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The purpose of this study is to evaluate the safety and efficacy of TA-7284 as monotherapy or combination therapy with other oral anti-hyperglycaemic agent in Japanese patients with Type 2 diabetes mellitus on 52 weeks oral administration.
This is a randomized, 2-arm, parallel group, open-label study to evaluate the safety and efficacy of TA-7284 in Japanese patients with Type 2 diabetes mellitus, who are not optimally controlled on diet and exercise or with oral anti-hyperglycaemic agent. The patients will receive either TA-7284-Low or TA-7284-High orally alone or in combination with oral anit-hyperglycaemic agent for 52 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TA-7284-Low | Experimental |
| |
| TA-7284-High | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TA-7284-Low | Drug | TA-7284-Low |
| |
| TA-7284-High |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and Tolerability Assessed by Adverse Events, Hypoglycemic Events | 54 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in HbA1c | Week 52 | |
| Change in Fasting Plasma Glucose | Week 52 | |
| Change in Body Weight |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nobuya Inagaki, M.D. | Kyoto University, Graduate School of Medicine | Study Director |
| Kazuoki Kondo, M.D. | Tanabe Pharma Corporation | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research site | Chugoku | Japan | ||||
| Research site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26530268 | Derived | Inagaki N, Goda M, Yokota S, Maruyama N, Iijima H. Effects of Baseline Blood Pressure and Low-Density Lipoprotein Cholesterol on Safety and Efficacy of Canagliflozin in Japanese Patients with Type 2 Diabetes Mellitus. Adv Ther. 2015 Nov;32(11):1085-103. doi: 10.1007/s12325-015-0255-8. Epub 2015 Nov 3. | |
| 25802729 | Derived |
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| ID | Title | Description |
|---|---|---|
| FG000 | TA-7284-Low | TA-7284 low dose, once daily for 52 weeks |
| FG001 | TA-7284-High | TA-7284 high dose, once daily for 52 weeks |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | TA-7284-Low | TA-7284 low dose, once daily for 52 weeks |
| BG001 | TA-7284-High | TA-7284 high dose, once daily for 52 weeks |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Safety and Tolerability Assessed by Adverse Events, Hypoglycemic Events | Posted | Number | percentage of incidences | 54 weeks |
|
|
Week 52
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | TA-7284-Low | TA-7284 low dose, once daily for 52 weeks |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Appendicitis | Infections and infestations | MedDRA 15 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bronchitis | Infections and infestations | MedDRA 15 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Trials, Information Desk | Tanabe Pharma Corporation | cti-inq-ml.JP@ml.tanabe-pharma.com |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| Drug |
TA-7284-High |
|
| Week 52 |
| Change in Blood Pressure | Week 52 |
| Hokkaido |
| Japan |
| Research site | Kanto | Japan |
| Research site | Kinki | Japan |
| Research site | Kyushu | Japan |
| Research site | Shikoku | Japan |
| Research site | Tōhoku | Japan |
| Inagaki N, Kondo K, Yoshinari T, Kuki H. Efficacy and safety of canagliflozin alone or as add-on to other oral antihyperglycemic drugs in Japanese patients with type 2 diabetes: A 52-week open-label study. J Diabetes Investig. 2015 Mar;6(2):210-8. doi: 10.1111/jdi.12266. Epub 2014 Aug 25. |
| Physician Decision |
|
| Withdrawal by Subject |
|
| Clearly not eligible for the study |
|
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
| Secondary | Change in HbA1c | Not Posted | Week 52 | Participants |
| Secondary | Change in Fasting Plasma Glucose | Not Posted | Week 52 | Participants |
| Secondary | Change in Body Weight | Not Posted | Week 52 | Participants |
| Secondary | Change in Blood Pressure | Not Posted | Week 52 | Participants |
| 30 |
| 584 |
| 371 |
| 584 |
| EG001 | TA-7284-High | TA-7284 high dose, once daily for 52 weeks | 32 | 715 | 464 | 715 |
| Chronic sinusitis | Infections and infestations | MedDRA 15.1 |
|
| Diverticulitis | Infections and infestations | MedDRA 15.1 |
|
| Epiglottitis | Infections and infestations | MedDRA 15.1 |
|
| Gastroenteritis | Infections and infestations | MedDRA 15.1 |
|
| Genital herpes | Infections and infestations | MedDRA 15.1 |
|
| Lung abscess | Infections and infestations | MedDRA 15.1 |
|
| Pharyngitis | Infections and infestations | MedDRA 15.1 |
|
| Pneumonia | Infections and infestations | MedDRA 15.1 |
|
| Streptococcal sepsis | Infections and infestations | MedDRA 15.1 |
|
| Vestibular neuronitis | Infections and infestations | MedDRA 15.1 |
|
| Bile duct cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 |
|
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 |
|
| Colon adenoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 |
|
| Colon cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 |
|
| Extranodal marginal zone B-cell lymphoma (MALT type) | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 |
|
| Gastric cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 |
|
| Gastrooesophageal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 |
|
| Hepatic neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 |
|
| Large intestine carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 |
|
| Pancreatic carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 |
|
| Rectal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 |
|
| Seminoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 |
|
| Vocal cord neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 |
|
| Thyroiditis subacute | Endocrine disorders | MedDRA 15.1 |
|
| Diabetic ketoacidosis | Metabolism and nutrition disorders | MedDRA 15.1 |
|
| Cerebral infarction | Nervous system disorders | MedDRA 15.1 |
|
| Lacunar infarction | Nervous system disorders | MedDRA 15.1 |
|
| Loss of consciousness | Nervous system disorders | MedDRA 15.1 |
|
| Myelopathy | Nervous system disorders | MedDRA 15.1 |
|
| Acute myocardial infarction | Cardiac disorders | MedDRA 15.1 |
|
| Angina pectoris | Cardiac disorders | MedDRA 15.1 |
|
| Myocardial infarction | Cardiac disorders | MedDRA 15.1 |
|
| Myocardial ischaemia | Cardiac disorders | MedDRA 15.1 |
|
| Supraventricular tachycardia | Cardiac disorders | MedDRA 15.1 |
|
| Autoimmune pancreatitis | Gastrointestinal disorders | MedDRA 15.1 |
|
| Colonic polyp | Gastrointestinal disorders | MedDRA 15.1 |
|
| Bile duct stone | Hepatobiliary disorders | MedDRA 15.1 |
|
| Cholecystitis acute | Hepatobiliary disorders | MedDRA 15.1 |
|
| Dermal cyst | Skin and subcutaneous tissue disorders | MedDRA 15.1 |
|
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA 15 |
|
| Lumbar spinal stenosis | Musculoskeletal and connective tissue disorders | MedDRA 15.1 |
|
| Rotator cuff syndrome | Musculoskeletal and connective tissue disorders | MedDRA 15.1 |
|
| Spondylolisthesis | Musculoskeletal and connective tissue disorders | MedDRA 15.1 |
|
| Calculus ureteric | Renal and urinary disorders | MedDRA 15.1 |
|
| Urethral meatus stenosis | Renal and urinary disorders | MedDRA 15.1 |
|
| Acquired hydrocele | Reproductive system and breast disorders | MedDRA 15.1 |
|
| Benign prostatic hyperplasia | Reproductive system and breast disorders | MedDRA 15.1 |
|
| Cervical dysplasia | Reproductive system and breast disorders | MedDRA 15.1 |
|
| Mass | General disorders | MedDRA 15.1 |
|
| Ankle fracture | Injury, poisoning and procedural complications | MedDRA 15.1 |
|
| Heat illness | Injury, poisoning and procedural complications | MedDRA 15.1 |
|
| Ligament injury | Injury, poisoning and procedural complications | MedDRA 15.1 |
|
| Limb traumatic amputation | Injury, poisoning and procedural complications | MedDRA 15.1 |
|
| Meniscus lesion | Injury, poisoning and procedural complications | MedDRA 15.1 |
|
| Radius fracture | Injury, poisoning and procedural complications | MedDRA 15.1 |
|
| Suture removal | Surgical and medical procedures | MedDRA 15.1 |
|
| Cystitis | Infections and infestations | MedDRA 15.1 |
|
| Gastroenteritis | Infections and infestations | MedDRA 15.1 |
|
| Influenza | Infections and infestations | MedDRA 15.1 |
|
| Nasopharyngitis | Infections and infestations | MedDRA 15.1 |
|
| Periodontitis | Infections and infestations | MedDRA 15.1 |
|
| Pharyngitis | Infections and infestations | MedDRA 15.1 |
|
| Vulvovaginal candidiasis | Infections and infestations | MedDRA 15.1 |
|
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 15.1 |
|
| Hypoglycaemia unawareness | Metabolism and nutrition disorders | MedDRA 15.1 |
|
| Upper respiratory tract inflammation | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 |
|
| Constipation | Gastrointestinal disorders | MedDRA 15.1 |
|
| Dental caries | Gastrointestinal disorders | MedDRA 15.1 |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 15.1 |
|
| Gastritis | Gastrointestinal disorders | MedDRA 15.1 |
|
| Eczema | Skin and subcutaneous tissue disorders | MedDRA 15.1 |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 15.1 |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 15.1 |
|
| Pollakiuria | Renal and urinary disorders | MedDRA 15.1 |
|
| Thirst | General disorders | MedDRA 15.1 |
|
| Blood ketone body increased | Investigations | MedDRA 15.1 |
|
| Contusion | Injury, poisoning and procedural complications | MedDRA 15.1 |
|
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| D004700 | Endocrine System Diseases |