Type II Diabetes Mellitus MedDRA version: 17.0 Level: PT Classification code 10067585 Term: Type 2 diabetes mellitus System Organ Class: 10027433 - Metabolism and nutrition disorders
Conditions
Sponsors
sanofi-aventis recherche & développement
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Type 2 diabetes mellitus diagnosed at least 1 year before the screening visit. •Treatment with basal insulin for at least 6 months before the screening visit. • Stable basal insulin regimen (i.e. type of insulin and time/frequency of the injection) for at least 3 months before the screening visit. • Stable (plus/minus 20 percent) total daily basal insulin dose between 15 and 40U/day for at least 2 months prior to the screening visit. • For patients receiving basal insulin AND 1 or 2 oral anti-diabetic drugs (OADs): the OAD dose(s) must be stable during the 3 months before the screening visit. The OADs can be 1 to 2 out of: - metformin (more than or equal to1500mg/day or maximal tolerated dose), - a sulfonylurea - a glinide, - a dipeptidyl-peptidase-4 inhibitor - a sodium glucose co-transporter 2 inhibitor • Fasting plasma glucose (FPG) less than or equal to 180 mg/dL(10.0 mmol/L) at screening visit for patients receiving basal insulin in combination with 2 OADs or with 1 OAD other than metformin; FPG less than or equal to 200 mg/dL (11.1 mmol/L) at screening visit for patients on basal insulin only or basal insulin plus metformin at screening visit, • Signed written informed consent. 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 570 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 130
Exclusion criteria
Exclusion criteria: • Age under legal age of adulthood at screening visit • HbA1c at screening visit less than 7.5% or above 10%. • Pregnancy or lactation, women of childbearing potential with no effective contraceptive method. • Use of other oral or injectable glucose-lowering agents than stated in the inclusion criteria in a period of 3 months prior to screening. • Previous use of insulin other than basal insulin e.g. prandial or pre-mixed insulin, in the year prior to screening. Note: Short term treatment (<or=10) due to intercurrent illness is allowed. • History discontinuation of a previous treatment with Glucagon Like Peptide -1 Receptor Agonists for safety/tolerability or lack of efficacy. • Patient who has previously participated in any clinical trial with lixisenatide or the insulin glargine/lixisenatide fixed ratio combination or has previously received lixisenatide. • 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 (eg, 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/m² • At screening visit amylase and/or lipase more than 3 times the upper limit of the normal (ULN) laboratory range, • At screening visit ALT or AST more than 3 ULN • At screening visit calcitonin above or equal to 20 pg/mL (5.9 pmol/L) • Any contraindication to metformin use, according to local labeling, if the patient is taking metformin. • Patient who has a renal function impairment with creatinine clearance less than 30 mL/min (using the Cockroft and Gault formula) or end-stage renal disease for patients, not treated with metformin. Exclusion criteria for randomization: • HbA1c less than 7% or above 10% . • Mean fasting Self Measured Plasma Glucose (SMPG) calculated from the self-measurements for 7 days the week before randomization visit is above 140 mg/dL (7.8 mmol/L). • Average insulin glargine daily dose less than 20U or above 50U ( in the week before randomization visit). • Amylase and/or lipase more than 3 ULN
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate the superiority of the insulin glargine/lixisenatide fixed ratio combination to insulin glargine in HbA1c change from baseline to week 30.;Secondary Objective: To compare the overall efficacy and safety of insulin glargine/lixisenatide fixed ratio combination to insulin glargine (with or without metformin) over a 30 week treatment period in patients with type 2 diabetes;Primary end point(s): Change in HbA1c from baseline;Timepoint(s) of evaluation of this end point: week 30 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Percentage of patients reaching HbA1c targets - Change in 2-hour Post Prandial Glucose and in blood glucose excursion during standardized meal test from baseline to week 30 - Change in body weight from baseline - Change in 7-point Self-Monitoring Plasma Glucose profiles from baseline - Change in daily dose of insulin glargine from baseline - Change in Fasting Plasma Glucose from baseline - Documented (plasma glucose less than or equal to 70 mg/dl) symptomatic hypoglycemia - Severe symptomatic hypoglycemia;Timepoint(s) of evaluation of this end point: Week 30/ 30 weeks | — |
Countries
Australia, Canada, Chile, Czech Republic, Denmark, Estonia, Hungary, Lithuania, Mexico, Netherlands, Poland, Romania, Russian Federation, Slovakia, Spain, Sweden, Ukraine, United States
Contacts
Public ContactClinical Study Unit
sanofi-aventis Estonia OÜ
Outcome results
None listed