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Comparison of the Efficacy and Safety of Insulin Glargine/Lixisenatide Fixed Ratio Combination to Insulin Glargine in Patients With Type 2 Diabetes Insufficiently Controlled on Basal Insulin

NCT03798080 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 426

Last updated 2022-07-19

No results posted yet for this study

Summary

Primary Objective:

To demonstrate the superiority of iGlarLixi (fixed ratio combination of insulin glargine and lixisenatide) to insulin glargine on glycemic control as assessed by glycated hemoglobin A1c (HbA1c) change in patients with type 2 diabetes mellitus (T2DM) who are not sufficiently controlled with basal insulin.

Secondary Objectives:

* To assess the effects of iGlarLixi in comparison with insulin glargine
* To assess the safety in each treatment group

Conditions

Interventions

DRUG

Insulin glargine/Lixisenatide (HOE901/AVE0010)

Pharmaceutical form: solution Route of administration: subcutaneous

DRUG

Insulin glargine (HOE901)

Pharmaceutical form: solution Route of administration: subcutaneous

DRUG

Metformin

Pharmaceutical form: tablet Route of administration: oral

Sponsors & Collaborators

Principal Investigators

  • Clinical Sciences & Operations · Sanofi

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-02-19
Primary Completion
2020-12-01
Completion
2020-12-01

Countries

  • China

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03798080 on ClinicalTrials.gov