Efficacy and Safety of Insulin Glargine/Lixisenatide Fixed Combination Versus Insulin Glargine Alone on Top of Metformin in Type 2 Diabetic Patients
Public ClinicalTrials.gov record NCT01476475. 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, 24-week, Open-label, 2-arm Parallel-group, Multicenter Study Comparing the Efficacy and Safety of Insulin Glargine/Lixisenatide Fixed Ratio Combination Versus Insulin Glargine on Top of Metformin in Type 2 Diabetic Patients
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
Primary Objective: * The purpose of this study was to compare insulin glargine/ lixisenatide fixed ratio combination (FRC) versus insulin glargine on glycemic control over 24 weeks, as evaluated by glycosylated hemoglobin (HbA1c) reduction in type 2 diabetic participants treated with metformin. Secondary Objectives: * To compare insulin glargine/lixisenatide FRC versus insulin glargine over 24 weeks on: * Glycemic control in relation to a meal as evaluated by post-prandial plasma glucose and glucose excursions during a standardized meal test; * Percentage of participants reaching HbA1c \<7% or ≤6.5%; * 7-point Self-Monitored Plasma Glucose (SMPG) profile; * Body weight; * Insulin glargine dose * Fasting Plasma Glucose (FPG); * Percentage of participants requiring rescue therapy during the 24-week open label treatment period; * To assess safety and tolerability of insulin glargine/lixisenatide FRC.
Study identification
- NCT ID
- NCT01476475
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 323 participants
Conditions and interventions
Conditions
Interventions
- Insulin glargine /lixisenatide Fixed Ratio Combination Drug
- Insulin glargine 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
- Nov 2011 (Type not available)
- Primary completion
- Dec 2012 (Actual)
- Completion
- Dec 2012 (Actual)
- Last update posted
- Feb 10, 2017
2011 – 2012
United States locations
- U.S. sites
- 14
- U.S. states
- 12
- U.S. cities
- 14
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Investigational Site Number 840408 | Little Rock | Arkansas | 72205 | — |
| Investigational Site Number 840412 | Paramount | California | 90723 | — |
| Investigational Site Number 840401 | Larenceville | Georgia | 30045 | — |
| Investigational Site Number 840417 | Roswell | Georgia | 30076 | — |
| Investigational Site Number 840403 | Lexington | Kentucky | 40504 | — |
| Investigational Site Number 840404 | Hyattsville | Maryland | 20782 | — |
| Investigational Site Number 840405 | Rockville | Maryland | 20852 | — |
| Investigational Site Number 840411 | Las Vegas | Nevada | 89148 | — |
| Investigational Site Number 840415 | West Seneca | New York | 14224 | — |
| Investigational Site Number 840402 | Norman | Oklahoma | 73069 | — |
| Investigational Site Number 840407 | Medford | Oregon | 97504 | — |
| Investigational Site Number 840413 | Durham | Pennsylvania | 27713 | — |
| Investigational Site Number 840410 | Dallas | Texas | 75230 | — |
| Investigational Site Number 840414 | Renton | Washington | 98055 | — |
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 56 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01476475, 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 Feb 10, 2017 · Synced Oct 17, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT01476475 live on ClinicalTrials.gov.