Type II Diabetes Mellitus MedDRA version: 14.0 Level: PT Classification code 10067585 Term: Type 2 diabetes mellitus System Organ Class: 10027433 - Metabolism and nutrition disorders
Conditions
Interventions
Product Name: Insulin glargine/Lixisenatide
Product Code: Lantus/AVE0010
Pharmaceutical Form: Solution for injection in cartridge
INN or Proposed INN: lixisenatide
CAS Number: 320367-13-3
Current Spon
Sponsors
sanofi-aventis Recherche et Développement
Eligibility
Sex/Gender
All
Inclusion criteria
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 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 248 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 62
Exclusion criteria
Exclusion criteria: - Age 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: To compare insulin glargine/lixisenatide fixed ratio combination versus insulin glargine over 24 weeks on: - Glycemic control in relation to a meal as evaluated by post-prandial plasma glucose and lucose excursions during a standardized meal test - Percentage of patients reaching HbA1c <7% or =6.5% - 7-point Self-Monitored Plasma Glucose (SMPG) profile - Body weight - Insulin glargine dose - Fasting Plasma Glucose (FPG) - Percentage of patients requiring rescue therapy during the 24-week open label treatment period - To assess safety and tolerability of insulin glargine/ lixisenatide fixed ratio combination.;Primary end point(s): Change in HbA1c;Timepoint(s) of evaluation of this end point: from baseline to week 24;Main Objective: 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
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Change in post-prandial glucose during meal test - Change in blood excursion during meal test - Percentage of patients reaching HbA1c =6.5 % or <7 % - Change in 7-point SMPG profiles - Change in body weight - Insulin glargine dose - Change in FPG - Percentage of patients requiring rescue therapy during the 24-week openlabel treatment period;Timepoint(s) of evaluation of this end point: - Change in post-prandial glucose during meal test, Change in blood excursion during meal test, Change in 7-point SMPG profiles, Change in body weight, Change in FPG : from baseline to week 24 - Percentage of patients reaching HbA1c =6.5 % or <7 %, Insulin glargine dose : at week 24 - Percentage of patients requiring rescue therapy during the 24-week openlabel treatment period : over the 24-week treatment period | — |
Countries
Chile, Czech Republic, Denmark, Germany, Hungary, Lithuania, Mexico, Poland, Slovakia, United States
Outcome results
None listed