Trial Outcomes & Findings for Alogliptin Tablets Special Drug Use Surveillance: Mild Type 2 Diabetes Mellitus (NCT NCT01964963)

NCT ID: NCT01964963

Last Updated: 2019-11-21

Results Overview

Recruitment status

COMPLETED

Target enrollment

19192 participants

Primary outcome timeframe

Up to Month 36

Results posted on

2019-11-21

Participant Flow

Participants took part in the study at 1406 investigative sites in Japan, from 03 August 2011 to 31 July 2017.

Participants with a historical diagnosis of mild type 2 diabetes mellitus were enrolled. Participants received interventions as part of routine medical care.

Participant milestones

Participant milestones
Measure	Alogliptin 25 mg Alogliptin 25 mg, tablets, orally, once daily for up to 12 months. Participants received interventions as part of routine medical care.
Overall Study STARTED	19192
Overall Study COMPLETED	18249
Overall Study NOT COMPLETED	943

Reasons for withdrawal

Reasons for withdrawal
Measure	Alogliptin 25 mg Alogliptin 25 mg, tablets, orally, once daily for up to 12 months. Participants received interventions as part of routine medical care.
Overall Study Case Report Forms Uncollected	888
Overall Study Protocol Deviation	50
Overall Study Data Reliability was not Assured	5

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Alogliptin 25 mg n=18249 Participants Alogliptin 25 mg, tablets, orally, once daily for up to 12 months. Participants received interventions as part of routine medical care.
Age, Continuous	67.3 Years STANDARD_DEVIATION 11.41 • n=18249 Participants
Sex: Female, Male Female	7970 Participants n=18249 Participants
Sex: Female, Male Male	10279 Participants n=18249 Participants
Region of Enrollment Japan	18249 Participants n=18249 Participants
Number of Females who were not Pregnant	7970 Participants n=7970 Participants • This baseline characteristic was analyzed only in female participants.
Duration of Diagnosis of Type 2 Diabetes Mellitus	6.03 Years STANDARD_DEVIATION 6.452 • n=13939 Participants • The number analyzed is the number of participants with data available for analysis.
Height	159.6 Centimeters (cm) STANDARD_DEVIATION 9.61 • n=15139 Participants • The number analyzed is the number of participants with data available for analysis.
Weight	63.85 Kilograms (kg) STANDARD_DEVIATION 13.324 • n=13073 Participants • The number analyzed is the number of participants with data available for analysis.
BMI	24.95 kg/meter (m)^2 STANDARD_DEVIATION 4.067 • n=12378 Participants • The number analyzed is the number of participants with data available for analysis.
Healthcare Category Outpatient	18069 Participants n=18249 Participants
Healthcare Category Inpatient	180 Participants n=18249 Participants
Degree of Renal Dysfunction Normal	14808 Participants n=18249 Participants
Degree of Renal Dysfunction Mild	2766 Participants n=18249 Participants
Degree of Renal Dysfunction Moderate	598 Participants n=18249 Participants
Degree of Renal Dysfunction Severe	77 Participants n=18249 Participants
Medical Complications Had No Presence of Medical Complications	2322 Participants n=18249 Participants
Medical Complications Had Presence of Medical Complications	15927 Participants n=18249 Participants
Concomitant Diabetes Mellitus Had No Concomitant Diabetes Mellitus	16165 Participants n=18249 Participants
Concomitant Diabetes Mellitus Had Concomitant Diabetes Mellitus	2084 Participants n=18249 Participants
Concomitant Hypertension Had No Concomitant Hypertension	6764 Participants n=18249 Participants
Concomitant Hypertension Had Concomitant Hypertension	11485 Participants n=18249 Participants
Concomitant Hyperlipidemia Had No Concomitant Hyperlipidemia	7303 Participants n=18249 Participants
Concomitant Hyperlipidemia Had Concomitant Hyperlipidemia	10946 Participants n=18249 Participants
Concomitant Hyperuricaemia Had No Concomitant Hyperuricaemia	16614 Participants n=18249 Participants
Concomitant Hyperuricaemia Had Concomitant Hyperuricaemia	1635 Participants n=18249 Participants
Concomitant Hepatic Disorder Had No Concomitant Hepatic Disorder	16266 Participants n=18249 Participants
Concomitant Hepatic Disorder Had Concomitant Hepatic Disorder	1983 Participants n=18249 Participants
Concomitant Renal Disorder Had No Concomitant Renal Disorder	16572 Participants n=18249 Participants
Concomitant Renal Disorder Had Concomitant Renal Disorder	1677 Participants n=18249 Participants
Concomitant Cardiac Disease Had No Concomitant Cardiac Disease	16032 Participants n=18249 Participants
Concomitant Cardiac Disease Had Concomitant Cardiac Disease	2217 Participants n=18249 Participants
Concomitant Heart Failure Had No Concomitant Heart Failure	17709 Participants n=18249 Participants
Concomitant Heart Failure Had Concomitant Heart Failure	540 Participants n=18249 Participants
New York Heart Association (NYHA) Heart Failure Classification Class I	354 Participants n=540 Participants • This baseline characteristic was analyzed only for participants who had complications of heart failure.
New York Heart Association (NYHA) Heart Failure Classification Class II	143 Participants n=540 Participants • This baseline characteristic was analyzed only for participants who had complications of heart failure.
New York Heart Association (NYHA) Heart Failure Classification Class III	26 Participants n=540 Participants • This baseline characteristic was analyzed only for participants who had complications of heart failure.
New York Heart Association (NYHA) Heart Failure Classification Class IV	7 Participants n=540 Participants • This baseline characteristic was analyzed only for participants who had complications of heart failure.
New York Heart Association (NYHA) Heart Failure Classification Unknown	10 Participants n=540 Participants • This baseline characteristic was analyzed only for participants who had complications of heart failure.
Concomitant Stroke-Related Disease Had No Concomitant Stroke-Related Disease	17072 Participants n=18249 Participants
Concomitant Stroke-Related Disease Had Concomitant Stroke-Related Disease	1177 Participants n=18249 Participants
Concomitant Allergic Condition Had No Concomitant Allergic Condition	17224 Participants n=18249 Participants
Concomitant Allergic Condition Had Concomitant Allergic Condition	1025 Participants n=18249 Participants
Concomitant Malignant Tumor Had No Concomitant Malignant Tumor	17832 Participants n=18249 Participants
Concomitant Malignant Tumor Had Concomitant Malignant Tumor	417 Participants n=18249 Participants
Medical History Had No Medical History	14497 Participants n=18249 Participants
Medical History Had Medical History	2080 Participants n=18249 Participants
Medical History Unknown	1672 Participants n=18249 Participants
Predisposition to Hypersensitivity Had No Predisposition to Hypersensitivity	15551 Participants n=18249 Participants
Predisposition to Hypersensitivity Had Predisposition to Hypersensitivity	795 Participants n=18249 Participants
Predisposition to Hypersensitivity Unknown	1903 Participants n=18249 Participants
Drinking Habits Yes	5440 Participants n=18249 Participants
Drinking Habits No	9156 Participants n=18249 Participants
Drinking Habits Unknown	3653 Participants n=18249 Participants
Smoking Classification Never Smoked	8089 Participants n=18249 Participants
Smoking Classification Current Smoker	2330 Participants n=18249 Participants
Smoking Classification Ex-Smoker	3326 Participants n=18249 Participants
Smoking Classification Unknown	4504 Participants n=18249 Participants
Hemoglobin A1c (HbA1c) [National Glycohemoglobin Standardization Program (NGSP) Value]	6.88 Percentage of HbA1c STANDARD_DEVIATION 0.591 • n=17874 Participants • The number analyzed is the number of participants with data available for analysis.
Dietary Instruction Instructed	15433 Participants n=18249 Participants
Dietary Instruction Not Instructed	2816 Participants n=18249 Participants
Exercise Instruction Instructed	13909 Participants n=18249 Participants
Exercise Instruction Not Instructed	4340 Participants n=18249 Participants

PRIMARY outcome

Timeframe: Up to Month 36

Population: Safety Analysis Set; The safety analysis set was defined as all participants who completed the study.

Outcome measures

Outcome measures
Measure	Alogliptin 25 mg n=18249 Participants Alogliptin 25 mg, tablets, orally, once daily for up to 12 months. Participants received interventions as part of routine medical care.
Percentage of Participants Who Had One or More Adverse Events	10.54 Percentage of Participants

PRIMARY outcome

Timeframe: Baseline, and final assessment point (up to Month 36)

Population: The efficacy assessment population was defined as participants who completed the study and had available efficacy data at baseline and post baseline. The number analyzed is the number of participants with data available for analysis at the given time-point.

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 36) relative to baseline.

Outcome measures

Outcome measures
Measure	Alogliptin 25 mg n=16022 Participants Alogliptin 25 mg, tablets, orally, once daily for up to 12 months. Participants received interventions as part of routine medical care.
Change From Baseline in Glycosylated Hemoglobin (HbA1c)	-0.14 Percent HbA1c Standard Deviation 0.777

SECONDARY outcome

Timeframe: Baseline, and final assessment point (up to Month 36)

The change in the value of fasting blood glucose level collected at final assessment point (up to Month 36) relative to baseline.

Outcome measures

Outcome measures
Measure	Alogliptin 25 mg n=6031 Participants Alogliptin 25 mg, tablets, orally, once daily for up to 12 months. Participants received interventions as part of routine medical care.
Change From Baseline in Fasting Blood Glucose	-5.8 Milligram (mg)/ deciliter (dL) Standard Deviation 34.33

Adverse Events

Alogliptin 25 mg

Serious events: 65 serious events

Other events: 41 other events

Deaths: 20 deaths

Serious adverse events

Serious adverse events
Measure	Alogliptin 25 mg n=18249 participants at risk Alogliptin 25 mg, tablets, orally, once daily for up to 12 months. Participants received interventions as part of routine medical care.
Infections and infestations Peritonitis	0.01% 1/18249 • Up to Month 36 At each visit the investigator had to document any occurrence of adverse events (AEs) 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. Only adverse drug reactions (ADRs) were collected and reported on safety results sections here. ADRs are AEs which are in the investigator's opinion of causal relationship to the study treatment..
Infections and infestations Pneumonia	0.01% 2/18249 • Up to Month 36 At each visit the investigator had to document any occurrence of adverse events (AEs) 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. Only adverse drug reactions (ADRs) were collected and reported on safety results sections here. ADRs are AEs which are in the investigator's opinion of causal relationship to the study treatment..
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bile duct cancer	0.01% 1/18249 • Up to Month 36 At each visit the investigator had to document any occurrence of adverse events (AEs) 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. Only adverse drug reactions (ADRs) were collected and reported on safety results sections here. ADRs are AEs which are in the investigator's opinion of causal relationship to the study treatment..
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder cancer	0.01% 1/18249 • Up to Month 36 At each visit the investigator had to document any occurrence of adverse events (AEs) 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. Only adverse drug reactions (ADRs) were collected and reported on safety results sections here. ADRs are AEs which are in the investigator's opinion of causal relationship to the study treatment..
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder neoplasm	0.01% 1/18249 • Up to Month 36 At each visit the investigator had to document any occurrence of adverse events (AEs) 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. Only adverse drug reactions (ADRs) were collected and reported on safety results sections here. ADRs are AEs which are in the investigator's opinion of causal relationship to the study treatment..
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon cancer	0.01% 2/18249 • Up to Month 36 At each visit the investigator had to document any occurrence of adverse events (AEs) 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. Only adverse drug reactions (ADRs) were collected and reported on safety results sections here. ADRs are AEs which are in the investigator's opinion of causal relationship to the study treatment..
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Diffuse large B-cell lymphoma	0.01% 1/18249 • Up to Month 36 At each visit the investigator had to document any occurrence of adverse events (AEs) 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. Only adverse drug reactions (ADRs) were collected and reported on safety results sections here. ADRs are AEs which are in the investigator's opinion of causal relationship to the study treatment..
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gastric cancer	0.01% 1/18249 • Up to Month 36 At each visit the investigator had to document any occurrence of adverse events (AEs) 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. Only adverse drug reactions (ADRs) were collected and reported on safety results sections here. ADRs are AEs which are in the investigator's opinion of causal relationship to the study treatment..
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasm malignant	0.01% 1/18249 • Up to Month 36 At each visit the investigator had to document any occurrence of adverse events (AEs) 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. Only adverse drug reactions (ADRs) were collected and reported on safety results sections here. ADRs are AEs which are in the investigator's opinion of causal relationship to the study treatment..
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Oesophageal carcinoma	0.01% 1/18249 • Up to Month 36 At each visit the investigator had to document any occurrence of adverse events (AEs) 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. Only adverse drug reactions (ADRs) were collected and reported on safety results sections here. ADRs are AEs which are in the investigator's opinion of causal relationship to the study treatment..
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Ovarian cancer	0.01% 1/18249 • Up to Month 36 At each visit the investigator had to document any occurrence of adverse events (AEs) 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. Only adverse drug reactions (ADRs) were collected and reported on safety results sections here. ADRs are AEs which are in the investigator's opinion of causal relationship to the study treatment..
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pancreatic carcinoma	0.01% 2/18249 • Up to Month 36 At each visit the investigator had to document any occurrence of adverse events (AEs) 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. Only adverse drug reactions (ADRs) were collected and reported on safety results sections here. ADRs are AEs which are in the investigator's opinion of causal relationship to the study treatment..
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung neoplasm malignant	0.01% 1/18249 • Up to Month 36 At each visit the investigator had to document any occurrence of adverse events (AEs) 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. Only adverse drug reactions (ADRs) were collected and reported on safety results sections here. ADRs are AEs which are in the investigator's opinion of causal relationship to the study treatment..
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Intraductal papillary mucinous neoplasm	0.01% 1/18249 • Up to Month 36 At each visit the investigator had to document any occurrence of adverse events (AEs) 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. Only adverse drug reactions (ADRs) were collected and reported on safety results sections here. ADRs are AEs which are in the investigator's opinion of causal relationship to the study treatment..
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hepatic cancer	0.01% 1/18249 • Up to Month 36 At each visit the investigator had to document any occurrence of adverse events (AEs) 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. Only adverse drug reactions (ADRs) were collected and reported on safety results sections here. ADRs are AEs which are in the investigator's opinion of causal relationship to the study treatment..
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hepatic cancer recurrent	0.01% 1/18249 • Up to Month 36 At each visit the investigator had to document any occurrence of adverse events (AEs) 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. Only adverse drug reactions (ADRs) were collected and reported on safety results sections here. ADRs are AEs which are in the investigator's opinion of causal relationship to the study treatment..
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hepatocellular carcinoma	0.01% 1/18249 • Up to Month 36 At each visit the investigator had to document any occurrence of adverse events (AEs) 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. Only adverse drug reactions (ADRs) were collected and reported on safety results sections here. ADRs are AEs which are in the investigator's opinion of causal relationship to the study treatment..
Metabolism and nutrition disorders Cachexia	0.01% 1/18249 • Up to Month 36 At each visit the investigator had to document any occurrence of adverse events (AEs) 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. Only adverse drug reactions (ADRs) were collected and reported on safety results sections here. ADRs are AEs which are in the investigator's opinion of causal relationship to the study treatment..
Metabolism and nutrition disorders Hypoglycaemia	0.01% 2/18249 • Up to Month 36 At each visit the investigator had to document any occurrence of adverse events (AEs) 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. Only adverse drug reactions (ADRs) were collected and reported on safety results sections here. ADRs are AEs which are in the investigator's opinion of causal relationship to the study treatment..
Metabolism and nutrition disorders Marasmus	0.01% 1/18249 • Up to Month 36 At each visit the investigator had to document any occurrence of adverse events (AEs) 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. Only adverse drug reactions (ADRs) were collected and reported on safety results sections here. ADRs are AEs which are in the investigator's opinion of causal relationship to the study treatment..
Psychiatric disorders Completed suicide	0.01% 1/18249 • Up to Month 36 At each visit the investigator had to document any occurrence of adverse events (AEs) 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. Only adverse drug reactions (ADRs) were collected and reported on safety results sections here. ADRs are AEs which are in the investigator's opinion of causal relationship to the study treatment..
Psychiatric disorders Depression	0.01% 1/18249 • Up to Month 36 At each visit the investigator had to document any occurrence of adverse events (AEs) 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. Only adverse drug reactions (ADRs) were collected and reported on safety results sections here. ADRs are AEs which are in the investigator's opinion of causal relationship to the study treatment..
Nervous system disorders Cerebellar haemorrhage	0.01% 1/18249 • Up to Month 36 At each visit the investigator had to document any occurrence of adverse events (AEs) 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. Only adverse drug reactions (ADRs) were collected and reported on safety results sections here. ADRs are AEs which are in the investigator's opinion of causal relationship to the study treatment..
Nervous system disorders Cerebral infarction	0.01% 2/18249 • Up to Month 36 At each visit the investigator had to document any occurrence of adverse events (AEs) 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. Only adverse drug reactions (ADRs) were collected and reported on safety results sections here. ADRs are AEs which are in the investigator's opinion of causal relationship to the study treatment..
Nervous system disorders Cerebrovascular accident	0.01% 2/18249 • Up to Month 36 At each visit the investigator had to document any occurrence of adverse events (AEs) 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. Only adverse drug reactions (ADRs) were collected and reported on safety results sections here. ADRs are AEs which are in the investigator's opinion of causal relationship to the study treatment..
Nervous system disorders Epilepsy	0.01% 1/18249 • Up to Month 36 At each visit the investigator had to document any occurrence of adverse events (AEs) 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. Only adverse drug reactions (ADRs) were collected and reported on safety results sections here. ADRs are AEs which are in the investigator's opinion of causal relationship to the study treatment..
Nervous system disorders Headache	0.01% 1/18249 • Up to Month 36 At each visit the investigator had to document any occurrence of adverse events (AEs) 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. Only adverse drug reactions (ADRs) were collected and reported on safety results sections here. ADRs are AEs which are in the investigator's opinion of causal relationship to the study treatment..
Nervous system disorders Subdural hygroma	0.01% 1/18249 • Up to Month 36 At each visit the investigator had to document any occurrence of adverse events (AEs) 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. Only adverse drug reactions (ADRs) were collected and reported on safety results sections here. ADRs are AEs which are in the investigator's opinion of causal relationship to the study treatment..
Cardiac disorders Acute myocardial infarction	0.01% 1/18249 • Up to Month 36 At each visit the investigator had to document any occurrence of adverse events (AEs) 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. Only adverse drug reactions (ADRs) were collected and reported on safety results sections here. ADRs are AEs which are in the investigator's opinion of causal relationship to the study treatment..
Cardiac disorders Cardiac failure	0.01% 1/18249 • Up to Month 36 At each visit the investigator had to document any occurrence of adverse events (AEs) 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. Only adverse drug reactions (ADRs) were collected and reported on safety results sections here. ADRs are AEs which are in the investigator's opinion of causal relationship to the study treatment..
Cardiac disorders Cardiac failure acute	0.01% 2/18249 • Up to Month 36 At each visit the investigator had to document any occurrence of adverse events (AEs) 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. Only adverse drug reactions (ADRs) were collected and reported on safety results sections here. ADRs are AEs which are in the investigator's opinion of causal relationship to the study treatment..
Cardiac disorders Cardiac failure congestive	0.01% 1/18249 • Up to Month 36 At each visit the investigator had to document any occurrence of adverse events (AEs) 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. Only adverse drug reactions (ADRs) were collected and reported on safety results sections here. ADRs are AEs which are in the investigator's opinion of causal relationship to the study treatment..
Cardiac disorders Ventricular tachycardia	0.01% 1/18249 • Up to Month 36 At each visit the investigator had to document any occurrence of adverse events (AEs) 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. Only adverse drug reactions (ADRs) were collected and reported on safety results sections here. ADRs are AEs which are in the investigator's opinion of causal relationship to the study treatment..
Respiratory, thoracic and mediastinal disorders Pulmonary oedema	0.01% 1/18249 • Up to Month 36 At each visit the investigator had to document any occurrence of adverse events (AEs) 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. Only adverse drug reactions (ADRs) were collected and reported on safety results sections here. ADRs are AEs which are in the investigator's opinion of causal relationship to the study treatment..
Gastrointestinal disorders Anal fistula	0.01% 1/18249 • Up to Month 36 At each visit the investigator had to document any occurrence of adverse events (AEs) 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. Only adverse drug reactions (ADRs) were collected and reported on safety results sections here. ADRs are AEs which are in the investigator's opinion of causal relationship to the study treatment..
Gastrointestinal disorders Pancreatitis acute	0.02% 3/18249 • Up to Month 36 At each visit the investigator had to document any occurrence of adverse events (AEs) 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. Only adverse drug reactions (ADRs) were collected and reported on safety results sections here. ADRs are AEs which are in the investigator's opinion of causal relationship to the study treatment..
Hepatobiliary disorders Cholangitis	0.01% 1/18249 • Up to Month 36 At each visit the investigator had to document any occurrence of adverse events (AEs) 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. Only adverse drug reactions (ADRs) were collected and reported on safety results sections here. ADRs are AEs which are in the investigator's opinion of causal relationship to the study treatment..
Musculoskeletal and connective tissue disorders Rhabdomyolysis	0.01% 1/18249 • Up to Month 36 At each visit the investigator had to document any occurrence of adverse events (AEs) 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. Only adverse drug reactions (ADRs) were collected and reported on safety results sections here. ADRs are AEs which are in the investigator's opinion of causal relationship to the study treatment..
Renal and urinary disorders Diabetic nephropathy	0.01% 2/18249 • Up to Month 36 At each visit the investigator had to document any occurrence of adverse events (AEs) 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. Only adverse drug reactions (ADRs) were collected and reported on safety results sections here. ADRs are AEs which are in the investigator's opinion of causal relationship to the study treatment..
General disorders Death	0.02% 3/18249 • Up to Month 36 At each visit the investigator had to document any occurrence of adverse events (AEs) 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. Only adverse drug reactions (ADRs) were collected and reported on safety results sections here. ADRs are AEs which are in the investigator's opinion of causal relationship to the study treatment..
General disorders Pyrexia	0.01% 1/18249 • Up to Month 36 At each visit the investigator had to document any occurrence of adverse events (AEs) 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. Only adverse drug reactions (ADRs) were collected and reported on safety results sections here. ADRs are AEs which are in the investigator's opinion of causal relationship to the study treatment..
General disorders Sudden death	0.03% 5/18249 • Up to Month 36 At each visit the investigator had to document any occurrence of adverse events (AEs) 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. Only adverse drug reactions (ADRs) were collected and reported on safety results sections here. ADRs are AEs which are in the investigator's opinion of causal relationship to the study treatment..
Investigations C-reactive protein increased	0.01% 1/18249 • Up to Month 36 At each visit the investigator had to document any occurrence of adverse events (AEs) 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. Only adverse drug reactions (ADRs) were collected and reported on safety results sections here. ADRs are AEs which are in the investigator's opinion of causal relationship to the study treatment..
Investigations White blood cell count increased	0.01% 1/18249 • Up to Month 36 At each visit the investigator had to document any occurrence of adverse events (AEs) 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. Only adverse drug reactions (ADRs) were collected and reported on safety results sections here. ADRs are AEs which are in the investigator's opinion of causal relationship to the study treatment..
Injury, poisoning and procedural complications Fall	0.01% 1/18249 • Up to Month 36 At each visit the investigator had to document any occurrence of adverse events (AEs) 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. Only adverse drug reactions (ADRs) were collected and reported on safety results sections here. ADRs are AEs which are in the investigator's opinion of causal relationship to the study treatment..
Injury, poisoning and procedural complications Subdural haematoma	0.01% 2/18249 • Up to Month 36 At each visit the investigator had to document any occurrence of adverse events (AEs) 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. Only adverse drug reactions (ADRs) were collected and reported on safety results sections here. ADRs are AEs which are in the investigator's opinion of causal relationship to the study treatment..
Injury, poisoning and procedural complications Excoriation	0.01% 1/18249 • Up to Month 36 At each visit the investigator had to document any occurrence of adverse events (AEs) 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. Only adverse drug reactions (ADRs) were collected and reported on safety results sections here. ADRs are AEs which are in the investigator's opinion of causal relationship to the study treatment..
Injury, poisoning and procedural complications Contusion	0.01% 1/18249 • Up to Month 36 At each visit the investigator had to document any occurrence of adverse events (AEs) 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. Only adverse drug reactions (ADRs) were collected and reported on safety results sections here. ADRs are AEs which are in the investigator's opinion of causal relationship to the study treatment..

Other adverse events

Other adverse events
Measure	Alogliptin 25 mg n=18249 participants at risk Alogliptin 25 mg, tablets, orally, once daily for up to 12 months. Participants received interventions as part of routine medical care.
Metabolism and nutrition disorders Hypoglycaemia	0.22% 41/18249 • Up to Month 36 At each visit the investigator had to document any occurrence of adverse events (AEs) 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. Only adverse drug reactions (ADRs) were collected and reported on safety results sections here. ADRs are AEs which are in the investigator's opinion of causal relationship to the study treatment..

Additional Information

Medical Director

Takeda

Phone: +1-877-825-3327

Email: [email protected]

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