Trial Outcomes & Findings for Efficacy and Safety of Alogliptin Used in Combination With α-glucosidase Inhibitor in Participants With Type 2 Diabetes in Japan (NCT NCT01263483)

NCT ID: NCT01263483

Last Updated: 2012-02-03

Results Overview

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 week 12 or final visit and glycosylated hemoglobin collected at baseline.

• Recruitment status: COMPLETED
• Study phase: PHASE2/PHASE3
• Target enrollment: 230 participants
• Primary outcome timeframe: Baseline and Week 12.
• Results posted on: 2012-02-03

Participant Flow

Participants enrolled at investigative sites in Japan from to .

Participants with a historical diagnosis of type 2 diabetes mellitus with uncontrolled blood glucose despite diet and exercise therapies were enrolled in one of 3, once-daily (QD) or three-times daily (TID) treatment groups.

Participant milestones

Measure	Voglibose 0.2 mg TID Alogliptin placebo-matching tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks.	Alogliptin 12.5 mg QD Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID	Alogliptin 25 mg QD and Voglibose 0.2 mg TID Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks.
Overall Study STARTED	75	76	79
Overall Study COMPLETED	68	74	74
Overall Study NOT COMPLETED	7	2	5

Reasons for withdrawal

Measure	Voglibose 0.2 mg TID Alogliptin placebo-matching tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks.	Alogliptin 12.5 mg QD Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID	Alogliptin 25 mg QD and Voglibose 0.2 mg TID Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks.
Overall Study Adverse Event	4	0	3
Overall Study Withdrawal by Subject	1	0	0
Overall Study Lack of Efficacy	2	0	0
Overall Study Protocol Violation	0	1	1
Overall Study Participant Unavailability	0	1	1

Baseline Characteristics

Efficacy and Safety of Alogliptin Used in Combination With α-glucosidase Inhibitor in Participants With Type 2 Diabetes in Japan

Baseline characteristics by cohort

Measure	Voglibose 0.2 mg TID n=75 Participants Alogliptin placebo-matching tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks.	Alogliptin 12.5 mg QD n=76 Participants Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID	Alogliptin 25 mg QD and Voglibose 0.2 mg TID n=79 Participants Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks.	Total n=230 Participants Total of all reporting groups
Age, Customized ≤ 64 years	39 participants n=93 Participants	52 participants n=4 Participants	39 participants n=27 Participants	130 participants n=483 Participants
Age, Customized ≥ 65 years	36 participants n=93 Participants	24 participants n=4 Participants	40 participants n=27 Participants	100 participants n=483 Participants
Sex: Female, Male Female	27 Participants n=93 Participants	32 Participants n=4 Participants	29 Participants n=27 Participants	88 Participants n=483 Participants
Sex: Female, Male Male	48 Participants n=93 Participants	44 Participants n=4 Participants	50 Participants n=27 Participants	142 Participants n=483 Participants

PRIMARY outcome

Timeframe: Baseline and Week 12.

Population: Analysis based on last observation carried forward, where the last postbaseline double-blind observed value is carried forward and used for all subsequent scheduled time points where data is missing. Values are from the Full Analysis Set.

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 week 12 or final visit and glycosylated hemoglobin collected at baseline.

Outcome measures

Measure	Voglibose 0.2 mg TID n=74 Participants Alogliptin placebo-matching tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks.	Alogliptin 12.5 mg QD n=76 Participants Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID	Alogliptin 25 mg QD and Voglibose 0.2 mg TID n=79 Participants Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks.
Change From Baseline in Glycosylated Hemoglobin (Week 12).	0.04 percentage of Glycosylated Hemoglobin Standard Deviation 0.457	-0.96 percentage of Glycosylated Hemoglobin Standard Deviation 0.553	-0.91 percentage of Glycosylated Hemoglobin Standard Deviation 0.485

SECONDARY outcome

Timeframe: Baseline and Week 2.

Population: Analysis based on last observation carried forward, where the last postbaseline double-blind observed value is carried forward and used for all subsequent scheduled time points where data is missing. Values are from the Full Analysis Set.

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 week 2 and glycosylated hemoglobin collected at baseline.

Outcome measures

Measure	Voglibose 0.2 mg TID n=74 Participants Alogliptin placebo-matching tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks.	Alogliptin 12.5 mg QD n=76 Participants Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID	Alogliptin 25 mg QD and Voglibose 0.2 mg TID n=79 Participants Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks.
Change From Baseline in Glycosylated Hemoglobin (Week 2).	-0.01 percentage of Glycosylated Hemoglobin Standard Deviation 0.180	-0.19 percentage of Glycosylated Hemoglobin Standard Deviation 0.149	-0.21 percentage of Glycosylated Hemoglobin Standard Deviation 0.175

SECONDARY outcome

Timeframe: Baseline and Week 4.

Population: Analysis based on last observation carried forward, where the last postbaseline double-blind observed value is carried forward and used for all subsequent scheduled time points where data is missing. Values are from the Full Analysis Set.

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 week 4 and glycosylated hemoglobin collected at baseline.

Outcome measures

Measure	Voglibose 0.2 mg TID n=74 Participants Alogliptin placebo-matching tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks.	Alogliptin 12.5 mg QD n=76 Participants Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID	Alogliptin 25 mg QD and Voglibose 0.2 mg TID n=79 Participants Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks.
Change From Baseline in Glycosylated Hemoglobin (Week 4).	-0.02 percentage of Glycosylated Hemoglobin Standard Deviation 0.301	-0.44 percentage of Glycosylated Hemoglobin Standard Deviation 0.234	-0.43 percentage of Glycosylated Hemoglobin Standard Deviation 0.263

SECONDARY outcome

Timeframe: Baseline and Week 8.

Population: Analysis based on last observation carried forward, where the last postbaseline double-blind observed value is carried forward and used for all subsequent scheduled time points where data is missing. Values are from the Full Analysis Set.

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 week 8 and glycosylated hemoglobin collected at baseline.

Outcome measures

Measure	Voglibose 0.2 mg TID n=74 Participants Alogliptin placebo-matching tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks.	Alogliptin 12.5 mg QD n=76 Participants Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID	Alogliptin 25 mg QD and Voglibose 0.2 mg TID n=79 Participants Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks.
Change From Baseline in Glycosylated Hemoglobin (Week 8).	-0.01 percentage of Glycosylated Hemoglobin Standard Deviation 0.398	-0.74 percentage of Glycosylated Hemoglobin Standard Deviation 0.427	-0.75 percentage of Glycosylated Hemoglobin Standard Deviation 0.392

SECONDARY outcome

Timeframe: Baseline and Week 2

Population: Analysis based on last observation carried forward, where the last postbaseline double-blind observed value is carried forward and used for all subsequent scheduled time points where data is missing. Values are from the Full Analysis Set.

The change between the value of fasting plasma glucose collected at week 2 and fasting plasma glucose collected at baseline.

Outcome measures

Measure	Voglibose 0.2 mg TID n=73 Participants Alogliptin placebo-matching tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks.	Alogliptin 12.5 mg QD n=76 Participants Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID	Alogliptin 25 mg QD and Voglibose 0.2 mg TID n=79 Participants Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks.
Change From Baseline in Fasting Plasma Glucose (Week 2).	-3.5 mg/dL Standard Deviation 21.28	-15.5 mg/dL Standard Deviation 18.77	-18.8 mg/dL Standard Deviation 19.89

SECONDARY outcome

Timeframe: Baseline and Week 4.

Population: Analysis based on last observation carried forward, where the last postbaseline double-blind observed value is carried forward and used for all subsequent scheduled time points where data is missing. Values are from the Full Analysis Set.

The change between the value of fasting plasma glucose collected at week 4 and fasting plasma glucose collected at baseline.

Outcome measures

Measure	Voglibose 0.2 mg TID n=73 Participants Alogliptin placebo-matching tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks.	Alogliptin 12.5 mg QD n=76 Participants Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID	Alogliptin 25 mg QD and Voglibose 0.2 mg TID n=79 Participants Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks.
Change From Baseline in Fasting Plasma Glucose (Week 4).	-0.6 mg/dL Standard Deviation 23.71	-16.2 mg/dL Standard Deviation 21.84	-22.6 mg/dL Standard Deviation 23.96

SECONDARY outcome

Timeframe: Baseline and Week 8.

Population: Analysis based on last observation carried forward, where the last postbaseline double-blind observed value is carried forward and used for all subsequent scheduled time points where data is missing. Values are from the Full Analysis Set.

The change between the value of fasting plasma glucose collected at week 8 and fasting plasma glucose collected at baseline.

Outcome measures

Measure	Voglibose 0.2 mg TID n=73 Participants Alogliptin placebo-matching tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks.	Alogliptin 12.5 mg QD n=76 Participants Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID	Alogliptin 25 mg QD and Voglibose 0.2 mg TID n=79 Participants Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks.
Change From Baseline in Fasting Plasma Glucose (Week 8).	-2.5 mg/dL Standard Deviation 25.94	-20.8 mg/dL Standard Deviation 22.10	-21.9 mg/dL Standard Deviation 23.96

SECONDARY outcome

Timeframe: Baseline and Week 12.

Population: Analysis based on last observation carried forward, where the last postbaseline double-blind observed value is carried forward and used for all subsequent scheduled time points where data is missing. Values are from the Full Analysis Set.

The change between the value of fasting plasma glucose collected at week 12 or final visit and fasting plasma glucose collected at baseline.

Outcome measures

Measure	Voglibose 0.2 mg TID n=73 Participants Alogliptin placebo-matching tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks.	Alogliptin 12.5 mg QD n=76 Participants Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID	Alogliptin 25 mg QD and Voglibose 0.2 mg TID n=79 Participants Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks.
Change From Baseline in Fasting Plasma Glucose (Week 12).	-5.6 mg/dL Standard Deviation 27.87	-19.1 mg/dL Standard Deviation 20.70	-18.5 mg/dL Standard Deviation 25.53

SECONDARY outcome

Timeframe: Baseline and Week 2.

Population: Analysis based on last observation carried forward, where the last postbaseline double-blind observed value is carried forward and used for all subsequent scheduled time points where data is missing. Values are from the Full Analysis Set.

The change between the value of fasting C-peptide collected at week 2 and fasting C-peptide collected at baseline.

Outcome measures

Measure	Voglibose 0.2 mg TID n=73 Participants Alogliptin placebo-matching tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks.	Alogliptin 12.5 mg QD n=76 Participants Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID	Alogliptin 25 mg QD and Voglibose 0.2 mg TID n=79 Participants Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks.
Change From Baseline in Fasting C-peptide (Week 2).	0.03 ng/mL Standard Deviation 0.668	-0.07 ng/mL Standard Deviation 0.593	-0.01 ng/mL Standard Deviation 0.599

SECONDARY outcome

Timeframe: Baseline and Week 4.

Population: Analysis based on last observation carried forward, where the last postbaseline double-blind observed value is carried forward and used for all subsequent scheduled time points where data is missing. Values are from the Full Analysis Set.

The change between the value of fasting C-peptide collected at week 4 and fasting C-peptide collected at baseline.

Outcome measures

Measure	Voglibose 0.2 mg TID n=73 Participants Alogliptin placebo-matching tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks.	Alogliptin 12.5 mg QD n=76 Participants Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID	Alogliptin 25 mg QD and Voglibose 0.2 mg TID n=79 Participants Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks.
Change From Baseline in Fasting C-peptide (Week 4).	0.05 ng/mL Standard Deviation 0.753	0.06 ng/mL Standard Deviation 0.955	0.01 ng/mL Standard Deviation 0.682

SECONDARY outcome

Timeframe: Baseline and Week 8.

Population: Analysis based on last observation carried forward, where the last postbaseline double-blind observed value is carried forward and used for all subsequent scheduled time points where data is missing. Values are from the Full Analysis Set.

The change between the value of fasting C-peptide collected at week 8 and fasting C-peptide collected at baseline.

Outcome measures

Measure	Voglibose 0.2 mg TID n=73 Participants Alogliptin placebo-matching tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks.	Alogliptin 12.5 mg QD n=76 Participants Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID	Alogliptin 25 mg QD and Voglibose 0.2 mg TID n=79 Participants Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks.
Change From Baseline in Fasting C-peptide (Week 8).	0.07 ng/mL Standard Deviation 0.691	0.03 ng/mL Standard Deviation 0.725	-0.01 ng/mL Standard Deviation 0.468

SECONDARY outcome

Timeframe: Baseline and Week 12.

Population: Analysis based on last observation carried forward, where the last postbaseline double-blind observed value is carried forward and used for all subsequent scheduled time points where data is missing. Values are from the Full Analysis Set.

The change between the value of fasting C-peptide collected at week 12 or final visit and fasting C-peptide collected at baseline.

Outcome measures

Measure	Voglibose 0.2 mg TID n=73 Participants Alogliptin placebo-matching tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks.	Alogliptin 12.5 mg QD n=76 Participants Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID	Alogliptin 25 mg QD and Voglibose 0.2 mg TID n=79 Participants Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks.
Change From Baseline in Fasting C-peptide (Week 12).	0.02 ng/mL Standard Deviation 0.664	0.06 ng/mL Standard Deviation 0.680	0.10 ng/mL Standard Deviation 0.620

SECONDARY outcome

Timeframe: Baseline and Week 12.

Population: Values are from the Full Analysis Set.

The change between the value of blood glucose collected at week 12 or final visit and blood glucose collected at baseline. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and at 2 hours after the start of the meal.

Outcome measures

Measure	Voglibose 0.2 mg TID n=67 Participants Alogliptin placebo-matching tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks.	Alogliptin 12.5 mg QD n=75 Participants Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID	Alogliptin 25 mg QD and Voglibose 0.2 mg TID n=75 Participants Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks.
Change From Baseline in Blood Glucose Measured by Meal Tolerance Testing (2-hr Postprandial Value).	72.4 mg/dL Standard Deviation 34.89	40.9 mg/dL Standard Deviation 23.23	38.7 mg/dL Standard Deviation 32.33

SECONDARY outcome

Timeframe: Baseline and Week 12.

Population: Values are from the Full Analysis Set.

The change between the value of blood glucose collected at week 12 or final visit and blood glucose collected at baseline. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and at 2 hours after the start of the meal.

Outcome measures

Measure	Voglibose 0.2 mg TID n=67 Participants Alogliptin placebo-matching tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks.	Alogliptin 12.5 mg QD n=75 Participants Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID	Alogliptin 25 mg QD and Voglibose 0.2 mg TID n=74 Participants Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks.
Change From Baseline in Blood Glucose Measured by Meal Tolerance Testing (AUC (0-2)).	-4.3 mg·hr/dL Standard Deviation 60.23	-74.7 mg·hr/dL Standard Deviation 61.76	-76.8 mg·hr/dL Standard Deviation 63.19

SECONDARY outcome

Timeframe: Baseline and Week 12

Population: Values are from the Full Analysis Set.

The change between the value of insulin collected at week 12 or final visit and insulin collected at baseline as measured by the meal tolerance test. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and at 2 hours after the start of the meal.

Outcome measures

Measure	Voglibose 0.2 mg TID n=63 Participants Alogliptin placebo-matching tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks.	Alogliptin 12.5 mg QD n=70 Participants Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID	Alogliptin 25 mg QD and Voglibose 0.2 mg TID n=71 Participants Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks.
Change From Baseline in Insulin Measured by Meal Tolerance Testing (AUC(0-2).	-2.47 μU·hr/mL Standard Deviation 10.817	4.62 μU·hr/mL Standard Deviation 16.599	1.50 μU·hr/mL Standard Deviation 14.845

SECONDARY outcome

Timeframe: Baseline and Week 12.

Population: Values are from the Full Analysis Set.

The change between the value of C-peptide collected at week 12 or final visit and C-peptide collected at baseline as measured by the meal tolerance test. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and at 2 hours after the start of the meal.

Outcome measures

Measure	Voglibose 0.2 mg TID n=68 Participants Alogliptin placebo-matching tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks.	Alogliptin 12.5 mg QD n=75 Participants Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID	Alogliptin 25 mg QD and Voglibose 0.2 mg TID n=74 Participants Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks.
Change From Baseline in C-peptide Measured by Meal Tolerance Testing (AUC(0-2).	0.14 ng·hr/mL Standard Deviation 1.670	0.69 ng·hr/mL Standard Deviation 1.901	0.57 ng·hr/mL Standard Deviation 2.247

SECONDARY outcome

Timeframe: Baseline and Week 12

Population: Values are from the Full Analysis Set.

The change between the value of glucagons collected at week 12 or final visit and glucagons collected at baseline. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and at 2 hours after the start of the meal.

Outcome measures

Measure	Voglibose 0.2 mg TID n=68 Participants Alogliptin placebo-matching tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks.	Alogliptin 12.5 mg QD n=75 Participants Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID	Alogliptin 25 mg QD and Voglibose 0.2 mg TID n=75 Participants Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks.
Change From Baseline in Glucagon Measured by Meal Tolerance Testing (AUC (0-2)).	-0.4 pg·hr/mL Standard Deviation 64.18	-19.2 pg·hr/mL Standard Deviation 42.72	-20.5 pg·hr/mL Standard Deviation 41.97

Adverse Events

Voglibose 0.2 mg TID

Serious events: 9 serious events

Other events: 7 other events

Deaths: 0 deaths

Alogliptin 12.5 mg QD

Serious events: 0 serious events

Other events: 18 other events

Deaths: 0 deaths

Alogliptin 25 mg QD and Voglibose 0.2 mg TID

Serious events: 1 serious events

Other events: 13 other events

Deaths: 0 deaths

Serious adverse events

Measure	Voglibose 0.2 mg TID n=75 participants at risk Alogliptin placebo-matching tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks.	Alogliptin 12.5 mg QD n=76 participants at risk Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID	Alogliptin 25 mg QD and Voglibose 0.2 mg TID n=79 participants at risk Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks.
Infections and infestations Osteomyelitis	1.3% 1/75 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and the last dose of double-blind study drug. 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.	0.00% 0/76 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and the last dose of double-blind study drug. 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.	0.00% 0/79 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and the last dose of double-blind study drug. 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 Pneumonia	1.3% 1/75 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and the last dose of double-blind study drug. 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.	0.00% 0/76 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and the last dose of double-blind study drug. 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.	1.3% 1/79 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and the last dose of double-blind study drug. 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 acute	1.3% 1/75 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and the last dose of double-blind study drug. 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.	0.00% 0/76 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and the last dose of double-blind study drug. 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.	0.00% 0/79 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and the last dose of double-blind study drug. 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 Cerebral infarction	1.3% 1/75 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and the last dose of double-blind study drug. 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.	0.00% 0/76 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and the last dose of double-blind study drug. 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.	0.00% 0/79 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and the last dose of double-blind study drug. 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.
Cardiac disorders Acute myocardial infarction	1.3% 1/75 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and the last dose of double-blind study drug. 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.	0.00% 0/76 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and the last dose of double-blind study drug. 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.	0.00% 0/79 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and the last dose of double-blind study drug. 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.
Blood and lymphatic system disorders Cardiac failure acute	1.3% 1/75 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and the last dose of double-blind study drug. 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.	0.00% 0/76 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and the last dose of double-blind study drug. 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.	0.00% 0/79 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and the last dose of double-blind study drug. 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.
Cardiac disorders Intracardiac thrombus	1.3% 1/75 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and the last dose of double-blind study drug. 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.	0.00% 0/76 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and the last dose of double-blind study drug. 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.	0.00% 0/79 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and the last dose of double-blind study drug. 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 Periodontitis	1.3% 1/75 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and the last dose of double-blind study drug. 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.	0.00% 0/76 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and the last dose of double-blind study drug. 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.	0.00% 0/79 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and the last dose of double-blind study drug. 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 Fall	1.3% 1/75 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and the last dose of double-blind study drug. 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.	0.00% 0/76 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and the last dose of double-blind study drug. 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.	0.00% 0/79 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and the last dose of double-blind study drug. 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

Measure	Voglibose 0.2 mg TID n=75 participants at risk Alogliptin placebo-matching tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks.	Alogliptin 12.5 mg QD n=76 participants at risk Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID	Alogliptin 25 mg QD and Voglibose 0.2 mg TID n=79 participants at risk Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks.
Infections and infestations Nasopharyngitis	5.3% 4/75 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and the last dose of double-blind study drug. 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.	22.4% 17/76 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and the last dose of double-blind study drug. 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.	16.5% 13/79 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and the last dose of double-blind study drug. 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.
Skin and subcutaneous tissue disorders Eczema	4.0% 3/75 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and the last dose of double-blind study drug. 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.	1.3% 1/76 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and the last dose of double-blind study drug. 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.	0.00% 0/79 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and the last dose of double-blind study drug. 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

General Manager

Japan Development Center, Pharmaceutical Development Division

Phone: +81-6-6204-5257

Email: clinicaltrialregistry@tpna.com

Results disclosure agreements

• Principal investigator is a sponsor employee The clinical trial contract states that information should never be disclosed without prior consent of the sponsor, although it does not specify the number of days during which disclosure of information is limited.
• Publication restrictions are in place

Restriction type: OTHER