Trial Outcomes & Findings for Efficacy and Safety of Alogliptin in Participants With Type 2 Diabetes in Japan (NCT NCT01263470)

NCT ID: NCT01263470

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
• Target enrollment: 480 participants
• Primary outcome timeframe: Baseline and Week 12.
• Results posted on: 2012-02-03

Participant Flow

Participants enrolled at 54 investigative sites in Japan from 17 January 2007 to 22 December 2007.

Participants with a historical diagnosis of type 2 diabetes mellitus with uncontrolled blood glucose despite diet and exercise therapies were enrolled in one of 6, once-daily (QD) or three-times daily (TID) treatment groups.

Participant milestones

Measure	Placebo Placebo-matching tablets, orally, once or three times daily for up to 12 weeks.	Alogliptin 6.25 mg QD Alogliptin 6.25 mg, tablets, orally, once daily for up to 12 weeks.	Alogliptin 12.5 mg QD Alogliptin 12.5 mg, tablets, orally, once daily for up to 12 weeks.	Alogliptin 25 mg QD Alogliptin 25 mg, tablets, orally, once daily for up to 12 weeks.	Alogliptin 50 mg QD Alogliptin 50 mg, tablets, orally, once daily for up to 12 weeks.	Voglibose 0.2 mg TID Voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks.
Overall Study STARTED	75	79	84	80	79	83
Overall Study COMPLETED	73	74	80	77	76	78
Overall Study NOT COMPLETED	2	5	4	3	3	5

Reasons for withdrawal

Measure	Placebo Placebo-matching tablets, orally, once or three times daily for up to 12 weeks.	Alogliptin 6.25 mg QD Alogliptin 6.25 mg, tablets, orally, once daily for up to 12 weeks.	Alogliptin 12.5 mg QD Alogliptin 12.5 mg, tablets, orally, once daily for up to 12 weeks.	Alogliptin 25 mg QD Alogliptin 25 mg, tablets, orally, once daily for up to 12 weeks.	Alogliptin 50 mg QD Alogliptin 50 mg, tablets, orally, once daily for up to 12 weeks.	Voglibose 0.2 mg TID Voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks.
Overall Study Adverse Event	2	2	1	1	2	2
Overall Study Protocol Violation	0	1	0	0	0	1
Overall Study Withdrawal by Subject	0	1	1	2	0	2
Overall Study Lack of Efficacy	0	0	2	0	0	0
Overall Study Participant Unavailability	0	1	0	0	0	0
Overall Study Study Drug Non-compliance	0	0	0	0	1	0

Baseline Characteristics

Efficacy and Safety of Alogliptin in Participants With Type 2 Diabetes in Japan

Baseline characteristics by cohort

Measure	Placebo n=75 Participants Placebo-matching tablets, orally, once or three times daily for up to 12 weeks.	Alogliptin 6.25 mg QD n=79 Participants Alogliptin 6.25 mg, tablets, orally, once daily for up to 12 weeks.	Alogliptin 12.5 mg QD n=84 Participants Alogliptin 12.5 mg, tablets, orally, once daily for up to 12 weeks.	Alogliptin 25 mg QD n=80 Participants Alogliptin 25 mg, tablets, orally, once daily for up to 12 weeks.	Alogliptin 50 mg QD n=79 Participants Alogliptin 50 mg, tablets, orally, once daily for up to 12 weeks.	Voglibose 0.2 mg TID n=83 Participants Voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks.	Total n=480 Participants Total of all reporting groups
Age, Customized ≤ 64 years	48 participants n=5 Participants	58 participants n=7 Participants	56 participants n=5 Participants	52 participants n=4 Participants	54 participants n=21 Participants	51 participants n=10 Participants	319 participants n=115 Participants
Age, Customized ≥ 65 years	27 participants n=5 Participants	21 participants n=7 Participants	28 participants n=5 Participants	28 participants n=4 Participants	25 participants n=21 Participants	32 participants n=10 Participants	161 participants n=115 Participants
Sex: Female, Male Female	19 Participants n=5 Participants	23 Participants n=7 Participants	25 Participants n=5 Participants	17 Participants n=4 Participants	24 Participants n=21 Participants	27 Participants n=10 Participants	135 Participants n=115 Participants
Sex: Female, Male Male	56 Participants n=5 Participants	56 Participants n=7 Participants	59 Participants n=5 Participants	63 Participants n=4 Participants	55 Participants n=21 Participants	56 Participants n=10 Participants	345 Participants n=115 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	Placebo n=75 Participants Placebo-matching tablets, orally, once or three times daily for up to 12 weeks.	Alogliptin 6.25 mg QD n=79 Participants Alogliptin 6.25 mg, tablets, orally, once daily for up to 12 weeks.	Alogliptin 12.5 mg QD n=84 Participants Alogliptin 12.5 mg, tablets, orally, once daily for up to 12 weeks.	Alogliptin 25 mg QD n=79 Participants Alogliptin 25 mg, tablets, orally, once daily for up to 12 weeks.	Alogliptin 50 mg QD n=79 Participants Alogliptin 50 mg, tablets, orally, once daily for up to 12 weeks.	Voglibose 0.2 mg TID n=83 Participants Voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks.
Change From Baseline in Glycosylated Hemoglobin (Week 12).	0.06 percentage of Glycosylated Hemoglobin Standard Deviation 0.456	-0.51 percentage of Glycosylated Hemoglobin Standard Deviation 0.677	-0.70 percentage of Glycosylated Hemoglobin Standard Deviation 0.572	-0.76 percentage of Glycosylated Hemoglobin Standard Deviation 0.547	-0.82 percentage of Glycosylated Hemoglobin Standard Deviation 0.474	-0.16 percentage of Glycosylated Hemoglobin Standard Deviation 0.730

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	Placebo n=75 Participants Placebo-matching tablets, orally, once or three times daily for up to 12 weeks.	Alogliptin 6.25 mg QD n=79 Participants Alogliptin 6.25 mg, tablets, orally, once daily for up to 12 weeks.	Alogliptin 12.5 mg QD n=84 Participants Alogliptin 12.5 mg, tablets, orally, once daily for up to 12 weeks.	Alogliptin 25 mg QD n=79 Participants Alogliptin 25 mg, tablets, orally, once daily for up to 12 weeks.	Alogliptin 50 mg QD n=79 Participants Alogliptin 50 mg, tablets, orally, once daily for up to 12 weeks.	Voglibose 0.2 mg TID n=83 Participants Voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks.
Change From Baseline in Glycosylated Hemoglobin (Week 2).	0.00 percentage of Glycosylated Hemoglobin Standard Deviation 0.187	-0.16 percentage of Glycosylated Hemoglobin Standard Deviation 0.153	-0.17 percentage of Glycosylated Hemoglobin Standard Deviation 0.194	-0.16 percentage of Glycosylated Hemoglobin Standard Deviation 0.187	-0.15 percentage of Glycosylated Hemoglobin Standard Deviation 0.180	-0.10 percentage of Glycosylated Hemoglobin Standard Deviation 0.204

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	Placebo n=75 Participants Placebo-matching tablets, orally, once or three times daily for up to 12 weeks.	Alogliptin 6.25 mg QD n=79 Participants Alogliptin 6.25 mg, tablets, orally, once daily for up to 12 weeks.	Alogliptin 12.5 mg QD n=84 Participants Alogliptin 12.5 mg, tablets, orally, once daily for up to 12 weeks.	Alogliptin 25 mg QD n=79 Participants Alogliptin 25 mg, tablets, orally, once daily for up to 12 weeks.	Alogliptin 50 mg QD n=79 Participants Alogliptin 50 mg, tablets, orally, once daily for up to 12 weeks.	Voglibose 0.2 mg TID n=83 Participants Voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks.
Change From Baseline in Glycosylated Hemoglobin (Week 4).	-0.01 percentage of Glycosylated Hemoglobin Standard Deviation 0.336	-0.34 percentage of Glycosylated Hemoglobin Standard Deviation 0.243	-0.38 percentage of Glycosylated Hemoglobin Standard Deviation 0.309	-0.35 percentage of Glycosylated Hemoglobin Standard Deviation 0.281	-0.40 percentage of Glycosylated Hemoglobin Standard Deviation 0.284	-0.16 percentage of Glycosylated Hemoglobin Standard Deviation 0.395

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	Placebo n=75 Participants Placebo-matching tablets, orally, once or three times daily for up to 12 weeks.	Alogliptin 6.25 mg QD n=79 Participants Alogliptin 6.25 mg, tablets, orally, once daily for up to 12 weeks.	Alogliptin 12.5 mg QD n=84 Participants Alogliptin 12.5 mg, tablets, orally, once daily for up to 12 weeks.	Alogliptin 25 mg QD n=79 Participants Alogliptin 25 mg, tablets, orally, once daily for up to 12 weeks.	Alogliptin 50 mg QD n=79 Participants Alogliptin 50 mg, tablets, orally, once daily for up to 12 weeks.	Voglibose 0.2 mg TID n=83 Participants Voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks.
Change From Baseline in Glycosylated Hemoglobin (Week 8).	0.00 percentage of Glycosylated Hemoglobin Standard Deviation 0.473	-0.50 percentage of Glycosylated Hemoglobin Standard Deviation 0.432	-0.61 percentage of Glycosylated Hemoglobin Standard Deviation 0.481	-0.66 percentage of Glycosylated Hemoglobin Standard Deviation 0.432	-0.69 percentage of Glycosylated Hemoglobin Standard Deviation 0.382	-0.17 percentage of Glycosylated Hemoglobin Standard Deviation 0.634

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	Placebo n=75 Participants Placebo-matching tablets, orally, once or three times daily for up to 12 weeks.	Alogliptin 6.25 mg QD n=79 Participants Alogliptin 6.25 mg, tablets, orally, once daily for up to 12 weeks.	Alogliptin 12.5 mg QD n=84 Participants Alogliptin 12.5 mg, tablets, orally, once daily for up to 12 weeks.	Alogliptin 25 mg QD n=79 Participants Alogliptin 25 mg, tablets, orally, once daily for up to 12 weeks.	Alogliptin 50 mg QD n=79 Participants Alogliptin 50 mg, tablets, orally, once daily for up to 12 weeks.	Voglibose 0.2 mg TID n=83 Participants Voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks.
Change From Baseline in Fasting Plasma Glucose (Week 2).	1.8 mg/dL Standard Deviation 28.26	-13.8 mg/dL Standard Deviation 19.31	-15.9 mg/dL Standard Deviation 20.26	-14.3 mg/dL Standard Deviation 22.13	-21.7 mg/dL Standard Deviation 25.65	-8.0 mg/dL Standard Deviation 24.34

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	Placebo n=75 Participants Placebo-matching tablets, orally, once or three times daily for up to 12 weeks.	Alogliptin 6.25 mg QD n=79 Participants Alogliptin 6.25 mg, tablets, orally, once daily for up to 12 weeks.	Alogliptin 12.5 mg QD n=84 Participants Alogliptin 12.5 mg, tablets, orally, once daily for up to 12 weeks.	Alogliptin 25 mg QD n=79 Participants Alogliptin 25 mg, tablets, orally, once daily for up to 12 weeks.	Alogliptin 50 mg QD n=79 Participants Alogliptin 50 mg, tablets, orally, once daily for up to 12 weeks.	Voglibose 0.2 mg TID n=83 Participants Voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks.
Change From Baseline in Fasting Plasma Glucose (Week 4).	8.4 mg/dL Standard Deviation 30.74	-16.0 mg/dL Standard Deviation 20.88	-20.9 mg/dL Standard Deviation 19.78	-19.0 mg/dL Standard Deviation 20.64	-23.3 mg/dL Standard Deviation 23.40	-7.2 mg/dL Standard Deviation 26.77

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	Placebo n=75 Participants Placebo-matching tablets, orally, once or three times daily for up to 12 weeks.	Alogliptin 6.25 mg QD n=79 Participants Alogliptin 6.25 mg, tablets, orally, once daily for up to 12 weeks.	Alogliptin 12.5 mg QD n=84 Participants Alogliptin 12.5 mg, tablets, orally, once daily for up to 12 weeks.	Alogliptin 25 mg QD n=79 Participants Alogliptin 25 mg, tablets, orally, once daily for up to 12 weeks.	Alogliptin 50 mg QD n=79 Participants Alogliptin 50 mg, tablets, orally, once daily for up to 12 weeks.	Voglibose 0.2 mg TID n=83 Participants Voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks.
Change From Baseline in Fasting Plasma Glucose (Week 8).	5.7 mg/dL Standard Deviation 27.40	-12.0 mg/dL Standard Deviation 27.77	-18.5 mg/dL Standard Deviation 22.71	-18.6 mg/dL Standard Deviation 20.58	-22.6 mg/dL Standard Deviation 27.60	-3.5 mg/dL Standard Deviation 28.45

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	Placebo n=75 Participants Placebo-matching tablets, orally, once or three times daily for up to 12 weeks.	Alogliptin 6.25 mg QD n=79 Participants Alogliptin 6.25 mg, tablets, orally, once daily for up to 12 weeks.	Alogliptin 12.5 mg QD n=84 Participants Alogliptin 12.5 mg, tablets, orally, once daily for up to 12 weeks.	Alogliptin 25 mg QD n=79 Participants Alogliptin 25 mg, tablets, orally, once daily for up to 12 weeks.	Alogliptin 50 mg QD n=79 Participants Alogliptin 50 mg, tablets, orally, once daily for up to 12 weeks.	Voglibose 0.2 mg TID n=83 Participants 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 25.26	-9.3 mg/dL Standard Deviation 32.36	-14.6 mg/dL Standard Deviation 23.80	-17.5 mg/dL Standard Deviation 20.71	-22.6 mg/dL Standard Deviation 24.24	-3.0 mg/dL Standard Deviation 27.69

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	Placebo n=75 Participants Placebo-matching tablets, orally, once or three times daily for up to 12 weeks.	Alogliptin 6.25 mg QD n=79 Participants Alogliptin 6.25 mg, tablets, orally, once daily for up to 12 weeks.	Alogliptin 12.5 mg QD n=84 Participants Alogliptin 12.5 mg, tablets, orally, once daily for up to 12 weeks.	Alogliptin 25 mg QD n=79 Participants Alogliptin 25 mg, tablets, orally, once daily for up to 12 weeks.	Alogliptin 50 mg QD n=79 Participants Alogliptin 50 mg, tablets, orally, once daily for up to 12 weeks.	Voglibose 0.2 mg TID n=83 Participants Voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks.
Change From Baseline in Fasting C-peptide (Week 2).	0.04 ng/mL Standard Deviation 0.772	-0.11 ng/mL Standard Deviation 0.731	0.17 ng/mL Standard Deviation 0.756	0.18 ng/mL Standard Deviation 0.776	0.04 ng/mL Standard Deviation 0.619	-0.11 ng/mL Standard Deviation 0.830

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	Placebo n=75 Participants Placebo-matching tablets, orally, once or three times daily for up to 12 weeks.	Alogliptin 6.25 mg QD n=79 Participants Alogliptin 6.25 mg, tablets, orally, once daily for up to 12 weeks.	Alogliptin 12.5 mg QD n=84 Participants Alogliptin 12.5 mg, tablets, orally, once daily for up to 12 weeks.	Alogliptin 25 mg QD n=79 Participants Alogliptin 25 mg, tablets, orally, once daily for up to 12 weeks.	Alogliptin 50 mg QD n=79 Participants Alogliptin 50 mg, tablets, orally, once daily for up to 12 weeks.	Voglibose 0.2 mg TID n=83 Participants Voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks.
Change From Baseline in Fasting C-peptide (Week 4).	0.01 ng/mL Standard Deviation 0.624	-0.04 ng/mL Standard Deviation 0.634	0.02 ng/mL Standard Deviation 0.636	0.16 ng/mL Standard Deviation 0.697	0.05 ng/mL Standard Deviation 0.554	-0.16 ng/mL Standard Deviation 0.767

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	Placebo n=75 Participants Placebo-matching tablets, orally, once or three times daily for up to 12 weeks.	Alogliptin 6.25 mg QD n=79 Participants Alogliptin 6.25 mg, tablets, orally, once daily for up to 12 weeks.	Alogliptin 12.5 mg QD n=84 Participants Alogliptin 12.5 mg, tablets, orally, once daily for up to 12 weeks.	Alogliptin 25 mg QD n=79 Participants Alogliptin 25 mg, tablets, orally, once daily for up to 12 weeks.	Alogliptin 50 mg QD n=79 Participants Alogliptin 50 mg, tablets, orally, once daily for up to 12 weeks.	Voglibose 0.2 mg TID n=83 Participants Voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks.
Change From Baseline in Fasting C-peptide (Week 8).	0.17 ng/mL Standard Deviation 0.882	0.05 ng/mL Standard Deviation 1.144	0.07 ng/mL Standard Deviation 0.792	0.24 ng/mL Standard Deviation 0.646	0.05 ng/mL Standard Deviation 0.592	-0.05 ng/mL Standard Deviation 0.804

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	Placebo n=75 Participants Placebo-matching tablets, orally, once or three times daily for up to 12 weeks.	Alogliptin 6.25 mg QD n=79 Participants Alogliptin 6.25 mg, tablets, orally, once daily for up to 12 weeks.	Alogliptin 12.5 mg QD n=84 Participants Alogliptin 12.5 mg, tablets, orally, once daily for up to 12 weeks.	Alogliptin 25 mg QD n=79 Participants Alogliptin 25 mg, tablets, orally, once daily for up to 12 weeks.	Alogliptin 50 mg QD n=79 Participants Alogliptin 50 mg, tablets, orally, once daily for up to 12 weeks.	Voglibose 0.2 mg TID n=83 Participants Voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks.
Change From Baseline in Fasting C-peptide (Week 12).	-0.00 ng/mL Standard Deviation 0.692	0.04 ng/mL Standard Deviation 0.967	0.17 ng/mL Standard Deviation 0.609	0.25 ng/mL Standard Deviation 0.591	0.18 ng/mL Standard Deviation 0.696	-0.02 ng/mL Standard Deviation 0.888

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 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	Placebo n=73 Participants Placebo-matching tablets, orally, once or three times daily for up to 12 weeks.	Alogliptin 6.25 mg QD n=76 Participants Alogliptin 6.25 mg, tablets, orally, once daily for up to 12 weeks.	Alogliptin 12.5 mg QD n=80 Participants Alogliptin 12.5 mg, tablets, orally, once daily for up to 12 weeks.	Alogliptin 25 mg QD n=78 Participants Alogliptin 25 mg, tablets, orally, once daily for up to 12 weeks.	Alogliptin 50 mg QD n=76 Participants Alogliptin 50 mg, tablets, orally, once daily for up to 12 weeks.	Voglibose 0.2 mg TID n=79 Participants 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).	-4.2 mg/dL Standard Deviation 42.10	-28.1 mg/dL Standard Deviation 49.50	-27.6 mg/dL Standard Deviation 43.88	-44.8 mg/dL Standard Deviation 36.04	-47.0 mg/dL Standard Deviation 32.66	-22.7 mg/dL Standard Deviation 40.58

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 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	Placebo n=73 Participants Placebo-matching tablets, orally, once or three times daily for up to 12 weeks.	Alogliptin 6.25 mg QD n=76 Participants Alogliptin 6.25 mg, tablets, orally, once daily for up to 12 weeks.	Alogliptin 12.5 mg QD n=80 Participants Alogliptin 12.5 mg, tablets, orally, once daily for up to 12 weeks.	Alogliptin 25 mg QD n=78 Participants Alogliptin 25 mg, tablets, orally, once daily for up to 12 weeks.	Alogliptin 50 mg QD n=76 Participants Alogliptin 50 mg, tablets, orally, once daily for up to 12 weeks.	Voglibose 0.2 mg TID n=79 Participants 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 - Area Under the Curve at 2 Hours (AUC (0-2)).	5.6 mg·hr/dL Standard Deviation 62.45	-52.7 mg·hr/dL Standard Deviation 75.51	-55.0 mg·hr/dL Standard Deviation 63.73	-73.1 mg·hr/dL Standard Deviation 51.21	-81.8 mg·hr/dL Standard Deviation 53.69	-50.0 mg·hr/dL Standard Deviation 62.49

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 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 2 hours after the start of the meal.

Outcome measures

Measure	Placebo n=69 Participants Placebo-matching tablets, orally, once or three times daily for up to 12 weeks.	Alogliptin 6.25 mg QD n=71 Participants Alogliptin 6.25 mg, tablets, orally, once daily for up to 12 weeks.	Alogliptin 12.5 mg QD n=78 Participants Alogliptin 12.5 mg, tablets, orally, once daily for up to 12 weeks.	Alogliptin 25 mg QD n=70 Participants Alogliptin 25 mg, tablets, orally, once daily for up to 12 weeks.	Alogliptin 50 mg QD n=72 Participants Alogliptin 50 mg, tablets, orally, once daily for up to 12 weeks.	Voglibose 0.2 mg TID n=68 Participants Voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks.
Change From Baseline in Insulin Measured by Meal Tolerance Testing - Area Under the Curve at 2 Hours (AUC(0-2)).	-3.60 μU·hr/mL Standard Deviation 12.940	-0.74 μU·hr/mL Standard Deviation 19.745	1.86 μU·hr/mL Standard Deviation 15.602	4.12 μU·hr/mL Standard Deviation 14.057	-1.04 μU·hr/mL Standard Deviation 23.333	-15.40 μU·hr/mL Standard Deviation 20.416

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 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 2 hours after the start of the meal.

Outcome measures

Measure	Placebo n=73 Participants Placebo-matching tablets, orally, once or three times daily for up to 12 weeks.	Alogliptin 6.25 mg QD n=76 Participants Alogliptin 6.25 mg, tablets, orally, once daily for up to 12 weeks.	Alogliptin 12.5 mg QD n=80 Participants Alogliptin 12.5 mg, tablets, orally, once daily for up to 12 weeks.	Alogliptin 25 mg QD n=78 Participants Alogliptin 25 mg, tablets, orally, once daily for up to 12 weeks.	Alogliptin 50 mg QD n=76 Participants Alogliptin 50 mg, tablets, orally, once daily for up to 12 weeks.	Voglibose 0.2 mg TID n=79 Participants 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).	0.01 ng·hr/mL Standard Deviation 1.628	0.54 ng·hr/mL Standard Deviation 1.787	0.77 ng·hr/mL Standard Deviation 1.804	1.01 ng·hr/mL Standard Deviation 1.957	0.97 ng·hr/mL Standard Deviation 1.642	-0.39 ng·hr/mL Standard Deviation 2.091

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 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 2 hours after the start of the meal.

Outcome measures

Measure	Placebo n=72 Participants Placebo-matching tablets, orally, once or three times daily for up to 12 weeks.	Alogliptin 6.25 mg QD n=75 Participants Alogliptin 6.25 mg, tablets, orally, once daily for up to 12 weeks.	Alogliptin 12.5 mg QD n=79 Participants Alogliptin 12.5 mg, tablets, orally, once daily for up to 12 weeks.	Alogliptin 25 mg QD n=78 Participants Alogliptin 25 mg, tablets, orally, once daily for up to 12 weeks.	Alogliptin 50 mg QD n=76 Participants Alogliptin 50 mg, tablets, orally, once daily for up to 12 weeks.	Voglibose 0.2 mg TID n=79 Participants 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)).	-15.8 pg·hr/mL Standard Deviation 36.91	-11.5 pg·hr/mL Standard Deviation 37.45	-4.5 pg·hr/mL Standard Deviation 38.54	-12.6 pg·hr/mL Standard Deviation 47.23	-19.5 pg·hr/mL Standard Deviation 40.47	-16.3 pg·hr/mL Standard Deviation 52.26

Adverse Events

Placebo

Serious events: 1 serious events

Other events: 20 other events

Deaths: 0 deaths

Alogliptin 6.25 mg QD

Serious events: 2 serious events

Other events: 17 other events

Deaths: 0 deaths

Alogliptin 12.5 mg QD

Serious events: 2 serious events

Other events: 23 other events

Deaths: 0 deaths

Alogliptin 25 mg QD

Serious events: 1 serious events

Other events: 27 other events

Deaths: 0 deaths

Alogliptin 50 mg QD

Serious events: 2 serious events

Other events: 23 other events

Deaths: 0 deaths

Voglibose 0.2 mg TID

Serious events: 2 serious events

Other events: 38 other events

Deaths: 0 deaths

Serious adverse events

Measure	Placebo n=75 participants at risk Placebo-matching tablets, orally, once or three times daily for up to 12 weeks.	Alogliptin 6.25 mg QD n=79 participants at risk Alogliptin 6.25 mg, tablets, orally, once daily for up to 12 weeks.	Alogliptin 12.5 mg QD n=84 participants at risk Alogliptin 12.5 mg, tablets, orally, once daily for up to 12 weeks.	Alogliptin 25 mg QD n=80 participants at risk Alogliptin 25 mg, tablets, orally, once daily for up to 12 weeks.	Alogliptin 50 mg QD n=79 participants at risk Alogliptin 50 mg, tablets, orally, once daily for up to 12 weeks.	Voglibose 0.2 mg TID n=83 participants at risk Voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks.
Gastrointestinal disorders Crohn's disease	0.00% 0/75 • 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% 0/79 • 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.	0.00% 0/84 • 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.	1.2% 1/80 • 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.	0.00% 0/83 • 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 Inguinal hernia	0.00% 0/75 • 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% 0/79 • 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.	1.2% 1/84 • 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% 0/80 • 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.	0.00% 0/83 • 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 Gastroenteritis	0.00% 0/75 • 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% 0/79 • 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.	0.00% 0/84 • 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% 0/80 • 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.	0.00% 0/83 • 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	0.00% 0/75 • 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% 0/79 • 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.	0.00% 0/84 • 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% 0/80 • 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.	1.2% 1/83 • 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.
Hepatobiliary disorders Bile duct stone	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% 0/79 • 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.	0.00% 0/84 • 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% 0/80 • 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.	0.00% 0/83 • 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.
Hepatobiliary disorders Cholelithiasis	0.00% 0/75 • 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% 0/79 • 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.	1.2% 1/84 • 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% 0/80 • 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.	0.00% 0/83 • 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	0.00% 0/75 • 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% 1/79 • 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.	0.00% 0/84 • 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% 0/80 • 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.	0.00% 0/83 • 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Meningioma	0.00% 0/75 • 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% 1/79 • 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.	0.00% 0/84 • 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% 0/80 • 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.	0.00% 0/83 • 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Papillary thyroid cancer	0.00% 0/75 • 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% 0/79 • 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.	0.00% 0/84 • 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% 0/80 • 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.	0.00% 0/83 • 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer female	0.00% 0/75 • 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% 0/79 • 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.	0.00% 0/84 • 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% 0/80 • 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.	1.2% 1/83 • 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	Placebo n=75 participants at risk Placebo-matching tablets, orally, once or three times daily for up to 12 weeks.	Alogliptin 6.25 mg QD n=79 participants at risk Alogliptin 6.25 mg, tablets, orally, once daily for up to 12 weeks.	Alogliptin 12.5 mg QD n=84 participants at risk Alogliptin 12.5 mg, tablets, orally, once daily for up to 12 weeks.	Alogliptin 25 mg QD n=80 participants at risk Alogliptin 25 mg, tablets, orally, once daily for up to 12 weeks.	Alogliptin 50 mg QD n=79 participants at risk Alogliptin 50 mg, tablets, orally, once daily for up to 12 weeks.	Voglibose 0.2 mg TID n=83 participants at risk Voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks.
Gastrointestinal disorders Flatulence	2.7% 2/75 • 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.	2.5% 2/79 • 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.	4.8% 4/84 • 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.	1.2% 1/80 • 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.	9.6% 8/83 • 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 Abdominal distension	0.00% 0/75 • 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% 1/79 • 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.	2.4% 2/84 • 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.	3.8% 3/80 • 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.	2.5% 2/79 • 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.	4.8% 4/83 • 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 Constipation	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.	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.	1.2% 1/84 • 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.	1.2% 1/80 • 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.	8.4% 7/83 • 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 Abdominal pain upper	0.00% 0/75 • 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% 1/79 • 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.	1.2% 1/84 • 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.	3.8% 3/80 • 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.	2.5% 2/79 • 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.	1.2% 1/83 • 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 Diarrhoea	2.7% 2/75 • 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% 0/79 • 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.	1.2% 1/84 • 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% 0/80 • 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.	3.6% 3/83 • 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 Gastritis	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.	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.	0.00% 0/84 • 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% 0/80 • 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.	3.6% 3/83 • 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 Nasopharyngitis	6.7% 5/75 • 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.	6.3% 5/79 • 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.	8.3% 7/84 • 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.	12.5% 10/80 • 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.	10.1% 8/79 • 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.	4.8% 4/83 • 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 Bronchitis	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.	3.8% 3/79 • 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.	2.4% 2/84 • 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% 0/80 • 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.	2.5% 2/79 • 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.	0.00% 0/83 • 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 Headache	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.	2.5% 2/79 • 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.	0.00% 0/84 • 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.	6.2% 5/80 • 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.	1.2% 1/83 • 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.
General disorders Malaise	0.00% 0/75 • 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% 0/79 • 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.	0.00% 0/84 • 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.	3.8% 3/80 • 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.	0.00% 0/83 • 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.
Metabolism and nutrition disorders Hyperlipidaemia	0.00% 0/75 • 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% 1/79 • 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.	0.00% 0/84 • 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% 0/80 • 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.	3.6% 3/83 • 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 Urticaria	0.00% 0/75 • 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% 0/79 • 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.	3.6% 3/84 • 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% 0/80 • 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.	0.00% 0/83 • 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.
Investigations Blood creatine phosphokinase increased	2.7% 2/75 • 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% 1/79 • 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.	2.4% 2/84 • 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.	1.2% 1/80 • 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.	5.1% 4/79 • 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.	4.8% 4/83 • 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