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The purpose of this study is to evaluate the efficacy and safety of co-administration of Canagliflozin (TA-7284) and Teneligliptin (MP-513) once daily for 24 weeks in Japanese patients with Type 2 diabetes mellitus who are receiving treatment with Canagliflozin and have inadequate glycemic control.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Teneligliptin + Canagliflozin | Experimental | Patients receive Teneligliptin for 24 weeks in combination with Canagliflozin. |
|
| Placebo + Canagliflozin | Placebo Comparator | Patients receive placebo for 24 weeks in combination with Canagliflozin. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Canagliflozin | Drug |
|
| |
| 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 24. | Baseline, 24 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Fasting Plasma Glucose Level | The change from baseline in fasting plasma glucose level collected at Week 24. | Baseline, 24 Weeks |
| Percentage Change in Body Weight From Baseline |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Takashi Kadowaki, M.D. | Tokyo University | Study Director |
| Kazuoki Kondo, M.D. | Tanabe Pharma Corporation | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Reserch site | Kanto | Japan | ||||
| Reserch site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28786530 | Result | Kadowaki T, Inagaki N, Kondo K, Nishimura K, Kaneko G, Maruyama N, Nakanishi N, Gouda M, Iijima H, Watanabe Y. Efficacy and safety of teneligliptin added to canagliflozin monotherapy in Japanese patients with type 2 diabetes mellitus: A multicentre, randomized, double-blind, placebo-controlled, parallel-group comparative study. Diabetes Obes Metab. 2018 Feb;20(2):453-457. doi: 10.1111/dom.13079. Epub 2017 Sep 15. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Teneligliptin+Canagliflozin | Teneligliptin for 24 weeks in combination with Canagliflozin |
| FG001 | Placebo+Canagliflozin | Placebo for 24 weeks in combination with Canagliflozin |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Teneligliptin+Canagliflozin | Teneligliptin for 24 weeks in combination with Canagliflozin |
| BG001 | Placebo+Canagliflozin | Placebo for 24 weeks in combination with Canagliflozin |
| 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 | 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 24. | Full analysis set, last observation carried forward | Posted | Least Squares Mean | Standard Error | percentage of HbA1c | Baseline, 24 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 for 24 weeks in combination with Canagliflozin |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Colon cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 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 |
|---|---|
| D000068896 | Canagliflozin |
| C579035 | 3-(4-(4-(3-methyl-1-phenyl-1H-pyrazol-5-yl)piperazin-1-yl)pyrrolidin-2-ylcarbonyl)thiazolidine |
| ID | Term |
|---|---|
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D006573 | Heterocyclic Compounds, 1-Ring |
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| Teneligliptin |
| Drug |
|
|
| Placebo | Drug |
|
The percentage change from baseline in body weight collected at Week 24.
| Baseline, 24 Weeks |
| Change From Baseline in the AUC(0-2h) for Postprandial Plasma Glucose (PPG) | The change from Baseline in AUC(0-2h) for Postprandial Plasma Glucose collected at Week 24. | 0, 0.5, 1 and 2 hour postprandial, at Baseline and 24 Weeks |
| Change From Baseline in 2-hour Postprandial Plasma Glucose Level | The change from baseline in 2-hour postprandial plasma glucose level collected at Week 24. | 2 Hours Postprandial, at Baseline and 24 Weeks |
| Kinki |
| Japan |
| Reserch site | Tōhoku | Japan |
| Pregnancy |
|
| Withdrawal by Subject |
|
| Conflict with the stopping criteria |
|
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
|
|
| Secondary | Change From Baseline in Fasting Plasma Glucose Level | The change from baseline in fasting plasma glucose level collected at Week 24. | Full analysis set, last observation carried forward. Outcome measure for one patient was not assessed at a certain timepoint due to dropout. | Posted | Least Squares Mean | Standard Error | mg/dL | Baseline, 24 Weeks |
|
|
|
|
| Secondary | Percentage Change in Body Weight From Baseline | The percentage change from baseline in body weight collected at Week 24. | Full analysis set, last observation carried forward. Outcome measure for one patient was not assessed at a certain timepoint due to dropout. | Posted | Least Squares Mean | Standard Error | percent change | Baseline, 24 Weeks |
|
|
|
|
| Secondary | Change From Baseline in the AUC(0-2h) for Postprandial Plasma Glucose (PPG) | The change from Baseline in AUC(0-2h) for Postprandial Plasma Glucose collected at Week 24. | Full analysis set. Outcome measure for one patient was not assessed at a certain timepoint due to dropout. | Posted | Least Squares Mean | Standard Error | hour*mg/dL | 0, 0.5, 1 and 2 hour postprandial, at Baseline and 24 Weeks |
|
|
|
|
| Secondary | Change From Baseline in 2-hour Postprandial Plasma Glucose Level | The change from baseline in 2-hour postprandial plasma glucose level collected at Week 24. | Full analysis set. Outcome measure for one patient was not assessed at a certain timepoint due to dropout. | Posted | Least Squares Mean | Standard Error | mg/dL | 2 Hours Postprandial, at Baseline and 24 Weeks |
|
|
|
|
| 1 |
| 77 |
| 15 |
| 77 |
| EG001 | Placebo+Canagliflozin | Placebo for 24 weeks in combination with Canagliflozin | 2 | 77 | 8 | 77 |
| Pancreatic carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 |
|
| Large intestine polyp | Gastrointestinal disorders | MedDRA 18.1 |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA 18.1 |
|
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| D004700 | Endocrine System Diseases |
| D006571 |
| Heterocyclic Compounds |
| D005960 | Glucosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |