GLP-1 Receptor Agonist Lixisenatide in Patients With Type 2 Diabetes for Glycemic Control and Safety Evaluation, on Top of Pioglitazone
Public ClinicalTrials.gov record NCT00763815. 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, Double-blind, Placebo-controlled, 2-arm Parallel-group, Multicenter Study With a 24-week Main Treatment Period and an Extension Assessing the Efficacy and Safety of AVE0010 on Top of Pioglitazone in Patients With Type 2 Diabetes Not Adequately Controlled With Pioglitazone
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The purpose of this study is to evaluate the benefits and risks of lixisenatide (AVE0010), in comparison to placebo, as an add-on treatment to pioglitazone with or without metformin, over a period of 24 weeks of treatment, followed by an extension. The primary objective is to assess the effects of lixisenatide when added to pioglitazone on glycemic control in terms of glycosylated hemoglobin (HbA1c) reduction (absolute change) at Week 24. Secondary objectives are to assess the effects of lixisenatide when added to pioglitazone on the percentage of patients reaching HbA1c less than 7 percent (%) and less than or equal to 6.5%, fasting plasma glucose (FPG), body weight, beta-cell function (assessed by homeostatic model assessment of beta-cell function \[HOMA-beta\]), and on fasting plasma insulin (FPI), to assess the safety, tolerability, pharmacokinetics (PK) and anti-lixisenatide antibody development.
Study identification
- NCT ID
- NCT00763815
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 484 participants
Conditions and interventions
Conditions
Interventions
- Lixisenatide (AVE0010) Drug
- Placebo Drug
- Pen auto-injector Device
- Pioglitazone Drug
- 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
- Sep 2008 (Type not available)
- Primary completion
- Jun 2011 (Actual)
- Completion
- Jun 2011 (Actual)
- Last update posted
- Nov 28, 2016
2008 – 2011
United States locations
- U.S. sites
- 85
- U.S. states
- 33
- U.S. cities
- 75
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Sanofi-Aventis Investigational Site Number 840723 | Birmingham | Alabama | 35205 | — |
| Sanofi-Aventis Investigational Site Number 840744 | Birmingham | Alabama | 35205 | — |
| Sanofi-Aventis Investigational Site Number 840867 | Birmingham | Alabama | 35235 | — |
| Sanofi-Aventis Investigational Site Number 840720 | Birmingham | Alabama | 35242 | — |
| Sanofi-Aventis Investigational Site Number 840855 | Mobile | Alabama | 36608 | — |
| Sanofi-Aventis Investigational Site Number 840863 | Mobile | Alabama | 36608 | — |
| Sanofi-Aventis Investigational Site Number 840775 | Chandler | Arizona | 85224 | — |
| Sanofi-Aventis Investigational Site Number 840722 | Mesa | Arizona | 85213 | — |
| Sanofi-Aventis Investigational Site Number 840769 | Phoenix | Arizona | 85050 | — |
| Sanofi-Aventis Investigational Site Number 840729 | Harrisburg | Arkansas | 72432 | — |
| Sanofi-Aventis Investigational Site Number 840776 | Mountain Home | Arkansas | 72653 | — |
| Sanofi-Aventis Investigational Site Number 840795 | Artesia | California | 90701 | — |
| Sanofi-Aventis Investigational Site Number 840782 | Chino | California | 91710 | — |
| Sanofi-Aventis Investigational Site Number 840785 | Huntington Beach | California | 92648 | — |
| Sanofi-Aventis Investigational Site Number 840858 | La Jolla | California | 92037 | — |
| Sanofi-Aventis Investigational Site Number 840784 | Los Banos | California | 93635 | — |
| Sanofi-Aventis Investigational Site Number 840773 | Mission Hills | California | 91345 | — |
| Sanofi-Aventis Investigational Site Number 840707 | Mission Viejo | California | 92691 | — |
| Sanofi-Aventis Investigational Site Number 840733 | Northridge | California | 91325 | — |
| Sanofi-Aventis Investigational Site Number 840864 | Roseville | California | 95661 | — |
| Sanofi-Aventis Investigational Site Number 840772 | San Diego | California | 92123 | — |
| Sanofi-Aventis Investigational Site Number 840743 | San Mateo | California | 94401 | — |
| Sanofi-Aventis Investigational Site Number 840721 | Stockton | California | 95204 | — |
| Sanofi-Aventis Investigational Site Number 840763 | West Hills | California | 91307 | — |
| Sanofi-Aventis Investigational Site Number 840872 | Colorado Springs | Colorado | 80907 | — |
| Sanofi-Aventis Investigational Site Number 840868 | Colorado Springs | Colorado | 80909 | — |
| Sanofi-Aventis Investigational Site Number 840727 | Jacksonville | Florida | 32216 | — |
| Sanofi-Aventis Investigational Site Number 840745 | New Port Richey | Florida | 34652 | — |
| Sanofi-Aventis Investigational Site Number 840761 | Oviedo | Florida | 32765 | — |
| Sanofi-Aventis Investigational Site Number 840799 | Wellington | Florida | 33414 | — |
| Sanofi-Aventis Investigational Site Number 840857 | Augusta | Georgia | 30909 | — |
| Sanofi-Aventis Investigational Site Number 840724 | Idaho Falls | Idaho | 83404 | — |
| Sanofi-Aventis Investigational Site Number 840791 | Chicago | Illinois | 60611 | — |
| Sanofi-Aventis Investigational Site Number 840738 | Avon | Indiana | 46123 | — |
| Sanofi-Aventis Investigational Site Number 840794 | Indianapolis | Indiana | 46260 | — |
| Sanofi-Aventis Investigational Site Number 840767 | Kansas City | Kansas | 66160-7321 | — |
| Sanofi-Aventis Investigational Site Number 840779 | Lansing | Kansas | 66043 | — |
| Sanofi-Aventis Investigational Site Number 840739 | Wichita | Kansas | 67203 | — |
| Sanofi-Aventis Investigational Site Number 840789 | Lexington | Kentucky | 40503 | — |
| Sanofi-Aventis Investigational Site Number 840850 | Lexington | Kentucky | 40504 | — |
| Sanofi-Aventis Investigational Site Number 840862 | Baton Rouge | Louisiana | 70808 | — |
| Sanofi-Aventis Investigational Site Number 840879 | Shreveport | Louisiana | 71101 | — |
| Sanofi-Aventis Investigational Site Number 840764 | Hyattsville | Maryland | 20783 | — |
| Sanofi-Aventis Investigational Site Number 840871 | Rockville | Maryland | 20850 | — |
| Sanofi-Aventis Investigational Site Number 840851 | Russells Mills | Massachusetts | 2747 | — |
| Sanofi-Aventis Investigational Site Number 840708 | Kalamazoo | Michigan | 49001 | — |
| Sanofi-Aventis Investigational Site Number 840774 | Bloomington | Minnesota | 55435 | — |
| Sanofi-Aventis Investigational Site Number 840704 | Eagan | Minnesota | 55122 | — |
| Sanofi-Aventis Investigational Site Number 840717 | Picayune | Mississippi | 39466 | — |
| Sanofi-Aventis Investigational Site Number 840765 | St Louis | Missouri | 63104 | — |
| Sanofi-Aventis Investigational Site Number 840875 | Las Vegas | Nevada | 89119 | — |
| Sanofi-Aventis Investigational Site Number 840866 | Pahrump | Nevada | 89048 | — |
| Sanofi-Aventis Investigational Site Number 840865 | New York | New York | 10010 | — |
| Sanofi-Aventis Investigational Site Number 840766 | New York | New York | 10021 | — |
| Sanofi-Aventis Investigational Site Number 840874 | Staten Island | New York | 10301 | — |
| Sanofi-Aventis Investigational Site Number 840762 | West Seneca | New York | 14224 | — |
| Sanofi-Aventis Investigational Site Number 840747 | Burlington | North Carolina | 27215 | — |
| Sanofi-Aventis Investigational Site Number 840760 | Greensboro | North Carolina | 27401 | — |
| Sanofi-Aventis Investigational Site Number 840712 | High Point | North Carolina | 27262 | — |
| Sanofi-Aventis Investigational Site Number 840780 | Bismarck | North Dakota | 58501 | — |
| Sanofi-Aventis Investigational Site Number 840877 | Fargo | North Dakota | 58103 | — |
| Sanofi-Aventis Investigational Site Number 840777 | Athens | Ohio | 45701 | — |
| Sanofi-Aventis Investigational Site Number 840741 | Cleveland | Ohio | 44122 | — |
| Sanofi-Aventis Investigational Site Number 840728 | Dayton | Ohio | 45458 | — |
| Sanofi-Aventis Investigational Site Number 840709 | Mentor | Ohio | 44060 | — |
| Sanofi-Aventis Investigational Site Number 840716 | Norman | Oklahoma | 73069 | — |
| Sanofi-Aventis Investigational Site Number 840701 | Medford | Oregon | 97504 | — |
| Sanofi-Aventis Investigational Site Number 840751 | Beaver | Pennsylvania | 15009 | — |
| Sanofi-Aventis Investigational Site Number 840798 | Red Lion | Pennsylvania | 17356 | — |
| Sanofi-Aventis Investigational Site Number 840792 | Columbia | South Carolina | 29201 | — |
| Sanofi-Aventis Investigational Site Number 840740 | Simpsonville | South Carolina | 29681 | — |
| Sanofi-Aventis Investigational Site Number 840726 | Taylors | South Carolina | 29687-4105 | — |
| Sanofi-Aventis Investigational Site Number 840711 | Bristol | Tennessee | 37620 | — |
| Sanofi-Aventis Investigational Site Number 840853 | Colleyville | Texas | 76034 | — |
| Sanofi-Aventis Investigational Site Number 840730 | Houston | Texas | 77030 | — |
| Sanofi-Aventis Investigational Site Number 840854 | San Antonio | Texas | 78218 | — |
| Sanofi-Aventis Investigational Site Number 840796 | Clinton | Utah | 84015 | — |
| Sanofi-Aventis Investigational Site Number 840755 | Salt Lake City | Utah | 84102 | — |
| Sanofi-Aventis Investigational Site Number 840756 | Salt Lake City | Utah | 84107 | — |
| Sanofi-Aventis Investigational Site Number 840758 | Salt Lake City | Utah | 84107 | — |
| Sanofi-Aventis Investigational Site Number 840753 | Norfolk | Virginia | 23510 | — |
| Sanofi-Aventis Investigational Site Number 840770 | Norfolk | Virginia | 23510 | — |
| Sanofi-Aventis Investigational Site Number 840752 | Richmond | Virginia | 23220 | — |
| Sanofi-Aventis Investigational Site Number 840757 | Virginia Beach | Virginia | 23502 | — |
| Sanofi-Aventis Investigational Site Number 840735 | Spokane | Washington | 99209 | — |
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 NCT00763815, 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 Nov 28, 2016 · Synced Oct 19, 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 NCT00763815 live on ClinicalTrials.gov.