| Trial ID: | L3256 |
| Source ID: | NCT01188863
|
| Associated Drug: |
300 Mg Lx4211 (150 Mg Tablets)
|
| Title: |
Study of Two Oral Formulations of LX4211 in Patients With Type 2 Diabetes Mellitus
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Type 2 Diabetes Mellitus
|
| Interventions: |
DRUG: 300 mg LX4211 (150 mg tablets)|DRUG: 300 mg LX4211 (50 mg tablets)|DRUG: 300 mg LX4211 (liquid)
|
| Outcome Measures: |
Primary: 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). | Secondary: 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).|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.
|
| Sponsor/Collaborators: |
Sponsor: Lexicon Pharmaceuticals
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE1
|
| Enrollment: |
15
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2010-09
|
| Completion Date: |
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| Results First Posted: |
|
| Last Update Posted: |
2011-03-30
|
| Locations: |
Lexicon Investigational Site, San Antonio, Texas, 78209, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT01188863
|
