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®

Tonghua Dongbao Pharmaceutical Co.,Ltd2 sites in 1 country563 target enrollmentJune 19, 2015

ConditionsDiabetes

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Diabetes
Sponsor: Tonghua Dongbao Pharmaceutical Co.,Ltd
Enrollment: 563
Locations: 2
Primary Endpoint: The change of relative baseline HbA1c
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

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.

Registry

clinicaltrials.gov

Start Date

June 19, 2015

End Date

August 12, 2016

Last Updated

2 years ago

Study Type

Interventional

Study Design

Parallel