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
NCT ID: NCT02787551
Last Updated: 2022-03-25
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
514 participants
INTERVENTIONAL
2016-07-06
2018-11-17
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Efficacy and Safety of the Insulin Glargine/Lixisenatide Fixed Ratio Combination Versus Insulin Glargine in Patients With Type 2 Diabetes
NCT02058160
Efficacy and Safety of Insulin Glargine/ Lixisenatide Fixed Ratio Combination Compared to Insulin Glargine Alone and Lixisenatide Alone on Top of Metformin in Patients With T2DM
NCT02058147
Efficacy and Safety of Insulin Glargine/Lixisenatide Fixed Combination Versus Insulin Glargine Alone on Top of Metformin in Type 2 Diabetic Patients
NCT01476475
Evaluation of Insulin Glargine/Lixisenatide Fixed Ratio Combination in Patients With Type 2 Diabetes Insufficiently Controlled With Oral Antidiabetic Drug(s)
NCT03798054
Comparison of the Efficacy and Safety of Insulin Glargine/Lixisenatide Fixed Ratio Combination to Insulin Glargine in Patients With Type 2 Diabetes Insufficiently Controlled on Basal Insulin
NCT03798080
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Maximum duration for FRC participants was approximately 55 weeks: up to 2-week screening period, a 26-week randomized treatment period, a 26-week extension period and a 3-day post-treatment safety follow-up period.
All primary and secondary efficacy, safety and other outcome measures were assessed at the end of the extension period.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Insulin Glargine/Lixisenatide Fixed Ratio Combination (FRC)
Core period: FRC injected subcutaneously once daily (QD) for 26 weeks on top of oral anti-diabetic drug (OAD) therapy. Dose individually adjusted.
Single arm extension period: Participants who completed core treatment period and met eligibility criteria entered in extension treatment period and received same treatment (FRC injected subcutaneously QD on top of OAD therapy) for 26 weeks (up to Week 52). Dose individually adjusted.
Insulin glargine/lixisenatide fixed ratio combination
Pharmaceutical form: solution for injection
Route of administration: subcutaneous
Background therapy: Oral Anti-diabetic Drug (Metformin, Pioglitazone, SGLT2 inhibitor)
Pharmaceutical form: tablet Route of administration: oral If previously taken, doses to remain stable through the study.
GLP-1 Receptor Agonist
Core period: GLP-1 RA receptor agonist (liraglutide QD, exenatide twice daily \[BID\], exenatide extended-release QW, albiglutide QW, or dulaglutide QW) injected subcutaneously for 26 weeks on top of OAD therapy. GLP-1 RAs were administered as per local labeling at the same dose schedule as prior to randomization.
liraglutide
Pharmaceutical form: solution for injection
Route of administration: subcutaneous
exenatide
Pharmaceutical form: solution for injection
Route of administration: subcutaneous
exenatide extended-release
Pharmaceutical form: solution for injection
Route of administration: subcutaneous
albiglutide
Pharmaceutical form: solution for injection
Route of administration: subcutaneous
dulaglutide
Pharmaceutical form: solution for injection
Route of administration: subcutaneous
Background therapy: Oral Anti-diabetic Drug (Metformin, Pioglitazone, SGLT2 inhibitor)
Pharmaceutical form: tablet Route of administration: oral If previously taken, doses to remain stable through the study.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Insulin glargine/lixisenatide fixed ratio combination
Pharmaceutical form: solution for injection
Route of administration: subcutaneous
liraglutide
Pharmaceutical form: solution for injection
Route of administration: subcutaneous
exenatide
Pharmaceutical form: solution for injection
Route of administration: subcutaneous
exenatide extended-release
Pharmaceutical form: solution for injection
Route of administration: subcutaneous
albiglutide
Pharmaceutical form: solution for injection
Route of administration: subcutaneous
dulaglutide
Pharmaceutical form: solution for injection
Route of administration: subcutaneous
Background therapy: Oral Anti-diabetic Drug (Metformin, Pioglitazone, SGLT2 inhibitor)
Pharmaceutical form: tablet Route of administration: oral If previously taken, doses to remain stable through the study.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Participants who were treated with one of the following GLP-1 receptor agonists for at least 4 months prior to screening visit 1 (V1), and with stable dose for at least 3 months prior to screening visit (V1):
* Liraglutide (Victoza®) 1.8 milligram (mg) QD or 1.2 mg QD, if the 1.8 mg QD dose was not well tolerated according to the Investigator's judgment or
* Exenatide (Byetta®) 10 microgram (µg) BID or of 5 µg BID, if 10 µg BID dose was not well tolerated according to the Investigator's judgment
in combination with metformin (daily dose greater than equal to \[\>=\] 1500 mg/day or maximum tolerated dose \[MTD\]), with or without pioglitazone, with or without SGLT2 inhibitor, all at stable dose for at least 3 months prior to screening.
or
Participants who were treated with stable dose of one of the following GLP-1 receptor agonists for at least 6 months prior to screening visit (V1):
* Exenatide extended-release (Bydureon®) 2 mg once weekly (QW), if well tolerated according to Investigator's judgment,
* Albiglutide (Tanzeum®) 50 mg QW or 30 mg QW, if 50 mg QW was not well tolerated according to Investigator's judgment,
* Dulaglutide (Trulicity®) 1.5 mg QW or 0.75 mg QW, if 1.5 mg QW was not well tolerated according to Investigator's judgment
in combination with metformin (daily dose ≥1500 mg/day or MTD), with or without pioglitazone, with or without SGLT2 inhibitor, all at stable dose for at least 3 months prior to screening;
-Signed written informed consent.
* Previous treatment with insulin in the year prior to screening visit (note: short-term treatment with insulin \[\<=10 days\] due to intercurrent illness including gestational diabetes was allowed at the discretion of the study physician).
* Laboratory findings at the time of screening, including:
* Fasting plasma glucose (FPG) \>250 mg/dL (13.9 millimoles per litre \[mmol/L\]),
* Amylase and/or lipase \>3 times the upper limit of the normal laboratory range (ULN),
* Alanine transaminase or aspartate transaminase \>3 ULN,
* Calcitonin \>=20 pg/mL (5.9 pmol/L),
* Positive pregnancy test.
* Participant who had renal function impairment with estimated glomerular filtration rate \<30mL/min/1.73m\^2 (using the Modification of Diet in Renal Disease formula) or end-stage renal disease.
* Contraindication to use of insulin glargine, or lixisenatide or GLP-1 receptor agonist (Victoza®, Byetta®, Bydureon®, Tanzeum® or Trulicity®) according to local labeling.
* Any contraindication to metformin or pioglitazone or SGLT2 inhibitor use, according to local labeling.
* History of hypersensitivity to insulin glargine, or to any of the excipients.
* History of allergic reaction to any GLP-1 receptor agonist or to meta-cresol.
* Personal or immediate family history of medullary thyroid cancer (MTC) or genetic condition that predisposes to MTC (eg, multiple endocrine neoplasia type 2 syndromes).
* History of pancreatitis (unless pancreatitis was related to gallstones and cholecystectomy was already performed), chronic pancreatitis, pancreatitis during a previous treatment with incretin therapies, pancreatectomy.
* Body mass index \<=20 or \>40 kg/m\^2.
Exclusion Criteria
* Screening HbA1c \<7% and \>9%.
* Pregnancy or lactation, women of childbearing potential with no effective contraceptive method.
* Participants in the FRC arm with a rescue therapy and HbA1c \>8% at week 22.
* Participants in the FRC arm who discontinued prematurely from FRC treatment before week 26.
* Participants in the GLP-1 RA treatment arm after randomization.
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Sanofi
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Clinical Sciences & Operations
Role: STUDY_DIRECTOR
Sanofi
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Investigational Site Number 8400064
Birmingham, Alabama, United States
Investigational Site Number 8400073
Fountain Hills, Arizona, United States
Investigational Site Number 8400047
Phoenix, Arizona, United States
Investigational Site Number 8400103
Bakersfield, California, United States
Investigational Site Number 8400137
Fresno, California, United States
Investigational Site Number 8400043
Huntington Park, California, United States
Investigational Site Number 8400124
Lamont, California, United States
Investigational Site Number 8400027
Lancaster, California, United States
Investigational Site Number 8400098
Los Angeles, California, United States
Investigational Site Number 8400013
Los Angeles, California, United States
Investigational Site Number 8400042
Mission Hills, California, United States
Investigational Site Number 8400006
Northridge, California, United States
Investigational Site Number 8400021
Orange, California, United States
Investigational Site Number 8400126
Rialto, California, United States
Investigational Site Number 8400094
Santa Ana, California, United States
Investigational Site Number 8400009
Ventura, California, United States
Investigational Site Number 8400071
Denver, Colorado, United States
Investigational Site Number 8400036
Denver, Colorado, United States
Investigational Site Number 8400114
Jacksonville, Florida, United States
Investigational Site Number 8400133
Miami, Florida, United States
Investigational Site Number 8400058
Port Charlotte, Florida, United States
Investigational Site Number 8400084
Tampa, Florida, United States
Investigational Site Number 8400112
West Palm Beach, Florida, United States
Investigational Site Number 8400045
Lawrenceville, Georgia, United States
Investigational Site Number 8400096
Snellville, Georgia, United States
Investigational Site Number 8400023
Springfield, Illinois, United States
Investigational Site Number 8400049
Avon, Indiana, United States
Investigational Site Number 8400053
Avon, Indiana, United States
Investigational Site Number 8400085
Avon, Indiana, United States
Investigational Site Number 8400120
Avon, Indiana, United States
Investigational Site Number 8400041
Evansville, Indiana, United States
Investigational Site Number 8400038
Indianapolis, Indiana, United States
Investigational Site Number 8400130
Council Bluffs, Iowa, United States
Investigational Site Number 8400034
Lexington, Kentucky, United States
Investigational Site Number 8400091
Lexington, Kentucky, United States
Investigational Site Number 8400078
Marrero, Louisiana, United States
Investigational Site Number 8400032
Metairie, Louisiana, United States
Investigational Site Number 8400088
New Orleans, Louisiana, United States
Investigational Site Number 8400033
Baltimore, Maryland, United States
Investigational Site Number 8400051
Jefferson City, Missouri, United States
Investigational Site Number 8400083
Papillion, Nebraska, United States
Investigational Site Number 8400044
Henderson, Nevada, United States
Investigational Site Number 8400079
Albany, New York, United States
Investigational Site Number 8400061
New York, New York, United States
Investigational Site Number 8400123
North Massapequa, New York, United States
Investigational Site Number 8400095
Staten Island, New York, United States
Investigational Site Number 8400067
West Seneca, New York, United States
Investigational Site Number 8400111
Yonkers, New York, United States
Investigational Site Number 8400020
Morehead City, North Carolina, United States
Investigational Site Number 8400065
Wilmington, North Carolina, United States
Investigational Site Number 8400018
Fargo, North Dakota, United States
Investigational Site Number 8400019
Columbus, Ohio, United States
Investigational Site Number 8400056
Dayton, Ohio, United States
Investigational Site Number 8400125
Mentor, Ohio, United States
Investigational Site Number 8400099
Oklahoma City, Oklahoma, United States
Investigational Site Number 8400129
Scottdale, Pennsylvania, United States
Investigational Site Number 8400076
Smithfield, Pennsylvania, United States
Investigational Site Number 8400104
Warwick, Rhode Island, United States
Investigational Site Number 8400090
Columbia, South Carolina, United States
Investigational Site Number 8400139
Austin, Texas, United States
Investigational Site Number 8400001
Dallas, Texas, United States
Investigational Site Number 8400118
Edinburg, Texas, United States
Investigational Site Number 8400008
Houston, Texas, United States
Investigational Site Number 8400109
Houston, Texas, United States
Investigational Site Number 8400063
Houston, Texas, United States
Investigational Site Number 8400106
Houston, Texas, United States
Investigational Site Number 8400014
North Richland Hills, Texas, United States
Investigational Site Number 8400089
San Antonio, Texas, United States
Investigational Site Number 8400135
Schertz, Texas, United States
Investigational Site Number 8400075
Shavano Park, Texas, United States
Investigational Site Number 8400107
Sugar Land, Texas, United States
Investigational Site Number 8400054
Orem, Utah, United States
Investigational Site Number 8400025
Salt Lake City, Utah, United States
Investigational Site Number 8400092
Weber City, Virginia, United States
Investigational Site Number 1240003
Burlington, , Canada
Investigational Site Number 1240006
Corunna, , Canada
Investigational Site Number 1240002
Red Deer, , Canada
Investigational Site Number 1240001
Vancouver, , Canada
Investigational Site Number 2330002
Pärnu, , Estonia
Investigational Site Number 2330003
Tallinn, , Estonia
Investigational Site Number 2330001
Tallinn, , Estonia
Investigational Site Number 2330004
Viljandi, , Estonia
Investigational Site Number 2760001
Dresden, , Germany
Investigational Site Number 2760003
Oldenburg in Holstein, , Germany
Investigational Site Number 3760001
Haifa, , Israel
Investigational Site Number 3760002
Haifa, , Israel
Investigational Site Number 3760005
Jerusalem, , Israel
Investigational Site Number 3760006
Jerusalem, , Israel
Investigational Site Number 3760004
Tel Aviv, , Israel
Investigational Site Number 3800008
Bergamo, , Italy
Investigational Site Number 3800002
Bologna, , Italy
Investigational Site Number 3800001
Milan, , Italy
Investigational Site Number 3800006
Milan, , Italy
Investigational Site Number 3800005
Napoli, , Italy
Investigational Site Number 3800004
Roma, , Italy
Investigational Site Number 3800003
Roma, , Italy
Investigational Site Number 6420004
Bacau, , Romania
Investigational Site Number 6420006
Brasov, , Romania
Investigational Site Number 6420001
Bucharest, , Romania
Investigational Site Number 6420008
Buzău, , Romania
Investigational Site Number 6420003
Cluj-Napoca, , Romania
Investigational Site Number 6420002
Oradea, , Romania
Investigational Site Number 6420009
Târgovişte, , Romania
Investigational Site Number 6420007
Târgu Mureş, , Romania
Investigational Site Number 6420005
Timișoara, , Romania
Investigational Site Number 7030006
Bratislava, , Slovakia
Investigational Site Number 7030002
Lučenec, , Slovakia
Investigational Site Number 7030009
Ľubochňa, , Slovakia
Investigational Site Number 7030005
Malacky, , Slovakia
Investigational Site Number 7030007
Prešov, , Slovakia
Investigational Site Number 7030001
Rožňava, , Slovakia
Investigational Site Number 7030008
Sabinov, , Slovakia
Investigational Site Number 7030004
Trenčín, , Slovakia
Investigational Site Number 7030003
Žilina, , Slovakia
Investigational Site Number 7240012
Alzira, , Spain
Investigational Site Number 7240005
Barcelona, , Spain
Investigational Site Number 7240002
Ferrol, , Spain
Investigational Site Number 7240008
Málaga, , Spain
Investigational Site Number 7240011
Pozuelo de Alarcón, , Spain
Investigational Site Number 7240003
Quart de Poblet, , Spain
Investigational Site Number 7240006
Sabadell, , Spain
Investigational Site Number 7240007
Seville, , Spain
Investigational Site Number 7240009
Seville, , Spain
Investigational Site Number 7240004
Seville, , Spain
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Kuruvilla DE, Mann JI, Tepper SJ, Starling AJ, Panza G, Johnson MAL. Phase 3 randomized, double-blind, sham-controlled Trial of e-TNS for the Acute treatment of Migraine (TEAM). Sci Rep. 2022 Mar 24;12(1):5110. doi: 10.1038/s41598-022-09071-6.
Ferrannini E, Niemoeller E, Dex T, Servera S, Mari A. Fixed-ratio combination of insulin glargine plus lixisenatide (iGlarLixi) improves ss-cell function in people with type 2 diabetes. Diabetes Obes Metab. 2022 Jun;24(6):1159-1165. doi: 10.1111/dom.14688. Epub 2022 Mar 28.
Guja C, Giorgino F, Blonde L, Ali A, Prazny M, Meier JJ, Souhami E, Lubwama R, Ji C, Rosenstock J. Concomitant iGlarLixi and Sodium-Glucose Co-transporter-2 Inhibitor Therapy in Adults with Type 2 Diabetes: LixiLan-G Trial and Real-World Evidence Results. Diabetes Ther. 2022 Jan;13(1):205-215. doi: 10.1007/s13300-021-01180-1. Epub 2021 Dec 11.
Blonde L, Rosenstock J, Frias J, Birkenfeld AL, Niemoeller E, Souhami E, Ji C, Del Prato S, Aroda VR. Durable Effects of iGlarLixi Up to 52 Weeks in Type 2 Diabetes: The LixiLan-G Extension Study. Diabetes Care. 2021 Mar;44(3):774-780. doi: 10.2337/dc20-2023. Epub 2021 Jan 19.
Blonde L, Rosenstock J, Del Prato S, Henry R, Shehadeh N, Frias J, Niemoeller E, Souhami E, Ji C, Aroda VR. Switching to iGlarLixi Versus Continuing Daily or Weekly GLP-1 RA in Type 2 Diabetes Inadequately Controlled by GLP-1 RA and Oral Antihyperglycemic Therapy: The LixiLan-G Randomized Clinical Trial. Diabetes Care. 2019 Nov;42(11):2108-2116. doi: 10.2337/dc19-1357. Epub 2019 Sep 17.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2014-004850-32
Identifier Type: -
Identifier Source: secondary_id
U1111-1168-4639
Identifier Type: OTHER
Identifier Source: secondary_id
EFC13794
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.