Efficacy and Safety of Lixisenatide Versus Insulin Glulisine on Top of Insulin Glargine With or Without Metformin in Type 2 Diabetic Patients
Public ClinicalTrials.gov record NCT01768559. 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.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Randomized, Open-label, Active-controlled, 3-arm Parallel-group, 26-week Study Comparing the Efficacy and Safety of Lixisenatide to That of Insulin Glulisine Once Daily and Insulin Glulisine Three Times Daily in Patients With Type 2 Diabetes Insufficiently Controlled With Insulin Glargine With or Without Metformin
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
Primary Objective: \- To compare lixisenatide versus insulin glulisine in terms of glycosylated hemoglobin (HbA1c) reduction and body weight change at Week 26 in type 2 diabetic participants not adequately controlled on insulin glargine ± metformin. Secondary Objectives: \- To compare the treatments/regimens on: * The percentage of participants reaching the target of HbA1c \<7% or ≤6.5%, * Body weight, * Self-Monitored Glucose profiles, * Fasting Plasma Glucose (FPG), * Post-prandial plasma glucose (PPG) /glucose excursions during a standardized meal test (subset of participants), * Daily doses of insulins, * Safety and tolerability.
Study identification
- NCT ID
- NCT01768559
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 894 participants
Conditions and interventions
Conditions
Interventions
- Lixisenatide (AVE0010) Drug
- Insulin glulisine QD Drug
- Insulin glulisine TID Drug
- Insulin Glargine (Mandatory background drug) Drug
- Metformin (Background drug) Drug
Drug
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 2013 (Type not available)
- Primary completion
- Dec 2014 (Actual)
- Completion
- Dec 2014 (Actual)
- Last update posted
- Jan 4, 2017
2013 – 2014
United States locations
- U.S. sites
- 46
- U.S. states
- 26
- U.S. cities
- 44
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Investigational Site Number 840043 | Sun City | Arizona | 85351 | — |
| Investigational Site Number 840042 | Tempe | Arizona | 85282 | — |
| Investigational Site Number 840003 | Little Rock | Arkansas | 72205 | — |
| Investigational Site Number 840031 | La Mesa | California | 91942 | — |
| Investigational Site Number 840005 | Mission Viejo | California | 92691 | — |
| Investigational Site Number 840057 | Northridge | California | 91325 | — |
| Investigational Site Number 840035 | Santa Ana | California | 92704 | — |
| Investigational Site Number 840002 | Temecula | California | 92591 | — |
| Investigational Site Number 840037 | Walnut Creek | California | 94598 | — |
| Investigational Site Number 840023 | West Hills | California | 91345 | — |
| Investigational Site Number 840041 | Denver | Colorado | 80246 | — |
| Investigational Site Number 840012 | Miami | Florida | 33136 | — |
| Investigational Site Number 840061 | Miami | Florida | 33142 | — |
| Investigational Site Number 840045 | Lawrenceville | Georgia | 30045 | — |
| Investigational Site Number 840036 | Nampa | Idaho | 83686 | — |
| Investigational Site Number 840024 | Chicago | Illinois | 60611 | — |
| Investigational Site Number 840009 | Evanston | Illinois | 60201 | — |
| Investigational Site Number 840004 | Avon | Indiana | 46123 | — |
| Investigational Site Number 840055 | Avon | Indiana | 46123 | — |
| Investigational Site Number 840027 | Des Moines | Iowa | 50314 | — |
| Investigational Site Number 840006 | Wichita | Kansas | 67203 | — |
| Investigational Site Number 840047 | Lexington | Kentucky | 40504 | — |
| Investigational Site Number 840056 | Paducah | Kentucky | 42003 | — |
| Investigational Site Number 840022 | Marrero | Louisiana | 70072 | — |
| Investigational Site Number 840016 | Baltimore | Maryland | 21237 | — |
| Investigational Site Number 840017 | Rockville | Maryland | 20852 | — |
| Investigational Site Number 840025 | Buckley | Michigan | 49620 | — |
| Investigational Site Number 840048 | Dearborn | Michigan | 48124 | — |
| Investigational Site Number 840026 | Kalamazoo | Michigan | 49048 | — |
| Investigational Site Number 840049 | Las Vegas | Nevada | 89148 | — |
| Investigational Site Number 840029 | New Hyde Park | New York | 11042 | — |
| Investigational Site Number 840060 | Smithtown | New York | 11787 | — |
| Investigational Site Number 840030 | Staten Island | New York | 10301-3914 | — |
| Investigational Site Number 840011 | Salisbury | North Carolina | 28144 | — |
| Investigational Site Number 840028 | Fargo | North Dakota | 58103 | — |
| Investigational Site Number 840007 | Oklahoma City | Oklahoma | 73104 | — |
| Investigational Site Number 840021 | Pittsburgh | Pennsylvania | 15212 | — |
| Investigational Site Number 840052 | Myrtle Beach | South Carolina | 29572 | — |
| Investigational Site Number 840032 | Chattanooga | Tennessee | 37404 | — |
| Investigational Site Number 840033 | Nashville | Tennessee | 37232 | — |
| Investigational Site Number 840034 | Corpus Christi | Texas | 78404 | — |
| Investigational Site Number 840001 | Dallas | Texas | 75230 | — |
| Investigational Site Number 840020 | Houston | Texas | 77081 | — |
| Investigational Site Number 840018 | Norfolk | Virginia | 23502 | — |
| Investigational Site Number 840015 | Salem | Virginia | 24153 | — |
| Investigational Site Number 840010 | Milwaukee | Wisconsin | 53217 | — |
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 153 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01768559, 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 Jan 4, 2017 · Synced Oct 17, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT01768559 live on ClinicalTrials.gov.