Evaluation of the Prandial Treatment Adjustment Effect Via Continuous Glucose Monitoring on Type 2 Diabetes Mellitus (DM) Patients Uncontrolled With a Basal Insulin or Premix Once a Day

Study Overview
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Brief Summary
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Primary Objective: To evaluate the effect of prandial treatment adjustment, based on continuous blood glucose monitoring, on glucose control in type 2 diabetes patients who are not controlled by treatment with once daily basal insulin or mixed insulin, requiring treatment with basal plus regimen

Detailed Description
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The study duration for each patient is 24 weeks +/- 1 week broken down as follows: Run-in phase: 8 weeks Follow - up Period: 16 weeks The maximal possible time window during the study is +/- one week throughout the study.

Official Title
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A Comparative Study to Evaluate the Prandial Treatment Adjustment Effect Via Continuous Glucose Monitoring on Type 2 DM Patients Uncontrolled With a Basal Insulin or Premix Once a Day

Conditions
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Diabetes Mellitus, Type 2

Intervention / Treatment
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* Drug: INSULIN GLARGINE (HOE901)
* Drug: INSULIN GLULISINE (HMR1964)


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: Run-in period: Type 2 diabetes HbA1c≥ 8.5% (in a test of the last month) Age above 21 years Patients continuously treated with basal insulin or mixed insulin once daily for the last 6 months Signed informed consent form Patients who according to their physician are eligible to the study Randomization: HbA1c > 7.5% FPG < 130 mg/dl Exclusion criteria: Type 1 diabetes Patients continuously treated with short-acting insulin or mixed insulin more than once daily for 3 weeks during the last 6 months. Pregnant or breastfeeding women. Patients with allergy to insulin. Patients with severe diseases characterized by recurrent hospitalizations, including: Severe renal insufficiency, severe cardiac insufficiency, active oncological disease or oncological disease requiring chemotherapy. Patients with mobility difficulties and/or difficulties communicating with the investigator 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: 21 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 |
| --- | --- |
| Active Comparator: Arm A: Without Continous Glucose Monitoring (CGM) sensor<br>Run-in phase: insulin glargine is administered at initial dosage according to FBG measurements performed by the patient by using a glucometer . Treatment phase: insulin glulisine is administered at initial dosage according to FBG measurements performed by the patient by using a glucometer. Then, adjustment of the dosage is performed by the treating physician | Drug: INSULIN GLARGINE (HOE901)<br>* Pharmaceutical form: solution for injection Route of administration: subcutaneous<br>Drug: INSULIN GLULISINE (HMR1964)<br>* Pharmaceutical form:Solution for injection Route of administration: Subcutaneous<br>|
| Experimental: Arm B: Continous Glucose Monitoring (CGM) sensor<br>Run-in phase: insulin glargine is administered at initial dosage according to FBG measurements performed by the patient by using a glucometer . Treatment phase: the patients are connected to a CGM sensor. Insulin glulisine is administered at initial dosage according to FBG measurements performed by the patient by using a glucometer. Then, adjustment of the dosage is performed by the national coordinator based on the data collected in the past previous days of CGM sensor monitoring. | Drug: INSULIN GLARGINE (HOE901)<br>* Pharmaceutical form: solution for injection Route of administration: subcutaneous<br>Drug: INSULIN GLULISINE (HMR1964)<br>* Pharmaceutical form:Solution for injection Route of administration: Subcutaneous<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in Hemoglobin A1c (HbA1c) level |  | Baseline, week 24 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of hypoglycemia |  | Week 24 | 
| Changes in insulin glargine dose |  | Baseline, week 24 | 
| Changes in insulin glulisine dose |  | Baseline, week 24 |