Better Accepance of a Singe injection Apidra (insulin glulisine) Added to once daily Lantus (insulin glargine) versus twice daily Premixed insulin in a real Life Use Setting. - BASAAL PLUS

• Conditions: Type 2 Diabetes Mellitus

• Registration Number: EUCTR2009-015742-34-NL
• Lead Sponsor: sanofi-aventis

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-11-04
• Last Update Posted: 22 October 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

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

- 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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)<br>- To determine the mean HbA1c, FBG, prandial BG and proportion of patients with a HbA1c <7%.<br>- To determine the effect on adverse events (e.g. symptomatic hypoglycemic events, weight gain and injection site reactions).<br>- To determine the total insulin dose, average insulin glargine, insulin glulisine and premixed insulin dosages.<br>;Primary end point(s): The reduction in HbA1c percentage from baseline to end of trial.