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Completed Phase 4 Interventional Results available

Efficacy Assessment of Insulin Glargine Versus LiraglutidE After Oral Agents Failure

ClinicalTrials.gov ID: NCT01117350

Public ClinicalTrials.gov record NCT01117350. 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 Oct 20, 2026, 4:52 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, Multicenter, International, Randomized (1:1), Parallel-group, Open-label, Comparative Study of Insulin Glargine Versus Liraglutide in Insulin-naïve Patients With Type 2 Diabetes Treated With Oral Agents and Not Adequately Controlled, Followed by a 24-week Extension Period With Insulin Glargine for Patients Not Adequately Controlled With Liraglutide

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

Primary objective: To demonstrate the superiority of insulin glargine over liraglutide in terms of percentage of patients reaching a Glycosylated Haemoglobin (HbA1c) \< 7% at the end of the comparative period (24 weeks) in Type 2 diabetic patients failing lifestyle management and oral agents Secondary objectives of the comparative period (24 weeks): \>To assess the effect of insulin glargine in comparison with liraglutide on: * HbA1c level * Percentage of patients whose HbA1c has decreased but remains \>= 7% at the end of the comparative period * Percentage of patients whose HbA1c has increased at the end of the comparative period * Fasting Plasma Glucose (FPG) * 7-point Plasma Glucose (PG) profiles * Hypoglycemia occurrence * Body weight * Adverse events Objectives of the extension period (24 weeks): \>To assess the effect of insulin glargine in patients not adequately controlled with liraglutide on: * HbA1c level * FPG * 7-point PG profiles * Hypoglycemia occurrence * Body weight * Adverse events

Study identification

NCT ID
NCT01117350
Recruitment status
Completed
Study type
Interventional
Phase
Phase 4
Lead sponsor
Sanofi
Industry
Enrollment
978 participants

Conditions and interventions

Eligibility (public fields only)

Age range
35 Years to 75 Years
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
Jul 2010 (Type not available)
Primary completion
Oct 2012 (Actual)
Completion
Mar 2013 (Actual)
Last update posted
Apr 11, 2014

2010 – 2013

United States locations

U.S. sites
45
U.S. states
21
U.S. cities
42
Facility City State ZIP Site status
Investigational Site Number 840023 Birmingham Alabama 35294 —
Investigational Site Number 840002 Goodyear Arizona 85395 —
Investigational Site Number 840047 Phoenix Arizona 85020 —
Investigational Site Number 840017 La Jolla California 92037 —
Investigational Site Number 840036 La Mesa California 91942 —
Investigational Site Number 840037 Loma Linda California 92357 —
Investigational Site Number 840045 Long Beach California 90822 —
Investigational Site Number 840048 Mission Hills California 91345 —
Investigational Site Number 840033 Mission Viejo California 92691 —
Investigational Site Number 840019 Palm Springs California 92262 —
Investigational Site Number 840039 San Diego California 92101 —
Investigational Site Number 840042 San Diego California 92161 —
Investigational Site Number 840043 Tustin California 92780 —
Investigational Site Number 840028 Denver Colorado 80220 —
Investigational Site Number 840034 Grand Junction Colorado 81501 —
Investigational Site Number 840026 Longmont Colorado 80501 —
Investigational Site Number 840022 Lawrenceville Georgia — —
Investigational Site Number 840029 Roswell Georgia 30076 —
Investigational Site Number 840009 Arlington Heights Illinois 60004 —
Investigational Site Number 840051 Springfield Illinois 62704 —
Investigational Site Number 840050 Indianapolis Indiana 46222 —
Investigational Site Number 840031 Kansas City Kansas 66160 —
Investigational Site Number 840004 Paducah Kentucky 42003 —
Investigational Site Number 840010 Rockville Maryland 20850 —
Investigational Site Number 840038 Eagan Minnesota 55122 —
Investigational Site Number 840030 Minneapolis Minnesota 55414 —
Investigational Site Number 840012 St Louis Missouri 63128 —
Investigational Site Number 840044 St Louis Missouri 63141 —
Investigational Site Number 840015 Atco New Jersey 08004 —
Investigational Site Number 840008 Blackwood New Jersey 08012 —
Investigational Site Number 840027 Mineola New York 11501 —
Investigational Site Number 840011 Staten Island New York 10301-3914 —
Investigational Site Number 840005 Hickory North Carolina 28601 —
Investigational Site Number 840052 Winston-Salem North Carolina 27103 —
Investigational Site Number 840049 Fargo North Dakota 58103 —
Investigational Site Number 840006 Bryan Ohio 43506 —
Investigational Site Number 840035 Cincinnati Ohio 45220 —
Investigational Site Number 840016 Carnegie Pennsylvania 15106 —
Investigational Site Number 840020 Uniontown Pennsylvania 15401 —
Investigational Site Number 840024 Rapid City South Dakota 57701 —
Investigational Site Number 840001 Dallas Texas 75230 —
Investigational Site Number 840007 Dallas Texas 75246 —
Investigational Site Number 840013 Houston Texas 77030 —
Investigational Site Number 840014 Renton Washington 98057 —
Investigational Site Number 840046 Spokane Washington 99220-3649 —

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 91 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT01117350, 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 Apr 11, 2014 · Synced Oct 20, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT01117350 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →