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
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Sanofi
Approximately 37 weeks including up to 6 weeks of screening, 30-week treatment period, and a 3 days follow-up period.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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.
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).
You may not be if
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.
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.
Clareo Health | 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
