Trial Outcomes & Findings for TAK-875 (Fasiglifam) in Combination With Sitagliptin in Adults With Type 2 Diabetes (NCT NCT01829464)

NCT ID: NCT01829464

Last Updated: 2016-06-01

Results Overview

The change in the value of HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at Week 24 relative to baseline.

• Recruitment status: TERMINATED
• Study phase: PHASE3
• Target enrollment: 90 participants
• Primary outcome timeframe: Baseline and Week 24
• Results posted on: 2016-06-01

Participant Flow

Participants took part in the study at 49 investigative sites in the United States from 01 April 2013 to 12 March 2014.

Participants with historical diagnosis of type 2 diabetes who were inadequately controlled while on sitagliptin 100 milligram(mg) (with/without metformin) or on Dipeptidyl peptidase-4 inhibitor other than sitagliptin(with/without metformin) therapy enrolled in 1 of 3, placebo; fasiglifam 25 mg once daily (QD); fasiglifam 50 mg QD treatment groups.

Participant milestones

Measure	Placebo Fasiglifam placebo-matching tablets, orally, once daily and sitagliptin 100 mg, tablets, orally, once daily with or without metformin greater than or equal to (\>=) 1500 mg, tablets, orally, once daily for up to 24 weeks.	Fasiglifam 25 mg QD Fasiglifam 25 mg, tablets, orally, once daily and sitagliptin 100 mg, tablets, orally, once daily with or without metformin \>=1500 mg, tablets, orally, once daily for up to 24 weeks.	Fasiglifam 50 mg QD Fasiglifam 50 mg, tablets, orally, once daily and sitagliptin 100 mg, tablets, orally, once daily with or without metformin \>=1500 mg, tablets, orally, once daily for up to 24 weeks.
Overall Study STARTED	30	31	29
Overall Study COMPLETED	2	2	3
Overall Study NOT COMPLETED	28	29	26

Reasons for withdrawal

Measure	Placebo Fasiglifam placebo-matching tablets, orally, once daily and sitagliptin 100 mg, tablets, orally, once daily with or without metformin greater than or equal to (\>=) 1500 mg, tablets, orally, once daily for up to 24 weeks.	Fasiglifam 25 mg QD Fasiglifam 25 mg, tablets, orally, once daily and sitagliptin 100 mg, tablets, orally, once daily with or without metformin \>=1500 mg, tablets, orally, once daily for up to 24 weeks.	Fasiglifam 50 mg QD Fasiglifam 50 mg, tablets, orally, once daily and sitagliptin 100 mg, tablets, orally, once daily with or without metformin \>=1500 mg, tablets, orally, once daily for up to 24 weeks.
Overall Study Adverse Event	1	0	0
Overall Study Lost to Follow-up	0	0	1
Overall Study Withdrawal by Subject	2	0	0
Overall Study Study terminated by sponsor	25	28	25
Overall Study Lack of Efficacy	0	1	0

Baseline Characteristics

TAK-875 (Fasiglifam) in Combination With Sitagliptin in Adults With Type 2 Diabetes

Baseline characteristics by cohort

Measure	Placebo n=30 Participants Fasiglifam placebo-matching tablets, orally, once daily and sitagliptin 100 mg, tablets, orally, once daily with or without metformin greater than or equal to (\>=) 1500 mg, tablets, orally, once daily for up to 24 weeks.	Fasiglifam 25 mg QD n=31 Participants Fasiglifam 25 mg, tablets, orally, once daily and sitagliptin 100 mg, tablets, orally, once daily with or without metformin \>=1500 mg, tablets, orally, once daily for up to 24 weeks.	Fasiglifam 50 mg QD n=29 Participants Fasiglifam 50 mg, tablets, orally, once daily and sitagliptin 100 mg, tablets, orally, once daily with or without metformin \>=1500 mg, tablets, orally, once daily for up to 24 weeks.	Total n=90 Participants Total of all reporting groups
Age, Continuous	57.0 Years STANDARD_DEVIATION 10.45 • n=5 Participants	52.4 Years STANDARD_DEVIATION 11.61 • n=7 Participants	55.2 Years STANDARD_DEVIATION 8.57 • n=5 Participants	54.8 Years STANDARD_DEVIATION 10.38 • n=4 Participants
Age, Customized Less than (<) 65 years	22 Participants n=5 Participants	27 Participants n=7 Participants	24 Participants n=5 Participants	73 Participants n=4 Participants
Age, Customized >= 65 years	8 Participants n=5 Participants	4 Participants n=7 Participants	5 Participants n=5 Participants	17 Participants n=4 Participants
Sex/Gender, Customized Female	14 Participants n=5 Participants	13 Participants n=7 Participants	16 Participants n=5 Participants	43 Participants n=4 Participants
Sex/Gender, Customized Male	16 Participants n=5 Participants	18 Participants n=7 Participants	13 Participants n=5 Participants	47 Participants n=4 Participants
Race/Ethnicity, Customized Hispanic or Latino	6 Participants n=5 Participants	11 Participants n=7 Participants	5 Participants n=5 Participants	22 Participants n=4 Participants
Race/Ethnicity, Customized Not Hispanic or Latino	24 Participants n=5 Participants	20 Participants n=7 Participants	24 Participants n=5 Participants	68 Participants n=4 Participants
Race/Ethnicity, Customized Asian	1 Participants n=5 Participants	3 Participants n=7 Participants	1 Participants n=5 Participants	5 Participants n=4 Participants
Race/Ethnicity, Customized Black or African American	3 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants	6 Participants n=4 Participants
Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Race/Ethnicity, Customized White	25 Participants n=5 Participants	26 Participants n=7 Participants	26 Participants n=5 Participants	77 Participants n=4 Participants
Race/Ethnicity, Customized More than 1 race (multiracial)	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Height	168.3 centimeter (cm) STANDARD_DEVIATION 9.26 • n=5 Participants	169.0 centimeter (cm) STANDARD_DEVIATION 10.02 • n=7 Participants	166.8 centimeter (cm) STANDARD_DEVIATION 10.76 • n=5 Participants	168.0 centimeter (cm) STANDARD_DEVIATION 9.96 • n=4 Participants
Body Mass Index	34.49 kilogram per square meter (kg/m^2) STANDARD_DEVIATION 5.623 • n=5 Participants	32.12 kilogram per square meter (kg/m^2) STANDARD_DEVIATION 5.664 • n=7 Participants	33.10 kilogram per square meter (kg/m^2) STANDARD_DEVIATION 4.315 • n=5 Participants	33.23 kilogram per square meter (kg/m^2) STANDARD_DEVIATION 5.286 • n=4 Participants
Region of Enrollment	30 Participants n=5 Participants	31 Participants n=7 Participants	29 Participants n=5 Participants	90 Participants n=4 Participants
Smoking Classification Never smoked	18 Participants n=5 Participants	19 Participants n=7 Participants	22 Participants n=5 Participants	59 Participants n=4 Participants
Smoking Classification Current smoker	7 Participants n=5 Participants	5 Participants n=7 Participants	1 Participants n=5 Participants	13 Participants n=4 Participants
Smoking Classification Ex-smoker	5 Participants n=5 Participants	7 Participants n=7 Participants	6 Participants n=5 Participants	18 Participants n=4 Participants
Baseline Glycosylated Hemoglobin (HbA1c) Category < 8.5 percent (%)	16 Participants n=5 Participants	16 Participants n=7 Participants	15 Participants n=5 Participants	47 Participants n=4 Participants
Baseline Glycosylated Hemoglobin (HbA1c) Category >= 8.5%	14 Participants n=5 Participants	15 Participants n=7 Participants	14 Participants n=5 Participants	43 Participants n=4 Participants
Duration of Diabetes	9.291 years STANDARD_DEVIATION 8.039 • n=5 Participants	8.690 years STANDARD_DEVIATION 6.180 • n=7 Participants	6.406 years STANDARD_DEVIATION 4.390 • n=5 Participants	8.154 years STANDARD_DEVIATION 6.444 • n=4 Participants

PRIMARY outcome

Timeframe: Baseline and Week 24

Population: Full analysis set (FAS) included all randomized participants who received at least 1 dose of double blind study medication and who had a baseline and at least 1 post-baseline assessment.

The change in the value of HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at Week 24 relative to baseline.

Outcome measures

Measure	Placebo n=26 Participants Fasiglifam placebo-matching tablets, orally, once daily and sitagliptin 100 mg, tablets, orally, once daily with or without metformin greater than or equal to (\>=) 1500 mg, tablets, orally, once daily for up to 24 weeks.	Fasiglifam 25 mg QD n=31 Participants Fasiglifam 25 mg, tablets, orally, once daily and sitagliptin 100 mg, tablets, orally, once daily with or without metformin \>=1500 mg, tablets, orally, once daily for up to 24 weeks.	Fasiglifam 50 mg QD n=27 Participants Fasiglifam 50 mg, tablets, orally, once daily and sitagliptin 100 mg, tablets, orally, once daily with or without metformin \>=1500 mg, tablets, orally, once daily for up to 24 weeks.
Change From Baseline in HbA1c at Week 24 Baseline (n= 26, 31, 27)	8.39 Percentage of glycosylated haemoglobin Standard Deviation 0.766	8.46 Percentage of glycosylated haemoglobin Standard Deviation 0.932	8.52 Percentage of glycosylated haemoglobin Standard Deviation 0.956
Change From Baseline in HbA1c at Week 24 Change at Week 24 (n= 2, 4, 2)	0.25 Percentage of glycosylated haemoglobin Standard Deviation 0.495	-0.80 Percentage of glycosylated haemoglobin Standard Deviation 0.883	-1.85 Percentage of glycosylated haemoglobin Standard Deviation 0.495

SECONDARY outcome

Timeframe: Week 24

Population: Due to the relatively limited enrollment and follow-up at the time of study termination, the analysis of percentage of participants with HbA1c \<7% at Week 24 was not performed.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline and Week 24

Population: FAS included all randomized participants who received at least 1 dose of double blind study medication and who had a baseline and at least 1 post-baseline assessment.

The change between the fasting plasma glucose values collected at Week 24 relative to baseline.

Outcome measures

Measure	Placebo n=29 Participants Fasiglifam placebo-matching tablets, orally, once daily and sitagliptin 100 mg, tablets, orally, once daily with or without metformin greater than or equal to (\>=) 1500 mg, tablets, orally, once daily for up to 24 weeks.	Fasiglifam 25 mg QD n=31 Participants Fasiglifam 25 mg, tablets, orally, once daily and sitagliptin 100 mg, tablets, orally, once daily with or without metformin \>=1500 mg, tablets, orally, once daily for up to 24 weeks.	Fasiglifam 50 mg QD n=28 Participants Fasiglifam 50 mg, tablets, orally, once daily and sitagliptin 100 mg, tablets, orally, once daily with or without metformin \>=1500 mg, tablets, orally, once daily for up to 24 weeks.
Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24 Baseline (n= 29, 31, 28)	193.76 milligram per deciliter (mg/dL) Standard Deviation 50.090	184.52 milligram per deciliter (mg/dL) Standard Deviation 45.126	185.96 milligram per deciliter (mg/dL) Standard Deviation 53.767
Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24 Change at Week 24 (n= 2, 2, 2)	30.50 milligram per deciliter (mg/dL) Standard Deviation 55.861	-31.50 milligram per deciliter (mg/dL) Standard Deviation 16.263	-85.50 milligram per deciliter (mg/dL) Standard Deviation 23.335

Adverse Events

Placebo

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

Fasiglifam 25 mg QD

Serious events: 1 serious events

Other events: 10 other events

Deaths: 0 deaths

Fasiglifam 50 mg QD

Serious events: 0 serious events

Other events: 15 other events

Deaths: 0 deaths

Serious adverse events

Measure	Placebo n=30 participants at risk Fasiglifam placebo-matching tablets, orally, once daily and sitagliptin 100 mg, tablets, orally, once daily with or without metformin greater than or equal to (\>=) 1500 mg, tablets, orally, once daily for up to 24 weeks.	Fasiglifam 25 mg QD n=31 participants at risk Fasiglifam 25 mg, tablets, orally, once daily and sitagliptin 100 mg, tablets, orally, once daily with or without metformin \>=1500 mg, tablets, orally, once daily for up to 24 weeks.	Fasiglifam 50 mg QD n=29 participants at risk Fasiglifam 50 mg, tablets, orally, once daily and sitagliptin 100 mg, tablets, orally, once daily with or without metformin \>=1500 mg, tablets, orally, once daily for up to 24 weeks.
Reproductive system and breast disorders Ovarian cyst	0.00% 0/30 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 30 days after the last dose of double-blinded study drug. At each visit, the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	3.2% 1/31 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 30 days after the last dose of double-blinded study drug. At each visit, the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/29 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 30 days after the last dose of double-blinded study drug. At each visit, the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.

Other adverse events

Measure	Placebo n=30 participants at risk Fasiglifam placebo-matching tablets, orally, once daily and sitagliptin 100 mg, tablets, orally, once daily with or without metformin greater than or equal to (\>=) 1500 mg, tablets, orally, once daily for up to 24 weeks.	Fasiglifam 25 mg QD n=31 participants at risk Fasiglifam 25 mg, tablets, orally, once daily and sitagliptin 100 mg, tablets, orally, once daily with or without metformin \>=1500 mg, tablets, orally, once daily for up to 24 weeks.	Fasiglifam 50 mg QD n=29 participants at risk Fasiglifam 50 mg, tablets, orally, once daily and sitagliptin 100 mg, tablets, orally, once daily with or without metformin \>=1500 mg, tablets, orally, once daily for up to 24 weeks.
General disorders Influenza like illness	0.00% 0/30 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 30 days after the last dose of double-blinded study drug. At each visit, the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/31 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 30 days after the last dose of double-blinded study drug. At each visit, the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	6.9% 2/29 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 30 days after the last dose of double-blinded study drug. At each visit, the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Metabolism and nutrition disorders Hyperglycaemia	0.00% 0/30 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 30 days after the last dose of double-blinded study drug. At each visit, the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/31 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 30 days after the last dose of double-blinded study drug. At each visit, the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	6.9% 2/29 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 30 days after the last dose of double-blinded study drug. At each visit, the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Gastrointestinal disorders Dyspepsia	0.00% 0/30 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 30 days after the last dose of double-blinded study drug. At each visit, the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	6.5% 2/31 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 30 days after the last dose of double-blinded study drug. At each visit, the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/29 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 30 days after the last dose of double-blinded study drug. At each visit, the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Infections and infestations Sinusitis	3.3% 1/30 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 30 days after the last dose of double-blinded study drug. At each visit, the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/31 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 30 days after the last dose of double-blinded study drug. At each visit, the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	6.9% 2/29 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 30 days after the last dose of double-blinded study drug. At each visit, the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
General disorders Pain	0.00% 0/30 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 30 days after the last dose of double-blinded study drug. At each visit, the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	3.2% 1/31 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 30 days after the last dose of double-blinded study drug. At each visit, the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	6.9% 2/29 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 30 days after the last dose of double-blinded study drug. At each visit, the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Nervous system disorders Headache	0.00% 0/30 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 30 days after the last dose of double-blinded study drug. At each visit, the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	6.5% 2/31 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 30 days after the last dose of double-blinded study drug. At each visit, the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	6.9% 2/29 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 30 days after the last dose of double-blinded study drug. At each visit, the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	10.0% 3/30 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 30 days after the last dose of double-blinded study drug. At each visit, the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	6.5% 2/31 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 30 days after the last dose of double-blinded study drug. At each visit, the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/29 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 30 days after the last dose of double-blinded study drug. At each visit, the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Infections and infestations Nasopharyngitis	3.3% 1/30 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 30 days after the last dose of double-blinded study drug. At each visit, the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	3.2% 1/31 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 30 days after the last dose of double-blinded study drug. At each visit, the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	10.3% 3/29 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 30 days after the last dose of double-blinded study drug. At each visit, the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Gastrointestinal disorders Diarrhoea	3.3% 1/30 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 30 days after the last dose of double-blinded study drug. At each visit, the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	6.5% 2/31 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 30 days after the last dose of double-blinded study drug. At each visit, the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	6.9% 2/29 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 30 days after the last dose of double-blinded study drug. At each visit, the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Investigations Amylase increased	6.7% 2/30 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 30 days after the last dose of double-blinded study drug. At each visit, the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	3.2% 1/31 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 30 days after the last dose of double-blinded study drug. At each visit, the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	6.9% 2/29 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 30 days after the last dose of double-blinded study drug. At each visit, the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Infections and infestations Upper respiratory tract infection	0.00% 0/30 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 30 days after the last dose of double-blinded study drug. At each visit, the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	9.7% 3/31 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 30 days after the last dose of double-blinded study drug. At each visit, the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	10.3% 3/29 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 30 days after the last dose of double-blinded study drug. At each visit, the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Investigations Lipase increased	6.7% 2/30 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 30 days after the last dose of double-blinded study drug. At each visit, the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	6.5% 2/31 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 30 days after the last dose of double-blinded study drug. At each visit, the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	6.9% 2/29 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 30 days after the last dose of double-blinded study drug. At each visit, the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.

Additional Information

Medical Director

Takeda

Phone: +1-877-825-3327

Email: clinicaltrialregistry@tpna.com

Results disclosure agreements

• Principal investigator is a sponsor employee The first study related publication will be a multi-center publication submitted within 24 months after conclusion or termination of a study at all sites. After such multi site publication, all proposed site publications and presentations will be submitted to sponsor for review 60 days in advance of publication. Site will remove Sponsor confidential information unrelated to study results. Sponsor can delay a proposed publication for another 60 days to preserve intellectual property.
• Publication restrictions are in place

Restriction type: OTHER