Clinical trial NCT02058147: 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
Official title: A Randomized, 30 Week, Active-controlled, Open-label, 3-treatment Arm, Parallel-group Multicenter Study Comparing the Efficacy and Safety of Insulin Glargine/ Lixisenatide Fixed Ratio Combination to Insulin Glargine Alone and to Lixisenatide Alone on Top of Metformin in Patients With Type 2 Diabetes Mellitus (T2DM)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Type 2 Diabetes
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2014-02-07
Enrollment: 1170
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Primary Objective:

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.

Detailed description: Approximately 37 weeks including up to 6 weeks of screening, 30-week treatment period, and a 3 days follow-up period.

Eligibility criteria: Inclusion criteria:

* Participants with type 2 diabetes mellitus diagnosed for at least 1 year before the screening visit, treated for at least 3 months prior to visit 1 with metformin alone or metformin and a second oral anti-diabetic treatment that could be a sulfonylurea, a glinide, a sodium glucose co-transporter-2 inhibitor or a di-peptidyl peptidase 4 (DPP-4) inhibitors, and who were not adequately controlled with this treatment.
* Signed written informed consent.

Exclusion criteria:

* HbA1c at screening visit:

  * 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.
* Use of oral glucose-lowering agents other than those stated in the inclusion criteria or any injectable glucose-lowering agents during the 3 months before screening.
* 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 for randomization at the end of the screening period:

* 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.

Primary outcomes:
measure: Change in HbA1c From Baseline to Week 30
timeFrame: Baseline, Week 30
Secondary outcomes:
measure: Percentage of Participants With HbA1c <7.0% or ≤6.5% at Week 30
timeFrame: Week 30
measure: Change in Plasma Glucose Excursion From Baseline to Week 30
timeFrame: Baseline, Week 30
measure: Change in Body Weight From Baseline to Week 30
timeFrame: Baseline, Week 30
measure: Change in Fasting Plasma Glucose (FPG) From Baseline to Week 30
timeFrame: Baseline, Week 30
measure: Mean Change in 7-point Self-monitored Plasma Glucose (SMPG) Profile From Baseline to Week 30
timeFrame: Baseline, Week 30
measure: Percentage of Participants Reaching HbA1c <7.0% With No Body Weight Gain at Week 30
timeFrame: Week 30
measure: Percentage of Participants Reaching HbA1c <7.0% With No Body Weight Gain at Week 30 and No Documented Symptomatic Hypoglycemia (Plasma Glucose [PG] ≤ 70 mg/dL [3.9 mmol/L]) During 30-Week Treatment Period
timeFrame: Baseline up to Week 30
measure: Average Daily Insulin Glargine Dose at Week 30
timeFrame: Week 30
measure: Change in 2-Hour Postprandial Plasma Glucose (PPG) From Baseline to Week 30
timeFrame: Baseline, Week 30
measure: Percentage of Participants Reaching HbA1c <7.0% at Week 30 With No Documented Symptomatic Hypoglycemia (PG ≤ 70 mg/dL [3.9 mmol/L]) During 30-Week Treatment Period
timeFrame: Baseline up to Week 30
measure: Percentage of Participants Requiring Rescue Therapy During 30-Week Treatment Period
timeFrame: Baseline up to Week 30
measure: Number of Documented Symptomatic Hypoglycemia Events Per Subject-Year
timeFrame: First dose of study drug up to 1 day after the last dose administration (median treatment exposure: 211 days)
measure: Percentage of Participants With Documented Symptomatic Hypoglycemia
timeFrame: First dose of study drug up to 1 day after the last dose administration (median treatment exposure: 211 days)
measure: Percentage of Participants With Severe Symptomatic Hypoglycemia
timeFrame: First dose of study drug up to 1 day after the last dose administration (median treatment exposure: 211 days)
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Investigational Site Number 840027
state: Arizona
city: Phoenix
country: United States
facility: Investigational Site Number 840122
state: Arizona
city: Tempe
country: United States
facility: Investigational Site Number 840062
state: Arizona
city: Tempe
country: United States
facility: Investigational Site Number 840023
state: Arizona
city: Little Rock
country: United States
facility: Investigational Site Number 840084
state: Arkansas
city: Anaheim
country: United States
facility: Investigational Site Number 840100
state: California
city: Bell Gardens
country: United States
facility: Investigational Site Number 840065
state: California
city: Chino
country: United States
facility: Investigational Site Number 840090
state: California
city: Chula Vista
country: United States
facility: Investigational Site Number 840002
state: California
city: Concord
country: United States
facility: Investigational Site Number 840013
state: California
city: Fresno
country: United States
facility: Investigational Site Number 840053
state: California
city: La Jolla
country: United States
facility: Investigational Site Number 840017
state: California
city: Lancaster
country: United States
facility: Investigational Site Number 840070
state: California
city: Long Beach
country: United States
facility: Investigational Site Number 840121
state: California
city: Los Angeles
country: United States
facility: Investigational Site Number 840126
state: California
city: Los Angeles
country: United States
facility: Investigational Site Number 840044
state: California
city: Mission Hills
country: United States
facility: Investigational Site Number 840101
state: California
city: Mission Viejo
country: United States
facility: Investigational Site Number 840086
state: California
city: Mission Viejo
country: United States
facility: Investigational Site Number 840120
state: California
city: Northridge
country: United States
facility: Investigational Site Number 840005
state: California
city: Palm Springs
country: United States
facility: Investigational Site Number 840034
state: California
city: Port Hueneme
country: United States
facility: Investigational Site Number 840074
state: California
city: San Ramon
country: United States
facility: Investigational Site Number 840068
state: California
city: Santa Ana
country: United States
facility: Investigational Site Number 840067
state: California
city: Tarzana
country: United States
facility: Investigational Site Number 840029
state: California
city: Temecula
country: United States
facility: Investigational Site Number 840006
state: California
city: West Hills
country: United States
facility: Investigational Site Number 840078
state: California
city: Aurora
country: United States
facility: Investigational Site Number 840059
state: Colorado
city: Denver
country: United States
facility: Investigational Site Number 840038
state: Colorado
city: Bradenton
country: United States
facility: Investigational Site Number 840104
state: Florida
city: Miami
country: United States
facility: Investigational Site Number 840098
state: Florida
city: New Port Richey
country: United States
facility: Investigational Site Number 840014
state: Florida
city: Ocoee
country: United States
facility: Investigational Site Number 840047
state: Florida
city: Palm Harbor
country: United States
facility: Investigational Site Number 840056
state: Florida
city: Atlanta
country: United States
facility: Investigational Site Number 840089
state: Georgia
city: Lawrenceville
country: United States
facility: Investigational Site Number 840054
state: Georgia
city: Woodstock
country: United States
facility: Investigational Site Number 840119
state: Georgia
city: Idaho Falls
country: United States
facility: Investigational Site Number 840108
state: Idaho
city: Arlington Heights
country: United States
facility: Investigational Site Number 840075
state: Illinois
city: Chicago
country: United States
facility: Investigational Site Number 840080
state: Illinois
city: Chicago
country: United States
facility: Investigational Site Number 840026
state: Illinois
city: Chicago
country: United States
facility: Investigational Site Number 840116
state: Illinois
city: Springfield
country: United States
facility: Investigational Site Number 840050
state: Illinois
city: Avon
country: United States
facility: Investigational Site Number 840008
state: Indiana
city: Avon
country: United States
facility: Investigational Site Number 840015
state: Indiana
city: Avon
country: United States
facility: Investigational Site Number 840076
state: Indiana
city: Evansville
country: United States
facility: Investigational Site Number 840082
state: Indiana
city: Evansville
country: United States
facility: Investigational Site Number 840031
state: Indiana
city: Evansville
country: United States
facility: Investigational Site Number 840060
state: Indiana
city: Indianapolis
country: United States
facility: Investigational Site Number 840048
state: Indiana
city: Indianapolis
country: United States
facility: Investigational Site Number 840085
state: Indiana
city: Valparaiso
country: United States
facility: Investigational Site Number 840012
state: Indiana
city: Waterloo
country: United States
facility: Investigational Site Number 840025
state: Iowa
city: Lexington
country: United States
facility: Investigational Site Number 840022
state: Kentucky
city: Louisville
country: United States
facility: Investigational Site Number 840007
state: Kentucky
city: New Orleans
country: United States
facility: Investigational Site Number 840081
state: Louisiana
city: Auburn
country: United States
facility: Investigational Site Number 840097
state: Maine
city: Rockville
country: United States
facility: Investigational Site Number 840063
state: Maryland
city: Bloomfield Hills
country: United States
facility: Investigational Site Number 840028
state: Michigan
city: Chesterfield
country: United States
facility: Investigational Site Number 840071
state: Michigan
city: Dearborn
country: United States
facility: Investigational Site Number 840001
state: Michigan
city: Kalamazoo
country: United States
facility: Investigational Site Number 840091
state: Michigan
city: Minneapolis
country: United States
facility: Investigational Site Number 840009
state: Minnesota
city: Chesterfield
country: United States
facility: Investigational Site Number 840024
state: Missouri
city: Butte
country: United States
facility: Investigational Site Number 840057
state: Montana
city: Omaha
country: United States
facility: Investigational Site Number 840042
state: Nebraska
city: Henderson
country: United States
facility: Investigational Site Number 840109
state: Nevada
city: Las Vegas
country: United States
facility: Investigational Site Number 840052
state: Nevada
city: Nashua
country: United States
facility: Investigational Site Number 840069
state: New Hampshire
city: Morganville
country: United States
facility: Investigational Site Number 840123
state: New Jersey
city: Albuquerque
country: United States
facility: Investigational Site Number 840011
state: New Mexico
city: New Hyde Park
country: United States
facility: Investigational Site Number 840030
state: New York
city: Syracuse
country: United States
facility: Investigational Site Number 840096
state: New York
city: Asheville
country: United States
facility: Investigational Site Number 840039
state: North Carolina
city: Hickory
country: United States
facility: Investigational Site Number 840021
state: North Carolina
city: Morehead City
country: United States
facility: Investigational Site Number 840046
state: North Carolina
city: Morganton
country: United States
facility: Investigational Site Number 840072
state: North Carolina
city: Salisbury
country: United States
facility: Investigational Site Number 840110
state: North Carolina
city: Wilmington
country: United States
facility: Investigational Site Number 840095
state: North Carolina
city: Winston-Salem
country: United States
facility: Investigational Site Number 840099
state: North Carolina
city: Columbus
country: United States
facility: Investigational Site Number 840004
state: Ohio
city: Maumee
country: United States
facility: Investigational Site Number 840016
state: Ohio
city: Eugene
country: United States
facility: Investigational Site Number 840103
state: Oregon
city: Portland
country: United States
facility: Investigational Site Number 840113
state: Oregon
city: Pittsburgh
country: United States
facility: Investigational Site Number 840036
state: Pennsylvania
city: Tipton
country: United States
facility: Investigational Site Number 840043
state: Pennsylvania
city: Anderson
country: United States
facility: Investigational Site Number 840058
state: South Carolina
city: Charleston
country: United States
facility: Investigational Site Number 840127
state: South Carolina
city: Greer
country: United States
facility: Investigational Site Number 840049
state: South Carolina
city: Rapid City
country: United States
facility: Investigational Site Number 840114
state: South Dakota
city: Bristol
country: United States
facility: Investigational Site Number 840112
state: Tennessee
city: Knoxville
country: United States
facility: Investigational Site Number 840094
state: Tennessee
city: Austin
country: United States
facility: Investigational Site Number 840051
state: Texas
city: Corpus Christi
country: United States
facility: Investigational Site Number 840066
state: Texas
city: Dallas
country: United States
facility: Investigational Site Number 840111
state: Texas
city: Dallas
country: United States
facility: Investigational Site Number 840020
state: Texas
city: Dallas
country: United States
facility: Investigational Site Number 840064
state: Texas
city: Dallas
country: United States
facility: Investigational Site Number 840003
state: Texas
city: Edinburg
country: United States
facility: Investigational Site Number 840088
state: Texas
city: Fort Worth
country: United States
facility: Investigational Site Number 840118
state: Texas
city: Houston
country: United States
facility: Investigational Site Number 840055
state: Texas
city: Houston
country: United States
facility: Investigational Site Number 840087
state: Texas
city: Hurst
country: United States
facility: Investigational Site Number 840079
state: Texas
city: N Richland Hill
country: United States
facility: Investigational Site Number 840073
state: Texas
city: San Antonio
country: United States
facility: Investigational Site Number 840019
state: Texas
city: Draper
country: United States
facility: Investigational Site Number 840037
state: Utah
city: Ogden
country: United States
facility: Investigational Site Number 840093
state: Utah
city: Salt Lake City
country: United States
facility: Investigational Site Number 840061
state: Utah
city: Salt Lake City
country: United States
facility: Investigational Site Number 840041
state: Utah
city: Chesapeake
country: United States
facility: Investigational Site Number 840040
state: Virginia
city: Norfolk
country: United States
facility: Investigational Site Number 840045
state: Virginia
city: Norfolk
country: United States
facility: Investigational Site Number 840092
state: Virginia
city: Richmond
country: United States
facility: Investigational Site Number 840125
state: Virginia
city: Salem
country: United States
facility: Investigational Site Number 840115
state: Virginia
city: Weber City
country: United States
facility: Investigational Site Number 840010
state: Virginia
city: Federal Way
country: United States
facility: Investigational Site Number 840077
state: Washington
city: Renton
country: United States
facility: Investigational Site Number 840102
state: Washington
city: Milwaukee
country: United States
facility: Investigational Site Number 840033
state: Wisconsin
city: Box Hill
country: Australia
facility: Investigational Site Number 036005
city: Camperdown
country: Australia
facility: Investigational Site Number 036001
city: Kippa Ring
country: Australia
facility: Investigational Site Number 036006
city: Logan Central
country: Australia
facility: Investigational Site Number 036007
city: Brussels
country: Belgium
facility: Investigational Site Number 056005
city: Brussel
country: Belgium
facility: Investigational Site Number 056006
city: Leuven
country: Belgium
facility: Investigational Site Number 056001
city: Kelowna
country: Canada
facility: Investigational Site Number 124004
city: Toronto
country: Canada
facility: Investigational Site Number 124001
city: Vancouver
country: Canada
facility: Investigational Site Number 124002
city: Osorno
country: Chile
facility: Investigational Site Number 152008
city: Puerto Varas
country: Chile
facility: Investigational Site Number 152015
city: Santiago
country: Chile
facility: Investigational Site Number 152004
city: Santiago
country: Chile
facility: Investigational Site Number 152006
city: Santiago
country: Chile
facility: Investigational Site Number 152001
city: Santiago
country: Chile
facility: Investigational Site Number 152002
city: Santiago
country: Chile
facility: Investigational Site Number 152012
city: Santiago
country: Chile
facility: Investigational Site Number 152009
city: Talagante
country: Chile
facility: Investigational Site Number 152011
city: Temuco
country: Chile
facility: Investigational Site Number 152014
city: Temuco
country: Chile
facility: Investigational Site Number 152003
city: Beroun
country: Czech Republic
facility: Investigational Site Number 203004
city: Ceske Budejovice
country: Czech Republic
facility: Investigational Site Number 203008
city: Horovice
country: Czech Republic
facility: Investigational Site Number 203014
city: Koprivnice
country: Czech Republic
facility: Investigational Site Number 203012
city: Pardubice
country: Czech Republic
facility: Investigational Site Number 203001
city: Plzen
country: Czech Republic
facility: Investigational Site Number 203005
city: Praha 10
country: Czech Republic
facility: Investigational Site Number 203003
city: Praha 2
country: Czech Republic
facility: Investigational Site Number 203009
city: Praha 5
country: Czech Republic
facility: Investigational Site Number 203007
city: Praha 9 - Klanovice
country: Czech Republic
facility: Investigational Site Number 203013
city: Trutnov
country: Czech Republic
facility: Investigational Site Number 203006
city: Ujezd U Brna
country: Czech Republic
facility: Investigational Site Number 203016
city: Vsetin
country: Czech Republic
facility: Investigational Site Number 203015
city: Aarhus C
country: Denmark
facility: Investigational Site Number 208003
city: Horsens
country: Denmark
facility: Investigational Site Number 208009
city: Kolding
country: Denmark
facility: Investigational Site Number 208002
city: København Nv
country: Denmark
facility: Investigational Site Number 208001
city: København S
country: Denmark
facility: Investigational Site Number 208005
city: Viborg
country: Denmark
facility: Investigational Site Number 208004
city: Paide
country: Estonia
facility: Investigational Site Number 233004
city: Pärnu
country: Estonia
facility: Investigational Site Number 233002
city: Tallinn
country: Estonia
facility: Investigational Site Number 233003
city: Viljandimaa
country: Estonia
facility: Investigational Site Number 233001
city: Corbeil Essonnes
country: France
facility: Investigational Site Number 250006
city: La Rochelle Cedex
country: France
facility: Investigational Site Number 250002
city: Pierre Benite
country: France
facility: Investigational Site Number 250003
city: Venissieux
country: France
facility: Investigational Site Number 250001
city: Berlin
country: Germany
facility: Investigational Site Number 276005
city: Berlin
country: Germany
facility: Investigational Site Number 276003
city: Dortmund
country: Germany
facility: Investigational Site Number 276004
city: Dresden
country: Germany
facility: Investigational Site Number 276007
city: Dresden
country: Germany
facility: Investigational Site Number 276001
city: Hamburg
country: Germany
facility: Investigational Site Number 276006
city: Neumünster
country: Germany
facility: Investigational Site Number 276002
city: Balatonfüred
country: Hungary
facility: Investigational Site Number 348003
city: Budapest
country: Hungary
facility: Investigational Site Number 348007
city: Budapest
country: Hungary
facility: Investigational Site Number 348006
city: Budapest
country: Hungary
facility: Investigational Site Number 348002
city: Komárom
country: Hungary
facility: Investigational Site Number 348011
city: Nagykanizsa
country: Hungary
facility: Investigational Site Number 348008
city: Szeged
country: Hungary
facility: Investigational Site Number 348004
city: Szekesfehervar
country: Hungary
facility: Investigational Site Number 348010
city: Sátoraljaújhely
country: Hungary
facility: Investigational Site Number 348012
city: Zalaegerszeg
country: Hungary
facility: Investigational Site Number 348001
city: Bologna
country: Italy
facility: Investigational Site Number 380002
city: Catanzaro
country: Italy
facility: Investigational Site Number 380006
city: Milano
country: Italy
facility: Investigational Site Number 380001
city: Napoli
country: Italy
facility: Investigational Site Number 380003
city: Roma
country: Italy
facility: Investigational Site Number 380005
city: Riga
country: Latvia
facility: Investigational Site Number 428002
city: Riga
country: Latvia
facility: Investigational Site Number 428003
city: Riga
country: Latvia
facility: Investigational Site Number 428004
city: Sigulda
country: Latvia
facility: Investigational Site Number 428001
city: Jonava
country: Lithuania
facility: Investigational Site Number 440003
city: Kaunas
country: Lithuania
facility: Investigational Site Number 440002
city: Kaunas
country: Lithuania
facility: Investigational Site Number 440007
city: Kedainiai
country: Lithuania
facility: Investigational Site Number 440004
city: Panevezys
country: Lithuania
facility: Investigational Site Number 440006
city: Utena
country: Lithuania
facility: Investigational Site Number 440005
city: Vilnius
country: Lithuania
facility: Investigational Site Number 440001
city: Aguascalientes
country: Mexico
facility: Investigational Site Number 484005
city: Cuernavaca
country: Mexico
facility: Investigational Site Number 484001
city: Guadalajara
country: Mexico
facility: Investigational Site Number 484002
city: Guadalajara
country: Mexico
facility: Investigational Site Number 484004
city: Guadalajara
country: Mexico
facility: Investigational Site Number 484009
city: Monterrey
country: Mexico
facility: Investigational Site Number 484007
city: Monterrey
country: Mexico
facility: Investigational Site Number 484006
city: Zapopan
country: Mexico
facility: Investigational Site Number 484010
city: Bialystok
country: Poland
facility: Investigational Site Number 616002
city: Krakow
country: Poland
facility: Investigational Site Number 616005
city: Krakow
country: Poland
facility: Investigational Site Number 616006
city: Lodz
country: Poland
facility: Investigational Site Number 616007
city: Szczecin
country: Poland
facility: Investigational Site Number 616004
city: Warszawa
country: Poland
facility: Investigational Site Number 616003
city: Warszawa
country: Poland
facility: Investigational Site Number 616001
city: Zory
country: Poland
facility: Investigational Site Number 616008
city: Bucharest
country: Romania
facility: Investigational Site Number 642008
city: Bucuresti
country: Romania
facility: Investigational Site Number 642007
city: Cluj Napoca
country: Romania
facility: Investigational Site Number 642009
city: Hunedoara
country: Romania
facility: Investigational Site Number 642006
city: Iasi
country: Romania
facility: Investigational Site Number 642005
city: Oradea
country: Romania
facility: Investigational Site Number 642002
city: Targu Mures
country: Romania
facility: Investigational Site Number 642001
city: Timisoara
country: Romania
facility: Investigational Site Number 642004
city: Timisoara
country: Romania
facility: Investigational Site Number 642003
city: Moscow
country: Russian Federation
facility: Investigational Site Number 643006
city: Penza
country: Russian Federation
facility: Investigational Site Number 643008
city: Petrozavodsk
country: Russian Federation
facility: Investigational Site Number 643012
city: Saint-Petersburg
country: Russian Federation
facility: Investigational Site Number 643001
city: Samara
country: Russian Federation
facility: Investigational Site Number 643014
city: Saratov
country: Russian Federation
facility: Investigational Site Number 643009
city: Saratov
country: Russian Federation
facility: Investigational Site Number 643011
city: St-Petersburg
country: Russian Federation
facility: Investigational Site Number 643005
city: St-Petersburg
country: Russian Federation
facility: Investigational Site Number 643007
city: St-Petersburg
country: Russian Federation
facility: Investigational Site Number 643002
city: St. Petersburg
country: Russian Federation
facility: Investigational Site Number 643003
city: Tomsk
country: Russian Federation
facility: Investigational Site Number 643016
city: Voronezh
country: Russian Federation
facility: Investigational Site Number 643004
city: Cap Town
country: South Africa
facility: Investigational Site Number 710002
city: Cape Town
country: South Africa
facility: Investigational Site Number 710003
city: Meyerspark
country: South Africa
facility: Investigational Site Number 710005
city: Port Elizabeth
country: South Africa
facility: Investigational Site Number 710007
city: Pretoria
country: South Africa
facility: Investigational Site Number 710004
city: Somerset West
country: South Africa
facility: Investigational Site Number 710001
city: Soweto
country: South Africa
facility: Investigational Site Number 710006
city: Barcelona
country: Spain
facility: Investigational Site Number 724012
city: Granada
country: Spain
facility: Investigational Site Number 724009
city: Hostalets De Balenyà
country: Spain
facility: Investigational Site Number 724004
city: La Coruña
country: Spain
facility: Investigational Site Number 724011
city: Lugo
country: Spain
facility: Investigational Site Number 724007
city: Madrid
country: Spain
facility: Investigational Site Number 724008
city: Madrid
country: Spain
facility: Investigational Site Number 724005
city: Palma De Mallorca
country: Spain
facility: Investigational Site Number 724013
city: Quart De Poblet
country: Spain
facility: Investigational Site Number 724001
city: Sant Joan Despí
country: Spain
facility: Investigational Site Number 724006
city: Sevilla
country: Spain
facility: Investigational Site Number 724003
city: Ljungby
country: Sweden
facility: Investigational Site Number 752001
city: Malmö
country: Sweden
facility: Investigational Site Number 752003
city: Rättvik
country: Sweden
facility: Investigational Site Number 752004
city: Stockholm
country: Sweden
facility: Investigational Site Number 752005
city: Vällingby
country: Sweden
facility: Investigational Site Number 752002
city: Chernivtsi
country: Ukraine
facility: Investigational Site Number 804002
city: Ivano-Frankovsk
country: Ukraine
facility: Investigational Site Number 804009
city: Kyiv
country: Ukraine
facility: Investigational Site Number 804010
city: Kyiv
country: Ukraine
facility: Investigational Site Number 804007
city: Kyiv
country: Ukraine
facility: Investigational Site Number 804006
city: Lviv
country: Ukraine
facility: Investigational Site Number 804012
city: Vinnytsya
country: Ukraine
facility: Investigational Site Number 804011
city: Vinnytsya
country: Ukraine
facility: Investigational Site Number 804008
city: Coventry
country: United Kingdom
facility: Investigational Site Number 826001
city: Dundee
country: United Kingdom
facility: Investigational Site Number 826002
city: Guildford
country: United Kingdom
facility: Investigational Site Number 826006
city: Leicester
country: United Kingdom
facility: Investigational Site Number 826007
city: Norwich
country: United Kingdom
facility: Investigational Site Number 826003
Study officials:
affiliation: Sanofi
name: Clinical Sciences & Operations
role: STUDY_DIRECTOR
References:
citation: Rosenstock J, Aronson R, Grunberger G, Hanefeld M, Piatti P, Serusclat P, Cheng X, Zhou T, Niemoeller E, Souhami E, Davies M; LixiLan-O Trial Investigators. Benefits of LixiLan, a Titratable Fixed-Ratio Combination of Insulin Glargine Plus Lixisenatide, Versus Insulin Glargine and Lixisenatide Monocomponents in Type 2 Diabetes Inadequately Controlled on Oral Agents: The LixiLan-O Randomized Trial. Diabetes Care. 2016 Nov;39(11):2026-2035. doi: 10.2337/dc16-0917. Epub 2016 Aug 15.
citation: 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.
citation: Davies MJ, Russell-Jones D, Barber TM, Lavalle-Gonzalez FJ, Galstyan GR, Zhu D, Baxter M, Dessapt-Baradez C, McCrimmon RJ. Glycaemic benefit of iGlarLixi in insulin-naive type 2 diabetes patients with high HbA1c or those with inadequate glycaemic control on two oral antihyperglycaemic drugs in the LixiLan-O randomized trial. Diabetes Obes Metab. 2019 Aug;21(8):1967-1972. doi: 10.1111/dom.13791. Epub 2019 Jun 18.
citation: 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.
citation: Schmider W, Belder R, Lee M, Niemoeller E, Souhami E, Frias JP. Impact of dose capping in insulin glargine/lixisenatide fixed-ratio combination trials in patients with type 2 diabetes. Curr Med Res Opin. 2019 Jun;35(6):1081-1089. doi: 10.1080/03007995.2018.1558852. Epub 2019 Jan 11.
citation: Rosenstock J, Handelsman Y, Vidal J, Ampudia Blasco FJ, Giorgino F, Liu M, Perfetti R, Meier JJ. Propensity-score-matched comparative analyses of simultaneously administered fixed-ratio insulin glargine 100 U and lixisenatide (iGlarLixi) vs sequential administration of insulin glargine and lixisenatide in uncontrolled type 2 diabetes. Diabetes Obes Metab. 2018 Dec;20(12):2821-2829. doi: 10.1111/dom.13462. Epub 2018 Aug 13.
citation: Trujillo JM, Roberts M, Dex T, Chao J, White J, LaSalle J. Low incidence of gastrointestinal adverse events over time with a fixed-ratio combination of insulin glargine and lixisenatide versus lixisenatide alone. Diabetes Obes Metab. 2018 Nov;20(11):2690-2694. doi: 10.1111/dom.13444. Epub 2018 Aug 21.
citation: Davies MJ, Leiter LA, Guerci B, Grunberger G, Ampudia-Blasco FJ, Yu C, Stager W, Niemoeller E, Souhami E, Rosenstock J. Impact of baseline glycated haemoglobin, diabetes duration and body mass index on clinical outcomes in the LixiLan-O trial testing a titratable fixed-ratio combination of insulin glargine/lixisenatide (iGlarLixi) vs insulin glargine and lixisenatide monocomponents. Diabetes Obes Metab. 2017 Dec;19(12):1798-1804. doi: 10.1111/dom.12980. Epub 2017 Jul 7.