Trial results

Efficacy and Safety of Insulin Glargine/ Lixisenatide Fixed Ratio Combination Compared to Insulin Glargine Alone and Lixisenatide Alone on Top of Metformin in Patients With T2DM

NCT02058147 on ClinicalTrials.gov · last registry update 2017-05-09

An unusually large phase 3: 1,170 participants, more than double the 424 typical for the stage. The sponsor logged completion for June 2015. Primary outcome, as filed: Change in HbA1c From Baseline to Week 30. lixisenatide is already approved in the US for type 2 diabetes, so this is asking a further question rather than establishing the drug works at all. The registry entry has been edited 1 time since then.

Status

COMPLETED

Phase

P3

Drug

lixisenatide

Soliqua, Adlyxin

Sponsor

Sanofi

Sponsor type

Industry

Enrollment

1,170

Started

2014-02

Primary completion

2015-06 actual

Observed history

Every change this record has made since we started watching it. ClinicalTrials.gov shows only the current value. When a field is edited the previous one is overwritten and nothing is published to say so, so this history exists only because someone was recording it at the time.

Primary outcome

Change in HbA1c From Baseline to Week 30

Conditions studied

Type 2 Diabetes

Every field above is taken directly from the registry record. See all detected changes across the class, or the lixisenatide page for this molecule’s full trial and approval history.