values at the start of treatment with alogliptin. For the assessment of severity, the following categories were used and higher grades of serum AST or ALT were adopted. Normal: <50 units per liter (U/L) Grade 1: >=50 to <100 U/L Grade 2: >=100 to <500 U/L Grade 3: >=500 U/L | Count of Participants | Participants |
| ||||||||||
| Concomitant Renal Disorder | Count of Participants | Participants |
| |||||||||||
| Degree of Renal Dysfunction (eGFR) | Estimated glomerular filtration rate (eGFR) was calculated using variables of gender, age at the start of treatment, and serum creatinine values, and severity was determined based on the following categories. If the serum creatinine value or age at the start of treatment was not listed, the severity was reported as "unknown". Normal: >=90 milliliter per min (mL/min)/1.73^2, Mild: >=60 mL/min/1.73^2 to <90 mL/min/1.73^2, Moderate: >=30 mL/min/1.73^2 to <60 mL/min/1.73^2, Severe: <30 mL/min/1.73^2; eGFR= 194 * Cr^-1.094 * (age)^-0.287 (* 0.739 if female) where Cr is creatinine value. | Count of Participants | Participants |
| ||||||||||
| Degree of Renal Dysfunction (Cr) | Normal or Mild: =< 1.4 mg/dL (for male) or =< 1.2 mg/dL (for female), Moderate: >1.4 mg/dL to =< 2.4 mg/dL (for male) or >1.2 mg/dL to =< 2.0 mg/dL (for female), Severe: > 2.4 mg/dL (for male), > 2.0 mg/dL (for female). If the serum creatinine value (Cr) at the start of treatment was not listed, the severity was reported as "unknown". | Count of Participants | Participants |
| ||||||||||
| Concomitant Cardiac Disease | Count of Participants | Participants |
| |||||||||||
| Concomitant Heart Failure | Count of Participants | Participants |
| |||||||||||
| New York Heart Association (NYHA) Heart Failure Classification | NYHA functional classification ranges from Class I (participants with cardiac disease but without resulting limitations of physical activity), Class II (participants with cardiac disease resulting in slight limitation of physical activity), Class III (participants with cardiac disease resulting in marked limitation of physical activity), Class IV (participants with cardiac disease resulting in inability to carry on any physical activity without discomfort). | This baseline characteristic was analyzed only for participants who had complications of heart failure. | Count of Participants | Participants |
| |||||||||
| Concomitant Stroke-Related Disease | Count of Participants | Participants |
| |||||||||||
| Concomitant Allergic Condition | Count of Participants | Participants |
| |||||||||||
| Concomitant Malignant Tumor | Count of Participants | Participants |
| |||||||||||
| Medical History | Medical history defined as a disease or a health condition for each participant before start of the study. Medical history was classified as congenital anomalies, hematologic disorders, psychiatric and nervous system disorders, cardiovascular disorders, respiratory disorders, GI disorders, hepatic and biliary disorders, renal disease and other medical history. Other medical history included all medical history except for those mentioned above. | Count of Participants | Participants |
| ||||||||||
| Predisposition to Hypersensitivity | The baseline characteristic was analyzed in participants who had a liability or tendency to suffer from hypersensitivity. | Count of Participants | Participants |
| ||||||||||
| Drinking Habits | Participants who answered Yes or No for a question "Drink Alcohol Almost Every Day?" were reported. | Count of Participants | Participants |
| ||||||||||
| Smoking Classification | Count of Participants | Participants |
| |||||||||||
| Hemoglobin A1c (HbA1c) | The number analyzed is the number of participants with data available for analysis. | Mean | Standard Deviation | Percent |
|
| 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 Who Had One or More Adverse Reactions | Adverse drug reactions are defined as adverse events (AEs) which are in the investigator's opinion of causal relationship to the study treatment. AEs are defined as any unfavorable and unintended signs, symptoms or diseases temporally associated with the use of a medicinal product reported from the first dose of study drug to the last dose of study drug. | Safety Analysis Set; The safety analysis set was defined as all participants who completed the study. | Posted | Number | Percentage of Participants | Up to Month 12 |
|
|
| |||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Glycosylated Hemoglobin (HbA1c) | The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at final assessment point (up to Month 12) relative to baseline. | Efficacy assessment population was defined as participants who completed study and had available efficacy data at baseline and post baseline. Efficacy analysis was planned to be assessed in Alogliptin + Insulin, Alogliptin + Glinide and Alogliptin + SGLT-2 inhibitor groups and data for Alogliptin + Other were not collected as specified in protocol. | Posted | Mean | Standard Deviation | Percent | Baseline, and final assessment point (up to Month 12) |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants Achieving Specified HbA1c Level (< 7.0% and <6.0%) | The reported data were number of participants who achieved specified HbA1c Level (< 7.0% and <6.0%) during this study. | Efficacy assessment population was defined as participants who completed study and had available efficacy data at baseline and post baseline. Efficacy analysis was planned to be assessed in Alogliptin + Insulin, Alogliptin + Glinide and Alogliptin + SGLT-2 inhibitor groups and data for Alogliptin + Other were not collected as specified in protocol. | Posted | Count of Participants | Participants | Baseline, and final assessment point (up to Month 12) |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Laboratory Test Values (Fasting Blood Glucose Level) | The reported data were change from baseline in fasting blood glucose level. | Efficacy assessment population was defined as participants who completed study and had available efficacy data at baseline and post baseline. Efficacy analysis was planned to be assessed in Alogliptin + Insulin, Alogliptin + Glinide and Alogliptin + SGLT-2 inhibitor groups and data for Alogliptin + Other were not collected as specified in protocol. | Posted | Mean | Standard Deviation | Milligram (mg)/deciliter (dL) | Baseline, and final assessment point (up to Month 12) |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Laboratory Test Values (Fasting Insulin Level) | The reported data were change from baseline in fasting insulin level. | Efficacy assessment population was defined as participants who completed study and had available efficacy data at baseline and post baseline. Efficacy analysis was planned to be assessed in Alogliptin + Insulin, Alogliptin + Glinide and Alogliptin + SGLT-2 inhibitor groups and data for Alogliptin + Other were not collected as specified in protocol. | Posted | Mean | Standard Deviation | Micro Units per Milliliter (μU/mL) | Baseline, and final assessment point (up to Month 12) |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Laboratory Test Values (Homeostasis Model Assessment Ratio [HOMA-R]) | The reported data were change from baseline in HOMA-R. HOMA-R measures insulin resistance, calculated by fasting insulin (μU/mL) multiplied by fasting glucose (mg/dL), and divided by a constant (405). A higher score indicates higher insulin resistance. | Efficacy assessment population was defined as participants who completed study and had available efficacy data at baseline and post baseline. Efficacy analysis was planned to be assessed in Alogliptin + Insulin, Alogliptin + Glinide and Alogliptin + SGLT-2 inhibitor groups and data for Alogliptin + Other were not collected as specified in protocol. | Posted | Mean | Standard Deviation | HOMA-R Score | Baseline, and final assessment point (up to Month 12) |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Laboratory Test Values (Homeostasis Model Assessment of Beta-cell Function [HOMA-β]) | The reported data were change from baseline in HOMA-β. HOMA-β measures as following; HOMA-β = fasting insulin (μU/mL) ×360/{fasting glucose (mg/dL) - 63}. | Efficacy assessment population was defined as participants who completed study and had available efficacy data at baseline and post baseline. Efficacy analysis was planned to be assessed in Alogliptin + Insulin, Alogliptin + Glinide and Alogliptin + SGLT-2 inhibitor groups and data for Alogliptin + Other were not collected as specified in protocol. | Posted | Mean | Standard Deviation | Percentage of beta cell function | Baseline, and final assessment point (up to Month 12) |
|
Up to Month 12
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Only adverse drug reactions (ADRs) were collected and reported on safety results sections here. ADRs are adverse events (AEs) which are in the investigator's opinion of causal relationship to the study treatment.
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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 | Alogliptin + Insulin | Alogliptin 25 mg, tablets, orally, once daily for up to 12 months, along with insulin preparation within 3 months prior to the start of alogliptin treatment or during the alogliptin treatment period. Participants received interventions as part of routine medical care. | 3 | 573 | 3 | 573 | 10 | 573 |
| EG001 | Alogliptin + Glinide | Alogliptin 25 mg, tablets, orally, once daily for up to 12 months, along with rapid-acting insulin secretagogue (Glinide) within 3 months prior to the start of alogliptin treatment or during the alogliptin treatment period. Participants received interventions as part of routine medical care. | 0 | 166 | 0 | 166 | 2 | 166 |
| EG002 | Alogliptin + SGLT-2 Inhibit | Alogliptin 25 mg, tablets, orally, once daily for up to 12 months, along with SGLT-2 inhibitor within 3 months prior to the start of alogliptin treatment or during the alogliptin treatment period. Participants received interventions as part of routine medical care. | 0 | 102 | 0 | 102 | 0 | 102 |
| EG003 | Alogliptin + Other | Alogliptin 25 mg, tablets, orally, once daily for up to 12 months, along without insulin preparations, glinide, or SGLT-2 inhibitor within 3 months prior to the start of alogliptin treatment or during the alogliptin treatment period. Participants received interventions as part of routine medical care. | 0 | 62 | 0 | 62 | 0 | 62 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac failure acut | Cardiac disorders | MedDRA Ver.20.1 | Systematic Assessment |
| |
| Cardio-respiratory arrest | Cardiac disorders | MedDRA Ver.20.1 | Systematic Assessment |
| |
| Death | General disorders | MedDRA Ver.20.1 | Systematic Assessment | The reasons of events are not determined because assessment findings were insufficient to specify the reason. |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA Ver.20.1 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA Ver.20.1 | Systematic Assessment |
|
The first study related publication will be a multi-center publication submitted within 24 months after conclusion or termination of a study at all sites. After such multi site publication, all proposed site publications and presentations will be submitted to sponsor for review 60 days in advance of publication. Site will remove Sponsor confidential information unrelated to study results. Sponsor can delay a proposed publication for another 60 days to preserve intellectual property.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Director | Takeda | +1-877-825-3327 | trialdisclosures@takeda.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 11, 2018 | Feb 5, 2019 | 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 |
| D004700 | Endocrine System Diseases |
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Not provided
| ID | Term |
|---|---|
| C520853 | alogliptin |
Not provided
Not provided
Not provided
|
|
|
|
|
|
|
|
|
| >= 85 cm |
|
|
| Unknown |
|
|
|
| >= 90 cm |
|
|
| Unknown |
|
|
|
| Inpatient |
|
|
|
| Had Medical Complications |
|
|
|
| Had Concomitant Diabetes Mellitus |
|
|
|
| Had Concomitant Hypertension |
|
|
|
| Had Concomitant Hyperlipidemia |
|
|
|
| Had Concomitant Hyperuricaemia |
|
|
|
| Had Concomitant Hepatic Disorder |
|
|
|
| Grade 1 |
|
|
| Grade 2 |
|
|
| Unknown |
|
|
|
| Had Concomitant Renal Disorder |
|
|
|
| Mild |
|
|
| Moderate |
|
|
| Severe |
|
|
| Normal or Mild |
|
|
| Moderate or Severe |
|
|
| Unknown |
|
|
|
| Moderate |
|
|
| Severe |
|
|
| Moderate or Severe |
|
|
| Unknown |
|
|
|
| Had Concomitant Cardiac Disease |
|
|
|
| Had Concomitant Heart Failure |
|
|
|
| Class II |
|
|
| Unknown |
|
|
|
| Had Concomitant Stroke-Related Disease |
|
|
|
| Had Concomitant Allergic Condition |
|
|
|
| Had Concomitant Malignant Tumor |
|
|
|
| Had Medical History |
|
|
| Unknown |
|
|
|
| Had Predisposition to Hypersensitivity |
|
|
| Unknown |
|
|
|
| No |
|
|
| Unknown |
|
|
|
| Current Smoker |
|
|
| Ex-Smoker |
|
|
| Unknown |
|
|
|
| OG002 |
| Alogliptin + SGLT-2 Inhibitor |
Alogliptin 25 mg, tablets, orally, once daily for up to 12 months, along with SGLT-2 inhibitor within 3 months prior to the start of alogliptin treatment or during the alogliptin treatment period. Participants received interventions as part of routine medical care. |
|
|
Alogliptin 25 mg, tablets, orally, once daily for up to 12 months, along with SGLT-2 inhibitor within 3 months prior to the start of alogliptin treatment or during the alogliptin treatment period. Participants received interventions as part of routine medical care. |
|
|
Alogliptin 25 mg, tablets, orally, once daily for up to 12 months, along with SGLT-2 inhibitor within 3 months prior to the start of alogliptin treatment or during the alogliptin treatment period. Participants received interventions as part of routine medical care. |
|
|
Alogliptin 25 mg, tablets, orally, once daily for up to 12 months, along with SGLT-2 inhibitor within 3 months prior to the start of alogliptin treatment or during the alogliptin treatment period. Participants received interventions as part of routine medical care. |
|
|
| OG002 | Alogliptin + SGLT-2 Inhibitor | Alogliptin 25 mg, tablets, orally, once daily for up to 12 months, along with SGLT-2 inhibitor within 3 months prior to the start of alogliptin treatment or during the alogliptin treatment period. Participants received interventions as part of routine medical care. |
|
|
| OG002 |
| Alogliptin + SGLT-2 Inhibitor |
Alogliptin 25 mg, tablets, orally, once daily for up to 12 months, along with SGLT-2 inhibitor within 3 months prior to the start of alogliptin treatment or during the alogliptin treatment period. Participants received interventions as part of routine medical care. |
|
|