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| ID | Type | Description | Link |
|---|---|---|---|
| LX4211.111 | Other Identifier | Lexicon Pharmaceuticals, Inc. |
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The purpose of this study is to assess the effect of LX4211 and the comparator drug canagliflozin on intestinal glucose absorption and metabolism after a single dose in healthy subjects in comparison to placebo.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LX4211 | Experimental | 400 mg of LX4211 |
|
| Canagliflozin | Active Comparator | 300 mg canagliflozin |
|
| Placebo | Placebo Comparator | LX4211 placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LX4211 400 mg | Drug |
| ||
| canagliflozin 300 mg |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in rate of glucose appearance after meal (RaO) | Days 1, 8, 15 |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of total glucose appearance (RaT) | Days 1, 8, 15 | |
| Change from baseline in fasting plasma glucose | Days 1, 8, 15 | |
| Change from baseline in postprandial glucose |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Paul Strumph, M.D. | Lexicon Pharmaceuticals, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lexicon Investigational Site | Chula Vista | California | 91911 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31837264 | Derived | Powell DR, Zambrowicz B, Morrow L, Beysen C, Hompesch M, Turner S, Hellerstein M, Banks P, Strumph P, Lapuerta P. Sotagliflozin Decreases Postprandial Glucose and Insulin Concentrations by Delaying Intestinal Glucose Absorption. J Clin Endocrinol Metab. 2020 Apr 1;105(4):e1235-49. doi: 10.1210/clinem/dgz258. |
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| Drug |
|
| LX4211 Placebo | Drug |
|
| Days 1, 8, 15 |
| Change from baseline in insulin | Days 1, 8, 15 |
| ID | Term |
|---|---|
| C575681 | (2S,3R,4R,5S,6R)-2-(4-chloro-3-(4-ethoxybenzyl)phenyl)-6-(methylthio)tetrahydro-2H-pyran-3,4,5-triol |
| 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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