NCT01555008

Study to Evaluate the Pharmacodynamic and Pharmacokinetic Effects of LX4211 in Subjects With Type 2 Diabetes and Renal Impairment

A Phase 1, Randomized, Double-Blind, Placebo-Controlled Parallel Group Study to Evaluate the Pharmacodynamic and Pharmacokinetic Effects of LX4211 in Subjects With Type 2 Diabetes Mellitus and Moderate to Severe Renal Impairment

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 31 (actual)
• Sponsor: Lexicon Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
DRUG	LX4211	Subjects will receive LX4211 once daily for 7 days
DRUG	LX4211 Placebo	Subjects will receive LX4211 placebo once daily for 7 days

Timeline

• Start date: 2012-03-01
• Primary completion: 2013-08-01
• First posted: 2012-03-15
• Last updated: 2013-09-09

Locations

6 sites across 1 country: United States