Trial results

Safety Assessment of Lyxumia (Lixisenatide) and Sulfonylurea as Add-on Treatment to Basal Insulin in Uncontrolled Patients With Type 2 Diabetes Mellitus Who Elect to Fast During Ramadan

NCT02941367 on ClinicalTrials.gov · last registry update 2022-04-25

An unusually large phase 4: 184 participants, more than double the 72 typical for the stage. The sponsor logged completion for 4 August 2017. Primary outcome, as filed: Percentage of patients with at least 1 documented symptomatic hypoglycemia event (plasma glucose ≤70 mg/dL; 3.9 mmol/L). 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

P4

Drug

lixisenatide

Soliqua, Adlyxin

Sponsor

Sanofi

Sponsor type

Industry

Enrollment

184

Started

2017-02-23

Primary completion

2017-08-04 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

Percentage of patients with at least 1 documented symptomatic hypoglycemia event (plasma glucose ≤70 mg/dL; 3.9 mmol/L)

Conditions studied

Diabetes Mellitus, Type 2

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.