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
This extension study was designed to evaluate the safety and efficacy of Canagliflozin (TA-7284) in combination with Insulin in patients with type 2 Diabetes Mellitus. The extension study was an extension to double-blind study of 16 weeks (TA-7284-11)
This is an open-label extension study to evaluate the safety and efficacy of Canagliflozin (TA-7284) in combination with insulin in Japanese patients with Type 2 diabetes mellitus, who are not optimally controlled on diet and exercise. The patients will enroll from the double-blind study of 16 weeks and receive TA-7284 100mg orally for 36 weeks.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Canagliflozin (TA-7284) ＋insulin | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Canagliflozin (TA-7284) | Drug | The patients will receive Canagliflozin orally for 36 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety and Tolerability Assessed by Adverse Events (Number of Participants Experiencing With Adverse Events) | Placebo/CANA: 36 Weeks, CANA/CANA: 52 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Percentage of HbA1c | Placebo/CANA: Baseline, 36 Weeks; CANA/CANA: Baseline, 52 Weeks | |
| Change in Fasting Plasma Glucose | Placebo/CANA: Baseline, 36 Weeks; CANA/CANA: Baseline, 52 Weeks | |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Kazuoki Kondo, MD | Tanabe Pharma Corporation | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Reserch site | Chugoku | Japan | ||||
| Reserch site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29110384 | Result | Inagaki N, Harashima SI, Kaku K, Kondo K, Maruyama N, Otsuka M, Kawaguchi Y, Iijima H. Long-term efficacy and safety of canagliflozin in combination with insulin in Japanese patients with type 2 diabetes mellitus. Diabetes Obes Metab. 2018 Apr;20(4):812-820. doi: 10.1111/dom.13152. Epub 2017 Dec 5. |
Not provided
Not provided
The number of patients continued treatment in this study after TA-7284-11 study was 139. Four patients in the CANA/CANA group who did not continued this study were included in the analysis set. Analysis of this study was conducted 143 patients.
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Placebo/CANA + Insulin | Canagliflozin(CANA) 100mg once daily for 36 weeks, followed placebo for 16 weeks in TA-7284-11 study |
| FG001 | CANA/CANA + Insulin | Canagliflozin(CANA) 100mg once daily for 36 weeks, followed Canagliflozin(CANA) for 16 weeks in TA-7284-11 study |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Insulin | Drug |
|
| Percentage Change in Body Weight |
| Placebo/CANA: Baseline, 36 Weeks; CANA/CANA: Baseline, 52 Weeks |
| Chūbu |
| Japan |
| Reserch site | Hokkaido | Japan |
| Reserch site | Kanto | Japan |
| Reserch site | Kinki | Japan |
| Reserch site | Kyushu | Japan |
| Reserch site | Tōhoku | Japan |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Placebo/CANA + Insulin | Canagliflozin(CANA) 100mg once daily for 36 weeks, followed placebo for 16 weeks in TA-7284-11 study |
| BG001 | CANA/CANA + Insulin | Canagliflozin(CANA) 100mg once daily for 36 weeks, followed Canagliflozin(CANA) for 16 weeks in TA-7284-11 study |
| BG002 | Total | Total of all reporting groups |
| 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) | One patient of CANA/CANA group who mistakenly received placebo during TA-7284-11 study, did not continued this study. This patient was included in the full analysis set and was not included in the safety analysis set. | Posted | Count of Participants | Participants | Placebo/CANA: 36 Weeks, CANA/CANA: 52 Weeks |
|
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | Change in Percentage of HbA1c | Full analysis set, last observation carried forward. | Posted | Mean | Standard Deviation | percentage of HbA1c | Placebo/CANA: Baseline, 36 Weeks; CANA/CANA: Baseline, 52 Weeks |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | Change in Fasting Plasma Glucose | Full analysis set, last observation carried forward. Outcome measure for two patients of Placebo/CANA group and one patient of CANA/CANA group was not assessed at a certain timepoint due to dropout. | Posted | Mean | Standard Deviation | mg/dL | Placebo/CANA: Baseline, 36 Weeks; CANA/CANA: Baseline, 52 Weeks |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | Percentage Change in Body Weight | Full analysis set, last observation carried forward. Outcome measure for two patients of Placebo/CANA group and one patient of CANA/CANA group was not assessed at a certain timepoint due to dropout. | Posted | Mean | Standard Deviation | percent change | Placebo/CANA: Baseline, 36 Weeks; CANA/CANA: Baseline, 52 Weeks |
|
|
Placebo/CANA: 36 Weeks, CANA/CANA: 52 Weeks
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 | Placebo/CANA + Insulin | Canagliflozin(CANA) 100mg once daily for 36 weeks, followed placebo for 16 weeks in TA-7284-11 study | 7 | 67 | 49 | 67 | ||
| EG001 | CANA/CANA + Insulin | Canagliflozin(CANA) 100mg once daily for 36 weeks, followed Canagliflozin(CANA) for 16 weeks in TA-7284-11 study | 7 | 75 | 56 | 75 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Appendicitis perforated | Infections and infestations | MedDRA 18.1 |
| ||
| Peritonitis | Infections and infestations | MedDRA 18.1 |
| ||
| Pneumonia | Infections and infestations | MedDRA 18.1 |
| ||
| Colon cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 |
| ||
| Lung neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 |
| ||
| Lacunar infarction | Nervous system disorders | MedDRA 18.1 |
| ||
| Cataract | Eye disorders | MedDRA 18.1 |
| ||
| Retinal detachment | Eye disorders | MedDRA 18.1 |
| ||
| Retinal tear | Eye disorders | MedDRA 18.1 |
| ||
| Vitreous haemorrhage | Eye disorders | MedDRA 18.1 |
| ||
| Angina pectoris | Cardiac disorders | MedDRA 18.1 |
| ||
| Atrial fibrillation | Cardiac disorders | MedDRA 18.1 |
| ||
| Alcoholic liver disease | Hepatobiliary disorders | MedDRA 18.1 |
| ||
| Hydronephrosis | Renal and urinary disorders | MedDRA 18.1 |
| ||
| Chest pain | General disorders | MedDRA 18.1 |
| ||
| Lower limb fracture | Injury, poisoning and procedural complications | MedDRA 18.1 |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bronchitis | Infections and infestations | MedDRA 18.1 |
| ||
| Nasopharyngitis | Infections and infestations | MedDRA 18.1 |
| ||
| Pharyngitis | Infections and infestations | MedDRA 18.1 |
| ||
| Upper respiratory tract infection | Infections and infestations | MedDRA 18.1 |
| ||
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 18.1 |
| ||
| Insomnia | Psychiatric disorders | MedDRA 18.1 |
| ||
| Constipation | Gastrointestinal disorders | MedDRA 18.1 |
| ||
| Pollakiuria | Renal and urinary disorders | MedDRA 18.1 |
| ||
| Blood glucose decreased | Investigations | MedDRA 18.1 |
|
Not provided
| 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 |
Not provided
Not provided
| ID | Term |
|---|---|
| D000068896 | Canagliflozin |
| D007328 | Insulin |
| ID | Term |
|---|---|
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D005960 | Glucosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D011384 | Proinsulin |
| D061385 | Insulins |
| D010187 | Pancreatic Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
Not provided
Not provided
| >=65 years |
|
| Male |
|
|
|
|