| Trial ID: | L4877 |
| Source ID: | NCT01555008
|
| Associated Drug: |
Lx4211
|
| Title: |
Study to Evaluate the Pharmacodynamic and Pharmacokinetic Effects of LX4211 in Subjects With Type 2 Diabetes and Renal Impairment
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Type 2 Diabetes Mellitus|Renal Impairment
|
| Interventions: |
DRUG: LX4211|DRUG: LX4211 Placebo
|
| Outcome Measures: |
Primary: Change from baseline in postprandial glucose, baseline to 7 days | Secondary: Number of subjects experiencing an adverse event, 7 days|Change from baseline in fasting plasma glucose, baseline to 7 days|Change from baseline in glucagon-like peptide 1 (Glp-1), baseline to 7 days|Area Under Curve (AUC), Days 1 and 7; predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, and 48 hours post-dose
|
| Sponsor/Collaborators: |
Sponsor: Lexicon Pharmaceuticals
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE1
|
| Enrollment: |
31
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2012-03
|
| Completion Date: |
|
| Results First Posted: |
|
| Last Update Posted: |
2013-09-09
|
| Locations: |
Lexicon Investigational Site, Anniston, Alabama, 36207, United States|Lexicon Investigational Site, Chula Vista, California, 91911, United States|Lexicon Investigational Site, Edgewater, Florida, 32132, United States|Lexicon Investigational Site, Minneapolis, Minnesota, 55404, United States|Lexicon Investigational Site, San Antonio, Texas, 78209, United States|Lexicon Investigational Site, Renton, Washington, 98057, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT01555008
|
