Trial Outcomes & Findings for Long-term Safety Study of MP-513 as Monotherapy or in Combination With Sulfonylurea in Japanese Type 2 Diabetic Patients (NCT NCT02314637)
NCT ID: NCT02314637
Last Updated: 2026-01-05
Results Overview
Treatment-emergent adverse events (TEAE) were defined as any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug through 14 days after receiving the last dose of study drug.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
240 participants
Primary outcome timeframe
52 weeks
Results posted on
2026-01-05
Participant Flow
Participant milestones
| Measure |
Teneligliptin
Teneligliptin for 52 weeks
|
Teneligliptin + Sulfonylurea
Teneligliptin for 52 weeks in combination with sulfonylurea (glimepiride)
|
|---|---|---|
|
Overall Study
STARTED
|
151
|
89
|
|
Overall Study
COMPLETED
|
135
|
75
|
|
Overall Study
NOT COMPLETED
|
16
|
14
|
Reasons for withdrawal
| Measure |
Teneligliptin
Teneligliptin for 52 weeks
|
Teneligliptin + Sulfonylurea
Teneligliptin for 52 weeks in combination with sulfonylurea (glimepiride)
|
|---|---|---|
|
Overall Study
Adverse Event
|
4
|
8
|
|
Overall Study
Lack of Efficacy
|
1
|
0
|
|
Overall Study
Physician Decision
|
5
|
2
|
|
Overall Study
Withdrawal by Subject
|
5
|
4
|
|
Overall Study
Other Reason
|
1
|
0
|
Baseline Characteristics
Long-term Safety Study of MP-513 as Monotherapy or in Combination With Sulfonylurea in Japanese Type 2 Diabetic Patients
Baseline characteristics by cohort
| Measure |
Teneligliptin
n=151 Participants
Teneligliptin for 52 weeks
|
Teneligliptin + Sulfonylurea
n=89 Participants
Teneligliptin for 52 weeks in combination with sulfonylurea
|
Total
n=240 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
<65 years
|
108 participants
n=9667 Participants
|
65 participants
n=6597 Participants
|
173 participants
n=16264 Participants
|
|
Age, Customized
>=65 years
|
43 participants
n=9667 Participants
|
24 participants
n=6597 Participants
|
67 participants
n=16264 Participants
|
|
Sex: Female, Male
Female
|
56 Participants
n=9667 Participants
|
33 Participants
n=6597 Participants
|
89 Participants
n=16264 Participants
|
|
Sex: Female, Male
Male
|
95 Participants
n=9667 Participants
|
56 Participants
n=6597 Participants
|
151 Participants
n=16264 Participants
|
PRIMARY outcome
Timeframe: 52 weeksPopulation: Safety set, consisting of all patients, who received at least one dose of study drug and who had at least one safety data after the treatment of study drug.
Treatment-emergent adverse events (TEAE) were defined as any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug through 14 days after receiving the last dose of study drug.
Outcome measures
| Measure |
Teneligliptin
n=151 Participants
Teneligliptin for 52 weeks
|
Teneligliptin + Sulfonylurea
n=89 Participants
Teneligliptin for 52 weeks in combination with sulfonylurea
|
|---|---|---|
|
Number of Participants With Adverse Events
Serious Adverse Event
|
6 participants
|
7 participants
|
|
Number of Participants With Adverse Events
Other Adverse Event
|
136 participants
|
84 participants
|
SECONDARY outcome
Timeframe: Baseline and Week 52Population: 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 the treatment of study drug. Analysis based on last observation carried forward, where the last postbaseline observed value was carried forward and used for Week 52 where data was missing.
Outcome measures
| Measure |
Teneligliptin
n=151 Participants
Teneligliptin for 52 weeks
|
Teneligliptin + Sulfonylurea
n=89 Participants
Teneligliptin for 52 weeks in combination with sulfonylurea
|
|---|---|---|
|
Change From Baseline in HbA1c at Week 52
|
-0.63 percent
Standard Deviation 0.67
|
-0.81 percent
Standard Deviation 0.76
|
SECONDARY outcome
Timeframe: Baseline and Week 52Population: 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 the treatment of study drug. Analysis based on last observation carried forward, where the last postbaseline observed value was carried forward and used for Week 52 where data was missing.
Outcome measures
| Measure |
Teneligliptin
n=151 Participants
Teneligliptin for 52 weeks
|
Teneligliptin + Sulfonylurea
n=88 Participants
Teneligliptin for 52 weeks in combination with sulfonylurea
|
|---|---|---|
|
Change From Baseline in Fasting Plasma Glucose at Week 52
|
-12.4 mg/dL
Standard Deviation 22.9
|
-17.0 mg/dL
Standard Deviation 30.5
|
Adverse Events
Teneligliptin
Serious events: 6 serious events
Other events: 136 other events
Deaths: 0 deaths
Teneligliptin + Sulfonylurea
Serious events: 7 serious events
Other events: 84 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Teneligliptin
n=151 participants at risk
Teneligliptin for 52 weeks
|
Teneligliptin + Sulfonylurea
n=89 participants at risk
Teneligliptin for 52 weeks in combination with sulfonylurea
|
|---|---|---|
|
Infections and infestations
Diverticulitis
|
0.66%
1/151 • 52 weeks
|
0.00%
0/89 • 52 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric cancer
|
0.00%
0/151 • 52 weeks
|
1.1%
1/89 • 52 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Large intestine carcinoma
|
0.66%
1/151 • 52 weeks
|
0.00%
0/89 • 52 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Testicular neoplasm
|
0.00%
0/151 • 52 weeks
|
1.1%
1/89 • 52 weeks
|
|
Nervous system disorders
Myelopathy
|
0.00%
0/151 • 52 weeks
|
1.1%
1/89 • 52 weeks
|
|
Ear and labyrinth disorders
Sudden hearing loss
|
0.66%
1/151 • 52 weeks
|
0.00%
0/89 • 52 weeks
|
|
Gastrointestinal disorders
Gastritis
|
0.66%
1/151 • 52 weeks
|
0.00%
0/89 • 52 weeks
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.66%
1/151 • 52 weeks
|
0.00%
0/89 • 52 weeks
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/151 • 52 weeks
|
1.1%
1/89 • 52 weeks
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/151 • 52 weeks
|
1.1%
1/89 • 52 weeks
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.66%
1/151 • 52 weeks
|
1.1%
1/89 • 52 weeks
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/151 • 52 weeks
|
1.1%
1/89 • 52 weeks
|
|
Injury, poisoning and procedural complications
Joint sprain
|
0.00%
0/151 • 52 weeks
|
1.1%
1/89 • 52 weeks
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.00%
0/151 • 52 weeks
|
1.1%
1/89 • 52 weeks
|
Other adverse events
| Measure |
Teneligliptin
n=151 participants at risk
Teneligliptin for 52 weeks
|
Teneligliptin + Sulfonylurea
n=89 participants at risk
Teneligliptin for 52 weeks in combination with sulfonylurea
|
|---|---|---|
|
Infections and infestations
Acute tonsillitis
|
0.00%
0/151 • 52 weeks
|
1.1%
1/89 • 52 weeks
|
|
Infections and infestations
Bronchitis
|
6.0%
9/151 • 52 weeks
|
9.0%
8/89 • 52 weeks
|
|
Infections and infestations
Cellulitis
|
0.66%
1/151 • 52 weeks
|
1.1%
1/89 • 52 weeks
|
|
Infections and infestations
Chronic sinusitis
|
0.66%
1/151 • 52 weeks
|
0.00%
0/89 • 52 weeks
|
|
Infections and infestations
Cystitis
|
2.0%
3/151 • 52 weeks
|
2.2%
2/89 • 52 weeks
|
|
Infections and infestations
Dermatitis infected
|
0.00%
0/151 • 52 weeks
|
1.1%
1/89 • 52 weeks
|
|
Infections and infestations
Folliculitis
|
0.00%
0/151 • 52 weeks
|
1.1%
1/89 • 52 weeks
|
|
Infections and infestations
Gastroenteritis
|
2.0%
3/151 • 52 weeks
|
1.1%
1/89 • 52 weeks
|
|
Infections and infestations
Herpes zoster
|
1.3%
2/151 • 52 weeks
|
1.1%
1/89 • 52 weeks
|
|
Infections and infestations
Hordeolum
|
0.00%
0/151 • 52 weeks
|
2.2%
2/89 • 52 weeks
|
|
Infections and infestations
Influenza
|
0.66%
1/151 • 52 weeks
|
1.1%
1/89 • 52 weeks
|
|
Infections and infestations
Laryngitis
|
0.66%
1/151 • 52 weeks
|
0.00%
0/89 • 52 weeks
|
|
Infections and infestations
Nasopharyngitis
|
37.1%
56/151 • 52 weeks
|
32.6%
29/89 • 52 weeks
|
|
Infections and infestations
Onychomycosis
|
3.3%
5/151 • 52 weeks
|
1.1%
1/89 • 52 weeks
|
|
Infections and infestations
Otitis media
|
0.66%
1/151 • 52 weeks
|
0.00%
0/89 • 52 weeks
|
|
Infections and infestations
Otitis media chronic
|
0.66%
1/151 • 52 weeks
|
0.00%
0/89 • 52 weeks
|
|
Infections and infestations
Pharyngitis
|
5.3%
8/151 • 52 weeks
|
4.5%
4/89 • 52 weeks
|
|
Infections and infestations
Pulpitis dental
|
0.00%
0/151 • 52 weeks
|
1.1%
1/89 • 52 weeks
|
|
Infections and infestations
Rhinitis
|
0.00%
0/151 • 52 weeks
|
1.1%
1/89 • 52 weeks
|
|
Infections and infestations
Tinea pedis
|
4.6%
7/151 • 52 weeks
|
2.2%
2/89 • 52 weeks
|
|
Infections and infestations
Tonsillitis
|
0.66%
1/151 • 52 weeks
|
0.00%
0/89 • 52 weeks
|
|
Infections and infestations
Vulvitis
|
0.66%
1/151 • 52 weeks
|
0.00%
0/89 • 52 weeks
|
|
Infections and infestations
Vulvovaginitis
|
0.66%
1/151 • 52 weeks
|
0.00%
0/89 • 52 weeks
|
|
Infections and infestations
Wound infection
|
0.66%
1/151 • 52 weeks
|
0.00%
0/89 • 52 weeks
|
|
Infections and infestations
Gastritis viral
|
0.00%
0/151 • 52 weeks
|
1.1%
1/89 • 52 weeks
|
|
Infections and infestations
Helicobacter infection
|
0.00%
0/151 • 52 weeks
|
1.1%
1/89 • 52 weeks
|
|
Infections and infestations
Myringitis
|
0.00%
0/151 • 52 weeks
|
1.1%
1/89 • 52 weeks
|
|
Infections and infestations
Enterocolitis viral
|
0.66%
1/151 • 52 weeks
|
0.00%
0/89 • 52 weeks
|
|
Infections and infestations
Cystitis bacterial
|
0.00%
0/151 • 52 weeks
|
1.1%
1/89 • 52 weeks
|
|
Infections and infestations
Oral herpes
|
1.3%
2/151 • 52 weeks
|
1.1%
1/89 • 52 weeks
|
|
Infections and infestations
Latent syphilis
|
0.66%
1/151 • 52 weeks
|
0.00%
0/89 • 52 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acrochordon
|
0.00%
0/151 • 52 weeks
|
1.1%
1/89 • 52 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin papilloma
|
0.00%
0/151 • 52 weeks
|
1.1%
1/89 • 52 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
0.66%
1/151 • 52 weeks
|
0.00%
0/89 • 52 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastrointestinal neoplasm
|
1.3%
2/151 • 52 weeks
|
0.00%
0/89 • 52 weeks
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.66%
1/151 • 52 weeks
|
0.00%
0/89 • 52 weeks
|
|
Immune system disorders
Seasonal allergy
|
0.00%
0/151 • 52 weeks
|
2.2%
2/89 • 52 weeks
|
|
Endocrine disorders
Thyroid mass
|
0.66%
1/151 • 52 weeks
|
0.00%
0/89 • 52 weeks
|
|
Metabolism and nutrition disorders
Gout
|
0.00%
0/151 • 52 weeks
|
1.1%
1/89 • 52 weeks
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
0.00%
0/151 • 52 weeks
|
1.1%
1/89 • 52 weeks
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
3.3%
5/151 • 52 weeks
|
10.1%
9/89 • 52 weeks
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.66%
1/151 • 52 weeks
|
0.00%
0/89 • 52 weeks
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
0.66%
1/151 • 52 weeks
|
2.2%
2/89 • 52 weeks
|
|
Psychiatric disorders
Anxiety
|
0.66%
1/151 • 52 weeks
|
0.00%
0/89 • 52 weeks
|
|
Psychiatric disorders
Depression
|
0.66%
1/151 • 52 weeks
|
0.00%
0/89 • 52 weeks
|
|
Psychiatric disorders
Insomnia
|
4.0%
6/151 • 52 weeks
|
10.1%
9/89 • 52 weeks
|
|
Psychiatric disorders
Schizophrenia
|
0.00%
0/151 • 52 weeks
|
1.1%
1/89 • 52 weeks
|
|
Psychiatric disorders
Somatoform disorder gastrointestinal
|
0.00%
0/151 • 52 weeks
|
1.1%
1/89 • 52 weeks
|
|
Psychiatric disorders
Anxiety disorder
|
0.66%
1/151 • 52 weeks
|
0.00%
0/89 • 52 weeks
|
|
Nervous system disorders
Cervicobrachial syndrome
|
0.66%
1/151 • 52 weeks
|
1.1%
1/89 • 52 weeks
|
|
Nervous system disorders
Diabetic neuropathy
|
2.6%
4/151 • 52 weeks
|
0.00%
0/89 • 52 weeks
|
|
Nervous system disorders
Dizziness
|
0.66%
1/151 • 52 weeks
|
1.1%
1/89 • 52 weeks
|
|
Nervous system disorders
Dizziness postural
|
1.3%
2/151 • 52 weeks
|
0.00%
0/89 • 52 weeks
|
|
Nervous system disorders
Headache
|
4.6%
7/151 • 52 weeks
|
0.00%
0/89 • 52 weeks
|
|
Nervous system disorders
Migraine
|
0.66%
1/151 • 52 weeks
|
0.00%
0/89 • 52 weeks
|
|
Nervous system disorders
Somnolence
|
0.66%
1/151 • 52 weeks
|
0.00%
0/89 • 52 weeks
|
|
Nervous system disorders
Tension headache
|
0.00%
0/151 • 52 weeks
|
2.2%
2/89 • 52 weeks
|
|
Nervous system disorders
Carotid arteriosclerosis
|
2.0%
3/151 • 52 weeks
|
0.00%
0/89 • 52 weeks
|
|
Nervous system disorders
Occipital neuralgia
|
0.66%
1/151 • 52 weeks
|
0.00%
0/89 • 52 weeks
|
|
Eye disorders
Abnormal sensation in eye
|
0.00%
0/151 • 52 weeks
|
1.1%
1/89 • 52 weeks
|
|
Eye disorders
Cataract
|
2.6%
4/151 • 52 weeks
|
0.00%
0/89 • 52 weeks
|
|
Eye disorders
Conjunctival granuloma
|
0.66%
1/151 • 52 weeks
|
0.00%
0/89 • 52 weeks
|
|
Eye disorders
Conjunctivitis
|
1.3%
2/151 • 52 weeks
|
0.00%
0/89 • 52 weeks
|
|
Eye disorders
Conjunctivitis allergic
|
0.66%
1/151 • 52 weeks
|
1.1%
1/89 • 52 weeks
|
|
Eye disorders
Diabetic retinopathy
|
1.3%
2/151 • 52 weeks
|
1.1%
1/89 • 52 weeks
|
|
Eye disorders
Dry eye
|
0.00%
0/151 • 52 weeks
|
1.1%
1/89 • 52 weeks
|
|
Eye disorders
Keratitis
|
0.00%
0/151 • 52 weeks
|
1.1%
1/89 • 52 weeks
|
|
Eye disorders
Macular oedema
|
0.66%
1/151 • 52 weeks
|
0.00%
0/89 • 52 weeks
|
|
Eye disorders
Strabismus
|
0.66%
1/151 • 52 weeks
|
0.00%
0/89 • 52 weeks
|
|
Eye disorders
Vision blurred
|
0.66%
1/151 • 52 weeks
|
0.00%
0/89 • 52 weeks
|
|
Eye disorders
Vitreous detachment
|
0.66%
1/151 • 52 weeks
|
0.00%
0/89 • 52 weeks
|
|
Eye disorders
Vitreous floaters
|
0.00%
0/151 • 52 weeks
|
1.1%
1/89 • 52 weeks
|
|
Eye disorders
Entropion
|
0.66%
1/151 • 52 weeks
|
0.00%
0/89 • 52 weeks
|
|
Ear and labyrinth disorders
Meniere's disease
|
2.0%
3/151 • 52 weeks
|
0.00%
0/89 • 52 weeks
|
|
Ear and labyrinth disorders
Tinnitus
|
1.3%
2/151 • 52 weeks
|
2.2%
2/89 • 52 weeks
|
|
Ear and labyrinth disorders
Vertigo
|
2.6%
4/151 • 52 weeks
|
1.1%
1/89 • 52 weeks
|
|
Ear and labyrinth disorders
Vertigo positional
|
0.66%
1/151 • 52 weeks
|
0.00%
0/89 • 52 weeks
|
|
Ear and labyrinth disorders
Ear discomfort
|
0.66%
1/151 • 52 weeks
|
0.00%
0/89 • 52 weeks
|
|
Ear and labyrinth disorders
Sudden hearing loss
|
0.66%
1/151 • 52 weeks
|
0.00%
0/89 • 52 weeks
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/151 • 52 weeks
|
1.1%
1/89 • 52 weeks
|
|
Vascular disorders
Hypertension
|
5.3%
8/151 • 52 weeks
|
0.00%
0/89 • 52 weeks
|
|
Vascular disorders
Orthostatic hypotension
|
0.66%
1/151 • 52 weeks
|
0.00%
0/89 • 52 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.66%
1/151 • 52 weeks
|
0.00%
0/89 • 52 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.66%
1/151 • 52 weeks
|
0.00%
0/89 • 52 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
4.0%
6/151 • 52 weeks
|
0.00%
0/89 • 52 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
0.66%
1/151 • 52 weeks
|
0.00%
0/89 • 52 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract inflammation
|
6.0%
9/151 • 52 weeks
|
11.2%
10/89 • 52 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal granuloma
|
0.66%
1/151 • 52 weeks
|
0.00%
0/89 • 52 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Upper-airway cough syndrome
|
0.66%
1/151 • 52 weeks
|
0.00%
0/89 • 52 weeks
|
|
Gastrointestinal disorders
Abdominal discomfort
|
1.3%
2/151 • 52 weeks
|
1.1%
1/89 • 52 weeks
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/151 • 52 weeks
|
1.1%
1/89 • 52 weeks
|
|
Gastrointestinal disorders
Abdominal pain upper
|
1.3%
2/151 • 52 weeks
|
1.1%
1/89 • 52 weeks
|
|
Gastrointestinal disorders
Anal fissure
|
0.66%
1/151 • 52 weeks
|
0.00%
0/89 • 52 weeks
|
|
Gastrointestinal disorders
Cheilitis
|
1.3%
2/151 • 52 weeks
|
1.1%
1/89 • 52 weeks
|
|
Gastrointestinal disorders
Colonic polyp
|
3.3%
5/151 • 52 weeks
|
3.4%
3/89 • 52 weeks
|
|
Gastrointestinal disorders
Constipation
|
3.3%
5/151 • 52 weeks
|
2.2%
2/89 • 52 weeks
|
|
Gastrointestinal disorders
Dental caries
|
1.3%
2/151 • 52 weeks
|
2.2%
2/89 • 52 weeks
|
|
Gastrointestinal disorders
Diarrhoea
|
4.0%
6/151 • 52 weeks
|
0.00%
0/89 • 52 weeks
|
|
Gastrointestinal disorders
Duodenal ulcer
|
0.00%
0/151 • 52 weeks
|
1.1%
1/89 • 52 weeks
|
|
Gastrointestinal disorders
Duodenitis
|
0.00%
0/151 • 52 weeks
|
1.1%
1/89 • 52 weeks
|
|
Gastrointestinal disorders
Dyspepsia
|
0.66%
1/151 • 52 weeks
|
2.2%
2/89 • 52 weeks
|
|
Gastrointestinal disorders
Enterocolitis
|
0.00%
0/151 • 52 weeks
|
1.1%
1/89 • 52 weeks
|
|
Gastrointestinal disorders
Faeces hard
|
0.66%
1/151 • 52 weeks
|
0.00%
0/89 • 52 weeks
|
|
Gastrointestinal disorders
Food poisoning
|
0.66%
1/151 • 52 weeks
|
0.00%
0/89 • 52 weeks
|
|
Gastrointestinal disorders
Gastric polyps
|
3.3%
5/151 • 52 weeks
|
5.6%
5/89 • 52 weeks
|
|
Gastrointestinal disorders
Gastritis
|
3.3%
5/151 • 52 weeks
|
6.7%
6/89 • 52 weeks
|
|
Gastrointestinal disorders
Gastritis erosive
|
0.66%
1/151 • 52 weeks
|
1.1%
1/89 • 52 weeks
|
|
Gastrointestinal disorders
Gingivitis
|
0.66%
1/151 • 52 weeks
|
1.1%
1/89 • 52 weeks
|
|
Gastrointestinal disorders
Haemorrhoids
|
2.0%
3/151 • 52 weeks
|
2.2%
2/89 • 52 weeks
|
|
Gastrointestinal disorders
Hiatus hernia
|
0.00%
0/151 • 52 weeks
|
1.1%
1/89 • 52 weeks
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.66%
1/151 • 52 weeks
|
1.1%
1/89 • 52 weeks
|
|
Gastrointestinal disorders
Nausea
|
1.3%
2/151 • 52 weeks
|
0.00%
0/89 • 52 weeks
|
|
Gastrointestinal disorders
Periodontal disease
|
1.3%
2/151 • 52 weeks
|
1.1%
1/89 • 52 weeks
|
|
Gastrointestinal disorders
Periodontitis
|
0.66%
1/151 • 52 weeks
|
1.1%
1/89 • 52 weeks
|
|
Gastrointestinal disorders
Rectal polyp
|
0.00%
0/151 • 52 weeks
|
1.1%
1/89 • 52 weeks
|
|
Gastrointestinal disorders
Reflux oesophagitis
|
2.0%
3/151 • 52 weeks
|
1.1%
1/89 • 52 weeks
|
|
Gastrointestinal disorders
Stomatitis
|
2.0%
3/151 • 52 weeks
|
1.1%
1/89 • 52 weeks
|
|
Gastrointestinal disorders
Toothache
|
0.66%
1/151 • 52 weeks
|
1.1%
1/89 • 52 weeks
|
|
Gastrointestinal disorders
Vomiting
|
0.66%
1/151 • 52 weeks
|
1.1%
1/89 • 52 weeks
|
|
Gastrointestinal disorders
Gastroduodenitis
|
0.66%
1/151 • 52 weeks
|
0.00%
0/89 • 52 weeks
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
0.66%
1/151 • 52 weeks
|
0.00%
0/89 • 52 weeks
|
|
Hepatobiliary disorders
Hepatic steatosis
|
1.3%
2/151 • 52 weeks
|
1.1%
1/89 • 52 weeks
|
|
Hepatobiliary disorders
Hyperplastic cholecystopathy
|
0.66%
1/151 • 52 weeks
|
0.00%
0/89 • 52 weeks
|
|
Hepatobiliary disorders
Gallbladder polyp
|
1.3%
2/151 • 52 weeks
|
0.00%
0/89 • 52 weeks
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.66%
1/151 • 52 weeks
|
1.1%
1/89 • 52 weeks
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.66%
1/151 • 52 weeks
|
0.00%
0/89 • 52 weeks
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
0.66%
1/151 • 52 weeks
|
0.00%
0/89 • 52 weeks
|
|
Skin and subcutaneous tissue disorders
Dermatitis atopic
|
0.66%
1/151 • 52 weeks
|
1.1%
1/89 • 52 weeks
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
2.0%
3/151 • 52 weeks
|
0.00%
0/89 • 52 weeks
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.66%
1/151 • 52 weeks
|
0.00%
0/89 • 52 weeks
|
|
Skin and subcutaneous tissue disorders
Eczema
|
5.3%
8/151 • 52 weeks
|
3.4%
3/89 • 52 weeks
|
|
Skin and subcutaneous tissue disorders
Eczema asteatotic
|
0.66%
1/151 • 52 weeks
|
1.1%
1/89 • 52 weeks
|
|
Skin and subcutaneous tissue disorders
Haemorrhage subcutaneous
|
0.66%
1/151 • 52 weeks
|
0.00%
0/89 • 52 weeks
|
|
Skin and subcutaneous tissue disorders
Heat rash
|
0.66%
1/151 • 52 weeks
|
1.1%
1/89 • 52 weeks
|
|
Skin and subcutaneous tissue disorders
Hyperkeratosis
|
0.66%
1/151 • 52 weeks
|
0.00%
0/89 • 52 weeks
|
|
Skin and subcutaneous tissue disorders
Papule
|
0.66%
1/151 • 52 weeks
|
0.00%
0/89 • 52 weeks
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
2.0%
3/151 • 52 weeks
|
0.00%
0/89 • 52 weeks
|
|
Skin and subcutaneous tissue disorders
Pustular psoriasis
|
0.66%
1/151 • 52 weeks
|
0.00%
0/89 • 52 weeks
|
|
Skin and subcutaneous tissue disorders
Rash
|
2.6%
4/151 • 52 weeks
|
1.1%
1/89 • 52 weeks
|
|
Skin and subcutaneous tissue disorders
Rash generalised
|
0.66%
1/151 • 52 weeks
|
0.00%
0/89 • 52 weeks
|
|
Skin and subcutaneous tissue disorders
Seborrhoeic dermatitis
|
0.66%
1/151 • 52 weeks
|
0.00%
0/89 • 52 weeks
|
|
Skin and subcutaneous tissue disorders
Skin nodule
|
0.66%
1/151 • 52 weeks
|
0.00%
0/89 • 52 weeks
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/151 • 52 weeks
|
1.1%
1/89 • 52 weeks
|
|
Skin and subcutaneous tissue disorders
Xeroderma
|
0.66%
1/151 • 52 weeks
|
0.00%
0/89 • 52 weeks
|
|
Skin and subcutaneous tissue disorders
Pruritus generalised
|
0.00%
0/151 • 52 weeks
|
1.1%
1/89 • 52 weeks
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
7.3%
11/151 • 52 weeks
|
3.4%
3/89 • 52 weeks
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.66%
1/151 • 52 weeks
|
0.00%
0/89 • 52 weeks
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
4.6%
7/151 • 52 weeks
|
2.2%
2/89 • 52 weeks
|
|
Musculoskeletal and connective tissue disorders
Fasciitis
|
0.00%
0/151 • 52 weeks
|
1.1%
1/89 • 52 weeks
|
|
Musculoskeletal and connective tissue disorders
Joint effusion
|
0.66%
1/151 • 52 weeks
|
0.00%
0/89 • 52 weeks
|
|
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis
|
0.66%
1/151 • 52 weeks
|
0.00%
0/89 • 52 weeks
|
|
Musculoskeletal and connective tissue disorders
Monarthritis
|
0.66%
1/151 • 52 weeks
|
0.00%
0/89 • 52 weeks
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.66%
1/151 • 52 weeks
|
1.1%
1/89 • 52 weeks
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.66%
1/151 • 52 weeks
|
0.00%
0/89 • 52 weeks
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
1.3%
2/151 • 52 weeks
|
0.00%
0/89 • 52 weeks
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.66%
1/151 • 52 weeks
|
6.7%
6/89 • 52 weeks
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
0.66%
1/151 • 52 weeks
|
0.00%
0/89 • 52 weeks
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/151 • 52 weeks
|
1.1%
1/89 • 52 weeks
|
|
Musculoskeletal and connective tissue disorders
Periarthritis
|
2.0%
3/151 • 52 weeks
|
1.1%
1/89 • 52 weeks
|
|
Musculoskeletal and connective tissue disorders
Plantar fasciitis
|
0.66%
1/151 • 52 weeks
|
0.00%
0/89 • 52 weeks
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
2.0%
3/151 • 52 weeks
|
2.2%
2/89 • 52 weeks
|
|
Musculoskeletal and connective tissue disorders
Tenosynovitis
|
2.0%
3/151 • 52 weeks
|
0.00%
0/89 • 52 weeks
|
|
Musculoskeletal and connective tissue disorders
Trigger finger
|
0.66%
1/151 • 52 weeks
|
2.2%
2/89 • 52 weeks
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.66%
1/151 • 52 weeks
|
3.4%
3/89 • 52 weeks
|
|
Musculoskeletal and connective tissue disorders
Tenosynovitis stenosans
|
0.00%
0/151 • 52 weeks
|
1.1%
1/89 • 52 weeks
|
|
Musculoskeletal and connective tissue disorders
Spinal ligament ossification
|
0.00%
0/151 • 52 weeks
|
1.1%
1/89 • 52 weeks
|
|
Musculoskeletal and connective tissue disorders
Spondylolisthesis
|
0.00%
0/151 • 52 weeks
|
1.1%
1/89 • 52 weeks
|
|
Renal and urinary disorders
Hypertonic bladder
|
0.00%
0/151 • 52 weeks
|
1.1%
1/89 • 52 weeks
|
|
Renal and urinary disorders
Nephrolithiasis
|
2.0%
3/151 • 52 weeks
|
0.00%
0/89 • 52 weeks
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/151 • 52 weeks
|
1.1%
1/89 • 52 weeks
|
|
Renal and urinary disorders
Urinary incontinence
|
0.66%
1/151 • 52 weeks
|
0.00%
0/89 • 52 weeks
|
|
Renal and urinary disorders
Diabetic nephropathy
|
0.00%
0/151 • 52 weeks
|
1.1%
1/89 • 52 weeks
|
|
Renal and urinary disorders
Pyelocaliectasis
|
0.00%
0/151 • 52 weeks
|
1.1%
1/89 • 52 weeks
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.66%
1/151 • 52 weeks
|
1.1%
1/89 • 52 weeks
|
|
Reproductive system and breast disorders
Calculus prostatic
|
0.66%
1/151 • 52 weeks
|
0.00%
0/89 • 52 weeks
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
0.66%
1/151 • 52 weeks
|
0.00%
0/89 • 52 weeks
|
|
Reproductive system and breast disorders
Menstruation irregular
|
0.66%
1/151 • 52 weeks
|
0.00%
0/89 • 52 weeks
|
|
Reproductive system and breast disorders
Prostatitis
|
1.3%
2/151 • 52 weeks
|
0.00%
0/89 • 52 weeks
|
|
Reproductive system and breast disorders
Uterine prolapse
|
0.66%
1/151 • 52 weeks
|
0.00%
0/89 • 52 weeks
|
|
General disorders
Chest discomfort
|
0.66%
1/151 • 52 weeks
|
1.1%
1/89 • 52 weeks
|
|
General disorders
Chest pain
|
0.66%
1/151 • 52 weeks
|
0.00%
0/89 • 52 weeks
|
|
General disorders
Malaise
|
0.66%
1/151 • 52 weeks
|
1.1%
1/89 • 52 weeks
|
|
General disorders
Oedema peripheral
|
0.00%
0/151 • 52 weeks
|
1.1%
1/89 • 52 weeks
|
|
General disorders
Pain
|
0.66%
1/151 • 52 weeks
|
0.00%
0/89 • 52 weeks
|
|
General disorders
Pyrexia
|
0.00%
0/151 • 52 weeks
|
1.1%
1/89 • 52 weeks
|
|
General disorders
Vaccination site dermatitis
|
0.66%
1/151 • 52 weeks
|
0.00%
0/89 • 52 weeks
|
|
Investigations
Alanine aminotransferase increased
|
2.0%
3/151 • 52 weeks
|
3.4%
3/89 • 52 weeks
|
|
Investigations
Albumin urine present
|
1.3%
2/151 • 52 weeks
|
0.00%
0/89 • 52 weeks
|
|
Investigations
Aspartate aminotransferase increased
|
1.3%
2/151 • 52 weeks
|
3.4%
3/89 • 52 weeks
|
|
Investigations
Blood creatine phosphokinase increased
|
9.3%
14/151 • 52 weeks
|
7.9%
7/89 • 52 weeks
|
|
Investigations
Blood creatinine increased
|
0.00%
0/151 • 52 weeks
|
1.1%
1/89 • 52 weeks
|
|
Investigations
Blood potassium increased
|
3.3%
5/151 • 52 weeks
|
3.4%
3/89 • 52 weeks
|
|
Investigations
Blood triglycerides increased
|
2.0%
3/151 • 52 weeks
|
2.2%
2/89 • 52 weeks
|
|
Investigations
Blood uric acid increased
|
2.6%
4/151 • 52 weeks
|
2.2%
2/89 • 52 weeks
|
|
Investigations
Eosinophil count increased
|
0.66%
1/151 • 52 weeks
|
1.1%
1/89 • 52 weeks
|
|
Investigations
Gamma-glutamyltransferase increased
|
3.3%
5/151 • 52 weeks
|
3.4%
3/89 • 52 weeks
|
|
Investigations
Glucose urine present
|
6.0%
9/151 • 52 weeks
|
18.0%
16/89 • 52 weeks
|
|
Investigations
Blood urine present
|
7.3%
11/151 • 52 weeks
|
5.6%
5/89 • 52 weeks
|
|
Investigations
Monocyte count decreased
|
0.66%
1/151 • 52 weeks
|
0.00%
0/89 • 52 weeks
|
|
Investigations
White blood cell count increased
|
0.66%
1/151 • 52 weeks
|
1.1%
1/89 • 52 weeks
|
|
Investigations
Protein urine present
|
9.3%
14/151 • 52 weeks
|
14.6%
13/89 • 52 weeks
|
|
Investigations
Urine ketone body present
|
1.3%
2/151 • 52 weeks
|
5.6%
5/89 • 52 weeks
|
|
Investigations
Blood alkaline phosphatase increased
|
0.66%
1/151 • 52 weeks
|
1.1%
1/89 • 52 weeks
|
|
Investigations
Occult blood positive
|
0.66%
1/151 • 52 weeks
|
0.00%
0/89 • 52 weeks
|
|
Injury, poisoning and procedural complications
Arthropod sting
|
2.0%
3/151 • 52 weeks
|
1.1%
1/89 • 52 weeks
|
|
Injury, poisoning and procedural complications
Chillblains
|
0.66%
1/151 • 52 weeks
|
0.00%
0/89 • 52 weeks
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.66%
1/151 • 52 weeks
|
0.00%
0/89 • 52 weeks
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.00%
0/151 • 52 weeks
|
1.1%
1/89 • 52 weeks
|
|
Injury, poisoning and procedural complications
Joint sprain
|
2.0%
3/151 • 52 weeks
|
1.1%
1/89 • 52 weeks
|
|
Injury, poisoning and procedural complications
Muscle injury
|
0.66%
1/151 • 52 weeks
|
0.00%
0/89 • 52 weeks
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.66%
1/151 • 52 weeks
|
1.1%
1/89 • 52 weeks
|
|
Injury, poisoning and procedural complications
Ulna fracture
|
0.00%
0/151 • 52 weeks
|
1.1%
1/89 • 52 weeks
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
0.00%
0/151 • 52 weeks
|
1.1%
1/89 • 52 weeks
|
|
Injury, poisoning and procedural complications
Excoriation
|
1.3%
2/151 • 52 weeks
|
1.1%
1/89 • 52 weeks
|
|
Injury, poisoning and procedural complications
Contusion
|
6.0%
9/151 • 52 weeks
|
5.6%
5/89 • 52 weeks
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.66%
1/151 • 52 weeks
|
0.00%
0/89 • 52 weeks
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.00%
0/151 • 52 weeks
|
1.1%
1/89 • 52 weeks
|
|
Injury, poisoning and procedural complications
Open wound
|
0.66%
1/151 • 52 weeks
|
2.2%
2/89 • 52 weeks
|
|
Injury, poisoning and procedural complications
Heat illness
|
0.66%
1/151 • 52 weeks
|
1.1%
1/89 • 52 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER