Trial Outcomes & Findings for Safety and Efficacy Study of Alogliptin on Glycemic Control in Subjects With Type 2 Diabetes. (NCT NCT00755846)

NCT ID: NCT00755846

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 day 85 or final visit and glycosylated hemoglobin collected at baseline.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 265 participants
• Primary outcome timeframe: Baseline and Day 85.
• Results posted on: 2012-02-03

Participant Flow

Participants enrolled at 62 sites in Chile and the United States from 17 March 2005 to 10 June 2005.

Participants with a historical diagnosis of type 2 diabetes mellitus who were either receiving no current treatment or currently treated with diet and exercise, a sulfonylurea, metformin, or a combination of a sulfonylurea and metformin enrolled in once daily (QD) groups.

Participant milestones

Measure	Placebo QD Alogliptin placebo-matching tablets, orally, once 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.	Alogliptin 100 mg QD Alogliptin 100 mg, tablets, orally, once daily for up to 12 weeks.
Overall Study STARTED	43	44	44	45	44	45
Overall Study COMPLETED	18	27	32	32	27	31
Overall Study NOT COMPLETED	25	17	12	13	17	14

Reasons for withdrawal

Measure	Placebo QD Alogliptin placebo-matching tablets, orally, once 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.	Alogliptin 100 mg QD Alogliptin 100 mg, tablets, orally, once daily for up to 12 weeks.
Overall Study Adverse Event	0	0	0	1	3	2
Overall Study Protocol Violation	1	1	1	1	1	1
Overall Study Lost to Follow-up	0	2	1	0	4	2
Overall Study Withdrawal by Subject	2	3	5	2	0	1
Overall Study Hyperglycemic Rescue	21	7	5	8	8	7
Overall Study Physician Decision	1	3	0	1	0	1
Overall Study Administrative Error	0	1	0	0	0	0
Overall Study Participant Non-compliance	0	0	0	0	1	0

Baseline Characteristics

Safety and Efficacy Study of Alogliptin on Glycemic Control in Subjects With Type 2 Diabetes.

Baseline characteristics by cohort

Measure	Placebo QD n=43 Participants Alogliptin placebo-matching tablets, orally, once daily for up to 12 weeks.	Alogliptin 6.25 mg QD n=44 Participants Alogliptin 6.25 mg, tablets, orally, once daily for up to 12 weeks	Alogliptin 12.5 mg QD n=44 Participants Alogliptin 12.5 mg, tablets, orally, once daily for up to 12 weeks.	Alogliptin 25 mg QD n=45 Participants Alogliptin 25 mg, tablets, orally, once daily for up to 12 weeks.	Alogliptin 50 mg QD n=44 Participants Alogliptin 50 mg, tablets, orally, once daily for up to 12 weeks.	Alogliptin 100 mg QD n=45 Participants Alogliptin 100 mg, tablets, orally, once daily for up to 12 weeks.	Total n=265 Participants Total of all reporting groups
Age, Customized <65 years	33 participants n=5 Participants	38 participants n=7 Participants	33 participants n=5 Participants	36 participants n=4 Participants	31 participants n=21 Participants	34 participants n=10 Participants	205 participants n=115 Participants
Age, Customized ≥65 years	10 participants n=5 Participants	6 participants n=7 Participants	11 participants n=5 Participants	9 participants n=4 Participants	13 participants n=21 Participants	11 participants n=10 Participants	60 participants n=115 Participants
Sex: Female, Male Female	24 Participants n=5 Participants	25 Participants n=7 Participants	22 Participants n=5 Participants	17 Participants n=4 Participants	26 Participants n=21 Participants	25 Participants n=10 Participants	139 Participants n=115 Participants
Sex: Female, Male Male	19 Participants n=5 Participants	19 Participants n=7 Participants	22 Participants n=5 Participants	28 Participants n=4 Participants	18 Participants n=21 Participants	20 Participants n=10 Participants	126 Participants n=115 Participants

PRIMARY outcome

Timeframe: Baseline and Day 85.

Population: Randomized subjects who received at least 1 dose of study drug (Intent to Treat), and who had measurements at baseline and at Day 85. Missing data are imputed using last observation carried forward (LOCF).

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 day 85 or final visit and glycosylated hemoglobin collected at baseline.

Outcome measures

Measure	Placebo QD n=41 Participants Alogliptin placebo-matching tablets, orally, once daily for up to 12 weeks.	Alogliptin 6.25 mg QD n=42 Participants Alogliptin 6.25 mg, tablets, orally, once daily for up to 12 weeks	Alogliptin 12.5 mg QD n=42 Participants Alogliptin 12.5 mg, tablets, orally, once daily for up to 12 weeks.	Alogliptin 25 mg QD n=45 Participants Alogliptin 25 mg, tablets, orally, once daily for up to 12 weeks.	Alogliptin 50 mg QD n=43 Participants Alogliptin 50 mg, tablets, orally, once daily for up to 12 weeks.	Alogliptin 100 mg QD n=44 Participants Alogliptin 100 mg, tablets, orally, once daily for up to 12 weeks.
Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Day 85.	-0.01 percentage of Glycosylated Hemoglobin Standard Error 0.135	-0.19 percentage of Glycosylated Hemoglobin Standard Error 0.121	-0.54 percentage of Glycosylated Hemoglobin Standard Error 0.122	-0.56 percentage of Glycosylated Hemoglobin Standard Error 0.117	-0.44 percentage of Glycosylated Hemoglobin Standard Error 0.124	-0.51 percentage of Glycosylated Hemoglobin Standard Error 0.119

SECONDARY outcome

Timeframe: Baseline and Day 43.

Population: Randomized subjects who received at least 1 dose of study drug (Intent to treat), and who had measurements at baseline and at Day 43. Missing data are imputed using last observation carried forward (LOCF).

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 day 43 and glycosylated hemoglobin collected at baseline.

Outcome measures

Measure	Placebo QD n=41 Participants Alogliptin placebo-matching tablets, orally, once daily for up to 12 weeks.	Alogliptin 6.25 mg QD n=42 Participants Alogliptin 6.25 mg, tablets, orally, once daily for up to 12 weeks	Alogliptin 12.5 mg QD n=42 Participants Alogliptin 12.5 mg, tablets, orally, once daily for up to 12 weeks.	Alogliptin 25 mg QD n=44 Participants Alogliptin 25 mg, tablets, orally, once daily for up to 12 weeks.	Alogliptin 50 mg QD n=43 Participants Alogliptin 50 mg, tablets, orally, once daily for up to 12 weeks.	Alogliptin 100 mg QD n=44 Participants Alogliptin 100 mg, tablets, orally, once daily for up to 12 weeks.
Change From Baseline in Glycosylated Hemoglobin at Day 43.	0.02 percentage of Glycosylated Hemoglobin Standard Error 0.097	-0.12 percentage of Glycosylated Hemoglobin Standard Error 0.095	-0.35 percentage of Glycosylated Hemoglobin Standard Error 0.096	-0.36 percentage of Glycosylated Hemoglobin Standard Error 0.093	-0.32 percentage of Glycosylated Hemoglobin Standard Error 0.097	-0.31 percentage of Glycosylated Hemoglobin Standard Error 0.094

SECONDARY outcome

Timeframe: Baseline and Day 43

Population: Randomized subjects who received at least 1 dose of study drug (Intent to Treat), and who had measurements at baseline and at Day 43. Missing data are imputed using last observation carried forward (LOCF).

The change between the value of fasting plasma glucose collected at day 43 and fasting plasma glucose collected at baseline.

Outcome measures

Measure	Placebo QD n=41 Participants Alogliptin placebo-matching tablets, orally, once daily for up to 12 weeks.	Alogliptin 6.25 mg QD n=42 Participants Alogliptin 6.25 mg, tablets, orally, once daily for up to 12 weeks	Alogliptin 12.5 mg QD n=42 Participants Alogliptin 12.5 mg, tablets, orally, once daily for up to 12 weeks.	Alogliptin 25 mg QD n=45 Participants Alogliptin 25 mg, tablets, orally, once daily for up to 12 weeks.	Alogliptin 50 mg QD n=43 Participants Alogliptin 50 mg, tablets, orally, once daily for up to 12 weeks.	Alogliptin 100 mg QD n=44 Participants Alogliptin 100 mg, tablets, orally, once daily for up to 12 weeks.
Change From Baseline in Fasting Plasma Glucose (Day 43).	4.9 mg/dL Standard Error 6.09	-7.3 mg/dL Standard Error 6.00	-11.5 mg/dL Standard Error 6.02	-24.5 mg/dL Standard Error 5.80	-17.9 mg/dL Standard Error 6.10	-25.6 mg/dL Standard Error 5.88

SECONDARY outcome

Timeframe: Baseline and Day 85.

Population: Randomized subjects who received at least 1 dose of study drug (Intent to Treat), and who had measurements at baseline and at Day 85. Missing data are imputed using last observation carried forward (LOCF).

The change between the value of fasting plasma glucose collected at day 85 or final visit and fasting plasma glucose collected at baseline.

Outcome measures

Measure	Placebo QD n=41 Participants Alogliptin placebo-matching tablets, orally, once daily for up to 12 weeks.	Alogliptin 6.25 mg QD n=42 Participants Alogliptin 6.25 mg, tablets, orally, once daily for up to 12 weeks	Alogliptin 12.5 mg QD n=42 Participants Alogliptin 12.5 mg, tablets, orally, once daily for up to 12 weeks.	Alogliptin 25 mg QD n=45 Participants Alogliptin 25 mg, tablets, orally, once daily for up to 12 weeks.	Alogliptin 50 mg QD n=43 Participants Alogliptin 50 mg, tablets, orally, once daily for up to 12 weeks.	Alogliptin 100 mg QD n=44 Participants Alogliptin 100 mg, tablets, orally, once daily for up to 12 weeks.
Change From Baseline in Fasting Plasma Glucose (Day 85).	8.5 mg/dL Standard Error 6.45	-7.8 mg/dL Standard Error 6.36	-5.1 mg/dL Standard Error 6.39	-27.0 mg/dL Standard Error 6.14	-16.1 mg/dL Standard Error 6.47	-20.9 mg/dL Standard Error 6.23

SECONDARY outcome

Timeframe: Baseline and Day 43.

Population: Randomized subjects who received at least 1 dose of study drug (Intent to Treat), and who had measurements at baseline and at Day 43. Missing data are imputed using last observation carried forward (LOCF).

The change between the value of fasting fructosamine collected at day 43 and fasting fructosamine collected at baseline.

Outcome measures

Measure	Placebo QD n=39 Participants Alogliptin placebo-matching tablets, orally, once daily for up to 12 weeks.	Alogliptin 6.25 mg QD n=41 Participants Alogliptin 6.25 mg, tablets, orally, once daily for up to 12 weeks	Alogliptin 12.5 mg QD n=42 Participants Alogliptin 12.5 mg, tablets, orally, once daily for up to 12 weeks.	Alogliptin 25 mg QD n=43 Participants Alogliptin 25 mg, tablets, orally, once daily for up to 12 weeks.	Alogliptin 50 mg QD n=39 Participants Alogliptin 50 mg, tablets, orally, once daily for up to 12 weeks.	Alogliptin 100 mg QD n=43 Participants Alogliptin 100 mg, tablets, orally, once daily for up to 12 weeks.
Change From Baseline in Fasting Fructosamine (Day 43).	7.6 mg/dL Standard Error 5.35	-4.2 mg/dL Standard Error 5.16	-13.1 mg/dL Standard Error 5.12	-14.5 mg/dL Standard Error 5.05	-16.3 mg/dL Standard Error 5.47	-11.7 mg/dL Standard Error 5.09

SECONDARY outcome

Timeframe: Baseline and Day 85.

Population: Randomized subjects who received at least 1 dose of study drug (Intent to Treat), and who had measurements at baseline and at Day 85. Missing data are imputed using last observation carried forward (LOCF).

The change between the value of fasting fructosamine collected at day 85 or final visit and fasting fructosamine collected at baseline.

Outcome measures

Measure	Placebo QD n=41 Participants Alogliptin placebo-matching tablets, orally, once daily for up to 12 weeks.	Alogliptin 6.25 mg QD n=42 Participants Alogliptin 6.25 mg, tablets, orally, once daily for up to 12 weeks	Alogliptin 12.5 mg QD n=42 Participants Alogliptin 12.5 mg, tablets, orally, once daily for up to 12 weeks.	Alogliptin 25 mg QD n=45 Participants Alogliptin 25 mg, tablets, orally, once daily for up to 12 weeks.	Alogliptin 50 mg QD n=40 Participants Alogliptin 50 mg, tablets, orally, once daily for up to 12 weeks.	Alogliptin 100 mg QD n=44 Participants Alogliptin 100 mg, tablets, orally, once daily for up to 12 weeks.
Change From Baseline in Fasting Fructosamine (Day 85).	7.7 mg/dL Standard Error 6.03	0.2 mg/dL Standard Error 5.91	-9.8 mg/dL Standard Error 5.93	-16.4 mg/dL Standard Error 5.71	-12.4 mg/dL Standard Error 6.25	-4.8 mg/dL Standard Error 5.82

SECONDARY outcome

Timeframe: Baseline and Day 43

Population: Randomized subjects who received at least 1 dose of study drug (Intent to Treat), and who had measurements at baseline and at Day 43. Missing data are imputed using last observation carried forward (LOCF).

The change between the value of cholesterol collected at day 43 and cholesterol collected at baseline.

Outcome measures

Measure	Placebo QD n=40 Participants Alogliptin placebo-matching tablets, orally, once daily for up to 12 weeks.	Alogliptin 6.25 mg QD n=41 Participants Alogliptin 6.25 mg, tablets, orally, once daily for up to 12 weeks	Alogliptin 12.5 mg QD n=42 Participants Alogliptin 12.5 mg, tablets, orally, once daily for up to 12 weeks.	Alogliptin 25 mg QD n=43 Participants Alogliptin 25 mg, tablets, orally, once daily for up to 12 weeks.	Alogliptin 50 mg QD n=39 Participants Alogliptin 50 mg, tablets, orally, once daily for up to 12 weeks.	Alogliptin 100 mg QD n=42 Participants Alogliptin 100 mg, tablets, orally, once daily for up to 12 weeks.
Change From Baseline in Total Cholesterol (Day 43).	-11.1 mg/dL Standard Error 4.91	-9.7 mg/dL Standard Error 4.85	-9.6 mg/dL Standard Error 4.77	-9.8 mg/dL Standard Error 4.71	-12.0 mg/dL Standard Error 5.11	-4.7 mg/dL Standard Error 4.80

SECONDARY outcome

Timeframe: Baseline and Day 85.

Population: Randomized subjects who received at least 1 dose of study drug (Intent to Treat), and who had measurements at baseline and at Day 85. Missing data are imputed using last observation carried forward (LOCF).

The change between the value of cholesterol collected at day 85 or final visit and cholesterol collected at baseline.

Outcome measures

Measure	Placebo QD n=41 Participants Alogliptin placebo-matching tablets, orally, once daily for up to 12 weeks.	Alogliptin 6.25 mg QD n=42 Participants Alogliptin 6.25 mg, tablets, orally, once daily for up to 12 weeks	Alogliptin 12.5 mg QD n=42 Participants Alogliptin 12.5 mg, tablets, orally, once daily for up to 12 weeks.	Alogliptin 25 mg QD n=45 Participants Alogliptin 25 mg, tablets, orally, once daily for up to 12 weeks.	Alogliptin 50 mg QD n=40 Participants Alogliptin 50 mg, tablets, orally, once daily for up to 12 weeks.	Alogliptin 100 mg QD n=44 Participants Alogliptin 100 mg, tablets, orally, once daily for up to 12 weeks.
Change From Baseline in Total Cholesterol (Day 85).	-15.1 mg/dL Standard Error 4.46	-9.0 mg/dL Standard Error 4.41	-4.8 mg/dL Standard Error 4.39	-8.7 mg/dL Standard Error 4.24	-7.7 mg/dL Standard Error 4.64	-0.4 mg/dL Standard Error 4.31

SECONDARY outcome

Timeframe: Baseline and Day 43.

Population: Randomized subjects who received at least 1 dose of study drug (Intent to Treat), and who had measurements at baseline and at Day 43. Missing data are imputed using last observation carried forward (LOCF).

The change between high-density lipoprotein cholesterol collected at day 43 and high-density lipoprotein cholesterol collected at baseline.

Outcome measures

Measure	Placebo QD n=40 Participants Alogliptin placebo-matching tablets, orally, once daily for up to 12 weeks.	Alogliptin 6.25 mg QD n=41 Participants Alogliptin 6.25 mg, tablets, orally, once daily for up to 12 weeks	Alogliptin 12.5 mg QD n=42 Participants Alogliptin 12.5 mg, tablets, orally, once daily for up to 12 weeks.	Alogliptin 25 mg QD n=43 Participants Alogliptin 25 mg, tablets, orally, once daily for up to 12 weeks.	Alogliptin 50 mg QD n=39 Participants Alogliptin 50 mg, tablets, orally, once daily for up to 12 weeks.	Alogliptin 100 mg QD n=42 Participants Alogliptin 100 mg, tablets, orally, once daily for up to 12 weeks.
Change From Baseline in High-Density Lipoprotein Cholesterol (Day 43).	-1.4 mg/dL Standard Error 0.76	-0.6 mg/dL Standard Error 0.75	-2.0 mg/dL Standard Error 0.74	-2.4 mg/dL Standard Error 0.73	-2.8 mg/dL Standard Error 0.80	-1.1 mg/dL Standard Error 0.74

SECONDARY outcome

Timeframe: Baseline and Day 85.

Population: Randomized subjects who received at least 1 dose of study drug (Intent to Treat), and who had measurements at baseline and at Day 85. Missing data are imputed using last observation carried forward (LOCF).

The change between high-density lipoprotein cholesterol collected at day 85 or final visit and high-density lipoprotein cholesterol collected at baseline.

Outcome measures

Measure	Placebo QD n=41 Participants Alogliptin placebo-matching tablets, orally, once daily for up to 12 weeks.	Alogliptin 6.25 mg QD n=42 Participants Alogliptin 6.25 mg, tablets, orally, once daily for up to 12 weeks	Alogliptin 12.5 mg QD n=42 Participants Alogliptin 12.5 mg, tablets, orally, once daily for up to 12 weeks.	Alogliptin 25 mg QD n=45 Participants Alogliptin 25 mg, tablets, orally, once daily for up to 12 weeks.	Alogliptin 50 mg QD n=40 Participants Alogliptin 50 mg, tablets, orally, once daily for up to 12 weeks.	Alogliptin 100 mg QD n=44 Participants Alogliptin 100 mg, tablets, orally, once daily for up to 12 weeks.
Change From Baseline in High-Density Lipoprotein Cholesterol (Day 85).	-1.9 mg/dL Standard Error 0.87	-0.7 mg/dL Standard Error 0.86	-2.3 mg/dL Standard Error 0.85	-2.5 mg/dL Standard Error 0.83	-2.0 mg/dL Standard Error 0.92	0.4 mg/dL Standard Error 0.84

SECONDARY outcome

Timeframe: Baseline and Day 43.

Population: Randomized subjects who received at least 1 dose of study drug (Intent to Treat), and who had measurements at baseline and at Day 43. Missing data are imputed using last observation carried forward (LOCF).

The change between low-density lipoprotein cholesterol collected at day 43 and low-density lipoprotein cholesterol collected at baseline.

Outcome measures

Measure	Placebo QD n=35 Participants Alogliptin placebo-matching tablets, orally, once daily for up to 12 weeks.	Alogliptin 6.25 mg QD n=38 Participants Alogliptin 6.25 mg, tablets, orally, once daily for up to 12 weeks	Alogliptin 12.5 mg QD n=39 Participants Alogliptin 12.5 mg, tablets, orally, once daily for up to 12 weeks.	Alogliptin 25 mg QD n=40 Participants Alogliptin 25 mg, tablets, orally, once daily for up to 12 weeks.	Alogliptin 50 mg QD n=36 Participants Alogliptin 50 mg, tablets, orally, once daily for up to 12 weeks.	Alogliptin 100 mg QD n=37 Participants Alogliptin 100 mg, tablets, orally, once daily for up to 12 weeks.
Change From Baseline in Low-Density Lipoprotein Cholesterol (Day 43).	-8.9 mg/dL Standard Error 3.97	-3.8 mg/dL Standard Error 3.79	-6.4 mg/dL Standard Error 3.72	-1.5 mg/dL Standard Error 3.69	-9.9 mg/dL Standard Error 4.01	0.8 mg/dL Standard Error 3.84

SECONDARY outcome

Timeframe: Baseline and Day 85.

Population: Randomized subjects who received at least 1 dose of study drug (Intent to Treat), and who had measurements at baseline and at Day 85. Missing data are imputed using last observation carried forward (LOCF).

The change between low-density lipoprotein cholesterol collected at day 85 or final visit and low-density lipoprotein cholesterol collected at baseline.

Outcome measures

Measure	Placebo QD n=36 Participants Alogliptin placebo-matching tablets, orally, once daily for up to 12 weeks.	Alogliptin 6.25 mg QD n=39 Participants Alogliptin 6.25 mg, tablets, orally, once daily for up to 12 weeks	Alogliptin 12.5 mg QD n=39 Participants Alogliptin 12.5 mg, tablets, orally, once daily for up to 12 weeks.	Alogliptin 25 mg QD n=43 Participants Alogliptin 25 mg, tablets, orally, once daily for up to 12 weeks.	Alogliptin 50 mg QD n=38 Participants Alogliptin 50 mg, tablets, orally, once daily for up to 12 weeks.	Alogliptin 100 mg QD n=40 Participants Alogliptin 100 mg, tablets, orally, once daily for up to 12 weeks.
Change From Baseline in Low-Density Lipoprotein Cholesterol (Day 85).	-13.6 mg/dL Standard Error 3.72	-2.6 mg/dL Standard Error 3.55	-2.7 mg/dL Standard Error 3.54	-0.6 mg/dL Standard Error 3.38	-5.0 mg/dL Standard Error 3.70	4.0 mg/dL Standard Error 3.50

SECONDARY outcome

Timeframe: Baseline and Day 43.

Population: Randomized subjects who received at least 1 dose of study drug (Intent to Treat), and who had measurements at baseline and at Day 43. Missing data are imputed using last observation carried forward (LOCF).

The change between triglycerides collected at day 43 and triglycerides collected at baseline.

Outcome measures

Measure	Placebo QD n=40 Participants Alogliptin placebo-matching tablets, orally, once daily for up to 12 weeks.	Alogliptin 6.25 mg QD n=41 Participants Alogliptin 6.25 mg, tablets, orally, once daily for up to 12 weeks	Alogliptin 12.5 mg QD n=42 Participants Alogliptin 12.5 mg, tablets, orally, once daily for up to 12 weeks.	Alogliptin 25 mg QD n=43 Participants Alogliptin 25 mg, tablets, orally, once daily for up to 12 weeks.	Alogliptin 50 mg QD n=39 Participants Alogliptin 50 mg, tablets, orally, once daily for up to 12 weeks.	Alogliptin 100 mg QD n=42 Participants Alogliptin 100 mg, tablets, orally, once daily for up to 12 weeks.
Change From Baseline in Triglycerides (Day 43).	-18.7 mg/dL Standard Error 15.69	-28.0 mg/dL Standard Error 15.43	-10.1 mg/dL Standard Error 15.28	-27.7 mg/dL Standard Error 15.10	-7.2 mg/dL Standard Error 16.33	-31.5 mg/dL Standard Error 15.48

SECONDARY outcome

Timeframe: Baseline and Day 85.

Population: Randomized subjects who received at least 1 dose of study drug (Intent to Treat), and who had measurements at baseline and at Day 85. Missing data are imputed using last observation carried forward (LOCF).

The change between triglycerides collected at day 85 or final visit and triglycerides collected at baseline.

Outcome measures

Measure	Placebo QD n=41 Participants Alogliptin placebo-matching tablets, orally, once daily for up to 12 weeks.	Alogliptin 6.25 mg QD n=42 Participants Alogliptin 6.25 mg, tablets, orally, once daily for up to 12 weeks	Alogliptin 12.5 mg QD n=42 Participants Alogliptin 12.5 mg, tablets, orally, once daily for up to 12 weeks.	Alogliptin 25 mg QD n=45 Participants Alogliptin 25 mg, tablets, orally, once daily for up to 12 weeks.	Alogliptin 50 mg QD n=40 Participants Alogliptin 50 mg, tablets, orally, once daily for up to 12 weeks.	Alogliptin 100 mg QD n=44 Participants Alogliptin 100 mg, tablets, orally, once daily for up to 12 weeks.
Change From Baseline in Triglycerides (Day 85).	-13.9 mg/dL Standard Error 14.98	-26.4 mg/dL Standard Error 14.75	9.2 mg/dL Standard Error 14.77	-32.9 mg/dL Standard Error 14.27	-14.4 mg/dL Standard Error 15.58	-24.9 mg/dL Standard Error 14.59

SECONDARY outcome

Timeframe: 85 Days.

Population: Randomized participants who received at least 1 dose of study drug (Intent to Treat), and who had at least 1 fasting plasma glucose measurement after baseline. Note: Mean percent incidence of marked hyperglycemia was only summarized by treatment group using descriptive statistics.

The incidence of marked hyperglycemia occurring in participants with a fasting plasma glucose value greater than or equal to 200 mg per dL during study. Overall mean obtained by weighting the hyperglycemia percent incidence values at each time point by number of days in between visits. Mean percent incidence of marked hyperglycemia at each time point is the percent of self-monitored blood glucose measurements greater than or equal to 200 mg per dL, calculated per participant and then averaged across population.

Outcome measures

Measure	Placebo QD n=41 Participants Alogliptin placebo-matching tablets, orally, once daily for up to 12 weeks.	Alogliptin 6.25 mg QD n=42 Participants Alogliptin 6.25 mg, tablets, orally, once daily for up to 12 weeks	Alogliptin 12.5 mg QD n=42 Participants Alogliptin 12.5 mg, tablets, orally, once daily for up to 12 weeks.	Alogliptin 25 mg QD n=45 Participants Alogliptin 25 mg, tablets, orally, once daily for up to 12 weeks.	Alogliptin 50 mg QD n=43 Participants Alogliptin 50 mg, tablets, orally, once daily for up to 12 weeks.	Alogliptin 100 mg QD n=44 Participants Alogliptin 100 mg, tablets, orally, once daily for up to 12 weeks.
Mean Percent Incidence of Marked Hyperglycemia (Fasting Plasma Glucose ≥ 200 mg/dL).	54.0 percent incidence Standard Deviation 34.95	34.7 percent incidence Standard Deviation 33.43	25.8 percent incidence Standard Deviation 26.92	28.1 percent incidence Standard Deviation 25.94	30.4 percent incidence Standard Deviation 30.32	30.6 percent incidence Standard Deviation 29.92

Adverse Events

Placebo QD

Serious events: 2 serious events

Other events: 14 other events

Deaths: 0 deaths

Alogliptin 6.25 mg QD

Serious events: 1 serious events

Other events: 12 other events

Deaths: 0 deaths

Alogliptin 12.5 mg QD

Serious events: 0 serious events

Other events: 18 other events

Deaths: 0 deaths

Alogliptin 25 mg QD

Serious events: 1 serious events

Other events: 19 other events

Deaths: 0 deaths

Alogliptin 50 mg QD

Serious events: 0 serious events

Other events: 15 other events

Deaths: 0 deaths

Alogliptin 100 mg QD

Serious events: 0 serious events

Other events: 22 other events

Deaths: 0 deaths

Serious adverse events

Measure	Placebo QD n=41 participants at risk Alogliptin placebo-matching tablets, orally, once daily for up to 12 weeks.	Alogliptin 6.25 mg QD n=42 participants at risk Alogliptin 6.25 mg, tablets, orally, once daily for up to 12 weeks	Alogliptin 12.5 mg QD n=44 participants at risk Alogliptin 12.5 mg, tablets, orally, once daily for up to 12 weeks.	Alogliptin 25 mg QD n=45 participants at risk Alogliptin 25 mg, tablets, orally, once daily for up to 12 weeks.	Alogliptin 50 mg QD n=43 participants at risk Alogliptin 50 mg, tablets, orally, once daily for up to 12 weeks.	Alogliptin 100 mg QD n=44 participants at risk Alogliptin 100 mg, tablets, orally, once daily for up to 12 weeks.
Injury, poisoning and procedural complications Intentional overdose	2.4% 1/41 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days after the last dose of double-blind 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% 0/42 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days after the last dose of double-blind 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% 0/44 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days after the last dose of double-blind 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% 0/45 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days after the last dose of double-blind 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% 0/43 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days after the last dose of double-blind 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% 0/44 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days after the last dose of double-blind 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 Noncardiac chest pain	0.00% 0/41 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days after the last dose of double-blind 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% 1/42 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days after the last dose of double-blind 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% 0/44 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days after the last dose of double-blind 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.	2.2% 1/45 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days after the last dose of double-blind 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% 0/43 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days after the last dose of double-blind 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% 0/44 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days after the last dose of double-blind 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.
Musculoskeletal and connective tissue disorders Osteoarthritis	2.4% 1/41 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days after the last dose of double-blind 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% 0/42 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days after the last dose of double-blind 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% 0/44 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days after the last dose of double-blind 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% 0/45 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days after the last dose of double-blind 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% 0/43 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days after the last dose of double-blind 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% 0/44 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days after the last dose of double-blind 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 QD n=41 participants at risk Alogliptin placebo-matching tablets, orally, once daily for up to 12 weeks.	Alogliptin 6.25 mg QD n=42 participants at risk Alogliptin 6.25 mg, tablets, orally, once daily for up to 12 weeks	Alogliptin 12.5 mg QD n=44 participants at risk Alogliptin 12.5 mg, tablets, orally, once daily for up to 12 weeks.	Alogliptin 25 mg QD n=45 participants at risk Alogliptin 25 mg, tablets, orally, once daily for up to 12 weeks.	Alogliptin 50 mg QD n=43 participants at risk Alogliptin 50 mg, tablets, orally, once daily for up to 12 weeks.	Alogliptin 100 mg QD n=44 participants at risk Alogliptin 100 mg, tablets, orally, once daily for up to 12 weeks.
Gastrointestinal disorders Abdominal pain	0.00% 0/41 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days after the last dose of double-blind 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% 0/42 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days after the last dose of double-blind 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.	4.5% 2/44 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days after the last dose of double-blind 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.	2.2% 1/45 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days after the last dose of double-blind 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% 0/43 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days after the last dose of double-blind 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% 0/44 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days after the last dose of double-blind 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% 0/41 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days after the last dose of double-blind 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% 2/42 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days after the last dose of double-blind 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.	2.3% 1/44 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days after the last dose of double-blind 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.	6.7% 3/45 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days after the last dose of double-blind 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% 0/43 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days after the last dose of double-blind 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% 0/44 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days after the last dose of double-blind 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.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/41 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days after the last dose of double-blind 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% 1/42 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days after the last dose of double-blind 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.	4.5% 2/44 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days after the last dose of double-blind 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% 0/45 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days after the last dose of double-blind 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% 0/43 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days after the last dose of double-blind 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.	2.3% 1/44 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days after the last dose of double-blind 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.
Musculoskeletal and connective tissue disorders Back pain	2.4% 1/41 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days after the last dose of double-blind 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% 1/42 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days after the last dose of double-blind 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% 0/44 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days after the last dose of double-blind 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.	2.2% 1/45 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days after the last dose of double-blind 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.	4.7% 2/43 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days after the last dose of double-blind 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.	2.3% 1/44 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days after the last dose of double-blind 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	2.4% 1/41 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days after the last dose of double-blind 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% 0/42 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days after the last dose of double-blind 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.	4.5% 2/44 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days after the last dose of double-blind 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% 0/45 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days after the last dose of double-blind 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.	2.3% 1/43 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days after the last dose of double-blind 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% 0/44 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days after the last dose of double-blind 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.
Respiratory, thoracic and mediastinal disorders Cough	2.4% 1/41 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days after the last dose of double-blind 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% 0/42 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days after the last dose of double-blind 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.	2.3% 1/44 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days after the last dose of double-blind 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% 0/45 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days after the last dose of double-blind 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% 0/43 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days after the last dose of double-blind 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.	4.5% 2/44 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days after the last dose of double-blind 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	7.3% 3/41 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days after the last dose of double-blind 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% 0/42 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days after the last dose of double-blind 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.	2.3% 1/44 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days after the last dose of double-blind 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.	2.2% 1/45 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days after the last dose of double-blind 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.	7.0% 3/43 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days after the last dose of double-blind 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% 0/44 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days after the last dose of double-blind 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 Dizziness	0.00% 0/41 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days after the last dose of double-blind 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% 2/42 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days after the last dose of double-blind 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% 0/44 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days after the last dose of double-blind 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.	6.7% 3/45 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days after the last dose of double-blind 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.	2.3% 1/43 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days after the last dose of double-blind 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.	2.3% 1/44 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days after the last dose of double-blind 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 Fatigue	4.9% 2/41 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days after the last dose of double-blind 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% 0/42 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days after the last dose of double-blind 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.	2.3% 1/44 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days after the last dose of double-blind 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% 0/45 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days after the last dose of double-blind 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.	4.7% 2/43 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days after the last dose of double-blind 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.	6.8% 3/44 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days after the last dose of double-blind 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 Fungal infection	4.9% 2/41 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days after the last dose of double-blind 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% 0/42 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days after the last dose of double-blind 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% 0/44 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days after the last dose of double-blind 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% 0/45 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days after the last dose of double-blind 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% 0/43 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days after the last dose of double-blind 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% 0/44 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days after the last dose of double-blind 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	2.4% 1/41 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days after the last dose of double-blind 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% 0/42 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days after the last dose of double-blind 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% 0/44 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days after the last dose of double-blind 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.	4.4% 2/45 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days after the last dose of double-blind 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% 0/43 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days after the last dose of double-blind 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% 0/44 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days after the last dose of double-blind 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 viral	0.00% 0/41 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days after the last dose of double-blind 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% 0/42 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days after the last dose of double-blind 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.	4.5% 2/44 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days after the last dose of double-blind 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% 0/45 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days after the last dose of double-blind 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% 0/43 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days after the last dose of double-blind 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.	2.3% 1/44 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days after the last dose of double-blind 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	7.3% 3/41 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days after the last dose of double-blind 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% 2/42 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days after the last dose of double-blind 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% 0/44 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days after the last dose of double-blind 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.	8.9% 4/45 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days after the last dose of double-blind 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.	7.0% 3/43 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days after the last dose of double-blind 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.	9.1% 4/44 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days after the last dose of double-blind 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 Hyperglycaemia	0.00% 0/41 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days after the last dose of double-blind 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% 0/42 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days after the last dose of double-blind 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.	4.5% 2/44 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days after the last dose of double-blind 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% 0/45 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days after the last dose of double-blind 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% 0/43 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days after the last dose of double-blind 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% 0/44 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days after the last dose of double-blind 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.
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/41 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days after the last dose of double-blind 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% 1/42 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days after the last dose of double-blind 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.	2.3% 1/44 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days after the last dose of double-blind 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% 0/45 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days after the last dose of double-blind 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% 0/43 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days after the last dose of double-blind 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.	6.8% 3/44 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days after the last dose of double-blind 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	4.9% 2/41 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days after the last dose of double-blind 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% 0/42 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days after the last dose of double-blind 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.	4.5% 2/44 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days after the last dose of double-blind 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.	4.4% 2/45 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days after the last dose of double-blind 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.	2.3% 1/43 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days after the last dose of double-blind 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.	2.3% 1/44 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days after the last dose of double-blind 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 Nausea	0.00% 0/41 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days after the last dose of double-blind 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% 2/42 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days after the last dose of double-blind 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.	2.3% 1/44 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days after the last dose of double-blind 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.	2.2% 1/45 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days after the last dose of double-blind 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.	4.7% 2/43 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days after the last dose of double-blind 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.	11.4% 5/44 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days after the last dose of double-blind 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.
Musculoskeletal and connective tissue disorders Neck pain	0.00% 0/41 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days after the last dose of double-blind 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% 0/42 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days after the last dose of double-blind 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.	4.5% 2/44 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days after the last dose of double-blind 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% 0/45 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days after the last dose of double-blind 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% 0/43 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days after the last dose of double-blind 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% 0/44 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days after the last dose of double-blind 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 Oedema peripheral	2.4% 1/41 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days after the last dose of double-blind 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% 1/42 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days after the last dose of double-blind 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.	2.3% 1/44 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days after the last dose of double-blind 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% 0/45 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days after the last dose of double-blind 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.	2.3% 1/43 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days after the last dose of double-blind 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.	4.5% 2/44 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days after the last dose of double-blind 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.
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/41 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days after the last dose of double-blind 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% 1/42 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days after the last dose of double-blind 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.	2.3% 1/44 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days after the last dose of double-blind 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.	6.7% 3/45 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days after the last dose of double-blind 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% 0/43 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days after the last dose of double-blind 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.	4.5% 2/44 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days after the last dose of double-blind 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 Paraesthesia	0.00% 0/41 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days after the last dose of double-blind 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% 0/42 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days after the last dose of double-blind 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.	4.5% 2/44 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days after the last dose of double-blind 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% 0/45 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days after the last dose of double-blind 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% 0/43 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days after the last dose of double-blind 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% 0/44 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days after the last dose of double-blind 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.
Respiratory, thoracic and mediastinal disorders Pharyngolaryngeal pain	0.00% 0/41 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days after the last dose of double-blind 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% 0/42 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days after the last dose of double-blind 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% 0/44 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days after the last dose of double-blind 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.	4.4% 2/45 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days after the last dose of double-blind 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% 0/43 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days after the last dose of double-blind 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.	4.5% 2/44 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days after the last dose of double-blind 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 Rash	2.4% 1/41 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days after the last dose of double-blind 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% 0/42 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days after the last dose of double-blind 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.	9.1% 4/44 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days after the last dose of double-blind 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% 0/45 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days after the last dose of double-blind 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.	2.3% 1/43 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days after the last dose of double-blind 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.	2.3% 1/44 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days after the last dose of double-blind 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 Somnolence	0.00% 0/41 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days after the last dose of double-blind 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% 0/42 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days after the last dose of double-blind 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% 0/44 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days after the last dose of double-blind 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.	4.4% 2/45 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days after the last dose of double-blind 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% 0/43 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days after the last dose of double-blind 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% 0/44 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days after the last dose of double-blind 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 Upper respiratory tract infection	0.00% 0/41 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days after the last dose of double-blind 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% 1/42 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days after the last dose of double-blind 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% 0/44 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days after the last dose of double-blind 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.	4.4% 2/45 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days after the last dose of double-blind 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.	2.3% 1/43 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days after the last dose of double-blind 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.	2.3% 1/44 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days after the last dose of double-blind 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 Urinary tract infection	9.8% 4/41 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days after the last dose of double-blind 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.	7.1% 3/42 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days after the last dose of double-blind 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.	2.3% 1/44 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days after the last dose of double-blind 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.	6.7% 3/45 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days after the last dose of double-blind 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.	7.0% 3/43 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days after the last dose of double-blind 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.	9.1% 4/44 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days after the last dose of double-blind 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.
Eye disorders Vision blurred	0.00% 0/41 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days after the last dose of double-blind 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% 1/42 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days after the last dose of double-blind 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.	2.3% 1/44 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days after the last dose of double-blind 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.	4.4% 2/45 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days after the last dose of double-blind 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% 0/43 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days after the last dose of double-blind 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% 0/44 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days after the last dose of double-blind 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 Weight decreased	0.00% 0/41 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days after the last dose of double-blind 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% 0/42 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days after the last dose of double-blind 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.	2.3% 1/44 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days after the last dose of double-blind 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.	4.4% 2/45 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days after the last dose of double-blind 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% 0/43 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days after the last dose of double-blind 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.	2.3% 1/44 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days after the last dose of double-blind 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

Sr. VP, Clinical Science

Takeda Global Research and Development Center, Inc.

Phone: 800-778-2860

Email: clinicaltrialregistry@tpna.com

Results disclosure agreements

• Principal investigator is a sponsor employee No publication related to study results will be published prior to publication of a multi-center report submitted for publication within 18 months after conclusion or termination of a study at all study sites. Results publications will be submitted to sponsor for review 60 days in advance of publication. Sponsor can require removal of confidential information unrelated to study results. Sponsor can embargo a proposed publication for another 60 days to preserve intellectual property.
• Publication restrictions are in place

Restriction type: OTHER