Trial Outcomes & Findings for Efficacy and Safety Study of TA-7284 in Patients With Type 2 Diabetes (NCT NCT01413204)
NCT ID: NCT01413204
Last Updated: 2026-01-08
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
272 participants
Primary outcome timeframe
baseline and 24 weeks
Results posted on
2026-01-08
Participant Flow
Participant milestones
| Measure |
TA-7284 Low
TA-7284 low dose, once daily for 24 weeks
|
TA-7284 High
TA-7284 high dose, once daily for 24 weeks
|
Placebo
TA-7284 Placebo, once daily for 24 weeks
|
|---|---|---|---|
|
Overall Study
STARTED
|
90
|
89
|
93
|
|
Overall Study
COMPLETED
|
84
|
83
|
74
|
|
Overall Study
NOT COMPLETED
|
6
|
6
|
19
|
Reasons for withdrawal
| Measure |
TA-7284 Low
TA-7284 low dose, once daily for 24 weeks
|
TA-7284 High
TA-7284 high dose, once daily for 24 weeks
|
Placebo
TA-7284 Placebo, once daily for 24 weeks
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
1
|
2
|
2
|
|
Overall Study
Physician Decision
|
3
|
0
|
2
|
|
Overall Study
Withdrawal by Subject
|
1
|
4
|
4
|
|
Overall Study
Clearly not eligible for the study
|
0
|
0
|
1
|
|
Overall Study
Fasting plasma glucose level increased
|
1
|
0
|
10
|
Baseline Characteristics
Efficacy and Safety Study of TA-7284 in Patients With Type 2 Diabetes
Baseline characteristics by cohort
| Measure |
TA-7284 Low
n=90 Participants
TA-7284 low dose, once daily for 24 weeks
|
TA-7284 High
n=89 Participants
TA-7284 high dose, once daily for 24 weeks
|
Placebo
n=93 Participants
TA-7284 Placebo, once daily for 24 weeks
|
Total
n=272 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
58.4 years
STANDARD_DEVIATION 10.4 • n=18 Participants
|
57.3 years
STANDARD_DEVIATION 11.1 • n=17 Participants
|
58.2 years
STANDARD_DEVIATION 11 • n=35 Participants
|
58 years
STANDARD_DEVIATION 10.8 • n=42 Participants
|
|
Sex: Female, Male
Female
|
31 Participants
n=18 Participants
|
16 Participants
n=17 Participants
|
33 Participants
n=35 Participants
|
80 Participants
n=42 Participants
|
|
Sex: Female, Male
Male
|
59 Participants
n=18 Participants
|
73 Participants
n=17 Participants
|
60 Participants
n=35 Participants
|
192 Participants
n=42 Participants
|
PRIMARY outcome
Timeframe: baseline and 24 weeksPopulation: Full analysis set, last observation carried forward
Outcome measures
| Measure |
TA-7284 Low
n=90 Participants
TA-7284 low dose, once daily for 24 weeks
|
TA-7284 High
n=88 Participants
TA-7284 high dose, once daily for 24 weeks
|
Placebo
n=93 Participants
TA-7284 Placebo, once daily for 24 weeks
|
|---|---|---|---|
|
Change in Hemoglobin A1c (A1C) From Baseline (NGSP Value)
|
-0.74 percent HbA1C
Standard Error 0.07
|
-0.76 percent HbA1C
Standard Error 0.07
|
0.29 percent HbA1C
Standard Error 0.07
|
SECONDARY outcome
Timeframe: Week 24Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Week 24Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Week 24Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Week 24Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Week 24Outcome measures
Outcome data not reported
Adverse Events
TA-7284 Low
Serious events: 1 serious events
Other events: 59 other events
Deaths: 0 deaths
TA-7284 High
Serious events: 1 serious events
Other events: 55 other events
Deaths: 0 deaths
Placebo
Serious events: 2 serious events
Other events: 54 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
TA-7284 Low
n=90 participants at risk
TA-7284 low dose, once daily for 24 weeks
|
TA-7284 High
n=89 participants at risk
TA-7284 high dose, once daily for 24 weeks
|
Placebo
n=93 participants at risk
TA-7284 Placebo, once daily for 24 weeks
|
|---|---|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
1.1%
1/90 • 26 weeks
|
0.00%
0/89 • 26 weeks
|
0.00%
0/93 • 26 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric cancer
|
0.00%
0/90 • 26 weeks
|
0.00%
0/89 • 26 weeks
|
1.1%
1/93 • 26 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatic neoplasm malignant
|
0.00%
0/90 • 26 weeks
|
0.00%
0/89 • 26 weeks
|
1.1%
1/93 • 26 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oropharyngeal cancer stage unspecified
|
0.00%
0/90 • 26 weeks
|
1.1%
1/89 • 26 weeks
|
0.00%
0/93 • 26 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.00%
0/90 • 26 weeks
|
0.00%
0/89 • 26 weeks
|
1.1%
1/93 • 26 weeks
|
Other adverse events
| Measure |
TA-7284 Low
n=90 participants at risk
TA-7284 low dose, once daily for 24 weeks
|
TA-7284 High
n=89 participants at risk
TA-7284 high dose, once daily for 24 weeks
|
Placebo
n=93 participants at risk
TA-7284 Placebo, once daily for 24 weeks
|
|---|---|---|---|
|
Gastrointestinal disorders
Abdominal discomfort
|
3.3%
3/90 • 26 weeks
|
0.00%
0/89 • 26 weeks
|
0.00%
0/93 • 26 weeks
|
|
Gastrointestinal disorders
Abdominal distension
|
1.1%
1/90 • 26 weeks
|
0.00%
0/89 • 26 weeks
|
0.00%
0/93 • 26 weeks
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/90 • 26 weeks
|
1.1%
1/89 • 26 weeks
|
0.00%
0/93 • 26 weeks
|
|
Infections and infestations
Acute tonsillitis
|
1.1%
1/90 • 26 weeks
|
0.00%
0/89 • 26 weeks
|
0.00%
0/93 • 26 weeks
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/90 • 26 weeks
|
0.00%
0/89 • 26 weeks
|
2.2%
2/93 • 26 weeks
|
|
Skin and subcutaneous tissue disorders
Asteatosis
|
1.1%
1/90 • 26 weeks
|
0.00%
0/89 • 26 weeks
|
0.00%
0/93 • 26 weeks
|
|
General disorders
Asthenia
|
0.00%
0/90 • 26 weeks
|
1.1%
1/89 • 26 weeks
|
0.00%
0/93 • 26 weeks
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
2.2%
2/90 • 26 weeks
|
2.2%
2/89 • 26 weeks
|
1.1%
1/93 • 26 weeks
|
|
Infections and infestations
Bacteriuria
|
1.1%
1/90 • 26 weeks
|
0.00%
0/89 • 26 weeks
|
0.00%
0/93 • 26 weeks
|
|
Reproductive system and breast disorders
Balanoposthitis
|
0.00%
0/90 • 26 weeks
|
0.00%
0/89 • 26 weeks
|
1.1%
1/93 • 26 weeks
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
1.1%
1/90 • 26 weeks
|
0.00%
0/89 • 26 weeks
|
0.00%
0/93 • 26 weeks
|
|
Skin and subcutaneous tissue disorders
Blister
|
1.1%
1/90 • 26 weeks
|
0.00%
0/89 • 26 weeks
|
0.00%
0/93 • 26 weeks
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/90 • 26 weeks
|
0.00%
0/89 • 26 weeks
|
2.2%
2/93 • 26 weeks
|
|
Investigations
Blood creatinine increased
|
1.1%
1/90 • 26 weeks
|
0.00%
0/89 • 26 weeks
|
0.00%
0/93 • 26 weeks
|
|
Investigations
Blood ketone body increased
|
3.3%
3/90 • 26 weeks
|
7.9%
7/89 • 26 weeks
|
2.2%
2/93 • 26 weeks
|
|
Investigations
Blood parathyroid hormone increased
|
0.00%
0/90 • 26 weeks
|
1.1%
1/89 • 26 weeks
|
0.00%
0/93 • 26 weeks
|
|
Investigations
Blood pressure increased
|
0.00%
0/90 • 26 weeks
|
2.2%
2/89 • 26 weeks
|
4.3%
4/93 • 26 weeks
|
|
Investigations
Blood triglycerides increased
|
0.00%
0/90 • 26 weeks
|
0.00%
0/89 • 26 weeks
|
2.2%
2/93 • 26 weeks
|
|
Investigations
Blood uric acid increased
|
0.00%
0/90 • 26 weeks
|
0.00%
0/89 • 26 weeks
|
1.1%
1/93 • 26 weeks
|
|
Investigations
Blood urine present
|
3.3%
3/90 • 26 weeks
|
1.1%
1/89 • 26 weeks
|
0.00%
0/93 • 26 weeks
|
|
Infections and infestations
Bronchitis
|
0.00%
0/90 • 26 weeks
|
0.00%
0/89 • 26 weeks
|
1.1%
1/93 • 26 weeks
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
1.1%
1/90 • 26 weeks
|
0.00%
0/89 • 26 weeks
|
0.00%
0/93 • 26 weeks
|
|
Reproductive system and breast disorders
Cervical dysplasia
|
0.00%
0/90 • 26 weeks
|
1.1%
1/89 • 26 weeks
|
0.00%
0/93 • 26 weeks
|
|
Nervous system disorders
Cervicobrachial syndrome
|
1.1%
1/90 • 26 weeks
|
0.00%
0/89 • 26 weeks
|
0.00%
0/93 • 26 weeks
|
|
General disorders
Chest discomfort
|
1.1%
1/90 • 26 weeks
|
0.00%
0/89 • 26 weeks
|
0.00%
0/93 • 26 weeks
|
|
Infections and infestations
Chronic sinusitis
|
1.1%
1/90 • 26 weeks
|
0.00%
0/89 • 26 weeks
|
0.00%
0/93 • 26 weeks
|
|
Gastrointestinal disorders
Colonic polyp
|
0.00%
0/90 • 26 weeks
|
0.00%
0/89 • 26 weeks
|
1.1%
1/93 • 26 weeks
|
|
Eye disorders
Conjunctivitis allergic
|
0.00%
0/90 • 26 weeks
|
0.00%
0/89 • 26 weeks
|
1.1%
1/93 • 26 weeks
|
|
Gastrointestinal disorders
Constipation
|
1.1%
1/90 • 26 weeks
|
4.5%
4/89 • 26 weeks
|
1.1%
1/93 • 26 weeks
|
|
Injury, poisoning and procedural complications
Contusion
|
2.2%
2/90 • 26 weeks
|
4.5%
4/89 • 26 weeks
|
2.2%
2/93 • 26 weeks
|
|
Infections and infestations
Cystitis
|
0.00%
0/90 • 26 weeks
|
1.1%
1/89 • 26 weeks
|
1.1%
1/93 • 26 weeks
|
|
Gastrointestinal disorders
Dental caries
|
2.2%
2/90 • 26 weeks
|
1.1%
1/89 • 26 weeks
|
0.00%
0/93 • 26 weeks
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
1.1%
1/90 • 26 weeks
|
0.00%
0/89 • 26 weeks
|
1.1%
1/93 • 26 weeks
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
0.00%
0/90 • 26 weeks
|
0.00%
0/89 • 26 weeks
|
2.2%
2/93 • 26 weeks
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
2.2%
2/90 • 26 weeks
|
0.00%
0/89 • 26 weeks
|
1.1%
1/93 • 26 weeks
|
|
Gastrointestinal disorders
Diarrhoea
|
1.1%
1/90 • 26 weeks
|
1.1%
1/89 • 26 weeks
|
0.00%
0/93 • 26 weeks
|
|
Eye disorders
Diplopia
|
0.00%
0/90 • 26 weeks
|
0.00%
0/89 • 26 weeks
|
1.1%
1/93 • 26 weeks
|
|
Nervous system disorders
Dizziness
|
0.00%
0/90 • 26 weeks
|
0.00%
0/89 • 26 weeks
|
1.1%
1/93 • 26 weeks
|
|
Nervous system disorders
Dizziness postural
|
1.1%
1/90 • 26 weeks
|
0.00%
0/89 • 26 weeks
|
1.1%
1/93 • 26 weeks
|
|
Eye disorders
Dry eye
|
1.1%
1/90 • 26 weeks
|
1.1%
1/89 • 26 weeks
|
0.00%
0/93 • 26 weeks
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/90 • 26 weeks
|
1.1%
1/89 • 26 weeks
|
0.00%
0/93 • 26 weeks
|
|
Skin and subcutaneous tissue disorders
Eczema
|
1.1%
1/90 • 26 weeks
|
3.4%
3/89 • 26 weeks
|
1.1%
1/93 • 26 weeks
|
|
Skin and subcutaneous tissue disorders
Eczema asteatotic
|
0.00%
0/90 • 26 weeks
|
1.1%
1/89 • 26 weeks
|
2.2%
2/93 • 26 weeks
|
|
Infections and infestations
Enteritis infectious
|
0.00%
0/90 • 26 weeks
|
1.1%
1/89 • 26 weeks
|
1.1%
1/93 • 26 weeks
|
|
Gastrointestinal disorders
Enterocolitis
|
2.2%
2/90 • 26 weeks
|
0.00%
0/89 • 26 weeks
|
0.00%
0/93 • 26 weeks
|
|
Injury, poisoning and procedural complications
Excoriation
|
0.00%
0/90 • 26 weeks
|
1.1%
1/89 • 26 weeks
|
0.00%
0/93 • 26 weeks
|
|
Injury, poisoning and procedural complications
Face injury
|
0.00%
0/90 • 26 weeks
|
1.1%
1/89 • 26 weeks
|
0.00%
0/93 • 26 weeks
|
|
Musculoskeletal and connective tissue disorders
Fasciitis
|
0.00%
0/90 • 26 weeks
|
1.1%
1/89 • 26 weeks
|
0.00%
0/93 • 26 weeks
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/90 • 26 weeks
|
0.00%
0/89 • 26 weeks
|
1.1%
1/93 • 26 weeks
|
|
Infections and infestations
Folliculitis
|
1.1%
1/90 • 26 weeks
|
1.1%
1/89 • 26 weeks
|
0.00%
0/93 • 26 weeks
|
|
Injury, poisoning and procedural complications
Forearm fracture
|
0.00%
0/90 • 26 weeks
|
0.00%
0/89 • 26 weeks
|
1.1%
1/93 • 26 weeks
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.00%
0/90 • 26 weeks
|
1.1%
1/89 • 26 weeks
|
0.00%
0/93 • 26 weeks
|
|
Gastrointestinal disorders
Gastric ulcer
|
1.1%
1/90 • 26 weeks
|
0.00%
0/89 • 26 weeks
|
0.00%
0/93 • 26 weeks
|
|
Gastrointestinal disorders
Gastritis
|
2.2%
2/90 • 26 weeks
|
1.1%
1/89 • 26 weeks
|
3.2%
3/93 • 26 weeks
|
|
Gastrointestinal disorders
Gastritis atrophic
|
1.1%
1/90 • 26 weeks
|
1.1%
1/89 • 26 weeks
|
1.1%
1/93 • 26 weeks
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/90 • 26 weeks
|
1.1%
1/89 • 26 weeks
|
0.00%
0/93 • 26 weeks
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
1.1%
1/90 • 26 weeks
|
1.1%
1/89 • 26 weeks
|
1.1%
1/93 • 26 weeks
|
|
Gastrointestinal disorders
Gingivitis
|
2.2%
2/90 • 26 weeks
|
1.1%
1/89 • 26 weeks
|
0.00%
0/93 • 26 weeks
|
|
Metabolism and nutrition disorders
Gout
|
0.00%
0/90 • 26 weeks
|
1.1%
1/89 • 26 weeks
|
0.00%
0/93 • 26 weeks
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/90 • 26 weeks
|
1.1%
1/89 • 26 weeks
|
0.00%
0/93 • 26 weeks
|
|
General disorders
Hangover
|
0.00%
0/90 • 26 weeks
|
0.00%
0/89 • 26 weeks
|
1.1%
1/93 • 26 weeks
|
|
Nervous system disorders
Headache
|
1.1%
1/90 • 26 weeks
|
1.1%
1/89 • 26 weeks
|
0.00%
0/93 • 26 weeks
|
|
Skin and subcutaneous tissue disorders
Heat rash
|
0.00%
0/90 • 26 weeks
|
0.00%
0/89 • 26 weeks
|
1.1%
1/93 • 26 weeks
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
0.00%
0/90 • 26 weeks
|
0.00%
0/89 • 26 weeks
|
1.1%
1/93 • 26 weeks
|
|
Infections and infestations
Herpes virus infection
|
1.1%
1/90 • 26 weeks
|
0.00%
0/89 • 26 weeks
|
0.00%
0/93 • 26 weeks
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/90 • 26 weeks
|
1.1%
1/89 • 26 weeks
|
0.00%
0/93 • 26 weeks
|
|
Infections and infestations
Hordeolum
|
1.1%
1/90 • 26 weeks
|
0.00%
0/89 • 26 weeks
|
0.00%
0/93 • 26 weeks
|
|
Vascular disorders
Hot flush
|
1.1%
1/90 • 26 weeks
|
0.00%
0/89 • 26 weeks
|
0.00%
0/93 • 26 weeks
|
|
General disorders
Hunger
|
1.1%
1/90 • 26 weeks
|
1.1%
1/89 • 26 weeks
|
0.00%
0/93 • 26 weeks
|
|
Vascular disorders
Hypertension
|
0.00%
0/90 • 26 weeks
|
0.00%
0/89 • 26 weeks
|
3.2%
3/93 • 26 weeks
|
|
Nervous system disorders
Hypoaesthesia
|
1.1%
1/90 • 26 weeks
|
0.00%
0/89 • 26 weeks
|
2.2%
2/93 • 26 weeks
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
2.2%
2/90 • 26 weeks
|
1.1%
1/89 • 26 weeks
|
2.2%
2/93 • 26 weeks
|
|
Metabolism and nutrition disorders
Hypoglycaemia unawareness
|
4.4%
4/90 • 26 weeks
|
5.6%
5/89 • 26 weeks
|
2.2%
2/93 • 26 weeks
|
|
Infections and infestations
Influenza
|
3.3%
3/90 • 26 weeks
|
0.00%
0/89 • 26 weeks
|
2.2%
2/93 • 26 weeks
|
|
Injury, poisoning and procedural complications
Injury corneal
|
1.1%
1/90 • 26 weeks
|
0.00%
0/89 • 26 weeks
|
0.00%
0/93 • 26 weeks
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
2.2%
2/90 • 26 weeks
|
0.00%
0/89 • 26 weeks
|
0.00%
0/93 • 26 weeks
|
|
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis
|
1.1%
1/90 • 26 weeks
|
1.1%
1/89 • 26 weeks
|
1.1%
1/93 • 26 weeks
|
|
Nervous system disorders
Migraine
|
0.00%
0/90 • 26 weeks
|
1.1%
1/89 • 26 weeks
|
0.00%
0/93 • 26 weeks
|
|
Injury, poisoning and procedural complications
Mouth injury
|
0.00%
0/90 • 26 weeks
|
1.1%
1/89 • 26 weeks
|
0.00%
0/93 • 26 weeks
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
1.1%
1/90 • 26 weeks
|
0.00%
0/89 • 26 weeks
|
0.00%
0/93 • 26 weeks
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
2.2%
2/90 • 26 weeks
|
0.00%
0/89 • 26 weeks
|
1.1%
1/93 • 26 weeks
|
|
Musculoskeletal and connective tissue disorders
Myofascial pain syndrome
|
1.1%
1/90 • 26 weeks
|
0.00%
0/89 • 26 weeks
|
0.00%
0/93 • 26 weeks
|
|
Infections and infestations
Nasopharyngitis
|
21.1%
19/90 • 26 weeks
|
18.0%
16/89 • 26 weeks
|
29.0%
27/93 • 26 weeks
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/90 • 26 weeks
|
1.1%
1/89 • 26 weeks
|
0.00%
0/93 • 26 weeks
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
1.1%
1/90 • 26 weeks
|
0.00%
0/89 • 26 weeks
|
0.00%
0/93 • 26 weeks
|
|
Renal and urinary disorders
Nephropathy
|
1.1%
1/90 • 26 weeks
|
0.00%
0/89 • 26 weeks
|
0.00%
0/93 • 26 weeks
|
|
Infections and infestations
Oral herpes
|
0.00%
0/90 • 26 weeks
|
0.00%
0/89 • 26 weeks
|
1.1%
1/93 • 26 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
1.1%
1/90 • 26 weeks
|
0.00%
0/89 • 26 weeks
|
0.00%
0/93 • 26 weeks
|
|
Vascular disorders
Orthostatic hypotension
|
0.00%
0/90 • 26 weeks
|
1.1%
1/89 • 26 weeks
|
0.00%
0/93 • 26 weeks
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/90 • 26 weeks
|
1.1%
1/89 • 26 weeks
|
2.2%
2/93 • 26 weeks
|
|
Cardiac disorders
Palpitations
|
1.1%
1/90 • 26 weeks
|
0.00%
0/89 • 26 weeks
|
1.1%
1/93 • 26 weeks
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.00%
0/90 • 26 weeks
|
0.00%
0/89 • 26 weeks
|
1.1%
1/93 • 26 weeks
|
|
Musculoskeletal and connective tissue disorders
Periarthritis
|
1.1%
1/90 • 26 weeks
|
2.2%
2/89 • 26 weeks
|
1.1%
1/93 • 26 weeks
|
|
Gastrointestinal disorders
Periodontal disease
|
0.00%
0/90 • 26 weeks
|
1.1%
1/89 • 26 weeks
|
1.1%
1/93 • 26 weeks
|
|
Gastrointestinal disorders
Periodontitis
|
3.3%
3/90 • 26 weeks
|
3.4%
3/89 • 26 weeks
|
1.1%
1/93 • 26 weeks
|
|
Infections and infestations
Pharyngitis
|
6.7%
6/90 • 26 weeks
|
1.1%
1/89 • 26 weeks
|
1.1%
1/93 • 26 weeks
|
|
Infections and infestations
Pharyngitis bacterial
|
1.1%
1/90 • 26 weeks
|
0.00%
0/89 • 26 weeks
|
0.00%
0/93 • 26 weeks
|
|
Renal and urinary disorders
Pollakiuria
|
4.4%
4/90 • 26 weeks
|
1.1%
1/89 • 26 weeks
|
1.1%
1/93 • 26 weeks
|
|
Blood and lymphatic system disorders
Polycythaemia
|
0.00%
0/90 • 26 weeks
|
1.1%
1/89 • 26 weeks
|
0.00%
0/93 • 26 weeks
|
|
Nervous system disorders
Post herpetic neuralgia
|
0.00%
0/90 • 26 weeks
|
1.1%
1/89 • 26 weeks
|
0.00%
0/93 • 26 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary fibrosis
|
0.00%
0/90 • 26 weeks
|
1.1%
1/89 • 26 weeks
|
0.00%
0/93 • 26 weeks
|
|
Infections and infestations
Pulpitis dental
|
0.00%
0/90 • 26 weeks
|
2.2%
2/89 • 26 weeks
|
1.1%
1/93 • 26 weeks
|
|
Eye disorders
Punctate keratitis
|
0.00%
0/90 • 26 weeks
|
1.1%
1/89 • 26 weeks
|
0.00%
0/93 • 26 weeks
|
|
Infections and infestations
Pyelonephritis
|
1.1%
1/90 • 26 weeks
|
0.00%
0/89 • 26 weeks
|
0.00%
0/93 • 26 weeks
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/90 • 26 weeks
|
1.1%
1/89 • 26 weeks
|
1.1%
1/93 • 26 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.00%
0/90 • 26 weeks
|
1.1%
1/89 • 26 weeks
|
2.2%
2/93 • 26 weeks
|
|
Nervous system disorders
Sciatica
|
0.00%
0/90 • 26 weeks
|
1.1%
1/89 • 26 weeks
|
0.00%
0/93 • 26 weeks
|
|
Skin and subcutaneous tissue disorders
Seborrhoeic dermatitis
|
1.1%
1/90 • 26 weeks
|
0.00%
0/89 • 26 weeks
|
0.00%
0/93 • 26 weeks
|
|
Injury, poisoning and procedural complications
Skeletal injury
|
0.00%
0/90 • 26 weeks
|
1.1%
1/89 • 26 weeks
|
0.00%
0/93 • 26 weeks
|
|
Skin and subcutaneous tissue disorders
Skin fissures
|
1.1%
1/90 • 26 weeks
|
0.00%
0/89 • 26 weeks
|
0.00%
0/93 • 26 weeks
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.00%
0/90 • 26 weeks
|
0.00%
0/89 • 26 weeks
|
1.1%
1/93 • 26 weeks
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
0.00%
0/90 • 26 weeks
|
0.00%
0/89 • 26 weeks
|
1.1%
1/93 • 26 weeks
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/90 • 26 weeks
|
1.1%
1/89 • 26 weeks
|
1.1%
1/93 • 26 weeks
|
|
Musculoskeletal and connective tissue disorders
Tenosynovitis
|
0.00%
0/90 • 26 weeks
|
0.00%
0/89 • 26 weeks
|
1.1%
1/93 • 26 weeks
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.00%
0/90 • 26 weeks
|
1.1%
1/89 • 26 weeks
|
0.00%
0/93 • 26 weeks
|
|
General disorders
Thirst
|
0.00%
0/90 • 26 weeks
|
0.00%
0/89 • 26 weeks
|
1.1%
1/93 • 26 weeks
|
|
Infections and infestations
Tinea pedis
|
1.1%
1/90 • 26 weeks
|
0.00%
0/89 • 26 weeks
|
0.00%
0/93 • 26 weeks
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/90 • 26 weeks
|
1.1%
1/89 • 26 weeks
|
1.1%
1/93 • 26 weeks
|
|
Skin and subcutaneous tissue disorders
Toxic skin eruption
|
0.00%
0/90 • 26 weeks
|
1.1%
1/89 • 26 weeks
|
0.00%
0/93 • 26 weeks
|
|
Musculoskeletal and connective tissue disorders
Trigger finger
|
1.1%
1/90 • 26 weeks
|
0.00%
0/89 • 26 weeks
|
0.00%
0/93 • 26 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract inflammation
|
3.3%
3/90 • 26 weeks
|
2.2%
2/89 • 26 weeks
|
1.1%
1/93 • 26 weeks
|
|
Renal and urinary disorders
Urinary retention
|
1.1%
1/90 • 26 weeks
|
0.00%
0/89 • 26 weeks
|
0.00%
0/93 • 26 weeks
|
|
Investigations
Urine albumin/creatinine ratio increased
|
0.00%
0/90 • 26 weeks
|
1.1%
1/89 • 26 weeks
|
1.1%
1/93 • 26 weeks
|
|
Investigations
Urine ketone body present
|
1.1%
1/90 • 26 weeks
|
3.4%
3/89 • 26 weeks
|
0.00%
0/93 • 26 weeks
|
|
Investigations
Urine output increased
|
1.1%
1/90 • 26 weeks
|
1.1%
1/89 • 26 weeks
|
0.00%
0/93 • 26 weeks
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/90 • 26 weeks
|
2.2%
2/89 • 26 weeks
|
0.00%
0/93 • 26 weeks
|
|
Infections and infestations
Vulvitis
|
1.1%
1/90 • 26 weeks
|
0.00%
0/89 • 26 weeks
|
0.00%
0/93 • 26 weeks
|
|
Infections and infestations
Vulvovaginal candidiasis
|
0.00%
0/90 • 26 weeks
|
1.1%
1/89 • 26 weeks
|
0.00%
0/93 • 26 weeks
|
|
Infections and infestations
Vulvovaginal mycotic infection
|
1.1%
1/90 • 26 weeks
|
0.00%
0/89 • 26 weeks
|
0.00%
0/93 • 26 weeks
|
|
Investigations
Weight decreased
|
2.2%
2/90 • 26 weeks
|
0.00%
0/89 • 26 weeks
|
0.00%
0/93 • 26 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER