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

No results posted yet for this study

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

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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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01555008 on ClinicalTrials.gov