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About
Primary Objective:
The primary objective of this study is to assess the overall safety of lixisenatide once daily treatment in combination with background oral anti-diabetic treatment over 52 weeks in patients with type 2 diabetes in Japan.
Secondary Objective:
To assess the effects of lixisenatide in combination with background oral antidiabetic drug (OAD) on:
Full description
54 weeks +/-11 days
Enrollment
Sex
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Volunteers
Inclusion and exclusion criteria
Inclusion criteria :
Patients with type 2 diabetes mellitus diagnosed at least 1 year before the screening visit
Patient treated for at least 3 months prior to screening visit with one of following OADs at a stable dose of at least usual maintenance dose as described in the label
Signed written informed consent
Exclusion criteria:
At screening HbA1c <7% or >9.5%;
At screening: fasting plasma glucose >250 mg/dL (>13.9 mmol/L);
Use of any glucose-lowering agent(s) other than the authorized patient's background treatment defined in I02 (as given in inclusion critieria) within 3 months prior to screening;
Type 1 diabetes mellitus;
Women of childbearing potential with no effective contraceptive method;
Pregnancy or lactation;
Laboratory findings at the time of screening:
Any contra-indication to the patient's background oral anti-diabetic treatment;
History of acute or chronic pancreatitis, pancreatectomy, stomach/gastric surgery, inflammatory bowel disease;
Personal or immediate family history of medullary thyroid cancer (MTC) or genetic conditions that predispose to MTC (eg, multiple endocrine neoplasia syndromes);
Any previous treatment with lixisenatide (eg, participation in a previous study with lixisenatide) or any other GLP1 receptor agonist.
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Primary purpose
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294 participants in 4 patient groups
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Data sourced from clinicaltrials.gov
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