Trial Outcomes & Findings for An Observational Study of Alogliptin Benzoate in Participants With Diabetes Mellitus Type 2 (NCT NCT02756832)

NCT ID: NCT02756832

Last Updated: 2019-07-10

Results Overview

Recruitment status

COMPLETED

Target enrollment

1409 participants

Primary outcome timeframe

Baseline and Month 6

Results posted on

2019-07-10

Participant Flow

Participants took part in the study in Russia from 20-Sep-2016 to 28-Apr-2018.

Participants with a diagnosis of diabetes mellitus type 2 (T2DM) prescribed alogliptin benzoate in accordance with Russian SmPC were enrolled in this observational study.

Participant milestones

Participant milestones
Measure	Alogliptin Benzoate Participants with diabetes mellitus type 2 (T2DM) who received alogliptin benzoate tablets, orally, as prescribed by physician according to Russian summary of product characteristics (SmPC) were observed for approximately 6 months.
Overall Study STARTED	1409
Overall Study Received Therapy	1393
Overall Study Included in Efficacy and Safety Analysis	1399
Overall Study COMPLETED	1356
Overall Study NOT COMPLETED	53

Reasons for withdrawal

Reasons for withdrawal
Measure	Alogliptin Benzoate Participants with diabetes mellitus type 2 (T2DM) who received alogliptin benzoate tablets, orally, as prescribed by physician according to Russian summary of product characteristics (SmPC) were observed for approximately 6 months.
Overall Study Lost for Observation after Baseline	6
Overall Study Lost for Observation	13
Overall Study Patient's Unwillingness	12
Overall Study Insufficient Efficacy	2
Overall Study Sponsor Decision/Regulatory Requirement	1
Overall Study Reason not Specified	9
Overall Study Protocol Deviation	10

Baseline Characteristics

An Observational Study of Alogliptin Benzoate in Participants With Diabetes Mellitus Type 2

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Alogliptin Benzoate n=1399 Participants Participants with diabetes mellitus type 2 (T2DM) who received alogliptin benzoate tablets, orally, as prescribed by physician according to Russian summary of product characteristics (SmPC) were observed for approximately 6 months.
Age, Continuous	58.1 years STANDARD_DEVIATION 9.9 • n=99 Participants
Sex: Female, Male Female	907 Participants n=99 Participants
Sex: Female, Male Male	492 Participants n=99 Participants
Race/Ethnicity, Customized European	1375 Participants n=99 Participants
Race/Ethnicity, Customized Asian	21 Participants n=99 Participants
Race/Ethnicity, Customized African American or African	3 Participants n=99 Participants
Region of Enrollment Russia	1399 Participants n=99 Participants

PRIMARY outcome

Timeframe: Baseline and Month 6

Population: All participants with a diagnosis of diabetes mellitus type 2 (T2DM), newly diagnosed T2DM (drug naive) or inadequate glycemic control on previously prescribed any oral antidiabetic drug were enrolled in the study. Number analyzed is the number of participants with evaluable data at the given time-point.

Outcome measures

Outcome measures
Measure	Alogliptin Benzoate n=1399 Participants Participants with diabetes mellitus type 2 (T2DM) who received alogliptin benzoate tablets, orally, as prescribed by physician according to Russian summary of product characteristics (SmPC) were observed for approximately 6 months.
Change From Baseline in Glycosylated Hemoglobin (HbA1c) Level at Month 6 Baseline	8.1 percentage of glycosylated hemoglobin Standard Deviation 1.2
Change From Baseline in Glycosylated Hemoglobin (HbA1c) Level at Month 6 Change from Baseline at Month 6	-1.2 percentage of glycosylated hemoglobin Standard Deviation 1.0

SECONDARY outcome

Timeframe: Baseline and Month 6

Population: All participants with a diagnosis of T2DM, newly diagnosed T2DM (drug naive) or inadequate glycemic control on previously prescribed any oral antidiabetic drug were enrolled in the study. Number analyzed is the number of participants with evaluable data 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 Month 6 relative to baseline. Glycosylated hemoglobin (HbA1c) as a diagnostic criteria of diabetes mellitus is ≥6.5%. Subgroups included participants with different baseline clinical characteristics with predictors such as prior therapy of diabetes mellitus, sex, age group, cardiovascular risk group, therapy type (monotherapy or combined therapy), baseline body mass index (BMI) and initial glycemic control and T2DM duration. A negative change from Baseline indicates improvement.

Outcome measures

Outcome measures
Measure	Alogliptin Benzoate n=1314 Participants Participants with diabetes mellitus type 2 (T2DM) who received alogliptin benzoate tablets, orally, as prescribed by physician according to Russian summary of product characteristics (SmPC) were observed for approximately 6 months.
Change From Baseline in HbA1c Level at Month 6 in Subgroups of Participants With Different Clinical Characteristics BMI, Obesity Class III (BMI≥40 kg/m^2)	-1.2 percentage of glycosylated hemoglobin Standard Deviation 1.2
Change From Baseline in HbA1c Level at Month 6 in Subgroups of Participants With Different Clinical Characteristics Prior Therapy Diabetes Mellitus (DM), No Therapy	-1.4 percentage of glycosylated hemoglobin Standard Deviation 1.2
Change From Baseline in HbA1c Level at Month 6 in Subgroups of Participants With Different Clinical Characteristics Prior Therapy DM, Monotherapy: Biguanides	-1.1 percentage of glycosylated hemoglobin Standard Deviation 0.8
Change From Baseline in HbA1c Level at Month 6 in Subgroups of Participants With Different Clinical Characteristics Prior Therapy DM, Monotherapy: Sulfonylureas	-1.3 percentage of glycosylated hemoglobin Standard Deviation 1.3
Change From Baseline in HbA1c Level at Month 6 in Subgroups of Participants With Different Clinical Characteristics Prior Therapy DM, Monotherapy: Other	-1.1 percentage of glycosylated hemoglobin Standard Deviation 0.0
Change From Baseline in HbA1c Level at Month 6 in Subgroups of Participants With Different Clinical Characteristics Prior Therapy DM, Biguanides+Sulfonylureas	-1.3 percentage of glycosylated hemoglobin Standard Deviation 1.1
Change From Baseline in HbA1c Level at Month 6 in Subgroups of Participants With Different Clinical Characteristics Prior Therapy DM, Biguanides+SGLT2 inhibitors	-1.4 percentage of glycosylated hemoglobin Standard Deviation 1.1
Change From Baseline in HbA1c Level at Month 6 in Subgroups of Participants With Different Clinical Characteristics Prior Therapy DM, Combined therapy: Other	-1.8 percentage of glycosylated hemoglobin Standard Deviation 1.4
Change From Baseline in HbA1c Level at Month 6 in Subgroups of Participants With Different Clinical Characteristics Sex, Male	-1.4 percentage of glycosylated hemoglobin Standard Deviation 1.1
Change From Baseline in HbA1c Level at Month 6 in Subgroups of Participants With Different Clinical Characteristics Sex,Female	-1.1 percentage of glycosylated hemoglobin Standard Deviation 0.9
Change From Baseline in HbA1c Level at Month 6 in Subgroups of Participants With Different Clinical Characteristics Age Group, <58 Years	-1.3 percentage of glycosylated hemoglobin Standard Deviation 1.0
Change From Baseline in HbA1c Level at Month 6 in Subgroups of Participants With Different Clinical Characteristics Age Group, ≥58 Years	-1.1 percentage of glycosylated hemoglobin Standard Deviation 1.0
Change From Baseline in HbA1c Level at Month 6 in Subgroups of Participants With Different Clinical Characteristics Cardiovascular (CV) Risk Group, High CV Risk	-1.3 percentage of glycosylated hemoglobin Standard Deviation 1.1
Change From Baseline in HbA1c Level at Month 6 in Subgroups of Participants With Different Clinical Characteristics CV Risk Group, Very High CV Risk	-1.2 percentage of glycosylated hemoglobin Standard Deviation 1.0
Change From Baseline in HbA1c Level at Month 6 in Subgroups of Participants With Different Clinical Characteristics Therapy Type (TT), Monotherapy: VIPIDIA®	-1.3 percentage of glycosylated hemoglobin Standard Deviation 1.1
Change From Baseline in HbA1c Level at Month 6 in Subgroups of Participants With Different Clinical Characteristics TT, Combined: VIPIDIA®+Biguanides	-1.1 percentage of glycosylated hemoglobin Standard Deviation 0.9
Change From Baseline in HbA1c Level at Month 6 in Subgroups of Participants With Different Clinical Characteristics TT, Combined: VIPIDIA®+Sulfonylureas	-1 percentage of glycosylated hemoglobin Standard Deviation 1.1
Change From Baseline in HbA1c Level at Month 6 in Subgroups of Participants With Different Clinical Characteristics TT, Combined: VIPIDIA®+SGLT2 Inhibitors	0 percentage of glycosylated hemoglobin Standard Deviation 0
Change From Baseline in HbA1c Level at Month 6 in Subgroups of Participants With Different Clinical Characteristics TT, Combined: VIPIDIA®+Biguanides+Sulfonylureas	-1.4 percentage of glycosylated hemoglobin Standard Deviation 1.2
Change From Baseline in HbA1c Level at Month 6 in Subgroups of Participants With Different Clinical Characteristics TT, Combined: VIPIDIA®+Biguanides+SGLT2 Inhibitors	-1.3 percentage of glycosylated hemoglobin Standard Deviation 1.0
Change From Baseline in HbA1c Level at Month 6 in Subgroups of Participants With Different Clinical Characteristics TT, Combined: VIPIDIA®+Biguanides+Antidiabetics	-2.4 percentage of glycosylated hemoglobin Standard Deviation 0.0
Change From Baseline in HbA1c Level at Month 6 in Subgroups of Participants With Different Clinical Characteristics TT,Combined: VIPIDIA®+Biguanide+Sulfonylurea+SGLT2	-2.1 percentage of glycosylated hemoglobin Standard Deviation 0.5
Change From Baseline in HbA1c Level at Month 6 in Subgroups of Participants With Different Clinical Characteristics BMI, Normal Weight (<25 kg/m^2)	-1.3 percentage of glycosylated hemoglobin Standard Deviation 1.2
Change From Baseline in HbA1c Level at Month 6 in Subgroups of Participants With Different Clinical Characteristics BMI, Over-Weight (25≤BMI<30 kg/m^2)	-1.2 percentage of glycosylated hemoglobin Standard Deviation 0.9
Change From Baseline in HbA1c Level at Month 6 in Subgroups of Participants With Different Clinical Characteristics BMI, Obesity Class I (30≤BMI<35 kg/m^2)	-1.2 percentage of glycosylated hemoglobin Standard Deviation 1.0
Change From Baseline in HbA1c Level at Month 6 in Subgroups of Participants With Different Clinical Characteristics BMI, Obesity Class II (35≤BMI<40 kg/m^2)	-1.2 percentage of glycosylated hemoglobin Standard Deviation 1.1
Change From Baseline in HbA1c Level at Month 6 in Subgroups of Participants With Different Clinical Characteristics Glycemic Control, HBA1C<7.5%	-0.6 percentage of glycosylated hemoglobin Standard Deviation 0.5
Change From Baseline in HbA1c Level at Month 6 in Subgroups of Participants With Different Clinical Characteristics Glycemic Control, 7.5%≥HBA1C<9%	-1.1 percentage of glycosylated hemoglobin Standard Deviation 0.6
Change From Baseline in HbA1c Level at Month 6 in Subgroups of Participants With Different Clinical Characteristics Glycemic Control, HBA1C≥9%	-2.5 percentage of glycosylated hemoglobin Standard Deviation 1.4
Change From Baseline in HbA1c Level at Month 6 in Subgroups of Participants With Different Clinical Characteristics T2DM Duration, 0-3 Years	-1.3 percentage of glycosylated hemoglobin Standard Deviation 1.0
Change From Baseline in HbA1c Level at Month 6 in Subgroups of Participants With Different Clinical Characteristics T2DM Duration, 3-5 Years	-1.0 percentage of glycosylated hemoglobin Standard Deviation 0.9
Change From Baseline in HbA1c Level at Month 6 in Subgroups of Participants With Different Clinical Characteristics T2DM Duration, 5-10 Years	-1.2 percentage of glycosylated hemoglobin Standard Deviation 0.9
Change From Baseline in HbA1c Level at Month 6 in Subgroups of Participants With Different Clinical Characteristics T2DM Duration, >=10 Years	-1.2 percentage of glycosylated hemoglobin Standard Deviation 1.2

SECONDARY outcome

Timeframe: Baseline and Month 6

Population: All participants with a diagnosis of T2DM, newly diagnosed T2DM (drug naive) or inadequate glycemic control on previously prescribed any oral antidiabetic drug were enrolled in the study.

Outcome measures

Outcome measures
Measure	Alogliptin Benzoate n=1399 Participants Participants with diabetes mellitus type 2 (T2DM) who received alogliptin benzoate tablets, orally, as prescribed by physician according to Russian summary of product characteristics (SmPC) were observed for approximately 6 months.
Percentage of Participants With a Decrease in HbA1c Level by <7.0% at Month 6	52 percentage of participants Interval 49.2 to 54.7

SECONDARY outcome

Timeframe: Baseline, Months 3 and 6

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 Months 3 and 6 relative to baseline. Glycosylated hemoglobin (HbA1c) as a diagnostic criteria of diabetes mellitus is ≥6.5%. A negative change from Baseline indicates improvement.

Outcome measures

Outcome measures
Measure	Alogliptin Benzoate n=1399 Participants Participants with diabetes mellitus type 2 (T2DM) who received alogliptin benzoate tablets, orally, as prescribed by physician according to Russian summary of product characteristics (SmPC) were observed for approximately 6 months.
Change From Baseline in HbA1c Level Over Time Baseline	8.1 percentage of glycosylated hemoglobin Standard Deviation 1.2
Change From Baseline in HbA1c Level Over Time Change from Baseline to Month 3	-0.8 percentage of glycosylated hemoglobin Standard Deviation 0.9
Change From Baseline in HbA1c Level Over Time Change from Month 3 to Month 6	-0.4 percentage of glycosylated hemoglobin Standard Deviation 0.5

SECONDARY outcome

Timeframe: Month 3

Population: All participants with a diagnosis of T2DM, newly diagnosed T2DM (drug naive) or inadequate glycemic control on previously prescribed any oral antidiabetic drug were enrolled in the study.

Marked hyperglycemia is defined as fasting plasma glucose (FPG) higher than or equal to 11 mmol/L.

Outcome measures

Outcome measures
Measure	Alogliptin Benzoate n=1399 Participants Participants with diabetes mellitus type 2 (T2DM) who received alogliptin benzoate tablets, orally, as prescribed by physician according to Russian summary of product characteristics (SmPC) were observed for approximately 6 months.
Percentage of Participants With Marked Hyperglycemia at Month 3	0.9 percentage of participants Interval 0.5 to 1.6

SECONDARY outcome

Timeframe: Baseline, Months 3 and 6

The change in the value of fasting plasma glucose value collected at Months 3 and 6 relative to baseline. Target FPG depended on the defined individual targets of glycemic control by HbA1c level ≤6.5 to 8.0 mmol/l. A negative change from Baseline indicates improvement.

Outcome measures

Outcome measures
Measure	Alogliptin Benzoate n=1399 Participants Participants with diabetes mellitus type 2 (T2DM) who received alogliptin benzoate tablets, orally, as prescribed by physician according to Russian summary of product characteristics (SmPC) were observed for approximately 6 months.
Change From Baseline in Fasting Plasma Glucose (FPG) Levels Over Time Baseline	8.7 mmol/l Standard Deviation 2.1
Change From Baseline in Fasting Plasma Glucose (FPG) Levels Over Time Change from Baseline to Month 3	-1.7 mmol/l Standard Deviation 1.8
Change From Baseline in Fasting Plasma Glucose (FPG) Levels Over Time Change from Month 3 to Month 6	-0.4 mmol/l Standard Deviation 0.9
Change From Baseline in Fasting Plasma Glucose (FPG) Levels Over Time Change from Baseline to Month 6	-2.1 mmol/l Standard Deviation 2.0

SECONDARY outcome

Timeframe: Baseline, Months 3 and 6

Change in the participant's weight was collected at Months 3 and 6 relative to baseline.

Outcome measures

Outcome measures
Measure	Alogliptin Benzoate n=1399 Participants Participants with diabetes mellitus type 2 (T2DM) who received alogliptin benzoate tablets, orally, as prescribed by physician according to Russian summary of product characteristics (SmPC) were observed for approximately 6 months.
Change From Baseline in Weight Over Time Baseline	90.6 kg Standard Deviation 16.5
Change From Baseline in Weight Over Time Change from Baseline to Month 3	-1.5 kg Standard Deviation 3.0
Change From Baseline in Weight Over Time Change from Month 3 to Month 6	-1.1 kg Standard Deviation 2.9
Change From Baseline in Weight Over Time Change from Baseline to Month 6	-2.6 kg Standard Deviation 4.2

SECONDARY outcome

Timeframe: Baseline, Months 3 and 6

The change between the baseline (pre-prandial (before meal)) and postprandial (after meal) glucose values were collected at Months 3 and 6 relative to baseline.

Outcome measures

Outcome measures
Measure	Alogliptin Benzoate n=1399 Participants Participants with diabetes mellitus type 2 (T2DM) who received alogliptin benzoate tablets, orally, as prescribed by physician according to Russian summary of product characteristics (SmPC) were observed for approximately 6 months.
Change From Baseline in Postprandial Glycemia Over Time Baseline	10.4 mmol/l Standard Deviation 2.2
Change From Baseline in Postprandial Glycemia Over Time Change from Baseline to Month 3	-1.9 mmol/l Standard Deviation 2.0
Change From Baseline in Postprandial Glycemia Over Time Change from Month 3 to Month 6	-0.5 mmol/l Standard Deviation 1.0
Change From Baseline in Postprandial Glycemia Over Time Change from Baseline to Month 6	-2.4 mmol/l Standard Deviation 2.2

SECONDARY outcome

Timeframe: Baseline, Months 3 and 6

The change between the total cholesterol triglycerides, low density lipoproteins and high density lipoproteins values were collected at Months 3 and 6 relative to baseline.

Outcome measures

Outcome measures
Measure	Alogliptin Benzoate n=1399 Participants Participants with diabetes mellitus type 2 (T2DM) who received alogliptin benzoate tablets, orally, as prescribed by physician according to Russian summary of product characteristics (SmPC) were observed for approximately 6 months.
Change From Baseline in Total Cholesterol, Triglycerides, Low Density Lipoproteins and High Density Lipoproteins Over Time Total Cholesterol, Baseline	5.6 mmol/l Standard Deviation 1.2
Change From Baseline in Total Cholesterol, Triglycerides, Low Density Lipoproteins and High Density Lipoproteins Over Time Total Cholesterol, Change from Baseline to Month 3	-0.5 mmol/l Standard Deviation 0.8
Change From Baseline in Total Cholesterol, Triglycerides, Low Density Lipoproteins and High Density Lipoproteins Over Time Total Cholesterol, Change from Month 3 to Month 6	-0.2 mmol/l Standard Deviation 0.6
Change From Baseline in Total Cholesterol, Triglycerides, Low Density Lipoproteins and High Density Lipoproteins Over Time Total Cholesterol, Change from Baseline to Month 6	-0.6 mmol/l Standard Deviation 1.0
Change From Baseline in Total Cholesterol, Triglycerides, Low Density Lipoproteins and High Density Lipoproteins Over Time Triglycerides, Baseline	2.2 mmol/l Standard Deviation 2.2
Change From Baseline in Total Cholesterol, Triglycerides, Low Density Lipoproteins and High Density Lipoproteins Over Time Triglycerides, Change from Baseline to Month 3	-0.4 mmol/l Standard Deviation 1.7
Change From Baseline in Total Cholesterol, Triglycerides, Low Density Lipoproteins and High Density Lipoproteins Over Time Triglycerides, Change from Month 3 to Month 6	-0.1 mmol/l Standard Deviation 0.5
Change From Baseline in Total Cholesterol, Triglycerides, Low Density Lipoproteins and High Density Lipoproteins Over Time Triglycerides, Change from Baseline to Month 6	-0.4 mmol/l Standard Deviation 1.6
Change From Baseline in Total Cholesterol, Triglycerides, Low Density Lipoproteins and High Density Lipoproteins Over Time Low Density Lipoproteins (LDL), Baseline	3.4 mmol/l Standard Deviation 1.1
Change From Baseline in Total Cholesterol, Triglycerides, Low Density Lipoproteins and High Density Lipoproteins Over Time LDL, Change from Baseline to Month 3	-0.4 mmol/l Standard Deviation 0.7
Change From Baseline in Total Cholesterol, Triglycerides, Low Density Lipoproteins and High Density Lipoproteins Over Time LDL, Change from Month 3 to Month 6	-0.2 mmol/l Standard Deviation 0.6
Change From Baseline in Total Cholesterol, Triglycerides, Low Density Lipoproteins and High Density Lipoproteins Over Time LDL, Change from Baseline to Month 6	-0.6 mmol/l Standard Deviation 0.9
Change From Baseline in Total Cholesterol, Triglycerides, Low Density Lipoproteins and High Density Lipoproteins Over Time High Density Lipoproteins (HDL), Baseline	1.3 mmol/l Standard Deviation 0.5
Change From Baseline in Total Cholesterol, Triglycerides, Low Density Lipoproteins and High Density Lipoproteins Over Time HDL, Change from Baseline to Month 3	0.0 mmol/l Standard Deviation 0.3
Change From Baseline in Total Cholesterol, Triglycerides, Low Density Lipoproteins and High Density Lipoproteins Over Time HDL, Change from Month 3 to Month 6	0.0 mmol/l Standard Deviation 0.3
Change From Baseline in Total Cholesterol, Triglycerides, Low Density Lipoproteins and High Density Lipoproteins Over Time HDL, Change from Baseline to Month 6	0.1 mmol/l Standard Deviation 0.4

SECONDARY outcome

Timeframe: Baseline and Month 6

Population: All participants with a diagnosis of T2DM, newly diagnosed T2DM (drug naive) or inadequate glycemic control on previously prescribed any oral antidiabetic drug were enrolled in the study.

Outcome measures

Outcome measures
Measure	Alogliptin Benzoate n=1399 Participants Participants with diabetes mellitus type 2 (T2DM) who received alogliptin benzoate tablets, orally, as prescribed by physician according to Russian summary of product characteristics (SmPC) were observed for approximately 6 months.
Percentage of Participants With a Decrease in HbA1c Level by ≥0.3% at Month 6	89.1 percentage of participants Interval 87.3 to 90.8

SECONDARY outcome

Timeframe: Baseline up to Month 6

Population: All participants with a diagnosis of T2DM, newly diagnosed T2DM (drug naive) or inadequate glycemic control on previously prescribed any oral antidiabetic drug were enrolled in the study.

Healthcare resources included rate of hospitalization, emergency, emergency room visits, physician office visits, and other type of usage.

Outcome measures

Outcome measures
Measure	Alogliptin Benzoate n=1399 Participants Participants with diabetes mellitus type 2 (T2DM) who received alogliptin benzoate tablets, orally, as prescribed by physician according to Russian summary of product characteristics (SmPC) were observed for approximately 6 months.
Percentage of Participants Who Used Healthcare Resources Rate of Hospitalization	0.6 percentage of participants Interval 0.3 to 1.1
Percentage of Participants Who Used Healthcare Resources Rate of Emergency	0.1 percentage of participants Interval 0.0 to 0.5
Percentage of Participants Who Used Healthcare Resources Rate of Physician Office Visits	0.6 percentage of participants Interval 0.3 to 1.1
Percentage of Participants Who Used Healthcare Resources Rate of Other Type of Usage	0.1 percentage of participants Interval 0.0 to 0.4

Adverse Events

Alogliptin Benzoate

Serious events: 5 serious events

Other events: 69 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Alogliptin Benzoate n=1399 participants at risk Participants with diabetes mellitus type 2 (T2DM) who received alogliptin benzoate tablets, orally, as prescribed by physician according to Russian summary of product characteristics (SmPC) were observed for approximately 6 months.
Nervous system disorders Vertebrobasilar insufficiency	0.07% 1/1399 • From first dose of study drug administration up to Month 6 At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Endometrial adenocarcinoma	0.07% 1/1399 • From first dose of study drug administration up to Month 6 At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Vulval cancer	0.07% 1/1399 • From first dose of study drug administration up to Month 6 At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Injury, poisoning and procedural complications Femoral neck fracture	0.07% 1/1399 • From first dose of study drug administration up to Month 6 At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Psychiatric disorders Schizophrenia	0.07% 1/1399 • From first dose of study drug administration up to Month 6 At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.

Other adverse events

Other adverse events
Measure	Alogliptin Benzoate n=1399 participants at risk Participants with diabetes mellitus type 2 (T2DM) who received alogliptin benzoate tablets, orally, as prescribed by physician according to Russian summary of product characteristics (SmPC) were observed for approximately 6 months.
Investigations Blood cholesterol increased	0.71% 10/1399 • From first dose of study drug administration up to Month 6 At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Investigations HbA1C increased	0.71% 10/1399 • From first dose of study drug administration up to Month 6 At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Investigations Blood triglycerides increased	0.64% 9/1399 • From first dose of study drug administration up to Month 6 At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Investigations Blood glucose increased	0.50% 7/1399 • From first dose of study drug administration up to Month 6 At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Investigations Low density lipoprotein increased	0.43% 6/1399 • From first dose of study drug administration up to Month 6 At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Investigations High density lipoprotein decrease	0.14% 2/1399 • From first dose of study drug administration up to Month 6 At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Investigations Blood creatine increased	0.07% 1/1399 • From first dose of study drug administration up to Month 6 At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Investigations Glomerular filtration rate decreased	0.07% 1/1399 • From first dose of study drug administration up to Month 6 At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Vascular disorders Hypertension	0.71% 10/1399 • From first dose of study drug administration up to Month 6 At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Infections and infestations Upper respiratory tract infection	0.43% 6/1399 • From first dose of study drug administration up to Month 6 At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Infections and infestations Pyelonephritis chronic	0.14% 2/1399 • From first dose of study drug administration up to Month 6 At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Infections and infestations Respiratory tract infection	0.14% 2/1399 • From first dose of study drug administration up to Month 6 At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Infections and infestations Viral infection	0.14% 2/1399 • From first dose of study drug administration up to Month 6 At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Infections and infestations Viral tracheitis	0.14% 2/1399 • From first dose of study drug administration up to Month 6 At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Infections and infestations Bronchitis	0.07% 1/1399 • From first dose of study drug administration up to Month 6 At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Infections and infestations Cystitis	0.07% 1/1399 • From first dose of study drug administration up to Month 6 At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Infections and infestations Respiratory tract infection viral	0.07% 1/1399 • From first dose of study drug administration up to Month 6 At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Infections and infestations Tracheitis	0.07% 1/1399 • From first dose of study drug administration up to Month 6 At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Infections and infestations Tracheobronchitis	0.07% 1/1399 • From first dose of study drug administration up to Month 6 At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Metabolism and nutrition disorders Hyperglycaemia	0.50% 7/1399 • From first dose of study drug administration up to Month 6 At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Metabolism and nutrition disorders Dyslipidaemia	0.14% 2/1399 • From first dose of study drug administration up to Month 6 At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Metabolism and nutrition disorders Hypoglycaemia	0.14% 2/1399 • From first dose of study drug administration up to Month 6 At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Metabolism and nutrition disorders Hypercholesterolaemia	0.07% 1/1399 • From first dose of study drug administration up to Month 6 At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Metabolism and nutrition disorders Hypertriglyceridaemia	0.07% 1/1399 • From first dose of study drug administration up to Month 6 At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Metabolism and nutrition disorders Increased appetite	0.07% 1/1399 • From first dose of study drug administration up to Month 6 At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
General disorders Drug ineffective	0.29% 4/1399 • From first dose of study drug administration up to Month 6 At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Nervous system disorders Autonomic neuropathy	0.14% 2/1399 • From first dose of study drug administration up to Month 6 At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Endocrine disorders Goitre	0.14% 2/1399 • From first dose of study drug administration up to Month 6 At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Gastrointestinal disorders Diarrhea	0.07% 1/1399 • From first dose of study drug administration up to Month 6 At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Gastrointestinal disorders Dyspepsia	0.07% 1/1399 • From first dose of study drug administration up to Month 6 At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Endocrine disorders Hypothyroidism	0.07% 1/1399 • From first dose of study drug administration up to Month 6 At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Gastrointestinal disorders Nausea	0.07% 1/1399 • From first dose of study drug administration up to Month 6 At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Musculoskeletal and connective tissue disorders Arthralgia	0.07% 1/1399 • From first dose of study drug administration up to Month 6 At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Eye disorders Diabetic retinopathy	0.07% 1/1399 • From first dose of study drug administration up to Month 6 At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Social circumstances Disease risk factor	0.07% 1/1399 • From first dose of study drug administration up to Month 6 At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Ear and labyrinth disorders Vestibular disorder	0.07% 1/1399 • From first dose of study drug administration up to Month 6 At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.

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