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The purpose of this study is to evaluate the safety and efficacy of co-administration of Teneligliptin (MP-513) and Canagliflozin (TA-7284) once daily for 52 weeks in Japanese patients with Type 2 diabetes mellitus who are receiving treatment with Teneligliptin and have inadequate glycemic control.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Teneligliptin/Canagliflozin | Experimental | Patients receive Teneligliptin and Canagliflozin once daily for 52 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Teneligliptin/Canagliflozin | Drug | Co-administration of Teneligliptin and Canagliflozin orally once daily for 52 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Adverse Events | 52 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Percentage of Glycated Hemoglobin (HbA1c) | The change from baseline in percentage of HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at Week 52. | Baseline, 52 Weeks |
| Change From Baseline in Fasting Plasma Glucose Level |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Takashi Kadowaki, MD | Tokyo University | Study Director |
| Nobuya Inagaki, MD | Kyoto University | Study Director |
| Kazuoki Kondo, MD | Tanabe Pharma Corporation | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research site | Chugoku | Japan | ||||
| Research site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28608617 | Result | Kadowaki T, Inagaki N, Kondo K, Nishimura K, Kaneko G, Maruyama N, Nakanishi N, Watanabe Y, Gouda M, Iijima H. Long-term safety and efficacy of canagliflozin as add-on therapy to teneligliptin in Japanese patients with type 2 diabetes. Diabetes Obes Metab. 2018 Jan;20(1):77-84. doi: 10.1111/dom.13038. Epub 2017 Jul 31. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Teneligliptin+Canagliflozin | Teneligliptin and Canagliflozin once daily for 52 weeks. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Teneligliptin+Canagliflozin | Teneligliptin and Canagliflozin 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 | Number of Participants With Adverse Events | Posted | Number | participants | 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 | Teneligliptin+Canagliflozin | Teneligliptin and Canagliflozin once daily for 52 weeks. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Influenza | Infections and infestations | MedDRA 18.1 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations | 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 |
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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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| ID | Term |
|---|---|
| C579035 | 3-(4-(4-(3-methyl-1-phenyl-1H-pyrazol-5-yl)piperazin-1-yl)pyrrolidin-2-ylcarbonyl)thiazolidine |
| D000068896 | Canagliflozin |
| ID | Term |
|---|---|
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D006573 | Heterocyclic Compounds, 1-Ring |
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The change from baseline in fasting plasma glucose level collected at Week 52. |
| Baseline, 52 Weeks |
| Percentage Change in Body Weight From Baseline | The percentage change from baseline in body weight collected at Week 52. | Baseline, 52 Weeks |
| Chūbu |
| Japan |
| Research site | Hokkaido | Japan |
| Research site | Kanto | Japan |
| Research site | Kyushu | Japan |
| Research site | Tōhoku | Japan |
| Conflict with the stopping criteria |
|
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
| Secondary | Change From Baseline in Percentage of Glycated Hemoglobin (HbA1c) | The change from baseline in percentage of HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at Week 52. | Full analysis set, last observation carried forward | Posted | Mean | Standard Deviation | percentage of HbA1c | Baseline, 52 Weeks |
|
|
|
| Secondary | Change From Baseline in Fasting Plasma Glucose Level | The change from baseline in fasting plasma glucose level collected at Week 52. | 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 |
|
|
|
| Secondary | Percentage Change in Body Weight From Baseline | The percentage change from baseline in body weight collected at Week 52. | 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 |
|
|
|
| 11 |
| 153 |
| 61 |
| 153 |
| Pneumonia | Infections and infestations | MedDRA 18.1 |
|
| Herpes zoster disseminated | Infections and infestations | MedDRA 18.1 |
|
| Rectal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 |
|
| Hepatocellular carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 |
|
| Cataract | Eye disorders | MedDRA 18.1 |
|
| Myocardial infarction | Cardiac disorders | MedDRA 18.1 |
|
| Atrial fibrillation | Cardiac disorders | MedDRA 18.1 |
|
| Sinus node dysfunction | Cardiac disorders | MedDRA 18.1 |
|
| Ankle fracture | Injury, poisoning and procedural complications | MedDRA 18.1 |
|
| Constipation | Gastrointestinal disorders | MedDRA 18.1 |
|
| Eczema | Skin and subcutaneous tissue disorders | MedDRA 18.1 |
|
| Pollakiuria | Renal and urinary disorders | MedDRA 18.1 |
|
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| D004700 | Endocrine System Diseases |
| D006571 |
| Heterocyclic Compounds |
| D005960 | Glucosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |