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

Phase 3

Completed

• Conditions: Diabetes
• Interventions: Biological: insulin Aspart injection; Biological: insulin Aspart injection (NovoRapid)

• Registration Number: NCT02491528
• Lead Sponsor: Tonghua Dongbao Pharmaceutical Co.,Ltd

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.

Study Timeline

• Study First Submitted: 2015-06-05
• Study Start: 2015-06-19
• Status Verified: 2015-07
• Study First Submitted QC: 2015-07-02
• Study First Posted: 2015-07-08
• Primary Completion: 2016-08-12
• Study Completion: 2016-08-12
• Last Update Submitted: 2023-12-17
• Last Update Posted: 2023-12-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 563

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 .

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
insulin Aspart injection	insulin Aspart injection	Subcutaneous injection of insulin Aspart prior to three meals every day, while subcutaneous injection of Lantus at bedtime.
insulin Aspart injection (NovoRapid)	insulin Aspart injection (NovoRapid)	Subcutaneous injection of insulin Aspart (NovoRapid) prior to three meals every day, while subcutaneous injection of Lantus at bedtime.

Primary Outcome Measures

Name	Time	Method
The change of relative baseline HbA1c	24 weeks

Trial Locations

Locations (2)

The 6th people's hospital of Shanghai; 🇨🇳 Shanghai, Shanghai, China

Affiliated hospital of Weifang Medical University; 🇨🇳 Weifang, Shandong, China