NCT01376557

Safety and Efficacy of LX4211 With Metformin in Type 2 Diabetes Patients With Inadequate Glycemic Control on Metformin

A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Safety and Efficacy of LX4211 in Combination With Metformin in Subjects With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Metformin Monotherapy

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 299 (actual)
• Sponsor: Lexicon Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This study is intended to assess the effect on HbA1c of different dose regimens of LX4211 in combination with metformin in subjects with Type 2 Diabetes Mellitus who have inadequate glycemic control on metformin monotherapy.

Conditions

• Type 2 Diabetes Mellitus

Interventions

Type	Name	Description
DRUG	75 mg LX4211	Subjects will receive 75 mg LX4211 once daily
DRUG	200 mg LX4211	Subjects will receive 200 mg LX4211 once daily.
DRUG	400 mg LX4211	Subjects will receive 400 mg LX4211 once daily.
DRUG	200 mg LX4211	Subjects will receive 200 mg LX4211 twice daily.
DRUG	Placebo	Subjects will receive placebo once daily.

Timeline

• Start date: 2011-06-01
• Primary completion: 2012-05-01
• Completion: 2012-05-01
• First posted: 2011-06-20
• Last updated: 2014-10-31
• Results posted: 2014-10-31

Locations

56 sites across 1 country: United States