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Completed Phase 3 Interventional Results available

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

ClinicalTrials.gov ID: NCT01517412

Public ClinicalTrials.gov record NCT01517412. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Jul 22, 2026, 4:22 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A 24-week, Open-label, Randomized, 2-arm Parallel Group, Multinational, Multi-center Clinical Trial to Compare the Efficacy and Safety of Lixisenatide Injected Prior to the Main Meal of the Day Versus Lixisenatide Injected Prior to Breakfast in Type 2 Diabetic Patients Not Adequately Controlled on Metformin

Study identification

NCT ID
NCT01517412
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
Sanofi
Industry
Enrollment
451 participants

Conditions and interventions

Interventions

  • Lixisenatide (AVE0010) Drug
  • Self-injector pen device (OptiClik®) Device
  • Metformin Drug

Drug · Device

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Jan 31, 2012
Primary completion
Apr 30, 2013
Completion
Apr 30, 2013
Last update posted
Oct 13, 2016

2012 – 2013

United States locations

U.S. sites
17
U.S. states
8
U.S. cities
15
Facility City State ZIP Site status
Investigational Site Number 840112 Glendale Arizona 85306
Investigational Site Number 840113 Mesa Arizona 85213
Investigational Site Number 840105 Phoenix Arizona 85028
Investigational Site Number 840102 Tempe Arizona 85282
Investigational Site Number 840107 Tempe Arizona
Investigational Site Number 840116 Mission Viejo California 92691
Investigational Site Number 840103 Northridge California 91325
Investigational Site Number 840118 Redlands California 92374
Investigational Site Number 840104 Temecula California 92591
Investigational Site Number 840122 Chicago Illinois 60611
Investigational Site Number 840119 Chicago Illinois 60616
Investigational Site Number 840114 Springfield Illinois 62704
Investigational Site Number 840120 Flint Michigan 48504
Investigational Site Number 840115 Billings Montana 59103
Investigational Site Number 840101 Sea Girt New Jersey 08750
Investigational Site Number 840111 Fargo North Dakota 58103
Investigational Site Number 840110 West Jordan Utah 84088

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 65 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT01517412, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Oct 13, 2016 · Synced Jul 22, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT01517412 live on ClinicalTrials.gov.

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