Type 2 diabetes mellitus MedDRA version: 8.1 Level: LLT Classification code 10045242
Conditions
Interventions
Trade Name: Apidra 100 U/ml, solution for injection in cartridge
Product Name: Apidra 100 U/ml, solution for injection in cartridge
Pharmaceutical Form: Solution for in
Sponsors
sanofi aventis groupe
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Type 2 diabetic men or women - Aged 18 to 75 years - BMI =40 kg/m2 - HbA1c > 7% - Treated with basal insulin (NPH, Insulin Zinc, insulin glargine or insulin detemir), and at least, two OAD including an insulin secretagogue (sulfonylurea or glinide, at any dosage) and metformin (at the maximum tolerated dosage), for more than 6 months 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: - Type 1 diabetes mellitus - Treatment with OADs only - Treatment with thiazolidinediones - Treatment with an insulin other than basal insulin - Active proliferative diabetic retinopathy - Pregnancy - Breast-feeding - History of hypersensitivity to the study drug or to drugs with a similar chemical structure or to insulin glargine - Treatment with systemic corticosteroids, irrespective of the dose of administration and irrespective of the prior or foreseeable treatment duration - Treatment with any investigational product in the last 2 months before study entry, except for insulin glargine - Likelihood of requiring treatment during the study period with drugs not permitted by the clinical study protocol (see Section 6.2) - Clinically relevant cardiovascular, hepatic, neurological, endocrine, or other major disease making implementation of the protocol or interpretation of the study results difficult - Impaired hepatic function at study entry - Impaired renal function at study entry
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To show the non inferiority in terms of efficacy (HbA1c) of insulin glargine plus metformin combined with 1 to 3 bolus of insulin glulisine introduced progressively (Arm 2) compared with insulin glargine plus metformin combined with 3 bolus of insulin glulisine (Arm 1), in type 2 diabetes mellitus patients poorly controlled on basal insulin therapy with oral antidiabetic drugs. To show the non inferiority in terms of efficacy (HbA1c) of insulin glargine plus metformin combined with 1 to 3 bolus of insulin glulisine introduced progressively (Arm 2) compared with insulin glargine plus metformin and insulin secretagogue (sulfonylurea or glinide) combined with 1 to 3 bolus of insulin glulisine introduced progressively (Arm 3), in type 2 diabetes mellitus patients poorly controlled on basal insulin therapy with oral antidiabetic drugs. ;Secondary Objective: To compare between the 3 treatment groups: evolution of HbA1c over time, percentage of subjects with HbA1c = 7% at the end of the study, evolution of blood glucose profiles, incidence of hypoglycemia, insulin doses, evolution of body weight and treatment satisfaction. ;Primary end point(s): HbA1c | — |
Countries
Belgium, Greece, Hungary, Italy, Lithuania, Spain, Sweden, United Kingdom
Outcome results
None listed