Efficacy and Safety of Lixisenatide Versus Insulin Glulisine on Top of Insulin Glargine With or Without Metformin in Type 2 Diabetic Patients

Launched by SANOFI · Jan 11, 2013

Keywords

ClinConnect Summary

Approximately 41 weeks including a 26 week treatment period.

Gender

ALL

Eligibility criteria

• Inclusion criteria :
• • Participants with type 2 diabetes mellitus diagnosed at least 1 year before screening visit (V1).
• • Participants treated with basal insulin for at least 6 months.
• • Participants treated for at least 3 months prior to visit 1 with a stable basal insulin regimen (i.e. type of insulin and time/frequency of the injection). The insulin dose should be stable (± 20%) and ≥20 U/day for at least 2 months prior to visit 1.
• • Participants treated with basal insulin alone or in combination with 1 to 3 oral anti-diabetic drugs (OADs) that could be: metformin (≥1.5 g/day or maximal tolerated dose), a sulfonylurea (SU), a dipeptidyl-peptidase-4 (DPP-4) inhibitor, a glinide. The dose of OADs should be stable for at least 3 months prior to visit 1.
• Exclusion criteria:
• • At screening: age \< legal age of majority.
• • At screening, HbA1c: \<7.5% and \>10.0% for participants treated with basal insulin alone or in combination with metformin only; \< 7.0% and \> 10.0% for participants treated with basal insulin and a combination of oral anti-diabetic drugs which included a SU and/or a DPP-4 inhibitor and/or a glinide.
• • Women of childbearing potential with no effective contraceptive method, pregnancy or lactation.
• • Type 1 diabetes mellitus.
• • Treatment with glucose-lowering agent(s) other than stated in the inclusion criteria within 3 months prior to screening.
• • Previous treatment with short or rapid acting insulin other than in relation to hospitalization or an acute illness.
• • Any previous treatment with lixisenatide, or any discontinuation from another glucagon-like peptide 1 (GLP-1) receptor agonist due to safety/tolerability issue or lack of efficacy.
• • At screening, Body Mass Index (BMI) ≤20 or \>40 kg/m\^2.
• • Weight change of more than 5 kg during the 3 months prior to the screening visit; use of weight loss drugs within 3 months prior to screening.
• • Within the last 6 months prior to screening: history of myocardial infarction, stroke, or heart failure requiring hospitalization. Planned coronary, carotid or peripheral artery revascularisation procedures.
• • History of unexplained pancreatitis, chronic pancreatitis, pancreatectomy, stomach/gastric surgery.
• • At screening resting systolic blood pressure \>180 mmHg or diastolic blood pressure \>95 mmHg.
• • Personal or immediate family history of medullary thyroid cancer (MTC) or genetic condition that predisposed to MTC (e.g. multiple endocrine neoplasia syndromes).
• • Contraindication related to metformin (for participant receiving this treatment), insulin glargine, insulin glulisine or lixisenatide.
• • Participants with severe renal impairment (creatinine clearance less than 30 ml/min) or end-stage renal disease.
• • At screening, amylase and/or lipase \>3 times the upper limit of the normal laboratory range (ULN).
• • At screening alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \>3 ULN.
• • At screening calcitonin ≥20 pg/ml (5.9 pmol/L).
• Exclusion Criteria for randomization at the end of the screening period before randomization:
• • HbA1c \<7.0% or \>9.0%.
• • 7-day mean fasting SMPG \>140 mg/dl (7.8 mmol/L).
• • Amylase and/or lipase \>3 times ULN.
• • The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.