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
NCT ID: NCT02058147
Last Updated: 2017-05-09
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
1170 participants
INTERVENTIONAL
2014-02-28
2015-06-30
Brief Summary
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To compare the insulin glargine/lixisenatide fixed ratio combination to lixisenatide alone and to insulin glargine alone (on top of metformin treatment) in glycated hemoglobin (HbA1c) change from baseline to Week 30.
Secondary Objective:
To compare the overall efficacy and safety of insulin glargine/lixisenatide fixed ratio combination (FRC) to insulin glargine alone and to lixisenatide alone (on top of metformin treatment) over a 30 week treatment period in participants with type 2 diabetes.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Insulin Glargine/Lixisenatide Fixed Ratio Combination (FRC)
FRC once daily (QD) for 30 weeks. Dose individually adjusted.
Insulin glargine/lixisenatide Fixed Ratio Combination
Insulin glargine/Lixisenatide FRC was self-administered by subcutaneous (SC) injection in the morning within one hour before breakfast using one of the 2 prefilled disposable SoloStar® pen-injectors: Pen A containing 100 U/mL insulin glargine (Lantus, 100 U/mL) and 50 mcg/mL lixisenatide in a ratio of 2 U:1 mcg, used for administration of doses from 10 U to 40 U (10 U/5mcg to 40 U/20mcg). Pen B containing 100 U/mL insulin glargine (Lantus, 100 U/mL) and 33 mcg/mL lixisenatide in a ratio of 3 U:1 mcg, used to administer doses from 41 U to 60 U (41 U/13 mcg to 60 U/20 mcg). The starting dose was 10 U/5 mcg. Dose was then adjusted individually to reach and maintain fasting self-monitored plasma glucose (SMPG) of 80 mg/dL to 100 mg/dL (4.4 mmol/L to 5.6 mmol/L) while avoiding hypoglycemia.
Metformin
Pharmaceutical form: Tablet; Route of administration: Oral administration.
Insulin Glargine
Insulin glargine QD for 30 weeks. Dose individually adjusted.
Insulin glargine (HOE901)
Insulin glargine (100 U/mL) was self-administered by SC injection at approximately the same time every day. Dose was adjusted individually to reach and maintain fasting SMPG of 80 mg/dL to 100 mg/dL (4.4 mmol/L to 5.6 mmol/L) while avoiding hypoglycemia.
Metformin
Pharmaceutical form: Tablet; Route of administration: Oral administration.
Lixisenatide
Lixisenatide 10 mcg QD for 2 weeks, then 20 mcg QD (maintenance dose).
Lixisenatide (AVE0010)
Lixisenatide was self-administered by SC injection within 0 to 60 minutes before breakfast or evening meal. If the maintenance dose of 20 mcg was not tolerated, dose could be reduced to 10 mcg.
Metformin
Pharmaceutical form: Tablet; Route of administration: Oral administration.
Interventions
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Insulin glargine/lixisenatide Fixed Ratio Combination
Insulin glargine/Lixisenatide FRC was self-administered by subcutaneous (SC) injection in the morning within one hour before breakfast using one of the 2 prefilled disposable SoloStar® pen-injectors: Pen A containing 100 U/mL insulin glargine (Lantus, 100 U/mL) and 50 mcg/mL lixisenatide in a ratio of 2 U:1 mcg, used for administration of doses from 10 U to 40 U (10 U/5mcg to 40 U/20mcg). Pen B containing 100 U/mL insulin glargine (Lantus, 100 U/mL) and 33 mcg/mL lixisenatide in a ratio of 3 U:1 mcg, used to administer doses from 41 U to 60 U (41 U/13 mcg to 60 U/20 mcg). The starting dose was 10 U/5 mcg. Dose was then adjusted individually to reach and maintain fasting self-monitored plasma glucose (SMPG) of 80 mg/dL to 100 mg/dL (4.4 mmol/L to 5.6 mmol/L) while avoiding hypoglycemia.
Insulin glargine (HOE901)
Insulin glargine (100 U/mL) was self-administered by SC injection at approximately the same time every day. Dose was adjusted individually to reach and maintain fasting SMPG of 80 mg/dL to 100 mg/dL (4.4 mmol/L to 5.6 mmol/L) while avoiding hypoglycemia.
Lixisenatide (AVE0010)
Lixisenatide was self-administered by SC injection within 0 to 60 minutes before breakfast or evening meal. If the maintenance dose of 20 mcg was not tolerated, dose could be reduced to 10 mcg.
Metformin
Pharmaceutical form: Tablet; Route of administration: Oral administration.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Signed written informed consent.
* Previous Treatment with insulin (except for short-term treatment due to intercurrent illness including gestational diabetes, at the discretion of the trial physician).
* History of discontinuation of a previous treatment with a glucagon-like peptide (GLP-1) receptor agonist (GLP-1 RA) due to safety/tolerability issue or lack of efficacy.
* Participant who previously participated in any clinical trial with lixisenatide or the insulin glargine/lixisenatide fixed ratio combination or had previously received lixisenatide.
* Any contraindication to metformin use, according to local labeling.
* Use of weight loss drugs within 3 months prior to screening visit.
* Within the last 6 months prior to screening visit: history of stroke, myocardial infarction, unstable angina, or heart failure requiring hospitalization. Planned coronary, carotid or peripheral artery revascularisation procedures to be performed during the study period.
* 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, stomach/gastric surgery.
* Personal or immediate family history of medullary thyroid cancer (MTC) or genetic conditions that predispose to MTC (e.g, multiple endocrine neoplasia syndromes).
* Uncontrolled or inadequately controlled hypertension (systolic blood pressure above 180 mmHg or diastolic blood pressure above 95 mmHg) at screening visit.
* At screening visit, Body Mass Index (BMI) less than or equal to 20 or above 40 kg/m\^2.
* At screening visit amylase and/or lipase more than 3 times the upper limit of the normal (ULN) laboratory range.
* At screening visit alanine aminotransferase (ALT) or alkaline phosphatase (AST) more than 3 ULN.
* At screening visit calcitonin above or equal to 20 pg/mL (5.9 pmol/L).
Exclusion Criteria
* less than 7.5% or more than 10% for participants previously treated with metformin alone,
* less than 7.0% or more than 9% for participants previously treated with metformin and a second oral anti-diabetic treatment.
* Pregnancy or lactation, women of childbearing potential with no effective contraceptive method.
* HbA1c less than 7% or above 10%;
* Fasting Plasma glucose above 250 mg/dL (13.9 mmol/L);
* Metformin maximal tolerated dose less than 1500 mg/day;
* Amylase and/or lipase more than 3 ULN.
The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
18 Years
ALL
No
Sponsors
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Sanofi
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Sciences & Operations
Role: STUDY_DIRECTOR
Sanofi
Locations
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Investigational Site Number 840027
Phoenix, Arizona, United States
Investigational Site Number 840122
Phoenix, Arizona, United States
Investigational Site Number 840062
Tempe, Arizona, United States
Investigational Site Number 840023
Tempe, Arizona, United States
Investigational Site Number 840084
Little Rock, Arkansas, United States
Investigational Site Number 840100
Anaheim, California, United States
Investigational Site Number 840065
Bell Gardens, California, United States
Investigational Site Number 840090
Chino, California, United States
Investigational Site Number 840002
Chula Vista, California, United States
Investigational Site Number 840013
Concord, California, United States
Investigational Site Number 840053
Fresno, California, United States
Investigational Site Number 840017
La Jolla, California, United States
Investigational Site Number 840070
Lancaster, California, United States
Investigational Site Number 840121
Long Beach, California, United States
Investigational Site Number 840126
Los Angeles, California, United States
Investigational Site Number 840044
Los Angeles, California, United States
Investigational Site Number 840101
Mission Hills, California, United States
Investigational Site Number 840086
Mission Viejo, California, United States
Investigational Site Number 840120
Mission Viejo, California, United States
Investigational Site Number 840005
Northridge, California, United States
Investigational Site Number 840034
Palm Springs, California, United States
Investigational Site Number 840074
Port Hueneme, California, United States
Investigational Site Number 840068
San Ramon, California, United States
Investigational Site Number 840067
Santa Ana, California, United States
Investigational Site Number 840029
Tarzana, California, United States
Investigational Site Number 840006
Temecula, California, United States
Investigational Site Number 840078
West Hills, California, United States
Investigational Site Number 840059
Aurora, Colorado, United States
Investigational Site Number 840038
Denver, Colorado, United States
Investigational Site Number 840104
Bradenton, Florida, United States
Investigational Site Number 840098
Miami, Florida, United States
Investigational Site Number 840014
New Port Richey, Florida, United States
Investigational Site Number 840047
Ocoee, Florida, United States
Investigational Site Number 840056
Palm Harbor, Florida, United States
Investigational Site Number 840089
Atlanta, Georgia, United States
Investigational Site Number 840054
Lawrenceville, Georgia, United States
Investigational Site Number 840119
Woodstock, Georgia, United States
Investigational Site Number 840108
Idaho Falls, Idaho, United States
Investigational Site Number 840075
Arlington Heights, Illinois, United States
Investigational Site Number 840080
Chicago, Illinois, United States
Investigational Site Number 840026
Chicago, Illinois, United States
Investigational Site Number 840116
Chicago, Illinois, United States
Investigational Site Number 840050
Springfield, Illinois, United States
Investigational Site Number 840008
Avon, Indiana, United States
Investigational Site Number 840015
Avon, Indiana, United States
Investigational Site Number 840076
Avon, Indiana, United States
Investigational Site Number 840082
Evansville, Indiana, United States
Investigational Site Number 840031
Evansville, Indiana, United States
Investigational Site Number 840060
Evansville, Indiana, United States
Investigational Site Number 840048
Indianapolis, Indiana, United States
Investigational Site Number 840085
Indianapolis, Indiana, United States
Investigational Site Number 840012
Valparaiso, Indiana, United States
Investigational Site Number 840025
Waterloo, Iowa, United States
Investigational Site Number 840022
Lexington, Kentucky, United States
Investigational Site Number 840007
Louisville, Kentucky, United States
Investigational Site Number 840081
New Orleans, Louisiana, United States
Investigational Site Number 840097
Auburn, Maine, United States
Investigational Site Number 840063
Rockville, Maryland, United States
Investigational Site Number 840028
Bloomfield Hills, Michigan, United States
Investigational Site Number 840071
Chesterfield, Michigan, United States
Investigational Site Number 840001
Dearborn, Michigan, United States
Investigational Site Number 840091
Kalamazoo, Michigan, United States
Investigational Site Number 840009
Minneapolis, Minnesota, United States
Investigational Site Number 840024
Chesterfield, Missouri, United States
Investigational Site Number 840057
Butte, Montana, United States
Investigational Site Number 840042
Omaha, Nebraska, United States
Investigational Site Number 840109
Henderson, Nevada, United States
Investigational Site Number 840052
Las Vegas, Nevada, United States
Investigational Site Number 840069
Nashua, New Hampshire, United States
Investigational Site Number 840123
Morganville, New Jersey, United States
Investigational Site Number 840011
Albuquerque, New Mexico, United States
Investigational Site Number 840030
New Hyde Park, New York, United States
Investigational Site Number 840096
Syracuse, New York, United States
Investigational Site Number 840039
Asheville, North Carolina, United States
Investigational Site Number 840021
Hickory, North Carolina, United States
Investigational Site Number 840046
Morehead City, North Carolina, United States
Investigational Site Number 840072
Morganton, North Carolina, United States
Investigational Site Number 840110
Salisbury, North Carolina, United States
Investigational Site Number 840095
Wilmington, North Carolina, United States
Investigational Site Number 840099
Winston-Salem, North Carolina, United States
Investigational Site Number 840004
Columbus, Ohio, United States
Investigational Site Number 840016
Maumee, Ohio, United States
Investigational Site Number 840103
Eugene, Oregon, United States
Investigational Site Number 840113
Portland, Oregon, United States
Investigational Site Number 840036
Pittsburgh, Pennsylvania, United States
Investigational Site Number 840043
Tipton, Pennsylvania, United States
Investigational Site Number 840058
Anderson, South Carolina, United States
Investigational Site Number 840127
Charleston, South Carolina, United States
Investigational Site Number 840049
Greer, South Carolina, United States
Investigational Site Number 840114
Rapid City, South Dakota, United States
Investigational Site Number 840112
Bristol, Tennessee, United States
Investigational Site Number 840094
Knoxville, Tennessee, United States
Investigational Site Number 840051
Austin, Texas, United States
Investigational Site Number 840066
Corpus Christi, Texas, United States
Investigational Site Number 840111
Dallas, Texas, United States
Investigational Site Number 840020
Dallas, Texas, United States
Investigational Site Number 840064
Dallas, Texas, United States
Investigational Site Number 840003
Dallas, Texas, United States
Investigational Site Number 840088
Edinburg, Texas, United States
Investigational Site Number 840118
Fort Worth, Texas, United States
Investigational Site Number 840055
Houston, Texas, United States
Investigational Site Number 840087
Houston, Texas, United States
Investigational Site Number 840079
Hurst, Texas, United States
Investigational Site Number 840073
N Richland Hill, Texas, United States
Investigational Site Number 840019
San Antonio, Texas, United States
Investigational Site Number 840037
Draper, Utah, United States
Investigational Site Number 840093
Ogden, Utah, United States
Investigational Site Number 840061
Salt Lake City, Utah, United States
Investigational Site Number 840041
Salt Lake City, Utah, United States
Investigational Site Number 840040
Chesapeake, Virginia, United States
Investigational Site Number 840045
Norfolk, Virginia, United States
Investigational Site Number 840092
Norfolk, Virginia, United States
Investigational Site Number 840125
Richmond, Virginia, United States
Investigational Site Number 840115
Salem, Virginia, United States
Investigational Site Number 840010
Weber City, Virginia, United States
Investigational Site Number 840077
Federal Way, Washington, United States
Investigational Site Number 840102
Renton, Washington, United States
Investigational Site Number 840033
Milwaukee, Wisconsin, United States
Investigational Site Number 036005
Box Hill, , Australia
Investigational Site Number 036001
Camperdown, , Australia
Investigational Site Number 036006
Kippa-Ring, , Australia
Investigational Site Number 036007
Logan Central, , Australia
Investigational Site Number 056005
Brussels, , Belgium
Investigational Site Number 056006
Brussels, , Belgium
Investigational Site Number 056001
Leuven, , Belgium
Investigational Site Number 124004
Kelowna, , Canada
Investigational Site Number 124001
Toronto, , Canada
Investigational Site Number 124002
Vancouver, , Canada
Investigational Site Number 152008
Osorno, , Chile
Investigational Site Number 152015
Puerto Varas, , Chile
Investigational Site Number 152004
Santiago, , Chile
Investigational Site Number 152006
Santiago, , Chile
Investigational Site Number 152001
Santiago, , Chile
Investigational Site Number 152002
Santiago, , Chile
Investigational Site Number 152012
Santiago, , Chile
Investigational Site Number 152009
Santiago, , Chile
Investigational Site Number 152011
Talagante, , Chile
Investigational Site Number 152014
Temuco, , Chile
Investigational Site Number 152003
Temuco, , Chile
Investigational Site Number 203004
Beroun, , Czechia
Investigational Site Number 203008
České Budějovice, , Czechia
Investigational Site Number 203014
Hořovice, , Czechia
Investigational Site Number 203012
Kopřivnice, , Czechia
Investigational Site Number 203001
Pardubice, , Czechia
Investigational Site Number 203005
Pilsen, , Czechia
Investigational Site Number 203003
Prague, , Czechia
Investigational Site Number 203009
Prague, , Czechia
Investigational Site Number 203007
Prague, , Czechia
Investigational Site Number 203013
Praha 9 - Klanovice, , Czechia
Investigational Site Number 203006
Trutnov, , Czechia
Investigational Site Number 203016
Újezd u Brna, , Czechia
Investigational Site Number 203015
Vsetín, , Czechia
Investigational Site Number 208003
Aarhus C, , Denmark
Investigational Site Number 208009
Horsens, , Denmark
Investigational Site Number 208002
Kolding, , Denmark
Investigational Site Number 208001
København NV, , Denmark
Investigational Site Number 208005
København S, , Denmark
Investigational Site Number 208004
Viborg, , Denmark
Investigational Site Number 233004
Paide, , Estonia
Investigational Site Number 233002
Pärnu, , Estonia
Investigational Site Number 233003
Tallinn, , Estonia
Investigational Site Number 233001
Viljandimaa, , Estonia
Investigational Site Number 250006
Corbeil-Essonnes, , France
Investigational Site Number 250002
La Rochelle, , France
Investigational Site Number 250003
Pierre-Bénite, , France
Investigational Site Number 250001
Vénissieux, , France
Investigational Site Number 276005
Berlin, , Germany
Investigational Site Number 276003
Berlin, , Germany
Investigational Site Number 276004
Dortmund, , Germany
Investigational Site Number 276007
Dresden, , Germany
Investigational Site Number 276001
Dresden, , Germany
Investigational Site Number 276006
Hamburg, , Germany
Investigational Site Number 276002
Neumünster, , Germany
Investigational Site Number 348003
Balatonfüred, , Hungary
Investigational Site Number 348007
Budapest, , Hungary
Investigational Site Number 348006
Budapest, , Hungary
Investigational Site Number 348002
Budapest, , Hungary
Investigational Site Number 348011
Komárom, , Hungary
Investigational Site Number 348008
Nagykanizsa, , Hungary
Investigational Site Number 348012
Sátoraljaújhely, , Hungary
Investigational Site Number 348004
Szeged, , Hungary
Investigational Site Number 348010
Székesfehérvár, , Hungary
Investigational Site Number 348001
Zalaegerszeg, , Hungary
Investigational Site Number 380002
Bologna, , Italy
Investigational Site Number 380006
Catanzaro, , Italy
Investigational Site Number 380001
Milan, , Italy
Investigational Site Number 380003
Napoli, , Italy
Investigational Site Number 380005
Roma, , Italy
Investigational Site Number 428002
Riga, , Latvia
Investigational Site Number 428003
Riga, , Latvia
Investigational Site Number 428004
Riga, , Latvia
Investigational Site Number 428001
Sigulda, , Latvia
Investigational Site Number 440003
Jonava, , Lithuania
Investigational Site Number 440002
Kaunas, , Lithuania
Investigational Site Number 440007
Kaunas, , Lithuania
Investigational Site Number 440004
Kėdainiai, , Lithuania
Investigational Site Number 440006
Panevezys, , Lithuania
Investigational Site Number 440005
Utena, , Lithuania
Investigational Site Number 440001
Vilnius, , Lithuania
Investigational Site Number 484005
Aguascalientes, , Mexico
Investigational Site Number 484001
Cuernavaca, , Mexico
Investigational Site Number 484002
Guadalajara, , Mexico
Investigational Site Number 484004
Guadalajara, , Mexico
Investigational Site Number 484009
Guadalajara, , Mexico
Investigational Site Number 484007
Monterrey, , Mexico
Investigational Site Number 484006
Monterrey, , Mexico
Investigational Site Number 484010
Zapopan, , Mexico
Investigational Site Number 616002
Bialystok, , Poland
Investigational Site Number 616005
Krakow, , Poland
Investigational Site Number 616006
Krakow, , Poland
Investigational Site Number 616007
Lodz, , Poland
Investigational Site Number 616004
Szczecin, , Poland
Investigational Site Number 616003
Warsaw, , Poland
Investigational Site Number 616001
Warsaw, , Poland
Investigational Site Number 616008
Żory, , Poland
Investigational Site Number 642008
Bucharest, , Romania
Investigational Site Number 642007
Bucharest, , Romania
Investigational Site Number 642009
Cluj-Napoca, , Romania
Investigational Site Number 642006
Hunedoara, , Romania
Investigational Site Number 642005
Iași, , Romania
Investigational Site Number 642002
Oradea, , Romania
Investigational Site Number 642001
Târgu Mureş, , Romania
Investigational Site Number 642004
Timișoara, , Romania
Investigational Site Number 642003
Timișoara, , Romania
Investigational Site Number 643006
Moscow, , Russia
Investigational Site Number 643008
Penza, , Russia
Investigational Site Number 643012
Petrozavodsk, , Russia
Investigational Site Number 643001
Saint Petersburg, , Russia
Investigational Site Number 643005
Saint Petersburg, , Russia
Investigational Site Number 643007
Saint Petersburg, , Russia
Investigational Site Number 643003
Saint Petersburg, , Russia
Investigational Site Number 643002
Saint Petersburg, , Russia
Investigational Site Number 643014
Samara, , Russia
Investigational Site Number 643009
Saratov, , Russia
Investigational Site Number 643011
Saratov, , Russia
Investigational Site Number 643016
Tomsk, , Russia
Investigational Site Number 643004
Voronezh, , Russia
Investigational Site Number 710002
Cap Town, , South Africa
Investigational Site Number 710003
Cape Town, , South Africa
Investigational Site Number 710005
Meyerspark, , South Africa
Investigational Site Number 710007
Port Elizabeth, , South Africa
Investigational Site Number 710004
Pretoria, , South Africa
Investigational Site Number 710001
Somerset West, , South Africa
Investigational Site Number 710006
Soweto, , South Africa
Investigational Site Number 724011
A Coruña, , Spain
Investigational Site Number 724012
Barcelona, , Spain
Investigational Site Number 724009
Granada, , Spain
Investigational Site Number 724004
Hostalets de Balenyà, , Spain
Investigational Site Number 724007
Lugo, , Spain
Investigational Site Number 724008
Madrid, , Spain
Investigational Site Number 724005
Madrid, , Spain
Investigational Site Number 724013
Palma de Mallorca, , Spain
Investigational Site Number 724001
Quart de Poblet, , Spain
Investigational Site Number 724006
Sant Joan Despí, , Spain
Investigational Site Number 724003
Seville, , Spain
Investigational Site Number 752001
Ljungby, , Sweden
Investigational Site Number 752003
Malmo, , Sweden
Investigational Site Number 752004
Rättvik, , Sweden
Investigational Site Number 752005
Stockholm, , Sweden
Investigational Site Number 752002
Vällingby, , Sweden
Investigational Site Number 804002
Chernivtsi, , Ukraine
Investigational Site Number 804009
Ivano-Frankivsk, , Ukraine
Investigational Site Number 804010
Kyiv, , Ukraine
Investigational Site Number 804007
Kyiv, , Ukraine
Investigational Site Number 804006
Kyiv, , Ukraine
Investigational Site Number 804012
Lviv, , Ukraine
Investigational Site Number 804011
Vinnytsia, , Ukraine
Investigational Site Number 804008
Vinnytsia, , Ukraine
Investigational Site Number 826001
Coventry, , United Kingdom
Investigational Site Number 826002
Dundee, , United Kingdom
Investigational Site Number 826006
Guildford, , United Kingdom
Investigational Site Number 826007
Leicester, , United Kingdom
Investigational Site Number 826003
Norwich, , United Kingdom
Countries
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References
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Shao H, Kianmehr H, Guo J, Li P, Fonseca V, Shi L. Efficacy of iGlarLixi on 5-year risk of diabetes-related complications: A simulation study. J Diabetes Complications. 2022 Mar;36(3):108132. doi: 10.1016/j.jdiacomp.2022.108132. Epub 2022 Jan 25.
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Dailey G, Bajaj HS, Dex T, Groleau M, Stager W, Vinik A. Post hoc efficacy and safety analysis of insulin glargine/lixisenatide fixed- ratio combination in North American patients compared with the rest of world. BMJ Open Diabetes Res Care. 2019 Mar 21;7(1):e000581. doi: 10.1136/bmjdrc-2018-000581. eCollection 2019.
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Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2013-003131-30
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
U1111-1148-4334
Identifier Type: OTHER
Identifier Source: secondary_id
EFC12404
Identifier Type: -
Identifier Source: org_study_id
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