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| ID | Type | Description | Link |
|---|---|---|---|
| 28431754DIA3011 | Other Identifier | Janssen Research & Development, LLC | |
| 2011-000400-17 | EudraCT Number |
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The purpose of this study is to assess the effectiveness of the co-administration of canagliflozin and metformin extended release (XR) compared with canagliflozin alone, and metformin XR alone in patients with type 2 diabetes mellitus with inadequate control despite treatment with diet and exercise. The safety and tolerability of canagliflozin will also be assessed.
This study will be a randomized (the study medication is assigned by chance), double-blind (neither physician nor participant knows the identity of the assigned treatment), active-controlled (one of the treatments is an established effective treatment for type 2 diabetes mellitus), parallel-group (each group of participants will be treated at the same time), 5-arm (groups), multicenter study. Approximately 1,200 participants will be randomly assigned to the 5 treatment arms in a 1:1:1:1:1 ratio for 26 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Canagliflozin 100 mg | Experimental | Participants will receive one 100 mg canagliflozin capsule before the morning meal and one matching placebo capsule with the evening meal plus placebo tablets with the evening meal (to match the metformin XR tablets administered in other treatment arms) for 26 weeks. |
|
| Canagliflozin 300 mg | Experimental | Participants will receive one 300 mg canagliflozin capsule before the morning meal and one matching placebo capsule with the evening meal plus placebo tablets with the evening meal (to match the metformin XR tablets administered in other treatment arms) for 26 weeks. |
|
| Metformin XR | Experimental | Participants will receive metformin XR tablets (in doses titrated over 9 weeks) once daily with the evening meal, plus one placebo capsule before the morning meal and one placebo capsule with the evening meal (to match the canagliflozin capsules administered in other treatment arms) for 26 weeks. |
|
| Canagliflozin 100 mg + Metformin XR | Experimental | Participants will receive one 100 mg canagliflozin capsule with the evening meal and one matching placebo capsule before the morning meal plus metformin XR tablets (in doses titrated over 9 weeks) once daily with the evening meal for 26 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Canagliflozin 100 mg | Drug | One 100 mg capsule taken orally (by mouth) once daily either before the morning meal (for the Canagliflozin 100 mg arm) or with the evening meal (for the Canagliflozin 100 mg + Metformin XR arm). |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Glycated Hemoglobin (HbA1c) From Baseline at Week 26 | The change in the value of glycated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) from baseline at Week 26 was compared between the different treatment groups. | Day 1 (Baseline) and Week 26 |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change in Body Weight From Baseline to Week 26 | The percentage change in body weight from baseline to Week 26 was compared between the different treatment groups. | Day 1 (Baseline) and Week 26 |
| Percentage of Participants With Glycated Hemoglobin (HbAIc) Less Than 7 Percent at Week 26 |
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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 |
|---|---|---|---|---|---|---|
| Birmingham | Alabama | United States | ||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26786577 | Derived | Rosenstock J, Chuck L, Gonzalez-Ortiz M, Merton K, Craig J, Capuano G, Qiu R. Initial Combination Therapy With Canagliflozin Plus Metformin Versus Each Component as Monotherapy for Drug-Naive Type 2 Diabetes. Diabetes Care. 2016 Mar;39(3):353-62. doi: 10.2337/dc15-1736. Epub 2016 Jan 19. |
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A total of 1,186 participants were randomly allocated to the 5 treatment arms. All participants received at least 1 dose of study drug and were included in the modified intent-to-treat (mITT) analysis set.
The study was conducted between 16 May 2013 and 01 December 2014 and recruited participants from 158 study centers in 12 countries worldwide.
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| ID | Title | Description |
|---|---|---|
| FG000 | Metformin XR | Participants received metformin extended release (XR) tablets (in doses titrated over 9 weeks) once daily with the evening meal, plus one placebo capsule before the morning meal and one placebo capsule with the evening meal (to match the canagliflozin capsules administered in other treatment arms) for 26 weeks. |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Canagliflozin 300 mg + Metformin XR | Experimental | Participants will receive one 300 mg canagliflozin capsule with the evening meal and one matching placebo capsule before the morning meal plus metformin XR tablets (in doses titrated over 9 weeks) once daily with the evening meal for 26 weeks. |
|
| Canagliflozin 300 mg | Drug | One 300 mg capsule taken orally (by mouth) once daily either before the morning meal (for the Canagliflozin 300 mg arm) or with the evening meal (for the Canagliflozin 300 mg + Metformin XR arm). |
|
| Metformin XR | Drug | One 500 mg tablet (Day 1 up to week 1); two 500 mg tablets (Week 1 up to Week 3); three 500 mg tablets (Week 3 to Week 6); four 500 mg tablets (Week 6 to Week 9). Tablets will be administered with the evening meal. |
|
The percentage of participants achieved HbAIc less than 7 percent at Week 26 was compared between the different treatment groups. |
| Week 26 |
| Change in Systolic Blood Pressure From Baseline at Week 26 | The change in systolic blood pressure from baseline at Week 26 was compared between the different treatment groups. | Day 1 (Baseline) and Week 26 |
| Percent Change in Fasting High-Density Lipoprotein Cholesterol (HDL-C) From Baseline to Week 26 | The percentage change in Fasting High-Density Lipoprotein Cholesterol (HDL-C) from baseline to Week 26 was compared between the different treatment groups. | Day 1 (Baseline) and Week 26 |
| Percent Change in Triglycerides From Baseline to Week 26 | The percentage change in triglycerides from baseline to Week 26 was compared between the different treatment groups. | Day 1 (Baseline) and Week 26 |
| Number of Participants With Treatment Emergent Adverse Events (AEs) | An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between administration of study drug and up to 30 days after last dose of study drug that were absent before treatment or that worsened relative to pre-treatment state. | Up to 30 weeks of last study drug administration |
| Phoenix |
| Arizona |
| United States |
| Encinitas | California | United States |
| Newport Beach | California | United States |
| Northridge | California | United States |
| Norwalk | California | United States |
| Rancho Cucamonga | California | United States |
| Walnut Creek | California | United States |
| Denver | Colorado | United States |
| Northglenn | Colorado | United States |
| Hialeah | Florida | United States |
| Miami | Florida | United States |
| New Port Richey | Florida | United States |
| Opa-locka | Florida | United States |
| Perry | Georgia | United States |
| Evansville | Indiana | United States |
| Mandeville | Louisiana | United States |
| Metairie | Louisiana | United States |
| Sunset | Louisiana | United States |
| Flint | Michigan | United States |
| Kalamazoo | Michigan | United States |
| Royal Oak | Michigan | United States |
| Troy | Michigan | United States |
| Olive Branch | Mississippi | United States |
| Picayune | Mississippi | United States |
| Albuquerque | New Mexico | United States |
| West Seneca | New York | United States |
| Hickory | North Carolina | United States |
| Mooresville | North Carolina | United States |
| Franklin | Ohio | United States |
| Mason | Ohio | United States |
| Perrysburg | Ohio | United States |
| Zanesville | Ohio | United States |
| Oklahoma City | Oklahoma | United States |
| Yukon | Oklahoma | United States |
| Tualatin | Oregon | United States |
| Fleetwood | Pennsylvania | United States |
| Norristown | Pennsylvania | United States |
| Pittsburgh | Pennsylvania | United States |
| Rapid City | South Dakota | United States |
| Nashville | Tennessee | United States |
| Austin | Texas | United States |
| Bellaire | Texas | United States |
| Dallas | Texas | United States |
| Houston | Texas | United States |
| Pearland | Texas | United States |
| Plano | Texas | United States |
| Bountiful | Utah | United States |
| Salt Lake City | Utah | United States |
| Danville | Virginia | United States |
| Norfolk | Virginia | United States |
| Richmond | Virginia | United States |
| Buenos Aires | Argentina |
| Ciudad Autonoma Buenos Aires | Argentina |
| Córdoba | Argentina |
| Mar del Plata | Argentina |
| Morón | Argentina |
| Rosario | Argentina |
| Zárate | Argentina |
| Passo Fundo | Brazil |
| São Paulo | Brazil |
| Kroměříž | Czechia |
| Pardubice | Czechia |
| Prague | Czechia |
| Uničov | Czechia |
| Balatonfüred | Hungary |
| Budapest | Hungary |
| Eger | Hungary |
| Szikszó | Hungary |
| Zalaegerszeg | Hungary |
| Celaya | Mexico |
| Durango | Mexico |
| Guadalajara | Mexico |
| México | Mexico |
| Monterrey | Mexico |
| Pachuca | Mexico |
| Tampico | Mexico |
| Carolina | Puerto Rico |
| Ponce | Puerto Rico |
| San Juan | Puerto Rico |
| Trujillo Alto | Puerto Rico |
| Bacau | Romania |
| Brasov | Romania |
| Bucharest | Romania |
| Oradea | Romania |
| Tg Mures | Romania |
| Arkhangelsk | Russia |
| Barnaul | Russia |
| Chelyabinsk | Russia |
| Kemerovo | Russia |
| Moscow | Russia |
| Penza | Russia |
| Rostov-on-Don | Russia |
| Saint Petersburg | Russia |
| Samara | Russia |
| Saratov | Russia |
| Smolensk | Russia |
| Syktyvkar | Russia |
| Tomsk | Russia |
| Tyumen | Russia |
| Voronezh | Russia |
| Banská Bystrica | Slovakia |
| Bratislava | Slovakia |
| Malacky | Slovakia |
| Prešov | Slovakia |
| Rimavská Sobota | Slovakia |
| Šahy | Slovakia |
| Trebišov | Slovakia |
| Cape Town | South Africa |
| Durban | South Africa |
| Halfway | South Africa |
| Johannesburg | South Africa |
| Soweto, Johannesburg | South Africa |
| Worcester | South Africa |
| Goyang-si | South Korea |
| Seoul | South Korea |
| Suwon | South Korea |
| Cherkasy | Ukraine |
| Dnipro | Ukraine |
| Donetsk | Ukraine |
| Ivano-Frankivsk | Ukraine |
| Kharkiv | Ukraine |
| Kiev | Ukraine |
| Kyiv | Ukraine |
| Lviv | Ukraine |
| Odesa | Ukraine |
| Poltava | Ukraine |
| Sumy | Ukraine |
| Zaporizhzhya | Ukraine |
| Canagliflozin 100 Milligram (mg) |
Participants received one 100 milligram (mg) canagliflozin capsule before the morning meal and one matching placebo capsule with the evening meal plus placebo tablets with the evening meal (to match the metformin XR tablets administered in other treatment arms) for 26 weeks. |
| FG002 | Canagliflozin 300 mg | Participants received one 300 mg canagliflozin capsule before the morning meal and one matching placebo capsule with the evening meal plus placebo tablets with the evening meal (to match the metformin XR tablets administered in other treatment arms) for 26 weeks. |
| FG003 | Canagliflozin 100 mg + Metformin XR | Participants received one 100 mg canagliflozin capsule with the evening meal and one matching placebo capsule before the morning meal plus metformin XR tablets (in doses titrated over 9 weeks) once daily with the evening meal for 26 weeks. |
| FG004 | Canagliflozin 300 mg + Metformin XR | Participants received one 300 mg canagliflozin capsule with the evening meal and one matching placebo capsule before the morning meal plus metformin XR tablets (in doses titrated over 9 weeks) once daily with the evening meal for 26 weeks. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Metformin XR | Participants received metformin extended release (XR) tablets (in doses titrated over 9 weeks) once daily with the evening meal, plus one placebo capsule before the morning meal and one placebo capsule with the evening meal (to match the canagliflozin capsules administered in other treatment arms) for 26 weeks. |
| BG001 | Canagliflozin 100 Milligram (mg) | Participants received one 100 milligram (mg) canagliflozin capsule before the morning meal and one matching placebo capsule with the evening meal plus placebo tablets with the evening meal (to match the metformin XR tablets administered in other treatment arms) for 26 weeks. |
| BG002 | Canagliflozin 300 mg | Participants received one 300 mg canagliflozin capsule before the morning meal and one matching placebo capsule with the evening meal plus placebo tablets with the evening meal (to match the metformin XR tablets administered in other treatment arms) for 26 weeks. |
| BG003 | Canagliflozin 100 mg + Metformin XR | Participants received one 100 mg canagliflozin capsule with the evening meal and one matching placebo capsule before the morning meal plus metformin XR tablets (in doses titrated over 9 weeks) once daily with the evening meal for 26 weeks. |
| BG004 | Canagliflozin 300 mg + Metformin XR | Participants received one 300 mg canagliflozin capsule with the evening meal and one matching placebo capsule before the morning meal plus metformin XR tablets (in doses titrated over 9 weeks) once daily with the evening meal for 26 weeks. |
| BG005 | 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, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | 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 in Glycated Hemoglobin (HbA1c) From Baseline at Week 26 | The change in the value of glycated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) from baseline at Week 26 was compared between the different treatment groups. | This analysis was conducted using the modified intent-to-treat analysis set, which included all participants who were randomly assigned to a treatment group and received at least 1 dose of study drug. Here "N" (Number of Participants Analyzed) signifies number of Participants who were evaluable for this outcome measure. | Posted | Least Squares Mean | Standard Error | percentage of hemoglobin | Day 1 (Baseline) and Week 26 |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percent Change in Body Weight From Baseline to Week 26 | The percentage change in body weight from baseline to Week 26 was compared between the different treatment groups. | This analysis was conducted using the modified intent-to-treat analysis set, which included all participants who were randomly assigned to a treatment group and received at least 1 dose of study drug. Here "N" (Number of Participants Analyzed) signifies number of Participants who were evaluable for this outcome measure. | Posted | Least Squares Mean | Standard Error | percent change | Day 1 (Baseline) and Week 26 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Glycated Hemoglobin (HbAIc) Less Than 7 Percent at Week 26 | The percentage of participants achieved HbAIc less than 7 percent at Week 26 was compared between the different treatment groups. | This analysis was conducted using the modified intent-to-treat analysis set, which included all participants who were randomly assigned to a treatment group and received at least 1 dose of study drug. Here "N" (Number of Participants Analyzed) signifies number of Participants who were evaluable for this outcome measure. | Posted | Number | percentage of participants | Week 26 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change in Systolic Blood Pressure From Baseline at Week 26 | The change in systolic blood pressure from baseline at Week 26 was compared between the different treatment groups. | This analysis was conducted using the modified intent-to-treat analysis set, which included all participants who were randomly assigned to a treatment group and received at least 1 dose of study drug. Here "N" (Number of Participants Analyzed) signifies number of Participants who were evaluable for this outcome measure. | Posted | Least Squares Mean | Standard Error | millimeter of mercury (mm Hg) | Day 1 (Baseline) and Week 26 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percent Change in Fasting High-Density Lipoprotein Cholesterol (HDL-C) From Baseline to Week 26 | The percentage change in Fasting High-Density Lipoprotein Cholesterol (HDL-C) from baseline to Week 26 was compared between the different treatment groups. | Analysis used mITT analysis set (all randomized patients who received at least 1 dose of study drug). Here "N" (Number of Participants Analyzed) signifies number of Participants who were evaluable for this outcome measure. | Posted | Least Squares Mean | Standard Error | percent change | Day 1 (Baseline) and Week 26 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percent Change in Triglycerides From Baseline to Week 26 | The percentage change in triglycerides from baseline to Week 26 was compared between the different treatment groups. | Analysis used mITT analysis set (all randomized patients who received at least 1 dose of study drug). Here "N" (Number of Participants Analyzed) signifies number of Participants who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | percent change | Day 1 (Baseline) and Week 26 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Treatment Emergent Adverse Events (AEs) | An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between administration of study drug and up to 30 days after last dose of study drug that were absent before treatment or that worsened relative to pre-treatment state. | Safety Analysis Set included all randomized participants who received at least 1 dose of double-blind study drug. | Posted | Number | participants | Up to 30 weeks of last study drug administration |
|
Up to 30 weeks of last study drug administration
The total number of adverse events listed in the "Other (non-Serious) Adverse Event" table are based on atleast 2 percent of participants experiencing the adverse event in any treatment arm.
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 | Metformin XR | Participants received metformin extended release (XR) tablets (in doses titrated over 9 weeks) once daily with the evening meal, plus one placebo capsule before the morning meal and one placebo capsule with the evening meal (to match the canagliflozin capsules administered in other treatment arms) for 26 weeks. | 7 | 237 | 37 | 237 | ||
| EG001 | Canagliflozin 100 Milligram (mg) | Participants received one 100 milligram (mg) canagliflozin capsule before the morning meal and one matching placebo capsule with the evening meal plus placebo tablets with the evening meal (to match the metformin XR tablets administered in other treatment arms) for 26 weeks. | 4 | 237 | 38 | 237 | ||
| EG002 | Canagliflozin 300 mg | Participants received one 300 mg canagliflozin capsule before the morning meal and one matching placebo capsule with the evening meal plus placebo tablets with the evening meal (to match the metformin XR tablets administered in other treatment arms) for 26 weeks. | 7 | 238 | 38 | 238 | ||
| EG003 | Canagliflozin 100 mg + Metformin XR | Participants received one 100 mg canagliflozin capsule with the evening meal and one matching placebo capsule before the morning meal plus metformin XR tablets (in doses titrated over 9 weeks) once daily with the evening meal for 26 weeks. | 7 | 237 | 42 | 237 | ||
| EG004 | Canagliflozin 300 mg + Metformin XR | Participants received one 300 mg canagliflozin capsule with the evening meal and one matching placebo capsule before the morning meal plus metformin XR tablets (in doses titrated over 9 weeks) once daily with the evening meal for 26 weeks. | 4 | 237 | 43 | 237 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA Version 17.1 | Non-systematic Assessment |
| |
| Immune Thrombocytopenic Purpura | Blood and lymphatic system disorders | MedDRA Version 17.1 | Non-systematic Assessment |
| |
| Angina Pectoris | Cardiac disorders | MedDRA Version 17.1 | Non-systematic Assessment |
| |
| Angina Unstable | Cardiac disorders | MedDRA Version 17.1 | Non-systematic Assessment |
| |
| Arrhythmia | Cardiac disorders | MedDRA Version 17.1 | Non-systematic Assessment |
| |
| Atrial Fibrillation | Cardiac disorders | MedDRA Version 17.1 | Non-systematic Assessment |
| |
| Coronary Artery Disease | Cardiac disorders | MedDRA Version 17.1 | Non-systematic Assessment |
| |
| Goitre | Endocrine disorders | MedDRA Version 17.1 | Non-systematic Assessment |
| |
| Diverticulum | Gastrointestinal disorders | MedDRA Version 17.1 | Non-systematic Assessment |
| |
| Epiploic Appendagitis | Gastrointestinal disorders | MedDRA Version 17.1 | Non-systematic Assessment |
| |
| Cardiac Death | General disorders | MedDRA Version 17.1 | Non-systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA Version 17.1 | Non-systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA Version 17.1 | Non-systematic Assessment |
| |
| Lobar Pneumonia | Infections and infestations | MedDRA Version 17.1 | Non-systematic Assessment |
| |
| Ophthalmic Herpes Simplex | Infections and infestations | MedDRA Version 17.1 | Non-systematic Assessment |
| |
| Urinary Tract Infection | Infections and infestations | MedDRA Version 17.1 | Non-systematic Assessment |
| |
| Extradural Haematoma | Injury, poisoning and procedural complications | MedDRA Version 17.1 | Non-systematic Assessment |
| |
| Post Laminectomy Syndrome | Injury, poisoning and procedural complications | MedDRA Version 17.1 | Non-systematic Assessment |
| |
| Ketoacidosis | Metabolism and nutrition disorders | MedDRA Version 17.1 | Non-systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA Version 17.1 | Non-systematic Assessment |
| |
| Endometrial Adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 17.1 | Non-systematic Assessment |
| |
| Medullary Thyroid Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 17.1 | Non-systematic Assessment |
| |
| Pancreatic Carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 17.1 | Non-systematic Assessment |
| |
| Cerebrovascular Accident | Nervous system disorders | MedDRA Version 17.1 | Non-systematic Assessment |
| |
| Cervicobrachial Syndrome | Nervous system disorders | MedDRA Version 17.1 | Non-systematic Assessment |
| |
| Ischaemic Stroke | Nervous system disorders | MedDRA Version 17.1 | Non-systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA Version 17.1 | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA Version 17.1 | Non-systematic Assessment |
| |
| Arterial Occlusive Disease | Vascular disorders | MedDRA Version 17.1 | Non-systematic Assessment |
| |
| Deep Vein Thrombosis | Vascular disorders | MedDRA Version 17.1 | Non-systematic Assessment |
| |
| Peripheral Arterial Occlusive Disease | Vascular disorders | MedDRA Version 17.1 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA Version 17.1 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA Version 17.1 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA Version 17.1 | Non-systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA Version 17.1 | Non-systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA Version 17.1 | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA Version 17.1 | Non-systematic Assessment |
| |
| Upper Respiratory Tract Infection | Infections and infestations | MedDRA Version 17.1 | Non-systematic Assessment |
| |
| Urinary Tract Infection | Infections and infestations | MedDRA Version 17.1 | Non-systematic Assessment |
| |
| Glomerular Filtration Rate Decreased | Investigations | MedDRA Version 17.1 | Non-systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA Version 17.1 | Non-systematic Assessment |
| |
| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA Version 17.1 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA Version 17.1 | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA Version 17.1 | Non-systematic Assessment |
|
A copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. If requested in writing, such publication will be withheld for up to an additional 60 days.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Director Clinical Research | Janssen Research & Development, LLC | ClinicalTrialDisclosure@its.jnj.com |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000068896 | Canagliflozin |
| ID | Term |
|---|---|
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D005960 | Glucosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
Not provided
Not provided
| Male |
|
| Brazil |
|
| Czech Republic |
|
| Hungary |
|
| Mexico |
|
| Romania |
|
| Russian Federation |
|
| Slovakia |
|
| South Africa |
|
| South Korea |
|
| Ukraine |
|
| United States |
|
| 0.001 |
| Least-Squares Mean Difference |
| -0.48 |
| Standard Error of the Mean |
| 0.099 |
| 2-Sided |
| 95 |
| -0.670 |
| -0.280 |
| Superiority or Other |
| Mixed Model for Repeated Measures (MMRM) | 0.001 | Least-Squares Mean Difference | -0.40 | Standard Error of the Mean | 0.099 | 2-Sided | 95 | -0.594 | -0.207 | Superiority or Other |
| Mixed Model for Repeated Measures (MMRM) | 0.001 | Least-Squares Mean Difference | -0.36 | Standard Error of the Mean | 0.099 | 2-Sided | 95 | -0.557 | -0.169 | Superiority or Other |
| Mixed Model for Repeated Measures (MMRM) | 0.001 | Least-Squares Mean Difference | -0.06 | Standard Error of the Mean | 0.100 | 2-Sided | 95 | -0.258 | 0.133 | Non-Inferiority or Equivalence | P value corresponds to a comparison that canagliflozin is noninferior to Metformin XR by a margin of 0.35%. |
| Mixed Model for Repeated Measures (MMRM) | 0.001 | Least-Squares Mean Difference | -0.11 | Standard Error of the Mean | 0.099 | 2-Sided | 95 | -0.307 | 0.082 | Non-Inferiority or Equivalence | P value corresponds to a comparison that canagliflozin is noninferior to Metformin XR by a margin of 0.35%. |
Participants received one 300 mg canagliflozin capsule before the morning meal and one matching placebo capsule with the evening meal plus placebo tablets with the evening meal (to match the metformin XR tablets administered in other treatment arms) for 26 weeks. |
| OG003 | Canagliflozin 100 mg + Metformin XR | Participants received one 100 mg canagliflozin capsule with the evening meal and one matching placebo capsule before the morning meal plus metformin XR tablets (in doses titrated over 9 weeks) once daily with the evening meal for 26 weeks. |
| OG004 | Canagliflozin 300 mg + Metformin XR | Participants received one 300 mg canagliflozin capsule with the evening meal and one matching placebo capsule before the morning meal plus metformin XR tablets (in doses titrated over 9 weeks) once daily with the evening meal for 26 weeks. |
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Participants received one 300 mg canagliflozin capsule before the morning meal and one matching placebo capsule with the evening meal plus placebo tablets with the evening meal (to match the metformin XR tablets administered in other treatment arms) for 26 weeks. |
| OG003 | Canagliflozin 100 mg + Metformin XR | Participants received one 100 mg canagliflozin capsule with the evening meal and one matching placebo capsule before the morning meal plus metformin XR tablets (in doses titrated over 9 weeks) once daily with the evening meal for 26 weeks. |
| OG004 | Canagliflozin 300 mg + Metformin XR | Participants received one 300 mg canagliflozin capsule with the evening meal and one matching placebo capsule before the morning meal plus metformin XR tablets (in doses titrated over 9 weeks) once daily with the evening meal for 26 weeks. |
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Participants received one 300 mg canagliflozin capsule before the morning meal and one matching placebo capsule with the evening meal plus placebo tablets with the evening meal (to match the metformin XR tablets administered in other treatment arms) for 26 weeks. |
| OG003 | Canagliflozin 100 mg + Metformin XR | Participants received one 100 mg canagliflozin capsule with the evening meal and one matching placebo capsule before the morning meal plus metformin XR tablets (in doses titrated over 9 weeks) once daily with the evening meal for 26 weeks. |
| OG004 | Canagliflozin 300 mg + Metformin XR | Participants received one 300 mg canagliflozin capsule with the evening meal and one matching placebo capsule before the morning meal plus metformin XR tablets (in doses titrated over 9 weeks) once daily with the evening meal for 26 weeks. |
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Participants received one 300 mg canagliflozin capsule before the morning meal and one matching placebo capsule with the evening meal plus placebo tablets with the evening meal (to match the metformin XR tablets administered in other treatment arms) for 26 weeks. |
| OG003 | Canagliflozin 100 mg + Metformin XR | Participants received one 100 mg canagliflozin capsule with the evening meal and one matching placebo capsule before the morning meal plus metformin XR tablets (in doses titrated over 9 weeks) once daily with the evening meal for 26 weeks. |
| OG004 | Canagliflozin 300 mg + Metformin XR | Participants received one 300 mg canagliflozin capsule with the evening meal and one matching placebo capsule before the morning meal plus metformin XR tablets (in doses titrated over 9 weeks) once daily with the evening meal for 26 weeks. |
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| OG003 | Canagliflozin 100 mg + Metformin XR | Participants received one 100 mg canagliflozin capsule with the evening meal and one matching placebo capsule before the morning meal plus metformin XR tablets (in doses titrated over 9 weeks) once daily with the evening meal for 26 weeks. |
| OG004 | Canagliflozin 300 mg + Metformin XR | Participants received one 300 mg canagliflozin capsule with the evening meal and one matching placebo capsule before the morning meal plus metformin XR tablets (in doses titrated over 9 weeks) once daily with the evening meal for 26 weeks. |
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| OG002 | Canagliflozin 300 mg | Participants received one 300 mg canagliflozin capsule before the morning meal and one matching placebo capsule with the evening meal plus placebo tablets with the evening meal (to match the metformin XR tablets administered in other treatment arms) for 26 weeks. |
| OG003 | Canagliflozin 100 mg + Metformin XR | Participants received one 100 mg canagliflozin capsule with the evening meal and one matching placebo capsule before the morning meal plus metformin XR tablets (in doses titrated over 9 weeks) once daily with the evening meal for 26 weeks. |
| OG004 | Canagliflozin 300 mg + Metformin XR | Participants received one 300 mg canagliflozin capsule with the evening meal and one matching placebo capsule before the morning meal plus metformin XR tablets (in doses titrated over 9 weeks) once daily with the evening meal for 26 weeks. |
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