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Evaluation of Insulin Glargine/Lixisenatide Fixed Ratio Combination in Patients With Type 2 Diabetes Insufficiently Controlled With Oral Antidiabetic Drug(s)

NCT03798054 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 878

Last updated 2022-07-19

No results posted yet for this study

Summary

Primary Objectives:

The co-primary objective of this study is:

* To demonstrate the superiority of iGlarLixi (fixed ratio combination of insulin glargine and lixisenatide) versus lixisenatide on glycemic control as assessed by glycated hemoglobin A1c (HbA1c) change.
* To demonstrate the non-inferiority of iGlarLixi versus insulin glargine on glycemic control as assessed by HbA1c change.

Secondary Objectives:

* To assess the effects of iGlarLixi in comparison with insulin glargine alone and lixisenatide alone.
* 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

Lixisenatide (AVE0010)

Pharmaceutical form: solution Route of administration: subcutaneous

DRUG

Metformin

Pharmaceutical form: tablet Route of administration: oral

DRUG

SGLT2 inhibitor

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
2019-02-15
Primary Completion
2021-03-01
Completion
2021-03-01

Countries

  • China
  • Malaysia
  • South Korea
  • Taiwan

Study Locations

More Related Trials

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 NCT03798054 on ClinicalTrials.gov