Efficacy and Safety of Insuman Basal/Comb/Rapid in Patients With Type 2 Diabetes

Study Overview
=================
Brief Summary
-----------------
Primary Objective: - To evaluate the decrease of Hb A1c ≥ 1% after 6 month treatment in patients with Type 2 Diabetes Mellitus (T2DM) uncontrolled on Oral Antidiabetics (OADs) Secondary Objectives: To evaluate the percentage of patients with Hb A1c < 7.5%, To evaluate the rate of hypoglycaemia (symptomatic, severe) To evaluate the middle dose of insulin per product - Insuman Basal, Insuman Comb, Insuman Rapid after 6 month treatment To evaluate the change in Fasting Plasma Glucose (FPG) after 6 month treatment To assess the overall safety To evaluate the efficacy of education courses in Diabetes Schools (% of correct answers after second test compare to the testing of the initial level)

Detailed Description
-----------------
6 months

Official Title
-----------------
Multicenter, Open, Non-randomized 6 Months Study to Evaluate Efficacy and Safety Insuman® Basal, Insuman® Comb 25, Insuman® Rapid in Insulin-naÏve Patients With T2DM Who Received Baseline Education Course in the Diabetes School.

Conditions
-----------------
Type 2 Diabetes Mellitus

Intervention / Treatment
-----------------
* Drug: insulin human (HR1799)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria : T2DM patients uncontrolled by maximum tolerated dose of 1-2 OADs Males and Female > 18 years HbA1c > 7.5% Patients with abilities of self-monitoring of Diabetes, managing of patient's diary, ability to obtain education in Diabetes School, completion of Questionnaire It is expected that the patient will remain on a stable dose of OADs within 6 months of treatment Exclusion criteria : Type 1 diabetes Current temporary insulin therapy (gestational diabetes, pancreas cancer, surgery, clinical trial) Any clinically significant acute major organ or systemic diseases making interpretation of the evaluation results difficult Patient planning a pregnancy now or in the next 6 months The patient is participating in another clinical study now or in the last 28 days prior to Visit 1 The patient is a drug user (currently or in the past) 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
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Human Insulin<br>Dosage of human insulin (Insuman Basal/Comb/Rapid) will be individually adjusted in accordance with the Summary of Product Characteristics (SmPC). Patients will follow the titration algorithm recommended by the physician. | Drug: insulin human (HR1799)<br>* Pharmaceutical form: solution for injection Route of administration: subcutaneous<br>* Other names: Insuman Basal / Insuman Comb / Insuman Rapid;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Decrease of Hb A1c ≥ 1% |  | Baseline, 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of patients with Hb A1c < 7.5% |  | 6 months | 
| Rate of hypoglycaemias (symptomatic, severe) |  | 6 months | 
| Middle dose of insulin per product (Insuman Basal, Insuman Comb, Insuman Rapid) |  | 6 months | 
| Change in FPG |  | Baseline 6 months | 
| Number of patients with adverse events |  | 6 months | 
| Assessment of efficacy of education courses in Diabetes Schools | Percentage of correct answers after second test compare to the testing of the initial level | Baseline, 6 months |