Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to evaluate the efficacy and safety of co-administration of Teneligliptin (MP-513) and Canagliflozin (TA-7284) once daily for 24 weeks in Japanese patients with Type 2 diabetes mellitus who are receiving treatment with Teneligliptin and have inadequate glycemic control.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Canagliflozin + Teneligliptin | Experimental | Patients receive Canagliflozin for 24 weeks in combination with Teneligliptin. |
|
| Placebo + Teneligliptin | Placebo Comparator | Patients receive placebo for 24 weeks in combination with Teneligliptin. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Teneligliptin | 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Takashi Kadowaki, MD | Tokyo University | Study Director |
| Kazuoki Kondo, MD | Tanabe Pharma Corporation | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Reserch site | Kanto | Japan | ||||
| Reserch site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28177187 | Result | Kadowaki T, Inagaki N, Kondo K, Nishimura K, Kaneko G, Maruyama N, Nakanishi N, Iijima H, Watanabe Y, Gouda M. Efficacy and safety of canagliflozin as add-on therapy to teneligliptin in Japanese patients with type 2 diabetes mellitus: Results of a 24-week, randomized, double-blind, placebo-controlled trial. Diabetes Obes Metab. 2017 Jun;19(6):874-882. doi: 10.1111/dom.12898. Epub 2017 Mar 31. |
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Canagliflozin+Teneligliptin | Canagliflozin for 24 weeks in combination with Teneligliptin |
| FG001 | Placebo+Teneligliptin | Placebo for 24 weeks in combination with Teneligliptin |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Canagliflozin+Teneligliptin | Canagliflozin for 24 weeks in combination with Teneligliptin |
| BG001 | Placebo+Teneligliptin | Placebo for 24 weeks in combination with Teneligliptin |
| 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 |
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Canagliflozin+Teneligliptin | Canagliflozin for 24 weeks in combination with Teneligliptin |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Gastric 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 |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Trials, Information Desk | Tanabe Pharma Corporation | cti-inq-ml.JP@ml.tanabe-pharma.com |
Not provided
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
Not provided
Not provided
| 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 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Canagliflozin |
| 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 |
| 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 of each group 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 of each group 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 | 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 | Posted | Least Squares Mean | Standard Error | mg/dL | 2 Hours Postprandial, at Baseline and 24 Weeks |
|
|
|
|
| 1 |
| 70 |
| 13 |
| 70 |
| EG001 | Placebo+Teneligliptin | Placebo for 24 weeks in combination with Teneligliptin | 2 | 68 | 11 | 68 |
| Cerebral infarction | Nervous system disorders | MedDRA 18.1 |
|
| Chondrocalcinosis pyrophosphate | Musculoskeletal and connective tissue disorders | MedDRA 18.1 |
|
Not provided
| D004700 | Endocrine System Diseases |
| D006571 |
| Heterocyclic Compounds |
| D005960 | Glucosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |