Type 2 Diabetes Mellitus
Conditions
Interventions
Trade Name: Lantus
Product Name: insulin glargine
Pharmaceutical Form: Solution for injection
Trade Name: Apidra
Product Name: insulin glulisine
Pharmaceutical Form: Solution for injection
Trade Nam
Sponsors
sanofi-aventis
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Patients with type 2 diabetes mellitus treated with insulin glargine once daily and oral blood glucose lowering medication - Patients with a HbA1c > 7% - Patients with a FBG within range (4-7 mmol/L) at baseline, based on the mean of 3 FBG values (measured 5x during the run-in phase, with the highest and lowest value excluded) - Obtained written informed consent - Aged 18 yrs and above 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: - Patients treated with an insulin other than insulin glargine - Patients with hypersensitivity to insulin glargine, insulin glulisine, biphasic insulin aspart/insulin aspart protamine 30/70 or any of the exipients - Pregnant or lactating women - Patients who are unable to fill in the PRO questionnaires
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate non-inferiority of once daily injection of insuline glargine (Lantus®) plus one injection of mealtime insulin glulisine (Apidra®) at the main meal versus twice daily premixed insulin (NovoMix® 30/70) based on the reduction of HbA1c percentage from baseline to endpoint.;Secondary Objective: - To determine treatment satisfaction (DTSQs, DTSQc and ITSQ) - To determine the mean HbA1c, FBG, prandial BG and proportion of patients with a HbA1c <7%. - To determine the effect on adverse events (e.g. symptomatic hypoglycemic events, weight gain and injection site reactions). - To determine the total insulin dose, average insulin glargine, insulin glulisine and premixed insulin dosages. ;Primary end point(s): The reduction in HbA1c percentage from baseline to end of trial. | — |
Countries
Netherlands
Outcome results
None listed