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Trial Outcomes & Findings for Efficacy and Safety Study of MP-513 in Combination With Thiazolidinedione in Patients With Type 2 Diabetes (NCT NCT01026194)

NCT ID: NCT01026194

Last Updated: 2026-01-05

Results Overview

The change from Baseline in HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at Week 12. Least squares means were derived from an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline HbA1c as a covariate.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

204 participants

Primary outcome timeframe

at Week 0 and Week 12

Results posted on

2026-01-05

Participant Flow

Participant milestones

Participant milestones
Measure
Placebo/Teneli + Pio
Placebo for 12 weeks (double-blind period) followed by teneligliptin for an additional 40 weeks (open-label period) in combination with pioglitazone.
Teneli/Teneli + Pio
Teneligliptin for 12 weeks (double-blind period) followed by teneligliptin for an additional 40 weeks (open-label period) in combination with pioglitazone.
Period 1：Double Blind Period
STARTED
101
103
Period 1：Double Blind Period
COMPLETED
98
98
Period 1：Double Blind Period
NOT COMPLETED
3
5
Period 2：Open-label Period
STARTED
98
98
Period 2：Open-label Period
COMPLETED
91
88
Period 2：Open-label Period
NOT COMPLETED
7
10

Reasons for withdrawal

Reasons for withdrawal
Measure
Placebo/Teneli + Pio
Placebo for 12 weeks (double-blind period) followed by teneligliptin for an additional 40 weeks (open-label period) in combination with pioglitazone.
Teneli/Teneli + Pio
Teneligliptin for 12 weeks (double-blind period) followed by teneligliptin for an additional 40 weeks (open-label period) in combination with pioglitazone.
Period 1：Double Blind Period
Adverse Event
2
1
Period 1：Double Blind Period
Lack of Efficacy
1
0
Period 1：Double Blind Period
Physician Decision
0
4
Period 2：Open-label Period
Adverse Event
4
5
Period 2：Open-label Period
Physician Decision
3
1
Period 2：Open-label Period
Withdrawal by Subject
0
4

Baseline Characteristics

Efficacy and Safety Study of MP-513 in Combination With Thiazolidinedione in Patients With Type 2 Diabetes

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Placebo/Teneli + Pio
n=101 Participants
Placebo for 12 weeks (double-blind period) followed by teneligliptin for an additional 40 weeks (open-label period) in combination with pioglitazone.
Teneli/Teneli + Pio
n=103 Participants
Teneligliptin for 12 weeks (double-blind period) followed by teneligliptin for an additional 40 weeks (open-label period) in combination with pioglitazone.
Total
n=204 Participants
Total of all reporting groups
Age, Continuous
61.1 years
STANDARD_DEVIATION 8.9 • n=9667 Participants
59.7 years
STANDARD_DEVIATION 9.7 • n=6597 Participants
60.4 years
STANDARD_DEVIATION 9.3 • n=16264 Participants
Sex: Female, Male
Female
25 Participants
n=9667 Participants
35 Participants
n=6597 Participants
60 Participants
n=16264 Participants
Sex: Female, Male
Male
76 Participants
n=9667 Participants
68 Participants
n=6597 Participants
144 Participants
n=16264 Participants

PRIMARY outcome

Timeframe: at Week 0 and Week 12

Population: The full analysis set, consisting of all type 2 diabetic patients, who received at least one dose of study drug and who had at least one efficacy data after randomization. Analysis based on last observation carried forward, where the last postbaseline double-blind observed value was carried forward and used for Week 12 where data was missing.

The change from Baseline in HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at Week 12. Least squares means were derived from an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline HbA1c as a covariate.

Outcome measures

Outcome measures
Measure
Placebo/Teneli + Pio
n=101 Participants
Placebo for 12 weeks (double-blind period) followed by teneligliptin for an additional 40 weeks (open-label period) in combination with pioglitazone.
Teneli/Teneli + Pio
n=103 Participants
Teneligliptin for 12 weeks (double-blind period) followed by teneligliptin for an additional 40 weeks (open-label period) in combination with pioglitazone.
Change From Baseline in HbA1c at Week 12
-0.20 Percent of HbA1c
Standard Error 0.05
-0.94 Percent of HbA1c
Standard Error 0.04

SECONDARY outcome

Timeframe: at Week 0 and Week 12

Population: The full analysis set, consisting of all type 2 diabetic patients, who received at least one dose of study drug and who had at least one efficacy data after randomization. Analysis based on last observation carried forward, where the last postbaseline double-blind observed value was carried forward and used for Week 12 where data was missing.

The change from Baseline in Fasting Plasma Glucose collected at Week 12. Least squares means were derived from an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline Fasting Plasma Glucose as a covariate.

Outcome measures

Outcome measures
Measure
Placebo/Teneli + Pio
n=101 Participants
Placebo for 12 weeks (double-blind period) followed by teneligliptin for an additional 40 weeks (open-label period) in combination with pioglitazone.
Teneli/Teneli + Pio
n=103 Participants
Teneligliptin for 12 weeks (double-blind period) followed by teneligliptin for an additional 40 weeks (open-label period) in combination with pioglitazone.
Change From Baseline in Fasting Plasma Glucose at Week 12
-4.5 mg / dL
Standard Error 2.0
-21.0 mg / dL
Standard Error 1.9

SECONDARY outcome

Timeframe: 0, 0.5, 1, 2 hours post-dose at Week 0 and Week 12

Population: The full analysis set, consisting of all type 2 diabetic patients, who received at least one dose of study drug and who had at least one efficacy data after randomization.

The change from Baseline in AUC0-2h for Postprandial Plasma Glucose collected at Week 12. Least squares means were derived from an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline AUC0-2h for Postprandial Plasma Glucose as a covariate.

Outcome measures

Outcome measures
Measure
Placebo/Teneli + Pio
n=98 Participants
Placebo for 12 weeks (double-blind period) followed by teneligliptin for an additional 40 weeks (open-label period) in combination with pioglitazone.
Teneli/Teneli + Pio
n=98 Participants
Teneligliptin for 12 weeks (double-blind period) followed by teneligliptin for an additional 40 weeks (open-label period) in combination with pioglitazone.
Change From Baseline in the Areas Under the Curve From 0 to 2 h (AUC0-2h) for Postprandial Plasma Glucose at Week 12
-13.722 mg*h / dL
Standard Error 5.134
-85.031 mg*h / dL
Standard Error 5.134

SECONDARY outcome

Timeframe: at Week 0 and Week 12

Population: The full analysis set, consisting of all type 2 diabetic patients, who received at least one dose of study drug and who had at least one efficacy data after randomization.

The change from Baseline in 2-hour Postprandial Plasma Glucose collected at Week 12. Least squares means were derived from an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline 2-hour Postprandial Plasma Glucose as a covariate.

Outcome measures

Outcome measures
Measure
Placebo/Teneli + Pio
n=98 Participants
Placebo for 12 weeks (double-blind period) followed by teneligliptin for an additional 40 weeks (open-label period) in combination with pioglitazone.
Teneli/Teneli + Pio
n=98 Participants
Teneligliptin for 12 weeks (double-blind period) followed by teneligliptin for an additional 40 weeks (open-label period) in combination with pioglitazone.
Change From Baseline in 2-hour Postprandial Plasma Glucose at Week 12
-5.6 mg / dL
Standard Error 3.6
-56.9 mg / dL
Standard Error 3.6

Adverse Events

Placebo/Teneli + Pio (Data Through Week 12)

Serious events: 1 serious events
Other events: 47 other events
Deaths: 0 deaths

Teneli/Teneli + Pio (Data Through Week 12)

Serious events: 4 serious events
Other events: 63 other events
Deaths: 0 deaths

Placebo/Teneli + Pio (Data From Week 12 to Week 52)

Serious events: 3 serious events
Other events: 89 other events
Deaths: 0 deaths

Teneli/Teneli + Pio (Data Through Week 52)

Serious events: 11 serious events
Other events: 88 other events
Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure
Placebo/Teneli + Pio (Data Through Week 12)
n=101 participants at risk
Placebo for 12 weeks (double-blind period) followed by teneligliptin for an additional 40 weeks (open-label period) in combination with pioglitazone. The adverse events which occured from Week 0 to Week 12 were shown.
Teneli/Teneli + Pio (Data Through Week 12)
n=103 participants at risk
Teneligliptin for 12 weeks (double-blind period) followed by teneligliptin for an additional 40 weeks (open-label period) in combination with pioglitazone. The adverse events which occured from Week 0 to Week 12 were shown.
Placebo/Teneli + Pio (Data From Week 12 to Week 52)
n=98 participants at risk
Placebo for 12 weeks (double-blind period) followed by teneligliptin for an additional 40 weeks (open-label period) in combination with pioglitazone. The adverse events which occured from Week 12 to Week 52 were shown.
Teneli/Teneli + Pio (Data Through Week 52)
n=103 participants at risk
Teneligliptin for 12 weeks (double-blind period) followed by teneligliptin for an additional 40 weeks (open-label period) in combination with pioglitazone. The adverse events which occured from Week 12 to Week 52 were shown.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric cancer
0.99%
1/101
0.00%
0/103
1.0%
1/98
0.00%
0/103
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to bone
0.00%
0/101
0.00%
0/103
0.00%
0/98
0.97%
1/103
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal carcinoma
0.00%
0/101
0.00%
0/103
1.0%
1/98
0.00%
0/103
Eye disorders
Cataract
0.00%
0/101
0.97%
1/103
0.00%
0/98
0.97%
1/103
Cardiac disorders
Acute myocardial infarction
0.00%
0/101
0.00%
0/103
1.0%
1/98
0.00%
0/103
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract inflammation
0.00%
0/101
0.00%
0/103
0.00%
0/98
0.97%
1/103
Gastrointestinal disorders
Colonic polyp
0.99%
1/101
0.00%
0/103
0.00%
0/98
1.9%
2/103
Gastrointestinal disorders
Gastric polyps
0.00%
0/101
0.97%
1/103
0.00%
0/98
0.97%
1/103
Gastrointestinal disorders
Haemorrhoids
0.00%
0/101
0.97%
1/103
0.00%
0/98
0.97%
1/103
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
0.00%
0/101
0.00%
0/103
0.00%
0/98
0.97%
1/103
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Large intestine carcinoma
0.00%
0/101
0.00%
0/103
0.00%
0/98
0.97%
1/103
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian cancer
0.00%
0/101
0.00%
0/103
1.0%
1/98
0.00%
0/103
Nervous system disorders
Loss of consciousness
0.00%
0/101
0.97%
1/103
0.00%
0/98
0.97%
1/103
Nervous system disorders
Carotid artery stenosis
0.00%
0/101
0.00%
0/103
0.00%
0/98
0.97%
1/103
Nervous system disorders
Myelopathy
0.00%
0/101
0.00%
0/103
0.00%
0/98
0.97%
1/103

Other adverse events

Other adverse events
Measure
Placebo/Teneli + Pio (Data Through Week 12)
n=101 participants at risk
Placebo for 12 weeks (double-blind period) followed by teneligliptin for an additional 40 weeks (open-label period) in combination with pioglitazone. The adverse events which occured from Week 0 to Week 12 were shown.
Teneli/Teneli + Pio (Data Through Week 12)
n=103 participants at risk
Teneligliptin for 12 weeks (double-blind period) followed by teneligliptin for an additional 40 weeks (open-label period) in combination with pioglitazone. The adverse events which occured from Week 0 to Week 12 were shown.
Placebo/Teneli + Pio (Data From Week 12 to Week 52)
n=98 participants at risk
Placebo for 12 weeks (double-blind period) followed by teneligliptin for an additional 40 weeks (open-label period) in combination with pioglitazone. The adverse events which occured from Week 12 to Week 52 were shown.
Teneli/Teneli + Pio (Data Through Week 52)
n=103 participants at risk
Teneligliptin for 12 weeks (double-blind period) followed by teneligliptin for an additional 40 weeks (open-label period) in combination with pioglitazone. The adverse events which occured from Week 12 to Week 52 were shown.
Musculoskeletal and connective tissue disorders
Myalgia
0.00%
0/101
1.9%
2/103
3.1%
3/98
1.9%
2/103
Musculoskeletal and connective tissue disorders
Neck pain
0.99%
1/101
0.00%
0/103
0.00%
0/98
0.00%
0/103
Musculoskeletal and connective tissue disorders
Osteoarthritis
0.00%
0/101
1.9%
2/103
1.0%
1/98
2.9%
3/103
Musculoskeletal and connective tissue disorders
Pain in extremity
0.99%
1/101
0.97%
1/103
3.1%
3/98
0.00%
0/103
Musculoskeletal and connective tissue disorders
Periarthritis
0.00%
0/101
0.97%
1/103
1.0%
1/98
1.9%
2/103
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
0.99%
1/101
0.97%
1/103
1.0%
1/98
1.9%
2/103
Musculoskeletal and connective tissue disorders
Tenosynovitis
0.00%
0/101
0.97%
1/103
0.00%
0/98
1.9%
2/103
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
0.99%
1/101
0.00%
0/103
1.0%
1/98
0.00%
0/103
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
0.00%
0/101
0.97%
1/103
0.00%
0/98
1.9%
2/103
Musculoskeletal and connective tissue disorders
Groin pain
0.00%
0/101
0.00%
0/103
0.00%
0/98
0.97%
1/103
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis
0.00%
0/101
0.00%
0/103
2.0%
2/98
0.97%
1/103
Musculoskeletal and connective tissue disorders
Osteoporosis
0.00%
0/101
0.00%
0/103
0.00%
0/98
0.97%
1/103
Musculoskeletal and connective tissue disorders
Plantar fasciitis
0.00%
0/101
0.00%
0/103
1.0%
1/98
0.00%
0/103
Musculoskeletal and connective tissue disorders
Scoliosis
0.00%
0/101
0.00%
0/103
1.0%
1/98
0.00%
0/103
Musculoskeletal and connective tissue disorders
Spinal column stenosis
0.00%
0/101
0.00%
0/103
1.0%
1/98
0.00%
0/103
Musculoskeletal and connective tissue disorders
Tendonitis
0.00%
0/101
0.00%
0/103
0.00%
0/98
0.97%
1/103
Musculoskeletal and connective tissue disorders
Trigger finger
0.00%
0/101
0.00%
0/103
2.0%
2/98
0.00%
0/103
Musculoskeletal and connective tissue disorders
Spondylolisthesis
0.00%
0/101
0.00%
0/103
0.00%
0/98
0.97%
1/103
Renal and urinary disorders
Nephrolithiasis
0.00%
0/101
0.97%
1/103
1.0%
1/98
1.9%
2/103
Renal and urinary disorders
Calculus urinary
0.00%
0/101
0.00%
0/103
2.0%
2/98
0.00%
0/103
Renal and urinary disorders
Dysuria
0.00%
0/101
0.00%
0/103
0.00%
0/98
0.97%
1/103
Renal and urinary disorders
Hypertonic bladder
0.00%
0/101
0.00%
0/103
0.00%
0/98
0.97%
1/103
Renal and urinary disorders
Nocturia
0.00%
0/101
0.00%
0/103
0.00%
0/98
0.97%
1/103
Renal and urinary disorders
Pollakiuria
0.00%
0/101
0.00%
0/103
0.00%
0/98
0.97%
1/103
Renal and urinary disorders
Diabetic nephropathy
0.00%
0/101
0.00%
0/103
1.0%
1/98
0.00%
0/103
Reproductive system and breast disorders
Calculus prostatic
0.00%
0/101
0.00%
0/103
1.0%
1/98
0.00%
0/103
Reproductive system and breast disorders
Erectile dysfunction
0.00%
0/101
0.00%
0/103
1.0%
1/98
0.97%
1/103
General disorders
Chest discomfort
0.99%
1/101
0.00%
0/103
2.0%
2/98
0.00%
0/103
General disorders
Oedema peripheral
5.9%
6/101
1.9%
2/103
4.1%
4/98
3.9%
4/103
General disorders
Pyrexia
0.99%
1/101
0.00%
0/103
0.00%
0/98
0.97%
1/103
General disorders
Chest pain
0.00%
0/101
0.00%
0/103
1.0%
1/98
0.00%
0/103
General disorders
Feeling abnormal
0.00%
0/101
0.00%
0/103
1.0%
1/98
0.00%
0/103
General disorders
Malaise
0.00%
0/101
0.00%
0/103
0.00%
0/98
0.97%
1/103
General disorders
Mass
0.00%
0/101
0.00%
0/103
1.0%
1/98
0.00%
0/103
General disorders
Thirst
0.00%
0/101
0.00%
0/103
0.00%
0/98
0.97%
1/103
Investigations
Blood calcium decreased
0.99%
1/101
0.00%
0/103
0.00%
0/98
0.00%
0/103
Investigations
Blood creatine phosphokinase increased
2.0%
2/101
2.9%
3/103
4.1%
4/98
8.7%
9/103
Investigations
Blood triglycerides increased
0.99%
1/101
1.9%
2/103
1.0%
1/98
4.9%
5/103
Investigations
Blood urea increased
0.99%
1/101
0.00%
0/103
1.0%
1/98
0.00%
0/103
Investigations
Blood uric acid increased
0.99%
1/101
0.00%
0/103
1.0%
1/98
0.97%
1/103
Investigations
Gamma-glutamyltransferase increased
0.99%
1/101
0.00%
0/103
0.00%
0/98
0.97%
1/103
Investigations
Glucose urine present
7.9%
8/101
2.9%
3/103
6.1%
6/98
6.8%
7/103
Investigations
Blood urine present
2.0%
2/101
2.9%
3/103
5.1%
5/98
11.7%
12/103
Investigations
White blood cell count increased
0.00%
0/101
0.97%
1/103
2.0%
2/98
0.97%
1/103
Investigations
Protein urine present
0.99%
1/101
3.9%
4/103
3.1%
3/98
8.7%
9/103
Investigations
Urine ketone body present
2.0%
2/101
0.00%
0/103
6.1%
6/98
1.9%
2/103
Investigations
Occult blood positive
0.00%
0/101
0.97%
1/103
0.00%
0/98
0.97%
1/103
Injury, poisoning and procedural complications
Animal bite
0.00%
0/101
0.97%
1/103
0.00%
0/98
0.97%
1/103
Injury, poisoning and procedural complications
Joint sprain
2.0%
2/101
1.9%
2/103
4.1%
4/98
4.9%
5/103
Injury, poisoning and procedural complications
Scratch
0.00%
0/101
0.97%
1/103
0.00%
0/98
0.97%
1/103
Injury, poisoning and procedural complications
Thoracic vertebral fracture
0.00%
0/101
0.97%
1/103
0.00%
0/98
0.97%
1/103
Injury, poisoning and procedural complications
Contusion
0.99%
1/101
0.00%
0/103
1.0%
1/98
3.9%
4/103
Injury, poisoning and procedural complications
Post procedural complication
0.99%
1/101
0.00%
0/103
0.00%
0/98
0.00%
0/103
Injury, poisoning and procedural complications
Open wound
0.00%
0/101
0.97%
1/103
0.00%
0/98
0.97%
1/103
Injury, poisoning and procedural complications
Arthropod sting
0.00%
0/101
0.00%
0/103
3.1%
3/98
2.9%
3/103
Injury, poisoning and procedural complications
Bite
0.00%
0/101
0.00%
0/103
1.0%
1/98
0.00%
0/103
Injury, poisoning and procedural complications
Nail avulsion
0.00%
0/101
0.00%
0/103
1.0%
1/98
0.00%
0/103
Injury, poisoning and procedural complications
Radius fracture
0.00%
0/101
0.00%
0/103
1.0%
1/98
0.00%
0/103
Injury, poisoning and procedural complications
Excoriation
0.00%
0/101
0.00%
0/103
0.00%
0/98
0.97%
1/103
Injury, poisoning and procedural complications
Iliotibial band syndrome
0.00%
0/101
0.00%
0/103
0.00%
0/98
0.97%
1/103
Injury, poisoning and procedural complications
Heat illness
0.00%
0/101
0.00%
0/103
1.0%
1/98
0.00%
0/103
Infections and infestations
Abscess
0.00%
0/101
0.97%
1/103
0.00%
0/98
0.97%
1/103
Infections and infestations
Acute tonsillitis
0.99%
1/101
0.00%
0/103
0.00%
0/98
0.97%
1/103
Infections and infestations
Bronchitis
2.0%
2/101
0.97%
1/103
4.1%
4/98
1.9%
2/103
Infections and infestations
Cystitis
3.0%
3/101
0.97%
1/103
2.0%
2/98
3.9%
4/103
Infections and infestations
Nasal abscess
0.00%
0/101
0.97%
1/103
0.00%
0/98
0.97%
1/103
Infections and infestations
Nasopharyngitis
7.9%
8/101
11.7%
12/103
33.7%
33/98
32.0%
33/103
Infections and infestations
Pharyngitis
0.00%
0/101
0.97%
1/103
3.1%
3/98
1.9%
2/103
Infections and infestations
Pneumonia
0.00%
0/101
0.97%
1/103
0.00%
0/98
0.97%
1/103
Infections and infestations
Tonsillitis
0.00%
0/101
0.97%
1/103
0.00%
0/98
1.9%
2/103
Infections and infestations
Gastritis viral
0.00%
0/101
0.97%
1/103
0.00%
0/98
0.97%
1/103
Infections and infestations
Herpes dermatitis
0.99%
1/101
0.00%
0/103
1.0%
1/98
0.00%
0/103
Infections and infestations
Oral herpes
0.99%
1/101
0.00%
0/103
2.0%
2/98
0.00%
0/103
Infections and infestations
Folliculitis
0.00%
0/101
0.00%
0/103
2.0%
2/98
0.00%
0/103
Infections and infestations
Gastroenteritis
0.00%
0/101
0.00%
0/103
2.0%
2/98
0.00%
0/103
Infections and infestations
Herpes simplex
0.00%
0/101
0.00%
0/103
1.0%
1/98
0.00%
0/103
Infections and infestations
Hordeolum
0.00%
0/101
0.00%
0/103
1.0%
1/98
0.00%
0/103
Infections and infestations
Influenza
0.00%
0/101
0.00%
0/103
3.1%
3/98
0.00%
0/103
Infections and infestations
Laryngitis
0.00%
0/101
0.00%
0/103
1.0%
1/98
0.00%
0/103
Infections and infestations
Oesophageal candidiasis
0.00%
0/101
0.00%
0/103
1.0%
1/98
0.00%
0/103
Infections and infestations
Onychomycosis
0.00%
0/101
0.00%
0/103
1.0%
1/98
0.00%
0/103
Infections and infestations
Otitis externa
0.00%
0/101
0.00%
0/103
0.00%
0/98
0.97%
1/103
Infections and infestations
Paronychia
0.00%
0/101
0.00%
0/103
0.00%
0/98
0.97%
1/103
Infections and infestations
Parotitis
0.00%
0/101
0.00%
0/103
1.0%
1/98
0.00%
0/103
Infections and infestations
Rhinitis
0.00%
0/101
0.00%
0/103
0.00%
0/98
0.97%
1/103
Infections and infestations
Sinusitis
0.00%
0/101
0.00%
0/103
0.00%
0/98
0.97%
1/103
Infections and infestations
Tinea pedis
0.00%
0/101
0.00%
0/103
3.1%
3/98
0.00%
0/103
Infections and infestations
Urethritis
0.00%
0/101
0.00%
0/103
0.00%
0/98
1.9%
2/103
Infections and infestations
Gingival abscess
0.00%
0/101
0.00%
0/103
0.00%
0/98
0.97%
1/103
Infections and infestations
Helicobacter infection
0.00%
0/101
0.00%
0/103
2.0%
2/98
2.9%
3/103
Infections and infestations
Tinea versicolour
0.00%
0/101
0.00%
0/103
0.00%
0/98
0.97%
1/103
Infections and infestations
Bone abscess
0.00%
0/101
0.00%
0/103
0.00%
0/98
0.97%
1/103
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid neoplasm
0.00%
0/101
0.00%
0/103
0.00%
0/98
0.97%
1/103
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian neoplasm
0.00%
0/101
0.00%
0/103
1.0%
1/98
0.00%
0/103
Blood and lymphatic system disorders
Iron deficiency anaemia
0.00%
0/101
0.00%
0/103
0.00%
0/98
0.97%
1/103
Blood and lymphatic system disorders
Leukopenia
0.00%
0/101
0.00%
0/103
0.00%
0/98
0.97%
1/103
Immune system disorders
Seasonal allergy
0.00%
0/101
0.00%
0/103
1.0%
1/98
0.97%
1/103
Metabolism and nutrition disorders
Hypoglycaemia
0.00%
0/101
1.9%
2/103
1.0%
1/98
1.9%
2/103
Metabolism and nutrition disorders
Hyperphosphatasaemia
0.00%
0/101
0.97%
1/103
0.00%
0/98
0.97%
1/103
Metabolism and nutrition disorders
Dehydration
0.00%
0/101
0.00%
0/103
0.00%
0/98
0.97%
1/103
Metabolism and nutrition disorders
Gout
0.00%
0/101
0.00%
0/103
0.00%
0/98
0.97%
1/103
Metabolism and nutrition disorders
Hyperuricaemia
0.00%
0/101
0.00%
0/103
0.00%
0/98
0.97%
1/103
Metabolism and nutrition disorders
Hyperlipidaemia
0.00%
0/101
0.00%
0/103
0.00%
0/98
0.97%
1/103
Psychiatric disorders
Insomnia
0.99%
1/101
0.00%
0/103
4.1%
4/98
1.9%
2/103
Nervous system disorders
Cervicobrachial syndrome
0.99%
1/101
0.00%
0/103
1.0%
1/98
0.00%
0/103
Nervous system disorders
Dizziness
0.99%
1/101
0.00%
0/103
4.1%
4/98
2.9%
3/103
Nervous system disorders
Headache
0.99%
1/101
1.9%
2/103
3.1%
3/98
1.9%
2/103
Nervous system disorders
Hypoaesthesia
0.99%
1/101
0.97%
1/103
3.1%
3/98
1.9%
2/103
Nervous system disorders
Neuralgia
0.00%
0/101
0.97%
1/103
0.00%
0/98
0.97%
1/103
Nervous system disorders
Tension headache
0.99%
1/101
0.00%
0/103
1.0%
1/98
0.00%
0/103
Nervous system disorders
Lacunar infarction
0.99%
1/101
0.00%
0/103
1.0%
1/98
0.97%
1/103
Nervous system disorders
Spinocerebellar disorder
0.00%
0/101
0.97%
1/103
0.00%
0/98
0.97%
1/103
Nervous system disorders
Cerebrovascular stenosis
0.99%
1/101
0.00%
0/103
1.0%
1/98
0.00%
0/103
Nervous system disorders
Carotid artery stenosis
0.00%
0/101
0.00%
0/103
1.0%
1/98
0.00%
0/103
Nervous system disorders
Intercostal neuralgia
0.00%
0/101
0.00%
0/103
2.0%
2/98
0.00%
0/103
Nervous system disorders
VIIth nerve paralysis
0.00%
0/101
0.00%
0/103
1.0%
1/98
0.00%
0/103
Nervous system disorders
Carotid arteriosclerosis
0.00%
0/101
0.00%
0/103
1.0%
1/98
0.00%
0/103
Nervous system disorders
Occipital neuralgia
0.00%
0/101
0.00%
0/103
0.00%
0/98
0.97%
1/103
Eye disorders
Conjunctivitis
0.99%
1/101
0.97%
1/103
0.00%
0/98
0.97%
1/103
Eye disorders
Blepharitis
0.00%
0/101
0.00%
0/103
1.0%
1/98
0.00%
0/103
Eye disorders
Cataract
0.00%
0/101
0.00%
0/103
1.0%
1/98
1.9%
2/103
Eye disorders
Conjunctival haemorrhage
0.00%
0/101
0.00%
0/103
2.0%
2/98
0.00%
0/103
Eye disorders
Conjunctivitis allergic
0.00%
0/101
0.00%
0/103
0.00%
0/98
1.9%
2/103
Eye disorders
Corneal opacity
0.00%
0/101
0.00%
0/103
0.00%
0/98
0.97%
1/103
Eye disorders
Diabetic retinopathy
0.00%
0/101
0.00%
0/103
2.0%
2/98
1.9%
2/103
Eye disorders
Dry eye
0.00%
0/101
0.00%
0/103
1.0%
1/98
0.00%
0/103
Eye disorders
Eyelid oedema
0.00%
0/101
0.00%
0/103
0.00%
0/98
0.97%
1/103
Eye disorders
Glaucoma
0.00%
0/101
0.00%
0/103
1.0%
1/98
0.00%
0/103
Eye disorders
Keratoconjunctivitis sicca
0.00%
0/101
0.00%
0/103
1.0%
1/98
0.00%
0/103
Eye disorders
Retinal vein occlusion
0.00%
0/101
0.00%
0/103
0.00%
0/98
0.97%
1/103
Eye disorders
Vision blurred
0.00%
0/101
0.00%
0/103
1.0%
1/98
0.00%
0/103
Eye disorders
Meibomian gland dysfunction
0.00%
0/101
0.00%
0/103
0.00%
0/98
0.97%
1/103
Ear and labyrinth disorders
Vertigo
0.00%
0/101
0.00%
0/103
1.0%
1/98
0.97%
1/103
Cardiac disorders
Bundle branch block left
0.00%
0/101
0.97%
1/103
0.00%
0/98
0.97%
1/103
Cardiac disorders
Cardiomegaly
0.00%
0/101
0.97%
1/103
0.00%
0/98
0.97%
1/103
Cardiac disorders
Atrial fibrillation
0.00%
0/101
0.00%
0/103
0.00%
0/98
0.97%
1/103
Cardiac disorders
Palpitations
0.00%
0/101
0.00%
0/103
0.00%
0/98
0.97%
1/103
Cardiac disorders
Cardiac valve disease
0.00%
0/101
0.00%
0/103
0.00%
0/98
0.97%
1/103
Vascular disorders
Hypertension
0.99%
1/101
0.00%
0/103
2.0%
2/98
0.97%
1/103
Vascular disorders
Hypotension
0.00%
0/101
0.97%
1/103
0.00%
0/98
0.97%
1/103
Respiratory, thoracic and mediastinal disorders
Cough
2.0%
2/101
0.97%
1/103
2.0%
2/98
2.9%
3/103
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract inflammation
0.99%
1/101
3.9%
4/103
10.2%
10/98
10.7%
11/103
Respiratory, thoracic and mediastinal disorders
Oropharyngeal discomfort
0.99%
1/101
0.00%
0/103
1.0%
1/98
0.00%
0/103
Respiratory, thoracic and mediastinal disorders
Asthma
0.00%
0/101
0.00%
0/103
0.00%
0/98
0.97%
1/103
Respiratory, thoracic and mediastinal disorders
Epistaxis
0.00%
0/101
0.00%
0/103
1.0%
1/98
0.00%
0/103
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
0.00%
0/101
0.00%
0/103
1.0%
1/98
1.9%
2/103
Gastrointestinal disorders
Abdominal discomfort
0.00%
0/101
0.97%
1/103
0.00%
0/98
1.9%
2/103
Gastrointestinal disorders
Abdominal distension
0.00%
0/101
0.97%
1/103
0.00%
0/98
1.9%
2/103
Gastrointestinal disorders
Abdominal pain upper
0.00%
0/101
0.97%
1/103
0.00%
0/98
0.97%
1/103
Gastrointestinal disorders
Anal fissure
0.00%
0/101
0.97%
1/103
0.00%
0/98
0.97%
1/103
Gastrointestinal disorders
Cheilitis
0.00%
0/101
0.97%
1/103
0.00%
0/98
0.97%
1/103
Gastrointestinal disorders
Colonic polyp
0.00%
0/101
0.97%
1/103
4.1%
4/98
2.9%
3/103
Gastrointestinal disorders
Constipation
0.99%
1/101
1.9%
2/103
4.1%
4/98
2.9%
3/103
Gastrointestinal disorders
Dental caries
0.99%
1/101
0.00%
0/103
0.00%
0/98
1.9%
2/103
Gastrointestinal disorders
Diarrhoea
0.00%
0/101
0.97%
1/103
2.0%
2/98
0.97%
1/103
Gastrointestinal disorders
Gastric polyps
0.00%
0/101
0.97%
1/103
1.0%
1/98
3.9%
4/103
Gastrointestinal disorders
Gastritis
0.00%
0/101
1.9%
2/103
4.1%
4/98
5.8%
6/103
Gastrointestinal disorders
Gingival swelling
0.99%
1/101
0.00%
0/103
0.00%
0/98
0.00%
0/103
Gastrointestinal disorders
Reflux oesophagitis
0.00%
0/101
1.9%
2/103
4.1%
4/98
3.9%
4/103
Gastrointestinal disorders
Stomatitis
0.99%
1/101
0.00%
0/103
0.00%
0/98
0.97%
1/103
Gastrointestinal disorders
Gastric xanthoma
0.00%
0/101
0.97%
1/103
0.00%
0/98
0.97%
1/103
Gastrointestinal disorders
Abdominal pain lower
0.00%
0/101
0.00%
0/103
1.0%
1/98
0.00%
0/103
Gastrointestinal disorders
Duodenal ulcer
0.00%
0/101
0.00%
0/103
2.0%
2/98
0.00%
0/103
Gastrointestinal disorders
Enterocolitis
0.00%
0/101
0.00%
0/103
1.0%
1/98
0.00%
0/103
Gastrointestinal disorders
Flatulence
0.00%
0/101
0.00%
0/103
0.00%
0/98
0.97%
1/103
Gastrointestinal disorders
Gastric ulcer
0.00%
0/101
0.00%
0/103
0.00%
0/98
2.9%
3/103
Gastrointestinal disorders
Gastritis atrophic
0.00%
0/101
0.00%
0/103
1.0%
1/98
0.00%
0/103
Gastrointestinal disorders
Gastritis erosive
0.00%
0/101
0.00%
0/103
1.0%
1/98
0.97%
1/103
Gastrointestinal disorders
Gingivitis
0.00%
0/101
0.00%
0/103
1.0%
1/98
2.9%
3/103
Gastrointestinal disorders
Haemorrhoids
0.00%
0/101
0.00%
0/103
1.0%
1/98
2.9%
3/103
Gastrointestinal disorders
Nausea
0.00%
0/101
0.00%
0/103
3.1%
3/98
0.97%
1/103
Gastrointestinal disorders
Periodontal disease
0.00%
0/101
0.00%
0/103
1.0%
1/98
0.00%
0/103
Gastrointestinal disorders
Periodontitis
0.00%
0/101
0.00%
0/103
1.0%
1/98
3.9%
4/103
Gastrointestinal disorders
Supernumerary teeth
0.00%
0/101
0.00%
0/103
0.00%
0/98
0.97%
1/103
Gastrointestinal disorders
Vomiting
0.00%
0/101
0.00%
0/103
1.0%
1/98
0.00%
0/103
Gastrointestinal disorders
Gastric mucosal lesion
0.00%
0/101
0.00%
0/103
1.0%
1/98
0.00%
0/103
Gastrointestinal disorders
Erosive oesophagitis
0.00%
0/101
0.00%
0/103
0.00%
0/98
0.97%
1/103
Hepatobiliary disorders
Hepatic steatosis
0.00%
0/101
0.97%
1/103
2.0%
2/98
2.9%
3/103
Hepatobiliary disorders
Cholelithiasis
0.00%
0/101
0.00%
0/103
2.0%
2/98
0.00%
0/103
Hepatobiliary disorders
Hepatic congestion
0.00%
0/101
0.00%
0/103
1.0%
1/98
0.00%
0/103
Hepatobiliary disorders
Hyperplastic cholecystopathy
0.00%
0/101
0.00%
0/103
1.0%
1/98
0.00%
0/103
Skin and subcutaneous tissue disorders
Acne
0.00%
0/101
0.97%
1/103
0.00%
0/98
0.97%
1/103
Skin and subcutaneous tissue disorders
Dermatitis allergic
0.00%
0/101
1.9%
2/103
0.00%
0/98
1.9%
2/103
Skin and subcutaneous tissue disorders
Dry skin
0.99%
1/101
0.00%
0/103
0.00%
0/98
0.00%
0/103
Skin and subcutaneous tissue disorders
Eczema
0.00%
0/101
1.9%
2/103
4.1%
4/98
5.8%
6/103
Skin and subcutaneous tissue disorders
Eczema asteatotic
0.99%
1/101
0.00%
0/103
1.0%
1/98
0.00%
0/103
Skin and subcutaneous tissue disorders
Heat rash
0.00%
0/101
0.97%
1/103
1.0%
1/98
1.9%
2/103
Skin and subcutaneous tissue disorders
Ingrowing nail
0.00%
0/101
0.97%
1/103
1.0%
1/98
0.97%
1/103
Skin and subcutaneous tissue disorders
Pruritus
0.00%
0/101
1.9%
2/103
0.00%
0/98
2.9%
3/103
Skin and subcutaneous tissue disorders
Rash
0.99%
1/101
0.97%
1/103
0.00%
0/98
1.9%
2/103
Skin and subcutaneous tissue disorders
Skin exfoliation
0.99%
1/101
0.00%
0/103
0.00%
0/98
0.00%
0/103
Skin and subcutaneous tissue disorders
Urticaria
0.00%
0/101
1.9%
2/103
0.00%
0/98
1.9%
2/103
Skin and subcutaneous tissue disorders
Dandruff
0.00%
0/101
0.00%
0/103
0.00%
0/98
0.97%
1/103
Skin and subcutaneous tissue disorders
Dermatitis atopic
0.00%
0/101
0.00%
0/103
0.00%
0/98
0.97%
1/103
Skin and subcutaneous tissue disorders
Dermatitis contact
0.00%
0/101
0.00%
0/103
1.0%
1/98
0.97%
1/103
Skin and subcutaneous tissue disorders
Eczema nummular
0.00%
0/101
0.00%
0/103
0.00%
0/98
0.97%
1/103
Skin and subcutaneous tissue disorders
Pityriasis rosea
0.00%
0/101
0.00%
0/103
1.0%
1/98
0.00%
0/103
Skin and subcutaneous tissue disorders
Seborrhoeic dermatitis
0.00%
0/101
0.00%
0/103
0.00%
0/98
0.97%
1/103
Skin and subcutaneous tissue disorders
Xeroderma
0.00%
0/101
0.00%
0/103
1.0%
1/98
0.00%
0/103
Skin and subcutaneous tissue disorders
Photodermatosis
0.00%
0/101
0.00%
0/103
0.00%
0/98
0.97%
1/103
Skin and subcutaneous tissue disorders
Hyperkeratosis palmaris and plantaris
0.00%
0/101
0.00%
0/103
0.00%
0/98
0.97%
1/103
Musculoskeletal and connective tissue disorders
Arthralgia
0.99%
1/101
0.00%
0/103
2.0%
2/98
2.9%
3/103
Musculoskeletal and connective tissue disorders
Back pain
0.99%
1/101
1.9%
2/103
6.1%
6/98
6.8%
7/103
Musculoskeletal and connective tissue disorders
Haemarthrosis
0.99%
1/101
0.00%
0/103
0.00%
0/98
0.00%
0/103
Musculoskeletal and connective tissue disorders
Muscle spasms
0.00%
0/101
1.9%
2/103
1.0%
1/98
2.9%
3/103

Additional Information

Clinical Trials, Information Desk

Tanabe Pharma Corporation

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place

Restriction type: OTHER