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| ID | Type | Description | Link |
|---|---|---|---|
| LX4211.102 | Other Identifier | Lexicon Pharmaceuticals, Inc. |
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This protocol is intended to compare the effects of both a solid (tablet) and liquid oral dosage form of LX4211 in subjects with type 2 diabetes mellitus.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Solid Oral Dose - 150 mg tablets | Experimental |
| |
| Solid Oral Dose - 50 mg tablets | Experimental |
| |
| Liquid Oral Dose | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 300 mg LX4211 (150 mg tablets) | Drug | Single oral dose of two 150 mg tablets LX4211 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum observed plasma concentration | Pharmacokinetics samples collected on day of dosing and 24 and 48 hours post-dose (Follow-up). | |
| Time at which maximum observed plasma concentration occurs | Pharmacokinetics samples collected on day of dosing and 24 and 48 hours post-dose (Follow-up). | |
| Half-life of the drug in plasma | Pharmacokinetics samples collected on day of dosing and 24 and 48 hours post-dose (Follow-up). |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma glucose | Samples collected on initial visit; Day -15 and Day -5 (Washout); numerous timepoints on Day -1 (Washout) and day of dosing; 24 hours post-dose (Follow-up); and upon discharge. | |
| Urinary glucose excretion | Samples collected on Day -1 (Washout), day of dosing, and 24 and 48 hours post-dose (Follow-up). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Joel P. Freiman, MD, MPH | Lexicon Pharmaceuticals, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lexicon Investigational Site | San Antonio | Texas | 78209 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22739142 | Derived | Zambrowicz B, Freiman J, Brown PM, Frazier KS, Turnage A, Bronner J, Ruff D, Shadoan M, Banks P, Mseeh F, Rawlins DB, Goodwin NC, Mabon R, Harrison BA, Wilson A, Sands A, Powell DR. LX4211, a dual SGLT1/SGLT2 inhibitor, improved glycemic control in patients with type 2 diabetes in a randomized, placebo-controlled trial. Clin Pharmacol Ther. 2012 Aug;92(2):158-69. doi: 10.1038/clpt.2012.58. Epub 2012 Jul 4. |
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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 |
|---|---|
| C575681 | (2S,3R,4R,5S,6R)-2-(4-chloro-3-(4-ethoxybenzyl)phenyl)-6-(methylthio)tetrahydro-2H-pyran-3,4,5-triol |
| D005440 | Fluid Therapy |
| ID | Term |
|---|---|
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
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| 300 mg LX4211 (50 mg tablets) | Drug | Single oral dose of six 50 mg tablets LX4211 |
|
| 300 mg LX4211 (liquid) | Drug | Single 30 mL dose of liquid oral solution LX4211 (10 mg/mL) |
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| Insulin | Samples collected on initial visit; Day -15 and Day -5 (Washout); numerous timepoints on Day -1 (Washout) and day of dosing; 24 hours post-dose (Follow-up); and upon discharge. |
| Peptide YY | Samples collected on initial visit; Day -15 and Day -5 (Washout); numerous timepoints on Day -1 (Washout) and day of dosing; 24 hours post-dose (Follow-up); and upon discharge. |
| Glucagon-like Peptide 1 | Samples collected on initial visit; Day -15 and Day -5 (Washout); numerous timepoints on Day -1 (Washout) and day of dosing; 24 hours post-dose (Follow-up); and upon discharge. |
| D004700 | Endocrine System Diseases |