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Comparison of Lixisenatide Injected Prior to the Main Meal of the Day Versus Prior to Breakfast in Type 2 Diabetic Patients on Metformin

NCT01517412 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 451

Last updated 2016-10-14

Study results available
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Summary

Primary Objective:

\- To compare the two treatment regimens in terms of change of glycosylated hemoglobin (HbA1c) from baseline to endpoint (Week 24)

Secondary Objective:

* To assess the effect of the 2 lixisenatide regimens on:

* The percentage of participants who reached the target of HbA1c \< 7% or ≤ 6.5% at Week 24
* Fasting Plasma Glucose (FPG)
* 7-point Self-Monitored Plasma Glucose (SMPG) profiles
* Body weight
* To assess the safety and tolerability of the 2 lixisenatide regimens

Conditions

Interventions

DRUG

Lixisenatide (AVE0010)

Pharmaceutical form: Solution for injection; Route of administration: Subcutaneous

DEVICE

Self-injector pen device (OptiClik®)

DRUG

Metformin

To be kept at stable dose (≥1.5 g/day) throughout 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
2012-02-29
Primary Completion
2013-05-31
Completion
2013-05-31

Countries

  • United States
  • Canada
  • Czechia
  • France
  • Germany
  • Poland
  • Romania
  • Russia
  • Spain
  • Ukraine

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 NCT01517412 on ClinicalTrials.gov