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 (LixiLan-O)

Study Description

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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.

Condition or disease	Intervention/treatment	Phase
Type 2 Diabetes	Drug: Insulin glargine/lixisenatide Fixed Ratio Combination; Drug: Insulin glargine (HOE901); Drug: Lixisenatide (AVE0010); Drug: Metformin	Phase 3

Detailed Description:

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

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	1170 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
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 Start Date :	February 2014
Actual Primary Completion Date :	June 2015
Actual Study Completion Date :	June 2015

Arms and Interventions

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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 Fixed Ratio Combination; Insulin glargine/Lixisenatide FRC was self-administered by subcutaneous (SC) injection in the morning within one hour before breakfast using one of the 2 prefilled disposable SoloStar® pen-injectors: Pen A containing 100 U/mL insulin glargine (Lantus, 100 U/mL) and 50 mcg/mL lixisenatide in a ratio of 2 U:1 mcg, used for administration of doses from 10 U to 40 U (10 U/5mcg to 40 U/20mcg). Pen B containing 100 U/mL insulin glargine (Lantus, 100 U/mL) and 33 mcg/mL lixisenatide in a ratio of 3 U:1 mcg, used to administer doses from 41 U to 60 U (41 U/13 mcg to 60 U/20 mcg). The starting dose was 10 U/5 mcg. Dose was then adjusted individually to reach and maintain fasting self-monitored plasma glucose (SMPG) of 80 mg/dL to 100 mg/dL (4.4 mmol/L to 5.6 mmol/L) while avoiding hypoglycemia.; Other Name: (HOE901/AVE0010) Drug: Metformin; Pharmaceutical form: Tablet; Route of administration: Oral administration.
Active Comparator: Insulin Glargine; Insulin glargine QD for 30 weeks. Dose individually adjusted.	Drug: Insulin glargine (HOE901); Insulin glargine (100 U/mL) was self-administered by SC injection at approximately the same time every day. Dose was adjusted individually to reach and maintain fasting SMPG of 80 mg/dL to 100 mg/dL (4.4 mmol/L to 5.6 mmol/L) while avoiding hypoglycemia.; Other Name: Lantus Drug: Metformin; Pharmaceutical form: Tablet; Route of administration: Oral administration.
Active Comparator: Lixisenatide; Lixisenatide 10 mcg QD for 2 weeks, then 20 mcg QD (maintenance dose).	Drug: Lixisenatide (AVE0010); Lixisenatide was self-administered by SC injection within 0 to 60 minutes before breakfast or evening meal. If the maintenance dose of 20 mcg was not tolerated, dose could be reduced to 10 mcg.; Other Name: Lyxumia Drug: Metformin; Pharmaceutical form: Tablet; Route of administration: Oral administration.

Outcome Measures

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Primary Outcome Measures :

1. Change in HbA1c From Baseline to Week 30 [ Time Frame: Baseline, Week 30 ]

   Primary outcome was to test superiority of FRC versus Lixisenatide and non-inferiority versus Insulin glargine.

   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 ]
   Participants without Week 30 value for HbA1c were counted as non-responders.
2. Change in Plasma Glucose Excursion From Baseline to Week 30 [ Time Frame: Baseline, Week 30 ]
   Plasma glucose excursion = 2-hour postprandial plasma glucose (PPG) value minus plasma glucose value obtained 30 minutes prior to the start of meal and before investigational medicinal product (IMP) administration if IMP was injected before breakfast. Change in plasma glucose excursions were calculated by subtracting baseline value from Week 30 value. Missing data was imputed using last observation carried forward (LOCF).
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. Change in Fasting Plasma Glucose (FPG) From Baseline to Week 30 [ Time Frame: Baseline, Week 30 ]
   Change in FPG was calculated by subtracting baseline value from Week 30 value.
5. 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.
6. Percentage of Participants Reaching HbA1c <7.0% With No Body Weight Gain at Week 30 [ Time Frame: 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. Average Daily Insulin Glargine Dose at Week 30 [ Time Frame: Week 30 ]
   The analysis included scheduled measurements obtained up to the date of last injection of the IMP, including those obtained after introduction of rescue therapy.
9. Change in 2-Hour Postprandial Plasma Glucose (PPG) From Baseline to Week 30 [ Time Frame: Baseline, Week 30 ]
   The 2-hour PPG test measured blood glucose 2 hours after eating a liquid standardized breakfast meal. Change in PPG was calculated by subtracting baseline value from Week 30 value. Missing data was imputed using LOCF.
10. 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 [ 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). The analysis included all HbA1c measurements at Week 30, including those obtained after the IMP discontinuation or the introduction of rescue medication.
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) was 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) ]
    Documented symptomatic hypoglycemia was an event during which 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) ]
    Documented symptomatic hypoglycemia was an event during which 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) ]
    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 have 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 of injury to themselves or others.

Eligibility Criteria

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

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.

Contacts and Locations

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Locations

United States, Arizona
Investigational Site Number 840027
Phoenix, Arizona, United States, 85028
Investigational Site Number 840122
Phoenix, Arizona, United States, 85032
Investigational Site Number 840062
Tempe, Arizona, United States, 85282
Investigational Site Number 840023
Tempe, Arizona, United States
United States, Arkansas
Investigational Site Number 840084
Little Rock, Arkansas, United States, 72205
United States, California
Investigational Site Number 840100
Anaheim, California, United States, 92801
Investigational Site Number 840065
Bell Gardens, California, United States, 90201
Investigational Site Number 840090
Chino, California, United States, 91710
Investigational Site Number 840002
Chula Vista, California, United States, 91911
Investigational Site Number 840013
Concord, California, United States, 94520
Investigational Site Number 840053
Fresno, California, United States, 93720
Investigational Site Number 840017
La Jolla, California, United States, 92037
Investigational Site Number 840070
Lancaster, California, United States, 93534
Investigational Site Number 840121
Long Beach, California, United States, 90806
Investigational Site Number 840126
Los Angeles, California, United States, 90017
Investigational Site Number 840044
Los Angeles, California, United States, 90057
Investigational Site Number 840101
Mission Hills, California, United States, 91345
Investigational Site Number 840086
Mission Viejo, California, United States, 92691
Investigational Site Number 840120
Mission Viejo, California, United States, 92691
Investigational Site Number 840005
Northridge, California, United States, 91325
Investigational Site Number 840034
Palm Springs, California, United States, 92262
Investigational Site Number 840074
Port Hueneme, California, United States, 93041
Investigational Site Number 840068
San Ramon, California, United States, 94583
Investigational Site Number 840067
Santa Ana, California, United States, 92704
Investigational Site Number 840029
Tarzana, California, United States, 91356
Investigational Site Number 840006
Temecula, California, United States, 92591
Investigational Site Number 840078
West Hills, California, United States, 91345
United States, Colorado
Investigational Site Number 840059
Aurora, Colorado, United States, 80045
Investigational Site Number 840038
Denver, Colorado, United States, 80246
United States, Florida
Investigational Site Number 840104
Bradenton, Florida, United States, 34208
Investigational Site Number 840098
Miami, Florida, United States, 33156-7563
Investigational Site Number 840014
New Port Richey, Florida, United States, 34652
Investigational Site Number 840047
Ocoee, Florida, United States, 34761
Investigational Site Number 840056
Palm Harbor, Florida, United States, 34684
United States, Georgia
Investigational Site Number 840089
Atlanta, Georgia, United States, 30322
Investigational Site Number 840054
Lawrenceville, Georgia, United States, 30046
Investigational Site Number 840119
Woodstock, Georgia, United States, 30189
United States, Idaho
Investigational Site Number 840108
Idaho Falls, Idaho, United States, 83404
United States, Illinois
Investigational Site Number 840075
Arlington Heights, Illinois, United States, 60005
Investigational Site Number 840080
Chicago, Illinois, United States, 60607
Investigational Site Number 840026
Chicago, Illinois, United States, 60612
Investigational Site Number 840116
Chicago, Illinois, United States, 60616
Investigational Site Number 840050
Springfield, Illinois, United States, 62704
United States, Indiana
Investigational Site Number 840008
Avon, Indiana, United States, 46123
Investigational Site Number 840015
Avon, Indiana, United States, 46123
Investigational Site Number 840076
Avon, Indiana, United States, 46123
Investigational Site Number 840082
Evansville, Indiana, United States, 47713
Investigational Site Number 840031
Evansville, Indiana, United States, 47714
Investigational Site Number 840060
Evansville, Indiana, United States, 47714
Investigational Site Number 840048
Indianapolis, Indiana, United States, 46202
Investigational Site Number 840085
Indianapolis, Indiana, United States, 46260
Investigational Site Number 840012
Valparaiso, Indiana, United States
United States, Iowa
Investigational Site Number 840025
Waterloo, Iowa, United States, 50702
United States, Kentucky
Investigational Site Number 840022
Lexington, Kentucky, United States, 40504
Investigational Site Number 840007
Louisville, Kentucky, United States, 40213
United States, Louisiana
Investigational Site Number 840081
New Orleans, Louisiana, United States, 70112
United States, Maine
Investigational Site Number 840097
Auburn, Maine, United States, 04210
United States, Maryland
Investigational Site Number 840063
Rockville, Maryland, United States, 20852
United States, Michigan
Investigational Site Number 840028
Bloomfield Hills, Michigan, United States
Investigational Site Number 840071
Chesterfield, Michigan, United States, 48047
Investigational Site Number 840001
Dearborn, Michigan, United States, 48124
Investigational Site Number 840091
Kalamazoo, Michigan, United States, 49048
United States, Minnesota
Investigational Site Number 840009
Minneapolis, Minnesota, United States, 55416
United States, Missouri
Investigational Site Number 840024
Chesterfield, Missouri, United States, 63017
United States, Montana
Investigational Site Number 840057
Butte, Montana, United States, 59701
United States, Nebraska
Investigational Site Number 840042
Omaha, Nebraska, United States, 68131
United States, Nevada
Investigational Site Number 840109
Henderson, Nevada, United States, 89052
Investigational Site Number 840052
Las Vegas, Nevada, United States, 89148
United States, New Hampshire
Investigational Site Number 840069
Nashua, New Hampshire, United States, 03063
United States, New Jersey
Investigational Site Number 840123
Morganville, New Jersey, United States, 07751
United States, New Mexico
Investigational Site Number 840011
Albuquerque, New Mexico, United States, 87131
United States, New York
Investigational Site Number 840030
New Hyde Park, New York, United States, 11042
Investigational Site Number 840096
Syracuse, New York, United States, 13214-2016
United States, North Carolina
Investigational Site Number 840039
Asheville, North Carolina, United States, 28803
Investigational Site Number 840021
Hickory, North Carolina, United States, 28601
Investigational Site Number 840046
Morehead City, North Carolina, United States, 28557
Investigational Site Number 840072
Morganton, North Carolina, United States, 28655
Investigational Site Number 840110
Salisbury, North Carolina, United States, 28144
Investigational Site Number 840095
Wilmington, North Carolina, United States, 28401
Investigational Site Number 840099
Winston-Salem, North Carolina, United States, 27103
United States, Ohio
Investigational Site Number 840004
Columbus, Ohio, United States, 43213
Investigational Site Number 840016
Maumee, Ohio, United States, 43537
United States, Oregon
Investigational Site Number 840103
Eugene, Oregon, United States, 97404
Investigational Site Number 840113
Portland, Oregon, United States, 97201-3098
United States, Pennsylvania
Investigational Site Number 840036
Pittsburgh, Pennsylvania, United States, 15473
Investigational Site Number 840043
Tipton, Pennsylvania, United States, 16684
United States, South Carolina
Investigational Site Number 840058
Anderson, South Carolina, United States, 29621
Investigational Site Number 840127
Charleston, South Carolina, United States, 29407
Investigational Site Number 840049
Greer, South Carolina, United States, 29651
United States, South Dakota
Investigational Site Number 840114
Rapid City, South Dakota, United States, 57701
United States, Tennessee
Investigational Site Number 840112
Bristol, Tennessee, United States, 37620
Investigational Site Number 840094
Knoxville, Tennessee, United States, 37912
United States, Texas
Investigational Site Number 840051
Austin, Texas, United States, 78758
Investigational Site Number 840066
Corpus Christi, Texas, United States, 78404
Investigational Site Number 840111
Dallas, Texas, United States, 75208
Investigational Site Number 840020
Dallas, Texas, United States, 75216
Investigational Site Number 840064
Dallas, Texas, United States, 75230
Investigational Site Number 840003
Dallas, Texas, United States, 75231
Investigational Site Number 840088
Edinburg, Texas, United States, 78539
Investigational Site Number 840118
Fort Worth, Texas, United States, 76132
Investigational Site Number 840055
Houston, Texas, United States, 77004
Investigational Site Number 840087
Houston, Texas, United States, 77030
Investigational Site Number 840079
Hurst, Texas, United States, 76054
Investigational Site Number 840073
N Richland Hill, Texas, United States, 76180
Investigational Site Number 840019
San Antonio, Texas, United States, 78229
United States, Utah
Investigational Site Number 840037
Draper, Utah, United States, 84020
Investigational Site Number 840093
Ogden, Utah, United States, 84405
Investigational Site Number 840061
Salt Lake City, Utah, United States, 84102
Investigational Site Number 840041
Salt Lake City, Utah, United States, 84107
United States, Virginia
Investigational Site Number 840040
Chesapeake, Virginia, United States, 23321
Investigational Site Number 840045
Norfolk, Virginia, United States, 23510
Investigational Site Number 840092
Norfolk, Virginia, United States, 23510
Investigational Site Number 840125
Richmond, Virginia, United States, 23219
Investigational Site Number 840115
Salem, Virginia, United States, 24153
Investigational Site Number 840010
Weber City, Virginia, United States, 24290
United States, Washington
Investigational Site Number 840077
Federal Way, Washington, United States, 98003
Investigational Site Number 840102
Renton, Washington, United States, 98055
United States, Wisconsin
Investigational Site Number 840033
Milwaukee, Wisconsin, United States, 53209-0996
Australia
Investigational Site Number 036005
Box Hill, Australia, 3128
Investigational Site Number 036001
Camperdown, Australia, 2050
Investigational Site Number 036006
Kippa Ring, Australia, 4021
Investigational Site Number 036007
Logan Central, Australia, 4114
Belgium
Investigational Site Number 056005
Brussels, Belgium, 1070
Investigational Site Number 056006
Brussel, Belgium, 1090
Investigational Site Number 056001
Leuven, Belgium, 3000
Canada
Investigational Site Number 124004
Kelowna, Canada, V1Y 1Z9
Investigational Site Number 124001
Toronto, Canada, M4G 3E8
Investigational Site Number 124002
Vancouver, Canada, V5Z 1M9
Chile
Investigational Site Number 152008
Osorno, Chile, 5311092
Investigational Site Number 152015
Puerto Varas, Chile
Investigational Site Number 152004
Santiago, Chile, 7500010
Investigational Site Number 152006
Santiago, Chile, 7500010
Investigational Site Number 152001
Santiago, Chile, 7591047
Investigational Site Number 152002
Santiago, Chile, 7980378
Investigational Site Number 152012
Santiago, Chile, 8053095
Investigational Site Number 152009
Santiago, Chile, 8330008
Investigational Site Number 152011
Talagante, Chile
Investigational Site Number 152014
Temuco, Chile, 4781156
Investigational Site Number 152003
Temuco, Chile, 4813299
Czech Republic
Investigational Site Number 203004
Beroun, Czech Republic, 26601
Investigational Site Number 203008
Ceske Budejovice, Czech Republic, 370 01
Investigational Site Number 203014
Horovice, Czech Republic, 26801
Investigational Site Number 203012
Koprivnice, Czech Republic, 742 21
Investigational Site Number 203001
Pardubice, Czech Republic, 53002
Investigational Site Number 203005
Plzen, Czech Republic, 32600
Investigational Site Number 203003
Praha 10, Czech Republic, 100 00
Investigational Site Number 203009
Praha 2, Czech Republic, 12808
Investigational Site Number 203007
Praha 5, Czech Republic, 15000
Investigational Site Number 203013
Praha 9 - Klanovice, Czech Republic, 19014
Investigational Site Number 203006
Trutnov, Czech Republic, 54101
Investigational Site Number 203016
Ujezd U Brna, Czech Republic
Investigational Site Number 203015
Vsetin, Czech Republic, 75501
Denmark
Investigational Site Number 208003
Aarhus C, Denmark, 8000
Investigational Site Number 208009
Horsens, Denmark, 8700
Investigational Site Number 208002
Kolding, Denmark, 6000
Investigational Site Number 208001
København Nv, Denmark, 2400
Investigational Site Number 208005
København S, Denmark, 2300
Investigational Site Number 208004
Viborg, Denmark, 8800
Estonia
Investigational Site Number 233004
Paide, Estonia, 72713
Investigational Site Number 233002
Pärnu, Estonia, 80018
Investigational Site Number 233003
Tallinn, Estonia, 13415
Investigational Site Number 233001
Viljandimaa, Estonia, 71024
France
Investigational Site Number 250006
Corbeil Essonnes, France, 91109
Investigational Site Number 250002
La Rochelle Cedex, France, 17019
Investigational Site Number 250003
Pierre Benite, France, 69310
Investigational Site Number 250001
Venissieux, France, 69200
Germany
Investigational Site Number 276005
Berlin, Germany, 10115
Investigational Site Number 276003
Berlin, Germany, 13125
Investigational Site Number 276004
Dortmund, Germany, 44137
Investigational Site Number 276007
Dresden, Germany, 01069
Investigational Site Number 276001
Dresden, Germany, 01307
Investigational Site Number 276006
Hamburg, Germany, 20253
Investigational Site Number 276002
Neumünster, Germany, 24534
Hungary
Investigational Site Number 348003
Balatonfüred, Hungary, 8230
Investigational Site Number 348007
Budapest, Hungary, 1036
Investigational Site Number 348006
Budapest, Hungary, 1096
Investigational Site Number 348002
Budapest, Hungary, 1138
Investigational Site Number 348011
Komárom, Hungary, 2900
Investigational Site Number 348008
Nagykanizsa, Hungary, 8800
Investigational Site Number 348004
Szeged, Hungary, 6720
Investigational Site Number 348010
Szekesfehervar, Hungary, 8000
Investigational Site Number 348012
Sátoraljaújhely, Hungary, 3980
Investigational Site Number 348001
Zalaegerszeg, Hungary, 8900
Italy
Investigational Site Number 380002
Bologna, Italy, 40138
Investigational Site Number 380006
Catanzaro, Italy, 88100
Investigational Site Number 380001
Milano, Italy, 20132
Investigational Site Number 380003
Napoli, Italy, 80131
Investigational Site Number 380005
Roma, Italy, 00133
Latvia
Investigational Site Number 428002
Riga, Latvia, LV-1011
Investigational Site Number 428003
Riga, Latvia, LV-1011
Investigational Site Number 428004
Riga, Latvia, LV-1050
Investigational Site Number 428001
Sigulda, Latvia, LV-2150
Lithuania
Investigational Site Number 440003
Jonava, Lithuania, LT-55201
Investigational Site Number 440002
Kaunas, Lithuania, LT-49456
Investigational Site Number 440007
Kaunas, Lithuania, LT-50009
Investigational Site Number 440004
Kedainiai, Lithuania, LT-57164
Investigational Site Number 440006
Panevezys, Lithuania, LT-37355
Investigational Site Number 440005
Utena, Lithuania, LT-28151
Investigational Site Number 440001
Vilnius, Lithuania, LT-10323
Mexico
Investigational Site Number 484005
Aguascalientes, Mexico, 20230
Investigational Site Number 484001
Cuernavaca, Mexico, 62250
Investigational Site Number 484002
Guadalajara, Mexico, 44130
Investigational Site Number 484004
Guadalajara, Mexico, 44210
Investigational Site Number 484009
Guadalajara, Mexico, 44670
Investigational Site Number 484007
Monterrey, Mexico, 64020
Investigational Site Number 484006
Monterrey, Mexico, 64460
Investigational Site Number 484010
Zapopan, Mexico, 45116
Poland
Investigational Site Number 616002
Bialystok, Poland, 15-435
Investigational Site Number 616005
Krakow, Poland, 31-261
Investigational Site Number 616006
Krakow, Poland, 31-548
Investigational Site Number 616007
Lodz, Poland, 94-074
Investigational Site Number 616004
Szczecin, Poland, 70-506
Investigational Site Number 616003
Warszawa, Poland, 01-518
Investigational Site Number 616001
Warszawa, Poland, 02-507
Investigational Site Number 616008
Zory, Poland, 44-240
Romania
Investigational Site Number 642008
Bucharest, Romania, 010825
Investigational Site Number 642007
Bucuresti, Romania, 020475
Investigational Site Number 642009
Cluj Napoca, Romania, 400006
Investigational Site Number 642006
Hunedoara, Romania, 331057
Investigational Site Number 642005
Iasi, Romania, 700547
Investigational Site Number 642002
Oradea, Romania, 410169
Investigational Site Number 642001
Targu Mures, Romania, 540142
Investigational Site Number 642004
Timisoara, Romania, 300133
Investigational Site Number 642003
Timisoara, Romania, 300456
Russian Federation
Investigational Site Number 643006
Moscow, Russian Federation, 119991
Investigational Site Number 643008
Penza, Russian Federation, 440026
Investigational Site Number 643012
Petrozavodsk, Russian Federation, 185019
Investigational Site Number 643001
Saint-Petersburg, Russian Federation, 190013
Investigational Site Number 643014
Samara, Russian Federation, 443067
Investigational Site Number 643009
Saratov, Russian Federation, 410026
Investigational Site Number 643011
Saratov, Russian Federation, 410053
Investigational Site Number 643005
St-Petersburg, Russian Federation, 190068
Investigational Site Number 643007
St-Petersburg, Russian Federation, 194354
Investigational Site Number 643002
St-Petersburg, Russian Federation, 195257
Investigational Site Number 643003
St. Petersburg, Russian Federation, 194358
Investigational Site Number 643016
Tomsk, Russian Federation, 634050
Investigational Site Number 643004
Voronezh, Russian Federation, 394018
South Africa
Investigational Site Number 710002
Cap Town, South Africa, 7530
Investigational Site Number 710003
Cape Town, South Africa, 7500
Investigational Site Number 710005
Meyerspark, South Africa, 0184
Investigational Site Number 710007
Port Elizabeth, South Africa
Investigational Site Number 710004
Pretoria, South Africa, 0122
Investigational Site Number 710001
Somerset West, South Africa, 7130
Investigational Site Number 710006
Soweto, South Africa, 4309
Spain
Investigational Site Number 724012
Barcelona, Spain, 08003
Investigational Site Number 724009
Granada, Spain, 18012
Investigational Site Number 724004
Hostalets De Balenyà, Spain, 08550
Investigational Site Number 724011
La Coruña, Spain, 15006
Investigational Site Number 724007
Lugo, Spain, 27004
Investigational Site Number 724008
Madrid, Spain, 28034
Investigational Site Number 724005
Madrid, Spain, 28046
Investigational Site Number 724013
Palma De Mallorca, Spain, 07010
Investigational Site Number 724001
Quart De Poblet, Spain, 46930
Investigational Site Number 724006
Sant Joan Despí, Spain, 08970
Investigational Site Number 724003
Sevilla, Spain, 41010
Sweden
Investigational Site Number 752001
Ljungby, Sweden, 341 82
Investigational Site Number 752003
Malmö, Sweden, 211 52
Investigational Site Number 752004
Rättvik, Sweden, 79530
Investigational Site Number 752005
Stockholm, Sweden, 11526
Investigational Site Number 752002
Vällingby, Sweden, 16268
Ukraine
Investigational Site Number 804002
Chernivtsi, Ukraine, 58022
Investigational Site Number 804009
Ivano-Frankovsk, Ukraine, 76008
Investigational Site Number 804010
Kyiv, Ukraine, 03049
Investigational Site Number 804007
Kyiv, Ukraine, 04050
Investigational Site Number 804006
Kyiv, Ukraine
Investigational Site Number 804012
Lviv, Ukraine, 79010
Investigational Site Number 804011
Vinnytsya, Ukraine, 21001
Investigational Site Number 804008
Vinnytsya, Ukraine, 21010
United Kingdom
Investigational Site Number 826001
Coventry, United Kingdom, CV2 2DX
Investigational Site Number 826002
Dundee, United Kingdom, DD1 9SI
Investigational Site Number 826006
Guildford, United Kingdom, GU2 7XX
Investigational Site Number 826007
Leicester, United Kingdom, LE5 4PW
Investigational Site Number 826003
Norwich, United Kingdom, NR1 3SR

Sponsors and Collaborators

Sanofi

Investigators

Study Director:	Clinical Sciences & Operations	Sanofi

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications of Results:

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. Epub 2016 Aug 15. Erratum in: Diabetes Care. 2017 Jun;40(6):809.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

Responsible Party:	Sanofi
ClinicalTrials.gov Identifier:	NCT02058147 History of Changes
Other Study ID Numbers:	EFC12404; 2013-003131-30 ( EudraCT Number ); U1111-1148-4334 ( Other Identifier: UTN )
First Posted:	February 7, 2014
Results First Posted:	February 10, 2017
Last Update Posted:	May 9, 2017
Last Verified:	March 2017

Additional relevant MeSH terms:

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