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| ID | Type | Description | Link |
|---|---|---|---|
| 28431754DIA1025 | Other Identifier | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
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The purpose of this study is to compare the results from two methods used to determine the renal threshold for glucose excretion (defined as the lowest plasma glucose concentration at which appreciable amounts of glucose appear in the urine) in untreated patients with type 2 diabetes mellitus and in patients with type 2 diabetes mellitus who are treated with 100 mg once-daily canigliflozin for 8 days.
This is an open-label (patients will know if they are receiving treatment and the identity of the treatment) study that will compare renal threshold of glucose (RTG) values obtained by 2 different methods: an established method (ie, the stepwise hyperglycemic clamp method) and a new method (the mixed meal tolerance test [MMTT] method). The RTG is defined as the lowest plasma glucose concentration at which appreciable amounts of glucose appear in the urine. Each method for determining the RTG value will be performed in untreated patients with type 2 diabetes mellitus (T2DM) and in patients with T2DM who are treated with canagliflozin 100 mg once daily for 8 days. Canagliflozin (a Sodium-Glucose Cotransporter 2 inhibitor) is currently under development to lower blood sugar levels in patients with T2DM. Patients will not take study drug (canagliflozin 100 mg overencapsulated tablets) in Part 1 of the study. In Part 2 of the study, patients will take study drug once daily on Study Days 1 through 8.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1: no Intervention | No Intervention | In Part 1 of the study, patients will not receive any study drug. | |
| Part 2: canagliflozin | Experimental | In Part 2 of the study, patients will receive canagliflozin once daily on Days 1 through 8. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Canagliflozin | Drug | One 100 mg capsule taken orally (by mouth) on Days Days 1-8 |
|
| Measure | Description | Time Frame |
|---|---|---|
| RTG values using the MMTT and the stepwise hyperglycemic clamp methods | On Days 1 and 2 (Part 1) | |
| RTG values using the MMTT and the stepwise hyperglycemic clamp methods | On Days 7 and 8 (Part 2) |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma glucose (PG) concentration during the MMT and the hyperglycemic clamp procedure | On Days 1 and 2 (Part 1) | |
| Plasma glucose (PG) concentration during the MMT and the hyperglycemic clamp procedure | On Days 7 and 8 (Part 2) |
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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 |
|---|---|---|---|---|---|---|
| Neuss | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23585665 | Derived | Polidori D, Sha S, Ghosh A, Plum-Morschel L, Heise T, Rothenberg P. Validation of a novel method for determining the renal threshold for glucose excretion in untreated and canagliflozin-treated subjects with type 2 diabetes mellitus. J Clin Endocrinol Metab. 2013 May;98(5):E867-71. doi: 10.1210/jc.2012-4205. Epub 2013 Apr 12. |
| Label | URL |
|---|---|
| An Open-Label Study to Compare Two Methods for Determining the Renal Threshold for Glucose in Subjects With Type 2 Diabetes Mellitus | View source |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D000068896 | Canagliflozin |
| ID | Term |
|---|---|
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D006573 | Heterocyclic Compounds, 1-Ring |
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| Rate of Urinary glucose excretion (UGE) during the MMTT and the hyperglycemic clamp procedure | On Days 1 and 2 (Part 1) |
| Rate of Urinary glucose excretion (UGE) during the MMTT and the hyperglycemic clamp procedure | On Days 7 and 8 (Part 2) |
| D004700 | Endocrine System Diseases |
| D006571 |
| Heterocyclic Compounds |
| D005960 | Glucosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |