Type 2 Diabetes Mellitus
Conditions
Keywords
Drug Therapy
Brief summary
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.
Detailed description
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.
Interventions
Alogliptin benzoate tablets
Sponsors
Takeda
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
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: * Monotherapy with alogliptin * Combination therapy with the surveillance drug (alogliptin) in case of inadequate glycemic control with metformin or sulfonylurea or thiazolidinedione single therapy * Combination therapy with the surveillance drug (alogliptin) in case of inadequate glycemic control with thiazolidinedione and metformin combination therapy * Combination therapy with the surveillance drug (alogliptin) in case of inadequate glycemic control with insulin (single therapy or combination with metformin) therapy * Combination therapy with metformin in patients who have no prior history of antidiabetic medication and may not achieve adequate glycemic control with monotherapy alogliptin
Exclusion criteria
1. Had alogliptin treatment outside of the locally approved label in Korea 2. Had a contraindication for the use of alogliptin (as described in the Korean product label)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Unexpected Adverse Drug Reactions (ADRs) | From first dose of study drug up to 30 days post last dose of study drug (Up to 79.77 weeks) | 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. |
| Percentage of Participants With Serious Adverse Events (SAEs) | From first dose of study drug up to 30 days post last dose of study drug (Up to 79.77 weeks) | 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. |
| Percentage of Participants With Serious Adverse Drug Reactions (ADRs) | From first dose of study drug up to 30 days post last dose of study drug (Up to 79.77 weeks) | 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. |
| Percentage of Participants With Unexpected Adverse Events | From first dose of study drug up to 30 days post last dose of study drug (Up to 79.77 weeks) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Haemoglobin (HbA1c) Levels | Baseline (Before administration of alogliptin), 13 weeks (±2 weeks) and 26 weeks (±2 weeks) after administration | HbA1c are glycated haemoglobin or amount of glucose attached to haemoglobin. |
| Fasting Blood Glucose Levels | Baseline (Before administration of alogliptin), 13 weeks (±2 weeks) and 26 weeks (±2 weeks) after administration | — |
| Percentage of Participants With HbA1c < 7.00% | Baseline (Before administration of alogliptin), 13 weeks (±2 weeks) and 26 weeks (±2 weeks) after administration | HbA1c are glycated haemoglobin or amount of glucose attached to haemoglobin. |
| Percentage of Participants With Overall Improvement and Final Effectiveness Assessment | Up to Week 26 | 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'. |
Countries
South Korea
Participant flow
Recruitment details
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.
Pre-assignment details
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 by arm
| Arm | Count |
|---|---|
| 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. | 3,131 |
| Total | 3,131 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Administered the study drug prior to signing the informed consent form | 3 |
| Overall Study | Lost to Safety-Follow-up | 4 |
| Overall Study | Violated the Administration & Dosage | 225 |
| Overall Study | Violated the Inclusion Criteria | 260 |
Baseline characteristics
| Characteristic | Nesina® Tablet |
|---|---|
| Age, Continuous | 59.07 years STANDARD_DEVIATION 12.26 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 3131 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 0 Participants |
| Region of Enrollment Korea, Republic Of | 3131 Participants |
| Sex: Female, Male Female | 1322 Participants |
| Sex: Female, Male Male | 1809 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 3,131 |
| other Total, other adverse events | 0 / 3,131 |
| serious Total, serious adverse events | 37 / 3,131 |
Outcome results
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.
Time frame: From first dose of study drug up to 30 days post last dose of study drug (Up to 79.77 weeks)
Population: Safety Set included all participants who had been administered the study drug and completed the follow-up.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Nesina® Tablet | Percentage of Participants With Serious Adverse Drug Reactions (ADRs) | 0.16 percentage of participants |
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.
Time frame: From first dose of study drug up to 30 days post last dose of study drug (Up to 79.77 weeks)
Population: Safety Set included all participants who had been administered the study drug and completed the follow-up.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Nesina® Tablet | Percentage of Participants With Serious Adverse Events (SAEs) | 1.18 percentage of participants |
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.
Time frame: From first dose of study drug up to 30 days post last dose of study drug (Up to 79.77 weeks)
Population: Safety Set included all participants who had been administered the study drug and completed the follow-up.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Nesina® Tablet | Percentage of Participants With Unexpected Adverse Drug Reactions (ADRs) | 2.01 percentage of participants |
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.
Time frame: From first dose of study drug up to 30 days post last dose of study drug (Up to 79.77 weeks)
Population: Safety Set included all participants who had been administered the study drug and completed the follow-up.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Nesina® Tablet | Percentage of Participants With Unexpected Adverse Events | 8.88 percentage of participants |
Secondary
Fasting Blood Glucose Levels
Time frame: Baseline (Before administration of alogliptin), 13 weeks (±2 weeks) and 26 weeks (±2 weeks) after administration
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Nesina® Tablet | Fasting Blood Glucose Levels | Before Administration | 166.22 g/dL | Standard Deviation 58.14 |
| Nesina® Tablet | Fasting Blood Glucose Levels | 13 weeks (±2 weeks) After Administration | 136.84 g/dL | Standard Deviation 38.78 |
| Nesina® Tablet | Fasting Blood Glucose Levels | 26 weeks (±2 weeks) After Administration | 133.09 g/dL | Standard Deviation 34.73 |
Secondary
Haemoglobin (HbA1c) Levels
HbA1c are glycated haemoglobin or amount of glucose attached to haemoglobin.
Time frame: Baseline (Before administration of alogliptin), 13 weeks (±2 weeks) and 26 weeks (±2 weeks) after administration
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Nesina® Tablet | Haemoglobin (HbA1c) Levels | Before Administration | 8.05 percentage of Hb1Ac | Standard Deviation 1.48 |
| Nesina® Tablet | Haemoglobin (HbA1c) Levels | 13 weeks (±2 weeks) After Administration | 6.96 percentage of Hb1Ac | Standard Deviation 1.08 |
| Nesina® Tablet | Haemoglobin (HbA1c) Levels | 26 weeks (±2 weeks) After Administration | 6.87 percentage of Hb1Ac | Standard Deviation 0.97 |
Secondary
Percentage of Participants With HbA1c < 7.00%
HbA1c are glycated haemoglobin or amount of glucose attached to haemoglobin.
Time frame: Baseline (Before administration of alogliptin), 13 weeks (±2 weeks) and 26 weeks (±2 weeks) after administration
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Nesina® Tablet | Percentage of Participants With HbA1c < 7.00% | Before Administration | 17.84 percentage of participants |
| Nesina® Tablet | Percentage of Participants With HbA1c < 7.00% | 13 weeks After Administration | 60.96 percentage of participants |
| Nesina® Tablet | Percentage of Participants With HbA1c < 7.00% | 26 weeks After Administration | 63.49 percentage of participants |
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'.
Time frame: Up to Week 26
Population: Efficacy Set included participants who completed study drug treatment for a period exceeding 13 weeks, at the investigator's clinical judgment.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Nesina® Tablet | Percentage of Participants With Overall Improvement and Final Effectiveness Assessment | Improved | 82.57 percentage of participants |
| Nesina® Tablet | Percentage of Participants With Overall Improvement and Final Effectiveness Assessment | Unchanged | 9.64 percentage of participants |
| Nesina® Tablet | Percentage of Participants With Overall Improvement and Final Effectiveness Assessment | Worsened | 7.79 percentage of participants |