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Efficacy and Safety of the Insulin Glargine/Lixisenatide Fixed Ratio Combination Versus Insulin Glargine in Patients With Type 2 Diabetes (LixiLan-L)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02058160
Recruitment Status : Completed
First Posted : February 7, 2014
Results First Posted : February 10, 2017
Last Update Posted : May 9, 2017
Sponsor:
Information provided by (Responsible Party):
Sanofi

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.


Condition or disease Intervention/treatment Phase
Type 2 Diabetes Drug: Insulin glargine/lixisenatide (HOE901/AVE0010) Drug: Insulin glargine (HOE901) Drug: Metformin (Background Drug) Phase 3

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 736 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : January 2014
Actual Primary Completion Date : July 2015
Actual Study Completion Date : July 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Insulin Glargine/Lixisenatide Fixed Ratio Combination (FRC)
FRC once daily (QD) for 30 weeks. Dose individually adjusted.
Drug: Insulin glargine/lixisenatide (HOE901/AVE0010)

Insulin glargine/lixisenatide FRC was self-administered by subcutaneous (SC) injection within 1 hour before breakfast using one of 2 SoloStar® pen-injectors: Pen A (ratio of 2 Units (U) of insulin glargine U 100:1 mcg of lixisenatide) or Pen B (ratio of 3 U of insulin glargine U 100:1 mcg of lixisenatide). After run-in, the FRC was initiated at a dose of either 20 U/10 mcg with Pen A or 30 U/10 mcg with Pen B, depending on participant's dose of Insulin glargine on the day prior to randomization.

Dose was adjusted weekly 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). Pen A was used for administration of doses up to 40 U/20 mcg and Pen B for administration of doses from 30 U/10 mcg up to 60 U/20 mcg.


Drug: Metformin (Background Drug)
Pharmaceutical form: Tablet; Route of administration: Oral administration

Active Comparator: Insulin glargine
Insulin glargine 100 U/mL QD for 30 weeks. Dose individually adjusted.
Drug: Insulin glargine (HOE901)

Insulin glargine was self-administered QD by SC injection at approximately the same time every day.

After screening, eligible participants entered 6 week run-in phase during which they were switched (if necessary) to insulin glargine and dose was stabilized. The first dose after randomization was same as the one administered on the day prior to randomization and then dose was adjusted weekly to reach and maintain fasting SMPG of 80 mg/dL to 100 mg/dL (4.4 mmol/L to 5.6 mmol/L).

Other Name: Lantus

Drug: Metformin (Background Drug)
Pharmaceutical form: Tablet; Route of administration: Oral administration




Primary Outcome Measures :
  1. Change in Glycated Hemoglobin (HbA1c) From Baseline to Week 30 [ Time Frame: Baseline, Week 30 ]
    Change in HbA1c was calculated by subtracting baseline value from Week 30 value.


Secondary Outcome Measures :
  1. Percentage of Participants With HbA1c <7.0% or ≤6.5% at Week 30 [ Time Frame: Week 30 ]
  2. Change in 2-hour Plasma Blood Glucose Excursion From Baseline to Week 30 [ Time Frame: Baseline, Week 30 ]
    Plasma glucose excursion = 2-hour postprandial glucose (PPG) minus plasma glucose value obtained 30 minutes prior to the start of the meal and before investigational medicinal product (IMP) administration, if IMP was injected before breakfast. Change in plasma glucose excursions was calculated by subtracting baseline value from Week 30 value.

  3. Change in Body Weight From Baseline to Week 30 [ Time Frame: Baseline, Week 30 ]
    Change in body weight was calculated by subtracting baseline value from Week 30 value.

  4. Mean Change in 7-point Self-monitored Plasma Glucose (SMPG) Profile From Baseline to Week 30 [ Time Frame: Baseline, Week 30 ]
    Participants recorded a 7-point plasma glucose profile measured before and 2-hours after each meal and at bedtime, two times in a week before baseline, before visit Week 12 and before visit Week 30 and the average value across the profiles performed in the week before a visit for the 7 time points was calculated. Change in average 7 point SMPG was calculated by subtracting baseline value from Week 30 value. The analysis included all scheduled measurements obtained during the study. The missing data was handled by mixed effect model with repeated measures (MMRM) approach.

  5. Percentage of Participants Reaching HbA1c <7.0% With No Body Weight Gain at Week 30 [ Time Frame: Week 30 ]
  6. Change in Daily Insulin Glargine Dose From Baseline to Week 30 [ Time Frame: Baseline, Week 30 ]
  7. 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 [ Time Frame: Baseline up to Week 30 ]
    Documented symptomatic hypoglycemia was an event during which typical symptoms of hypoglycemia were accompanied by a measured plasma glucose concentration of ≤70 mg/dL (3.9 mmol/L).

  8. Change in FPG From Baseline to Week 30 [ Time Frame: Baseline, Week 30 ]
    Change in FPG was calculated by subtracting baseline value from Week 30 value.

  9. Change in 2-hour PPG From Baseline to Week 30 [ Time Frame: Baseline, Week 30 ]
    Change in PPG was calculated by subtracting baseline value from Week 30 value.

  10. 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 [ Time Frame: Baseline up to Week 30 ]
    Documented symptomatic hypoglycemia was an event during which typical symptoms of hypoglycemia were accompanied by a measured plasma glucose concentration of ≤70 mg/dL (3.9 mmol/L).

  11. Percentage of Participants Requiring Rescue Therapy During 30-Week Treatment Period [ Time Frame: Baseline up to Week 30 ]
    Routine fasting SMPG and central laboratory FPG (and HbA1c after Week 12) values were used to determine the requirement of rescue medication. If fasting SMPG value exceeded the specified limit for 3 consecutive days, the central laboratory FPG (and HbA1c after Week 12) were performed. Threshold values - from Week 8 to Week 12: fasting SMPG/FPG >240 mg/dL (13.3 mmol/L), and from Week 12 to Week 30: fasting SMPG/FPG >200 mg/dL (11.1 mmol/L) or HbA1c >8%.

  12. Number of Documented Symptomatic Hypoglycemia Events Per Subject-Year [ Time Frame: First dose of study drug up to 1 day after the last dose administration (median treatment exposure 211 days [FRC], 210 days [Insulin glargine]) ]
    Documented symptomatic hypoglycemia was an event during which typical symptoms of hypoglycemia were accompanied by a measured plasma glucose concentration of ≤70 mg/dL (3.9 mmol/L).

  13. Percentage of Participants With Documented Symptomatic Hypoglycemia [ Time Frame: First dose of study drug up to 1 day after the last dose administration (median treatment exposure 211 days [FRC], 210 days [Insulin glargine]) ]
    Documented symptomatic hypoglycemia was an event during which typical symptoms of hypoglycemia were accompanied by a measured plasma glucose concentration of ≤70 mg/dL (3.9 mmol/L).

  14. Percentage of Participants With Severe Symptomatic Hypoglycemia [ Time Frame: First dose of study drug up to 1 day after the last dose administration (median treatment exposure 211 days [FRC], 210 days [Insulin glargine]) ]
    Severe symptomatic hypoglycemia was an event requiring assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions. Plasma glucose measurements might not had been available during such an event, but neurological recovery attributable to the restoration of plasma glucose to normal was considered sufficient evidence that the event had been induced by a low plasma glucose concentration. Severe symptomatic hypoglycemia included all episodes in which neurological impairment was severe enough to prevent self-treatment, and which were thus thought to place participants at risk for injury to themselves or others.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02058160


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Locations
United States, Alabama
Investigational Site Number 840607
Birmingham, Alabama, United States, 35205
United States, Arizona
Investigational Site Number 840570
Sun City, Arizona, United States, 85351
Investigational Site Number 840562
Tempe, Arizona, United States
Investigational Site Number 840577
Tucson, Arizona, United States, 85723
United States, Arkansas
Investigational Site Number 840517
Little Rock, Arkansas, United States, 72205
Investigational Site Number 840537
Little Rock, Arkansas, United States, 72205
United States, California
Investigational Site Number 840568
Bell Gardens, California, United States, 90201
Investigational Site Number 840550
Chino, California, United States, 91710
Investigational Site Number 840529
Chula Vista, California, United States, 91911
Investigational Site Number 840623
Corona, California, United States, 92879
Investigational Site Number 840566
Fresno, California, United States, 93720
Investigational Site Number 840552
Greenbrae, California, United States, 94904
Investigational Site Number 840578
Lancaster, California, United States, 93534
Investigational Site Number 840626
Los Angeles, California, United States, 90017
Investigational Site Number 840581
Los Angeles, California, United States, 90057
Investigational Site Number 840621
Mission Viejo, California, United States, 92691
Investigational Site Number 840511
Northridge, California, United States, 91325
Investigational Site Number 840573
Palm Springs, California, United States, 92262
Investigational Site Number 840559
Port Hueneme, California, United States, 93041
Investigational Site Number 840536
San Ramon, California, United States, 94583
Investigational Site Number 840567
Santa Ana, California, United States, 92704
Investigational Site Number 840569
Tarzana, California, United States, 91356
Investigational Site Number 840572
West Hills, California, United States, 91345
United States, Colorado
Investigational Site Number 840582
Aurora, Colorado, United States, 80045
Investigational Site Number 840509
Denver, Colorado, United States, 80246
United States, Delaware
Investigational Site Number 840549
Wilmington, Delaware, United States, 19713
United States, Florida
Investigational Site Number 840510
Miami, Florida, United States, 33156-7563
Investigational Site Number 840521
New Port Richey, Florida, United States, 34652
Investigational Site Number 840602
Ocala, Florida, United States, 34471
Investigational Site Number 840538
Ocoee, Florida, United States, 34761
Investigational Site Number 840534
Palm Harbor, Florida, United States, 34684
United States, Georgia
Investigational Site Number 840594
Atlanta, Georgia, United States, 30322
Investigational Site Number 840614
Columbus, Georgia, United States, 31904
Investigational Site Number 840501
Lawrenceville, Georgia, United States, 30046
Investigational Site Number 840525
Roswell, Georgia, United States, 30076
United States, Idaho
Investigational Site Number 840588
Idaho Falls, Idaho, United States, 83404
United States, Illinois
Investigational Site Number 840580
Arlington Heights, Illinois, United States, 60005
Investigational Site Number 840519
Chicago, Illinois, United States, 60607
Investigational Site Number 840612
Chicago, Illinois, United States, 60616
Investigational Site Number 840556
Springfield, Illinois, United States, 62704
United States, Indiana
Investigational Site Number 840543
Avon, Indiana, United States, 46123
Investigational Site Number 840565
Evansville, Indiana, United States, 47713
Investigational Site Number 840585
Evansville, Indiana, United States, 47714
Investigational Site Number 840615
Evansville, Indiana, United States, 47714
Investigational Site Number 840563
Indianapolis, Indiana, United States, 46202
Investigational Site Number 840507
Indianapolis, Indiana, United States, 46260
United States, Kentucky
Investigational Site Number 840516
Louisville, Kentucky, United States, 40213
United States, Maine
Investigational Site Number 840595
Lewiston, Maine, United States, 04240
United States, Maryland
Investigational Site Number 840520
Baltimore, Maryland, United States, 21237
Investigational Site Number 840560
Baltimore, Maryland, United States, 21237
Investigational Site Number 840522
Rockville, Maryland, United States, 20852
United States, Michigan
Investigational Site Number 840505
Dearborn, Michigan, United States, 48124
Investigational Site Number 840575
Flint, Michigan, United States, 48504
United States, Minnesota
Investigational Site Number 840564
Minneapolis, Minnesota, United States, 55416
United States, Montana
Investigational Site Number 840558
Butte, Montana, United States, 59701
United States, Nebraska
Investigational Site Number 840506
Omaha, Nebraska, United States, 68131
United States, Nevada
Investigational Site Number 840600
Henderson, Nevada, United States, 89074
Investigational Site Number 840532
Las Vegas, Nevada, United States, 89119
Investigational Site Number 840599
Las Vegas, Nevada, United States, 89148
United States, New Hampshire
Investigational Site Number 840539
Nashua, New Hampshire, United States, 03063
United States, New Mexico
Investigational Site Number 840576
Albuquerque, New Mexico, United States, 87131
United States, New York
Investigational Site Number 840583
Jamaica, New York, United States, 11432
Investigational Site Number 840531
New Hyde Park, New York, United States, 11042
Investigational Site Number 840557
Syracuse, New York, United States, 13214-2016
United States, North Carolina
Investigational Site Number 840541
Durham, North Carolina, United States, 27710
Investigational Site Number 840604
Greenville, North Carolina, United States, 27858
Investigational Site Number 840540
Hickory, North Carolina, United States, 28601
Investigational Site Number 840513
Morehead City, North Carolina, United States, 28557
Investigational Site Number 840592
Salisbury, North Carolina, United States, 28144
Investigational Site Number 840535
Wilmington, North Carolina, United States, 28401
Investigational Site Number 840515
Winston-Salem, North Carolina, United States, 27103
United States, Ohio
Investigational Site Number 840579
Columbus, Ohio, United States, 43213
Investigational Site Number 840524
Dayton, Ohio, United States, 45439
Investigational Site Number 840503
Maumee, Ohio, United States, 43537
United States, Oregon
Investigational Site Number 840618
Eugene, Oregon, United States, 97404
United States, Pennsylvania
Investigational Site Number 840610
Philadelphia, Pennsylvania, United States, 19107
Investigational Site Number 840551
Smithfield, Pennsylvania, United States, 15478
Investigational Site Number 840584
Tipton, Pennsylvania, United States, 16684
United States, South Carolina
Investigational Site Number 840622
Charleston, South Carolina, United States, 29407
United States, South Dakota
Investigational Site Number 840611
Rapid City, South Dakota, United States, 57701
United States, Texas
Investigational Site Number 840605
Amarillo, Texas, United States, 79106
Investigational Site Number 840553
Austin, Texas, United States, 78731
Investigational Site Number 840598
Austin, Texas, United States, 78731
Investigational Site Number 840502
Corpus Christi, Texas, United States, 78404
Investigational Site Number 840601
Dallas, Texas, United States, 75208
Investigational Site Number 840586
Dallas, Texas, United States, 75216
Investigational Site Number 840547
Dallas, Texas, United States, 75230
Investigational Site Number 840530
Dallas, Texas, United States, 75231
Investigational Site Number 840545
Dallas, Texas, United States, 75246
Investigational Site Number 840554
Edinburg, Texas, United States, 78539
Investigational Site Number 840544
Houston, Texas, United States, 77030
Investigational Site Number 840514
Hurst, Texas, United States, 76054
Investigational Site Number 840617
N Richland Hill, Texas, United States, 76180
United States, Utah
Investigational Site Number 840512
Draper, Utah, United States, 84020
Investigational Site Number 840591
Murray, Utah, United States, 84123
Investigational Site Number 840526
Ogden, Utah, United States, 84405
Investigational Site Number 840597
Orem, Utah, United States, 84058
Investigational Site Number 840590
Salt Lake City, Utah, United States, 84102
United States, Vermont
Investigational Site Number 840613
Burlington, Vermont, United States, 05401
United States, Virginia
Investigational Site Number 840504
Chesapeake, Virginia, United States, 23321
Investigational Site Number 840561
Norfolk, Virginia, United States, 23510
Investigational Site Number 840625
Norfolk, Virginia, United States, 23510
Investigational Site Number 840606
Richmond, Virginia, United States, 23227
Investigational Site Number 840608
Salem, Virginia, United States, 24153
United States, Washington
Investigational Site Number 840571
Federal Way, Washington, United States, 98003
Investigational Site Number 840593
Spokane, Washington, United States, 99220
Investigational Site Number 840609
Tacoma, Washington, United States, 98415-0299
United States, Wisconsin
Investigational Site Number 840546
Milwaukee, Wisconsin, United States, 53209-0996
Australia
Investigational Site Number 036505
Box Hill, Australia, 3128
Investigational Site Number 036501
Heidelberg, Australia, 3081
Investigational Site Number 036504
Parkville, Australia, 3050
Canada
Investigational Site Number 124504
Beamsville, Canada, L0R 1B0
Investigational Site Number 124512
Brampton, Canada, L6R 3J5
Investigational Site Number 124502
Guelph, Canada, N1H 1B1
Investigational Site Number 124507
Kelowna, Canada, V1Y 1Z9
Investigational Site Number 124505
Montreal, Canada, H1W 2R7
Investigational Site Number 124511
Oakville, Canada, L6H 3P1
Investigational Site Number 124509
St-Romuald, Canada, G6W 5M6
Investigational Site Number 124503
Toronto, Canada, M9V 4B4
Investigational Site Number 124510
Toronto, Canada, M9W 4L9
Investigational Site Number 124501
Vancouver, Canada, V5Y 3W2
Investigational Site Number 124508
Victoria, Canada, V8V 4A1
Chile
Investigational Site Number 152511
Puerto Varas, Chile, 5480000
Investigational Site Number 152502
Santiago, Chile, 7500347
Investigational Site Number 152501
Santiago, Chile, 7500710
Investigational Site Number 152514
Santiago, Chile, 7500739
Investigational Site Number 152503
Santiago, Chile, 8053095
Investigational Site Number 152507
Santiago, Chile
Investigational Site Number 152509
Talagante, Chile
Investigational Site Number 152513
Temuco, Chile, 4780000
Investigational Site Number 152504
Vina Del Mar, Chile
Czech Republic
Investigational Site Number 203502
Cheb, Czech Republic, 35002
Investigational Site Number 203504
Hranice, Czech Republic, 75301
Investigational Site Number 203507
Krnov, Czech Republic, 79401
Investigational Site Number 203506
Liberec, Czech Republic, 460 01
Investigational Site Number 203503
Olomouc, Czech Republic, 77900
Investigational Site Number 203514
Plzen, Czech Republic, 301 66
Investigational Site Number 203515
Plzen, Czech Republic, 301 66
Investigational Site Number 203511
Praha 4, Czech Republic, 14900
Investigational Site Number 203508
Praha 5, Czech Republic, 15030
Investigational Site Number 203509
Praha 8, Czech Republic, 18100
Investigational Site Number 203505
Prostejov, Czech Republic, 79601
Denmark
Investigational Site Number 208503
Aarhus C, Denmark, 8000
Investigational Site Number 208509
Horsens, Denmark, 8700
Investigational Site Number 208502
Kolding, Denmark, 6000
Investigational Site Number 208501
København Nv, Denmark, 2400
Investigational Site Number 208505
København S, Denmark, 2300
Investigational Site Number 208504
Viborg, Denmark, 8800
Estonia
Investigational Site Number 233502
Pärnu, Estonia, 80018
Investigational Site Number 233503
Tallinn, Estonia, 10138
Investigational Site Number 233501
Tartu, Estonia, 50406
Hungary
Investigational Site Number 348503
Budapest, Hungary, 1134
Investigational Site Number 348501
Budapest, Hungary, 1138
Investigational Site Number 348505
Budapest, Hungary, 1212
Investigational Site Number 348502
Debrecen, Hungary, 4031
Investigational Site Number 348506
Kaposvár, Hungary, 7400
Investigational Site Number 348504
Pápa, Hungary, 8500
Lithuania
Investigational Site Number 440501
Kaunas, Lithuania, 48259
Investigational Site Number 440503
Kaunas, Lithuania, 49449
Investigational Site Number 440505
Kedainiai, Lithuania, LT-57164
Investigational Site Number 440504
Klaipeda, Lithuania, LT-92253
Investigational Site Number 440502
Vilnius, Lithuania, LT-10323
Mexico
Investigational Site Number 484508
Celaya, Mexico, 38000
Investigational Site Number 484501
Cuernavaca, Mexico, 62250
Investigational Site Number 484503
Guadalajara, Mexico, 44130
Investigational Site Number 484504
Guadalajara, Mexico, 44210
Investigational Site Number 484506
Guadalajara, Mexico, 44600
Investigational Site Number 484509
México, Mexico, 06700
Investigational Site Number 484507
Pachuca, Mexico, 42084
Investigational Site Number 484505
Puebla, Mexico, 72190
Netherlands
Investigational Site Number 528505
Almere, Netherlands, 1311 RL
Poland
Investigational Site Number 616502
Bialystok, Poland, 15-435
Investigational Site Number 616505
Krakow, Poland, 31-261
Investigational Site Number 616506
Krakow, Poland, 31-548
Investigational Site Number 616507
Plock, Poland, 09-400
Investigational Site Number 616504
Szczecin, Poland, 70-506
Investigational Site Number 616503
Warszawa, Poland, 01-518
Investigational Site Number 616501
Warszawa, Poland, 02-507
Romania
Investigational Site Number 642507
Brasov, Romania, 500365
Investigational Site Number 642510
Bucharest, Romania, 010825
Investigational Site Number 642508
Bucuresti, Romania, 020042
Investigational Site Number 642509
Bucuresti, Romania, 020475
Investigational Site Number 642506
Hunedoara, Romania, 331057
Investigational Site Number 642505
Iasi, Romania, 700547
Investigational Site Number 642502
Oradea, Romania, 410169
Investigational Site Number 642511
Sibiu, Romania, 550371
Investigational Site Number 642501
Targu Mures, Romania, 540142
Investigational Site Number 642504
Timisoara, Romania, 300125
Investigational Site Number 642503
Timisoara, Romania, 300456
Russian Federation
Investigational Site Number 643511
Arkhangelsk, Russian Federation, 163045
Investigational Site Number 643512
Moscow, Russian Federation, 119435
Investigational Site Number 643508
Penza, Russian Federation, 440026
Investigational Site Number 643501
Saint-Petersburg, Russian Federation, 190013
Investigational Site Number 643513
Samara, Russian Federation, 443041
Investigational Site Number 643507
Saratov, Russian Federation, 410030
Investigational Site Number 643514
Saratov, Russian Federation, 410053
Investigational Site Number 643506
St-Petersburg, Russian Federation, 194291
Investigational Site Number 643503
St-Petersburg, Russian Federation, 194354
Investigational Site Number 643504
St-Petersburg, Russian Federation, 194354
Investigational Site Number 643502
St-Petersburg, Russian Federation, 195257
Investigational Site Number 643505
St. Petersburg, Russian Federation, 194358
Investigational Site Number 643509
Voronezh, Russian Federation, 394018
Slovakia
Investigational Site Number 703505
Bratislava, Slovakia, 85101
Investigational Site Number 703507
Bytca, Slovakia, 01401
Investigational Site Number 703502
Kosice, Slovakia, 04001
Investigational Site Number 703512
Kosice, Slovakia, 04001
Investigational Site Number 703510
Kosice, Slovakia, 04013
Investigational Site Number 703511
Lubochna, Slovakia, 3491
Investigational Site Number 703508
Moldava Nad Bodvou, Slovakia, 04525
Investigational Site Number 703504
Nove Mesto Nad Vahom, Slovakia, 91501
Investigational Site Number 703509
Nove Zamky, Slovakia, 94001
Investigational Site Number 703513
Trnava, Slovakia, 91701
Investigational Site Number 703501
Zilina, Slovakia, 01001
Spain
Investigational Site Number 724509
Alicante, Spain, 03010
Investigational Site Number 724506
Alzira, Spain, 46600
Investigational Site Number 724504
Barcelona, Spain, 08035
Investigational Site Number 724510
Barcelona, Spain, 08036
Investigational Site Number 724505
Cáceres, Spain, 10003
Investigational Site Number 724503
El Ferrol, Spain, 15405
Investigational Site Number 724508
La Coruña, Spain, 15006
Investigational Site Number 724501
Sabadell, Spain, 08208
Investigational Site Number 724507
Segovia, Spain, 40002
Investigational Site Number 724502
Valencia, Spain, 46014
Sweden
Investigational Site Number 752501
Ljungby, Sweden, 341 82
Investigational Site Number 752503
Malmö, Sweden, 211 52
Investigational Site Number 752504
Rättvik, Sweden, 79530
Investigational Site Number 752506
Stenungssund, Sweden, 44431
Investigational Site Number 752505
Stockholm, Sweden, 11526
Investigational Site Number 752502
Vällingby, Sweden, 16268
Ukraine
Investigational Site Number 804501
Chernivtsi, Ukraine, 58022
Investigational Site Number 804510
Kyiv, Ukraine, 03049
Investigational Site Number 804507
Kyiv, Ukraine, 04050
Investigational Site Number 804511
Kyiv, Ukraine
Investigational Site Number 804513
Lviv, Ukraine, 79010
Investigational Site Number 804502
Vinnytsya, Ukraine, 21001
Investigational Site Number 804508
Vinnytsya, Ukraine, 21010
Sponsors and Collaborators
Sanofi
Investigators
Study Director: Clinical Sciences & Operations Sanofi

Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT02058160     History of Changes
Other Study ID Numbers: EFC12405
2013-003132-79 ( EudraCT Number )
U1111-1148-4351 ( Other Identifier: UTN )
First Posted: February 7, 2014    Key Record Dates
Results First Posted: February 10, 2017
Last Update Posted: May 9, 2017
Last Verified: March 2017

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin, Globin Zinc
Lixisenatide
Insulin
Metformin
Insulin Glargine
Hypoglycemic Agents
Physiological Effects of Drugs