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Efficacy and Safety of the Insulin Glargine/Lixisenatide Fixed Ratio Combination (FRC) Versus GLP-1 Receptor Agonist in Patients With Type 2 Diabetes, With a FRC Extension Period

NCT02787551 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 514

Last updated 2022-03-25

Study results available
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Summary

Primary Objective:

To demonstrate the superiority of the insulin glargine/lixisenatide fixed ratio combination (FRC) versus GLP-1 receptor agonist (GLP-1 RA) in hemoglobin A1c (HbA1c) change.

Secondary Objectives:

To compare the overall efficacy and safety of the insulin glargine/lixisenatide FRC to GLP-1 RA on top of metformin (with or without pioglitazone, with or without sodium-glucose co-transporter 2 \[SGLT2\] inhibitor) in participants with type 2 diabetes.

To evaluate safety, efficacy and other endpoints of FRC up to the end of the extension period.

Conditions

Interventions

DRUG

Insulin glargine/lixisenatide fixed ratio combination

Pharmaceutical form: solution for injection Route of administration: subcutaneous

DRUG

liraglutide

Pharmaceutical form: solution for injection Route of administration: subcutaneous

DRUG

exenatide

Pharmaceutical form: solution for injection Route of administration: subcutaneous

DRUG

exenatide extended-release

Pharmaceutical form: solution for injection Route of administration: subcutaneous

DRUG

albiglutide

Pharmaceutical form: solution for injection Route of administration: subcutaneous

DRUG

dulaglutide

Pharmaceutical form: solution for injection Route of administration: subcutaneous

DRUG

Background therapy: Oral Anti-diabetic Drug (Metformin, Pioglitazone, SGLT2 inhibitor)

Pharmaceutical form: tablet Route of administration: oral If previously taken, doses to remain stable through the study.

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
2016-07-06
Primary Completion
2018-05-25
Completion
2018-11-17

Countries

  • United States
  • Canada
  • Estonia
  • Germany
  • Israel
  • Italy
  • Romania
  • Slovakia
  • Spain

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 NCT02787551 on ClinicalTrials.gov