Study to Evaluate the Pharmacodynamic and Pharmacokinetic Effects of LX4211 in Subjects With Type 2 Diabetes and Renal Impairment
NCT01555008 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 31
Last updated 2013-09-09
Summary
This Phase 1 study is intended to assess the pharmacodynamics (PD), pharmacokinetics (PK), safety and tolerability of LX4211 following once daily oral administration in subjects with type 2 diabetes mellitus (T2DM) and moderate to severe renal impairment.
Conditions
- Type 2 Diabetes Mellitus
- Renal Impairment
Interventions
- DRUG
-
LX4211
Subjects will receive LX4211 once daily for 7 days
- DRUG
-
LX4211 Placebo
Subjects will receive LX4211 placebo once daily for 7 days
Sponsors & Collaborators
-
Lexicon Pharmaceuticals
lead INDUSTRY
Principal Investigators
-
Ike Ogbaa, M.D. · Lexicon Pharmaceuticals, Inc.
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 80 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2012-03-31
- Primary Completion
- 2013-08-31
Countries
- United States
Study Locations
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