Type 2 diabetes failing lifestyle management and oral agents MedDRA version: 12.1 Level: LLT Classification code 10063624 Term: Type II diabetes mellitus inadequate control
Conditions
Sponsors
SANOFI AVENTIS GROUPE
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Men or women = 35 years old - With Type 2 diabetes diagnosed for more than 1 year - Insulin naïve - Treated with lifestyle interventions and oral antidiabetic drugs, at least metformin at the maximum tolerated dose (with a minimum dose of 1g/day), for at least 3 months - HbA1c = 7.0 % and = 10.5% - BMI = 40 kg/m2 - Ability and willingness to perform plasma glucose (PG) monitoring using the sponsor-provided glucose meter and to complete the patient diary - Willingness and ability to comply with the study protocol - Signed informed consent obtained prior any study procedure 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Treatment with GLP-1 agonists in the 3 months prior to study entry - Previous treatment with insulin (except for treatment of gestational diabetes or brief treatment with insulin for less than 1 week) - Diabetes other than type 2 diabetes (e.g. type 1 diabetes, diabetes secondary to pancreatic disorders, drug or chemical agent intake…) - Pregnant or lactating women (women of childbearing potential must have a negative pregnancy test at study entry and a medically approved contraception method) - Hospitalized patient (except for routine diabetes check-up) - Active proliferative retinopathy, as defined by a photocoagulation or vitrectomy occurrence in the 6 months prior to study entry, or any other unstable (rapidly progressing) retinopathy that may require photocoagulation or surgical treatment during the study, documented by retina examination, in the 2 years prior to study entry - History of sensitivity to the study drugs or to drugs with a similar chemical structure - Impaired renal function: creatinine clearance 3 x upper limit of normal range) - Severe gastro-intestinal disease - Treatment with corticosteroids with potential systemic action within the 3 months prior to study entry - Alcohol or drug abuse within the last 5 years - Night shift worker - Presence of any condition (medical, psychological, social or geographical), current or anticipated that would compromise the patient’s safety or limit the patient successful participation in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to demonstrate the superiority of a strategy with insulin glargine in comparison with a strategy including the premixed insulin in term of percentage of patients reaching HbA1c below 7% at the end of the treatment period and who do not experience documented symptomatic hypoglycemia (confirmed by a Plasma Glucose (PG) =56 mg/dL (3.1 mmol/L)) over the treatment period, in Type 2 diabetes patients failing lifestyle management and oral agents.;Secondary Objective: The secondary objectives of this study are to assess the effect of insulin glargine in comparison with premixed insulin on : - Evolution of HbA1c level during the treatment period - Percentage of patients who reach the target of HbA1c < 7 % and who do not experience documented symptomatic hypoglycemia confirmed by a PG = 70 mg/dL (3.9 mmol/L) - Percentage of patients who reach the target of HbA1c < 6.5% and who do not experience documented symptomatic hypoglycemia confirmed by a PG = 56 mg/dL (3.1 mmol/L) - Percentage of patients who reach the target of HbA1c < 6.5% and who do not experience documented symptomatic hypoglycemia confirmed by a PG = 70 mg/dL (3.9 mmol/L) - Evolution of Fasting Plasma Glucose - Evolution of 7-point plasma glucose profiles - Evolution of weight - Hypoglycemia occurrence - Dose of insulins - Evolution of liver function - PRO: DTSQs and DTSQc - Overall safety;Primary end point(s): The primary efficacy criterion will be the percentage of patients with an HbA1c <7% at the end of the treatment period, with no documented symptomatic hypoglycemia (confirmed by a PG =56 mg/dL) over the 24 week treatment period. | — |
Countries
Austria, Denmark, Greece, Italy, Spain
Outcome results
None listed