Efficacy and Safety of the Insulin Glargine/Lixisenatide Fixed Ratio Combination (FRC) Versus GLP-1 Receptor Agonist in Patients With Type 2 Diabetes, With a FRC Extension Period
Public ClinicalTrials.gov record NCT02787551. 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 26-Week Randomized, Open-label, Active Controlled, Parallel-group, Study Assessing the Efficacy and Safety of the Insulin Glargine/Lixisenatide Fixed Ratio Combination in Adults With Type 2 Diabetes Inadequately Controlled on GLP-1 Receptor Agonist and Metformin (Alone or With Pioglitazone and/or SGLT2 Inhibitors), Followed by a Fixed Ratio Combination Single-arm 26-Week Extension Period
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
Primary Objective: To demonstrate the superiority of the insulin glargine/lixisenatide fixed ratio combination (FRC) versus GLP-1 receptor agonist (GLP-1 RA) in hemoglobin A1c (HbA1c) change. Secondary Objectives: To compare the overall efficacy and safety of the insulin glargine/lixisenatide FRC to GLP-1 RA on top of metformin (with or without pioglitazone, with or without sodium-glucose co-transporter 2 \[SGLT2\] inhibitor) in participants with type 2 diabetes. To evaluate safety, efficacy and other endpoints of FRC up to the end of the extension period.
Study identification
- NCT ID
- NCT02787551
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 514 participants
Conditions and interventions
Conditions
Interventions
- Insulin glargine/lixisenatide fixed ratio combination Drug
- liraglutide Drug
- exenatide Drug
- exenatide extended-release Drug
- albiglutide Drug
- dulaglutide Drug
- Background therapy: Oral Anti-diabetic Drug (Metformin, Pioglitazone, SGLT2 inhibitor) 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
- Jul 6, 2016 (Actual)
- Primary completion
- May 25, 2018 (Actual)
- Completion
- Nov 17, 2018 (Actual)
- Last update posted
- Mar 25, 2022
2016 – 2018
United States locations
- U.S. sites
- 74
- U.S. states
- 26
- U.S. cities
- 65
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Investigational Site Number 8400064 | Birmingham | Alabama | 35205 | — |
| Investigational Site Number 8400073 | Fountain Hills | Arizona | 85268 | — |
| Investigational Site Number 8400047 | Phoenix | Arizona | 85028 | — |
| Investigational Site Number 8400103 | Bakersfield | California | 93309 | — |
| Investigational Site Number 8400137 | Fresno | California | 93720 | — |
| Investigational Site Number 8400043 | Huntington Park | California | 90255 | — |
| Investigational Site Number 8400124 | Lamont | California | 93241 | — |
| Investigational Site Number 8400027 | Lancaster | California | 93534 | — |
| Investigational Site Number 8400098 | Los Angeles | California | 90017 | — |
| Investigational Site Number 8400013 | Los Angeles | California | 90057 | — |
| Investigational Site Number 8400042 | Mission Hills | California | 91345 | — |
| Investigational Site Number 8400006 | Northridge | California | 91325 | — |
| Investigational Site Number 8400021 | Orange | California | 92868 | — |
| Investigational Site Number 8400126 | Rialto | California | 92377 | — |
| Investigational Site Number 8400094 | Santa Ana | California | 92704 | — |
| Investigational Site Number 8400009 | Ventura | California | 93003 | — |
| Investigational Site Number 8400071 | Denver | Colorado | 80209 | — |
| Investigational Site Number 8400036 | Denver | Colorado | 80246 | — |
| Investigational Site Number 8400114 | Jacksonville | Florida | 32216 | — |
| Investigational Site Number 8400133 | Miami | Florida | 33165 | — |
| Investigational Site Number 8400058 | Port Charlotte | Florida | 33952 | — |
| Investigational Site Number 8400084 | Tampa | Florida | 33612 | — |
| Investigational Site Number 8400112 | West Palm Beach | Florida | 33401 | — |
| Investigational Site Number 8400045 | Lawrenceville | Georgia | 30046 | — |
| Investigational Site Number 8400096 | Snellville | Georgia | 30078 | — |
| Investigational Site Number 8400023 | Springfield | Illinois | 62711 | — |
| Investigational Site Number 8400049 | Avon | Indiana | 46123 | — |
| Investigational Site Number 8400053 | Avon | Indiana | 46123 | — |
| Investigational Site Number 8400085 | Avon | Indiana | 46123 | — |
| Investigational Site Number 8400120 | Avon | Indiana | 46123 | — |
| Investigational Site Number 8400041 | Evansville | Indiana | 47714 | — |
| Investigational Site Number 8400038 | Indianapolis | Indiana | 46254-5469 | — |
| Investigational Site Number 8400130 | Council Bluffs | Iowa | 51501 | — |
| Investigational Site Number 8400034 | Lexington | Kentucky | 40503 | — |
| Investigational Site Number 8400091 | Lexington | Kentucky | 40503 | — |
| Investigational Site Number 8400078 | Marrero | Louisiana | 70072 | — |
| Investigational Site Number 8400032 | Metairie | Louisiana | 70006 | — |
| Investigational Site Number 8400088 | New Orleans | Louisiana | 70121 | — |
| Investigational Site Number 8400033 | Baltimore | Maryland | 21237 | — |
| Investigational Site Number 8400051 | Jefferson City | Missouri | 65109 | — |
| Investigational Site Number 8400083 | Papillion | Nebraska | 68046-3136 | — |
| Investigational Site Number 8400044 | Henderson | Nevada | 89052 | — |
| Investigational Site Number 8400079 | Albany | New York | 12206 | — |
| Investigational Site Number 8400061 | New York | New York | 10001 | — |
| Investigational Site Number 8400123 | North Massapequa | New York | 11758 | — |
| Investigational Site Number 8400095 | Staten Island | New York | 10301 | — |
| Investigational Site Number 8400067 | West Seneca | New York | 14224 | — |
| Investigational Site Number 8400111 | Yonkers | New York | 10704 | — |
| Investigational Site Number 8400020 | Morehead City | North Carolina | 28557 | — |
| Investigational Site Number 8400065 | Wilmington | North Carolina | 28401 | — |
| Investigational Site Number 8400018 | Fargo | North Dakota | 58104 | — |
| Investigational Site Number 8400019 | Columbus | Ohio | 43201 | — |
| Investigational Site Number 8400056 | Dayton | Ohio | 45439 | — |
| Investigational Site Number 8400125 | Mentor | Ohio | 44060 | — |
| Investigational Site Number 8400099 | Oklahoma City | Oklahoma | 73112 | — |
| Investigational Site Number 8400129 | Scottdale | Pennsylvania | 15683 | — |
| Investigational Site Number 8400076 | Smithfield | Pennsylvania | 15478 | — |
| Investigational Site Number 8400104 | Warwick | Rhode Island | 02886 | — |
| Investigational Site Number 8400090 | Columbia | South Carolina | 29204 | — |
| Investigational Site Number 8400139 | Austin | Texas | 78749 | — |
| Investigational Site Number 8400001 | Dallas | Texas | 75230-6885 | — |
| Investigational Site Number 8400118 | Edinburg | Texas | 78539 | — |
| Investigational Site Number 8400008 | Houston | Texas | 77004 | — |
| Investigational Site Number 8400109 | Houston | Texas | 77040 | — |
| Investigational Site Number 8400063 | Houston | Texas | 77061 | — |
| Investigational Site Number 8400106 | Houston | Texas | 77081 | — |
| Investigational Site Number 8400014 | North Richland Hills | Texas | 76180 | — |
| Investigational Site Number 8400089 | San Antonio | Texas | 78240 | — |
| Investigational Site Number 8400135 | Schertz | Texas | 78154 | — |
| Investigational Site Number 8400075 | Shavano Park | Texas | 78231 | — |
| Investigational Site Number 8400107 | Sugar Land | Texas | 77478 | — |
| Investigational Site Number 8400054 | Orem | Utah | 84058 | — |
| Investigational Site Number 8400025 | Salt Lake City | Utah | 84102 | — |
| Investigational Site Number 8400092 | Weber City | Virginia | 24290 | — |
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 50 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02787551, 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 Mar 25, 2022 · Synced Oct 23, 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 NCT02787551 live on ClinicalTrials.gov.