Better Acceptance of Single Injection Apidra Added to Once Daily Lantus Versus Twice Daily Premixed Insulin in Real Life Use Setting

Study Overview
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Brief Summary
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Primary Objective: To demonstrate non-inferiority of once daily injection of insulin 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/Diabetes Treatment Questionnaire - Status, DTSQc/ Diabetes Treatment Questionnaire - change and ITSQ/Insulin Treatment Satisfaction Questionnaire) To determine the mean HbA1c, FBG (Fasting Blood Glucose), prandial BG (Blood Glucose) 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.

Official Title
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Better Acceptance of a Single Injection Apidra (Insulin Glulisine) Added to Once Daily Lantus (Insulin Glargine) Versus Twice Daily Premixed Insulin in a Real Life Use Setting

Conditions
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Diabetes Mellitus, Type 2

Intervention / Treatment
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* Drug: Insulin glulisine
* Drug: Insulin glargine
* Drug: Premixed insulin (Insulin Aspart 30/70 )


Participation Criteria
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Eligibility Criteria
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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) 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 excipients Patients with a (pre)proliferative retinopathy (an optic fundus examination should have been performed within the 2 years prior to study entry) Pregnant or lactating women Patients who are unable to fill in the PRO (Patient Reported Outcomes) questionnaires The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Insulin glargine + Insulin glulisine<br>Daily injection of insulin glargine plus one injection of mealtime insulin glulisine at the main meal | Drug: Insulin glulisine<br>* Pharmaceutical form: boxes of 5 SoloStar® pens Route of administration: injection Dose regimen: once a day<br>* Other names: Apidra®;Drug: Insulin glargine<br>* Pharmaceutical form: boxes of 5 SoloStar® pens Route of administration: injection Dose regimen: once a day<br>* Other names: Lantus®;|
| Active Comparator: Premixed insulin<br>twice daily premixed insulin (before breakfast and evening meal). | Drug: Premixed insulin (Insulin Aspart 30/70 )<br>* Pharmaceutical form:boxes of 5 FlexPens Route of administration: Injection Dose regimen: twice daily<br>* Other names: NovoMix 30/70®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glycosylated Haemoglobin (HbA1c) Value | Glycosylated Haemoglobin (HbA1c) is a biological parameter that reflects the blood glucose concentration over a long period of time. It is the standard parameter for glycemic control follow -up in diabetic patients. | at screening (week - 2), week 12 (if available) and 24 | 
| Self Measured Blood Glucose (SMBG) |  | at Baseline (week 0), week 2, 12 and 24 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| DTSQs (Diabetes Treatment Satisfaction Questionnaire - status) |  | at week 0, 12 and 24 | 
| DTSQc (Diabetes Treatment Satisfaction Questionnaire - change) |  | at week 24 | 
| ITSQ (Insulin Treatment Satisfaction Questionnaire) |  | at week 0, 12 and 24 | 
| Hypoglycemic events |  | at week 0, 2, 12 and 24 | 
| Adverse Events (excluding hypoglycemic events) |  | at week - 2, 0, 2, 12 and 24 |