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Safety And Tolerability Of Lixisenatide In Monotherapy In Patients With Type 2 Diabetes

NCT01960179 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 361

Last updated 2015-04-09

No results posted yet for this study

Summary

Primary Objective:

To assess the overall safety of lixisenatide once daily treatment in monotherapy over 24 and 52 weeks in patients with type 2 diabetes in Japan

Secondary Objective:

To assess the effects of lixisenatide once daily treatment in monotherapy over 24 and 52 weeks on:

* HbA1c (Glycated hemoglobin A1c) reduction;
* Fasting plasma glucose;
* Body weight.

Conditions

Interventions

DRUG

lixisenatide AVE0010

Pharmaceutical form:solution Route of administration: Subcutaneous injection

Sponsors & Collaborators

Principal Investigators

  • Clinical Sciences & Operations · Sanofi

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-11-30
Primary Completion
2015-03-31
Completion
2015-03-31

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 NCT01960179 on ClinicalTrials.gov