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Efficacy and Safety of the Insulin Glargine/Lixisenatide Fixed Ratio Combination (LixiLan) to Insulin Glargine Alone on Top of Oral Anti-diabetic Drugs (OADs) With Type 2 Diabetes in Japan

NCT02752828 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 521

Last updated 2020-06-16

No results posted yet for this study

Summary

Primary Objective:

To compare LixiLan to insulin glargine in glycated hemoglobin (HbA1c) change from baseline to Week 26 in patients with type 2 Diabetes.

Secondary Objective:

To compare the overall efficacy and safety of LixiLan to insulin glargine (with or without OADs) over a 26 Week treatment period in patients with type 2 Diabetes.

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

Oral anti-diabetic drugs

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
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-05-23
Primary Completion
2018-03-12
Completion
2018-03-12

Countries

  • Japan

Study Locations

More Related Trials

Entities

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 NCT02752828 on ClinicalTrials.gov