Clinical trial NCT02058160: Efficacy and Safety of the Insulin Glargine/Lixisenatide Fixed Ratio Combination Versus Insulin Glargine in Patients With Type 2 Diabetes
Official title: A Randomized, 30-week, Active-controlled, Open Label, 2- Treatment Arm, Parallel-group, Multicenter Study Comparing the Efficacy and Safety of the Insulin Glargine/Lixisenatide Fixed Ratio Combination to Insulin Glargine With or Without 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: 736
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 demonstrate the superiority of the insulin glargine/lixisenatide fixed ratio combination (FRC) to insulin glargine in glycated hemoglobin (HbA1c) change from baseline to Week 30.

Secondary Objective:

To compare the overall efficacy and safety of insulin glargine/lixisenatide FRC to insulin glargine (with or without metformin) over a 30 week treatment period in participants with type 2 diabetes.

Detailed description: Maximum duration of approximately 39 weeks: an up to 8-week screening period, a 30-week randomized treatment period and 3 days post-treatment safety follow up period.

Eligibility criteria: Inclusion criteria :

* Type 2 diabetes mellitus diagnosed at least 1 year before the screening visit.
* Treatment with basal insulin for at least 6 months before the screening visit.
* Stable basal insulin regimen (i.e. type of insulin and time/frequency of the injection) for at least 3 months before the screening visit.
* Stable (plus/minus 20 percent) total daily basal insulin dose between 15 and 40 Units/day for at least 2 months prior to the screening visit.
* For participants receiving basal insulin and 1 or 2 oral anti-diabetic drugs (OADs): the OAD dose(s) must be stable during the 3 months before the screening visit. The OADs could be 1 to 2 out of:

  * metformin (more than or equal to 1500 mg/day or maximal tolerated dose),
  * a sulfonylurea,
  * a glinide,
  * a dipeptidyl-peptidase-4 inhibitor,
  * a sodium glucose co-transporter 2 inhibitor,
* Fasting Plasma Glucose (FPG) less than or equal to 180 mg/dL(10.0 mmol/L) at screening visit for participants receiving basal insulin in combination with 2 OADs or with 1 OAD other than metformin; FPG less than or equal to 200 mg/dL (11.1 mmol/L) at screening visit for participants on basal insulin only or basal insulin plus metformin at screening visit.
* Signed written informed consent.

Exclusion criteria:

* Age under legal age of adulthood at screening visit.
* HbA1c at screening visit less than 7.5% or above 10%.
* Pregnancy or lactation, women of childbearing potential with no effective contraceptive method.
* Use of other oral or injectable glucose-lowering agents than stated in the inclusion criteria in a period of 3 months prior to screening.
* Previous use of insulin other than basal insulin eg, prandial or pre-mixed insulin, in the year prior to screening. Note: Short term treatment (≤10 days) due to intercurrent illness is allowed.
* History discontinuation of a previous treatment with Glucagon Like Peptide -1 Receptor Agonists for safety/tolerability or lack of efficacy.
* Participant who had previously participated in any clinical trial with lixisenatide or the insulin glargine/lixisenatide FRC or had previously received lixisenatide.
* 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 (eg, 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).
* Any contraindication to metformin use, according to local labeling, if the participant was taking metformin.
* Participant who had a renal function impairment with creatinine clearance less than 30 mL/min (using the Cockcroft and Gault formula) or end-stage renal disease for participants, not treated with metformin.

Exclusion criteria for randomization:

* HbA1c less than 7% or above 10% .
* Mean fasting SMPG calculated from the self-measurements for 7 days the week before randomization visit was above 140 mg/dL (7.8 mmol/L).
* Average insulin glargine daily dose less than 20 Units or above 50 Units (in the week before randomization visit).
* 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 Glycated Hemoglobin (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 2-hour Plasma Blood 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: 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: Change in Daily Insulin Glargine Dose 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 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: Change in FPG From Baseline to Week 30
timeFrame: Baseline, Week 30
measure: Change in 2-hour PPG From Baseline to Week 30
timeFrame: Baseline, Week 30
measure: Percentage of Participants Reaching HbA1c <7.0% 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 [FRC], 210 days [Insulin glargine])
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 [FRC], 210 days [Insulin glargine])
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 [FRC], 210 days [Insulin glargine])
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Investigational Site Number 840607
state: Alabama
city: Sun City
country: United States
facility: Investigational Site Number 840570
state: Arizona
city: Tempe
country: United States
facility: Investigational Site Number 840562
state: Arizona
city: Tucson
country: United States
facility: Investigational Site Number 840577
state: Arizona
city: Little Rock
country: United States
facility: Investigational Site Number 840517
state: Arkansas
city: Little Rock
country: United States
facility: Investigational Site Number 840537
state: Arkansas
city: Bell Gardens
country: United States
facility: Investigational Site Number 840568
state: California
city: Chino
country: United States
facility: Investigational Site Number 840550
state: California
city: Chula Vista
country: United States
facility: Investigational Site Number 840529
state: California
city: Corona
country: United States
facility: Investigational Site Number 840623
state: California
city: Fresno
country: United States
facility: Investigational Site Number 840566
state: California
city: Greenbrae
country: United States
facility: Investigational Site Number 840552
state: California
city: Lancaster
country: United States
facility: Investigational Site Number 840578
state: California
city: Los Angeles
country: United States
facility: Investigational Site Number 840626
state: California
city: Los Angeles
country: United States
facility: Investigational Site Number 840581
state: California
city: Mission Viejo
country: United States
facility: Investigational Site Number 840621
state: California
city: Northridge
country: United States
facility: Investigational Site Number 840511
state: California
city: Palm Springs
country: United States
facility: Investigational Site Number 840573
state: California
city: Port Hueneme
country: United States
facility: Investigational Site Number 840559
state: California
city: San Ramon
country: United States
facility: Investigational Site Number 840536
state: California
city: Santa Ana
country: United States
facility: Investigational Site Number 840567
state: California
city: Tarzana
country: United States
facility: Investigational Site Number 840569
state: California
city: West Hills
country: United States
facility: Investigational Site Number 840572
state: California
city: Aurora
country: United States
facility: Investigational Site Number 840582
state: Colorado
city: Denver
country: United States
facility: Investigational Site Number 840509
state: Colorado
city: Wilmington
country: United States
facility: Investigational Site Number 840549
state: Delaware
city: Miami
country: United States
facility: Investigational Site Number 840510
state: Florida
city: New Port Richey
country: United States
facility: Investigational Site Number 840521
state: Florida
city: Ocala
country: United States
facility: Investigational Site Number 840602
state: Florida
city: Ocoee
country: United States
facility: Investigational Site Number 840538
state: Florida
city: Palm Harbor
country: United States
facility: Investigational Site Number 840534
state: Florida
city: Atlanta
country: United States
facility: Investigational Site Number 840594
state: Georgia
city: Columbus
country: United States
facility: Investigational Site Number 840614
state: Georgia
city: Lawrenceville
country: United States
facility: Investigational Site Number 840501
state: Georgia
city: Roswell
country: United States
facility: Investigational Site Number 840525
state: Georgia
city: Idaho Falls
country: United States
facility: Investigational Site Number 840588
state: Idaho
city: Arlington Heights
country: United States
facility: Investigational Site Number 840580
state: Illinois
city: Chicago
country: United States
facility: Investigational Site Number 840519
state: Illinois
city: Chicago
country: United States
facility: Investigational Site Number 840612
state: Illinois
city: Springfield
country: United States
facility: Investigational Site Number 840556
state: Illinois
city: Avon
country: United States
facility: Investigational Site Number 840543
state: Indiana
city: Evansville
country: United States
facility: Investigational Site Number 840565
state: Indiana
city: Evansville
country: United States
facility: Investigational Site Number 840585
state: Indiana
city: Evansville
country: United States
facility: Investigational Site Number 840615
state: Indiana
city: Indianapolis
country: United States
facility: Investigational Site Number 840563
state: Indiana
city: Indianapolis
country: United States
facility: Investigational Site Number 840507
state: Indiana
city: Louisville
country: United States
facility: Investigational Site Number 840516
state: Kentucky
city: Lewiston
country: United States
facility: Investigational Site Number 840595
state: Maine
city: Baltimore
country: United States
facility: Investigational Site Number 840520
state: Maryland
city: Baltimore
country: United States
facility: Investigational Site Number 840560
state: Maryland
city: Rockville
country: United States
facility: Investigational Site Number 840522
state: Maryland
city: Dearborn
country: United States
facility: Investigational Site Number 840505
state: Michigan
city: Flint
country: United States
facility: Investigational Site Number 840575
state: Michigan
city: Minneapolis
country: United States
facility: Investigational Site Number 840564
state: Minnesota
city: Butte
country: United States
facility: Investigational Site Number 840558
state: Montana
city: Omaha
country: United States
facility: Investigational Site Number 840506
state: Nebraska
city: Henderson
country: United States
facility: Investigational Site Number 840600
state: Nevada
city: Las Vegas
country: United States
facility: Investigational Site Number 840532
state: Nevada
city: Las Vegas
country: United States
facility: Investigational Site Number 840599
state: Nevada
city: Nashua
country: United States
facility: Investigational Site Number 840539
state: New Hampshire
city: Albuquerque
country: United States
facility: Investigational Site Number 840576
state: New Mexico
city: Jamaica
country: United States
facility: Investigational Site Number 840583
state: New York
city: New Hyde Park
country: United States
facility: Investigational Site Number 840531
state: New York
city: Syracuse
country: United States
facility: Investigational Site Number 840557
state: New York
city: Durham
country: United States
facility: Investigational Site Number 840541
state: North Carolina
city: Greenville
country: United States
facility: Investigational Site Number 840604
state: North Carolina
city: Hickory
country: United States
facility: Investigational Site Number 840540
state: North Carolina
city: Morehead City
country: United States
facility: Investigational Site Number 840513
state: North Carolina
city: Salisbury
country: United States
facility: Investigational Site Number 840592
state: North Carolina
city: Wilmington
country: United States
facility: Investigational Site Number 840535
state: North Carolina
city: Winston-Salem
country: United States
facility: Investigational Site Number 840515
state: North Carolina
city: Columbus
country: United States
facility: Investigational Site Number 840579
state: Ohio
city: Dayton
country: United States
facility: Investigational Site Number 840524
state: Ohio
city: Maumee
country: United States
facility: Investigational Site Number 840503
state: Ohio
city: Eugene
country: United States
facility: Investigational Site Number 840618
state: Oregon
city: Philadelphia
country: United States
facility: Investigational Site Number 840610
state: Pennsylvania
city: Smithfield
country: United States
facility: Investigational Site Number 840551
state: Pennsylvania
city: Tipton
country: United States
facility: Investigational Site Number 840584
state: Pennsylvania
city: Charleston
country: United States
facility: Investigational Site Number 840622
state: South Carolina
city: Rapid City
country: United States
facility: Investigational Site Number 840611
state: South Dakota
city: Amarillo
country: United States
facility: Investigational Site Number 840605
state: Texas
city: Austin
country: United States
facility: Investigational Site Number 840553
state: Texas
city: Austin
country: United States
facility: Investigational Site Number 840598
state: Texas
city: Corpus Christi
country: United States
facility: Investigational Site Number 840502
state: Texas
city: Dallas
country: United States
facility: Investigational Site Number 840601
state: Texas
city: Dallas
country: United States
facility: Investigational Site Number 840586
state: Texas
city: Dallas
country: United States
facility: Investigational Site Number 840547
state: Texas
city: Dallas
country: United States
facility: Investigational Site Number 840530
state: Texas
city: Dallas
country: United States
facility: Investigational Site Number 840545
state: Texas
city: Edinburg
country: United States
facility: Investigational Site Number 840554
state: Texas
city: Houston
country: United States
facility: Investigational Site Number 840544
state: Texas
city: Hurst
country: United States
facility: Investigational Site Number 840514
state: Texas
city: N Richland Hill
country: United States
facility: Investigational Site Number 840617
state: Texas
city: Draper
country: United States
facility: Investigational Site Number 840512
state: Utah
city: Murray
country: United States
facility: Investigational Site Number 840591
state: Utah
city: Ogden
country: United States
facility: Investigational Site Number 840526
state: Utah
city: Orem
country: United States
facility: Investigational Site Number 840597
state: Utah
city: Salt Lake City
country: United States
facility: Investigational Site Number 840590
state: Utah
city: Burlington
country: United States
facility: Investigational Site Number 840613
state: Vermont
city: Chesapeake
country: United States
facility: Investigational Site Number 840504
state: Virginia
city: Norfolk
country: United States
facility: Investigational Site Number 840561
state: Virginia
city: Norfolk
country: United States
facility: Investigational Site Number 840625
state: Virginia
city: Richmond
country: United States
facility: Investigational Site Number 840606
state: Virginia
city: Salem
country: United States
facility: Investigational Site Number 840608
state: Virginia
city: Federal Way
country: United States
facility: Investigational Site Number 840571
state: Washington
city: Spokane
country: United States
facility: Investigational Site Number 840593
state: Washington
city: Tacoma
country: United States
facility: Investigational Site Number 840609
state: Washington
city: Milwaukee
country: United States
facility: Investigational Site Number 840546
state: Wisconsin
city: Box Hill
country: Australia
facility: Investigational Site Number 036505
city: Heidelberg
country: Australia
facility: Investigational Site Number 036501
city: Parkville
country: Australia
facility: Investigational Site Number 036504
city: Beamsville
country: Canada
facility: Investigational Site Number 124504
city: Brampton
country: Canada
facility: Investigational Site Number 124512
city: Guelph
country: Canada
facility: Investigational Site Number 124502
city: Kelowna
country: Canada
facility: Investigational Site Number 124507
city: Montreal
country: Canada
facility: Investigational Site Number 124505
city: Oakville
country: Canada
facility: Investigational Site Number 124511
city: St-Romuald
country: Canada
facility: Investigational Site Number 124509
city: Toronto
country: Canada
facility: Investigational Site Number 124503
city: Toronto
country: Canada
facility: Investigational Site Number 124510
city: Vancouver
country: Canada
facility: Investigational Site Number 124501
city: Victoria
country: Canada
facility: Investigational Site Number 124508
city: Puerto Varas
country: Chile
facility: Investigational Site Number 152511
city: Santiago
country: Chile
facility: Investigational Site Number 152502
city: Santiago
country: Chile
facility: Investigational Site Number 152501
city: Santiago
country: Chile
facility: Investigational Site Number 152514
city: Santiago
country: Chile
facility: Investigational Site Number 152503
city: Santiago
country: Chile
facility: Investigational Site Number 152507
city: Talagante
country: Chile
facility: Investigational Site Number 152509
city: Temuco
country: Chile
facility: Investigational Site Number 152513
city: Vina Del Mar
country: Chile
facility: Investigational Site Number 152504
city: Cheb
country: Czech Republic
facility: Investigational Site Number 203502
city: Hranice
country: Czech Republic
facility: Investigational Site Number 203504
city: Krnov
country: Czech Republic
facility: Investigational Site Number 203507
city: Liberec
country: Czech Republic
facility: Investigational Site Number 203506
city: Olomouc
country: Czech Republic
facility: Investigational Site Number 203503
city: Plzen
country: Czech Republic
facility: Investigational Site Number 203514
city: Plzen
country: Czech Republic
facility: Investigational Site Number 203515
city: Praha 4
country: Czech Republic
facility: Investigational Site Number 203511
city: Praha 5
country: Czech Republic
facility: Investigational Site Number 203508
city: Praha 8
country: Czech Republic
facility: Investigational Site Number 203509
city: Prostejov
country: Czech Republic
facility: Investigational Site Number 203505
city: Aarhus C
country: Denmark
facility: Investigational Site Number 208503
city: Horsens
country: Denmark
facility: Investigational Site Number 208509
city: Kolding
country: Denmark
facility: Investigational Site Number 208502
city: København Nv
country: Denmark
facility: Investigational Site Number 208501
city: København S
country: Denmark
facility: Investigational Site Number 208505
city: Viborg
country: Denmark
facility: Investigational Site Number 208504
city: Pärnu
country: Estonia
facility: Investigational Site Number 233502
city: Tallinn
country: Estonia
facility: Investigational Site Number 233503
city: Tartu
country: Estonia
facility: Investigational Site Number 233501
city: Budapest
country: Hungary
facility: Investigational Site Number 348503
city: Budapest
country: Hungary
facility: Investigational Site Number 348501
city: Budapest
country: Hungary
facility: Investigational Site Number 348505
city: Debrecen
country: Hungary
facility: Investigational Site Number 348502
city: Kaposvár
country: Hungary
facility: Investigational Site Number 348506
city: Pápa
country: Hungary
facility: Investigational Site Number 348504
city: Kaunas
country: Lithuania
facility: Investigational Site Number 440501
city: Kaunas
country: Lithuania
facility: Investigational Site Number 440503
city: Kedainiai
country: Lithuania
facility: Investigational Site Number 440505
city: Klaipeda
country: Lithuania
facility: Investigational Site Number 440504
city: Vilnius
country: Lithuania
facility: Investigational Site Number 440502
city: Celaya
country: Mexico
facility: Investigational Site Number 484508
city: Cuernavaca
country: Mexico
facility: Investigational Site Number 484501
city: Guadalajara
country: Mexico
facility: Investigational Site Number 484503
city: Guadalajara
country: Mexico
facility: Investigational Site Number 484504
city: Guadalajara
country: Mexico
facility: Investigational Site Number 484506
city: México
country: Mexico
facility: Investigational Site Number 484509
city: Pachuca
country: Mexico
facility: Investigational Site Number 484507
city: Puebla
country: Mexico
facility: Investigational Site Number 484505
city: Almere
country: Netherlands
facility: Investigational Site Number 528505
city: Bialystok
country: Poland
facility: Investigational Site Number 616502
city: Krakow
country: Poland
facility: Investigational Site Number 616505
city: Krakow
country: Poland
facility: Investigational Site Number 616506
city: Plock
country: Poland
facility: Investigational Site Number 616507
city: Szczecin
country: Poland
facility: Investigational Site Number 616504
city: Warszawa
country: Poland
facility: Investigational Site Number 616503
city: Warszawa
country: Poland
facility: Investigational Site Number 616501
city: Brasov
country: Romania
facility: Investigational Site Number 642507
city: Bucharest
country: Romania
facility: Investigational Site Number 642510
city: Bucuresti
country: Romania
facility: Investigational Site Number 642508
city: Bucuresti
country: Romania
facility: Investigational Site Number 642509
city: Hunedoara
country: Romania
facility: Investigational Site Number 642506
city: Iasi
country: Romania
facility: Investigational Site Number 642505
city: Oradea
country: Romania
facility: Investigational Site Number 642502
city: Sibiu
country: Romania
facility: Investigational Site Number 642511
city: Targu Mures
country: Romania
facility: Investigational Site Number 642501
city: Timisoara
country: Romania
facility: Investigational Site Number 642504
city: Timisoara
country: Romania
facility: Investigational Site Number 642503
city: Arkhangelsk
country: Russian Federation
facility: Investigational Site Number 643511
city: Moscow
country: Russian Federation
facility: Investigational Site Number 643512
city: Penza
country: Russian Federation
facility: Investigational Site Number 643508
city: Saint-Petersburg
country: Russian Federation
facility: Investigational Site Number 643501
city: Samara
country: Russian Federation
facility: Investigational Site Number 643513
city: Saratov
country: Russian Federation
facility: Investigational Site Number 643507
city: Saratov
country: Russian Federation
facility: Investigational Site Number 643514
city: St-Petersburg
country: Russian Federation
facility: Investigational Site Number 643506
city: St-Petersburg
country: Russian Federation
facility: Investigational Site Number 643503
city: St-Petersburg
country: Russian Federation
facility: Investigational Site Number 643504
city: St-Petersburg
country: Russian Federation
facility: Investigational Site Number 643502
city: St. Petersburg
country: Russian Federation
facility: Investigational Site Number 643505
city: Voronezh
country: Russian Federation
facility: Investigational Site Number 643509
city: Bratislava
country: Slovakia
facility: Investigational Site Number 703505
city: Bytca
country: Slovakia
facility: Investigational Site Number 703507
city: Kosice
country: Slovakia
facility: Investigational Site Number 703502
city: Kosice
country: Slovakia
facility: Investigational Site Number 703512
city: Kosice
country: Slovakia
facility: Investigational Site Number 703510
city: Lubochna
country: Slovakia
facility: Investigational Site Number 703511
city: Moldava Nad Bodvou
country: Slovakia
facility: Investigational Site Number 703508
city: Nove Mesto Nad Vahom
country: Slovakia
facility: Investigational Site Number 703504
city: Nove Zamky
country: Slovakia
facility: Investigational Site Number 703509
city: Trnava
country: Slovakia
facility: Investigational Site Number 703513
city: Zilina
country: Slovakia
facility: Investigational Site Number 703501
city: Alicante
country: Spain
facility: Investigational Site Number 724509
city: Alzira
country: Spain
facility: Investigational Site Number 724506
city: Barcelona
country: Spain
facility: Investigational Site Number 724504
city: Barcelona
country: Spain
facility: Investigational Site Number 724510
city: Cáceres
country: Spain
facility: Investigational Site Number 724505
city: El Ferrol
country: Spain
facility: Investigational Site Number 724503
city: La Coruña
country: Spain
facility: Investigational Site Number 724508
city: Sabadell
country: Spain
facility: Investigational Site Number 724501
city: Segovia
country: Spain
facility: Investigational Site Number 724507
city: Valencia
country: Spain
facility: Investigational Site Number 724502
city: Ljungby
country: Sweden
facility: Investigational Site Number 752501
city: Malmö
country: Sweden
facility: Investigational Site Number 752503
city: Rättvik
country: Sweden
facility: Investigational Site Number 752504
city: Stenungssund
country: Sweden
facility: Investigational Site Number 752506
city: Stockholm
country: Sweden
facility: Investigational Site Number 752505
city: Vällingby
country: Sweden
facility: Investigational Site Number 752502
city: Chernivtsi
country: Ukraine
facility: Investigational Site Number 804501
city: Kyiv
country: Ukraine
facility: Investigational Site Number 804510
city: Kyiv
country: Ukraine
facility: Investigational Site Number 804507
city: Kyiv
country: Ukraine
facility: Investigational Site Number 804511
city: Lviv
country: Ukraine
facility: Investigational Site Number 804513
city: Vinnytsya
country: Ukraine
facility: Investigational Site Number 804502
city: Vinnytsya
country: Ukraine
facility: Investigational Site Number 804508
Study officials:
affiliation: Sanofi
name: Clinical Sciences & Operations
role: STUDY_DIRECTOR
References:
citation: Aroda VR, Rosenstock J, Wysham C, Unger J, Bellido D, Gonzalez-Galvez G, Takami A, Guo H, Niemoeller E, Souhami E, Bergenstal RM; LixiLan-L Trial Investigators. Efficacy and Safety of LixiLan, a Titratable Fixed-Ratio Combination of Insulin Glargine Plus Lixisenatide in Type 2 Diabetes Inadequately Controlled on Basal Insulin and Metformin: The LixiLan-L Randomized Trial. Diabetes Care. 2016 Nov;39(11):1972-1980. doi: 10.2337/dc16-1495. Epub 2016 Sep 20.
citation: Tabak AG, Anderson J, Aschner P, Liu M, Saremi A, Stella P, Tinahones FJ, Wysham C, Meier JJ. Efficacy and Safety of iGlarLixi, Fixed-Ratio Combination of Insulin Glargine and Lixisenatide, Compared with Basal-Bolus Regimen in Patients with Type 2 Diabetes: Propensity Score Matched Analysis. Diabetes Ther. 2020 Jan;11(1):305-318. doi: 10.1007/s13300-019-00735-7. Epub 2019 Dec 17.
citation: Blonde L, Bailey TS, Chao J, Dex TA, Frias JP, Meneghini LF, Roberts M, Aroda VR. Clinical Characteristics and Glycemic Outcomes of Patients with Type 2 Diabetes Requiring Maximum Dose Insulin Glargine/Lixisenatide Fixed-Ratio Combination or Insulin Glargine in the LixiLan-L Trial. Adv Ther. 2019 Sep;36(9):2310-2326. doi: 10.1007/s12325-019-01033-1. Epub 2019 Jul 29.
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: Zisman A, Dex T, Roberts M, Saremi A, Chao J, Aroda VR. Bedtime-to-Morning Glucose Difference and iGlarLixi in Type 2 Diabetes: Post Hoc Analysis of LixiLan-L. Diabetes Ther. 2018 Oct;9(5):2155-2162. doi: 10.1007/s13300-018-0507-0. Epub 2018 Sep 14.
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: Niemoeller E, Souhami E, Wu Y, Jensen KH. iGlarLixi Reduces Glycated Hemoglobin to a Greater Extent Than Basal Insulin Regardless of Levels at Screening: Post Hoc Analysis of LixiLan-L. Diabetes Ther. 2018 Feb;9(1):373-382. doi: 10.1007/s13300-017-0336-6. Epub 2017 Nov 16.
citation: Wysham C, Bonadonna RC, Aroda VR, Puig Domingo M, Kapitza C, Stager W, Yu C, Niemoeller E, Souhami E, Bergenstal RM; LixiLan-L trial investigators. Consistent findings in glycaemic control, body weight and hypoglycaemia with iGlarLixi (insulin glargine/lixisenatide titratable fixed-ratio combination) vs insulin glargine across baseline HbA1c, BMI and diabetes duration categories in the LixiLan-L trial. Diabetes Obes Metab. 2017 Oct;19(10):1408-1415. doi: 10.1111/dom.12961. Epub 2017 Jun 8.