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.

Phase 4

Completed

Conditions: Diabetes type 2
10018424

Registration Number: NL-OMON36312

Lead Sponsor: Sanofi-aventis

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 220

Inclusion Criteria

o Patients with type 2 diabetes mellitus treated with insulin glargine once daily and oral blood glucose lowering medication
o Patients with a HbA1c >53mmol/mol (7%)
o Patients for which the physician indicates that the best possible FBG value, with insulin glargine and oral blood glucose lowering medication only, has been reached.
o Aged 18 years and above
o Obtained written informed consent

Exclusion Criteria

o Patients treated with an insulin other than insulin glargine
o Patients with hypersensitivity to insulin glargine, insulin glulisine, biphasic insulin aspart/insulin aspart protamine 30/70 or any of the exipients
o Pregnant or lactating women
o Patients who are unable to fill in the PRO questionnaires

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary:<br /><br>To demonstrate non-inferiority of once daily injection of insuline glargine<br /><br>(Lantus®) plus one injection of mealtime insulin glulisine (Apidra®) at the<br /><br>main meal versus twice daily premixed insulin (NovoMix® 30/70) based on the<br /><br>reduction of HbA1c percentage from baseline to endpoint.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary:<br /><br>- To determine treatment satisfaction (DTSQs, DTSQc and ITSQ)<br /><br>- To determine the mean HbA1c, FBG, prandial BG and proportion of patients with<br /><br>a HbA1c <7%.<br /><br>- To determine the effect on adverse events (e.g. symptomatic hypoglycemic<br /><br>events, weight gain and injection site reactions).<br /><br>- To determine the total insulin dose, average insulin glargine, insulin<br /><br>glulisine and premixed insulin dosages.</p><br>