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| ID | Type | Description | Link |
|---|---|---|---|
| JapicCTI-132265 | Registry Identifier | JapicCTI | |
| JapicCTI-R150770 | Registry Identifier | JapicCTI |
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The purpose of this study is to determine the safety and efficacy of long-term combination therapy with alogliptin (Nesina) and thiazolidinediones in patients with type 2 diabetes mellitus who failed to respond adequately to treatment with thiazolidinediones in addition to diet therapy and exercise therapy.
This is a special drug use surveillance on long-term use of alogliptin with a 1-year (12-month) observational period, designed to investigate the safety and efficacy of long-term combination therapy with alogliptin and thiazolidinediones in patients with type 2 diabetes mellitus in a routine clinical setting.
Participants will be patients with type 2 diabetes mellitus who failed to respond adequately to treatment with thiazolidinediones in addition to diet therapy and exercise therapy. The planned sample size is 1,000 subjects.
The usual adult dosage for oral use is 1 alogliptin tablet (25 mg) once daily.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Alogilptin 25mg, tablets, orally, once daily, up to 12 months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Alogliptin | Drug | Alogliptin tablets |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Reporting One or More Adverse Drug 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. The safety analysis was planned to be assessed in alogliptin + thiazolidinedione and alogliptin + other arm separately. | Baseline up to 12 months |
| Number of Participants Reporting One or More Serious Adverse Drug Reactions | Serious adverse drug reactions are defined as serious adverse events (SAEs) which are in the investigator's opinion of causal relationship to the study treatment. An SAE was an AE 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. The safety analysis was planned to be assessed in alogliptin + thiazolidinedione and alogliptin + other arm separately. | Baseline 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 1 month, 3 months, 6 months, 12 months or final visit (last visit for a participant in the study, up to Month 12) relative to baseline. The efficacy analysis was planned to be assessed in the total alogliptin arm irrespective of the thiazolidinedione treatment. |
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Inclusion Criteria:
Exclusion Criteria:
Patients contraindicated for Nesina
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Patients with type 2 diabetes mellitus who have been examined at a medical institution
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| Name | Affiliation | Role |
|---|---|---|
| Postmarketing Group Manager | Takeda | Study Chair |
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Participants with a historical diagnosis of type 2 diabetes mellitus who failed to respond adequately to treatment receiving thiazolidinediones were enrolled in 1 of 2 treatment groups as follows: alogliptin + thiazolidinediones; alogliptin + other.
Participants took part in the study at 252 investigative site in Japan from 25 March 2011 to 30 June 2014.
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| ID | Title | Description |
|---|---|---|
| FG000 | Alogliptin + Thiazolidinedione | Alogliptin 25 milligram (mg), tablets, orally, once daily for up to 12 months in participants who received a thiazolidinedione within 3 months from the start of administration of alogliptin and during the treatment period of alogliptin. |
| FG001 | Alogliptin + Other | Alogliptin 25 mg, tablets, orally, once daily for up to 12 months in participants who did not receive a thiazolidinedione within 3 months from the start of administration of alogliptin or during the treatment period of alogliptin. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
The safety analysis set was defined as all participants who were enrolled and completed the study.
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| ID | Title | Description |
|---|---|---|
| BG000 | Alogliptin + Thiazolidinedione | Alogliptin 25 milligram (mg), tablets, orally, once daily for up to 12 months in participants who received a thiazolidinedione within 3 months from the start of administration of alogliptin and during the treatment period of alogliptin. |
| BG001 | Alogliptin + Other |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number |
| 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 | Number of Participants Reporting One or More Adverse Drug 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. The safety analysis was planned to be assessed in alogliptin + thiazolidinedione and alogliptin + other arm separately. | The safety analysis set was defined as all participants who were enrolled and completed the study. | Posted | Number | participants | Baseline up to 12 months |
|
Baseline up to 12 months
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.
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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 + Thiazolidinedione | Alogliptin 25 milligram (mg), tablets, orally, once daily for up to 12 months in participants who received a thiazolidinedione within 3 months from the start of administration of alogliptin and during the treatment period of alogliptin. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA (17.0) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA (17.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Director | Takeda | +1-877-825-3327 | trialdisclosures@takeda.com |
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| ID | Term |
|---|---|
| C520853 | alogliptin |
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| Baseline, Months 1, 3, 6, 12, and final assessment (up to 12 months) |
| Percentage of Participants of Achieving Objective Glycemic Control | The rate of achieving objective glycemic control in HbA1c level, was calculated at 1 month, 3 months, 6 months, 12 months or final visit (last visit for a participant in the study, up to Month 12). Glycemic control was measured as <8.0 percent, <7.0 percent, and <6.0 percent of glycosylated hemoglobin. The efficacy analysis was planned to be assessed in the total alogliptin arm irrespective of the thiazolidinedione treatment. | Baseline, Months 1, 3, 6, 12, and final assessment (up to 12 months) |
| Change From Baseline in Fasting Blood Glucose | The change between the fasting blood glucose value collected at 1 month, 3 months, 6 months, 12 months or final visit (last visit for a participant in the study, up to Month 12) relative to baseline. The efficacy analysis was planned to be assessed in the total alogliptin arm irrespective of the thiazolidinedione treatment. | Baseline, Months 1, 3, 6, 12, and final assessment (up to 12 months) |
| Change From Baseline in Fasting Insulin | The change between the fasting insulin value collected at 1 month, 3 months, 6 months, 12 months or final visit (last visit for a participant in the study, up to Month 12) relative to baseline. The efficacy analysis was planned to be assessed in the total alogliptin arm irrespective of the thiazolidinedione treatment. | Baseline, Months 1, 3, 6, 12, and final assessment (up to 12 months) |
Alogliptin 25 mg, tablets, orally, once daily for up to 12 months in participants who did not receive a thiazolidinedione within 3 months from the start of administration of alogliptin or during the treatment period of alogliptin. |
| BG002 | Total | Total of all reporting groups |
| participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Body Mass Index | Number | participants |
|
| Waist Circumference | Number | participants |
|
| Pregnancy Status | The baseline characteristic was analyzed only in female participants. | Number | participants |
|
| Healthcare category | Participants were categorized as outpatient, inpatient, and outpatient and Inpatient (participants who were both outpatient and inpatient at any time prior to enrollment). | Number | participants |
|
| Health-related Complications | Participants were asssed on the basis of primary illness (had complications and had no complications) at the start of study. | Number | participants |
|
| Diabetic complications | Number | participants |
|
| Breakdown of diabetic complications | The baseline characteristic was analyzed only in participants who had diabetic complications. Participants could be counted in more than 1 category (including duplicates). | Number | participants |
|
| Complications of Hypertension | Number | participants |
|
| Complications of Dyslipidemia | Number | participants |
|
| Complications of Hyperuricemia | Number | participants |
|
| Complications of Liver Damage | Number | participants |
|
| Breakdown of Complications of Liver Damage | Liver damage complications were categorized as hepatic steatosis, hepatitis alcoholic, chronic hepatitis, hepatic cirrhosis and any other complications related to liver damage. The baseline characteristic was analyzed only in participants who had liver damage complications. Participants could be counted in more than 1 category (including duplicates). | Number | 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 international units per liter (IU/L) Grade 1: >=50 to <100 IU/L Grade 2: >=100 to <500 IU/L Grade 3: >=500 IU/L | Number | participants |
|
| Complications of Renal Damage | Number | participants |
|
| Breakdown of Complications of Renal Damage | Renal damage complications were categorized as nephrotic syndrome, glomerulonephritis,renal failure chronic and any other complications related to renal damage. The baseline characteristic was analyzed only in participants who had renal damage complications. Participants could be counted in more than 1 category (including duplicates). | Number | participants |
|
| Degree of Renal Dysfunction | 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 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 clearance. | Number | participants |
|
| Complications of Heart Disease | Number | participants |
|
| Breakdown of Complications of Heart Disease | Heart disease complications were categorized as Cardiac failure, Myocardial infarction, Angina pectoris, and any other complications related to heart disease. The baseline characteristic was analyzed only in participants who had heart disease complications. Participants could be counted in more than 1 category (including duplicates). | Number | participants |
|
| Complications of Heart Failure | Number | 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). The baseline measure was analyzed only for participants who had complications of heart failure. | Number | participants |
|
| Complications of Stroke-related Disease | Number | participants |
|
| Breakdown of complications of stroke-related disease | The baseline characteristic was analyzed only in participants who had stroke-related disease complications. Participants could be counted in more than 1 category (including duplicates). | Number | participants |
|
| Complications of Allergic Disease | Number | participants |
|
| Breakdown of Complications of Allergic Disease | The baseline characteristic was analyzed only in participants who had allergic disease complications. Participants could be counted in more than 1 category (including duplicates). | Number | participants |
|
| Complications of Malignant Tumor | This baseline measure was analysed for participants who had malignant tumor at the start of the study. | Number | participants |
|
| Complications of Malignant Tumor (narrow definition) | This baseline measure was analysed for participants who had malignant tumor and/or benign tumor at the start of the study. | Number | participants |
|
| Other Complications | Participants who had complications other than diabetic, hypertension, dyslipidemia, hyperuricemia, liver damage, renal damage, heart disease, heart failure, stroke-related disease, allergic disease, and malignant tumor were analyzed. | Number | participants |
|
| Presence of Medical History | The baseline characteristic was analysed in participants who had any illness (medical history of any previous illness) at the start of the study. | Number | participants |
|
| History of Allergies | Number | participants |
|
| History of Alcohol Consumption | Number | participants |
|
| Smoking Classification | Number | participants |
|
| Time from Diagnosis of Type 2 Diabetes | Number | participants |
|
| Glycosylated Hemoglobin A1c (HbA1c) | Number | participants |
|
| OG001 | Alogliptin + Other | Alogliptin 25 mg, tablets, orally, once daily for up to 12 months in participants who did not receive a thiazolidinedione within 3 months from the start of administration of alogliptin or during the treatment period of alogliptin. |
|
|
| Primary | Number of Participants Reporting One or More Serious Adverse Drug Reactions | Serious adverse drug reactions are defined as serious adverse events (SAEs) which are in the investigator's opinion of causal relationship to the study treatment. An SAE was an AE 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. The safety analysis was planned to be assessed in alogliptin + thiazolidinedione and alogliptin + other arm separately. | The safety analysis set was defined as all participants who were enrolled and completed the study. | Posted | Number | participants | Baseline 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 1 month, 3 months, 6 months, 12 months or final visit (last visit for a participant in the study, up to Month 12) relative to baseline. The efficacy analysis was planned to be assessed in the total alogliptin arm irrespective of the thiazolidinedione treatment. | The efficacy assessment population was defined as participants who completed the study and had available efficacy data at baseline and post baseline. | Posted | Mean | Standard Deviation | percentage of glycosylated hemoglobin | Baseline, Months 1, 3, 6, 12, and final assessment (up to 12 months) |
|
|
|
| Secondary | Percentage of Participants of Achieving Objective Glycemic Control | The rate of achieving objective glycemic control in HbA1c level, was calculated at 1 month, 3 months, 6 months, 12 months or final visit (last visit for a participant in the study, up to Month 12). Glycemic control was measured as <8.0 percent, <7.0 percent, and <6.0 percent of glycosylated hemoglobin. The efficacy analysis was planned to be assessed in the total alogliptin arm irrespective of the thiazolidinedione treatment. | The efficacy assessment population was defined as participants who completed the study and had available efficacy data at baseline and post baseline. | Posted | Number | percentage of participants | Baseline, Months 1, 3, 6, 12, and final assessment (up to 12 months) |
|
|
|
| Secondary | Change From Baseline in Fasting Blood Glucose | The change between the fasting blood glucose value collected at 1 month, 3 months, 6 months, 12 months or final visit (last visit for a participant in the study, up to Month 12) relative to baseline. The efficacy analysis was planned to be assessed in the total alogliptin arm irrespective of the thiazolidinedione treatment. | The efficacy assessment population was defined as participants who completed the study and had available efficacy data at baseline and post baseline. | Posted | Mean | Standard Deviation | milligram per deciliter (mg/dL) | Baseline, Months 1, 3, 6, 12, and final assessment (up to 12 months) |
|
|
|
| Secondary | Change From Baseline in Fasting Insulin | The change between the fasting insulin value collected at 1 month, 3 months, 6 months, 12 months or final visit (last visit for a participant in the study, up to Month 12) relative to baseline. The efficacy analysis was planned to be assessed in the total alogliptin arm irrespective of the thiazolidinedione treatment. | The efficacy assessment population was defined as participants who completed the study and had available efficacy data at baseline and post baseline. | Posted | Mean | Standard Deviation | mg/dL | Baseline, Months 1, 3, 6, 12, and final assessment (up to 12 months) |
|
|
|
| 3 |
| 1,248 |
| 11 |
| 1,248 |
| EG001 | Alogliptin + Other | Alogliptin 25 mg, tablets, orally, once daily for up to 12 months in participants who did not receive a thiazolidinedione within 3 months from the start of administration of alogliptin or during the treatment period of alogliptin. | 0 | 120 | 2 | 120 |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA (17.0) | 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 | Measurements |
|---|---|
|
| Change at Month 6 (n=988) |
|
| Change at Month 12 (n=949) |
|
| Change at Final assessment (n=1124) |
|
|
| <8.0 percent (Month 6) (n=988) |
|
| <8.0 percent (Month 12) (n=949) |
|
| <8.0 percent (Final assessment) (n=1124) |
|
| <7.0 percent (Baseline) (n=1124) |
|
| <7.0 percent (Month 1) (n=879) |
|
| <7.0 percent (Month 3) (n=1005) |
|
| <7.0 percent (Month 6) (n=988) |
|
| <7.0 percent (Month 12) (n=949) |
|
| <7.0 percent (Final assessment) (n=1124) |
|
| <6.0 percent (Baseline) (n=1124) |
|
| <6.0 percent (Month 1) (n=879) |
|
| <6.0 percent (Month 3) (n=1005) |
|
| <6.0 percent (Month 6) (n=988) |
|
| <6.0 percent (Month 12) (n=949) |
|
| <6.0 percent (Final assessment) (n=1124) |
|
| Title | Measurements |
|---|---|
|
| Change at Month 6 (n=297) |
|
| Change at Month 12 (n=293) |
|
| Change at Final assessment (n=398) |
|
| Title | Measurements |
|---|---|
|
| Change at Month 6 (n=60) |
|
| Change at Month 12 (n=68) |
|
| Change at Final assessment (n=82) |
|