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 endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02058147




Registration number
NCT02058147
Ethics application status
Date submitted
6/02/2014
Date registered
7/02/2014
Date last updated
9/05/2017

Titles & IDs
Public title
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
Scientific 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)
Secondary ID [1] 0 0
2013-003131-30
Secondary ID [2] 0 0
EFC12404
Universal Trial Number (UTN)
Trial acronym
LixiLan-O
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 2 Diabetes 0 0
Condition category
Condition code
Metabolic and Endocrine 0 0 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Insulin glargine/lixisenatide Fixed Ratio Combination
Treatment: Drugs - Insulin glargine (HOE901)
Treatment: Drugs - Lixisenatide (AVE0010)
Treatment: Drugs - Metformin

Experimental: Insulin Glargine/Lixisenatide Fixed Ratio Combination (FRC) - FRC once daily (QD) for 30 weeks. Dose individually adjusted.

Active Comparator: Insulin Glargine - Insulin glargine QD for 30 weeks. Dose individually adjusted.

Active Comparator: Lixisenatide - Lixisenatide 10 mcg QD for 2 weeks, then 20 mcg QD (maintenance dose).


Treatment: Drugs: 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.

Treatment: Drugs: 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.

Treatment: Drugs: 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.

Treatment: Drugs: Metformin
Pharmaceutical form: Tablet; Route of administration: Oral administration.

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change in HbA1c From Baseline to 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.
Timepoint [1] 0 0
Baseline, Week 30
Secondary outcome [1] 0 0
Percentage of Participants With HbA1c <7.0% or =6.5% at Week 30 - Participants without Week 30 value for HbA1c were counted as non-responders.
Timepoint [1] 0 0
Week 30
Secondary outcome [2] 0 0
Change in Plasma Glucose Excursion From Baseline to 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).
Timepoint [2] 0 0
Baseline, Week 30
Secondary outcome [3] 0 0
Change in Body Weight From Baseline to Week 30 - Change in body weight was calculated by subtracting baseline value from Week 30 value.
Timepoint [3] 0 0
Baseline, Week 30
Secondary outcome [4] 0 0
Change in Fasting Plasma Glucose (FPG) From Baseline to Week 30 - Change in FPG was calculated by subtracting baseline value from Week 30 value.
Timepoint [4] 0 0
Baseline, Week 30
Secondary outcome [5] 0 0
Mean Change in 7-point Self-monitored Plasma Glucose (SMPG) Profile From Baseline to 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.
Timepoint [5] 0 0
Baseline, Week 30
Secondary outcome [6] 0 0
Percentage of Participants Reaching HbA1c <7.0% With No Body Weight Gain at Week 30
Timepoint [6] 0 0
Week 30
Secondary outcome [7] 0 0
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 - 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).
Timepoint [7] 0 0
Baseline up to Week 30
Secondary outcome [8] 0 0
Average Daily Insulin Glargine Dose at 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.
Timepoint [8] 0 0
Week 30
Secondary outcome [9] 0 0
Change in 2-Hour Postprandial Plasma Glucose (PPG) From Baseline to 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.
Timepoint [9] 0 0
Baseline, Week 30
Secondary outcome [10] 0 0
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 - 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.
Timepoint [10] 0 0
Baseline up to Week 30
Secondary outcome [11] 0 0
Percentage of Participants Requiring Rescue Therapy During 30-Week Treatment Period - 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%.
Timepoint [11] 0 0
Baseline up to Week 30
Secondary outcome [12] 0 0
Number of Documented Symptomatic Hypoglycemia Events Per Subject-Year - 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).
Timepoint [12] 0 0
First dose of study drug up to 1 day after the last dose administration (median treatment exposure: 211 days)
Secondary outcome [13] 0 0
Percentage of Participants With Documented Symptomatic Hypoglycemia - 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).
Timepoint [13] 0 0
First dose of study drug up to 1 day after the last dose administration (median treatment exposure: 211 days)
Secondary outcome [14] 0 0
Percentage of Participants With Severe Symptomatic Hypoglycemia - 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.
Timepoint [14] 0 0
First dose of study drug up to 1 day after the last dose administration (median treatment exposure: 211 days)

Eligibility
Key inclusion 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.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Investigational Site Number 036005 - Box Hill
Recruitment hospital [2] 0 0
Investigational Site Number 036001 - Camperdown
Recruitment hospital [3] 0 0
Investigational Site Number 036006 - Kippa Ring
Recruitment hospital [4] 0 0
Investigational Site Number 036007 - Logan Central
Recruitment postcode(s) [1] 0 0
3128 - Box Hill
Recruitment postcode(s) [2] 0 0
2050 - Camperdown
Recruitment postcode(s) [3] 0 0
4021 - Kippa Ring
Recruitment postcode(s) [4] 0 0
4114 - Logan Central
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
Arkansas
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
Colorado
Country [5] 0 0
United States of America
State/province [5] 0 0
Florida
Country [6] 0 0
United States of America
State/province [6] 0 0
Georgia
Country [7] 0 0
United States of America
State/province [7] 0 0
Idaho
Country [8] 0 0
United States of America
State/province [8] 0 0
Illinois
Country [9] 0 0
United States of America
State/province [9] 0 0
Indiana
Country [10] 0 0
United States of America
State/province [10] 0 0
Iowa
Country [11] 0 0
United States of America
State/province [11] 0 0
Kentucky
Country [12] 0 0
United States of America
State/province [12] 0 0
Louisiana
Country [13] 0 0
United States of America
State/province [13] 0 0
Maine
Country [14] 0 0
United States of America
State/province [14] 0 0
Maryland
Country [15] 0 0
United States of America
State/province [15] 0 0
Michigan
Country [16] 0 0
United States of America
State/province [16] 0 0
Minnesota
Country [17] 0 0
United States of America
State/province [17] 0 0
Missouri
Country [18] 0 0
United States of America
State/province [18] 0 0
Montana
Country [19] 0 0
United States of America
State/province [19] 0 0
Nebraska
Country [20] 0 0
United States of America
State/province [20] 0 0
Nevada
Country [21] 0 0
United States of America
State/province [21] 0 0
New Hampshire
Country [22] 0 0
United States of America
State/province [22] 0 0
New Jersey
Country [23] 0 0
United States of America
State/province [23] 0 0
New Mexico
Country [24] 0 0
United States of America
State/province [24] 0 0
New York
Country [25] 0 0
United States of America
State/province [25] 0 0
North Carolina
Country [26] 0 0
United States of America
State/province [26] 0 0
Ohio
Country [27] 0 0
United States of America
State/province [27] 0 0
Oregon
Country [28] 0 0
United States of America
State/province [28] 0 0
Pennsylvania
Country [29] 0 0
United States of America
State/province [29] 0 0
South Carolina
Country [30] 0 0
United States of America
State/province [30] 0 0
South Dakota
Country [31] 0 0
United States of America
State/province [31] 0 0
Tennessee
Country [32] 0 0
United States of America
State/province [32] 0 0
Texas
Country [33] 0 0
United States of America
State/province [33] 0 0
Utah
Country [34] 0 0
United States of America
State/province [34] 0 0
Virginia
Country [35] 0 0
United States of America
State/province [35] 0 0
Washington
Country [36] 0 0
United States of America
State/province [36] 0 0
Wisconsin
Country [37] 0 0
Belgium
State/province [37] 0 0
Brussels
Country [38] 0 0
Belgium
State/province [38] 0 0
Brussel
Country [39] 0 0
Belgium
State/province [39] 0 0
Leuven
Country [40] 0 0
Canada
State/province [40] 0 0
Kelowna
Country [41] 0 0
Canada
State/province [41] 0 0
Toronto
Country [42] 0 0
Canada
State/province [42] 0 0
Vancouver
Country [43] 0 0
Chile
State/province [43] 0 0
Osorno
Country [44] 0 0
Chile
State/province [44] 0 0
Puerto Varas
Country [45] 0 0
Chile
State/province [45] 0 0
Santiago
Country [46] 0 0
Chile
State/province [46] 0 0
Talagante
Country [47] 0 0
Chile
State/province [47] 0 0
Temuco
Country [48] 0 0
Czech Republic
State/province [48] 0 0
Beroun
Country [49] 0 0
Czech Republic
State/province [49] 0 0
Ceske Budejovice
Country [50] 0 0
Czech Republic
State/province [50] 0 0
Horovice
Country [51] 0 0
Czech Republic
State/province [51] 0 0
Koprivnice
Country [52] 0 0
Czech Republic
State/province [52] 0 0
Pardubice
Country [53] 0 0
Czech Republic
State/province [53] 0 0
Plzen
Country [54] 0 0
Czech Republic
State/province [54] 0 0
Praha 10
Country [55] 0 0
Czech Republic
State/province [55] 0 0
Praha 2
Country [56] 0 0
Czech Republic
State/province [56] 0 0
Praha 5
Country [57] 0 0
Czech Republic
State/province [57] 0 0
Praha 9 - Klanovice
Country [58] 0 0
Czech Republic
State/province [58] 0 0
Trutnov
Country [59] 0 0
Czech Republic
State/province [59] 0 0
Ujezd U Brna
Country [60] 0 0
Czech Republic
State/province [60] 0 0
Vsetin
Country [61] 0 0
Denmark
State/province [61] 0 0
Aarhus C
Country [62] 0 0
Denmark
State/province [62] 0 0
Horsens
Country [63] 0 0
Denmark
State/province [63] 0 0
Kolding
Country [64] 0 0
Denmark
State/province [64] 0 0
København Nv
Country [65] 0 0
Denmark
State/province [65] 0 0
København S
Country [66] 0 0
Denmark
State/province [66] 0 0
Viborg
Country [67] 0 0
Estonia
State/province [67] 0 0
Paide
Country [68] 0 0
Estonia
State/province [68] 0 0
Pärnu
Country [69] 0 0
Estonia
State/province [69] 0 0
Tallinn
Country [70] 0 0
Estonia
State/province [70] 0 0
Viljandimaa
Country [71] 0 0
France
State/province [71] 0 0
Corbeil Essonnes
Country [72] 0 0
France
State/province [72] 0 0
La Rochelle Cedex
Country [73] 0 0
France
State/province [73] 0 0
Pierre Benite
Country [74] 0 0
France
State/province [74] 0 0
Venissieux
Country [75] 0 0
Germany
State/province [75] 0 0
Berlin
Country [76] 0 0
Germany
State/province [76] 0 0
Dortmund
Country [77] 0 0
Germany
State/province [77] 0 0
Dresden
Country [78] 0 0
Germany
State/province [78] 0 0
Hamburg
Country [79] 0 0
Germany
State/province [79] 0 0
Neumünster
Country [80] 0 0
Hungary
State/province [80] 0 0
Balatonfüred
Country [81] 0 0
Hungary
State/province [81] 0 0
Budapest
Country [82] 0 0
Hungary
State/province [82] 0 0
Komárom
Country [83] 0 0
Hungary
State/province [83] 0 0
Nagykanizsa
Country [84] 0 0
Hungary
State/province [84] 0 0
Szeged
Country [85] 0 0
Hungary
State/province [85] 0 0
Szekesfehervar
Country [86] 0 0
Hungary
State/province [86] 0 0
Sátoraljaújhely
Country [87] 0 0
Hungary
State/province [87] 0 0
Zalaegerszeg
Country [88] 0 0
Italy
State/province [88] 0 0
Bologna
Country [89] 0 0
Italy
State/province [89] 0 0
Catanzaro
Country [90] 0 0
Italy
State/province [90] 0 0
Milano
Country [91] 0 0
Italy
State/province [91] 0 0
Napoli
Country [92] 0 0
Italy
State/province [92] 0 0
Roma
Country [93] 0 0
Latvia
State/province [93] 0 0
Riga
Country [94] 0 0
Latvia
State/province [94] 0 0
Sigulda
Country [95] 0 0
Lithuania
State/province [95] 0 0
Jonava
Country [96] 0 0
Lithuania
State/province [96] 0 0
Kaunas
Country [97] 0 0
Lithuania
State/province [97] 0 0
Kedainiai
Country [98] 0 0
Lithuania
State/province [98] 0 0
Panevezys
Country [99] 0 0
Lithuania
State/province [99] 0 0
Utena
Country [100] 0 0
Lithuania
State/province [100] 0 0
Vilnius
Country [101] 0 0
Mexico
State/province [101] 0 0
Aguascalientes
Country [102] 0 0
Mexico
State/province [102] 0 0
Cuernavaca
Country [103] 0 0
Mexico
State/province [103] 0 0
Guadalajara
Country [104] 0 0
Mexico
State/province [104] 0 0
Monterrey
Country [105] 0 0
Mexico
State/province [105] 0 0
Zapopan
Country [106] 0 0
Poland
State/province [106] 0 0
Bialystok
Country [107] 0 0
Poland
State/province [107] 0 0
Krakow
Country [108] 0 0
Poland
State/province [108] 0 0
Lodz
Country [109] 0 0
Poland
State/province [109] 0 0
Szczecin
Country [110] 0 0
Poland
State/province [110] 0 0
Warszawa
Country [111] 0 0
Poland
State/province [111] 0 0
Zory
Country [112] 0 0
Romania
State/province [112] 0 0
Bucharest
Country [113] 0 0
Romania
State/province [113] 0 0
Bucuresti
Country [114] 0 0
Romania
State/province [114] 0 0
Cluj Napoca
Country [115] 0 0
Romania
State/province [115] 0 0
Hunedoara
Country [116] 0 0
Romania
State/province [116] 0 0
Iasi
Country [117] 0 0
Romania
State/province [117] 0 0
Oradea
Country [118] 0 0
Romania
State/province [118] 0 0
Targu Mures
Country [119] 0 0
Romania
State/province [119] 0 0
Timisoara
Country [120] 0 0
Russian Federation
State/province [120] 0 0
Moscow
Country [121] 0 0
Russian Federation
State/province [121] 0 0
Penza
Country [122] 0 0
Russian Federation
State/province [122] 0 0
Petrozavodsk
Country [123] 0 0
Russian Federation
State/province [123] 0 0
Saint-Petersburg
Country [124] 0 0
Russian Federation
State/province [124] 0 0
Samara
Country [125] 0 0
Russian Federation
State/province [125] 0 0
Saratov
Country [126] 0 0
Russian Federation
State/province [126] 0 0
St-Petersburg
Country [127] 0 0
Russian Federation
State/province [127] 0 0
St. Petersburg
Country [128] 0 0
Russian Federation
State/province [128] 0 0
Tomsk
Country [129] 0 0
Russian Federation
State/province [129] 0 0
Voronezh
Country [130] 0 0
South Africa
State/province [130] 0 0
Cap Town
Country [131] 0 0
South Africa
State/province [131] 0 0
Cape Town
Country [132] 0 0
South Africa
State/province [132] 0 0
Meyerspark
Country [133] 0 0
South Africa
State/province [133] 0 0
Port Elizabeth
Country [134] 0 0
South Africa
State/province [134] 0 0
Pretoria
Country [135] 0 0
South Africa
State/province [135] 0 0
Somerset West
Country [136] 0 0
South Africa
State/province [136] 0 0
Soweto
Country [137] 0 0
Spain
State/province [137] 0 0
Barcelona
Country [138] 0 0
Spain
State/province [138] 0 0
Granada
Country [139] 0 0
Spain
State/province [139] 0 0
Hostalets De Balenyà
Country [140] 0 0
Spain
State/province [140] 0 0
La Coruña
Country [141] 0 0
Spain
State/province [141] 0 0
Lugo
Country [142] 0 0
Spain
State/province [142] 0 0
Madrid
Country [143] 0 0
Spain
State/province [143] 0 0
Palma De Mallorca
Country [144] 0 0
Spain
State/province [144] 0 0
Quart De Poblet
Country [145] 0 0
Spain
State/province [145] 0 0
Sant Joan Despí
Country [146] 0 0
Spain
State/province [146] 0 0
Sevilla
Country [147] 0 0
Sweden
State/province [147] 0 0
Ljungby
Country [148] 0 0
Sweden
State/province [148] 0 0
Malmö
Country [149] 0 0
Sweden
State/province [149] 0 0
Rättvik
Country [150] 0 0
Sweden
State/province [150] 0 0
Stockholm
Country [151] 0 0
Sweden
State/province [151] 0 0
Vällingby
Country [152] 0 0
Ukraine
State/province [152] 0 0
Chernivtsi
Country [153] 0 0
Ukraine
State/province [153] 0 0
Ivano-Frankovsk
Country [154] 0 0
Ukraine
State/province [154] 0 0
Kyiv
Country [155] 0 0
Ukraine
State/province [155] 0 0
Lviv
Country [156] 0 0
Ukraine
State/province [156] 0 0
Vinnytsya
Country [157] 0 0
United Kingdom
State/province [157] 0 0
Coventry
Country [158] 0 0
United Kingdom
State/province [158] 0 0
Dundee
Country [159] 0 0
United Kingdom
State/province [159] 0 0
Guildford
Country [160] 0 0
United Kingdom
State/province [160] 0 0
Leicester
Country [161] 0 0
United Kingdom
State/province [161] 0 0
Norwich

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Sanofi
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/show/NCT02058147
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Clinical Sciences & Operations
Address 0 0
Sanofi
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications