Type 2 Diabetes mellitus MedDRA version: 14.1 Level: PT Classification code 10067585 Term: Type 2 diabetes mellitus System Organ Class: 10027433 - Metabolism and nutrition disorders
Conditions
Interventions
Trade Name: Lyxumia 10 micrograms solution for injection
Product Name: lixisenatide
Product Code: AVE0010
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Lixisenatide
CAS Number: 3203
Sponsors
Sanofi-Aventis Recherche & Développement
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Patients with type 2 diabetes mellitus diagnosed at least 1 year before screening visit (V1) . • Patients treated with basal insulin for at least 6 months. • Patients treated for at least 3 months prior to visit 1 with a stable basal insulin regimen (ie 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. • Patients treated with basal insulin alone or in combination with 1 to 3 oral anti-diabetic drugs (OADs) that can be: metformin (=1.5g/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. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 700 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 155
Exclusion criteria
Exclusion criteria: • At screening: age 10.0% for patients treated with basal insulin alone or in combination with metformin only; 10.0% for patients treated with basal insulin and a combination of oral anti-diabetic drugs which includes a SU and/or a DPP4 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 GLP-1 receptor agonist due to safety/tolerability issue or lack of efficacy. •At screening, Body Mass Index (BMI) =20 or >40 kg/m². •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 predisposes to MTC (e.g. multiple endocrine neoplasia syndromes) • Contraindication related to metformin (for patient receiving this treatment), insulin glargine, insulin glulisine or lixisenatide. • Patients with severe renal impairment (creatinine clearance less than 30 ml/min) or end-stage renal disease, if no treatment with metformin • At screening, amylase and/or lipase > 3 times the upper limit of the normal laboratory range (ULN) • At screening ALT or AST>3ULN • At screening calcitonin =20 pg/ml (5.9 pmol/L) Exclusion Criteria for randomization at the end of the screening period before randomization: • HbA1c 9.0%. • 7-day mean fasting SMPG >140 mg/dl (7.8 mmol/L). • Amylase and/or lipase > 3 times ULN.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare lixisenatide versus insulin glulisine in terms of HbA1c reduction and body weight change at week 26 in type 2 diabetic patients not adequately controlled on insulin glargine ± metformin.;Secondary Objective: To compare the treatments/regimens on: • The percentage of patients reaching the target of HbA1c <7% or =6.5% • Body weight; • Self-Monitored Glucose profiles • Fasting Plasma Glucose (FPG) • Post-prandial plasma glucose /glucose excursions during a standardized meal test (subset of patients) • Daily doses of insulins • Safety and tolerability ;Primary end point(s): - Change from baseline in HbA1c - Change from baseline in body weight;Timepoint(s) of evaluation of this end point: week 26 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Percentage of patients reaching HbA1c <7% - Percentage of patients reaching HbA1c =6.5% - Change in body weight from baseline - Percentage of patients with no weight gain. - Change in 7-point SMPG profiles from baseline - Change from baseline in FPG - Change from baseline in post-prandial glucose /glucose excursions during a standardized meal test (subset of patients) - Change from baseline in insulin glargine dose - Daily dose of insulin glulisine - Total daily dose of insulins - Documented (PG <60 mg/dl) symptomatic hypoglycemia (percentage of subjects with at least one episode, number of events per patient-year) - Severe hypoglycemia ;Timepoint(s) of evaluation of this end point: - week 26 - 26 weeks for: Documented (PG <60 mg/dl) symptomatic hypoglycemia (percentage of subjects with at least one episode, number of events per patient-year) and Severe hypoglycemia | — |
Countries
Canada, Chile, Czech Republic, Estonia, France, Germany, Greece, Hungary, Italy, Latvia, Lithuania, Mexico, Netherlands, Poland, Romania, Russian Federation, Slovakia, Spain, Ukraine, United Kingdom, United States
Contacts
Public Contactwww.sanofi-aventis.cz
sanofi-aventis, s.r.o.
Outcome results
None listed