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The purpose of this study is to evaluate the safety and efficacy of Canagliflozin (TA-7284) in combination with GLP-1 analogue in patients with type 2 Diabetes for 52 weeks.
This is an open-label study to evaluate the long-term safety and efficacy of Canagliflozin (TA-7284) in Japanese patients with type 2 diabetes mellitus, who are receiving treatment with GLP-1 analogue on diet and exercise and have inadequate glycemic control. The patients will receive TA-7284 100mg orally for 52 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Canagliflozin (TA-7284) +GLP-1 analogue | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Canagliflozin (TA-7284) | Drug | The patients will receive Canagliflozin orally for 52 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety and Tolerability Assessed by Adverse Events (Number of Participants Experiencing With Adverse Events) | 52 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Percentage of HbA1c | Baseline, 52 Weeks | |
| Change in Fasting Plasma Glucose | Baseline, 52 Weeks | |
| Percentage Change in Body Weight |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nobuya Inagaki, Professor | Kyoto University, Graduate School of Medicine | Study Director |
| Kazuoki Kondo, MD | Tanabe Pharma Corporation | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Reserch site | Chūbu | Japan | ||||
| Reserch site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29473709 | Result | Harashima SI, Inagaki N, Kondo K, Maruyama N, Otsuka M, Kawaguchi Y, Watanabe Y. Efficacy and safety of canagliflozin as add-on therapy to a glucagon-like peptide-1 receptor agonist in Japanese patients with type 2 diabetes mellitus: A 52-week, open-label, phase IV study. Diabetes Obes Metab. 2018 Jul;20(7):1770-1775. doi: 10.1111/dom.13267. Epub 2018 Mar 24. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Canagliflozin (TA-7284) + GLP-1 Analogue | Canagliflozin (TA-7284) 100mg once daily for 52 weeks in combination with GLP-1 analogue |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| GLP-1 analogue | Drug |
|
| Baseline, 52 Weeks |
| Change in Blood Pressure | Baseline, 52 Weeks |
| Hokkaido |
| Japan |
| Reserch site | Kanto | Japan |
| Reserch site | Kinki | Japan |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Canagliflozin (TA-7284) + GLP-1 Analogue | Canagliflozin (TA-7284) 100mg once daily for 52 weeks in combination with GLP-1 analogue |
| 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 | Participants |
| ||||||||||||||||||||
| Sex: Female, Male | Count of Participants | 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 (Number of Participants Experiencing With Adverse Events) | Posted | Count of Participants | Participants | 52 Weeks |
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| Secondary | Change in Percentage of HbA1c | Full analysis set, last observation carried forward. | Posted | Mean | Standard Deviation | percentage of HbA1c | Baseline, 52 Weeks |
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| Secondary | Change in Fasting Plasma Glucose | Full analysis set, last observation carried forward. Outcome measure for one patient was not assessed at a certain timepoint due to dropout. | Posted | Mean | Standard Deviation | mg/dL | Baseline, 52 Weeks |
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| Secondary | Percentage Change in Body Weight | Full analysis set, last observation carried forward. Outcome measure for one patient was not assessed at a certain timepoint due to dropout. | Posted | Mean | Standard Deviation | percent change | Baseline, 52 Weeks |
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| Secondary | Change in Blood Pressure | Full analysis set, last observation carried forward. | Posted | Mean | Standard Deviation | mmHg | Baseline, 52 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 | Canagliflozin (TA-7284) + GLP-1 Analogue | Canagliflozin (TA-7284) 100mg once daily for 52 weeks in combination with GLP-1 analogue | 5 | 71 | 43 | 71 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Erysipelas | Infections and infestations | MedDRA 18.1 |
| ||
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 |
| ||
| Colon cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 |
| ||
| Vertigo positional | Ear and labyrinth disorders | MedDRA 18.1 |
| ||
| Sinus node dysfunction | Cardiac disorders | MedDRA 18.1 |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Gastroenteritis | Infections and infestations | MedDRA 18.1 |
| ||
| Nasopharyngitis | Infections and infestations | MedDRA 18.1 |
| ||
| Pharyngitis | Infections and infestations | MedDRA 18.1 |
| ||
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 18.1 |
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| Constipation | Gastrointestinal disorders | MedDRA 18.1 |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 18.1 |
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| Pollakiuria | Renal and urinary disorders | MedDRA 18.1 |
| ||
| Polyuria | Renal and urinary disorders | MedDRA 18.1 |
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| Contusion | Injury, poisoning and procedural complications | MedDRA 18.1 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Trials, Information Desk | Tanabe Pharma Corporation | cti-inq-ml.JP@ml.tanabe-pharma.com |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D007333 | Insulin Resistance |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D006946 | Hyperinsulinism |
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| ID | Term |
|---|---|
| D000068896 | Canagliflozin |
| ID | Term |
|---|---|
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D005960 | Glucosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
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| Categories |
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| Title |
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| Systolic blood pressure |
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| Diastolic blood pressure |
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