Trial Outcomes & Findings for Efficacy and Safety Study of MP-513 in Patients With Type 2 Diabetes (NCT NCT00628212)
NCT ID: NCT00628212
Last Updated: 2026-01-02
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
PHASE2
Target enrollment
324 participants
Primary outcome timeframe
12 weeks
Results posted on
2026-01-02
Participant Flow
Participant milestones
| Measure |
Placebo
Teneligliptin placebo-matching tablets, orally, once daily
|
Teneligliptin 10 mg
Teneligliptin 10 mg, orally, once daily
|
Teneligliptin 20 mg
Teneligliptin 20 mg, orally, once daily
|
Teneligliptin 40 mg
Teneligliptin 40 mg, orally, once daily
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
80
|
84
|
79
|
81
|
|
Overall Study
COMPLETED
|
77
|
83
|
76
|
76
|
|
Overall Study
NOT COMPLETED
|
3
|
1
|
3
|
5
|
Reasons for withdrawal
| Measure |
Placebo
Teneligliptin placebo-matching tablets, orally, once daily
|
Teneligliptin 10 mg
Teneligliptin 10 mg, orally, once daily
|
Teneligliptin 20 mg
Teneligliptin 20 mg, orally, once daily
|
Teneligliptin 40 mg
Teneligliptin 40 mg, orally, once daily
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
2
|
0
|
1
|
2
|
|
Overall Study
Physician Decision
|
1
|
1
|
2
|
3
|
Baseline Characteristics
Efficacy and Safety Study of MP-513 in Patients With Type 2 Diabetes
Baseline characteristics by cohort
| Measure |
Teneligliptin 40 mg
n=81 Participants
Teneligliptin 40 mg, orally, once daily
|
Total
n=324 Participants
Total of all reporting groups
|
Placebo
n=80 Participants
Teneligliptin placebo-matching tablets, orally, once daily
|
Teneligliptin 10 mg
n=84 Participants
Teneligliptin 10 mg, orally, once daily
|
Teneligliptin 20 mg
n=79 Participants
Teneligliptin 20 mg, orally, once daily
|
|---|---|---|---|---|---|
|
Age, Continuous
|
57.5 years
STANDARD_DEVIATION 10.4 • n=18 Participants
|
58.2 years
STANDARD_DEVIATION 9.6 • n=89 Participants
|
58.5 years
STANDARD_DEVIATION 9.6 • n=228 Participants
|
57.7 years
STANDARD_DEVIATION 9.1 • n=115 Participants
|
59.2 years
STANDARD_DEVIATION 9.5 • n=343 Participants
|
|
Sex: Female, Male
Female
|
28 Participants
n=18 Participants
|
111 Participants
n=89 Participants
|
29 Participants
n=228 Participants
|
34 Participants
n=115 Participants
|
20 Participants
n=343 Participants
|
|
Sex: Female, Male
Male
|
53 Participants
n=18 Participants
|
213 Participants
n=89 Participants
|
51 Participants
n=228 Participants
|
50 Participants
n=115 Participants
|
59 Participants
n=343 Participants
|
PRIMARY outcome
Timeframe: 12 weeksPopulation: 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
| Measure |
Placebo
n=80 Participants
Teneligliptin placebo-matching tablets, orally, once daily
|
Teneligliptin 10 mg
n=84 Participants
Teneligliptin 10 mg, orally, once daily
|
Teneligliptin 20 mg
n=79 Participants
Teneligliptin 20 mg, orally, once daily
|
Teneligliptin 40 mg
n=81 Participants
Teneligliptin 40 mg, orally, once daily
|
|---|---|---|---|---|
|
Change From Baseline in HbA1c at Week 12
|
0.11 Percent
Standard Error 0.05
|
-0.77 Percent
Standard Error 0.05
|
-0.80 Percent
Standard Error 0.05
|
-0.91 Percent
Standard Error 0.05
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: 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
| Measure |
Placebo
n=80 Participants
Teneligliptin placebo-matching tablets, orally, once daily
|
Teneligliptin 10 mg
n=84 Participants
Teneligliptin 10 mg, orally, once daily
|
Teneligliptin 20 mg
n=79 Participants
Teneligliptin 20 mg, orally, once daily
|
Teneligliptin 40 mg
n=81 Participants
Teneligliptin 40 mg, orally, once daily
|
|---|---|---|---|---|
|
Change From Baseline in Fasting Plasma Glucose at Week 12
|
2.8 mg / dL
Standard Error 2.0
|
-15.0 mg / dL
Standard Error 2.0
|
-14.1 mg / dL
Standard Error 2.1
|
-17.2 mg / dL
Standard Error 2.0
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: 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
| Measure |
Placebo
n=80 Participants
Teneligliptin placebo-matching tablets, orally, once daily
|
Teneligliptin 10 mg
n=84 Participants
Teneligliptin 10 mg, orally, once daily
|
Teneligliptin 20 mg
n=79 Participants
Teneligliptin 20 mg, orally, once daily
|
Teneligliptin 40 mg
n=81 Participants
Teneligliptin 40 mg, orally, once daily
|
|---|---|---|---|---|
|
Change From Baseline in 2-hour Postprandial Plasma Glucose at Week 12
|
7.3 mg / dL
Standard Error 4.5
|
-43.3 mg / dL
Standard Error 4.3
|
-49.4 mg / dL
Standard Error 4.5
|
-51.3 mg / dL
Standard Error 4.5
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: 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
| Measure |
Placebo
n=80 Participants
Teneligliptin placebo-matching tablets, orally, once daily
|
Teneligliptin 10 mg
n=84 Participants
Teneligliptin 10 mg, orally, once daily
|
Teneligliptin 20 mg
n=79 Participants
Teneligliptin 20 mg, orally, once daily
|
Teneligliptin 40 mg
n=81 Participants
Teneligliptin 40 mg, orally, once daily
|
|---|---|---|---|---|
|
Change From Baseline in the Areas Under the Curve From 0 to 2 h (AUC0-2h) for Postprandial Plasma Glucose at Week 12
|
5.897 mg*h / dL
Standard Error 6.410
|
-65.445 mg*h / dL
Standard Error 6.141
|
-73.211 mg*h / dL
Standard Error 6.409
|
-75.326 mg*h / dL
Standard Error 6.422
|
Adverse Events
Placebo
Serious events: 1 serious events
Other events: 44 other events
Deaths: 0 deaths
Teneligliptin 10 mg
Serious events: 0 serious events
Other events: 50 other events
Deaths: 0 deaths
Teneligliptin 20 mg
Serious events: 0 serious events
Other events: 40 other events
Deaths: 0 deaths
Teneligliptin 40 mg
Serious events: 0 serious events
Other events: 46 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=80 participants at risk
Teneligliptin placebo-matching tablets, orally, once daily
|
Teneligliptin 10 mg
n=84 participants at risk
Teneligliptin 10 mg, orally, once daily
|
Teneligliptin 20 mg
n=79 participants at risk
Teneligliptin 20 mg, orally, once daily
|
Teneligliptin 40 mg
n=81 participants at risk
Teneligliptin 40 mg, orally, once daily
|
|---|---|---|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic neoplasm
|
1.2%
1/80
|
0.00%
0/84
|
0.00%
0/79
|
0.00%
0/81
|
Other adverse events
| Measure |
Placebo
n=80 participants at risk
Teneligliptin placebo-matching tablets, orally, once daily
|
Teneligliptin 10 mg
n=84 participants at risk
Teneligliptin 10 mg, orally, once daily
|
Teneligliptin 20 mg
n=79 participants at risk
Teneligliptin 20 mg, orally, once daily
|
Teneligliptin 40 mg
n=81 participants at risk
Teneligliptin 40 mg, orally, once daily
|
|---|---|---|---|---|
|
Infections and infestations
Acute tonsillitis
|
0.00%
0/80
|
1.2%
1/84
|
0.00%
0/79
|
0.00%
0/81
|
|
Infections and infestations
Bronchitis
|
0.00%
0/80
|
0.00%
0/84
|
0.00%
0/79
|
1.2%
1/81
|
|
Infections and infestations
Chronic sinusitis
|
0.00%
0/80
|
1.2%
1/84
|
0.00%
0/79
|
1.2%
1/81
|
|
Infections and infestations
Cystitis
|
0.00%
0/80
|
1.2%
1/84
|
0.00%
0/79
|
0.00%
0/81
|
|
Infections and infestations
Fungal skin infection
|
1.2%
1/80
|
0.00%
0/84
|
0.00%
0/79
|
0.00%
0/81
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/80
|
1.2%
1/84
|
0.00%
0/79
|
0.00%
0/81
|
|
Infections and infestations
Hordeolum
|
1.2%
1/80
|
0.00%
0/84
|
0.00%
0/79
|
0.00%
0/81
|
|
Infections and infestations
Nasopharyngitis
|
13.8%
11/80
|
19.0%
16/84
|
11.4%
9/79
|
17.3%
14/81
|
|
Infections and infestations
Onychomycosis
|
2.5%
2/80
|
0.00%
0/84
|
0.00%
0/79
|
0.00%
0/81
|
|
Infections and infestations
Paronychia
|
0.00%
0/80
|
0.00%
0/84
|
0.00%
0/79
|
1.2%
1/81
|
|
Infections and infestations
Pharyngitis
|
1.2%
1/80
|
0.00%
0/84
|
1.3%
1/79
|
0.00%
0/81
|
|
Infections and infestations
Pneumonia
|
0.00%
0/80
|
0.00%
0/84
|
0.00%
0/79
|
1.2%
1/81
|
|
Infections and infestations
Rhinitis
|
0.00%
0/80
|
1.2%
1/84
|
0.00%
0/79
|
0.00%
0/81
|
|
Infections and infestations
Tinea pedis
|
1.2%
1/80
|
0.00%
0/84
|
0.00%
0/79
|
1.2%
1/81
|
|
Infections and infestations
Tonsillitis
|
0.00%
0/80
|
0.00%
0/84
|
0.00%
0/79
|
1.2%
1/81
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/80
|
0.00%
0/84
|
0.00%
0/79
|
1.2%
1/81
|
|
Infections and infestations
Acarodermatitis
|
0.00%
0/80
|
0.00%
0/84
|
0.00%
0/79
|
1.2%
1/81
|
|
Infections and infestations
Oral herpes
|
1.2%
1/80
|
1.2%
1/84
|
0.00%
0/79
|
0.00%
0/81
|
|
Infections and infestations
Tinea manuum
|
0.00%
0/80
|
1.2%
1/84
|
0.00%
0/79
|
0.00%
0/81
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Seborrhoeic keratosis
|
0.00%
0/80
|
1.2%
1/84
|
0.00%
0/79
|
0.00%
0/81
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm
|
0.00%
0/80
|
1.2%
1/84
|
0.00%
0/79
|
0.00%
0/81
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.00%
0/80
|
1.2%
1/84
|
0.00%
0/79
|
0.00%
0/81
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/80
|
0.00%
0/84
|
0.00%
0/79
|
1.2%
1/81
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/80
|
1.2%
1/84
|
0.00%
0/79
|
0.00%
0/81
|
|
Metabolism and nutrition disorders
Gout
|
1.2%
1/80
|
0.00%
0/84
|
0.00%
0/79
|
0.00%
0/81
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
1.2%
1/80
|
0.00%
0/84
|
0.00%
0/79
|
0.00%
0/81
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
0.00%
0/80
|
0.00%
0/84
|
0.00%
0/79
|
1.2%
1/81
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
3.8%
3/80
|
0.00%
0/84
|
1.3%
1/79
|
3.7%
3/81
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
0.00%
0/80
|
0.00%
0/84
|
0.00%
0/79
|
1.2%
1/81
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/80
|
0.00%
0/84
|
1.3%
1/79
|
0.00%
0/81
|
|
Nervous system disorders
Carpal tunnel syndrome
|
0.00%
0/80
|
1.2%
1/84
|
0.00%
0/79
|
0.00%
0/81
|
|
Nervous system disorders
Diabetic neuropathy
|
1.2%
1/80
|
0.00%
0/84
|
0.00%
0/79
|
0.00%
0/81
|
|
Nervous system disorders
Dizziness
|
2.5%
2/80
|
0.00%
0/84
|
0.00%
0/79
|
0.00%
0/81
|
|
Nervous system disorders
Headache
|
2.5%
2/80
|
1.2%
1/84
|
2.5%
2/79
|
0.00%
0/81
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/80
|
1.2%
1/84
|
0.00%
0/79
|
0.00%
0/81
|
|
Nervous system disorders
Migraine
|
0.00%
0/80
|
1.2%
1/84
|
0.00%
0/79
|
0.00%
0/81
|
|
Nervous system disorders
Neuralgia
|
1.2%
1/80
|
0.00%
0/84
|
0.00%
0/79
|
0.00%
0/81
|
|
Nervous system disorders
Somnolence
|
1.2%
1/80
|
0.00%
0/84
|
0.00%
0/79
|
0.00%
0/81
|
|
Nervous system disorders
Syncope vasovagal
|
1.2%
1/80
|
0.00%
0/84
|
0.00%
0/79
|
0.00%
0/81
|
|
Eye disorders
Blepharitis
|
1.2%
1/80
|
0.00%
0/84
|
0.00%
0/79
|
0.00%
0/81
|
|
Eye disorders
Cataract
|
0.00%
0/80
|
1.2%
1/84
|
0.00%
0/79
|
1.2%
1/81
|
|
Eye disorders
Conjunctivitis
|
1.2%
1/80
|
0.00%
0/84
|
0.00%
0/79
|
1.2%
1/81
|
|
Eye disorders
Conjunctivitis allergic
|
0.00%
0/80
|
0.00%
0/84
|
1.3%
1/79
|
0.00%
0/81
|
|
Eye disorders
Diabetic retinopathy
|
0.00%
0/80
|
0.00%
0/84
|
1.3%
1/79
|
1.2%
1/81
|
|
Eye disorders
Dry eye
|
1.2%
1/80
|
0.00%
0/84
|
0.00%
0/79
|
0.00%
0/81
|
|
Eye disorders
Glaucoma
|
0.00%
0/80
|
0.00%
0/84
|
0.00%
0/79
|
1.2%
1/81
|
|
Eye disorders
Keratitis
|
1.2%
1/80
|
0.00%
0/84
|
0.00%
0/79
|
0.00%
0/81
|
|
Eye disorders
Keratoconjunctivitis sicca
|
0.00%
0/80
|
1.2%
1/84
|
0.00%
0/79
|
0.00%
0/81
|
|
Eye disorders
Macular degeneration
|
0.00%
0/80
|
1.2%
1/84
|
0.00%
0/79
|
1.2%
1/81
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/80
|
1.2%
1/84
|
0.00%
0/79
|
1.2%
1/81
|
|
Vascular disorders
Hypotension
|
0.00%
0/80
|
0.00%
0/84
|
1.3%
1/79
|
0.00%
0/81
|
|
Vascular disorders
Neurogenic shock
|
0.00%
0/80
|
0.00%
0/84
|
0.00%
0/79
|
1.2%
1/81
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/80
|
0.00%
0/84
|
1.3%
1/79
|
0.00%
0/81
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.00%
0/80
|
0.00%
0/84
|
1.3%
1/79
|
0.00%
0/81
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
1.2%
1/80
|
0.00%
0/84
|
0.00%
0/79
|
0.00%
0/81
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract inflammation
|
0.00%
0/80
|
3.6%
3/84
|
1.3%
1/79
|
2.5%
2/81
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/80
|
0.00%
0/84
|
0.00%
0/79
|
1.2%
1/81
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/80
|
1.2%
1/84
|
0.00%
0/79
|
1.2%
1/81
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/80
|
1.2%
1/84
|
1.3%
1/79
|
0.00%
0/81
|
|
Gastrointestinal disorders
Cheilitis
|
1.2%
1/80
|
0.00%
0/84
|
0.00%
0/79
|
0.00%
0/81
|
|
Gastrointestinal disorders
Colitis ischaemic
|
0.00%
0/80
|
0.00%
0/84
|
0.00%
0/79
|
1.2%
1/81
|
|
Gastrointestinal disorders
Colonic polyp
|
0.00%
0/80
|
0.00%
0/84
|
0.00%
0/79
|
1.2%
1/81
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/80
|
3.6%
3/84
|
2.5%
2/79
|
1.2%
1/81
|
|
Gastrointestinal disorders
Diarrhoea
|
1.2%
1/80
|
0.00%
0/84
|
0.00%
0/79
|
0.00%
0/81
|
|
Gastrointestinal disorders
Duodenal ulcer
|
0.00%
0/80
|
0.00%
0/84
|
0.00%
0/79
|
1.2%
1/81
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/80
|
0.00%
0/84
|
1.3%
1/79
|
0.00%
0/81
|
|
Gastrointestinal disorders
Enterocolitis
|
0.00%
0/80
|
0.00%
0/84
|
1.3%
1/79
|
0.00%
0/81
|
|
Gastrointestinal disorders
Flatulence
|
1.2%
1/80
|
0.00%
0/84
|
0.00%
0/79
|
0.00%
0/81
|
|
Gastrointestinal disorders
Gastric polyps
|
0.00%
0/80
|
0.00%
0/84
|
1.3%
1/79
|
0.00%
0/81
|
|
Gastrointestinal disorders
Gastric ulcer
|
1.2%
1/80
|
0.00%
0/84
|
0.00%
0/79
|
0.00%
0/81
|
|
Gastrointestinal disorders
Gastritis
|
1.2%
1/80
|
1.2%
1/84
|
0.00%
0/79
|
0.00%
0/81
|
|
Gastrointestinal disorders
Gastritis erosive
|
0.00%
0/80
|
0.00%
0/84
|
0.00%
0/79
|
1.2%
1/81
|
|
Gastrointestinal disorders
Gingivitis
|
1.2%
1/80
|
0.00%
0/84
|
0.00%
0/79
|
0.00%
0/81
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/80
|
0.00%
0/84
|
1.3%
1/79
|
0.00%
0/81
|
|
Gastrointestinal disorders
Reflux oesophagitis
|
1.2%
1/80
|
0.00%
0/84
|
0.00%
0/79
|
1.2%
1/81
|
|
Gastrointestinal disorders
Stomach discomfort
|
0.00%
0/80
|
0.00%
0/84
|
0.00%
0/79
|
1.2%
1/81
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/80
|
1.2%
1/84
|
1.3%
1/79
|
0.00%
0/81
|
|
Gastrointestinal disorders
Tooth loss
|
1.2%
1/80
|
0.00%
0/84
|
0.00%
0/79
|
0.00%
0/81
|
|
Gastrointestinal disorders
Dyschezia
|
0.00%
0/80
|
1.2%
1/84
|
0.00%
0/79
|
0.00%
0/81
|
|
Gastrointestinal disorders
Gastrointestinal motility disorder
|
0.00%
0/80
|
0.00%
0/84
|
0.00%
0/79
|
1.2%
1/81
|
|
Hepatobiliary disorders
Hepatic steatosis
|
0.00%
0/80
|
0.00%
0/84
|
1.3%
1/79
|
1.2%
1/81
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/80
|
0.00%
0/84
|
1.3%
1/79
|
0.00%
0/81
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
1.2%
1/80
|
0.00%
0/84
|
2.5%
2/79
|
1.2%
1/81
|
|
Skin and subcutaneous tissue disorders
Dyshidrosis
|
2.5%
2/80
|
1.2%
1/84
|
0.00%
0/79
|
0.00%
0/81
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/80
|
1.2%
1/84
|
2.5%
2/79
|
0.00%
0/81
|
|
Skin and subcutaneous tissue disorders
Eczema asteatotic
|
1.2%
1/80
|
0.00%
0/84
|
0.00%
0/79
|
0.00%
0/81
|
|
Skin and subcutaneous tissue disorders
Hyperkeratosis
|
0.00%
0/80
|
0.00%
0/84
|
0.00%
0/79
|
1.2%
1/81
|
|
Skin and subcutaneous tissue disorders
Prurigo
|
0.00%
0/80
|
0.00%
0/84
|
0.00%
0/79
|
1.2%
1/81
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
0.00%
0/80
|
0.00%
0/84
|
0.00%
0/79
|
1.2%
1/81
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/80
|
1.2%
1/84
|
0.00%
0/79
|
1.2%
1/81
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
0.00%
0/80
|
1.2%
1/84
|
0.00%
0/79
|
0.00%
0/81
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/80
|
2.4%
2/84
|
0.00%
0/79
|
0.00%
0/81
|
|
Skin and subcutaneous tissue disorders
Urticaria thermal
|
0.00%
0/80
|
0.00%
0/84
|
1.3%
1/79
|
0.00%
0/81
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
1.2%
1/80
|
1.2%
1/84
|
2.5%
2/79
|
1.2%
1/81
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/80
|
1.2%
1/84
|
0.00%
0/79
|
0.00%
0/81
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/80
|
3.6%
3/84
|
1.3%
1/79
|
1.2%
1/81
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/80
|
0.00%
0/84
|
1.3%
1/79
|
0.00%
0/81
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/80
|
0.00%
0/84
|
1.3%
1/79
|
0.00%
0/81
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
1.2%
1/80
|
1.2%
1/84
|
2.5%
2/79
|
1.2%
1/81
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/80
|
0.00%
0/84
|
1.3%
1/79
|
0.00%
0/81
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/80
|
1.2%
1/84
|
0.00%
0/79
|
1.2%
1/81
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
1.2%
1/80
|
0.00%
0/84
|
0.00%
0/79
|
0.00%
0/81
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
0.00%
0/80
|
0.00%
0/84
|
0.00%
0/79
|
1.2%
1/81
|
|
Musculoskeletal and connective tissue disorders
Periarthritis
|
0.00%
0/80
|
0.00%
0/84
|
1.3%
1/79
|
1.2%
1/81
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
0.00%
0/80
|
0.00%
0/84
|
1.3%
1/79
|
0.00%
0/81
|
|
Musculoskeletal and connective tissue disorders
Tenosynovitis
|
0.00%
0/80
|
0.00%
0/84
|
0.00%
0/79
|
1.2%
1/81
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
1.2%
1/80
|
0.00%
0/84
|
0.00%
0/79
|
0.00%
0/81
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.00%
0/80
|
0.00%
0/84
|
0.00%
0/79
|
1.2%
1/81
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc disorder
|
0.00%
0/80
|
1.2%
1/84
|
0.00%
0/79
|
0.00%
0/81
|
|
Renal and urinary disorders
Calculus ureteric
|
0.00%
0/80
|
0.00%
0/84
|
0.00%
0/79
|
1.2%
1/81
|
|
Renal and urinary disorders
Calculus urinary
|
1.2%
1/80
|
0.00%
0/84
|
0.00%
0/79
|
0.00%
0/81
|
|
Renal and urinary disorders
Hydronephrosis
|
0.00%
0/80
|
1.2%
1/84
|
0.00%
0/79
|
0.00%
0/81
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/80
|
1.2%
1/84
|
0.00%
0/79
|
0.00%
0/81
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
1.2%
1/80
|
0.00%
0/84
|
0.00%
0/79
|
1.2%
1/81
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
0.00%
0/80
|
1.2%
1/84
|
0.00%
0/79
|
0.00%
0/81
|
|
General disorders
Chills
|
0.00%
0/80
|
0.00%
0/84
|
0.00%
0/79
|
1.2%
1/81
|
|
General disorders
Fatigue
|
0.00%
0/80
|
0.00%
0/84
|
1.3%
1/79
|
0.00%
0/81
|
|
General disorders
Malaise
|
0.00%
0/80
|
1.2%
1/84
|
2.5%
2/79
|
1.2%
1/81
|
|
General disorders
Oedema peripheral
|
1.2%
1/80
|
0.00%
0/84
|
0.00%
0/79
|
0.00%
0/81
|
|
General disorders
Pain
|
1.2%
1/80
|
0.00%
0/84
|
0.00%
0/79
|
0.00%
0/81
|
|
Investigations
Blood creatine phosphokinase increased
|
1.2%
1/80
|
4.8%
4/84
|
1.3%
1/79
|
0.00%
0/81
|
|
Investigations
Blood creatinine increased
|
0.00%
0/80
|
0.00%
0/84
|
0.00%
0/79
|
1.2%
1/81
|
|
Investigations
Blood lactate dehydrogenase increased
|
0.00%
0/80
|
1.2%
1/84
|
0.00%
0/79
|
0.00%
0/81
|
|
Investigations
Blood potassium increased
|
0.00%
0/80
|
0.00%
0/84
|
0.00%
0/79
|
1.2%
1/81
|
|
Investigations
Blood triglycerides increased
|
0.00%
0/80
|
1.2%
1/84
|
1.3%
1/79
|
1.2%
1/81
|
|
Investigations
Blood uric acid increased
|
0.00%
0/80
|
2.4%
2/84
|
0.00%
0/79
|
1.2%
1/81
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.00%
0/80
|
0.00%
0/84
|
1.3%
1/79
|
0.00%
0/81
|
|
Investigations
Glucose urine present
|
7.5%
6/80
|
1.2%
1/84
|
5.1%
4/79
|
3.7%
3/81
|
|
Investigations
Blood urine present
|
1.2%
1/80
|
4.8%
4/84
|
2.5%
2/79
|
1.2%
1/81
|
|
Investigations
White blood cell count increased
|
0.00%
0/80
|
0.00%
0/84
|
1.3%
1/79
|
0.00%
0/81
|
|
Investigations
Protein urine present
|
5.0%
4/80
|
4.8%
4/84
|
2.5%
2/79
|
2.5%
2/81
|
|
Investigations
Urobilin urine present
|
0.00%
0/80
|
0.00%
0/84
|
1.3%
1/79
|
0.00%
0/81
|
|
Investigations
Urine ketone body present
|
1.2%
1/80
|
3.6%
3/84
|
5.1%
4/79
|
2.5%
2/81
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/80
|
0.00%
0/84
|
1.3%
1/79
|
0.00%
0/81
|
|
Injury, poisoning and procedural complications
Arthropod sting
|
0.00%
0/80
|
0.00%
0/84
|
0.00%
0/79
|
3.7%
3/81
|
|
Injury, poisoning and procedural complications
Deafness traumatic
|
0.00%
0/80
|
0.00%
0/84
|
1.3%
1/79
|
0.00%
0/81
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.00%
0/80
|
0.00%
0/84
|
0.00%
0/79
|
1.2%
1/81
|
|
Injury, poisoning and procedural complications
Joint sprain
|
1.2%
1/80
|
0.00%
0/84
|
0.00%
0/79
|
1.2%
1/81
|
|
Injury, poisoning and procedural complications
Traumatic haematoma
|
0.00%
0/80
|
1.2%
1/84
|
0.00%
0/79
|
0.00%
0/81
|
|
Injury, poisoning and procedural complications
Excoriation
|
0.00%
0/80
|
1.2%
1/84
|
0.00%
0/79
|
0.00%
0/81
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/80
|
1.2%
1/84
|
0.00%
0/79
|
0.00%
0/81
|
|
Injury, poisoning and procedural complications
Neck injury
|
0.00%
0/80
|
0.00%
0/84
|
0.00%
0/79
|
2.5%
2/81
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/80
|
0.00%
0/84
|
1.3%
1/79
|
0.00%
0/81
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER