Type 2 Diabetes Mellitus
Conditions
Keywords
Drug Therapy
Brief summary
The purpose of this post marketing surveillance (PMS) study is to estimate the proportion of all adverse events (AEs) including serious adverse events (SAEs) and serious adverse drug reactions (SADRs) in participants who are treated for type 2 diabetes mellitus under NesinaAct® tablet therapy (alogliptin/pioglitazone) once daily by physicians in the real-world clinical practice setting over a period of 26 weeks.
Detailed description
The drug being tested in this survey is called NesinaAct® tablet. A surveillance is planned to examine safety and effectiveness of NesinaAct® tablet therapy in participants who are being treated for type 2 diabetes mellitus. The study will enroll approximately 730 patients. The study observes percentage of participants with adverse events (AEs) including serious adverse events (SAEs) and serious adverse drug reactions (SADRs) administered a dose of NesinaAct® tablet (alogliptin/pioglitazone) once daily as prescribed by the physician in routine practice over a period of 26 weeks. This multi-center trial is conducted in a total of 19 sites in Korea. The data is collected between October 2 2015 to August 30 2019 from the re-examination period up to 26 weeks.
Interventions
DRUGNesinaAct® Tablet
NesinaAct® tablet is a fixed dose combination (FDC) of alogliptin benzoate with pioglitazone HCl.
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
* Participants inadequately controlled on diet and exercise. * Participants inadequately controlled on metformin alone. * Participants inadequately controlled on pioglitazone alone. * Participants inadequately controlled on metformin and pioglitazone combination therapy. * Participants switching from alogliptin co-administered with pioglitazone.
Exclusion criteria
* Participants treated with study drug outside of the locally approved label in Korea. * Participants with contraindication for the use of study drug (as described in the Korean product label).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Abnormal Laboratory Findings Reported as AEs | First dose of surveillance drug treatment to within 30 days after the end of the treatment (up to 153 weeks) | Presence and absence of significant data in laboratory results were recorded. 95% Confidence Interval was calculated using exact method. |
| Percentage of Participants With Serious Adverse Events (SAEs) and Serious Adverse Drug Reactions (SADRs) | First dose of surveillance drug treatment to within 30 days after the end of the treatment (up to 153 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. Serious ADRs are defined as SAEs 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 Unexpected Adverse Events (AEs) and Adverse Drug Reactions (ADRs) Not Mentioned in Precautions | First dose of surveillance drug treatment to within 30 days after the end of the treatment (up to 153 weeks) | An AE is any and all undesirable or unintended signs (including abnormal clinical laboratory values), symptoms, or disease that are incurred when the drug is administered, and is not related to causal relationship with the drug. An ADR is a harmful and unintended reaction resulting from usual administration and use of the drug, whose causal relationship with the drug cannot be excluded, and if causal relationship with the drug is unknown among AEs reported spontaneously, it is regarded as ADR. An unexpected ADR is an ADR with difference in the nature or severity, specificity, or the outcome, compared to the product licensure/notification of the drug. 95% Confidence Interval was calculated using exact method. |
| Percentage of Participants With Expected/Already Known ADRs at Week 13 | Week 13 | An ADR is a harmful and unintended reaction resulting from usual administration and use of the drug, whose causal relationship with the drug cannot be excluded, and if causal relationship with the drug is unknown among AEs reported spontaneously, it is regarded as ADR. Expected/already known ADRs are those listed in product licensure/notification of the drug. Data is reported as per duration of study drug treatment for this outcome measure from administration start date to AE onset date. 95% Confidence Interval was calculated using exact method. |
| Percentage of Participants With Expected/Already Known ADRs at Week 26 | Week 26 | An ADR is a harmful and unintended reaction resulting from usual administration and use of the drug, whose causal relationship with the drug cannot be excluded, and if causal relationship with the drug is unknown among AEs reported spontaneously, it is regarded as ADR. Expected/already known ADRs are those listed in product licensure/notification of the drug. Data is reported as per duration of study drug treatment for this outcome measure from administration start date to AE onset date. 95% Confidence Interval was calculated using exact method. |
| Percentage of Participants With Expected/Already Known ADRs at Week 39 | Week 39 | An ADR is a harmful and unintended reaction resulting from usual administration and use of the drug, whose causal relationship with the drug cannot be excluded, and if causal relationship with the drug is unknown among AEs reported spontaneously, it is regarded as ADR. Expected/already known ADRs are those listed in product licensure/notification of the drug. Data is reported as per duration of study drug treatment for this outcome measure from administration start date to AE onset date. 95% Confidence Interval was calculated using exact method. |
| Percentage of Participants With Expected/Already Known ADRs at Week 52 | Week 52 | An ADR is a harmful and unintended reaction resulting from usual administration and use of the drug, whose causal relationship with the drug cannot be excluded, and if causal relationship with the drug is unknown among AEs reported spontaneously, it is regarded as ADR. Expected/already known ADRs are those listed in product licensure/notification of the drug. Data is reported as per duration of study drug treatment for this outcome measure from administration start date to AE onset date. 95% Confidence Interval was calculated using exact method. |
| Percentage of Participants With Expected/Already Known ADRs at Week 153 | Week 153 | An ADR is a harmful and unintended reaction resulting from usual administration and use of the drug, whose causal relationship with the drug cannot be excluded, and if causal relationship with the drug is unknown among AEs reported spontaneously, it is regarded as ADR. Expected/already known ADRs are those listed in product licensure/notification of the drug. Data is reported as per duration of study drug treatment for this outcome measure from administration start date to AE onset date. 95% Confidence Interval was calculated using exact method. |
| Percentage of Participants With Non-serious ADRs | First dose of surveillance drug treatment to within 30 days after the end of the treatment (up to 153 weeks) | An ADR is a harmful and unintended reaction resulting from usual administration and use of the drug, whose causal relationship with the drug cannot be excluded, and if causal relationship with the drug is unknown among AEs reported spontaneously, it is regarded as ADR. 95% Confidence Interval was calculated using exact method. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Fasting Serum Glucose | Baseline, Weeks 13 and 26 | — |
| Change From Baseline in Total Cholesterol | Baseline, Weeks 13 and 26 | Total cholesterol is a measure of the total amount of cholesterol in the blood. It includes both low-density lipoprotein (LDL) cholesterol and high-density lipoprotein (HDL) cholesterol. |
| Change From Baseline in Low Density Lipoprotein-Cholesterol (LDL-C) | Baseline, Weeks 13 and 26 | — |
| Change From Baseline in High Density Lipoprotein-Cholesterol (HDL-C) | Baseline, Weeks 13 and 26 | — |
| Change From Baseline in Body Weight | Baseline, Weeks 13 and 26 | — |
| Change From Baseline in Systolic Blood Pressure | Baseline, Weeks 13 and 26 | — |
| Change From Baseline in Diastolic Blood Pressure | Baseline, Weeks 13 and 26 | — |
| Change From Baseline in Haemoglobin A1c (HbA1c) Levels | Baseline, Weeks 13 and 26 | HbA1c are glycated haemoglobin or amount of glucose attached to haemoglobin. |
Countries
South Korea
Participant flow
Recruitment details
Participants took part in this Post-Marketing Surveillance study at 19 investigative sites in Korea from 2 October 2015 to 30 August 2019 from the re-examination period.
Pre-assignment details
Participants with a diagnosis of Type 2 Diabetes who took NesinaAct® Tablet, as prescribed by the physician, were enrolled in this study.
Participants by arm
| Arm | Count |
|---|---|
| NesinaAct® Tablet Participants with a diagnosis of Type 2 Diabetes who took NesinaAct® tablet, a fixed dose combination of alogliptin along with pioglitazone, as prescribed by the physician, were observed in this study. | 655 |
| Total | 655 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Follow-up Failure | 13 |
| Overall Study | Participants who are Duplicated | 1 |
| Overall Study | Participants who did not Receive NesinaAct® Tablet | 2 |
| Overall Study | Participants who Have Been Administered NesinaAct® Tablet prior to the consent | 2 |
| Overall Study | Participants who Violated Inclusion/Exclusion Criteria | 57 |
Baseline characteristics
| Characteristic | NesinaAct® Tablet |
|---|---|
| Age, Continuous | 58.32 years STANDARD_DEVIATION 12.54 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 655 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 | 655 Participants |
| Sex: Female, Male Female | 400 Participants |
| Sex: Female, Male Male | 255 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 655 |
| other Total, other adverse events | 0 / 655 |
| serious Total, serious adverse events | 1 / 655 |
Outcome results
Primary
Percentage of Participants With Abnormal Laboratory Findings Reported as AEs
Presence and absence of significant data in laboratory results were recorded. 95% Confidence Interval was calculated using exact method.
Time frame: First dose of surveillance drug treatment to within 30 days after the end of the treatment (up to 153 weeks)
Population: Safety Analysis set included participants who were treated with NesinaAct® tablet at least once and completed the follow-up for safety.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| NesinaAct® Tablet | Percentage of Participants With Abnormal Laboratory Findings Reported as AEs | Hyperglycaemia | 0.46 percentage of participants |
| NesinaAct® Tablet | Percentage of Participants With Abnormal Laboratory Findings Reported as AEs | Weight Increase | 0.31 percentage of participants |
| NesinaAct® Tablet | Percentage of Participants With Abnormal Laboratory Findings Reported as AEs | Diabetes Mellitus Aggravated | 0.15 percentage of participants |
| NesinaAct® Tablet | Percentage of Participants With Abnormal Laboratory Findings Reported as AEs | Hyperlipaemia | 0.15 percentage of participants |
| NesinaAct® Tablet | Percentage of Participants With Abnormal Laboratory Findings Reported as AEs | Sugar Blood Level Increase | 0.15 percentage of participants |
| NesinaAct® Tablet | Percentage of Participants With Abnormal Laboratory Findings Reported as AEs | Vitamin D Deficiency | 0.15 percentage of participants |
Primary
Percentage of Participants With Expected/Already Known ADRs at Week 13
An ADR is a harmful and unintended reaction resulting from usual administration and use of the drug, whose causal relationship with the drug cannot be excluded, and if causal relationship with the drug is unknown among AEs reported spontaneously, it is regarded as ADR. Expected/already known ADRs are those listed in product licensure/notification of the drug. Data is reported as per duration of study drug treatment for this outcome measure from administration start date to AE onset date. 95% Confidence Interval was calculated using exact method.
Time frame: Week 13
Population: Safety Analysis Set included participants who were treated with NesinaAct® tablet at least once and completed the follow-up for safety, with data available for analyses.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| NesinaAct® Tablet | Percentage of Participants With Expected/Already Known ADRs at Week 13 | 1.99 percentage of participants |
Primary
Percentage of Participants With Expected/Already Known ADRs at Week 153
An ADR is a harmful and unintended reaction resulting from usual administration and use of the drug, whose causal relationship with the drug cannot be excluded, and if causal relationship with the drug is unknown among AEs reported spontaneously, it is regarded as ADR. Expected/already known ADRs are those listed in product licensure/notification of the drug. Data is reported as per duration of study drug treatment for this outcome measure from administration start date to AE onset date. 95% Confidence Interval was calculated using exact method.
Time frame: Week 153
Population: Safety Analysis set included participants who were treated with NesinaAct® tablet at least once and completed the follow-up for safety, with data available for analyses.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| NesinaAct® Tablet | Percentage of Participants With Expected/Already Known ADRs at Week 153 | 0.00 percentage of participants |
Primary
Percentage of Participants With Expected/Already Known ADRs at Week 26
An ADR is a harmful and unintended reaction resulting from usual administration and use of the drug, whose causal relationship with the drug cannot be excluded, and if causal relationship with the drug is unknown among AEs reported spontaneously, it is regarded as ADR. Expected/already known ADRs are those listed in product licensure/notification of the drug. Data is reported as per duration of study drug treatment for this outcome measure from administration start date to AE onset date. 95% Confidence Interval was calculated using exact method.
Time frame: Week 26
Population: Safety Analysis set included participants who were treated with NesinaAct® tablet at least once and completed the follow-up for safety, with data available for analyses.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| NesinaAct® Tablet | Percentage of Participants With Expected/Already Known ADRs at Week 26 | 0.19 percentage of participants |
Primary
Percentage of Participants With Expected/Already Known ADRs at Week 39
An ADR is a harmful and unintended reaction resulting from usual administration and use of the drug, whose causal relationship with the drug cannot be excluded, and if causal relationship with the drug is unknown among AEs reported spontaneously, it is regarded as ADR. Expected/already known ADRs are those listed in product licensure/notification of the drug. Data is reported as per duration of study drug treatment for this outcome measure from administration start date to AE onset date. 95% Confidence Interval was calculated using exact method.
Time frame: Week 39
Population: Safety Analysis Set included participants who were treated with NesinaAct® tablet at least once and completed the follow-up for safety, with data available for analyses.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| NesinaAct® Tablet | Percentage of Participants With Expected/Already Known ADRs at Week 39 | 0.00 percentage of participants |
Primary
Percentage of Participants With Expected/Already Known ADRs at Week 52
An ADR is a harmful and unintended reaction resulting from usual administration and use of the drug, whose causal relationship with the drug cannot be excluded, and if causal relationship with the drug is unknown among AEs reported spontaneously, it is regarded as ADR. Expected/already known ADRs are those listed in product licensure/notification of the drug. Data is reported as per duration of study drug treatment for this outcome measure from administration start date to AE onset date. 95% Confidence Interval was calculated using exact method.
Time frame: Week 52
Population: Safety Analysis set included participants who were treated with NesinaAct® tablet at least once and completed the follow-up for safety, with data available for analyses.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| NesinaAct® Tablet | Percentage of Participants With Expected/Already Known ADRs at Week 52 | 0.93 percentage of participants |
Primary
Percentage of Participants With Non-serious ADRs
An ADR is a harmful and unintended reaction resulting from usual administration and use of the drug, whose causal relationship with the drug cannot be excluded, and if causal relationship with the drug is unknown among AEs reported spontaneously, it is regarded as ADR. 95% Confidence Interval was calculated using exact method.
Time frame: First dose of surveillance drug treatment to within 30 days after the end of the treatment (up to 153 weeks)
Population: Safety Analysis set included participants who were treated with NesinaAct® tablet at least once and completed the follow-up for safety.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| NesinaAct® Tablet | Percentage of Participants With Non-serious ADRs | 3.36 percentage of participants |
Primary
Percentage of Participants With Serious Adverse Events (SAEs) and Serious Adverse Drug Reactions (SADRs)
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. Serious ADRs are defined as SAEs that are, in the investigator's opinion, of causal relationship to the study treatment. 95% Confidence Interval was calculated using exact method.
Time frame: First dose of surveillance drug treatment to within 30 days after the end of the treatment (up to 153 weeks)
Population: Safety Analysis set included participants who were treated with NesinaAct® tablet at least once and completed the follow-up for safety.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| NesinaAct® Tablet | Percentage of Participants With Serious Adverse Events (SAEs) and Serious Adverse Drug Reactions (SADRs) | SAEs | 0.15 percentage of participants |
| NesinaAct® Tablet | Percentage of Participants With Serious Adverse Events (SAEs) and Serious Adverse Drug Reactions (SADRs) | SADRs | 0.00 percentage of participants |
Primary
Percentage of Participants With Unexpected Adverse Events (AEs) and Adverse Drug Reactions (ADRs) Not Mentioned in Precautions
An AE is any and all undesirable or unintended signs (including abnormal clinical laboratory values), symptoms, or disease that are incurred when the drug is administered, and is not related to causal relationship with the drug. An ADR is a harmful and unintended reaction resulting from usual administration and use of the drug, whose causal relationship with the drug cannot be excluded, and if causal relationship with the drug is unknown among AEs reported spontaneously, it is regarded as ADR. An unexpected ADR is an ADR with difference in the nature or severity, specificity, or the outcome, compared to the product licensure/notification of the drug. 95% Confidence Interval was calculated using exact method.
Time frame: First dose of surveillance drug treatment to within 30 days after the end of the treatment (up to 153 weeks)
Population: Safety Analysis set included participants who were treated with NesinaAct® tablet at least once and completed the follow-up for safety.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| NesinaAct® Tablet | Percentage of Participants With Unexpected Adverse Events (AEs) and Adverse Drug Reactions (ADRs) Not Mentioned in Precautions | Unexpected AEs | 4.58 percentage of participants |
| NesinaAct® Tablet | Percentage of Participants With Unexpected Adverse Events (AEs) and Adverse Drug Reactions (ADRs) Not Mentioned in Precautions | Unexpected ADRs | 1.22 percentage of participants |
Secondary
Change From Baseline in Body Weight
Time frame: Baseline, Weeks 13 and 26
Population: Participants from the Effectiveness Analysis Set, included participants who completed NesinaAct® tablet treatment for more than 13 weeks and performed Final effectiveness assessment according to the investigator's clinical discretion, with data available for analyses. Number analyzed are participants with data available for analyses at the given timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| NesinaAct® Tablet | Change From Baseline in Body Weight | Baseline | 69.98 kg | Standard Deviation 11.73 |
| NesinaAct® Tablet | Change From Baseline in Body Weight | Change from Baseline at Week 13 | -0.67 kg | Standard Deviation 2.01 |
| NesinaAct® Tablet | Change From Baseline in Body Weight | Change from Baseline at Week 26 | -0.48 kg | Standard Deviation 2.6 |
Secondary
Change From Baseline in Diastolic Blood Pressure
Time frame: Baseline, Weeks 13 and 26
Population: Participants from the Effectiveness Analysis Set, included participants who completed NesinaAct® tablet treatment for more than 13 weeks and performed Final effectiveness assessment according to the investigator's clinical discretion, with data available for analyses. Number analyzed are participants with data available for analyses at the given timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| NesinaAct® Tablet | Change From Baseline in Diastolic Blood Pressure | Baseline | 79.84 mm Hg | Standard Deviation 10.98 |
| NesinaAct® Tablet | Change From Baseline in Diastolic Blood Pressure | Change from Baseline at Week 13 | -1.40 mm Hg | Standard Deviation 9.75 |
| NesinaAct® Tablet | Change From Baseline in Diastolic Blood Pressure | Change from Baseline at Week 26 | -0.34 mm Hg | Standard Deviation 9.32 |
Secondary
Change From Baseline in Fasting Serum Glucose
Time frame: Baseline, Weeks 13 and 26
Population: Participants from the Effectiveness Analysis Set, included participants who completed NesinaAct® tablet treatment for more than 13 weeks and performed Final effectiveness assessment according to the investigator's clinical discretion, with data available for analyses. Number analyzed are participants with data available for analyses at the given timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| NesinaAct® Tablet | Change From Baseline in Fasting Serum Glucose | Baseline | 170.75 g/dL | Standard Deviation 46.65 |
| NesinaAct® Tablet | Change From Baseline in Fasting Serum Glucose | Change from Baseline at Week 13 | -25.26 g/dL | Standard Deviation 40.44 |
| NesinaAct® Tablet | Change From Baseline in Fasting Serum Glucose | Change from Baseline at Week 26 | -33.49 g/dL | Standard Deviation 43.18 |
Secondary
Change From Baseline in Haemoglobin A1c (HbA1c) Levels
HbA1c are glycated haemoglobin or amount of glucose attached to haemoglobin.
Time frame: Baseline, Weeks 13 and 26
Population: Participants from the Effectiveness Analysis Set, included participants who completed NesinaAct® tablet treatment for more than 13 weeks and performed Final effectiveness assessment according to the investigator's clinical discretion, with data available for analyses. Number analyzed are participants with data available for analyses at the given timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| NesinaAct® Tablet | Change From Baseline in Haemoglobin A1c (HbA1c) Levels | Baseline | 7.90 percentage of HbA1c | Standard Deviation 1.49 |
| NesinaAct® Tablet | Change From Baseline in Haemoglobin A1c (HbA1c) Levels | Change from Baseline at Week 13 | -0.93 percentage of HbA1c | Standard Deviation 1.36 |
| NesinaAct® Tablet | Change From Baseline in Haemoglobin A1c (HbA1c) Levels | Change from Baseline at Week 26 | -1.40 percentage of HbA1c | Standard Deviation 1.62 |
Secondary
Change From Baseline in High Density Lipoprotein-Cholesterol (HDL-C)
Time frame: Baseline, Weeks 13 and 26
Population: Participants from the Effectiveness Analysis Set, included participants who completed NesinaAct® tablet treatment for more than 13 weeks and performed Final effectiveness assessment according to the investigator's clinical discretion, with data available for analyses. Number analyzed are participants with data available for analyses at the given timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| NesinaAct® Tablet | Change From Baseline in High Density Lipoprotein-Cholesterol (HDL-C) | Baseline | 47.18 mg/dL | Standard Deviation 10.46 |
| NesinaAct® Tablet | Change From Baseline in High Density Lipoprotein-Cholesterol (HDL-C) | Change from Baseline at Week 13 | 2.36 mg/dL | Standard Deviation 6.61 |
| NesinaAct® Tablet | Change From Baseline in High Density Lipoprotein-Cholesterol (HDL-C) | Change from Baseline at Week 126 | 1.90 mg/dL | Standard Deviation 7.02 |
Secondary
Change From Baseline in Low Density Lipoprotein-Cholesterol (LDL-C)
Time frame: Baseline, Weeks 13 and 26
Population: Participants from the Effectiveness Analysis Set, included participants who completed NesinaAct® tablet treatment for more than 13 weeks and performed Final effectiveness assessment according to the investigator's clinical discretion, with data available for analyses. Number analyzed are participants with data available for analyses at the given timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| NesinaAct® Tablet | Change From Baseline in Low Density Lipoprotein-Cholesterol (LDL-C) | Baseline | 104.65 mg/dL | Standard Deviation 33.17 |
| NesinaAct® Tablet | Change From Baseline in Low Density Lipoprotein-Cholesterol (LDL-C) | Change from Baseline at Week 13 | -7.85 mg/dL | Standard Deviation 23.4 |
| NesinaAct® Tablet | Change From Baseline in Low Density Lipoprotein-Cholesterol (LDL-C) | Change from Baseline at Week 26 | -8.28 mg/dL | Standard Deviation 27.99 |
Secondary
Change From Baseline in Systolic Blood Pressure
Time frame: Baseline, Weeks 13 and 26
Population: Participants from the Effectiveness Analysis Set, included participants who completed NesinaAct® tablet treatment for more than 13 weeks and performed Final effectiveness assessment according to the investigator's clinical discretion, with data available for analyses. Number analyzed are participants with data available for analyses at the given timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| NesinaAct® Tablet | Change From Baseline in Systolic Blood Pressure | Baseline | 128.20 mm Hg | Standard Deviation 12.52 |
| NesinaAct® Tablet | Change From Baseline in Systolic Blood Pressure | Change from Baseline at Week 13 | -0.88 mm Hg | Standard Deviation 11.48 |
| NesinaAct® Tablet | Change From Baseline in Systolic Blood Pressure | Change from Baseline at Week 26 | -1.66 mm Hg | Standard Deviation 12.44 |
Secondary
Change From Baseline in Total Cholesterol
Total cholesterol is a measure of the total amount of cholesterol in the blood. It includes both low-density lipoprotein (LDL) cholesterol and high-density lipoprotein (HDL) cholesterol.
Time frame: Baseline, Weeks 13 and 26
Population: Participants from the Effectiveness Analysis Set, included participants who completed NesinaAct® tablet treatment for more than 13 weeks and performed Final effectiveness assessment according to the investigator's clinical discretion, with data available for analyses. Number analyzed are participants with data available for analyses at the given timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| NesinaAct® Tablet | Change From Baseline in Total Cholesterol | Baseline | 182.51 mg/dL | Standard Deviation 39.37 |
| NesinaAct® Tablet | Change From Baseline in Total Cholesterol | Change from Baseline at Week 13 | -13.14 mg/dL | Standard Deviation 30.86 |
| NesinaAct® Tablet | Change From Baseline in Total Cholesterol | Change from Baseline at Week 26 | -8.64 mg/dL | Standard Deviation 35.84 |