Trial Outcomes & Findings for A Study for Post-Marketing Surveillance of Nesina® Tablet Monotherapy or Combination Therapy in Participants With Type 2 Diabetes (T2DM) in South Korea (NCT NCT04980040)
NCT ID: NCT04980040
Last Updated: 2022-04-05
Results Overview
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.
Recruitment status
COMPLETED
Target enrollment
3623 participants
Primary outcome timeframe
From first dose of study drug up to 30 days post last dose of study drug (Up to 79.77 weeks)
Results posted on
2022-04-05
Participant Flow
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.
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.
Participant milestones
| Measure |
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.
|
|---|---|
|
Overall Study
STARTED
|
3623
|
|
Overall Study
COMPLETED
|
3131
|
|
Overall Study
NOT COMPLETED
|
492
|
Reasons for withdrawal
| Measure |
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.
|
|---|---|
|
Overall Study
Violated the Inclusion Criteria
|
260
|
|
Overall Study
Violated the Administration & Dosage
|
225
|
|
Overall Study
Lost to Safety-Follow-up
|
4
|
|
Overall Study
Administered the study drug prior to signing the informed consent form
|
3
|
Baseline Characteristics
A Study for Post-Marketing Surveillance of Nesina® Tablet Monotherapy or Combination Therapy in Participants With Type 2 Diabetes (T2DM) in South Korea
Baseline characteristics by cohort
| Measure |
Nesina® Tablet
n=3131 Participants
Participants with a diagnosis of Type 2 Diabetes who took Nesina® tablet (alogliptin), as prescribed by the physician, were observed in this study.
|
|---|---|
|
Age, Continuous
|
59.07 years
STANDARD_DEVIATION 12.26 • n=5 Participants
|
|
Sex: Female, Male
Female
|
1322 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1809 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
3131 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
Korea, Republic Of
|
3131 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Nesina® Tablet
n=3131 Participants
Participants with a diagnosis of Type 2 Diabetes who took Nesina® tablet (alogliptin), as prescribed by the physician, were observed in this study.
|
|---|---|
|
Percentage of Participants With Serious Adverse Events (SAEs)
|
1.18 percentage of participants
Interval 0.83 to 1.63
|
PRIMARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Nesina® Tablet
n=3131 Participants
Participants with a diagnosis of Type 2 Diabetes who took Nesina® tablet (alogliptin), as prescribed by the physician, were observed in this study.
|
|---|---|
|
Percentage of Participants With Serious Adverse Drug Reactions (ADRs)
|
0.16 percentage of participants
Interval 0.05 to 0.37
|
PRIMARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Nesina® Tablet
n=3131 Participants
Participants with a diagnosis of Type 2 Diabetes who took Nesina® tablet (alogliptin), as prescribed by the physician, were observed in this study.
|
|---|---|
|
Percentage of Participants With Unexpected Adverse Events
|
8.88 percentage of participants
Interval 7.91 to 9.93
|
PRIMARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Nesina® Tablet
n=3131 Participants
Participants with a diagnosis of Type 2 Diabetes who took Nesina® tablet (alogliptin), as prescribed by the physician, were observed in this study.
|
|---|---|
|
Percentage of Participants With Unexpected Adverse Drug Reactions (ADRs)
|
2.01 percentage of participants
Interval 1.55 to 2.57
|
SECONDARY outcome
Timeframe: Baseline (Before administration of alogliptin), 13 weeks (±2 weeks) and 26 weeks (±2 weeks) after administrationPopulation: 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.
HbA1c are glycated haemoglobin or amount of glucose attached to haemoglobin.
Outcome measures
| Measure |
Nesina® Tablet
n=1738 Participants
Participants with a diagnosis of Type 2 Diabetes who took Nesina® tablet (alogliptin), as prescribed by the physician, were observed in this study.
|
|---|---|
|
Haemoglobin (HbA1c) Levels
Before Administration
|
8.05 percentage of Hb1Ac
Standard Deviation 1.48
|
|
Haemoglobin (HbA1c) Levels
13 weeks (±2 weeks) After Administration
|
6.96 percentage of Hb1Ac
Standard Deviation 1.08
|
|
Haemoglobin (HbA1c) Levels
26 weeks (±2 weeks) After Administration
|
6.87 percentage of Hb1Ac
Standard Deviation 0.97
|
SECONDARY outcome
Timeframe: Baseline (Before administration of alogliptin), 13 weeks (±2 weeks) and 26 weeks (±2 weeks) after administrationPopulation: 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.
Outcome measures
| Measure |
Nesina® Tablet
n=1681 Participants
Participants with a diagnosis of Type 2 Diabetes who took Nesina® tablet (alogliptin), as prescribed by the physician, were observed in this study.
|
|---|---|
|
Fasting Blood Glucose Levels
Before Administration
|
166.22 g/dL
Standard Deviation 58.14
|
|
Fasting Blood Glucose Levels
13 weeks (±2 weeks) After Administration
|
136.84 g/dL
Standard Deviation 38.78
|
|
Fasting Blood Glucose Levels
26 weeks (±2 weeks) After Administration
|
133.09 g/dL
Standard Deviation 34.73
|
SECONDARY outcome
Timeframe: Baseline (Before administration of alogliptin), 13 weeks (±2 weeks) and 26 weeks (±2 weeks) after administrationPopulation: 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.
HbA1c are glycated haemoglobin or amount of glucose attached to haemoglobin.
Outcome measures
| Measure |
Nesina® Tablet
n=1738 Participants
Participants with a diagnosis of Type 2 Diabetes who took Nesina® tablet (alogliptin), as prescribed by the physician, were observed in this study.
|
|---|---|
|
Percentage of Participants With HbA1c < 7.00%
Before Administration
|
17.84 percentage of participants
|
|
Percentage of Participants With HbA1c < 7.00%
13 weeks After Administration
|
60.96 percentage of participants
|
|
Percentage of Participants With HbA1c < 7.00%
26 weeks After Administration
|
63.49 percentage of participants
|
SECONDARY outcome
Timeframe: Up to Week 26Population: Efficacy Set included participants who completed study drug treatment for a period exceeding 13 weeks, at the investigator's clinical judgment.
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'.
Outcome measures
| Measure |
Nesina® Tablet
n=1784 Participants
Participants with a diagnosis of Type 2 Diabetes who took Nesina® tablet (alogliptin), as prescribed by the physician, were observed in this study.
|
|---|---|
|
Percentage of Participants With Overall Improvement and Final Effectiveness Assessment
Improved
|
82.57 percentage of participants
|
|
Percentage of Participants With Overall Improvement and Final Effectiveness Assessment
Unchanged
|
9.64 percentage of participants
|
|
Percentage of Participants With Overall Improvement and Final Effectiveness Assessment
Worsened
|
7.79 percentage of participants
|
Adverse Events
Nesina® Tablet
Serious events: 37 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Nesina® Tablet
n=3131 participants at risk
Participants with a diagnosis of Type 2 Diabetes who took Nesina® tablet (alogliptin), as prescribed by the physician, were observed in this study.
|
|---|---|
|
Musculoskeletal and connective tissue disorders
Tenosynovitis
|
0.03%
1/3131 • 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.
|
|
Musculoskeletal and connective tissue disorders
Fracture
|
0.03%
1/3131 • 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.
|
|
Musculoskeletal and connective tissue disorders
Costochondritis
|
0.03%
1/3131 • 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.
|
|
Musculoskeletal and connective tissue disorders
Fracture lower limb
|
0.03%
1/3131 • 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.
|
|
Musculoskeletal and connective tissue disorders
Fracture upper limb
|
0.03%
1/3131 • 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.
|
|
Musculoskeletal and connective tissue disorders
Fracture vertebral
|
0.03%
1/3131 • 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.
|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
0.03%
1/3131 • 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.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.03%
1/3131 • 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.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.03%
1/3131 • 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.
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.03%
1/3131 • 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.
|
|
Gastrointestinal disorders
Gastritis aggravated
|
0.03%
1/3131 • 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.
|
|
Gastrointestinal disorders
Gastric ulcer haemorrhagic
|
0.03%
1/3131 • 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.
|
|
Gastrointestinal disorders
Appendicitis
|
0.03%
1/3131 • 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.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.06%
2/3131 • 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.
|
|
Metabolism and nutrition disorders
Diabetes mellitus aggravated
|
0.06%
2/3131 • 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.
|
|
Metabolism and nutrition disorders
Acidosis
|
0.03%
1/3131 • 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.
|
|
Infections and infestations
Abscess
|
0.06%
2/3131 • 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.
|
|
Infections and infestations
Infection
|
0.03%
1/3131 • 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.
|
|
Infections and infestations
Wound dehiscence
|
0.03%
1/3131 • 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.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pulmonary carcinoma
|
0.03%
1/3131 • 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.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid carcinoma
|
0.03%
1/3131 • 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.
|
|
General disorders
Back ache
|
0.03%
1/3131 • 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.
|
|
General disorders
Oedema generalised
|
0.03%
1/3131 • 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.
|
|
General disorders
Weakness generalized
|
0.03%
1/3131 • 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.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma aggravated
|
0.03%
1/3131 • 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.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aggravated
|
0.03%
1/3131 • 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.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.03%
1/3131 • 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.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory arrest
|
0.03%
1/3131 • 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.
|
|
Renal and urinary disorders
Renal failure acute
|
0.03%
1/3131 • 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.
|
|
Renal and urinary disorders
Kidney stone
|
0.03%
1/3131 • 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.
|
|
Renal and urinary disorders
Renal function abnormal
|
0.03%
1/3131 • 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.
|
|
Hepatobiliary disorders
Hepatic cirrhosis
|
0.03%
1/3131 • 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.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.03%
1/3131 • 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.
|
|
Cardiac disorders
Myocardial infarction
|
0.03%
1/3131 • 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.
|
|
Cardiac disorders
Angina pectoris
|
0.03%
1/3131 • 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.
|
|
Psychiatric disorders
Anorexia
|
0.06%
2/3131 • 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.
|
|
Vascular disorders
Cerebral infarction
|
0.03%
1/3131 • 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.
|
|
Vascular disorders
Transient ischaemic attack
|
0.03%
1/3131 • 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.
|
|
Cardiac disorders
Fibrillation atrial aggravated
|
0.03%
1/3131 • 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.
|
|
Infections and infestations
Laceration
|
0.03%
1/3131 • 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.
|
|
Nervous system disorders
Dysarthria
|
0.03%
1/3131 • 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.
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER