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| ID | Type | Description | Link |
|---|---|---|---|
| 28431754DIA3014 | Other Identifier | Janssen Research & Development, LLC |
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The purpose of this study is to assess the safety, tolerability, and efficacy of the addition of canagliflozin relative to the addition of placebo in patients with inadequate glycemic control on metformin alone or in combination with a sulphonylurea.
This is a double-blind (neither study staff or the patient will know the identity of the treatment assigned) study of canagliflozin where Chinese and other Asian adult patients with Type 2 Diabetes Mellitus (T2DM) who have inadequate glycemic control on metformin alone or in combination with a sulphonylurea (SU) will be randomized (assigned to 1 of 3 treatments by chance) to receive the addition of treatment with canagliflozin 100 mg once daily, canagliflozin 300 mg once daily, or matching placebo capsules (placebo is a treatment identical in appearance to canagliflozin but does not contain active drug). All patients will take orally (by mouth) 1 single-blind placebo capsule once daily before the first meal of the day for up to 2 weeks (last dose of single-blind placebo to be taken the day before the baseline (Day 1) visit. On Day 1, patients will take orally, once daily 1 capsule of canagliflozin 100 mg, canagliflozin 300 mg, or placebo before the first meal of the day for up to 18 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Canagliflozin 100mg | Experimental | Each participant will receive 100 mg of canagliflozin once daily for 18 weeks with protocol-specified doses of metformin alone or metformin plus sulphonylurea. |
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| Canagliflozin 300mg | Experimental | Each participant will receive 300 mg of canagliflozin once daily for 18 weeks with protocol-specified doses of metformin alone or metformin plus sulphonylurea. |
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| Placebo | Placebo Comparator | Each participant will receive matching placebo once daily for 18 weeks with protocol-specified doses of metformin alone or metformin plus sulphonylurea. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | Form=capsule, route=oral administration. One capsule once daily for up to 18 weeks after completing a single-blind placebo run-in period (1 placebo capsule once daily for up to 2 weeks). |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Glycosylated Hemoglobin (HbA1c) From Baseline to Week 18 | The table below shows the least-squares (LS) mean change in HbA1c from baseline to Week 18 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the LS mean change. | Day 1 (Baseline) and Week 18 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Fasting Plasma Glucose (FPG) From Baseline to Week 18 | The table below shows the least-squares (LS) mean change in FPG from Baseline to Week 18 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the LS mean change. | Day 1 (Baseline) and Week 18 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Janssen Research & Development, LLC Clinical Trial | Janssen Research & Development, LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Baotou | China | |||||
The study had two background treatment strata: 331 participants in the metformin alone stratum and 347 in the metformin plus SU. In total, 678 participants were randomly allocated to the 3 treatment arms, 676 received at least 1 dose of study drug and were included in the modified intent-to-treat (mITT) analysis set and the safety analysis set.
This study evaluated the efficacy and safety of canagliflozin in Asian participants with type 2 diabetes mellitus who had inadequate glycemic control on a maximally effective or tolerated dose of metformin alone or metformin plus sulphonylurea (SU). It was conducted between 30 June 2011 and 21 December 2012 and recruited patients from 36 sites.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Each participant received matching placebo once daily for 18 weeks with protocol-specified doses of metformin alone or metformin plus sulphonylurea. |
| FG001 | Canagliflozin 100 mg |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Canagliflozin 100mg | Drug | Type=1, unit=mg, number=100, form=capsule, route=oral use. One capsule once daily for up to 18 weeks after completing a single-blind placebo run-in period (1 placebo capsule once daily for up to 2 weeks). |
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| Canagliflozin 300mg | Drug | Type=1, unit=mg, number=300, form=capsule, route=oral use. One capsule once daily for up to 18 weeks after completing a single-blind placebo run-in period (1 placebo capsule once daily for up to 2 weeks). |
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| Metformin | Drug | The participant's stable dose of background therapy of metformin should be continued throughout the study. |
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| Sulphonylurea | Drug | The participant's stable dose of background therapy of metformin plus sulphonylurea should be continued throughout the study. |
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| Percent Change in Body Weight From Baseline to Week 18 |
The table below shows the least-squares (LS) mean percent change in body weight from Baseline to Week 18 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the LS mean percent change. |
| Day 1 (Baseline) and Week 18 |
| Percentage of Patients With Glycosylated Hemoglobin (HbA1c) <7% at Week 18 | The table below shows the percentage of patients with HbA1c <7% at Week 18 in each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the percentage. | Day 1 (Baseline) and Week 18 |
| Percentage of Patients With Glycosylated Hemoglobin (HbA1c) <6.5% at Week 18 | The table below shows the percentage of patients with HbA1c <6.5% at Week 18 in each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the percentage. | Day 1 (Baseline) and Week 18 |
| Beijing |
| China |
| Changchun | China |
| Changsha | China |
| Chengdu | China |
| Chongqing | China |
| Guangzhou | China |
| Hangzhou | China |
| Harbin | China |
| Nanchang | China |
| Nanjing | China |
| Nanning | China |
| Shanghai | China |
| Shenyang | China |
| Shiyan | China |
| Siping | China |
| Suzhou | China |
| Tianjin | China |
| Wuxi | China |
| Xi'an | China |
| Kota Bharu | Malaysia |
| Kuala Selangor | Malaysia |
| Pulau Pinang | Malaysia |
| Hanoi | Vietnam |
| Ho Chi Minh City | Vietnam |
Each participant received 100 mg of canagliflozin once daily for 18 weeks with protocol-specified doses of metformin alone or metformin plus sulphonylurea.
| FG002 | Canagliflozin 300 mg | Each participant received 300 mg of canagliflozin once daily for 18 weeks with protocol-specified doses of metformin alone or metformin plus sulphonylurea. |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Each participant received matching placebo once daily for 18 weeks with protocol-specified doses of metformin alone or metformin plus sulphonylurea. |
| BG001 | Canagliflozin 100 mg | Each participant received 100 mg of canagliflozin once daily for 18 weeks with protocol-specified doses of metformin alone or metformin plus sulphonylurea. |
| BG002 | Canagliflozin 300 mg | Each participant received 300 mg of canagliflozin once daily for 18 weeks with protocol-specified doses of metformin alone or metformin plus sulphonylurea. |
| BG003 | 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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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region Enroll | Number | 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 Glycosylated Hemoglobin (HbA1c) From Baseline to Week 18 | The table below shows the least-squares (LS) mean change in HbA1c from baseline to Week 18 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the LS mean change. | Analysis used overall mITT analysis set (all randomized patients who received at least 1 dose of double-blind study drug). Last-observation-carried-forward method used for missing Week 18 values. Table includes only participants with both baseline and post baseline values. | Posted | Least Squares Mean | Standard Error | Percent | Day 1 (Baseline) and Week 18 |
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| Secondary | Change in Fasting Plasma Glucose (FPG) From Baseline to Week 18 | The table below shows the least-squares (LS) mean change in FPG from Baseline to Week 18 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the LS mean change. | Analysis used overall mITT analysis set (all randomized patients who received at least 1 dose of study drug). Last-observation-carried-forward method used for missing Week 18 values. Table includes only participants with both baseline and post baseline values. | Posted | Least Squares Mean | Standard Error | mg/dL | Day 1 (Baseline) and Week 18 |
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| Secondary | Percent Change in Body Weight From Baseline to Week 18 | The table below shows the least-squares (LS) mean percent change in body weight from Baseline to Week 18 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the LS mean percent change. | Analysis used overall mITT analysis set (all randomized patients who received at least 1 dose of study drug). Last-observation-carried-forward method used for missing Week 18 values. Table includes only participants with both baseline and post baseline values. | Posted | Least Squares Mean | Standard Error | Pecent change | Day 1 (Baseline) and Week 18 |
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| Secondary | Percentage of Patients With Glycosylated Hemoglobin (HbA1c) <7% at Week 18 | The table below shows the percentage of patients with HbA1c <7% at Week 18 in each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the percentage. | Analysis used overall mITT analysis set (all randomized patients who received at least 1 dose of study drug). Last-observation-carried-forward method used for missing Week 18 values. Table includes only participants with both baseline and post baseline values. | Posted | Number | Percentage of patients | Day 1 (Baseline) and Week 18 |
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| Secondary | Percentage of Patients With Glycosylated Hemoglobin (HbA1c) <6.5% at Week 18 | The table below shows the percentage of patients with HbA1c <6.5% at Week 18 in each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the percentage. | Analysis used overall mITT analysis set (all randomized patients who received at least 1 dose of study drug). Last-observation-carried-forward method used for missing Week 18 values. Table includes only participants with both baseline and post baseline values. | Posted | Number | Percentage of patients | Day 1 (Baseline) and Week 18 |
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Adverse event data were collected for the duration of the study, consisting of an 18-week double-blind treatment phase and a 4-week follow-up period.
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any of the treatment arms during the study.
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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 | Placebo | Each participant received matching placebo once daily for 18 weeks with protocol-specified doses of metformin alone or metformin plus sulphonylurea. | 4 | 226 | 22 | 226 | ||
| EG001 | Canagliflozin 100 mg | Each participant received 100 mg of canagliflozin once daily for 18 weeks with protocol-specified doses of metformin alone or metformin plus sulphonylurea. | 5 | 223 | 27 | 223 | ||
| EG002 | Canagliflozin 300 mg | Each participant received 300 mg of canagliflozin once daily for 18 weeks with protocol-specified doses of metformin alone or metformin plus sulphonylurea. | 4 | 227 | 27 | 227 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrial flutter | Cardiac disorders | MEDDRA 15.1 | Systematic Assessment |
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| Appendicitis | Infections and infestations | MEDDRA 15.1 | Systematic Assessment |
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| Lung infection | Infections and infestations | MEDDRA 15.1 | Systematic Assessment |
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| Pneumonia | Infections and infestations | MEDDRA 15.1 | Systematic Assessment |
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| Tracheitis | Infections and infestations | MEDDRA 15.1 | Systematic Assessment |
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| Spinal compression fracture | Injury, poisoning and procedural complications | MEDDRA 15.1 | Systematic Assessment |
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| Hypoglycaemia | Metabolism and nutrition disorders | MEDDRA 15.1 | Systematic Assessment |
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| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MEDDRA 15.1 | Systematic Assessment |
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| Rotator cuff syndrome | Musculoskeletal and connective tissue disorders | MEDDRA 15.1 | Systematic Assessment |
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| Cerebral infarction | Nervous system disorders | MEDDRA 15.1 | Systematic Assessment |
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| Neuritis | Nervous system disorders | MEDDRA 15.1 | Systematic Assessment |
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| Neuropathy peripheral | Nervous system disorders | MEDDRA 15.1 | Systematic Assessment |
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| Transient ischaemic attack | Nervous system disorders | MEDDRA 15.1 | Systematic Assessment |
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| Bronchiectasis | Respiratory, thoracic and mediastinal disorders | MEDDRA 15.1 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Upper respiratory tract infection | Infections and infestations | MEDDRA 15.1 | Systematic Assessment |
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| Hypoglycaemia | Metabolism and nutrition disorders | MEDDRA 15.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Vice President, Franchise Medical Leader, Cardiovascular & Metabolism Franchise | Janssen Research & Development, LLC | 1-800-526-7736 |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D000068896 | Canagliflozin |
| D008687 | Metformin |
| D013453 | Sulfonylurea Compounds |
| ID | Term |
|---|---|
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D005960 | Glucosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D014508 | Urea |
| D000577 | Amides |
| D013450 | Sulfones |
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| Between 18 and 65 years |
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| >=65 years |
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| Male |
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| Malaysia |
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| Vietnam |
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| Least-Squares Mean Difference |
| -0.59 |
| Standard Error of the Mean |
| 0.071 |
| 2-Sided |
| 95 |
| -0.731 |
| -0.453 |
| No |
| Superiority or Other |
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