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| ID | Type | Description | Link |
|---|---|---|---|
| 28431754DIA1056 | Other Identifier | Janssen-Cilag International NV | |
| 2013-000994-54 | EudraCT Number |
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The purpose of this study is to compare the pharmacodynamics (ie, how the drug affects the body) of canagliflozin with the pharmacodynamics of dapagliflozin.
The study will be conducted as a 2-part study. Part 1 is an open-label pilot study (the investigator and the participants know the identity of the assigned treatment) in which 6 healthy volunteers will be given 300 mg of canagliflozin once daily for 4 consecutive days. The total study duration for each volunteer in Part 1 will be approximately 35 days (including a screening phase, an open-label treatment phase, and a follow-up phase). Part 2 will be a double-blind (neither the investigator nor volunteers know the identity of the assigned treatment), randomized (the treatment is assigned by chance), 2-period crossover study (all volunteers will receive each of the 2 treatments but in a different order) with a two-stage sequential group design.
Approximately 34 healthy volunteers will be participating in the first stage. After all the participants of the first stage will complete Part 2, and the results are analyzed, based on the first stage outcomes the study will be either terminated or will proceed to the second stage, which will be conducted using the same study method as in the first stage.
Potentially, up to 30 volunteers will participate in the second stage. A total number of participants in Part 2 will be up to 64.
Volunteers assigned to Treatment Sequence 1 will receive 10 mg of dapagliflozin once daily for 4 consecutive days (Period 1), and after a 12- to 14-day washout period (with no medication), 300 mg of canagliflozin once daily for 4 days (Period 2). Volunteers assigned to Treatment Sequence 2 will receive 300 mg of canagliflozin once daily for 4 days (Period 1), and after a 12- to 14-day washout period, 10 mg of dapagliflozin once daily for 4 consecutive days (Period 2). The total study duration for each volunteer in Part 2 will be up to approximately 65 days (including a screening phase, a baseline phase, a double-blind treatment phase, a washout period, and a follow-up phase).
Volunteers can participate in Part 1 or Part 2 of the study, but not in both parts. Canagliflozin and dapagliflozin are used for the treatment of type 2 diabetes mellitus.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1: Cana | Experimental | Each volunteer will receive 300 mg of canagliflozin once daily for 4 days. |
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| Part 2: Sequence 1 (Dapa/Cana) | Experimental | Each volunteer will receive 10 mg of dapagliflozin once daily for 4 days (treatment period 1) followed by 300 mg of canagliflozin once daily for 4 days (treatment period 2). Each treatment period will be separated by a 12- to 14-day washout period (with no medication). |
|
| Part 2: Sequence 2 (Cana/Dapa) | Experimental | Each volunteer will receive 300 mg of canagliflozin once daily for 4 days (treatment period 1) followed by 10 mg of dapagliflozin once daily for 4 days (treatment period 2). Each treatment period will be separated by a 12- to 14-day washout period. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Canagliflozin | Drug | One 300 mg over-encapsulated tablet taken orally (by mouth) once daily for 4 days during Part 1 and Part 2 (Sequence 1 [treatment period 2] or Sequence 2 [treatment period 1]). |
| Measure | Description | Time Frame |
|---|---|---|
| Between treatment difference in 24-hour mean renal threshold for glucose for canagliflozin (300 mg once daily for 4 days) compared to dapagliflozin (10 mg once daily for 4 days) | Renal threshold is defined as the plasma glucose concentration above which glucose is excreted in the urine. | Day 4 |
| Measure | Description | Time Frame |
|---|---|---|
| Percent change from baseline in postprandial glucose area under the curve at 0-2 hours post-dose on Day 4 following 300 mg of canagliflozin once daily for 4 days or 10 mg of dapagliflozin once daily for 4 days | Area under the concentration time curve (or area under the curve) is a measure of the body's exposure to glucose over a specific time period. | Day -10 (Baseline) and Day 4 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Janssen-Cilag International NV Clinical Trial | Janssen-Cilag International NV | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Neuss | Germany |
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| ID | Term |
|---|---|
| D000068896 | Canagliflozin |
| C529054 | dapagliflozin |
| ID | Term |
|---|---|
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D006573 | Heterocyclic Compounds, 1-Ring |
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| Dapagliflozin | Drug | One 10 mg over-encapsulated tablet taken orally once daily for 4 days during Part 2 (Sequence 1 [treatment period 1] or Sequence 2 [treatment period 2]). |
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| Number of volunteers with adverse events | Adverse events will be used as a measure of safety and tolerability | Up to Day 65 |
| D006571 |
| Heterocyclic Compounds |
| D005960 | Glucosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |