Assessment of Efficacy and Safety of Insuman Comb 25 Versus Novolin® 30R Twice Daily Over 24 Weeks in Type 2 Diabetes Patients With Insulin Therapy

Study Overview
=================
Brief Summary
-----------------
Primary Objective: To compare the efficacy of Insuman Comb 25 versus Novolin® 30R on HbA1c reduction during a 24-week treatment period in patients with type 2 diabetes mellitus. Secondary Objectives: To assess the effects of Insuman Comb 25 versus Novolin® 30R in patients with type 2 diabetes mellitus on fasting plasma glucose (FPG) To assess the safety and tolerability of Insuman Comb 25 versus Novolin® 30R in patients with type 2 diabetes mellitus

Detailed Description
-----------------
The study duration per patient is about 27 weeks (up to 2 weeks screening + 24 weeks open-label treatment + 1 week follow-up).

Official Title
-----------------
A Multicenter, Randomized, Active-controlled, Parallel-group Study to Assess the Efficacy and Safety of Insuman Comb 25 (Insulin Human) Versus Novolin® 30R Twice Daily Over 24 Weeks in Patients With Type 2 Diabetes Mellitus Who Are Under Insulin Therapy

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

Intervention / Treatment
-----------------
* Drug: Insulin human/Insuman Comb 25 (HR1799)
* Drug: Insulin human/Novolin® 30R


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Type 2 diabetes mellitus patients, as defined by World Health Organization (WHO), diagnosed for at least 1 year at the time of screening visit who are under premix insulin therapy, with or without oral anti-diabetic drug (OAD) Signed written informed consent Exclusion criteria: HbA1c <7% or HbA1c >10% at screening No self-monitoring of blood glucose within 3 months prior to screening visit Premix insulin treatment for less than 3 months. Insulins other than premix insulin treatment within 3 months prior to screening visit In case of treatment with OAD, treatment with a stable OAD dose and regimen for less than 3 months prior to screening visit 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
Maximum Age: 75 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Insuman Comb 25<br>Insuman Comb 25 will be self-injected subcutaneously twice daily 30-45 minutes before breakfast and dinner. The dose will be adjusted individually by monitoring the blood glucose values and symptoms, and following China guideline. | Drug: Insulin human/Insuman Comb 25 (HR1799)<br>* Pharmaceutical form:Suspension Route of administration: Subcutaneous<br>|
| Active Comparator: Novolin® 30R<br>Novolin® 30R will be self-injected subcutaneously twice daily within 30 minutes before breakfast and dinner. The dose will be adjusted individually by monitoring the blood glucose values and symptoms, and following China guideline and the package insert of Novolin® 30R | Drug: Insulin human/Novolin® 30R<br>* Pharmaceutical form:Suspension Route of administration: Subcutaneous<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in HbA1c from baseline to the end of treatment |  | 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in fasting plasma glucose from baseline to the end of treatment |  | 24 weeks |