Comparison of Insulin Glargine/Insulin Glulisine Regimen to Insulin Aspart/Insulin Aspart Protamine 30/70 in Type 2 Diabetes Mellitus Patients (T2DM)

Study Overview
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Brief Summary
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Primary Objective: To demonstrate the non-inferiority of hemoglobin A1c (HbA1c) control at six months between the basal plus one and the biphasic insulin regimen. Secondary Objective: To demonstrate favorable outcome for basal plus over biphasic insulin when it comes to comparing when both hemoglobin A1c (HbA1c) target goal achievement and non-hypoglycemic event is taken into account.

Official Title
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Comparison of a Basal Plus (Insulin Glargine/Insulin Glulisine) Regimen to Biphasic Insulin (InsulinAspart/Insulin Aspart Protamine 30/70) in T2DM Patients Who Require Insulin Intensification After Basal Insulin Optimization.

Conditions
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Diabetes Mellitus, Type 2

Intervention / Treatment
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* Drug: INSULIN GLARGINE
* Drug: INSULIN GLULISINE
* Drug: Insulin aspart


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: Sub-optimally controlled Type 2 Diabetes Mellitus (T2DM) patients treated with insulin glargine for a minimum of 3 months: Sub-optimal: HbA1c level >7% and fasting blood glucose <130mg/dL Male or Female ≥18 years old Body Mass Index (BMI) <40 10% ≥HbA1c ≥7% If taking Oral anti-diabetics (OADs), must be on stable dose for at least 1 months Patients willing to sign data release consent form Exclusion criteria: Diabetes other than T2DM Enrolled in other clinical trials Previous treatment with an insulin other than insulin glargine Treatment with Glucagon-like peptide-1 (GLP-1) receptor agonists or with Di Peptidyl Peptidase 4 (DPP-IV) inhibitors Pregnant or lactating women Contraindicated to Lantus (insulin glargine) / Apidra (insulin glulisine) / Novomix 30 (insulin aspart) Treatment with systemic corticoid steroids within the last 3 months prior to study enter Treatment with any investigational product within the last 3 months prior to study entry 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: group 1: Basal plus<br>Insulin glargine with dosage adjustment determined according to the mean value of the last three days Fasting Blood Glucose (FBG) Insulin glulisine, at initial dosing of 4IU, then weekly adjusted according to the mean value of the last three days PostPrandial Blood Glucose (PPBG) | Drug: INSULIN GLARGINE<br>* Pharmaceutical form: solution for injection Route of administration: subcutaneous Dose regimen: once daily<br>* Other names: Lantus;Drug: INSULIN GLULISINE<br>* Pharmaceutical form: solution for injection Route of administration: subcutaneous Dose regimen: once daily<br>* Other names: Apidra;|
| Active Comparator: group 2: Biphasic insulin<br>Insulin aspart/insulin aspart protamine 30/70 (novomix 30) given twice daily and titrated weekly (before breakfast and dinner) according to the lowest of three previous days' pre-meal levels (both breakfast and dinner). Target is 70 mg/dL < Pre-meal blood glucose (dinner and breakfast). | Drug: Insulin aspart<br>* Pharmaceutical form: solution for injection Route of administration: subcutaneous Dose regimen: twice daily<br>* Other names: NovoMix 30;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in hemoglobin A1c level (HbA1c) |  | At 6 months of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of hypoglycemic events (total, severe, nocturnal) |  | from baseline to the study endpoint (over 6 months of treatment) | 
| Proportion of patients with HbA1c < 7% |  | from baseline to the study endpoint (over 6 months of treatment) | 
| Change in body weight |  | from baseline to the study endpoint (over 6 months of treatment) | 
| Reactive Oxidative Stress (ROS) level changes |  | from baseline to the study endpoint (over 6 months of treatment) | 
| Change in Quality of Life |  | from baseline to the study endpoint (over 6 months of treatment) | 
| Continuous Glucose Monitoring System (CGMS) data |  | at baseline, 3 and 6 months |