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The purpose of this study is to evaluate safety by determining the incidence rates of all adverse events (AEs) including serious adverse events (SAEs)/serious adverse drug reactions (ADRs), unexpected AEs and ADRs that are not reflected in the precautions for use, ADRs already known, non-serious ADRs and other safety related information among participants who have received alogliptin for type 2 diabetes mellitus.
This is a long-term prospective, observational post-marketing surveillance study of alogliptin in participants with T2DM. The study assessed the safety and effectiveness of alogliptin for its approved indication within a real-world setting in South Korea.
The study will enroll approximately 3000 participants. The data is collected prospectively at the study sites and recorded in electronic case report forms (e-CRFs). All the participants are assigned to a single observational cohort:
• Nesina® Tablet
The multi-center study is conducted in South Korea. Data is collected at 13 and 26 weeks after enrollment during standard of care office visits. The overall study was conducted during re-examination period of approximately 5 years and 4 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nesina® Tablet | Participants with a diagnosis of Type 2 Diabetes who took Nesina® tablet (alogliptin), as prescribed by the physician, are observed in this study. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Alogliptin Benzoate | Drug | Alogliptin benzoate tablets |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Serious Adverse Events (SAEs) | An SAE is an adverse event resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. 95% Confidence Interval was calculated using exact method. | From first dose of study drug up to 30 days post last dose of study drug (Up to 79.77 weeks) |
| Percentage of Participants With Serious Adverse Drug Reactions (ADRs) | Serious ADRs are defined as SAEs that are, in the investigator's opinion, of causal relationship to the study treatment. An SAE is an adverse event resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. 95% Confidence Interval was calculated using exact method. | From first dose of study drug up to 30 days post last dose of study drug (Up to 79.77 weeks) |
| Percentage of Participants With Unexpected Adverse Events | An unexpected AE is an AE with a difference in nature, severity, specificity, or outcome, compared to the product licensure/safety notification of the drug. 95% Confidence Interval was calculated using exact method. | From first dose of study drug up to 30 days post last dose of study drug (Up to 79.77 weeks) |
| Percentage of Participants With Unexpected Adverse Drug Reactions (ADRs) | Unexpected ADRs are unexpected AEs that are, in the investigator's opinion, of causal relationship to the study treatment. 95% Confidence Interval was calculated using exact method. | From first dose of study drug up to 30 days post last dose of study drug (Up to 79.77 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| Haemoglobin (HbA1c) Levels | HbA1c are glycated haemoglobin or amount of glucose attached to haemoglobin. | Baseline (Before administration of alogliptin), 13 weeks (±2 weeks) and 26 weeks (±2 weeks) after administration |
| Fasting Blood Glucose Levels |
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Inclusion Criteria:
1. Had one of the following treatments with alogliptin for the first time as an adjunct to diet and exercise to improve glycemic control:
Exclusion Criteria:
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Adult participants diagnosed with type 2 diabetes mellitus are observed.
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| Name | Affiliation | Role |
|---|---|---|
| Study Director | Takeda | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Andong | South Korea | |||||
Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
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IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.
This post-marketing surveillance (PMS) study was conducted during a re-examination period of approximately 5 years and 4 months to investigate the safety and efficacy of monotherapy or combination therapy with alogliptin in participants with type 2 diabetes in routine care settings.
Participants took part in the study at 81 investigative sites in South Korea during the re-examination period: 19 April 2014 to 30 August 2019.
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| ID | Title | Description |
|---|---|---|
| FG000 | Nesina® Tablet | Participants with a diagnosis of Type 2 Diabetes who took Nesina® tablet (alogliptin), as prescribed by the physician, were observed in this study. |
| 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 | May 22, 2019 | Dec 6, 2021 |
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| Baseline (Before administration of alogliptin), 13 weeks (±2 weeks) and 26 weeks (±2 weeks) after administration |
| Percentage of Participants With HbA1c < 7.00% | HbA1c are glycated haemoglobin or amount of glucose attached to haemoglobin. | Baseline (Before administration of alogliptin), 13 weeks (±2 weeks) and 26 weeks (±2 weeks) after administration |
| Percentage of Participants With Overall Improvement and Final Effectiveness Assessment | Participants were assessed for overall improvement and effectiveness assessments as per the following categories: 'Improved - signs and symptoms are significantly improved'; 'Unchanged - improvement in signs and symptoms is not significant or there is no change in signs and symptoms'. | Up to Week 26 |
| Anyang-si |
| South Korea |
| Bucheon-si | South Korea |
| Busan | South Korea |
| Daegu | South Korea |
| Daejeon | South Korea |
| Gimhae | South Korea |
| Gongju | South Korea |
| Goyang-si | South Korea |
| Gwangju | South Korea |
| Gyeongju | South Korea |
| Incheon | South Korea |
| Jeonju | South Korea |
| Namyangju | South Korea |
| Osan | South Korea |
| Seongnam | South Korea |
| Seongnam-si | South Korea |
| Seoul | South Korea |
| Suncheon | South Korea |
| Suwon | South Korea |
| Ulsan | South Korea |
| Wŏnju | South Korea |
| COMPLETED |
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| NOT COMPLETED |
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Safety Analysis Set included participants who were treated with the surveillance drug at least once and completed the follow-up for safety.
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| ID | Title | Description |
|---|---|---|
| BG000 | Nesina® Tablet | Participants with a diagnosis of Type 2 Diabetes who took Nesina® tablet (alogliptin), as prescribed by the physician, were observed in this study. |
| Units | Counts |
|---|---|
| Participants |
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| 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 |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | 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 Participants With Serious Adverse Events (SAEs) | An SAE is an adverse event resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. 95% Confidence Interval was calculated using exact method. | Safety Set included all participants who had been administered the study drug and completed the follow-up. | Posted | Number | 95% Confidence Interval | percentage of participants | From first dose of study drug up to 30 days post last dose of study drug (Up to 79.77 weeks) |
|
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| |||||||||||||||||||||||||
| Primary | Percentage of Participants With Serious Adverse Drug Reactions (ADRs) | Serious ADRs are defined as SAEs that are, in the investigator's opinion, of causal relationship to the study treatment. An SAE is an adverse event resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. 95% Confidence Interval was calculated using exact method. | Safety Set included all participants who had been administered the study drug and completed the follow-up. | Posted | Number | 95% Confidence Interval | percentage of participants | From first dose of study drug up to 30 days post last dose of study drug (Up to 79.77 weeks) |
|
| ||||||||||||||||||||||||||
| Primary | Percentage of Participants With Unexpected Adverse Events | An unexpected AE is an AE with a difference in nature, severity, specificity, or outcome, compared to the product licensure/safety notification of the drug. 95% Confidence Interval was calculated using exact method. | Safety Set included all participants who had been administered the study drug and completed the follow-up. | Posted | Number | 95% Confidence Interval | percentage of participants | From first dose of study drug up to 30 days post last dose of study drug (Up to 79.77 weeks) |
|
| ||||||||||||||||||||||||||
| Primary | Percentage of Participants With Unexpected Adverse Drug Reactions (ADRs) | Unexpected ADRs are unexpected AEs that are, in the investigator's opinion, of causal relationship to the study treatment. 95% Confidence Interval was calculated using exact method. | Safety Set included all participants who had been administered the study drug and completed the follow-up. | Posted | Number | 95% Confidence Interval | percentage of participants | From first dose of study drug up to 30 days post last dose of study drug (Up to 79.77 weeks) |
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| Secondary | Haemoglobin (HbA1c) Levels | HbA1c are glycated haemoglobin or amount of glucose attached to haemoglobin. | Participants from the Efficacy Set, included participants who completed study drug treatment for a period exceeding 13 weeks, at the investigator's clinical judgment, with data available for analyses. Number analyzed are participants with data available for analyses at the given timepoint. | Posted | Mean | Standard Deviation | percentage of Hb1Ac | Baseline (Before administration of alogliptin), 13 weeks (±2 weeks) and 26 weeks (±2 weeks) after administration |
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| Secondary | Fasting Blood Glucose Levels | Participants from the Efficacy Set, included participants who completed study drug treatment for a period exceeding 13 weeks, at the investigator's clinical judgment, with data available for analyses. Number analyzed are participants with data available for analyses at the given timepoint. | Posted | Mean | Standard Deviation | g/dL | Baseline (Before administration of alogliptin), 13 weeks (±2 weeks) and 26 weeks (±2 weeks) after administration |
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| Secondary | Percentage of Participants With HbA1c < 7.00% | HbA1c are glycated haemoglobin or amount of glucose attached to haemoglobin. | Participants from the Efficacy Set, included participants who completed study drug treatment for a period exceeding 13 weeks, at the investigator's clinical judgment, with data available for analyses. Number analyzed are participants with data available for analyses at the given timepoint. | Posted | Number | percentage of participants | Baseline (Before administration of alogliptin), 13 weeks (±2 weeks) and 26 weeks (±2 weeks) after administration |
|
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| Secondary | Percentage of Participants With Overall Improvement and Final Effectiveness Assessment | Participants were assessed for overall improvement and effectiveness assessments as per the following categories: 'Improved - signs and symptoms are significantly improved'; 'Unchanged - improvement in signs and symptoms is not significant or there is no change in signs and symptoms'. | Efficacy Set included participants who completed study drug treatment for a period exceeding 13 weeks, at the investigator's clinical judgment. | Posted | Number | percentage of participants | Up to Week 26 |
|
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From first dose of study drug up to 30 days post last dose of study drug (Up to 79.77 weeks)
Safety Set included all participants who had been administered the study drug and completed the follow-up.
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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 | Nesina® Tablet | Participants with a diagnosis of Type 2 Diabetes who took Nesina® tablet (alogliptin), as prescribed by the physician, were observed in this study. | 0 | 3,131 | 37 | 3,131 | 0 | 3,131 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Tenosynovitis | Musculoskeletal and connective tissue disorders | WHO-ART(Ver.092) | Systematic Assessment |
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| Fracture | Musculoskeletal and connective tissue disorders | WHO-ART(Ver.092) | Systematic Assessment |
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| Costochondritis | Musculoskeletal and connective tissue disorders | WHO-ART(Ver.092) | Systematic Assessment |
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| Fracture lower limb | Musculoskeletal and connective tissue disorders | WHO-ART(Ver.092) | Systematic Assessment |
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| Fracture upper limb | Musculoskeletal and connective tissue disorders | WHO-ART(Ver.092) | Systematic Assessment |
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| Fracture vertebral | Musculoskeletal and connective tissue disorders | WHO-ART(Ver.092) | Systematic Assessment |
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| Rhabdomyolysis | Musculoskeletal and connective tissue disorders | WHO-ART(Ver.092) | Systematic Assessment |
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| Pancreatitis acute | Gastrointestinal disorders | WHO-ART(Ver.092) | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | WHO-ART(Ver.092) | Systematic Assessment |
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| Gastric ulcer | Gastrointestinal disorders | WHO-ART(Ver.092) | Systematic Assessment |
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| Gastritis aggravated | Gastrointestinal disorders | WHO-ART(Ver.092) | Systematic Assessment |
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| Gastric ulcer haemorrhagic | Gastrointestinal disorders | WHO-ART(Ver.092) | Systematic Assessment |
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| Appendicitis | Gastrointestinal disorders | WHO-ART(Ver.092) | Systematic Assessment |
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| Hyperglycaemia | Metabolism and nutrition disorders | WHO-ART(Ver.092) | Systematic Assessment |
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| Diabetes mellitus aggravated | Metabolism and nutrition disorders | WHO-ART(Ver.092) | Systematic Assessment |
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| Acidosis | Metabolism and nutrition disorders | WHO-ART(Ver.092) | Systematic Assessment |
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| Abscess | Infections and infestations | WHO-ART(Ver.092) | Systematic Assessment |
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| Infection | Infections and infestations | WHO-ART(Ver.092) | Systematic Assessment |
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| Wound dehiscence | Infections and infestations | WHO-ART(Ver.092) | Systematic Assessment |
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| Pulmonary carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | WHO-ART(Ver.092) | Systematic Assessment |
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| Thyroid carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | WHO-ART(Ver.092) | Systematic Assessment |
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| Pulmonary carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | WHO-ART(Ver.092) | Systematic Assessment |
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| Back ache | General disorders | WHO-ART(Ver.092) | Systematic Assessment |
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| Oedema generalised | General disorders | WHO-ART(Ver.092) | Systematic Assessment |
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| Weakness generalized | General disorders | WHO-ART(Ver.092) | Systematic Assessment |
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| Asthma aggravated | Respiratory, thoracic and mediastinal disorders | WHO-ART(Ver.092) | Systematic Assessment |
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| Pneumonia aggravated | Respiratory, thoracic and mediastinal disorders | WHO-ART(Ver.092) | Systematic Assessment |
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| Dyspnoea | Respiratory, thoracic and mediastinal disorders | WHO-ART(Ver.092) | Systematic Assessment |
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| Respiratory arrest | Respiratory, thoracic and mediastinal disorders | WHO-ART(Ver.092) | Systematic Assessment |
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| Renal failure acute | Renal and urinary disorders | WHO-ART(Ver.092) | Systematic Assessment |
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| Kidney stone | Renal and urinary disorders | WHO-ART(Ver.092) | Systematic Assessment |
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| Renal function abnormal | Renal and urinary disorders | WHO-ART(Ver.092) | Systematic Assessment |
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| Hepatic cirrhosis | Hepatobiliary disorders | WHO-ART(Ver.092) | Systematic Assessment |
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| Cholelithiasis | Hepatobiliary disorders | WHO-ART(Ver.092) | Systematic Assessment |
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| Myocardial infarction | Cardiac disorders | WHO-ART(Ver.092) | Systematic Assessment |
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| Angina pectoris | Cardiac disorders | WHO-ART(Ver.092) | Systematic Assessment |
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| Anorexia | Psychiatric disorders | WHO-ART(Ver.092) | Systematic Assessment |
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| Cerebral infarction | Vascular disorders | WHO-ART(Ver.092) | Systematic Assessment |
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| Transient ischaemic attack | Vascular disorders | WHO-ART(Ver.092) | Systematic Assessment |
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| Fibrillation atrial aggravated | Cardiac disorders | WHO-ART(Ver.092) | Systematic Assessment |
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| Laceration | Infections and infestations | WHO-ART(Ver.092) | Systematic Assessment |
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| Dysarthria | Nervous system disorders | WHO-ART(Ver.092) | Systematic Assessment |
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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 | Jun 12, 2019 | Dec 6, 2021 | 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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| ID | Term |
|---|---|
| C520853 | alogliptin |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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