Trial Outcomes & Findings for Long-Term Safety Study of TA-7284 in Patients With Type 2 Diabetes Mellitus (NCT NCT01387737)
NCT ID: NCT01387737
Last Updated: 2026-01-08
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
1299 participants
Primary outcome timeframe
54 weeks
Results posted on
2026-01-08
Participant Flow
Participant milestones
| Measure |
TA-7284-Low
TA-7284 low dose, once daily for 52 weeks
|
TA-7284-High
TA-7284 high dose, once daily for 52 weeks
|
|---|---|---|
|
Overall Study
STARTED
|
584
|
715
|
|
Overall Study
COMPLETED
|
532
|
641
|
|
Overall Study
NOT COMPLETED
|
52
|
74
|
Reasons for withdrawal
| Measure |
TA-7284-Low
TA-7284 low dose, once daily for 52 weeks
|
TA-7284-High
TA-7284 high dose, once daily for 52 weeks
|
|---|---|---|
|
Overall Study
Adverse Event
|
20
|
30
|
|
Overall Study
Lack of Efficacy
|
1
|
0
|
|
Overall Study
Physician Decision
|
3
|
10
|
|
Overall Study
Withdrawal by Subject
|
27
|
31
|
|
Overall Study
Clearly not eligible for the study
|
1
|
3
|
Baseline Characteristics
Long-Term Safety Study of TA-7284 in Patients With Type 2 Diabetes Mellitus
Baseline characteristics by cohort
| Measure |
TA-7284-Low
n=584 Participants
TA-7284 low dose, once daily for 52 weeks
|
TA-7284-High
n=715 Participants
TA-7284 high dose, once daily for 52 weeks
|
Total
n=1299 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=18 Participants
|
0 Participants
n=17 Participants
|
0 Participants
n=35 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
436 Participants
n=18 Participants
|
520 Participants
n=17 Participants
|
956 Participants
n=35 Participants
|
|
Age, Categorical
>=65 years
|
148 Participants
n=18 Participants
|
195 Participants
n=17 Participants
|
343 Participants
n=35 Participants
|
|
Sex: Female, Male
Female
|
163 Participants
n=18 Participants
|
212 Participants
n=17 Participants
|
375 Participants
n=35 Participants
|
|
Sex: Female, Male
Male
|
421 Participants
n=18 Participants
|
503 Participants
n=17 Participants
|
924 Participants
n=35 Participants
|
PRIMARY outcome
Timeframe: 54 weeksOutcome measures
| Measure |
TA-7284-Low
n=584 Participants
TA-7284 low dose, once daily for 52 weeks
|
TA-7284-High
n=715 Participants
TA-7284 high dose, once daily for 52 weeks
|
|---|---|---|
|
Safety and Tolerability Assessed by Adverse Events, Hypoglycemic Events
adverse events
|
81.8 percentage of incidences
|
82.8 percentage of incidences
|
|
Safety and Tolerability Assessed by Adverse Events, Hypoglycemic Events
hypoglycemia
|
14.9 percentage of incidences
|
13.3 percentage of incidences
|
SECONDARY outcome
Timeframe: Week 52Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Week 52Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Week 52Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Week 52Outcome measures
Outcome data not reported
Adverse Events
TA-7284-Low
Serious events: 30 serious events
Other events: 371 other events
Deaths: 0 deaths
TA-7284-High
Serious events: 32 serious events
Other events: 464 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
TA-7284-Low
n=584 participants at risk
TA-7284 low dose, once daily for 52 weeks
|
TA-7284-High
n=715 participants at risk
TA-7284 high dose, once daily for 52 weeks
|
|---|---|---|
|
Infections and infestations
Appendicitis
|
0.17%
1/584 • Week 52
|
0.28%
2/715 • Week 52
|
|
Infections and infestations
Chronic sinusitis
|
0.00%
0/584 • Week 52
|
0.14%
1/715 • Week 52
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/584 • Week 52
|
0.14%
1/715 • Week 52
|
|
Infections and infestations
Epiglottitis
|
0.17%
1/584 • Week 52
|
0.00%
0/715 • Week 52
|
|
Infections and infestations
Gastroenteritis
|
0.17%
1/584 • Week 52
|
0.00%
0/715 • Week 52
|
|
Infections and infestations
Genital herpes
|
0.17%
1/584 • Week 52
|
0.00%
0/715 • Week 52
|
|
Infections and infestations
Lung abscess
|
0.00%
0/584 • Week 52
|
0.14%
1/715 • Week 52
|
|
Infections and infestations
Pharyngitis
|
0.17%
1/584 • Week 52
|
0.00%
0/715 • Week 52
|
|
Infections and infestations
Pneumonia
|
0.00%
0/584 • Week 52
|
0.14%
1/715 • Week 52
|
|
Infections and infestations
Streptococcal sepsis
|
0.00%
0/584 • Week 52
|
0.14%
1/715 • Week 52
|
|
Infections and infestations
Vestibular neuronitis
|
0.00%
0/584 • Week 52
|
0.14%
1/715 • Week 52
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bile duct cancer
|
0.17%
1/584 • Week 52
|
0.00%
0/715 • Week 52
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.17%
1/584 • Week 52
|
0.00%
0/715 • Week 52
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon adenoma
|
0.00%
0/584 • Week 52
|
0.14%
1/715 • Week 52
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.17%
1/584 • Week 52
|
0.14%
1/715 • Week 52
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Extranodal marginal zone B-cell lymphoma (MALT type)
|
0.17%
1/584 • Week 52
|
0.00%
0/715 • Week 52
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric cancer
|
0.17%
1/584 • Week 52
|
0.14%
1/715 • Week 52
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastrooesophageal cancer
|
0.00%
0/584 • Week 52
|
0.14%
1/715 • Week 52
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatic neoplasm malignant
|
0.00%
0/584 • Week 52
|
0.14%
1/715 • Week 52
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Large intestine carcinoma
|
0.00%
0/584 • Week 52
|
0.28%
2/715 • Week 52
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma
|
0.00%
0/584 • Week 52
|
0.14%
1/715 • Week 52
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal cancer
|
0.17%
1/584 • Week 52
|
0.00%
0/715 • Week 52
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Seminoma
|
0.17%
1/584 • Week 52
|
0.00%
0/715 • Week 52
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Vocal cord neoplasm
|
0.17%
1/584 • Week 52
|
0.00%
0/715 • Week 52
|
|
Endocrine disorders
Thyroiditis subacute
|
0.00%
0/584 • Week 52
|
0.14%
1/715 • Week 52
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.17%
1/584 • Week 52
|
0.00%
0/715 • Week 52
|
|
Nervous system disorders
Cerebral infarction
|
0.00%
0/584 • Week 52
|
0.14%
1/715 • Week 52
|
|
Nervous system disorders
Lacunar infarction
|
0.17%
1/584 • Week 52
|
0.00%
0/715 • Week 52
|
|
Nervous system disorders
Loss of consciousness
|
0.17%
1/584 • Week 52
|
0.00%
0/715 • Week 52
|
|
Nervous system disorders
Myelopathy
|
0.00%
0/584 • Week 52
|
0.14%
1/715 • Week 52
|
|
Cardiac disorders
Acute myocardial infarction
|
0.17%
1/584 • Week 52
|
0.14%
1/715 • Week 52
|
|
Cardiac disorders
Angina pectoris
|
0.17%
1/584 • Week 52
|
0.00%
0/715 • Week 52
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/584 • Week 52
|
0.14%
1/715 • Week 52
|
|
Cardiac disorders
Myocardial ischaemia
|
0.17%
1/584 • Week 52
|
0.14%
1/715 • Week 52
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/584 • Week 52
|
0.14%
1/715 • Week 52
|
|
Gastrointestinal disorders
Autoimmune pancreatitis
|
0.00%
0/584 • Week 52
|
0.14%
1/715 • Week 52
|
|
Gastrointestinal disorders
Colonic polyp
|
0.51%
3/584 • Week 52
|
0.14%
1/715 • Week 52
|
|
Hepatobiliary disorders
Bile duct stone
|
0.17%
1/584 • Week 52
|
0.00%
0/715 • Week 52
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.00%
0/584 • Week 52
|
0.14%
1/715 • Week 52
|
|
Skin and subcutaneous tissue disorders
Dermal cyst
|
0.00%
0/584 • Week 52
|
0.14%
1/715 • Week 52
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/584 • Week 52
|
0.14%
1/715 • Week 52
|
|
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis
|
0.00%
0/584 • Week 52
|
0.14%
1/715 • Week 52
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.17%
1/584 • Week 52
|
0.14%
1/715 • Week 52
|
|
Musculoskeletal and connective tissue disorders
Spondylolisthesis
|
0.00%
0/584 • Week 52
|
0.14%
1/715 • Week 52
|
|
Renal and urinary disorders
Calculus ureteric
|
0.17%
1/584 • Week 52
|
0.00%
0/715 • Week 52
|
|
Renal and urinary disorders
Urethral meatus stenosis
|
0.17%
1/584 • Week 52
|
0.00%
0/715 • Week 52
|
|
Reproductive system and breast disorders
Acquired hydrocele
|
0.17%
1/584 • Week 52
|
0.00%
0/715 • Week 52
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.17%
1/584 • Week 52
|
0.00%
0/715 • Week 52
|
|
Reproductive system and breast disorders
Cervical dysplasia
|
0.00%
0/584 • Week 52
|
0.14%
1/715 • Week 52
|
|
General disorders
Mass
|
0.17%
1/584 • Week 52
|
0.00%
0/715 • Week 52
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.00%
0/584 • Week 52
|
0.28%
2/715 • Week 52
|
|
Injury, poisoning and procedural complications
Heat illness
|
0.17%
1/584 • Week 52
|
0.00%
0/715 • Week 52
|
|
Injury, poisoning and procedural complications
Ligament injury
|
0.17%
1/584 • Week 52
|
0.00%
0/715 • Week 52
|
|
Injury, poisoning and procedural complications
Limb traumatic amputation
|
0.00%
0/584 • Week 52
|
0.14%
1/715 • Week 52
|
|
Injury, poisoning and procedural complications
Meniscus lesion
|
0.17%
1/584 • Week 52
|
0.14%
1/715 • Week 52
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.00%
0/584 • Week 52
|
0.14%
1/715 • Week 52
|
|
Surgical and medical procedures
Suture removal
|
0.17%
1/584 • Week 52
|
0.00%
0/715 • Week 52
|
Other adverse events
| Measure |
TA-7284-Low
n=584 participants at risk
TA-7284 low dose, once daily for 52 weeks
|
TA-7284-High
n=715 participants at risk
TA-7284 high dose, once daily for 52 weeks
|
|---|---|---|
|
Infections and infestations
Bronchitis
|
3.9%
23/584 • Week 52
|
4.1%
29/715 • Week 52
|
|
Infections and infestations
Cystitis
|
2.6%
15/584 • Week 52
|
1.8%
13/715 • Week 52
|
|
Infections and infestations
Gastroenteritis
|
2.4%
14/584 • Week 52
|
3.1%
22/715 • Week 52
|
|
Infections and infestations
Influenza
|
2.2%
13/584 • Week 52
|
1.4%
10/715 • Week 52
|
|
Infections and infestations
Nasopharyngitis
|
30.1%
176/584 • Week 52
|
31.2%
223/715 • Week 52
|
|
Infections and infestations
Periodontitis
|
1.4%
8/584 • Week 52
|
2.4%
17/715 • Week 52
|
|
Infections and infestations
Pharyngitis
|
5.1%
30/584 • Week 52
|
5.2%
37/715 • Week 52
|
|
Infections and infestations
Vulvovaginal candidiasis
|
1.9%
11/584 • Week 52
|
2.4%
17/715 • Week 52
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
7.5%
44/584 • Week 52
|
6.2%
44/715 • Week 52
|
|
Metabolism and nutrition disorders
Hypoglycaemia unawareness
|
9.2%
54/584 • Week 52
|
9.2%
66/715 • Week 52
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract inflammation
|
7.5%
44/584 • Week 52
|
8.3%
59/715 • Week 52
|
|
Gastrointestinal disorders
Constipation
|
4.8%
28/584 • Week 52
|
5.6%
40/715 • Week 52
|
|
Gastrointestinal disorders
Dental caries
|
2.4%
14/584 • Week 52
|
3.4%
24/715 • Week 52
|
|
Gastrointestinal disorders
Diarrhoea
|
2.1%
12/584 • Week 52
|
3.4%
24/715 • Week 52
|
|
Gastrointestinal disorders
Gastritis
|
2.7%
16/584 • Week 52
|
1.8%
13/715 • Week 52
|
|
Skin and subcutaneous tissue disorders
Eczema
|
5.0%
29/584 • Week 52
|
3.4%
24/715 • Week 52
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
2.7%
16/584 • Week 52
|
4.6%
33/715 • Week 52
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.68%
4/584 • Week 52
|
2.1%
15/715 • Week 52
|
|
Renal and urinary disorders
Pollakiuria
|
4.1%
24/584 • Week 52
|
4.1%
29/715 • Week 52
|
|
General disorders
Thirst
|
2.4%
14/584 • Week 52
|
2.4%
17/715 • Week 52
|
|
Investigations
Blood ketone body increased
|
2.1%
12/584 • Week 52
|
2.0%
14/715 • Week 52
|
|
Injury, poisoning and procedural complications
Contusion
|
3.3%
19/584 • Week 52
|
2.4%
17/715 • Week 52
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER