Trial Outcomes & Findings for Efficacy and Safety Study of MP-513 in Combination With Sulfonylurea in Patients With Type 2 Diabetes (NCT NCT00974090)
NCT ID: NCT00974090
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
194 participants
Primary outcome timeframe
at Week 0 and Week 12
Results posted on
2026-01-05
Participant Flow
Participant milestones
| Measure |
Placebo / Teneli + SU
Placebo for 12 weeks (double-blind period) followed by teneligliptin for an additional 40 weeks (open-label period) in combination with glimepiride
|
Teneli / Teneli + SU
Teneligliptin for 12 weeks (double-blind period) followed by teneligliptin for an additional 40 weeks (open-label period) in combination with glimepiride
|
|---|---|---|
|
Period 1: Double Blind Period
STARTED
|
98
|
96
|
|
Period 1: Double Blind Period
COMPLETED
|
95
|
95
|
|
Period 1: Double Blind Period
NOT COMPLETED
|
3
|
1
|
|
Period 2: Open-label Period
STARTED
|
95
|
95
|
|
Period 2: Open-label Period
COMPLETED
|
87
|
85
|
|
Period 2: Open-label Period
NOT COMPLETED
|
8
|
10
|
Reasons for withdrawal
| Measure |
Placebo / Teneli + SU
Placebo for 12 weeks (double-blind period) followed by teneligliptin for an additional 40 weeks (open-label period) in combination with glimepiride
|
Teneli / Teneli + SU
Teneligliptin for 12 weeks (double-blind period) followed by teneligliptin for an additional 40 weeks (open-label period) in combination with glimepiride
|
|---|---|---|
|
Period 1: Double Blind Period
Adverse Event
|
2
|
1
|
|
Period 1: Double Blind Period
Physician Decision
|
1
|
0
|
|
Period 2: Open-label Period
Adverse Event
|
4
|
6
|
|
Period 2: Open-label Period
Lack of Efficacy
|
3
|
1
|
|
Period 2: Open-label Period
Physician Decision
|
0
|
3
|
|
Period 2: Open-label Period
Withdrawal by Subject
|
1
|
0
|
Baseline Characteristics
Efficacy and Safety Study of MP-513 in Combination With Sulfonylurea in Patients With Type 2 Diabetes
Baseline characteristics by cohort
| Measure |
Placebo / Teneli + SU
n=98 Participants
Placebo for 12 weeks (double-blind period) followed by teneligliptin for an additional 40 weeks (open-label period) in combination with glimepiride
|
Teneli / Teneli + SU
n=96 Participants
Teneligliptin for 12 weeks (double-blind period) followed by teneligliptin for an additional 40 weeks (open-label period) in combination with glimepiride
|
Total
n=194 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
60.3 years
STANDARD_DEVIATION 7.8 • n=9667 Participants
|
58.4 years
STANDARD_DEVIATION 8.6 • n=6597 Participants
|
59.4 years
STANDARD_DEVIATION 8.2 • n=16264 Participants
|
|
Sex: Female, Male
Female
|
32 Participants
n=9667 Participants
|
34 Participants
n=6597 Participants
|
66 Participants
n=16264 Participants
|
|
Sex: Female, Male
Male
|
66 Participants
n=9667 Participants
|
62 Participants
n=6597 Participants
|
128 Participants
n=16264 Participants
|
PRIMARY outcome
Timeframe: at Week 0 and Week 12Population: 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 / Teneli + SU
n=98 Participants
Placebo for 12 weeks (double-blind period) followed by teneligliptin for an additional 40 weeks (open-label period) in combination with glimepiride
|
Teneli / Teneli + SU
n=96 Participants
Teneligliptin for 12 weeks (double-blind period) followed by teneligliptin for an additional 40 weeks (open-label period) in combination with glimepiride
|
|---|---|---|
|
Change From Baseline in HbA1c at Week 12
|
0.29 percentage of HbA1c
Standard Error 0.06
|
-0.71 percentage of HbA1c
Standard Error 0.06
|
SECONDARY outcome
Timeframe: at Week 0 and Week 12Population: 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 / Teneli + SU
n=98 Participants
Placebo for 12 weeks (double-blind period) followed by teneligliptin for an additional 40 weeks (open-label period) in combination with glimepiride
|
Teneli / Teneli + SU
n=96 Participants
Teneligliptin for 12 weeks (double-blind period) followed by teneligliptin for an additional 40 weeks (open-label period) in combination with glimepiride
|
|---|---|---|
|
Change From Baseline in Fasting Plasma Glucose at Week 12
|
9.8 mg / dL
Standard Error 2.2
|
-17.3 mg / dL
Standard Error 2.2
|
SECONDARY outcome
Timeframe: 0, 0.5, 1, 2 hours post-dose at Week 0 and Week 12Population: 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 / Teneli + SU
n=92 Participants
Placebo for 12 weeks (double-blind period) followed by teneligliptin for an additional 40 weeks (open-label period) in combination with glimepiride
|
Teneli / Teneli + SU
n=92 Participants
Teneligliptin for 12 weeks (double-blind period) followed by teneligliptin for an additional 40 weeks (open-label period) in combination with glimepiride
|
|---|---|---|
|
Change From Baseline in the Areas Under the Curve From 0 to 2 h (AUC0-2h) for Postprandial Plasma Glucose at Week 12
|
15.514 mg・hr/dL
Standard Error 6.072
|
-65.544 mg・hr/dL
Standard Error 6.072
|
SECONDARY outcome
Timeframe: at Week 0 and Week 12Population: 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 / Teneli + SU
n=92 Participants
Placebo for 12 weeks (double-blind period) followed by teneligliptin for an additional 40 weeks (open-label period) in combination with glimepiride
|
Teneli / Teneli + SU
n=93 Participants
Teneligliptin for 12 weeks (double-blind period) followed by teneligliptin for an additional 40 weeks (open-label period) in combination with glimepiride
|
|---|---|---|
|
Change From Baseline in 2-hour Postprandial Plasma Glucose at Week 12
|
6.0 mg / dL
Standard Error 4.4
|
-43.1 mg / dL
Standard Error 4.4
|
Adverse Events
Placebo/Teneli + SU (Data Through Week 12)
Serious events: 2 serious events
Other events: 60 other events
Deaths: 0 deaths
Teneli/Teneli + SU (Data Through Week 12)
Serious events: 0 serious events
Other events: 62 other events
Deaths: 0 deaths
Placebo/Teneli + SU (Data From Week 12 to Week 52)
Serious events: 2 serious events
Other events: 89 other events
Deaths: 0 deaths
Teneli/Teneli + SU (Data Through Week 52)
Serious events: 7 serious events
Other events: 89 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo/Teneli + SU (Data Through Week 12)
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 glimepiride. The adverse events which occured from Week 0 to Week 12 were shown.
MedDRA 13.0
|
Teneli/Teneli + SU (Data Through Week 12)
n=96 participants at risk
Teneligliptin for 12 weeks (double-blind period) followed by teneligliptin for an additional 40 weeks (open-label period) in combination with glimepiride. The adverse events which occured from Week 0 to Week 12 were shown.
MedDRA 13.0
|
Placebo/Teneli + SU (Data From Week 12 to Week 52)
n=95 participants at risk
Placebo for 12 weeks (double-blind period) followed by teneligliptin for an additional 40 weeks (open-label period) in combination with glimepiride. The adverse events which occured from Week 12 to Week 52 were shown.
MedDRA 13.1
|
Teneli/Teneli + SU (Data Through Week 52)
n=96 participants at risk
Teneligliptin for 12 weeks (double-blind period) followed by teneligliptin for an additional 40 weeks (open-label period) in combination with glimepiride. The adverse events which occured from Week 12 to Week 52 were shown.
MedDRA 13.1
|
|---|---|---|---|---|
|
Infections and infestations
Pneumonia
|
1.0%
1/98
|
0.00%
0/96
|
0.00%
0/95
|
0.00%
0/96
|
|
Ear and labyrinth disorders
Sudden hearing loss
|
1.0%
1/98
|
0.00%
0/96
|
0.00%
0/95
|
0.00%
0/96
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric cancer
|
0.00%
0/98
|
0.00%
0/96
|
0.00%
0/95
|
2.1%
2/96
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Large intestine carcinoma
|
0.00%
0/98
|
0.00%
0/96
|
0.00%
0/95
|
2.1%
2/96
|
|
Eye disorders
Maculopathy
|
0.00%
0/98
|
0.00%
0/96
|
1.1%
1/95
|
0.00%
0/96
|
|
Eye disorders
Cataract
|
0.00%
0/98
|
0.00%
0/96
|
1.1%
1/95
|
0.00%
0/96
|
|
Eye disorders
Retinal vein occlusion
|
0.00%
0/98
|
0.00%
0/96
|
1.1%
1/95
|
0.00%
0/96
|
|
Gastrointestinal disorders
Colonic polyp
|
0.00%
0/98
|
0.00%
0/96
|
0.00%
0/95
|
1.0%
1/96
|
|
Hepatobiliary disorders
Cholangitis
|
0.00%
0/98
|
0.00%
0/96
|
0.00%
0/95
|
1.0%
1/96
|
|
Hepatobiliary disorders
Bile duct stone
|
0.00%
0/98
|
0.00%
0/96
|
0.00%
0/95
|
1.0%
1/96
|
|
Musculoskeletal and connective tissue disorders
Loose body in joint
|
0.00%
0/98
|
0.00%
0/96
|
0.00%
0/95
|
1.0%
1/96
|
|
Reproductive system and breast disorders
Ovarian enlargement
|
0.00%
0/98
|
0.00%
0/96
|
0.00%
0/95
|
1.0%
1/96
|
|
Injury, poisoning and procedural complications
Meniscus lesion
|
0.00%
0/98
|
0.00%
0/96
|
0.00%
0/95
|
1.0%
1/96
|
Other adverse events
| Measure |
Placebo/Teneli + SU (Data Through Week 12)
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 glimepiride. The adverse events which occured from Week 0 to Week 12 were shown.
MedDRA 13.0
|
Teneli/Teneli + SU (Data Through Week 12)
n=96 participants at risk
Teneligliptin for 12 weeks (double-blind period) followed by teneligliptin for an additional 40 weeks (open-label period) in combination with glimepiride. The adverse events which occured from Week 0 to Week 12 were shown.
MedDRA 13.0
|
Placebo/Teneli + SU (Data From Week 12 to Week 52)
n=95 participants at risk
Placebo for 12 weeks (double-blind period) followed by teneligliptin for an additional 40 weeks (open-label period) in combination with glimepiride. The adverse events which occured from Week 12 to Week 52 were shown.
MedDRA 13.1
|
Teneli/Teneli + SU (Data Through Week 52)
n=96 participants at risk
Teneligliptin for 12 weeks (double-blind period) followed by teneligliptin for an additional 40 weeks (open-label period) in combination with glimepiride. The adverse events which occured from Week 12 to Week 52 were shown.
MedDRA 13.1
|
|---|---|---|---|---|
|
Infections and infestations
Body tinea
|
0.00%
0/98
|
0.00%
0/96
|
2.1%
2/95
|
0.00%
0/96
|
|
Infections and infestations
Bronchitis
|
0.00%
0/98
|
2.1%
2/96
|
3.2%
3/95
|
8.3%
8/96
|
|
Infections and infestations
Bronchopneumonia
|
0.00%
0/98
|
0.00%
0/96
|
0.00%
0/95
|
1.0%
1/96
|
|
Infections and infestations
Cellulitis
|
0.00%
0/98
|
1.0%
1/96
|
0.00%
0/95
|
1.0%
1/96
|
|
Infections and infestations
Cystitis
|
0.00%
0/98
|
0.00%
0/96
|
2.1%
2/95
|
1.0%
1/96
|
|
Infections and infestations
Dermatitis infected
|
0.00%
0/98
|
1.0%
1/96
|
0.00%
0/95
|
1.0%
1/96
|
|
Infections and infestations
Folliculitis
|
0.00%
0/98
|
0.00%
0/96
|
0.00%
0/95
|
2.1%
2/96
|
|
Infections and infestations
Gastroenteritis
|
1.0%
1/98
|
0.00%
0/96
|
5.3%
5/95
|
2.1%
2/96
|
|
Infections and infestations
Gastroenteritis vibrio
|
0.00%
0/98
|
0.00%
0/96
|
1.1%
1/95
|
0.00%
0/96
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/98
|
0.00%
0/96
|
2.1%
2/95
|
1.0%
1/96
|
|
Infections and infestations
Impetigo
|
0.00%
0/98
|
1.0%
1/96
|
0.00%
0/95
|
1.0%
1/96
|
|
Infections and infestations
Infected bites
|
0.00%
0/98
|
0.00%
0/96
|
1.1%
1/95
|
0.00%
0/96
|
|
Infections and infestations
Influenza
|
1.0%
1/98
|
2.1%
2/96
|
1.1%
1/95
|
2.1%
2/96
|
|
Infections and infestations
Nasopharyngitis
|
16.3%
16/98
|
19.8%
19/96
|
27.4%
26/95
|
33.3%
32/96
|
|
Infections and infestations
Onychomycosis
|
0.00%
0/98
|
1.0%
1/96
|
0.00%
0/95
|
2.1%
2/96
|
|
Infections and infestations
Otitis externa
|
0.00%
0/98
|
0.00%
0/96
|
1.1%
1/95
|
0.00%
0/96
|
|
Infections and infestations
Pharyngitis
|
3.1%
3/98
|
4.2%
4/96
|
11.6%
11/95
|
5.2%
5/96
|
|
Infections and infestations
Tinea cruris
|
0.00%
0/98
|
0.00%
0/96
|
0.00%
0/95
|
1.0%
1/96
|
|
Infections and infestations
Tinea pedis
|
0.00%
0/98
|
1.0%
1/96
|
0.00%
0/95
|
2.1%
2/96
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/98
|
0.00%
0/96
|
1.1%
1/95
|
0.00%
0/96
|
|
Infections and infestations
Wound infection
|
0.00%
0/98
|
1.0%
1/96
|
0.00%
0/95
|
1.0%
1/96
|
|
Infections and infestations
Anal abscess
|
0.00%
0/98
|
0.00%
0/96
|
1.1%
1/95
|
0.00%
0/96
|
|
Infections and infestations
Infected epidermal cyst
|
0.00%
0/98
|
0.00%
0/96
|
1.1%
1/95
|
0.00%
0/96
|
|
Infections and infestations
Gingival abscess
|
0.00%
0/98
|
0.00%
0/96
|
0.00%
0/95
|
1.0%
1/96
|
|
Infections and infestations
Helicobacter infection
|
0.00%
0/98
|
0.00%
0/96
|
1.1%
1/95
|
0.00%
0/96
|
|
Infections and infestations
Enteritis infectious
|
0.00%
0/98
|
0.00%
0/96
|
1.1%
1/95
|
0.00%
0/96
|
|
Infections and infestations
Conjunctivitis bacterial
|
0.00%
0/98
|
0.00%
0/96
|
0.00%
0/95
|
1.0%
1/96
|
|
Infections and infestations
Oral herpes
|
0.00%
0/98
|
0.00%
0/96
|
1.1%
1/95
|
0.00%
0/96
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lipoma
|
0.00%
0/98
|
0.00%
0/96
|
0.00%
0/95
|
1.0%
1/96
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Seborrhoeic keratosis
|
0.00%
0/98
|
0.00%
0/96
|
0.00%
0/95
|
1.0%
1/96
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.00%
0/98
|
0.00%
0/96
|
1.1%
1/95
|
1.0%
1/96
|
|
Blood and lymphatic system disorders
Lymphadenitis
|
0.00%
0/98
|
1.0%
1/96
|
1.1%
1/95
|
1.0%
1/96
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
3.1%
3/98
|
2.1%
2/96
|
12.6%
12/95
|
9.4%
9/96
|
|
Psychiatric disorders
Depression
|
0.00%
0/98
|
0.00%
0/96
|
2.1%
2/95
|
0.00%
0/96
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/98
|
0.00%
0/96
|
0.00%
0/95
|
1.0%
1/96
|
|
Psychiatric disorders
Sleep disorder
|
0.00%
0/98
|
0.00%
0/96
|
1.1%
1/95
|
0.00%
0/96
|
|
Nervous system disorders
Cerebral infarction
|
0.00%
0/98
|
0.00%
0/96
|
0.00%
0/95
|
1.0%
1/96
|
|
Nervous system disorders
Cervicobrachial syndrome
|
0.00%
0/98
|
0.00%
0/96
|
0.00%
0/95
|
1.0%
1/96
|
|
Nervous system disorders
Diabetic neuropathy
|
0.00%
0/98
|
0.00%
0/96
|
2.1%
2/95
|
4.2%
4/96
|
|
Nervous system disorders
Dizziness
|
1.0%
1/98
|
0.00%
0/96
|
3.2%
3/95
|
0.00%
0/96
|
|
Nervous system disorders
Headache
|
1.0%
1/98
|
2.1%
2/96
|
1.1%
1/95
|
2.1%
2/96
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/98
|
1.0%
1/96
|
2.1%
2/95
|
1.0%
1/96
|
|
Nervous system disorders
Migraine
|
0.00%
0/98
|
0.00%
0/96
|
1.1%
1/95
|
0.00%
0/96
|
|
Nervous system disorders
Post herpetic neuralgia
|
0.00%
0/98
|
0.00%
0/96
|
1.1%
1/95
|
0.00%
0/96
|
|
Nervous system disorders
VIIth nerve paralysis
|
0.00%
0/98
|
0.00%
0/96
|
1.1%
1/95
|
0.00%
0/96
|
|
Nervous system disorders
Parkinson's disease
|
0.00%
0/98
|
0.00%
0/96
|
1.1%
1/95
|
0.00%
0/96
|
|
Nervous system disorders
Carotid arteriosclerosis
|
1.0%
1/98
|
0.00%
0/96
|
1.1%
1/95
|
0.00%
0/96
|
|
Nervous system disorders
Occipital neuralgia
|
0.00%
0/98
|
0.00%
0/96
|
1.1%
1/95
|
0.00%
0/96
|
|
Eye disorders
Cataract
|
0.00%
0/98
|
0.00%
0/96
|
3.2%
3/95
|
0.00%
0/96
|
|
Eye disorders
Conjunctivitis
|
0.00%
0/98
|
1.0%
1/96
|
3.2%
3/95
|
3.1%
3/96
|
|
Eye disorders
Conjunctivitis allergic
|
2.0%
2/98
|
0.00%
0/96
|
3.2%
3/95
|
0.00%
0/96
|
|
Eye disorders
Diabetic retinopathy
|
0.00%
0/98
|
1.0%
1/96
|
3.2%
3/95
|
8.3%
8/96
|
|
Eye disorders
Eyelid ptosis
|
0.00%
0/98
|
1.0%
1/96
|
0.00%
0/95
|
1.0%
1/96
|
|
Eye disorders
Keratitis
|
0.00%
0/98
|
1.0%
1/96
|
0.00%
0/95
|
1.0%
1/96
|
|
Eye disorders
Trichiasis
|
0.00%
0/98
|
0.00%
0/96
|
0.00%
0/95
|
1.0%
1/96
|
|
Eye disorders
Vision blurred
|
0.00%
0/98
|
0.00%
0/96
|
1.1%
1/95
|
0.00%
0/96
|
|
Eye disorders
Visual acuity reduced
|
0.00%
0/98
|
0.00%
0/96
|
1.1%
1/95
|
0.00%
0/96
|
|
Eye disorders
Vitreous floaters
|
0.00%
0/98
|
0.00%
0/96
|
1.1%
1/95
|
0.00%
0/96
|
|
Eye disorders
Normal tension glaucoma
|
0.00%
0/98
|
1.0%
1/96
|
0.00%
0/95
|
1.0%
1/96
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/98
|
0.00%
0/96
|
0.00%
0/95
|
1.0%
1/96
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/98
|
0.00%
0/96
|
2.1%
2/95
|
2.1%
2/96
|
|
Ear and labyrinth disorders
Vertigo positional
|
0.00%
0/98
|
0.00%
0/96
|
0.00%
0/95
|
2.1%
2/96
|
|
Ear and labyrinth disorders
External ear pain
|
0.00%
0/98
|
0.00%
0/96
|
0.00%
0/95
|
1.0%
1/96
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/98
|
0.00%
0/96
|
0.00%
0/95
|
1.0%
1/96
|
|
Cardiac disorders
Palpitations
|
1.0%
1/98
|
0.00%
0/96
|
1.1%
1/95
|
0.00%
0/96
|
|
Vascular disorders
Hypertension
|
1.0%
1/98
|
1.0%
1/96
|
2.1%
2/95
|
4.2%
4/96
|
|
Vascular disorders
Hot flush
|
0.00%
0/98
|
0.00%
0/96
|
1.1%
1/95
|
0.00%
0/96
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/98
|
1.0%
1/96
|
0.00%
0/95
|
1.0%
1/96
|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis chronic
|
0.00%
0/98
|
0.00%
0/96
|
0.00%
0/95
|
1.0%
1/96
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/98
|
1.0%
1/96
|
0.00%
0/95
|
1.0%
1/96
|
|
Respiratory, thoracic and mediastinal disorders
Emphysema
|
0.00%
0/98
|
0.00%
0/96
|
0.00%
0/95
|
1.0%
1/96
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/98
|
0.00%
0/96
|
1.1%
1/95
|
0.00%
0/96
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary fibrosis
|
0.00%
0/98
|
0.00%
0/96
|
0.00%
0/95
|
1.0%
1/96
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.00%
0/98
|
1.0%
1/96
|
1.1%
1/95
|
2.1%
2/96
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/98
|
0.00%
0/96
|
1.1%
1/95
|
0.00%
0/96
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnoea syndrome
|
0.00%
0/98
|
0.00%
0/96
|
0.00%
0/95
|
1.0%
1/96
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract inflammation
|
3.1%
3/98
|
5.2%
5/96
|
7.4%
7/95
|
9.4%
9/96
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal discomfort
|
0.00%
0/98
|
0.00%
0/96
|
1.1%
1/95
|
0.00%
0/96
|
|
Gastrointestinal disorders
Abdominal discomfort
|
1.0%
1/98
|
0.00%
0/96
|
1.1%
1/95
|
0.00%
0/96
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/98
|
1.0%
1/96
|
1.1%
1/95
|
1.0%
1/96
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/98
|
0.00%
0/96
|
0.00%
0/95
|
1.0%
1/96
|
|
Gastrointestinal disorders
Cheilitis
|
0.00%
0/98
|
0.00%
0/96
|
0.00%
0/95
|
1.0%
1/96
|
|
Gastrointestinal disorders
Colonic polyp
|
0.00%
0/98
|
0.00%
0/96
|
0.00%
0/95
|
1.0%
1/96
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/98
|
2.1%
2/96
|
3.2%
3/95
|
6.2%
6/96
|
|
Gastrointestinal disorders
Dental caries
|
1.0%
1/98
|
0.00%
0/96
|
2.1%
2/95
|
3.1%
3/96
|
|
Gastrointestinal disorders
Diarrhoea
|
1.0%
1/98
|
3.1%
3/96
|
3.2%
3/95
|
4.2%
4/96
|
|
Gastrointestinal disorders
Duodenal ulcer
|
0.00%
0/98
|
0.00%
0/96
|
1.1%
1/95
|
1.0%
1/96
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/98
|
1.0%
1/96
|
0.00%
0/95
|
1.0%
1/96
|
|
Gastrointestinal disorders
Enterocolitis
|
0.00%
0/98
|
1.0%
1/96
|
1.1%
1/95
|
1.0%
1/96
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/98
|
0.00%
0/96
|
1.1%
1/95
|
0.00%
0/96
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.00%
0/98
|
0.00%
0/96
|
0.00%
0/95
|
1.0%
1/96
|
|
Gastrointestinal disorders
Gastritis
|
1.0%
1/98
|
0.00%
0/96
|
2.1%
2/95
|
1.0%
1/96
|
|
Gastrointestinal disorders
Gastritis atrophic
|
0.00%
0/98
|
0.00%
0/96
|
1.1%
1/95
|
0.00%
0/96
|
|
Gastrointestinal disorders
Gastritis erosive
|
0.00%
0/98
|
0.00%
0/96
|
1.1%
1/95
|
0.00%
0/96
|
|
Gastrointestinal disorders
Gingivitis
|
1.0%
1/98
|
0.00%
0/96
|
0.00%
0/95
|
1.0%
1/96
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/98
|
0.00%
0/96
|
0.00%
0/95
|
1.0%
1/96
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/98
|
0.00%
0/96
|
1.1%
1/95
|
1.0%
1/96
|
|
Gastrointestinal disorders
Periodontal disease
|
2.0%
2/98
|
1.0%
1/96
|
2.1%
2/95
|
4.2%
4/96
|
|
Gastrointestinal disorders
Periodontitis
|
1.0%
1/98
|
1.0%
1/96
|
2.1%
2/95
|
4.2%
4/96
|
|
Gastrointestinal disorders
Periproctitis
|
0.00%
0/98
|
1.0%
1/96
|
0.00%
0/95
|
1.0%
1/96
|
|
Gastrointestinal disorders
Reflux oesophagitis
|
0.00%
0/98
|
0.00%
0/96
|
1.1%
1/95
|
0.00%
0/96
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/98
|
2.1%
2/96
|
1.1%
1/95
|
3.1%
3/96
|
|
Gastrointestinal disorders
Toothache
|
1.0%
1/98
|
0.00%
0/96
|
1.1%
1/95
|
0.00%
0/96
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
1.0%
1/98
|
0.00%
0/96
|
0.00%
0/95
|
0.00%
0/96
|
|
Hepatobiliary disorders
Hepatic steatosis
|
0.00%
0/98
|
1.0%
1/96
|
3.2%
3/95
|
3.1%
3/96
|
|
Hepatobiliary disorders
Jaundice
|
1.0%
1/98
|
0.00%
0/96
|
0.00%
0/95
|
0.00%
0/96
|
|
Skin and subcutaneous tissue disorders
Cutaneous amyloidosis
|
0.00%
0/98
|
0.00%
0/96
|
1.1%
1/95
|
0.00%
0/96
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.00%
0/98
|
0.00%
0/96
|
1.1%
1/95
|
0.00%
0/96
|
|
Skin and subcutaneous tissue disorders
Drug eruption
|
0.00%
0/98
|
0.00%
0/96
|
0.00%
0/95
|
1.0%
1/96
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/98
|
1.0%
1/96
|
4.2%
4/95
|
6.2%
6/96
|
|
Skin and subcutaneous tissue disorders
Eczema asteatotic
|
0.00%
0/98
|
0.00%
0/96
|
0.00%
0/95
|
1.0%
1/96
|
|
Skin and subcutaneous tissue disorders
Eczema nummular
|
0.00%
0/98
|
0.00%
0/96
|
1.1%
1/95
|
0.00%
0/96
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/98
|
0.00%
0/96
|
1.1%
1/95
|
0.00%
0/96
|
|
Skin and subcutaneous tissue disorders
Haemorrhage subcutaneous
|
0.00%
0/98
|
0.00%
0/96
|
1.1%
1/95
|
0.00%
0/96
|
|
Skin and subcutaneous tissue disorders
Heat rash
|
0.00%
0/98
|
0.00%
0/96
|
1.1%
1/95
|
1.0%
1/96
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/98
|
0.00%
0/96
|
1.1%
1/95
|
0.00%
0/96
|
|
Skin and subcutaneous tissue disorders
Hyperkeratosis
|
0.00%
0/98
|
0.00%
0/96
|
0.00%
0/95
|
1.0%
1/96
|
|
Skin and subcutaneous tissue disorders
Intertrigo
|
0.00%
0/98
|
0.00%
0/96
|
1.1%
1/95
|
0.00%
0/96
|
|
Skin and subcutaneous tissue disorders
Papule
|
0.00%
0/98
|
0.00%
0/96
|
1.1%
1/95
|
0.00%
0/96
|
|
Skin and subcutaneous tissue disorders
Photosensitivity reaction
|
0.00%
0/98
|
0.00%
0/96
|
1.1%
1/95
|
1.0%
1/96
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
1.0%
1/98
|
0.00%
0/96
|
2.1%
2/95
|
1.0%
1/96
|
|
Skin and subcutaneous tissue disorders
Pustular psoriasis
|
0.00%
0/98
|
0.00%
0/96
|
1.1%
1/95
|
0.00%
0/96
|
|
Skin and subcutaneous tissue disorders
Rash
|
1.0%
1/98
|
0.00%
0/96
|
3.2%
3/95
|
1.0%
1/96
|
|
Skin and subcutaneous tissue disorders
Seborrhoeic dermatitis
|
0.00%
0/98
|
1.0%
1/96
|
0.00%
0/95
|
1.0%
1/96
|
|
Skin and subcutaneous tissue disorders
Senile pruritus
|
0.00%
0/98
|
0.00%
0/96
|
0.00%
0/95
|
1.0%
1/96
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
1.0%
1/98
|
0.00%
0/96
|
2.1%
2/95
|
3.1%
3/96
|
|
Skin and subcutaneous tissue disorders
Xeroderma
|
0.00%
0/98
|
0.00%
0/96
|
0.00%
0/95
|
1.0%
1/96
|
|
Skin and subcutaneous tissue disorders
Hyperkeratosis palmaris and plantaris
|
0.00%
0/98
|
0.00%
0/96
|
0.00%
0/95
|
1.0%
1/96
|
|
Skin and subcutaneous tissue disorders
Pruritus generalised
|
0.00%
0/98
|
0.00%
0/96
|
1.1%
1/95
|
0.00%
0/96
|
|
Skin and subcutaneous tissue disorders
Toxic skin eruption
|
0.00%
0/98
|
0.00%
0/96
|
1.1%
1/95
|
0.00%
0/96
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/98
|
2.1%
2/96
|
1.1%
1/95
|
10.4%
10/96
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/98
|
2.1%
2/96
|
1.1%
1/95
|
2.1%
2/96
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
1.0%
1/98
|
2.1%
2/96
|
2.1%
2/95
|
3.1%
3/96
|
|
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis
|
0.00%
0/98
|
0.00%
0/96
|
1.1%
1/95
|
0.00%
0/96
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
1.0%
1/98
|
0.00%
0/96
|
2.1%
2/95
|
1.0%
1/96
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
2.0%
2/98
|
0.00%
0/96
|
3.2%
3/95
|
3.1%
3/96
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/98
|
0.00%
0/96
|
1.1%
1/95
|
3.1%
3/96
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/98
|
0.00%
0/96
|
0.00%
0/95
|
2.1%
2/96
|
|
Musculoskeletal and connective tissue disorders
Periarthritis
|
0.00%
0/98
|
3.1%
3/96
|
1.1%
1/95
|
4.2%
4/96
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
0.00%
0/98
|
0.00%
0/96
|
1.1%
1/95
|
0.00%
0/96
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
0.00%
0/98
|
0.00%
0/96
|
1.1%
1/95
|
0.00%
0/96
|
|
Musculoskeletal and connective tissue disorders
Trigger finger
|
1.0%
1/98
|
1.0%
1/96
|
0.00%
0/95
|
2.1%
2/96
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
1.0%
1/98
|
0.00%
0/96
|
1.1%
1/95
|
1.0%
1/96
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/98
|
0.00%
0/96
|
0.00%
0/95
|
1.0%
1/96
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.00%
0/98
|
2.1%
2/96
|
1.1%
1/95
|
3.1%
3/96
|
|
Renal and urinary disorders
Calculus ureteric
|
0.00%
0/98
|
0.00%
0/96
|
1.1%
1/95
|
0.00%
0/96
|
|
Renal and urinary disorders
Hypertonic bladder
|
0.00%
0/98
|
0.00%
0/96
|
1.1%
1/95
|
0.00%
0/96
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/98
|
0.00%
0/96
|
1.1%
1/95
|
0.00%
0/96
|
|
Renal and urinary disorders
Pollakiuria
|
1.0%
1/98
|
0.00%
0/96
|
0.00%
0/95
|
0.00%
0/96
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.00%
0/98
|
0.00%
0/96
|
1.1%
1/95
|
2.1%
2/96
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
0.00%
0/98
|
0.00%
0/96
|
1.1%
1/95
|
0.00%
0/96
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
0.00%
0/98
|
0.00%
0/96
|
1.1%
1/95
|
1.0%
1/96
|
|
General disorders
Chest pain
|
0.00%
0/98
|
0.00%
0/96
|
0.00%
0/95
|
2.1%
2/96
|
|
General disorders
Feeling abnormal
|
0.00%
0/98
|
0.00%
0/96
|
2.1%
2/95
|
0.00%
0/96
|
|
General disorders
Malaise
|
0.00%
0/98
|
0.00%
0/96
|
2.1%
2/95
|
2.1%
2/96
|
|
General disorders
Oedema peripheral
|
0.00%
0/98
|
0.00%
0/96
|
0.00%
0/95
|
1.0%
1/96
|
|
General disorders
Thirst
|
0.00%
0/98
|
0.00%
0/96
|
1.1%
1/95
|
0.00%
0/96
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/98
|
4.2%
4/96
|
3.2%
3/95
|
6.2%
6/96
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/98
|
1.0%
1/96
|
1.1%
1/95
|
4.2%
4/96
|
|
Investigations
Blood creatine phosphokinase increased
|
2.0%
2/98
|
2.1%
2/96
|
3.2%
3/95
|
8.3%
8/96
|
|
Investigations
Blood potassium increased
|
0.00%
0/98
|
2.1%
2/96
|
2.1%
2/95
|
2.1%
2/96
|
|
Investigations
Blood pressure decreased
|
0.00%
0/98
|
0.00%
0/96
|
0.00%
0/95
|
1.0%
1/96
|
|
Investigations
Blood triglycerides increased
|
2.0%
2/98
|
3.1%
3/96
|
4.2%
4/95
|
5.2%
5/96
|
|
Investigations
Blood urea increased
|
1.0%
1/98
|
1.0%
1/96
|
0.00%
0/95
|
2.1%
2/96
|
|
Investigations
Blood uric acid increased
|
0.00%
0/98
|
2.1%
2/96
|
3.2%
3/95
|
4.2%
4/96
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.00%
0/98
|
2.1%
2/96
|
3.2%
3/95
|
3.1%
3/96
|
|
Investigations
Glucose urine present
|
21.4%
21/98
|
2.1%
2/96
|
17.9%
17/95
|
11.5%
11/96
|
|
Investigations
Blood urine present
|
3.1%
3/98
|
1.0%
1/96
|
7.4%
7/95
|
6.2%
6/96
|
|
Investigations
Platelet count decreased
|
0.00%
0/98
|
1.0%
1/96
|
0.00%
0/95
|
1.0%
1/96
|
|
Investigations
White blood cell count decreased
|
0.00%
0/98
|
1.0%
1/96
|
0.00%
0/95
|
1.0%
1/96
|
|
Investigations
White blood cell count increased
|
0.00%
0/98
|
0.00%
0/96
|
1.1%
1/95
|
1.0%
1/96
|
|
Investigations
Protein urine present
|
5.1%
5/98
|
4.2%
4/96
|
13.7%
13/95
|
16.7%
16/96
|
|
Investigations
Urine ketone body present
|
2.0%
2/98
|
2.1%
2/96
|
2.1%
2/95
|
6.2%
6/96
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/98
|
1.0%
1/96
|
0.00%
0/95
|
2.1%
2/96
|
|
Investigations
Carotid intima-media thickness increased
|
0.00%
0/98
|
0.00%
0/96
|
0.00%
0/95
|
1.0%
1/96
|
|
Investigations
Helicobacter test positive
|
0.00%
0/98
|
0.00%
0/96
|
0.00%
0/95
|
1.0%
1/96
|
|
Injury, poisoning and procedural complications
Animal bite
|
0.00%
0/98
|
1.0%
1/96
|
1.1%
1/95
|
1.0%
1/96
|
|
Injury, poisoning and procedural complications
Arthropod sting
|
0.00%
0/98
|
0.00%
0/96
|
5.3%
5/95
|
5.2%
5/96
|
|
Injury, poisoning and procedural complications
Bite
|
0.00%
0/98
|
0.00%
0/96
|
0.00%
0/95
|
1.0%
1/96
|
|
Injury, poisoning and procedural complications
Eye penetration
|
1.0%
1/98
|
0.00%
0/96
|
0.00%
0/95
|
0.00%
0/96
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.00%
0/98
|
0.00%
0/96
|
1.1%
1/95
|
0.00%
0/96
|
|
Injury, poisoning and procedural complications
Foreign body in eye
|
0.00%
0/98
|
1.0%
1/96
|
0.00%
0/95
|
1.0%
1/96
|
|
Injury, poisoning and procedural complications
Hand fracture
|
0.00%
0/98
|
0.00%
0/96
|
1.1%
1/95
|
0.00%
0/96
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.00%
0/98
|
0.00%
0/96
|
0.00%
0/95
|
1.0%
1/96
|
|
Injury, poisoning and procedural complications
Joint sprain
|
0.00%
0/98
|
1.0%
1/96
|
0.00%
0/95
|
1.0%
1/96
|
|
Injury, poisoning and procedural complications
Muscle injury
|
0.00%
0/98
|
0.00%
0/96
|
0.00%
0/95
|
1.0%
1/96
|
|
Injury, poisoning and procedural complications
Muscle rupture
|
0.00%
0/98
|
0.00%
0/96
|
1.1%
1/95
|
0.00%
0/96
|
|
Injury, poisoning and procedural complications
Nail avulsion
|
0.00%
0/98
|
0.00%
0/96
|
1.1%
1/95
|
0.00%
0/96
|
|
Injury, poisoning and procedural complications
Stab wound
|
0.00%
0/98
|
0.00%
0/96
|
0.00%
0/95
|
0.00%
0/96
|
|
Injury, poisoning and procedural complications
Tendon rupture
|
0.00%
0/98
|
0.00%
0/96
|
1.1%
1/95
|
0.00%
0/96
|
|
Injury, poisoning and procedural complications
Excoriation
|
0.00%
0/98
|
1.0%
1/96
|
0.00%
0/95
|
1.0%
1/96
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.00%
0/98
|
1.0%
1/96
|
1.1%
1/95
|
0.00%
0/96
|
|
Injury, poisoning and procedural complications
Contusion
|
1.0%
1/98
|
1.0%
1/96
|
3.2%
3/95
|
6.2%
6/96
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.00%
0/98
|
0.00%
0/96
|
1.1%
1/95
|
1.0%
1/96
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.00%
0/98
|
1.0%
1/96
|
0.00%
0/95
|
1.0%
1/96
|
|
Injury, poisoning and procedural complications
Open wound
|
1.0%
1/98
|
1.0%
1/96
|
1.1%
1/95
|
3.1%
3/96
|
|
Injury, poisoning and procedural complications
Skeletal injury
|
0.00%
0/98
|
0.00%
0/96
|
0.00%
0/95
|
1.0%
1/96
|
|
Injury, poisoning and procedural complications
Ear abrasion
|
0.00%
0/98
|
0.00%
0/96
|
0.00%
0/95
|
1.0%
1/96
|
|
Injury, poisoning and procedural complications
Procedural hypotension
|
0.00%
0/98
|
0.00%
0/96
|
0.00%
0/95
|
1.0%
1/96
|
|
Injury, poisoning and procedural complications
Tooth fracture
|
0.00%
0/98
|
0.00%
0/96
|
0.00%
0/95
|
1.0%
1/96
|
|
Injury, poisoning and procedural complications
Avulsion fracture
|
0.00%
0/98
|
0.00%
0/96
|
0.00%
0/95
|
1.0%
1/96
|
|
Musculoskeletal and connective tissue disorders
Loose body in joint
|
0.00%
0/98
|
1.0%
1/96
|
0.00%
0/95
|
0.00%
0/96
|
|
Injury, poisoning and procedural complications
Injury
|
1.0%
1/98
|
0.00%
0/96
|
0.00%
0/95
|
0.00%
0/96
|
|
Injury, poisoning and procedural complications
Meniscus lesion
|
0.00%
0/98
|
1.0%
1/96
|
0.00%
0/95
|
0.00%
0/96
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER