CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 299 enrolled
Drug / intervention
75 mg LX4211 +4 moredrug
Likely dose
75 mg LX4211from record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01376557
NCT01376557Phase 2Completed

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

Lexicon Pharmaceuticals·interventional·Posted Jun 20, 2011·Updated Oct 31, 2014

In Brief

A Phase 2 clinical trial evaluating 75 mg LX4211, 200 mg LX4211, and 2 other interventions for Type 2 Diabetes Mellitus. Completed, enrolled 299 participants across 56 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedJun 20, 2011
Enrollment StartJun 1, 2011
Primary CompletionMay 1, 2012
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 15.0 years ago

Interventions

75 mg LX4211drug

Subjects will receive 75 mg LX4211 once daily

200 mg LX4211drug

Subjects will receive 200 mg LX4211 once daily.

400 mg LX4211drug

Subjects will receive 400 mg LX4211 once daily.

200 mg LX4211drug

Subjects will receive 200 mg LX4211 twice daily.

Placebodrug

Subjects will receive placebo once daily.