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The purpose of this study is to evaluate the efficacy and safety of TA-7284 as monotherapy in patients with type 2 Diabetes for 24 weeks administration.
This is a randomized, 3-arm, parallel group, double blind study to evaluate the efficacy and safety of TA-7284 in Japanese patients with Type 2 diabetes mellitus, who are not optimally controlled on diet and exercise. The patients will receive either TA-7284-Low, TA-7284-High or Placebo orally alone for 24 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TA-7284 Low | Experimental |
| |
| TA-7284 High | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TA-7284 Low | Drug | The patients will receive TA-7284-Low orally for 24 weeks. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Hemoglobin A1c (A1C) From Baseline (NGSP Value) | baseline and 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Fasting Plasma Glucose | Week 24 | |
| Change in Body Weight | Week 24 | |
| Change in Blood Pressure |
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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 |
|---|---|---|---|---|---|---|
| Reserch site | Chūbu | Japan | ||||
| Reserch site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25010793 | Derived | Inagaki N, Kondo K, Yoshinari T, Takahashi N, Susuta Y, Kuki H. Efficacy and safety of canagliflozin monotherapy in Japanese patients with type 2 diabetes inadequately controlled with diet and exercise: a 24-week, randomized, double-blind, placebo-controlled, Phase III study. Expert Opin Pharmacother. 2014 Aug;15(11):1501-15. doi: 10.1517/14656566.2014.935764. |
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| ID | Title | Description |
|---|---|---|
| FG000 | TA-7284 Low | TA-7284 low dose, once daily for 24 weeks |
| FG001 | TA-7284 High | TA-7284 high dose, once daily for 24 weeks |
| FG002 | Placebo | TA-7284 Placebo, once daily for 24 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 24 weeks |
| BG001 | TA-7284 High | TA-7284 high dose, once daily for 24 weeks |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Change in Hemoglobin A1c (A1C) From Baseline (NGSP Value) | Full analysis set, last observation carried forward | Posted | Least Squares Mean | Standard Error | percent HbA1C | baseline and 24 weeks |
|
26 weeks
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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 24 weeks |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal discomfort | Gastrointestinal disorders | MedDRA 15.0 |
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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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| TA-7284 High |
| Drug |
The patients will receive TA-7284-High orally for 24 weeks. |
|
| Placebo | Drug | The patients will receive Placebo orally for 24 weeks. |
|
| Week 24 |
| Change in Postprandial Plasma Glucose, Insulin and Urinary Glucose Excretion After a 75 g Oral Glucose Tolerance Test | Week 24 |
| Safety and Tolerability Assessed by Adverse Events, Hypoglycemic Events, Laboratory Tests, 12-lead ECG and Vital Signs | Week 24 |
| Kanto |
| Japan |
| Reserch site | Kinki | Japan |
| Reserch site | Shikoku | Japan |
| Reserch site | Tōhoku | Japan |
| Withdrawal by Subject |
|
| Clearly not eligible for the study |
|
| Fasting plasma glucose level increased |
|
| BG002 | Placebo | TA-7284 Placebo, once daily for 24 weeks |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
|
| Secondary | Change in Fasting Plasma Glucose | Not Posted | Week 24 | Participants |
| Secondary | Change in Body Weight | Not Posted | Week 24 | Participants |
| Secondary | Change in Blood Pressure | Not Posted | Week 24 | Participants |
| Secondary | Change in Postprandial Plasma Glucose, Insulin and Urinary Glucose Excretion After a 75 g Oral Glucose Tolerance Test | Not Posted | Week 24 | Participants |
| Secondary | Safety and Tolerability Assessed by Adverse Events, Hypoglycemic Events, Laboratory Tests, 12-lead ECG and Vital Signs | Not Posted | Week 24 | Participants |
| 1 |
| 90 |
| 59 |
| 90 |
| EG001 | TA-7284 High | TA-7284 high dose, once daily for 24 weeks | 1 | 89 | 55 | 89 |
| EG002 | Placebo | TA-7284 Placebo, once daily for 24 weeks | 2 | 93 | 54 | 93 |
| Gastric cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.0 |
|
| Hepatic neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.0 |
|
| Oropharyngeal cancer stage unspecified | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.0 |
|
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.0 |
|
| Abdominal distension | Gastrointestinal disorders | MedDRA 15.0 |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 15.0 |
|
| Acute tonsillitis | Infections and infestations | MedDRA 15 |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 15 |
|
| Asteatosis | Skin and subcutaneous tissue disorders | MedDRA 15.0 |
|
| Asthenia | General disorders | MedDRA 15.0 |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 15.0 |
|
| Bacteriuria | Infections and infestations | MedDRA 15.0 |
|
| Balanoposthitis | Reproductive system and breast disorders | MedDRA 15.0 |
|
| Benign prostatic hyperplasia | Reproductive system and breast disorders | MedDRA 15.0 |
|
| Blister | Skin and subcutaneous tissue disorders | MedDRA 15.0 |
|
| Blood creatine phosphokinase increased | Investigations | MedDRA 15.0 |
|
| Blood creatinine increased | Investigations | MedDRA 15.0 |
|
| Blood ketone body increased | Investigations | MedDRA 15.0 |
|
| Blood parathyroid hormone increased | Investigations | MedDRA 15.0 |
|
| Blood pressure increased | Investigations | MedDRA 15.0 |
|
| Blood triglycerides increased | Investigations | MedDRA 15.0 |
|
| Blood uric acid increased | Investigations | MedDRA 15.0 |
|
| Blood urine present | Investigations | MedDRA 15.0 |
|
| Bronchitis | Infections and infestations | MedDRA 15.0 |
|
| Bursitis | Musculoskeletal and connective tissue disorders | MedDRA 15.0 |
|
| Cervical dysplasia | Reproductive system and breast disorders | MedDRA 15.0 |
|
| Cervicobrachial syndrome | Nervous system disorders | MedDRA 15.0 |
|
| Chest discomfort | General disorders | MedDRA 15.0 |
|
| Chronic sinusitis | Infections and infestations | MedDRA 15.0 |
|
| Colonic polyp | Gastrointestinal disorders | MedDRA 15.0 |
|
| Conjunctivitis allergic | Eye disorders | MedDRA 15.0 |
|
| Constipation | Gastrointestinal disorders | MedDRA 15.0 |
|
| Contusion | Injury, poisoning and procedural complications | MedDRA 15.0 |
|
| Cystitis | Infections and infestations | MedDRA 15.0 |
|
| Dental caries | Gastrointestinal disorders | MedDRA 15.0 |
|
| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA 15.0 |
|
| Dermatitis allergic | Skin and subcutaneous tissue disorders | MedDRA 15.0 |
|
| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA 15.0 |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 15.0 |
|
| Diplopia | Eye disorders | MedDRA 15.0 |
|
| Dizziness | Nervous system disorders | MedDRA 15.0 |
|
| Dizziness postural | Nervous system disorders | MedDRA 15.0 |
|
| Dry eye | Eye disorders | MedDRA 15.0 |
|
| Dry mouth | Gastrointestinal disorders | MedDRA 15.0 |
|
| Eczema | Skin and subcutaneous tissue disorders | MedDRA 15.0 |
|
| Eczema asteatotic | Skin and subcutaneous tissue disorders | MedDRA 15.0 |
|
| Enteritis infectious | Infections and infestations | MedDRA 15.0 |
|
| Enterocolitis | Gastrointestinal disorders | MedDRA 15.0 |
|
| Excoriation | Injury, poisoning and procedural complications | MedDRA 15 |
|
| Face injury | Injury, poisoning and procedural complications | MedDRA 15.0 |
|
| Fasciitis | Musculoskeletal and connective tissue disorders | MedDRA 15.0 |
|
| Flank pain | Musculoskeletal and connective tissue disorders | MedDRA 15.0 |
|
| Folliculitis | Infections and infestations | MedDRA 15.0 |
|
| Forearm fracture | Injury, poisoning and procedural complications | MedDRA 15.0 |
|
| Gamma-glutamyltransferase increased | Investigations | MedDRA 15.0 |
|
| Gastric ulcer | Gastrointestinal disorders | MedDRA 15.0 |
|
| Gastritis | Gastrointestinal disorders | MedDRA 15.0 |
|
| Gastritis atrophic | Gastrointestinal disorders | MedDRA 15.0 |
|
| Gastroenteritis viral | Infections and infestations | MedDRA 15.0 |
|
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 15.0 |
|
| Gingivitis | Gastrointestinal disorders | MedDRA 15.0 |
|
| Gout | Metabolism and nutrition disorders | MedDRA 15.0 |
|
| Haemorrhoids | Gastrointestinal disorders | MedDRA 15.0 |
|
| Hangover | General disorders | MedDRA 15.0 |
|
| Headache | Nervous system disorders | MedDRA 15.0 |
|
| Heat rash | Skin and subcutaneous tissue disorders | MedDRA 15.0 |
|
| Hepatic function abnormal | Hepatobiliary disorders | MedDRA 15.0 |
|
| Herpes virus infection | Infections and infestations | MedDRA 15.0 |
|
| Herpes zoster | Infections and infestations | MedDRA 15.0 |
|
| Hordeolum | Infections and infestations | MedDRA 15.0 |
|
| Hot flush | Vascular disorders | MedDRA 15 |
|
| Hunger | General disorders | MedDRA 15.0 |
|
| Hypertension | Vascular disorders | MedDRA 15.0 |
|
| Hypoaesthesia | Nervous system disorders | MedDRA 15.0 |
|
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 15.0 |
|
| Hypoglycaemia unawareness | Metabolism and nutrition disorders | MedDRA 15.0 |
|
| Influenza | Infections and infestations | MedDRA 15.0 |
|
| Injury corneal | Injury, poisoning and procedural complications | MedDRA 15.0 |
|
| Ligament sprain | Injury, poisoning and procedural complications | MedDRA 15.0 |
|
| Lumbar spinal stenosis | Musculoskeletal and connective tissue disorders | MedDRA 15.0 |
|
| Migraine | Nervous system disorders | MedDRA 15.0 |
|
| Mouth injury | Injury, poisoning and procedural complications | MedDRA 15.0 |
|
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 15.0 |
|
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 15.0 |
|
| Myofascial pain syndrome | Musculoskeletal and connective tissue disorders | MedDRA 15.0 |
|
| Nasopharyngitis | Infections and infestations | MedDRA 15.0 |
|
| Nausea | Gastrointestinal disorders | MedDRA 15.0 |
|
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 15.0 |
|
| Nephropathy | Renal and urinary disorders | MedDRA 15.0 |
|
| Oral herpes | Infections and infestations | MedDRA 15.0 |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 |
|
| Orthostatic hypotension | Vascular disorders | MedDRA 15.0 |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 15.0 |
|
| Palpitations | Cardiac disorders | MedDRA 15.0 |
|
| Pancreatitis acute | Gastrointestinal disorders | MedDRA 15.0 |
|
| Periarthritis | Musculoskeletal and connective tissue disorders | MedDRA 15.0 |
|
| Periodontal disease | Gastrointestinal disorders | MedDRA 15.0 |
|
| Periodontitis | Gastrointestinal disorders | MedDRA 15.0 |
|
| Pharyngitis | Infections and infestations | MedDRA 15.0 |
|
| Pharyngitis bacterial | Infections and infestations | MedDRA 15.0 |
|
| Pollakiuria | Renal and urinary disorders | MedDRA 15.0 |
|
| Polycythaemia | Blood and lymphatic system disorders | MedDRA 15.0 |
|
| Post herpetic neuralgia | Nervous system disorders | MedDRA 15.0 |
|
| Pulmonary fibrosis | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 |
|
| Pulpitis dental | Infections and infestations | MedDRA 15.0 |
|
| Punctate keratitis | Eye disorders | MedDRA 15.0 |
|
| Pyelonephritis | Infections and infestations | MedDRA 15.0 |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 15.0 |
|
| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 |
|
| Sciatica | Nervous system disorders | MedDRA 15.0 |
|
| Seborrhoeic dermatitis | Skin and subcutaneous tissue disorders | MedDRA 15.0 |
|
| Skeletal injury | Injury, poisoning and procedural complications | MedDRA 15.0 |
|
| Skin fissures | Skin and subcutaneous tissue disorders | MedDRA 15.0 |
|
| Spinal compression fracture | Injury, poisoning and procedural complications | MedDRA 15.0 |
|
| Spinal osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 15.0 |
|
| Stomatitis | Gastrointestinal disorders | MedDRA 15.0 |
|
| Tenosynovitis | Musculoskeletal and connective tissue disorders | MedDRA 15.0 |
|
| Thermal burn | Injury, poisoning and procedural complications | MedDRA 15.0 |
|
| Thirst | General disorders | MedDRA 15.0 |
|
| Tinea pedis | Infections and infestations | MedDRA 15.0 |
|
| Toothache | Gastrointestinal disorders | MedDRA 15.0 |
|
| Toxic skin eruption | Skin and subcutaneous tissue disorders | MedDRA 15 |
|
| Trigger finger | Musculoskeletal and connective tissue disorders | MedDRA 15.0 |
|
| Upper respiratory tract inflammation | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 |
|
| Urinary retention | Renal and urinary disorders | MedDRA 15.0 |
|
| Urine albumin/creatinine ratio increased | Investigations | MedDRA 15.0 |
|
| Urine ketone body present | Investigations | MedDRA 15.0 |
|
| Urine output increased | Investigations | MedDRA 15.0 |
|
| Vertigo | Ear and labyrinth disorders | MedDRA 15.0 |
|
| Vulvitis | Infections and infestations | MedDRA 15.0 |
|
| Vulvovaginal candidiasis | Infections and infestations | MedDRA 15.0 |
|
| Vulvovaginal mycotic infection | Infections and infestations | MedDRA 15.0 |
|
| Weight decreased | Investigations | MedDRA 15.0 |
|
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| D004700 | Endocrine System Diseases |