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Efficacy and Safety of the Insulin Glargine/Lixisenatide Fixed Ratio Combination Versus Insulin Glargine in Patients With Type 2 Diabetes (LixiLan-India)

NCT03529123 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 247

Last updated 2022-04-25

No results posted yet for this study

Summary

Primary Objective:

To demonstrate the superiority of the insulin glargine/lixisenatide fixed ratio combination (FRC) to insulin glargine by demonstrating change in glycosylated hemoglobin (HbA1c).

Secondary Objectives:

* To assess the effects of the FRC in comparison with insulin glargine on:
* Percentage of patients reaching HbA1c targets (\<7% );
* Glycemic control in relation to a meal as evaluated by 2-hour Post-prandial Plasma Glucose; (PPG);
* Body weight
* Fasting Plasma Glucose (FPG);
* Percentage of patients reaching HbA1c targets of \<7% with no body weight gain and no hypoglycemia (as defined in the evaluation criteria);
* 7-point Self-Monitoring Plasma Glucose (SMPG) profile;
* Insulin glargine dose.
* To assess the safety and tolerability in each treatment group.

Conditions

Interventions

DRUG

INSULIN GLARGINE/LIXISENATIDE (HOE901/AVE0010)

Pharmaceutical form: Injection Route of administration: Subcutaneous

DRUG

INSULIN GLARGINE (HOE901)

Pharmaceutical form: Injection Route of administration: Subcutaneous

DRUG

Metformin

Pharmaceutical form: Tablet Route of administration: Oral

DRUG

Insulin Glulisine (HMR1964)

Pharmaceutical form: Injection Route of administration: Subcutaneous

Sponsors & Collaborators

Principal Investigators

  • Clinical Sciences & Operations · Sanofi

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
64 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-06-19
Primary Completion
2019-11-25
Completion
2019-11-25

Countries

  • India

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 NCT03529123 on ClinicalTrials.gov