Trial results

Efficacy and Safety of Insulin Glargine/Lixisenatide Fixed Combination Versus Insulin Glargine Alone on Top of Metformin in Type 2 Diabetic Patients

NCT01476475 on ClinicalTrials.gov · last registry update 2017-02-10

An unusually large phase 2: 323 participants, more than double the 114 typical for the stage. The sponsor logged completion for December 2012. Primary outcome, as filed: Change in HbA1c From Baseline to Week 24. 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

P2

Drug

lixisenatide

Soliqua, Adlyxin

Sponsor

Sanofi

Sponsor type

Industry

Enrollment

323

Started

2011-11

Primary completion

2012-12 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 24

Conditions studied

Type 2 Diabetes Mellitus

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.