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| ID | Type | Description | Link |
|---|---|---|---|
| 2013-005078-24 | EudraCT Number | ||
| 28431754DIA2004 | Other Identifier | Janssen Research & Development, LLC |
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The purpose of this study is to assess the effects of administration of canagliflozin 100 mg and 300 mg, compared with placebo as an addition to insulin therapy for the treatment of Type 1 Diabetes Mellitus (T1DM).
This is a randomized (the study medication is assigned by chance), double-blind (neither physician nor participant knows the identity of the assigned treatment), placebo-controlled (an inactive substance that is compared with a medication to test whether the medication has a real effect) parallel-group, multicenter study of canagliflozin as an addition to insulin therapy for participants with type 1 diabetes mellitus and inadequate glycemic control.
Approximately 330 participants will be randomly assigned in a 1:1:1 ratio to either canagliflozin 100 mg, canagliflozin 300 mg, or placebo groups. About 90 participants (30 per treatment group) will be selected for a substudy with a purpose of a continuous glucose monitoring (CGM) assessment for 7 days at baseline and 7 days at the end of treatment.
The total duration of the participation will be about 22 weeks, during which participants will need to return to investigational sites for approximately 9 visits. During the study participants will receive advice on treatment of hypoglycemia and diabetic ketoacidosis (DKA), as well as on compliance with diet and exercise.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Canagliflozin 100 mg | Experimental | Each participant will receive 100 mg of canagliflozin once daily for 18 weeks. |
|
| Canagliflozin 300 mg | Experimental | Each participant will receive 300 mg of canagliflozin once daily for 18 weeks. |
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| Placebo | Placebo Comparator | Each participant will receive matching placebo once daily for 18 weeks |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Canagliflozin 100 mg | Drug | Canagliflozin capsule of 100 mg dose will be taken orally, before the first meal of the day. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Hemoglobin A1c (HbA1c) Reduction Greater Than or Equal to (>=) 0.4 Percent (%) and no Increase in Body Weight | Clinical response at Weeks 18 was assessed by the percentage of participants with Hemoglobin A1c (HbA1c) reduction greater than or equal to 0.4 % and had no increase in body weight. | Week 18 |
| Percentage of Participants With Adverse Events | Up to 22 Weeks |
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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 |
|---|---|---|---|---|---|---|
| Little Rock | Arkansas | United States | ||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27899497 | Derived | Rodbard HW, Peters AL, Slee A, Cao A, Traina SB, Alba M. The Effect of Canagliflozin, a Sodium Glucose Cotransporter 2 Inhibitor, on Glycemic End Points Assessed by Continuous Glucose Monitoring and Patient-Reported Outcomes Among People With Type 1 Diabetes. Diabetes Care. 2017 Feb;40(2):171-180. doi: 10.2337/dc16-1353. Epub 2016 Nov 29. | |
| 26989182 |
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A total of 614 participants were screened and 352 subjects (57.3%) were randomized to study drug. One subject randomized to placebo did not take any study drug and withdrew consent on the day of randomization.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Participants received canagliflozin matching placebo capsules once daily for 18 weeks. |
| FG001 | Canagliflozin 100 Milligram (mg) | Participants received 100 mg of canagliflozin capsules once daily for 18 weeks. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Canagliflozin 300 mg | Drug | Canagliflozin capsule of 300 mg dose will be taken orally, before the first meal of the day. |
|
| Placebo | Drug | Matching placebo capsule will be taken orally, before the first meal of the day. |
|
| Concord |
| California |
| United States |
| La Jolla | California | United States |
| Los Angeles | California | United States |
| Los Gatos | California | United States |
| Northridge | California | United States |
| Orange | California | United States |
| San Francisco | California | United States |
| Temecula | California | United States |
| Tustin | California | United States |
| Ventura | California | United States |
| Walnut Creek | California | United States |
| Denver | Colorado | United States |
| Miami | Florida | United States |
| Palm Harbor | Florida | United States |
| Atlanta | Georgia | United States |
| Honolulu | Hawaii | United States |
| Council Bluffs | Iowa | United States |
| Des Moines | Iowa | United States |
| Baton Rouge | Louisiana | United States |
| Rockville | Maryland | United States |
| Billings | Montana | United States |
| Omaha | Nebraska | United States |
| El Paso | Nevada | United States |
| Las Vegas | Nevada | United States |
| Nashua | New Hampshire | United States |
| Billings | New York | United States |
| Smithtown | New York | United States |
| Morehead City | North Carolina | United States |
| Columbus | Ohio | United States |
| Mentor | Ohio | United States |
| Philadelphia | Pennsylvania | United States |
| Greer | South Carolina | United States |
| Bloomington | Tennessee | United States |
| Arlington | Texas | United States |
| Austin | Texas | United States |
| Dallas | Texas | United States |
| El Paso | Texas | United States |
| Houston | Texas | United States |
| San Antonio | Texas | United States |
| Schertz | Texas | United States |
| Tomball | Texas | United States |
| Ogden | Utah | United States |
| Salt Lake City | Utah | United States |
| Spokane | Washington | United States |
| Milwaukee | Wisconsin | United States |
| Calgary | Alberta | Canada |
| London | Ontario | Canada |
| Oakville | Ontario | Canada |
| Thornhill | Ontario | Canada |
| Toronto | Ontario | Canada |
| Laval | Quebec | Canada |
| Sainte-Foy | Quebec | Canada |
| Peters AL, Henry RR, Thakkar P, Tong C, Alba M. Diabetic Ketoacidosis With Canagliflozin, a Sodium-Glucose Cotransporter 2 Inhibitor, in Patients With Type 1 Diabetes. Diabetes Care. 2016 Apr;39(4):532-8. doi: 10.2337/dc15-1995. |
| 26486192 | Derived | Henry RR, Thakkar P, Tong C, Polidori D, Alba M. Efficacy and Safety of Canagliflozin, a Sodium-Glucose Cotransporter 2 Inhibitor, as Add-on to Insulin in Patients With Type 1 Diabetes. Diabetes Care. 2015 Dec;38(12):2258-65. doi: 10.2337/dc15-1730. Epub 2015 Oct 20. |
| FG002 | Canagliflozin 300 mg | Participants received 300 mg of canagliflozin capsules once daily for 18 weeks. |
| COMPLETED |
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| NOT COMPLETED |
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Modified intent-to-treat analysis set included all randomized participants who took at least 1 dose of double-blind study drug.
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Participants received canagliflozin matching placebo capsules once daily for 18 weeks. |
| BG001 | Canagliflozin 100 Milligram (mg) | Participants received 100 mg of canagliflozin capsules once daily for 18 weeks. |
| BG002 | Canagliflozin 300 mg | Participants received 300 mg of canagliflozin capsules once daily for 18 weeks. |
| BG003 | 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 |
| ||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| 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 | |||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants With Hemoglobin A1c (HbA1c) Reduction Greater Than or Equal to (>=) 0.4 Percent (%) and no Increase in Body Weight | Clinical response at Weeks 18 was assessed by the percentage of participants with Hemoglobin A1c (HbA1c) reduction greater than or equal to 0.4 % and had no increase in body weight. | Modified intent-to-treat analysis set included all randomized participants who took at least 1 dose of double-blind study drug. 'N (Number of Participants Analyzed)' signifies participants who were evaluable for this outcome measure. | Posted | Number | percentage of participants | Week 18 |
|
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| Primary | Percentage of Participants With Adverse Events | Safety Analysis Set included all randomized participants who took at least 1 dose of double-blind study drug. | Posted | Number | percentage of participants | Up to 22 Weeks |
|
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Up to 22 Weeks
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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 | Participants received canagliflozin matching placebo capsules once daily for 18 weeks. | 0 | 117 | 32 | 117 | ||
| EG001 | Canagliflozin 100 Milligram (mg) | Participants received 100 mg of canagliflozin capsules once daily for 18 weeks. | 9 | 117 | 36 | 117 | ||
| EG002 | Canagliflozin 300 mg | Participants received 300 mg of canagliflozin capsules once daily for 18 weeks. | 8 | 117 | 43 | 117 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Non-cardiac chest pain | General disorders | 17.1 | Non-systematic Assessment |
| |
| Cellulitis | Infections and infestations | 17.1 | Non-systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | 17.1 | Non-systematic Assessment |
| |
| Diabetic ketoacidosis | Metabolism and nutrition disorders | 17.1 | Non-systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | 17.1 | Non-systematic Assessment |
| |
| Papillary thyroid cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 17.1 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | 17.1 | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | 17.1 | Non-systematic Assessment |
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| Sinusitis | Infections and infestations | 17.1 | Non-systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | 17.1 | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | 17.1 | Non-systematic Assessment |
| |
| Vulvovaginal mycotic infection | Infections and infestations | 17.1 | Non-systematic Assessment |
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| Hypoglycaemia | Metabolism and nutrition disorders | 17.1 | Non-systematic Assessment |
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| Pollakiuria | Renal and urinary disorders | 17.1 | Non-systematic Assessment |
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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 |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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| 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 |
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| Between 18 and 65 years |
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| >=65 years |
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| Male |
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| United Stats |
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| Title | Measurements |
|---|---|
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