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The purpose of this study is to evaluate the efficacy and safety of Canagliflozin (TA-7284) in combination with Insulin in patients with type 2 Diabetes for 16 weeks administration.
This is a randomized, 2-arm, parallel group, double blind study to evaluate the efficacy and safety of Canagliflozin (TA-7284) in Japanese patients with type 2 diabetes mellitus, who are receiving treatment with insulin therapy on diet and exercise and have inadequate glycemic control. The patients will receive either TA-7284 100mg or Placebo orally for 16 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Canagliflozin (TA-7284) +insulin | Experimental |
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| Placebo+insulin | Placebo Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Canagliflozin (TA-7284) | Drug | The patients will receive Canagliflozin orally for 16 weeks |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in HbA1c From Baseline | baseline and Week 16 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Fasting Plasma Glucose | baseline and Week 16 | |
| Percent Change in Body Weight | baseline and Week 16 | |
| Change in Blood Pressure |
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Inclusion Criteria:
Exclusion Criteria:
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| 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 |
|---|---|---|---|
| 27316668 | Result | Inagaki N, Harashima S, Maruyama N, Kawaguchi Y, Goda M, Iijima H. Efficacy and safety of canagliflozin in combination with insulin: a double-blind, randomized, placebo-controlled study in Japanese patients with type 2 diabetes mellitus. Cardiovasc Diabetol. 2016 Jun 18;15:89. doi: 10.1186/s12933-016-0407-4. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Canagliflozin (TA-7284) +Insulin | Canagliflozin, once daily for 16 weeks |
| FG001 | Placebo+Insulin | Placebo, once daily for 16 weeks |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Placebo | Drug | The patients will receive Placebo orally for 16 weeks |
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| Insulin | Drug |
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| baseline and Week 16 |
| Percentage of Participants With "Adverse Events" and "Hypoglycemia and Blood Glucose Decreased" | Week 16 |
| Chūbu |
| Japan |
| Reserch site | Hokkaido | Japan |
| Reserch site | Kanto | Japan |
| Reserch site | Kinki | Japan |
| Reserch site | Kyushu | Japan |
| Reserch site | Tōhoku | Japan |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Canagliflozin (TA-7284) +Insulin | Canagliflozin, once daily for 16 weeks |
| BG001 | Placebo+Insulin | Placebo, once daily for 16 weeks |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| 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 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Change in HbA1c From Baseline | Full analysis set, last observation carried forward | Posted | Least Squares Mean | Standard Error | Percent | baseline and Week 16 |
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| Secondary | Change in Fasting Plasma Glucose | Full analysis set, last observation carried forward. There was a lack of measurement of fasting plasma glucose at the end of treatment visit(Week 4) in one participant who was randomized to "Canagliflozin(TA-7284) + Insulin" group. | Posted | Least Squares Mean | Standard Error | mg/dL | baseline and Week 16 |
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| Secondary | Percent Change in Body Weight | Full analysis set, last observation carried forward. There was a lack of measurement of body weight at the end of treatment visit(Week 4) in one participant who was randomized to "Canagliflozin(TA-7284) + Insulin" group. | Posted | Least Squares Mean | Standard Error | percent change | baseline and Week 16 |
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| Secondary | Change in Blood Pressure | Full analysis set, last observation carried forward | Posted | Least Squares Mean | Standard Error | mmHg | baseline and Week 16 |
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| Secondary | Percentage of Participants With "Adverse Events" and "Hypoglycemia and Blood Glucose Decreased" | Safety analysis set. "Safety Population" reflects the "as treated" population, and one "Canagliflozin (TA-7284) + Insulin" participant actually received "Placebo + Insulin". | Posted | Number | percentage of participants | Week 16 |
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"Safety Population" reflects the "as treated" population, and one "Canagliflozin(TA-7284) + Insulin" participant actually received "Placebo + Insulin".
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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) +Insulin | Canagliflozin, once daily for 16 weeks | 3 | 75 | 39 | 75 | ||
| EG001 | Placebo+Insulin | Placebo, once daily for 16 weeks | 1 | 71 | 34 | 71 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cataract | Eye disorders | MedDRA 18.0 |
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| Retinal detachment | Eye disorders | MedDRA 18.0 |
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| Vitreous haemorrhage | Eye disorders | MedDRA 18.0 |
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| Alcoholic liver disease | Hepatobiliary disorders | MedDRA 18.0 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations | MedDRA 18.0 |
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| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 18.0 |
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| Pollakiuria | Renal and urinary disorders | MedDRA 18.0 |
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| Blood glucose decreased | Investigations | MedDRA 18.0 |
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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 |
| 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 |
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| >=65 years |
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| Male |
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