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| ID | Type | Description | Link |
|---|---|---|---|
| 28431754DIA1022 |
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The purpose of this study is to evaluate the effect of canagliflozin on gastrointestinal glucose absorption in healthy volunteers.
This is a single center study that will be conducted in two Parts (Part 1 and Part 2) to evaluate the effect of a single-dose of canagliflozin on the absorption of glucose in healthy volunteers. Part 1 is a pilot (small) study where responses to key pharmocodynamic (PD) parameters (ie, specific tests on blood samples to evaluate effects of no treatment on the body) will be measured to confirm the study design and number of volunteers planned for Part 2. Part 2 is the main study where volunteers will be randomized (assigned to study drug or placebo by chance) to receive double-blind (neither the volunteer or study physician will know the identity of the treatment assigned) treatment with canagliflozin or placebo (treatment identical in appearance to canagliflozin but contains no active drug) to evaluate the effect of canagliflozin compared to placebo on gastrointestinal glucose absorption using a radiolabeled glucose tracer approach (ie, where a radioactive substance is combined with glucose allowing the movement of glucose in the body to be traced or detected). Blood and urine samples will be collected from volunteers at pre-defined times during the study for PD analysis. Safety will be monitored during the study by evaluating adverse events and results from clinical laboratory tests, vital signs measurements, electrocardiograms (ECGs), and physical examinations performed. Volunteers in Part 1 will receive 240 ml of water 10 minutes before starting of the MMTT in each period (Periods 1 and 2). Volunteers in Part 2 will receive study drug 20 minutes prior to starting of the MMTT in treatment sequence 1 (a single 300-mg dose of canagliflozin in Period 1 followed by matching placebo in Period 2) or in treatment Sequence 2 (matching placebo in Period 1 followed by a single 300-mg dose of canagliflozin in Period 2). Periods 1 and 2 will be separated by 7 to 21 days.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 001 | Experimental | no intervention Part 1: 240 mL water 10 minutes (min) prior to the start of the MMTT on Day 1 of Periods 1 and 2. Periods 1 and 2 will be separated by 7 to 21 days. |
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| 002 | Experimental | Canagliflozin/Placebo Placebo/Canagliflozin Part 2: 240 mL water 20 min prior to the MMTT on Day 1 of Periods 1 and 2 in each treatment sequence (1 dose of canagliflozin in Period 1 followed by 1 dose of placebo in Period 2 and then crossover to 1 dose of placebo in Period 1 followed by 1 dose of canagliflozin in Period 2). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Canagliflozin/Placebo Placebo/Canagliflozin | Drug | Part 2: 240 mL water 20 min prior to the MMTT on Day 1 of Periods 1 and 2 in each treatment sequence (1 dose of canagliflozin in Period 1 followed by 1 dose of placebo in Period 2 and then crossover to 1 dose of placebo in Period 1 followed by 1 dose of canagliflozin in Period 2). |
| Measure | Description | Time Frame |
|---|---|---|
| The amount of ingested glucose that is absorbed in systemic circulation | During the first 1 and 2 hours after a standard mixed meal |
| Measure | Description | Time Frame |
|---|---|---|
| The amount of ingested glucose that is absorbed in systemic circulation | 2-6 hr and 0-6 hr after a standard mixed meal | |
| Endogenous glucose production (EGP) | At protocol-specified time points after a standard mixed meal |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| La Jolla | California | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23412078 | Derived | Polidori D, Sha S, Mudaliar S, Ciaraldi TP, Ghosh A, Vaccaro N, Farrell K, Rothenberg P, Henry RR. Canagliflozin lowers postprandial glucose and insulin by delaying intestinal glucose absorption in addition to increasing urinary glucose excretion: results of a randomized, placebo-controlled study. Diabetes Care. 2013 Aug;36(8):2154-61. doi: 10.2337/dc12-2391. Epub 2013 Feb 14. |
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| no intervention | Other | Part 1: 240 mL water 10 minutes (min) prior to the start of the MMTT on Day 1 of Periods 1 and 2. Periods 1 and 2 will be separated by 7 to 21 days. |
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| Total and incremental plasma glucose and insulin area under the curve (AUC) | 0-1, 0-2, 2-6, and 0-6 hours after a standard mixed meal |
| Gastric emptying: peak level, time to peak level, and AUCs | 0-6 hours after a standard mixed meal |
| Rate of Peripheral glucose disposal (Rd) | At protocol-specified time points after a standard mixed meal |
| 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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