24-week Treatment With Lixisenatide in Type 2 Diabetes Insufficiently Controlled With Metformin and Insulin Glargine
Public ClinicalTrials.gov record NCT00975286. 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, Placebo-controlled, 2-arm Parallel-group, Multicenter Study With a 24-week Double-blind Treatment Period Assessing the Efficacy and Safety of Lixisenatide in Patients With Type 2 Diabetes Insufficiently Controlled With Insulin Glargine and Metformin
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The purpose of the study is to evaluate the benefits and risks of lixisenatide (AVE0010), in comparison to placebo, as an add-on treatment to insulin glargine and metformin with or without thiazolidinediones (TZDs), over a period of 24 weeks of treatment. The primary objective is to assess the effects of lixisenatide in comparison to placebo, when added to insulin glargine and metformin, on glycemic control in terms of glycosylated hemoglobin (HbA1c) reduction (absolute change) at Week 24. The secondary objectives are to assess the effects of lixisenatide on the percentage of patients reaching HbA1c less than (\<) 7 percent (%) and less than or equal to (\<=) 6.5%, plasma glucose (fasting, postprandial during a standardized meal challenge test, 7-point self monitored profiles), body weight, insulin glargine doses, to evaluate safety and tolerability (including anti-lixisenatide antibody assessment), and to assess the impact on treatment satisfaction using the Diabetes Treatment Satisfaction Questionnaire (state) (DTSQs) in the participating countries where it is validated.
Study identification
- NCT ID
- NCT00975286
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 446 participants
Conditions and interventions
Conditions
Interventions
- Lixisenatide (AVE0010) Drug
- Placebo Drug
- Insulin glargine Drug
- Pen auto-injector Device
- Metformin Drug
- Thiazolidinedione (TZD) 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
- Oct 2009 (Type not available)
- Primary completion
- Aug 2011 (Actual)
- Completion
- Aug 2011 (Actual)
- Last update posted
- Oct 11, 2016
2009 – 2011
United States locations
- U.S. sites
- 23
- U.S. states
- 15
- U.S. cities
- 22
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Sanofi-Aventis Investigational Site Number 840223 | Mesa | Arizona | 85206 | — |
| Sanofi-Aventis Investigational Site Number 840206 | Hot Springs | Arkansas | 71913 | — |
| Sanofi-Aventis Investigational Site Number 840201 | Little Rock | Arkansas | 72205 | — |
| Sanofi-Aventis Investigational Site Number 840212 | Mountain Home | Arkansas | 72653 | — |
| Sanofi-Aventis Investigational Site Number 840215 | Concord | California | 94520 | — |
| Sanofi-Aventis Investigational Site Number 840214 | Greenbrae | California | 94904 | — |
| Sanofi-Aventis Investigational Site Number 840221 | Orlando | Florida | 32835 | — |
| Sanofi-Aventis Investigational Site Number 840211 | Baton Rouge | Louisiana | 70808 | — |
| Sanofi-Aventis Investigational Site Number 840230 | Hyattsville | Maryland | 20781 | — |
| Sanofi-Aventis Investigational Site Number 840209 | Rockville | Maryland | 20852 | — |
| Sanofi-Aventis Investigational Site Number 840219 | Brighton | Michigan | 48114 | — |
| Sanofi-Aventis Investigational Site Number 840231 | Sea Girt | New Jersey | 08750 | — |
| Sanofi-Aventis Investigational Site Number 840208 | Fargo | North Dakota | 58103 | — |
| Sanofi-Aventis Investigational Site Number 840225 | Mentor | Ohio | 44060 | — |
| Sanofi-Aventis Investigational Site Number 840222 | Portland | Oregon | 97201-3098 | — |
| Sanofi-Aventis Investigational Site Number 840202 | Philadelphia | Pennsylvania | 19146 | — |
| Sanofi-Aventis Investigational Site Number 840229 | Bristol | Tennessee | 37620 | — |
| Sanofi-Aventis Investigational Site Number 840205 | Germantown | Tennessee | 38138 | — |
| Sanofi-Aventis Investigational Site Number 840210 | Dallas | Texas | 75230 | — |
| Sanofi-Aventis Investigational Site Number 840217 | Houston | Texas | 77081 | — |
| Sanofi-Aventis Investigational Site Number 840228 | Houston | Texas | 77081 | — |
| Sanofi-Aventis Investigational Site Number 840213 | Plano | Texas | 75093 | — |
| Sanofi-Aventis Investigational Site Number 840227 | Norfolk | Virginia | 23502 | — |
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 117 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00975286, 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 11, 2016 · Synced Oct 18, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT00975286 live on ClinicalTrials.gov.