A Phase III Study of Insulin Aspart Injection to Evaluate the Efficacy and Safety

Study Overview
=================
Brief Summary
-----------------
This is a multicenter, randomized, open, parallel group, active-controlled study. The study period is 25 to 26 weeks, including screening period of 1-2 weeks and treatment period of 24 weeks.

Detailed Description
-----------------
After the screening visit, all patients who met all inclusion criteria and do not meet any of the exclusion criteria were randomized into the experimental group or the controlled group. The subjects in the experimental arm will receive insulin aspart injection combined with basal insulin (Lantus ®), and the subjects in the controlled arm will receive NovoRapid ® (active control) combined with basal insulin (Lantus ®). The experimental drug or the controlled drug will be administered subcutaneously prior to three meals (or can be administered immediately after meal if necessary), and the basal insulin (Lantus ®) will be administered at bedtime. The treatment period is 24 weeks, during which the subjects will be followed up at the clincic cetres at 1, 2, 4, 8, 12, 18, 24 weeks of treatment. At the end of 24-week treatment, if the adverse events continue, the subjects will be followed until recovery or stabilization of the AEs.

Official Title
-----------------
A Multi-center, Randomized, Open-label, Parallel-group, Phase Ⅲ Study to Evaluate the Efficacy and Safety of Insulin Aspart Injection in Patients With Diabetes Mellitus Compared to NovoRapid®

Conditions
-----------------
Diabetes

Intervention / Treatment
-----------------
* Biological: insulin Aspart injection
* Biological: insulin Aspart injection (NovoRapid)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients were diagnosed with diabetes； BMI≤35.0 kg/m2； Insulin therapy for at least 3 months before recruitment； HbA1c7 13% Exclusion Criteria: Patients to study drug allergy； to Liver and kidney impairment； Liver and kidney impairment； used systemic steroid treatment in past 2 months .

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: insulin Aspart injection<br>Subcutaneous injection of insulin Aspart prior to three meals every day, while subcutaneous injection of Lantus at bedtime. | Biological: insulin Aspart injection<br>* Subcutaneous injection of insulin Aspart prior to three meals every day, while subcutaneous injection of Lantus at bedtime.<br>|
| Active Comparator: insulin Aspart injection (NovoRapid)<br>Subcutaneous injection of insulin Aspart (NovoRapid) prior to three meals every day, while subcutaneous injection of Lantus at bedtime. | Biological: insulin Aspart injection (NovoRapid)<br>* Subcutaneous injection of insulin Aspart injection (NovoRapid) prior to three meals every day, while subcutaneous injection of Lantus at bedtime.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The change of relative baseline HbA1c |  | 24 weeks |