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| ID | Type | Description | Link |
|---|---|---|---|
| JapicCTI-183979 | Registry Identifier | JapicCTI |
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The purpose of this survey is to evaluate the long-term safety and efficacy of the alogliptin and metformin hydrochloride combination tablet in type 2 diabetes mellitus patients with renal impairment (mild), hepatic impairment (mild or moderate), or advanced age (65 years and more) in the routine clinical setting.
The drug being tested in this survey is called alogliptin and metformin hydrochloride combination tablet. This tablet is being tested to treat people who have type 2 diabetes mellitus with renal impairment (mild), hepatic impairment (mild or moderate), or advanced age (65 years and more).
This survey is an observational (non-interventional) study and will look at the long-term safety and efficacy of the alogliptin and metformin hydrochloride combination tablet in the routine clinical setting. The planned number of observed patients will be approximately 600.
This multi-center observational trial will be conducted in Japan.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Alogliptin and Metformin hydrochloride | Alogliptin 25 mg and metformin hydrochloride 500 mg, combination tablet, orally, once daily for up to 12 months. Participants received interventions as part of routine medical care. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Alogliptin and Metformin hydrochloride | Drug | Alogliptin and Metformin hydrochloride combination tablets |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Who Had One or More Adverse Events | An adverse event (AE) is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. | Up to 12 months |
| 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, up to final assessment point (up to Month 12) |
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Inclusion Criteria:
Participants should meet one or more of the following:
Exclusion Criteria:
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Patients with type 2 diabetes mellitus for whom combination therapy with alogliptin and metformin hydrochloride is appropriate in the opinion of a physician as the routine medical care.
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| Name | Affiliation | Role |
|---|---|---|
| Study Director | Takeda | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Takeda Selected Site | Tokyo | Japan |
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.
Participants with a historical diagnosis of type 2 diabetes mellitus with renal or hepatic impairment or advanced age were enrolled. Participants received alogliptin and metformin hydrochloride combination tablets as part of a routine medical care.
Participants took part in the survey at 115 investigative sites in Japan, from 28 February 2017 to 31 October 2019.
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| ID | Title | Description |
|---|---|---|
| FG000 | Alogliptin and Metformin Hydrochloride | Alogliptin 25 mg and metformin hydrochloride 500 mg, combination tablet, orally, once daily for up to 12 months. Participants received interventions as part of 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 1, 2019 | Oct 29, 2020 |
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| Change From Baseline in Fasting Blood Glucose | The change in the value of fasting blood glucose collected at final assessment point (up to Month 12) relative to baseline. | Baseline, up to final assessment point (up to Month 12) |
| Change From Baseline in Fasting Insulin Level | The change in the value of fasting insulin collected at final assessment point (up to Month 12) relative to baseline. | Baseline, up to final assessment point (up to Month 12) |
| COMPLETED |
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| NOT COMPLETED |
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|
Safety Analysis Set, The safety analysis set was defined as all participants who completed the survey.
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| ID | Title | Description |
|---|---|---|
| BG000 | Alogliptin and Metformin Hydrochloride | Alogliptin 25 mg and metformin hydrochloride 500 mg, combination tablet, orally, once daily for up to 12 months. Participants received interventions as part of routine medical care. |
| 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 | Count of Participants | Participants |
| ||||||||||||||||||
| Duration of Diagnosis of Type 2 Diabetes Mellitus | 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 |
| |||||||||||||||
| 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. | Mean | Standard Deviation | Kilogram (kg)/meter (m)^2 |
| |||||||||||||||
| Renal Impairment | Count of Participants | Participants |
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| Hepatic Impairment | Count of Participants | Participants |
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| Healthcare Category | Participants were categorized as outpatient and inpatient. | Count of Participants | Participants |
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| Predisposition to Hypersensitivity | Number of participants who had or did not have a liability or tendency to suffer from hypersensitivity was reported. | Count of Participants | Participants |
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| 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 |
| |||||||||||||||||
| 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 |
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| Smoking Classification | Count of Participants | Participants |
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| Drinking Habits | Participants who answered Yes or No for a question "Drink Alcohol Almost Every Day?" were reported. | Count of Participants | Participants |
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| Employment Status | Count of Participants | Participants |
| ||||||||||||||||||
| Hemoglobin A1c (HbA1c) Level | The number analyzed is the number of participants with data available for analysis. | Mean | Standard Deviation | Percent |
| ||||||||||||||||
| Alogliptin-Equivalent Dose per Day Given Immediate Before the Study Drug | The number analyzed is the number of participants with data available for analysis. | Count of Participants | Participants |
| |||||||||||||||||
| Metformin-Equivalent Dose per Day Given Immediately Before the Study Drug | The number analyzed is the number of participants with data available for analysis. | Count of Participants | Participants |
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| Combination of Drugs for Type 2 Diabetes Mellitus Other than Alogliptin or Metformin | Count of Participants | Participants |
| ||||||||||||||||||
| Status of Treatment Compliance to Alogliptin Medication Within 3 Months prior to the Study Drug | The number analyzed is the number of participants with data available for analysis. | Count of Participants | Participants |
| |||||||||||||||||
| Status of Treatment Compliance to Metformin Medication Within 3 Months prior to the Study Drug | The number analyzed is the number of participants with data available for analysis. | 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 Who Had One or More Adverse Events | An adverse event (AE) is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. | Safety Analysis Set, The safety analysis set was defined as all participants who completed the survey. | Posted | Number | Percentage of Participants | Up to 12 months |
|
|
| ||||||||||||||||||||||||||
| 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, The efficacy assessment population was defined as participants who completed the survey and had efficacy data at baseline and post-baseline time points available. | Posted | Mean | Standard Deviation | Percent | Baseline, up to final assessment point (up to Month 12) |
|
| ||||||||||||||||||||||||||
| Secondary | Change From Baseline in Fasting Blood Glucose | The change in the value of fasting blood glucose collected at final assessment point (up to Month 12) relative to baseline. | Efficacy assessment population, The efficacy assessment population was defined as participants who completed the survey and had efficacy data at baseline and post-baseline time points available. | Posted | Mean | Standard Deviation | milligram/deciliter (mg/dL) | Baseline, up to final assessment point (up to Month 12) |
|
| ||||||||||||||||||||||||||
| Secondary | Change From Baseline in Fasting Insulin Level | The change in the value of fasting insulin collected at final assessment point (up to Month 12) relative to baseline. | Efficacy assessment population, The efficacy assessment population was defined as participants who completed the survey and had efficacy data at baseline and post-baseline time points available. | Posted | Mean | Standard Deviation | microunit/milliliter (mcrU/mL) | Baseline, up to final assessment point (up to Month 12) |
|
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Up to 12 months
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey 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 and Metformin Hydrochloride | Alogliptin 25 mg and metformin hydrochloride 500 mg, combination tablet, orally, once daily for up to 12 months. Participants received interventions as part of routine medical care. | 1 | 1,011 | 4 | 1,011 | 13 | 1,011 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hepatocellular carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Ver. 23.0 | Systematic Assessment |
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| Atrial fibrillation | Cardiac disorders | MedDRA Ver. 23.0 | Systematic Assessment |
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| Deep vein thrombosis | Vascular disorders | MedDRA Ver. 23.0 | Systematic Assessment |
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| Large intestine polyp | Gastrointestinal disorders | MedDRA Ver. 23.0 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA Ver. 23.0 | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA Ver. 23.0 | Systematic Assessment |
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| Bundle branch block right | Cardiac disorders | MedDRA Ver. 23.0 | Systematic Assessment |
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| Palpitations | Cardiac disorders | MedDRA Ver. 23.0 | Systematic Assessment |
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| Chronic gastritis | Gastrointestinal disorders | MedDRA Ver. 23.0 | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDRA Ver. 23.0 | Systematic Assessment |
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| Cold sweat | Skin and subcutaneous tissue disorders | MedDRA Ver. 23.0 | Systematic Assessment |
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| Drug eruption | Skin and subcutaneous tissue disorders | MedDRA Ver. 23.0 | Systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | MedDRA Ver. 23.0 | Systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA Ver. 23.0 | Systematic Assessment |
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| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA Ver. 23.0 | Systematic Assessment |
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| Renal disorder | Renal and urinary disorders | MedDRA Ver. 23.0 | Systematic Assessment |
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| Malaise | General disorders | MedDRA Ver. 23.0 | 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 | |
|---|---|---|---|---|
| Study Director | Takeda (Note: This product was divested to Teijin Pharma Limited in 2023) | +1-877-825-3327 | TrialDisclosures@takeda.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 26, 2019 | Oct 29, 2020 | 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 |
| D008687 | Metformin |
| ID | Term |
|---|---|
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
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|
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| Inpatient |
|
| Had Predisposition to Hypersensitivity |
|
| Unknown |
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| Had Medical Complications |
|
| Had Medical History |
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| Unknown |
|
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| Ex-Smoker |
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| Unknown |
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| No |
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| Unknown |
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| Unknown |
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| 25 mg |
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| > 25 mg |
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| 500 mg |
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| > 500 mg |
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| Combined |
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| ≥ 70% and < 90% |
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| ≥ 50% and < 70% |
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| < 50% |
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| ≥ 70% and < 90% |
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| ≥ 50% and < 70% |
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| < 50% |
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