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

Tonghua Dongbao Pharma

Status and phase: Completed; Phase 3

Conditions: Diabetes

Treatments: Biological: insulin Aspart injection; Biological: insulin Aspart injection (NovoRapid)

Study type: Interventional

Funder types: Industry

Identifiers

NCT02491528

DB021L012015

Details and patient eligibility

About

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.

Full 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.

Enrollment: 563 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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 .

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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563 participants in 2 patient groups

insulin Aspart injection

Experimental group

Description:

Subcutaneous injection of insulin Aspart prior to three meals every day, while subcutaneous injection of Lantus at bedtime.

Treatment:

Biological: insulin Aspart injection

insulin Aspart injection (NovoRapid)

Active Comparator group

Description:

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

Treatment:

Biological: insulin Aspart injection (NovoRapid)