- The purpose of this study is to compare insulin glargine/ lixisenatide fixed ratio
combination versus insulin glargine on glycemic control over 24 weeks, as evaluated by
HbA1c (glycosylated hemoglobin) reduction in type 2 diabetic patients treated with
metformin
Secondary Objectives:
- To compare insulin glargine/lixisenatide fixed ratio combination versus insulin
- Glycemic control in relation to a meal as evaluated by post-prandial plasma
glucose and glucose excursions during a standardized meal test
- Percentage of patients reaching HbA1c <7% or ≤6. 5%
- Percentage of patients requiring rescue therapy during the 24-week open label
- To assess safety and tolerability of insulin glargine/ lixisenatide fixed ratio
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Inclusion criteria:
- Patient with type 2 diabetes mellitus diagnosed for at least 1 year.
- Metformin treatment at a stable dose of at least 1. 5 g/day for at least 3 months
prior to screening.
Exclusion criteria:
- Age < legal age of adulthood
- Screening HbA1c < 7% or > 10%
- Screening FPG > 250 mg/dL (> 13. 9 mmol/L)
- Pregnancy or lactation, women of childbearing potential with no effective
contraceptive method
- Type 1 diabetes mellitus
- Treatment with glucose-lowering agent(s) other than metformin in a period of 3 months
prior to screening
- Use of insulin within the last 6 months
- Previous use of insulin, except for episode(s) of short-term treatment (≤ 15
consecutive days) due to intercurrent illness
- Amylase and/or lipase > 3 times the upper limit of the normal laboratory range (ULN)
at screening
- Calcitonin ≥ 20 pg/ml (5. 9 pmol/l) at screening
- Alanine Transferase (ALT)> 3ULN at screening
- History of unexplained pancreatitis, chronic pancreatitis, pancreatectomy
- Personal or immediate family history of medullary thyroid cancer (MTC) or genetic
conditions that predisposes to MTC (e. g multiple endocrine neoplasia syndromes)
- Uncontrolled or inadequately controlled hypertension at the time of screening with a
resting supine systolic or diastolic blood pressure >180 mmHg or >110 mmHg,
respectively
- Within the last 6 months prior to screening: history of heart failure requiring
hospitalization, myocardial infarction, or stroke. Planned coronary, carotid or
peripheral artery revascularisation procedures
- Body Mass Index (BMI) ≤ 20 or > 40 kg/m²
- Any previous treatment with lixisenatide
The above information is not intended to contain all considerations relevant to a
patient's potential participation in a clinical trial.
Investigational Site Number 152401, Santiago 7980378, Chile
Investigational Site Number 152402, Santiago 8320000, Chile
Investigational Site Number 152403, Santiago 7500710, Chile
Investigational Site Number 152404, Santiago 7500347, Chile
Investigational Site Number 152405, Santiago 7500347, Chile
Investigational Site Number 203403, Novy Jicin 74101, Czech Republic
Investigational Site Number 203401, Plzen 32600, Czech Republic
Investigational Site Number 203402, Praha 2 12808, Czech Republic
Investigational Site Number 203405, Praha 8 18100, Czech Republic
Investigational Site Number 208401, København Nv 2400, Denmark
Investigational Site Number 208404, Køge 4600, Denmark
Investigational Site Number 208402, Slagelse 4200, Denmark
Investigational Site Number 208403, Svendborg 5700, Denmark
Investigational Site Number 250402, Narbonne 11018, France
Investigational Site Number 250404, Poitiers Cedex 86021, France
Investigational Site Number 250401, Vandoeuvre Les Nancy 54511, France
Investigational Site Number 276401, Dresden 01307, Germany
Investigational Site Number 276402, Ludwigshafen 67059, Germany
Investigational Site Number 276403, Oberhausen 46045, Germany
Investigational Site Number 348401, Balatonfüred 8230, Hungary
Investigational Site Number 348405, Budapest 1041, Hungary
Investigational Site Number 348406, Budapest 1212, Hungary
Investigational Site Number 348404, Debrecen 4043, Hungary
Investigational Site Number 348402, Szeged 6720, Hungary
Investigational Site Number 348403, Szeged 6722, Hungary
Investigational Site Number 440401, Kaunas LT-49456, Lithuania
Investigational Site Number 440402, Kaunas LT-51270, Lithuania
Investigational Site Number 440403, Kedainiai LT-57164, Lithuania
Investigational Site Number 440404, Klaipeda LT-92304, Lithuania
Investigational Site Number 484404, Acapulco 39670, Mexico
Investigational Site Number 484401, Cuernavaca 62250, Mexico
Investigational Site Number 484405, Durango 34270, Mexico
Investigational Site Number 484402, Guadalajara 44210, Mexico
Investigational Site Number 484403, Guadalajara 44656, Mexico
Investigational Site Number 616405, Bialystok 15-435, Poland
Investigational Site Number 616406, Gdansk 80-847, Poland
Investigational Site Number 616403, Krakow 31-548, Poland
Investigational Site Number 616407, Lodz 94-074, Poland
Investigational Site Number 616404, Pulawy 24-100, Poland
Investigational Site Number 616402, Szczecin 70-506, Poland
Investigational Site Number 616401, Warszawa 02-507, Poland
Investigational Site Number 642402, Brasov 500365, Romania
Investigational Site Number 642403, Bucuresti 020475, Romania
Investigational Site Number 642405, Iasi 700547, Romania
Investigational Site Number 642401, Oradea 410169, Romania
Investigational Site Number 642406, Targu Mures 540142, Romania
Investigational Site Number 642404, Timisoara 300133, Romania
Investigational Site Number 703402, Bratislava 85101, Slovakia
Investigational Site Number 703403, Kosice 04001, Slovakia
Investigational Site Number 703406, Kosice 04013, Slovakia
Investigational Site Number 703404, Moldava Nad Bodvou 04525, Slovakia
Investigational Site Number 703405, Nitra 94911, Slovakia
Investigational Site Number 703401, Zilina 01001, Slovakia
Investigational Site Number 752402, Skellefteå 931 32, Sweden
Investigational Site Number 752401, Stockholm 171 76, Sweden
Investigational Site Number 752403, Växjö 351 85, Sweden
Investigational Site Number 840408, Little Rock, Arkansas 72205, United States
Investigational Site Number 840412, Paramount, California 90723, United States
Investigational Site Number 840401, Larenceville, Georgia 30045, United States
Investigational Site Number 840417, Roswell, Georgia 30076, United States
Investigational Site Number 840403, Lexington, Kentucky 40504, United States
Investigational Site Number 840404, Hyattsville, Maryland 20782, United States
Investigational Site Number 840405, Rockville, Maryland 20852, United States
Investigational Site Number 840411, Las Vegas, Nevada 89148, United States
Investigational Site Number 840415, West Seneca, New York 14224, United States
Investigational Site Number 840402, Norman, Oklahoma 73069, United States
Investigational Site Number 840407, Medford, Oregon 97504, United States
Investigational Site Number 840413, Durham, Pennsylvania 27713, United States
Investigational Site Number 840410, Dallas, Texas 75230, United States
Investigational Site Number 840414, Renton, Washington 98055, United States