Comparison of Lixisenatide Injected Prior to the Main Meal of the Day Versus Prior to Breakfast in Type 2 Diabetic Patients on Metformin
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.
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
Primary Objective: \- To compare the two treatment regimens in terms of change of glycosylated hemoglobin (HbA1c) from baseline to endpoint (Week 24) Secondary Objective: * To assess the effect of the 2 lixisenatide regimens on: * The percentage of participants who reached the target of HbA1c \< 7% or ≤ 6.5% at Week 24 * Fasting Plasma Glucose (FPG) * 7-point Self-Monitored Plasma Glucose (SMPG) profiles * Body weight * To assess the safety and tolerability of the 2 lixisenatide regimens
Study identification
- NCT ID
- NCT01517412
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 451 participants
Conditions and interventions
Conditions
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
- Feb 2012 (Type not available)
- Primary completion
- May 2013 (Actual)
- Completion
- May 2013 (Actual)
- Last update posted
- Oct 14, 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 14, 2016 · Synced Oct 23, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT01517412 live on ClinicalTrials.gov.